UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Explanatory Note
On September 15, 2020, pursuant to the Agreement and Plan of Merger (the “Merger Agreement”), dated as of April 28, 2020, by and among resTORbio, Inc. (the “Company”), Adicet Bio, Inc. (“Adicet”) and Project Oasis Merger Sub, Inc., a direct, wholly-owned subsidiary of the Company (“Merger Sub”), the Company completed the previously announced acquisition of Adicet, by means of a merger of Merger Sub with and into Adicet, with Adicet surviving such merger as a wholly owned subsidiary of the Company (the “Merger”).
Item 1.01 | Entry into a Material Definitive Agreement. |
Escrow Agreement
As previously disclosed, concurrently with the execution of the Merger Agreement, Adicet and the Company entered into a funding agreement (the “Funding Agreement”) with certain investors of Adicet (the “Investors”), pursuant to which the Investors committed to fund up to an aggregate of $15,000,000 (the “Funding Amount”) into an escrow account, which will be used to subscribe for shares of the Company’s common stock, par value $0.0001 per share (the “Company Common Stock”) in a concurrent private placement in connection with a private placement or public offering of Company Common Stock for aggregate gross proceeds (including the Funding Amount) to the Company of at least $30,000,000 (a “Qualified Financing”), on the same economic conditions (including the price per share paid by other investors in the Qualified Financing) and similar other terms and conditions as set forth in as set forth in the Funding Agreement the Qualified Financing. If the Company fails to consummate a Qualified Financing within twelve months of the closing of the Merger or certain other events occur, the Funding Amount will be distributed back to the Investors. Concurrently with the closing of the Merger, on September 15, 2020, the Company, the Investors and PNC Bank, National Association (the “Escrow Agent”) entered into an escrow agreement (the “Escrow Agreement”) pursuant to which the Funding Amount was deposited in an escrow account with the Escrow Agent in accordance with the terms of the Funding Agreement.
The foregoing description of the Escrow Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the agreement, which is attached to this report as Exhibit 10.1, and is incorporated by reference in this Item 1.01.
Contingent Value Rights Agreement
In connection with the Merger, the Company entered into a Contingent Value Rights Agreement (the “CVR Agreement”) with Computershare Inc. and Computershare Trust Company, N.A. as joint rights agent. The CVR Agreement entitles each holder of Company Common Stock as of immediately prior to the effective time of the Merger (the “Effective Time”) to receive substantially all of the net proceeds from the commercialization, if any,
received from a third party commercial partner of RTB101, a small molecule product candidate, previously developed by the Company, that is a potent inhibitor of target of rapamycin complex 1 (TORC1), for a COVID-19 related indication. The contingent value rights are not transferable, except in certain limited circumstances as provided in the CVR Agreement, will not be certificated or evidenced by any instrument and will not be registered with the Securities and Exchange Commission (“SEC”) or listed for trading on any exchange.
The foregoing description of the CVR Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the agreement, which is attached to this report as Exhibit 10.2, and is incorporated by reference in this Item 1.01.
PacWest and Beech Hill Documents
In connection with the Merger, on September 14, 2020, Adicet and Pacific Western Bank (“PacWest”) entered into a Second Amendment (the “Second Amendment”) and, on September 15, 2020, a Third Amendment (the “Third Amendment” and, together with the Second Amendment, the “Amendments”) to that certain Loan and Security Agreement, dated April 28, 2020 (the “Loan Agreement”), by and among Adicet and PacWest. Pursuant to the Amendments and the Merger Agreement, the Company executed a secured guaranty agreement pursuant to which the Company granted PacWest a security interest in substantially all of its assets other than its intellectual property (the “Unconditional Secured Guaranty”) and the Company issued to PacWest a warrant to purchase up to 5,301 shares of Company Common Stock at an exercise price of $11.32 per share (the “PacWest Warrant”) to replace Adicet’s existing warrant with PacWest. The PacWest Warrant shall be exercisable for an additional number of shares of Company Common Stock equal to 1.00% of the aggregate original principal amount of all term loans made pursuant to the Loan Agreement (up to an aggregate maximum of 15,904 shares). The PacWest Warrant is immediately exercisable and expires on April 28, 2027.
In connection with the Merger and pursuant to the Merger Agreement, the Company also issued to Beech Hill Securities Inc. (“Beech Hill”) warrants to purchase 101,610 shares of Company Common Stock, 30,924 shares of Company Common Stock, 77,312 share of Company Common Stock and 11,044 shares of Company Common Stock, respectively, in each case at an exercise price of $11.32 per share (the “Beech Hill Warrants”), to replace Adicet’s existing warrants with Beech Hill. The Beech Hill Warrants are immediately exercisable and expire on July 25, 2026, August 21, 2026, September 19, 2026, and September 26, 2026, respectively.
The foregoing descriptions of the Second Amendment, the Third Amendment, the Unconditional Secured Guaranty, the PacWest Warrant and the Beech Hill Warrants are qualified in their entirety by reference to the full text of the agreements, which are attached to this report as Exhibits 10.3, 10.4, 10.5, 10.6 and 10.7, respectively, and are incorporated by reference in this Item 1.01.
Item 2.01 | Completion of Acquisition or Disposition of Assets |
On September 15, 2020, the Company completed the Merger pursuant to the Merger Agreement. In connection with the Merger, and immediately prior to the Effective Time, the Company effected a reverse stock split of the Company Common Stock at a ratio of 1-for-7 (the “Reverse Stock Split”). Also, in connection with the Merger, the Company changed its name from “resTORbio, Inc.” to “Adicet Bio, Inc.” (the “Name Change”), Adicet changed its name from “Adicet Bio, Inc.” to “Adicet Therapeutics, Inc.” and the business conducted by the Company became primarily the business conducted by Adicet, which is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases.
At the Effective Time, each outstanding share of Adicet capital stock was converted into the right to receive 0.1240 (the “Exchange Ratio”) shares of Company Common Stock, as set forth in the Merger Agreement. The Exchange Ratio was determined based on the total number of outstanding shares of Company Common Stock and Adicet capital stock, each on a fully diluted basis, and the respective valuations of Adicet and the Company at the time of execution of the Merger Agreement. In connection with the Merger, the Company also assumed certain outstanding Adicet warrants and Adicet stock options under Adicet’s 2015 Stock Incentive Plan (the “2015 Adicet Stock Incentive Plan”) and Adicet’s 2014 Share Option Plan (the “2014 Share Option Plan” and, together with the 2015 Adicet Stock Incentive Plan, the “Adicet Plans”), with such stock options and warrants henceforth representing the right to purchase a number of shares of Company Common Stock equal to the Exchange Ratio multiplied by the number of shares of Adicet’s capital stock previously represented by such stock options and warrants, as applicable, with a proportionate adjustment in exercise price. In connection with the Merger, the Company also assumed the Adicet Plans.
Immediately following the Effective Time, there were approximately 19,589,828 shares of Company Common Stock outstanding (post Reverse Stock Split). Immediately following the Effective Time, the former equityholders of Adicet held approximately 75% of the outstanding shares of Company Common Stock on a fully-diluted basis and the former equityholders of the Company held approximately 25% of the outstanding shares of Company Common Stock on a fully-diluted basis (in each case excluding equity incentives available for grant).
The shares of Company Common Stock listed on the Nasdaq Global Market, previously trading through the close of business on September 15, 2020 under the ticker symbol “TORC,” will commence trading on the Nasdaq Global Market, on a post-Reverse Stock Split adjusted basis, under the ticker symbol “ACET,” on September 16, 2020, at which time the Company Common Stock will be represented by a new CUSIP number, 007002108.
The issuance of the shares of Company Common Stock to the former equityholders of Adicet was registered with the SEC on a Registration Statement on Form S-4 (Reg. No. 333-239372) (the “Registration Statement”). The issuance of the shares of Company Common Stock to holders of stock options issued, or to be issued, under the Adicet Plans will be registered with the SEC on a Registration Statement on Form S-8.
The foregoing description of the Merger Agreement contained herein does not purport to be complete and is qualified in its entirety by reference to the full text of the Merger Agreement that was filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 29, 2020 and is incorporated herein by reference.
Item 2.03 | Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. |
The information provided in Item 1.01 of this Current Report on Form 8-K regarding the Second Amendment, the Third Amendment, the Unconditional Secured Guaranty and the PacWest Warrant is hereby incorporated by reference in this Item 2.03.
Item 3.03 | Material Modification to Rights of Security Holders |
To the extent required by Item 3.03 of Form 8-K, the information contained in Item 2.01 of this Current Report on Form 8-K is incorporated herein by reference.
As disclosed below under Item 5.07 of this Current Report on 8-K at the special meeting of the Company’s stockholders held on September 15, 2020 (the “Special Meeting”), the Company’s stockholders approved an amendment to the third amended and restated certificate of incorporation of the Company (the “Stock Split Amendment”) to effect the Reverse Stock Split.
On September 15, 2020, prior to the closing of the Merger, the Company filed the Stock Split Amendment with the Secretary of State of the State of Delaware to effect the Reverse Stock Split and the Company filed an amendment to the third amended and restated certificate of incorporation with the Secretary of State of the State of Delaware to effect the Name Change (the “Name Change Amendment”). As a result of the Reverse Stock Split, the number of issued and outstanding shares of Company Common Stock immediately prior to the Reverse Stock Split was reduced to a smaller number of shares, such that every seven shares of Company Common Stock held by a stockholder immediately prior to the Reverse Stock Split were combined and reclassified into one share of Company Common Stock.
No fractional shares were issued in connection with the Reverse Stock Split. Any fractional shares resulting from the Reverse Stock Split were rounded down to the nearest whole number, and each stockholder who would otherwise be entitled to a fraction of a share of Company Common Stock upon the Reverse Stock Split (after aggregating all fractions of a share to which such stockholder would otherwise be entitled) was, in lieu thereof, entitled to receive a cash payment determined by multiplying the average closing price per share of Company Common Stock on the Nasdaq Global Market on the 10 consecutive trading days prior to September 15, 2020, by the fraction of a share of Company Common Stock to which each stockholder would otherwise be entitled.
The foregoing descriptions of the Stock Split Amendment and the Name Change Amendment are not complete and are subject to and qualified in their entirety by reference to the Stock Split Amendment and the Name Change Amendment, copies of which are attached hereto as Exhibit 3.1 and Exhibit 3.2, respectively, and are incorporated herein by reference.
Item 5.01 | Changes in Control of Registrant |
The information set forth in Item 2.01 of this Current Report on Form 8-K regarding the Merger and the information set forth in Item 5.02 of this Current Report on Form 8-K regarding the Company’s board of directors (the “Board”) and executive officers following the Merger are incorporated by reference into this Item 5.01.
Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers |
Resignation of Directors
In accordance with the Merger Agreement, Jonathan Silverstein, Chen Schor, Jeffrey Chodakewitz, David Steinberg, Paul Fonteyne, Lynne Sullivan and Michael Grissinger resigned from the Board and any respective committees of the Board of which they were members. The resignations were not the result of any disagreements with the Company relating to the Company’s operations, policies or practices.
Appointment of Directors
In accordance with the Merger Agreement, on September 15, 2020, effective immediately after the Effective Time, the following individuals were appointed to the Board as directors: Chen Schor, Jeffrey Chodakewitz, Erez Chimovits, Carl Gordon, Ph.D., Aya Jakobovits, Ph.D., Yair Schindel, M.D. and Steve Dubin.
Other than pursuant to the Merger Agreement, there were no arrangements or understandings between the Company’s newly appointed directors and any person pursuant to which they were elected. None of the Company’s newly appointed directors has a direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
Class Designations
On September 15, 2020, the Board approved the reorganization of the classes of the Board as follows:
• | Class I Directors, whose terms expire at the Company’s 2022 Annual Meeting: Aya Jakobovits and Chen Schor |
• | Class II Directors, whose terms expire at the Company’s 2023 Annual Meeting: Carl Gordon, Steve Dubin and Jeffrey Chodakewitz |
• | Class III Directors, whose terms expire at the Company’s 2021 Annual Meeting: Yair Schindel and Erez Chimovits |
Chen Schor, Chief Executive Officer, President, Secretary and Director
Mr. Schor has served as the Company’s President and Chief Executive Officer and as a member of the Board since its incorporation in July 2016. Mr. Schor previously served as President, Chief Executive Officer and director of Synta Pharmaceuticals Corp. from May 2015 until its merger with Madrigal Pharmaceuticals in July 2016, and prior to that, from 2014 until 2016, Mr. Schor served as its Executive Vice President and Chief Operation Officer. From September 2012 to December 2014, Mr. Schor served as President and Chief Executive Officer of Novalere FP, Inc., a pre-commercial stage allergy therapeutics company. From September 2011 to October 2012, Mr. Schor served as Chief Business Officer of Eleven Biotherapeutics, an emerging therapeutics company. From March 2009 until September 2011, Mr. Schor served as Vice President of Business Development, global branded products at Teva Pharmaceuticals. Mr. Schor received his M.B.A. from Tel Aviv University, a B.A. in Economics and Accounting from Haifa University and a B.A. in Biology from Tel Aviv University. Mr. Schor was selected to serve on the Board due to his expected service as the President and Chief Executive Officer of the Company and his extensive industry knowledge.
Carl Gordon, Ph.D., Director
Dr. Gordon has served as a member of the Adicet Board of Directors (the “Adicet Board”) since August 2015. Dr. Gordon is a founding member, Managing Partner, and Co-Head of Global Private Equity at OrbiMed Advisors LLC, an investment firm. Dr. Gordon currently serves on the boards of directors of Turning Point Therapeutics, Inc., Keros Therapeutics, Inc., ORIC Pharmaceuticals, Inc., and Prevail Therapeutics, Inc. as well as several private companies. Dr. Gordon previously served on the boards of directors of Alector, Inc., X4 Pharmaceuticals, Inc. (formerly Arsanis, Inc.), Acceleron Pharma Inc., ARMO Biosciences, Inc., Intellia Therapeutics, Inc. Selecta Biosciences, Inc., Passage Bio, Inc., and SpringWorks Therapeutics Inc. Dr. Gordon received a B.A. in Chemistry from Harvard College and a Ph.D. in Molecular Biology from the Massachusetts Institute of Technology and was a Fellow at The Rockefeller University. Dr. Gordon was selected to serve as the initial Chairperson of the Board because of his venture capital experience, expertise in the scientific field of molecular biology and financial credentials.
Erez Chimovits, M.Sc., M.B.A., Director
Mr. Chimovits has served as a member of the Adicet Board since January 2016. Mr. Chimovits is a partner at OrbiMed Israel, a healthcare investment firm. He has extensive operational experience, including senior managerial experience at public companies. Prior to joining OrbiMed, he was Chief Executive Officer of NasVax Ltd. Previously, Mr. Chimovits served different roles at Compugen, as President of Compugen USA Inc. and as Executive Vice President in Commercial Operations. He currently serves as a member of the board of directors of LogicBio Therapeutics, Inc. and Novus Therapeutics, Inc. as well as several private companies. Mr. Chimovits earned his M.B.A., M.Sc. in Microbiology, and his B.Sc. from Tel Aviv University. Mr. Chimovits was selected to serve on the Board because of his venture capital experience, industry knowledge and extensive experience working for various pharmaceutical and biotechnology companies.
Steve Dubin, J.D., Director
Mr. Dubin was appointed to the Board in connection with the closing of the Merger. Since November 2011, Mr. Dubin has been a Principal in SDA Ventures LLC, a firm focused on assisting emerging growth and middle-market companies, primarily in the health & wellness and nutritional products markets, on matters including corporate development, business acquisition, customer relations, growth strategies and corporate finance. In connection with SDA Ventures LLC, Mr. Dubin acts as a Senior Advisor to Paine Schwartz Partners, LLC, a global private equity investment firm located in New York, and San Mateo, for the purpose of identifying and executing investment opportunities in the global human and animal food and nutritional products industries. From 2006 until its acquisition by Royal DSM N.V. in February 2011, Mr. Dubin served as Chief Executive Officer and a member of the board of directors of Martek Biosciences Corporation. He later served as President of DSM’s Nutritional Lipids Division from February 2011 through October 2011 and as a Senior Advisor to DSM Nutritional Products from November 2011 through October 2012.
After joining Martek in 1992 and serving in various management positions, including Chief Financial Officer, Treasurer, Secretary, General Counsel and Senior Vice President, Business Development, he served as President of Martek from 2003 to 2006. Mr. Dubin currently serves as a member of the board of directors of four privately held companies, Alcresta Therapeutics, Inc., The UCAN Company, Triton Algae Innovations, Ltd. and Phytolon LTD. From January 2014 to January 2018, Mr. Dubin served on the board of directors of Enzymotec Ltd. Mr. Dubin is a certified public accountant and a member of the Maryland Bar. He holds a bachelor’s degree in accounting from the University of Maryland and a J.D. from the National Law Center at George Washington University. Mr. Dubin was appointed to serve on the Board because of his accounting experience and extensive experience working with emerging growth and middle-market companies.
Aya Jakobovits, Ph.D., Director
Dr. Jakobovits founded Adicet, has served as a member of the Adicet Board since its incorporation in November 2014, and served as President and Chief Executive Officer of Adicet from its incorporation to February 2018. From February 2018 to February 2019, Dr. Jakobovits served as a senior strategic advisor to Adicet. Prior to starting Adicet, Dr. Jakobovits served as a Venture Partner with OrbiMed Advisors from 2011 to 2016. From September 2010 to December 2013, she served as President and Founding Chief Executive Officer of Kite Pharma Inc. From December 2007 to June 2010, she served as Executive Vice President, Head of Research and Development at Agensys Inc., an affiliate of Astellas Pharma, Inc. Before Agensys’ acquisition by Astellas, she served as Agensys’ Senior Vice President, Technology and Corporate Development and Chief Scientific Officer and led its research, development, clinical and corporate development operations from January 1999 to December 2007. Before Agensys, from 1966 to 1999, Dr. Jakobovits served as Director, Discovery Research and Principal Scientist at Abgenix Inc. which was spun out of Cell Genesys, Inc. in 1996 based on the XenoMouse® technology developed under her leadership. She joined Cell Genesys in 1989 and served ultimately as Director, Molecular Immunology. Dr. Jakobovits currently serves on the boards of directors of Dyve Biosciences Inc., Yeda Research and Development Co. Ltd. and the UCLA Technology Development Corporation. Dr. Jakobovits previously served on the boards of directors of cCAM therapeutics Ltd. from 2013 to 2015 and the Alliance for Cancer Gene Therapy from 2015 to 2019. Dr. Jakobovits received her B.Sc. from the Hebrew University of Jerusalem, her M.Sc. in Chemistry and Ph.D. in Life Sciences from the Weizmann Institute of Sciences, Israel, and was a postdoctoral fellow at University of California, San Francisco and at Genentech, Inc. Dr. Jakobovits was selected to serve on the Board because of her expertise, experience, and track record in forming and growing successful companies and in developing immunotherapy platform technologies and oncology products.
Yair Schindel, M.B.A., M.D., Director
Dr. Schindel has served as a member of the Adicet Board since September 2019. Dr. Schindel is the Managing Partner and Co-Founder of aMoon Fund, an investment house focused on accelerating cure in healthcare and life sciences. Prior to his time at aMoon, Dr. Schindel was the founding CEO of “Digital Israel”, the State of Israel’s National Digital Bureau which was setup at the Prime Minister’s Office to accelerate digital transformation nationally. Dr. Schindel was also the founder of the MAOZ Network, an NGO building collaboration between Israel’s most influential public leaders. Dr. Schindel earned his BSc and MD degrees at Ben-Gurion University Goldman Medical School and his MBA at Harvard Business School. Dr. Schindel was selected to serve on the Board because of his venture capital experience and his past experience in the development and business strategy of multiple companies in the life sciences sector.
Jeffrey Chodakewitz, M.D., Director
Dr. Chodakewitz has served as a member of the Board since August 2018. From April 2018 through March 2019, Dr. Chodakewitz served as Executive Vice President, Clinical Medicine and External Innovation, at Vertex Pharmaceuticals. Prior to that role, Dr. Chodakewitz held the roles of Chief Medical Officer and Executive Vice President, Global Medicines Development and Medical Affairs at Vertex from January 2014 to April 2018 and was a member of the Vertex Executive Committee. Prior to joining Vertex in January 2014, he spent over 20 years at Merck & Co., where he served in a number of positions including Head of Infectious Diseases and Vaccines Global Development from August 2013 to December 2013, Senior Vice President of Global Scientific Strategy (Infectious Disease, Respiratory & Immunology) from January 2013 to August 2013 and Senior Vice President of Late Stage
Development from March 2011 to January 2013. Dr. Chodakewitz is a Diplomate of the National Board of Medical Examiners and the American Board of Internal Medicine (both Internal Medicine and Infectious Disease). Dr. Chodakewitz currently serves on the board of Tetraphase Pharmaceuticals, Inc. and Freeline Therapeutics Ltd. He holds a B.S in Biochemistry cum laude from Yale University and an M.D. from the Yale University School of Medicine. Dr. Chodakewitz was selected to serve on the Board because of his extensive experience working for various pharmaceutical and biotechnology companies.
Committees
Audit Committee
In connection with the closing of the Merger, Steve Dubin, Jeffrey Chodakewitz and Yair Schindel were appointed to the audit committee of the Board, and Steve Dubin was appointed the chair of the audit committee.
Compensation Committee
In connection with the closing of the Merger, Carl Gordon, Aya Jakobovits and Jeffrey Chodakewitz were appointed to the compensation committee of the Board, and Carl Gordon was appointed the chair of the compensation committee.
Nominating and Corporate Governance Committee
In connection with the closing of the Merger, Erez Chimovits, Aya Jakobovits and Steve Dubin were appointed to the nominating and corporate governance committee of the Board, and Erez Chimovits was appointed the chair of the nominating and corporate governance committee.
Indemnification Agreements
On September 15, 2020, each of the newly appointed directors entered into the Company’s standard form of Indemnification Agreement, which is attached as Exhibit 10.8 to this Current Report on Form 8-K and incorporated herein by reference.
Appointment of Executive Officers
In accordance with the Merger Agreement and an action of the Board, on September 15, 2020, the Board appointed Chen Schor as the Company’s Chief Executive Officer, President, Secretary and Director, Stewart Abbot, M.D. as the Company’s Senior Vice President, Chief Scientific Officer and Chief Operating Officer, Francesco Galimi as the Company’s Senior Vice President and Chief Medical Officer, Lloyd Klickstein as the Company’s Chief Innovation Officer and Carrie Krehlik as the Company’s Senior Vice President and Chief Human Resource Officer, each effective as of the closing of the Merger and to serve at the discretion of the Board. Each of Mr. Schor, Mr. Abbot, Mr. Galimi, Mr. Klickstein and Ms. Krehlik have been determined by the Board to be executive officers of the Company.
On September 14, 2020, Joan Mannick, M.D. resigned from her position as the Chief Medical Officer of the Company. In connection with the Merger, she will become the Head of TORC1 Infectious Disease Program of the Company, effective as of the closing of the Merger. Dr. Mannick will no longer be an executive officer of the Company.
There are no family relationships among any of the Company’s newly appointed executive officers. None of the Company’s newly appointed executive officers has a direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
Chen Schor. Mr. Schor’s biographical information is disclosed in the section above under the heading “Appointment of Directors.”
Stewart Abbot, Ph.D., Senior Vice President, Chief Scientific Officer and Chief Operating Officer
Dr. Abbot has served as Adicet’s Senior Vice President, Chief Scientific Officer and Chief Operating Officer since July 2018. From July 2015 to June 2018, Dr. Abbot served as the VP of Translational Research and Chief Development Officer of Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company developing cellular immunotherapies for cancer and immune disorders. From June 2007 to July 2015, Dr. Abbot held multiple positions at Celgene Cellular Therapeutics, where he assisted with various cell therapy research and development programs. From October 2003 to June 2007, Dr. Abbot held various positions at GE Healthcare Biosciences and GE Global Research. Dr. Abbot received a B.Sc. in Biological Sciences from Edinburgh University, a M.Sc. in Biomedical Engineering from the University of Strathclyde, and a Ph.D. in Cell Biology and Pathology from the University of London.
Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer
Dr. Galimi has served as Adicet’s Senior Vice President, Chief Medical Officer in September 2019. Prior to Adicet, Dr. Galimi worked at Amgen Inc., where he served as Global Program General Manager, Early Development from 2015 to 2019. During his tenure at Amgen, he was responsible for the cross-functional strategy and execution of a portfolio of oncology programs, from pre-IND to late-stage. From 2014 to 2015, Dr. Galimi was the Head of Clinical Development at Onyx Pharmaceuticals Inc., where he led the Oncology Clinical Development Group. From 2011 to 2014 he served in leadership roles at the Genomics Institute of the Novartis Research Foundation, leading the early development of a portfolio of oncology programs. Dr. Galimi holds a M.D. from the University of Torino Medical School with a specialty certification in Medical Oncology, and a Ph.D. from the University of Torino Medical School.
Lloyd Klickstein, M.D., Ph.D., Chief Innovation Officer
Dr. Klickstein has served as the Company’s Chief Scientific Officer since May 2019. Prior to joining the Company, Dr. Klickstein was Head of Translational Medicine for the New Indication Discovery Unit (NIDU) and the Exploratory Disease Area (Dax) at Novartis Institutes for Biomedical Research. Under his decade of leadership, NIDU & Dax teams carried multiple projects forward from target identification through clinical proof-of-concept in novel areas of drug development including liver disease, hearing loss and aging, among others. Prior to his 13 years at Novartis, Dr. Klickstein was an academic physician-scientist at Brigham & Women’s Hospital (BWH) in Boston, where he directed an NIH-funded basic research laboratory and maintained an active clinical practice in the Arthritis Center. Dr. Klickstein received his B.S. degree from Tufts University, his M.D. and Ph.D. degrees from Harvard University, completed post-graduate clinical training in Internal Medicine, Rheumatology & Immunology at BWH and a post-doctoral research fellowship at the Center for Blood Research in Boston.
Carrie Krehlik, M.B.A., Senior Vice President and Chief Human Resources Officer
Ms. Krehlik has served as Adicet’s Senior Vice President and Chief Human Resource Officer since November 2017. From July 2016 to November 2017, Ms. Krehlik served as a consultant to Blue Beyond Consulting. From July 2015 to June 2016, Ms. Krehlik served as the Vice President of Human Resources of ZS Pharma, Inc., a biopharmaceutical company developing therapies for ion imbalances. From December 2012 to March 2015, Ms. Krehlik served as the Vice President of Human Resources at InterMune, a biopharmaceutical company developing and commercializing therapies in pulmonology and orphan fibrotic diseases. Ms. Krehlik received a B.Sc. in Organizational Behavior from Miami University, and an MBA in International Business from San Francisco State University.
Item 5.03 | Amendments to Certificate of Incorporation |
The information set forth in Item 3.03 of this Current Report on Form 8-K is incorporated by reference into this Item 5.03.
Item 5.07 | Submission of Matters to a Vote of Security Holders |
On September 15, 2020, the Company held its Special Meeting. The following is a brief description of the final voting results for each of the proposals submitted to a vote of the stockholders at the Special Meeting. The final voting results do not reflect the Reverse Stock Split.
(a) Proposal 1 — Approval of the Issuance of Common Stock in the Merger. Stockholders approved the issuance of Company Common Stock by the Company pursuant to the Merger Agreement and the resulting “change in control” of the Company under the rules of The Nasdaq Stock Market LLC, as follows:
Votes For |
Votes Against |
Abstentions |
Broker Non-Votes | |||
18,468,689 |
328,511 | 18,560 | 9,089,725 |
(b) Proposal 2 — Approval of the Reverse Stock Split. The Stock Split Amendment was approved, as follows:
Votes For |
Votes Against |
Abstentions |
Broker Non-Votes | |||
27,120,195 |
725,171 | 60,119 | 0 |
(c) Proposal 3 — Approval of the Amendment to the Company’s 2018 Stock Option and Incentive Plan. The stockholders approved the amendment to the Company’s 2018 Stock Option and Incentive Plan, as follows:
Votes For |
Votes Against |
Abstentions |
Broker Non-Votes | |||
12,687,459 |
6,100,386 | 27,915 | 9,089,725 |
(h) Proposal 4 — Consider and Vote Upon an Adjournment of the Special Meeting. The adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposals 1, 2 and/or 3 was approved, as follows:
Votes For |
Votes Against |
Abstentions |
Broker Non-Votes | |||
26,938,296 |
843,843 | 123,346 | 0 |
Item 7.01 |
The Company from time to time presents and/or distributes to the investment community at various industry and other conferences slide presentations to provide updates and summaries of its business. A copy of its current corporate slide presentation is furnished herewith as Exhibit 99.1 and incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials furnished herewith as Exhibit 99.1.
Item 8.01 | Other Events. |
Adicet Therapeutics, Inc.’s Risk Factors, Adicet Therapeutics, Inc.’s Management’s Discussion and Analysis of Financial Condition and Results of Operations and Adicet Therapeutics, Inc.’s Business Section are filed herewith and attached hereto as Exhibits 99.2, 99.3 and 99.4 respectively, and incorporated herein by reference.
Item 9.01 | Financial Statements and Exhibits |
(a) Financial Statements of Businesses Acquired
The audited financial statements of Adicet Therapeutics, Inc. contemplated by this Item are filed as Exhibit 99.5 to this Current Report on Form 8-K and incorporated herein by reference.
The unaudited financial statements of Adicet Therapeutics, Inc. contemplated by this Item are filed as Exhibit 99.6 to this Current Report on Form 8-K and incorporated herein by reference.
(b) Pro Forma Financial Information.
The pro forma financial information contemplated by this Item is filed as Exhibit 99.7 to this Current Report on Form 8-K and incorporated herein by reference.
(d) Exhibits
Below is a list of exhibits included with this Current Report on Form 8-K.
23.1 | Consent of PricewaterhouseCoopers LLP | |
99.1 | Corporate slide presentation of Adicet Bio, Inc., dated September 16, 2020. | |
99.2 | ||
99.3 | ||
99.4 | ||
99.5 | Consolidated financial statements of Adicet Therapeutics, Inc. | |
99.6 | Condensed Consolidated Financial Statements (Unaudited) of Adicet Therapeutics, Inc. | |
99.7 | Unaudited Pro Forma Condensed Combined Financial Information | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
# | Indicates a management contract or any compensatory plan, contract or arrangement |
+ | Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions with an asterisk because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed. |
* | Non-material schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Registrant hereby undertakes to furnish supplementally copies of any of the omitted schedules and exhibits upon request by the SEC. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Adicet Bio, Inc. | ||
By: | /s/ Chen Schor | |
Name: | Chen Schor | |
Title: | President and Chief Executive Officer |
Date: September 16, 2020
Exhibit 3.1
CERTIFICATE OF AMENDMENT OF THIRD
AMENDED AND RESTATED CERTIFICATE OF
INCORPORATION OF RESTORBIO, INC.
resTORbio, Inc., a Delaware corporation (the Corporation), hereby certifies as follows:
The Board of Directors of the Corporation (the Board of Directors), pursuant to Section 242 of the Delaware General Corporations Law (the DGCL), has duly adopted resolutions setting forth the following proposed amendment (the Amendment) to the Corporations third amended and restated certificate of incorporation as currently in effect (the Certificate of Incorporation) and declaring such amendment advisable, and the stockholders of the Corporation have duly approved and adopted the Amendment at the special meeting of stockholders called and held upon notice in accordance with Section 222 and Section 242 of the DGCL.
In order to effect such proposed amendment, ARTICLE IV of the Certificate of Incorporation is hereby amended so that the following paragraphs be inserted at the end of second full paragraph of such Article to read as follows:
That, effective upon the filing of this Certificate of Amendment of the Certificate of Incorporation with the Secretary of State of the State of Delaware (the Effective Time), each seven (7) (the Conversion Number) shares of the Common Stock (including treasury shares) issued and outstanding as of the Effective Time shall be combined into one validly issued, fully paid and non-assessable share of Common Stock, automatically and without any action by the holder thereof (the Reverse Stock Split). The par value of the Common Stock following the Reverse Stock Split shall remain at $0.0001 per share. No fractional shares of Common Stock shall be issued as a result of the Reverse Stock Split. In lieu of any fractional shares to which a stockholder would otherwise be entitled (after taking into account all fractional shares of Common Stock otherwise issuable to such holder), the Corporation shall, upon surrender of such holders certificate(s) representing such fractional shares of Common Stock, pay cash in an amount equal to such fractional shares of Common Stock multiplied by the then fair value of the Common Stock as determined by the average last reported sales price of the Common Stock during the ten (10) consecutive trading days ending on the day prior to the Effective Time.
Each stock certificate or book entry share that, immediately prior to the Effective Time, represented shares of Common Stock that were issued and outstanding immediately prior to the Effective Time shall, from and after the Effective Time, automatically and without the necessity of presenting the same for exchange, represent that number of whole shares of Common Stock after the Effective Time into which the shares formerly represented by such certificate or book entry share have been combined (as well as the right to receive cash in lieu of fractional shares of Common Stock after the Effective Time); provided, however, that each person of record holding a certificate that represented shares of Common Stock that were issued and outstanding immediately prior to the Effective Time shall receive, upon surrender of such certificate, a new certificate evidencing and representing the number of whole shares of Common Stock after the Effective Time into which the shares of Common Stock formerly represented by such certificate shall have been combined.
IN WITNESS WHEREOF, this Certificate of Amendment has been executed by a duly authorized officer of the Corporation on this day 15th of September, 2020.
resTORbio, Inc. | ||
By: | /s/ Chen Schor | |
Chen Schor | ||
President and Chief Executive Officer |
Exhibit 3.2
CERTIFICATE OF AMENDMENT OF THIRD
AMENDED AND RESTATED CERTIFICATE OF
INCORPORATION OF RESTORBIO, INC.
resTORbio, Inc., a Delaware corporation (the Corporation), hereby certifies as follows:
1. The Board of Directors of the Corporation duly adopted resolutions declaring advisable the amendment of the Third Amended and Restated Certificate of Incorporation of the Corporation (the Certificate of Incorporation) set forth in paragraph 3 of this Certificate of Amendment.
2. The amendment to the Certificate of Incorporation set forth in paragraph 3 of this Certificate of Amendment was duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware.
3. Article I of the Certificate of Incorporation is hereby deleted in its entirety and replaced by the following Article I in lieu thereof:
The name of this corporation is Adicet Bio, Inc.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
IN WITNESS WHEREOF, this Certificate of Amendment has been executed by a duly authorized officer of the Corporation on this 15th day of September, 2020.
By: | /s/ Chen Schor |
Name: | Chen Schor | |
Title: | President and Chief Executive Officer |
[Signature Page to Name Change Amendment]
Exhibit 10.1
EXECUTION VERSION
ESCROW AGREEMENT
THIS ESCROW AGREEMENT (this Escrow Agreement) is entered into and effective as of this 15th day of September, 2020, by and among PNC Bank, National Association, a national banking association (the Escrow Agent), resTORbio, Inc., a Delaware corporation (resTORbio) and the investors listed on Schedule 1 hereto under the heading Investors (each of which is herein referred to as an Investor and collectively as the Investors). Capitalized terms used but not defined herein shall have the meanings assigned to them in the Funding Agreement (as defined below).
WHEREAS, resTORbio, Adicet Bio, Inc., a Delaware corporation (Adicet), and the Investors have entered into that certain Funding Agreement dated April 28, 2020, as amended, modified or restated from time to time (the Funding Agreement), in connection with a merger of Oasis Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of resTORbio (Merger Sub), with and into Adicet, with Adicet continuing as the surviving entity (the Merger), pursuant to an Agreement and Plan of Merger, dated April 28, 2020, by and among resTORbio, Adicet and Merger Sub, as amended, modified or restated from time to time.
WHEREAS, pursuant to the Funding Agreement, the Investors have agreed to deposit certain funds into an escrow account (the Escrow Account) immediately prior to the closing of the Merger (the Merger Closing) by wire transfer of immediately available cash funds, with such funds to be held, invested and disbursed by the Escrow Agent in accordance with the terms and conditions of this Escrow Agreement and the Funding Agreement.
WHEREAS, resTORbio, Adicet, and certain stockholders of Adicet (the Non-Escrow Investors) have entered into that certain Non-Escrow Funding Agreement, dated September 15, 2020, as amended, modified or restated from time to time (the Non-Escrow Funding Agreement), pursuant to which such Non-Escrow Investors have agreed to fund to resTORbio at the Concurrent Private Placement Closing (as defined in the Funding Agreement) the amount opposite such stockholders name on Schedule A thereto.
WHEREAS, the parties desire to set forth their understandings with regard to the Escrow Account established by this Escrow Agreement.
NOW, THEREFORE, in consideration of the premises herein, the parties hereto agree as follows:
I. Terms and Conditions
1.1. Appointment of and Acceptance by Escrow Agent. resTORbio and each of the Investors hereby appoint the Escrow Agent to serve as escrow agent for the purposes set forth herein, and the Escrow Agent hereby accepts such appointment and agrees to perform its duties as provided herein.
1.2. Establishment of Escrow. At or immediately prior to the Merger Closing, each Investor will deposit (or cause to be deposited) into the Escrow Account pursuant to the wire instructions set forth on Schedule A hereto, in immediately available funds, the amount set forth opposite such Investors respective name on Schedule 1 hereto, for a total aggregate amount of US$15,000,000.00, representing the Total Funding Amount referred to in the Funding Agreement (together with all interest and earnings thereon, and less any disbursements hereunder, the Escrow Funds).
1.3. Application of the Escrow Funds. Subject to the terms, conditions and limitations contained herein and in the Funding Agreement, the Escrow Funds shall be available to be released in accordance with the Funding Agreement and this Escrow Agreement.
1.4. Disbursements of the Escrow Funds. The Escrow Agent shall only disburse amounts from the Escrow Funds as follows:
(a) Disbursement of the Escrow Funds.
i. The Escrow Agent shall disburse amounts then held in the Escrow Account to the applicable party or parties upon receipt of, and in accordance with, a written notification, in the form of Exhibit B hereto, signed by an authorized representative (a list of whom are provided in Exhibit A-1 to Exhibit A-15) of each of resTORbio and Investors that funded in the aggregate two-thirds or more of the Total Funding Amount (the Requisite Investors) (a Joint Written Direction). resTORbio and each Investor agree solely as between themselves to act in good faith and cause the timely delivery of any applicable Joint Written Direction to effect the releases or other actions contemplated by the Funding Agreement and this Escrow Agreement in accordance with the timeframes set forth therein and herein.
ii. Each of the parties hereto acknowledge and agree that, if one or more of the Non-Escrow Investors or their Affiliated Entities (as defined in the Funding Agreement), or any other existing investor in Adicet not listed on Schedule 1 (or such investors Affiliated Entities), fund into the Concurrent Private Placement (as defined in the Funding Agreement), a proportionate amount of funds will be released from the Escrow Funds back to the Investors set forth on Schedule 2 in accordance with their pro-rata respective percentages set forth on Schedule 2. Each of resTORbio and the Investors agree to timely execute a Joint Written Direction instructing the Escrow Agent to disburse the Escrow Funds in accordance with this Section 1.4(a)ii.
iii. Notwithstanding the provisions of Section 1.4(a)i or Section 1.4(a)ii, in the event that the Escrow Agent receives a copy of a final, non-appealable award or order of a court of competent jurisdiction or arbitrator or arbitration panel forwarded by either resTORbio or the Requisite Investors, which award or order specifies the specific dollar amounts to be paid out of the Escrow Funds to resTORbio and/or the Investors, and to which such copy resTORbio or the Requisite Investors shall attach payment instructions (an Demand Notice), the Escrow Agent shall distribute (I) to resTORbio, out of the Escrow Funds, any amounts payable to resTORbio as set forth in the order or award and (II) to the Investors, any amounts payable to the Investors as set forth in the order or award in proportion to the percentages listed on Schedule 1 opposite each such Investors respective name; provided that the party delivering the Demand Notice to the Escrow Agent shall simultaneously provide a copy of such Demand Notice to the other party pursuant to Section 4.4 below (which other party, in the case of a Demand Notice from resTORbio, shall be all of the Investors).
(b) Any final, non-appealable award or order of a court of competent jurisdiction or arbitrator or arbitration panel delivered under Section 1.4(a) shall be accompanied by a certificate of or on behalf of the presenting party that such order is final and non-appealable and from a court of competent jurisdiction or arbitrator or arbitration panel, upon which opinion the Escrow Agent shall be entitled to conclusively rely without further investigation. Any party requesting the disbursement of funds from the Escrow Account pursuant to a Demand Notice with respect to such an award or order shall include with its delivery of such Demand Notice to the Escrow Agent wire instructions to which the Escrow Agent is instructed to release the funds.
(c) Notwithstanding anything to the contrary in this Escrow Agreement, if any amount to be released at any time or under any circumstances exceeds the balance in the Escrow Account, the Escrow Agent shall release the balance in the Escrow Account and shall have no liability or responsibility to any party for any deficiency.
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(d) The Escrow Agent will disburse any amounts from the Escrow Funds as required by this Section 1.4 within two (2) Business Days (as defined below) or as soon as commercially reasonable thereafter from the date of the Escrow Agents receipt of a Joint Written Direction or Demand Notice, as applicable.
II. Provisions as to the Escrow Agent
2.1. Limited Duties of Escrow Agent. The Escrow Agent undertakes to perform only such duties as are expressly set forth in this Escrow Agreement that shall be deemed purely ministerial in nature. Under no circumstance will the Escrow Agent be deemed to be a fiduciary to any party or any other person under this Escrow Agreement. This Escrow Agreement expressly and exclusively sets forth the duties of the Escrow Agent with respect to any and all matters pertinent hereto and no implied duties or obligations shall be read into this Escrow Agreement against the Escrow Agent. The Escrow Agent shall not be bound by, deemed to have knowledge of, or have any obligation to determine, make inquiry into or consider, any term or provision of any agreement between the Investors, resTORbio and/or any other third party or as to which the escrow relationship created by this Escrow Agreement relates, including without limitation the Funding Agreement or any other documents referenced in this Escrow Agreement.
2.2. Limitations on Liability of Escrow Agent.
(a) In performing its duties under this Escrow Agreement, or upon the claimed failure to perform its duties, the Escrow Agent shall have no liability except for the Escrow Agents fraud, willful misconduct, bad faith or gross negligence. In no event shall the Escrow Agent be liable for incidental, indirect, special, consequential or punitive damages of any kind whatsoever (including but not limited to lost profits), even if the Escrow Agent has been advised of the likelihood of such loss or damage and regardless of the form of action, other than resulting from the Escrow Agents fraud.
(b) Except in cases of the Escrow Agents fraud, willful misconduct, bad faith or gross negligence, the Escrow Agent shall be fully protected (i) in acting in reliance upon any certificate, statement, request, notice, advice, instruction, direction, other agreement or instrument or signature reasonably and in good faith provided by any Investor or resTORbio with respect to such partys information and believed by the Escrow Agent to be genuine, (ii) in assuming that any person purporting to give the Escrow Agent any of the foregoing in connection with either this Escrow Agreement or the Escrow Agents duties has been duly authorized to do so and (iii) in acting or failing to act in good faith in accordance with the terms of this Escrow Agreement on the advice of outside counsel retained by the Escrow Agent.
(c) The Escrow Agent shall have no liability with respect to the transfer or distribution of any funds effected by the Escrow Agent pursuant to wiring or transfer instructions provided to the Escrow Agent in accordance with the provisions of this Escrow Agreement. The Escrow Agent shall be entitled to rely upon all bank and account information provided to the Escrow Agent by the applicable authorized representative of each of resTORbio and an Investor set forth on Exhibit A-1 to Exhibit A-15. The Escrow Agent shall have no duty to verify or otherwise confirm any written wire transfer instructions except as set forth in Section 2.3 below, but it may do so in its discretion on any occasion without incurring any liability to any party for failing to do so on any other occasion. The Escrow Agent shall process all wire transfers based on bank identification and account numbers rather than the names of the intended recipient of the funds, even if such numbers pertain to a recipient other than the recipient identified in the payment instructions. The Escrow Agent shall have no duty to detect any such inconsistencies and shall resolve any such inconsistencies by using the account number. In connection with any payments that the Escrow Agent is instructed to make by wire transfer, the Escrow Agent shall not be liable for the acts or omissions of (i) any Investor, resTORbio or other person providing such instructions, including without limitation errors
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as to the amount, bank information or bank account number; or (ii) any other person or entity, including without limitation any Federal Reserve Bank, any transmission or communications facility, any funds transfer system, any receiver or receiving depository financial institution, and no such person or entity shall be deemed to be an agent of the Escrow Agent. Any wire transfers of funds made by the Escrow Agent pursuant to this Escrow Agreement will be made subject to and in accordance with the Escrow Agents usual and ordinary wire transfer procedures in effect from time to time.
(d) No provision of this Escrow Agreement shall require the Escrow Agent to risk or advance its own funds or otherwise incur any financial liability or potential financial liability in the performance of its duties or the exercise of its rights under this Escrow Agreement. The Escrow Agent shall not be obligated to take any legal action or to commence any proceedings in connection with this Escrow Agreement or any property held hereunder or to appear in, prosecute or defend in any such legal action or proceedings.
2.3. Security Procedure For Funds Transfers. The Escrow Agent shall confirm each funds transfer instruction received in the name of a party by telephone call-back to an Authorized Representative specified on Exhibit A-1 to Exhibit A-15 at the telephone number specified for such authorized person on Exhibit A-1 to Exhibit A-15, as applicable (Authorized Representative). Once delivered to the Escrow Agent, Exhibit A-1 to Exhibit A-15 may be revised or rescinded only by a writing signed by an Authorized Representative of the applicable party. Such revisions or rescissions shall be effective only after actual receipt and following such period of time as may be necessary to afford the Escrow Agent a reasonable opportunity to act on it. If a revised Exhibit A-1 to Exhibit A-15 or a rescission of an existing Exhibit A-1 to Exhibit A-15 is delivered to the Escrow Agent by an entity that is a successor-in-interest to such party, such document shall be accompanied by additional documentation satisfactory to the Escrow Agent showing that such entity has succeeded to the rights and responsibilities of the applicable authorized representative of each of resTORbio and any Investor under this Escrow Agreement. resTORbio and each Investor understand that the Escrow Agents inability to receive or confirm funds transfer instructions pursuant to the above security procedure may result in a delay in accomplishing such funds transfer, and agree that the Escrow Agent shall not be liable for any loss caused by any such delay.
2.4. Depository Role. The Escrow Agent acts hereunder as a depository only, and is not responsible or liable in any manner whatsoever for the sufficiency, correctness, genuineness or validity of the subject matter of this Escrow Agreement or any part thereof, or of any person executing or depositing such subject matter.
2.5. No Duty to Notify. The Escrow Agent shall in no way be responsible for nor shall it be its duty to notify any party hereto or any other party interested in this Escrow Agreement of any payment required or maturity occurring under this Escrow Agreement or under the terms of any instrument deposited therewith unless such notice is explicitly provided for in this Escrow Agreement.
2.6. Other Relationships. The Escrow Agent may execute any of its powers and perform any of its duties hereunder directly or through affiliates or agents. The Escrow Agent and its affiliates, and any of their respective directors, officers or employees may become pecuniarily interested in any transaction in which any of the other parties hereto may be interested and may contract and lend money to any such party and otherwise act as fully and freely as though it were not escrow agent under this Escrow Agreement. Nothing herein shall preclude the Escrow Agent or its affiliates from acting in any other capacity for any such party.
2.7. Disputes.
(a) In the event of any disagreement between resTORbio and any Investor, or between either of them and any other party, resulting in adverse claims or demands being made in connection with the
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matters covered by this Escrow Agreement, or in the event that the Escrow Agent, in good faith, be in doubt as to what action it should take hereunder, the Escrow Agent may, at its option, refuse to comply with any claims or demands on it, or refuse to take any other action hereunder, so long as such disagreement continues or such doubt exists, and in any such event, the Escrow Agent shall not be or become liable in any way or to any party for its failure or refusal to act, and the Escrow Agent shall be entitled to continue to refrain from acting until directed by (i) an order of a court of competent jurisdiction, or (ii) directed otherwise a Joint Written Direction. Notwithstanding the preceding, the Escrow Agent may in its discretion obey the order, judgment, decree or levy of any court, whether with or without jurisdiction, or of an agency of the United States or any political subdivision thereof, or of any agency of any State of the United States or of any political subdivision thereof, and the Escrow Agent is hereby authorized in its sole discretion, to comply with and obey any such orders, judgments, decrees or levies. The Escrow Agent shall be under no duty to institute or defend any legal proceedings, although the Escrow Agent may, in its discretion and at the expense of resTORbio and the Investors as provided in the immediately following paragraph, institute or defend such proceedings. The rights of the Escrow Agent under this sub-paragraph are cumulative of all other rights which it may have by law or otherwise.
(b) In the event of any disagreement or doubt, as described above, the Escrow Agent shall have the right, in addition to the rights described above and at the election of the Escrow Agent, to tender into the registry or custody of any court having jurisdiction, all funds, equity and property held under this Escrow Agreement, and the Escrow Agent shall have the right to take such other legal action as may be appropriate or necessary, in the sole discretion of the Escrow Agent. Upon acceptance of any such tender and transfer of all funds, equity and property held under this Escrow Agreement, resTORbio and the Investors agree that the Escrow Agent shall be discharged from all further duties under this Escrow Agreement.
2.8. Indemnification. resTORbio and each Investor jointly and severally agree to defend, indemnify and hold harmless the Escrow Agent and each of the Escrow Agents officers, directors, agents and employees (the Escrow Indemnified Parties) from and against any and all losses, liabilities, claims, damages, expenses and costs (including, without limitation, attorneys fees and expenses) of every nature whatsoever (collectively, Escrow Agent Losses) which any such Escrow Indemnified Party may incur and which arise directly or indirectly from this Escrow Agreement or which arise directly or indirectly by virtue of the Escrow Agents undertaking to serve as the Escrow Agent hereunder; provided, however, that no Escrow Indemnified Party shall be entitled to indemnity with respect to Escrow Agent Losses that have been finally adjudicated by a court of competent jurisdiction to have been caused by such Escrow Indemnified Partys fraud, gross negligence, bad faith or willful misconduct. resTORbio and each Investor agree solely between themselves, and without affecting any Escrow Indemnified Partys right to indemnification hereunder, that (i) resTORbio and the Investors shall each be responsible for fifty percent (50%) of such indemnification obligations and shall have a right of contribution against the other to the extent that they pay more than their fifty percent (50%) share of such indemnification obligations and (ii) each Investor shall be responsible for the percentage of such indemnification obligations borne by the Investors set forth opposite such Investors respective name on Schedule 1 hereto and shall have a right of contribution against the other to the extent that such Investor pays more than its respective share of such indemnification obligations. The provisions of this section shall survive the termination of this Escrow Agreement and any resignation or removal of the Escrow Agent.
2.9. Mergers, Consolidations, Etc. Any entity into which the Escrow Agent may be merged or converted or with which it may be consolidated, or any entity to which all or substantially all the escrow business of the Escrow Agent may be transferred, shall be the successor Escrow Agent under this Escrow Agreement and shall have and succeed to the rights, powers, duties, immunities and privileges as its predecessor, in each case without the execution or filing of any instrument or paper or the performance of any further act (other than due notice to resTORbio and each Investor).
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2.10. Resignation; Removal.
(a) The Escrow Agent may resign and be discharged from it duties and obligations at any time under this Escrow Agreement by providing written notice to resTORbio and each Investor and complying with the provisions of this Section 2.10(a). Such resignation shall be effective on later of the date set forth in such written notice, which shall be no earlier than thirty (30) days after such written notice has been furnished, and the date that a successor agent has been appointed or final sentence of this Section 2.10(a) has been complied with. Thereafter, the Escrow Agent shall have no further obligation except to hold the Escrow Funds as depository and cooperate reasonably in the transfer of the Escrow Funds to a successor escrow agent. resTORbio and the Requisite Investors shall promptly appoint a successor escrow agent. The Escrow Agent shall refrain from taking any action until it shall receive a Joint Written Direction designating the successor escrow agent. However, in the event no successor escrow agent has been appointed on or prior to the date such resignation is to become effective, the Escrow Agent shall be entitled to tender into the custody of any court of competent jurisdiction all funds, equity and other property then held by the Escrow Agent hereunder and the Escrow Agent shall, upon acceptance of any such tender and transfer of all funds, equity and property held under this Escrow Agreement, be relieved of all further duties and obligations under this Escrow Agreement.
(b) resTORbio and the Requisite Investors acting together shall have the right to terminate the appointment of the Escrow Agent upon thirty (30) days joint written notice to the Escrow Agent specifying the date upon which such termination shall take effect. Thereafter, the Escrow Agent shall have no further obligation except to hold the Escrow Funds as depository and cooperate reasonably in the transfer of the Escrow Funds to a successor escrow agent. The Escrow Agent shall refrain from taking any action until it shall receive a Joint Written Direction designating the successor escrow agent. However, in the event no successor escrow agent has been appointed on or prior to the date such termination is to become effective, the Escrow Agent shall be entitled to tender into the custody of any court of competent jurisdiction all funds, equity and other property then held by the Escrow Agent hereunder and the Escrow Agent shall, upon acceptance of any such tender and transfer of all funds, equity and property held under this Escrow Agreement, be relieved of all further duties and obligations under this Escrow Agreement.
(c) In the case of a resignation or removal of the Escrow Agent, the Escrow Agent shall have no responsibility for the appointment of a successor escrow agent hereunder. The successor escrow agent appointed by resTORbio and the Requisite Investors shall execute, acknowledge and deliver to the Escrow Agent and the other parties an instrument in writing accepting its appointment hereunder, and thereafter, the Escrow Agent shall deliver all of the then-remaining balance of the Escrow Funds, less any fees and expenses then incurred by and unpaid to the Escrow Agent, to such successor escrow agent in accordance with the Joint Written Direction of resTORbio and the Requisite Investors and upon receipt of the Escrow Funds, the successor escrow agent shall be bound by all of the provisions of this Escrow Agreement.
2.11. Compensation of the Escrow Agent. [Reserved.]
III. Tax Matters
3.1. Tax Matters.
(a) On or before the execution and delivery of this Escrow Agreement, each of resTORbio and each Investor shall provide to the Escrow Agent a completed IRS Form W-9 or Form W-8 (or, in each case, any successor form), as applicable, and shall promptly update any such form to the extent such form becomes obsolete or inaccurate in any respect. The Escrow Agent shall have the right to request from any party to this Escrow Agreement, or any other person or entity entitled to payment hereunder, any additional forms, documentation or other information as may be reasonably necessary for the Escrow Agent to satisfy its reporting and withholding obligations under the Internal Revenue Code of 1986, as amended (the
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Code) and applicable state and local income tax law. To the extent any such forms to be delivered under this Section 3.1(a) are not provided prior to the date hereof or by the time the related payment is required to be made or are determined by the Escrow Agent to be incomplete and/or inaccurate in any respect, the Escrow Agent shall be entitled to withhold (without liability) a portion of any interest or other income earned on the investment of the Escrow Funds or on any such payments hereunder to the extent withholding is required by law and shall remit such taxes to the appropriate authorities, and shall have no obligation to gross up any such payment. The Escrow Agent shall have the sole right to make the determination as to which payments hereunder are reportable payments or withholdable payments under the Code.
(b) resTORbio and each Investor agree that, subject to the terms and conditions of this Escrow Agreement, the owners of the funds held in the Escrow Account (together with any interest or other income earned on the investment of the Escrow Funds) are the Investors (pro rata in proportion to the percentages listed on Schedule 1 opposite each such Investors respective name) for all tax purposes and the Escrow Agent shall report to the Internal Revenue Service (IRS), as of each calendar year-end, all income earned from the investment of any sum held in the Escrow Account (including income earned in respect of such earnings) as the income of the Investors for purposes of the Code and applicable state and local income tax law. The Escrow Agent is authorized and directed to report all interest and other income earned on the Escrow Funds in accordance with the IRS Form W-9 or Form W-8 provided to the Escrow Agent by the Investors. Each Investor shall report all interest or other income, if any, that is earned on the Escrow Funds as income in the taxable year or years in which such income is properly includable in such Investors gross income and shall pay any and all taxes attributable thereto.
(c) Notwithstanding anything to the contrary herein provided, except for the delivery of IRS Form 1099, IRS Form 1042-S or other applicable tax form, the Escrow Agent shall have no duty to prepare or file any Federal or state tax report or return with respect to any funds or equity held pursuant to this Escrow Agreement or any income earned thereon other than such information reports as the Escrow Agent is required to prepare and file as required by applicable law. The Escrow Agent shall have no responsibility to report any payments from the Escrow Fund other than the interest or other income earned on the Escrow Fund as set forth in this Section 3.1.
(d) resTORbio and each Investor jointly and severally, shall indemnify, defend and hold the Escrow Agent harmless from and against any tax, late payment, interest, penalty or other cost or expense that may be assessed against the Escrow Agent on or with respect to the funds and equity held under this Escrow Agreement or any earnings or interest thereon, unless such tax, late payment, interest, penalty or other cost or expense was finally adjudicated by a court of competent jurisdiction to have been directly caused by the fraud, gross negligence, bad faith or willful misconduct of the Escrow Agent or the failure of the Escrow Agent to follow the lawful instructions of resTORbio or any Investor. The indemnification provided in this section is in addition to the indemnification provided to the Escrow Agent elsewhere in this Escrow Agreement. resTORbio and each Investor agree solely between themselves, and without affecting the Escrow Agents right to indemnification hereunder, that (i) resTORbio and the Investors shall each be responsible for fifty percent (50%) of such indemnification obligations and shall have a right of contribution against the other to the extent that they pay more than their fifty percent (50%) share of such indemnification obligations and (ii) each Investor shall be responsible for the percentage of such indemnification obligations borne by the Investors set forth opposite such Investors respective name on Schedule 1 hereto and shall have a right of contribution against the other to the extent that such Investor pays more than its respective share of such indemnification obligations. The indemnification provided in this section is in addition to the indemnification provided in Section 2.8 and shall survive the resignation or removal of the Escrow Agent and the termination of this Escrow Agreement.
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IV. Miscellaneous
4.1. Disbursements. The Escrow Agent shall make no disbursement, investment or other use of funds until and unless it has collected funds. The Escrow Agent shall not be liable for collection items until such proceeds have been received or the Federal Reserve has given the Escrow Agent credit for the funds.
4.2. Permitted Investments. The Escrow Agent shall invest the Escrow Funds in a PNC Non-Interest Bearing Deposit Account, unless Schedule C is completed to provide direction for investment in the Money Market Deposit Account. Information relating to investment of Escrow Funds in a PNC Non-Interest Bearing Deposit Account or, if elected, the Money Market Deposit Account, are set forth on Schedule C. resTORbio and each Investor recognize and agree that the Escrow Agent will not provide supervision, recommendations or advice relating to the investment of moneys held hereunder or the purchase, sale, retention or other disposition of any investment, and the Escrow Agent shall not be liable to resTORbio or any Investor or any other person or entity for any loss incurred in connection with any such investment, including, without limitation, any loss due to interest rate fluctuation, early withdrawal penalty or the decline in value of any investment. Any investment earnings and income on the funds held in the Escrow Account shall become part of the Escrow Account and shall be disbursed in accordance with this Escrow Agreement. The Escrow Agent shall not be liable or responsible for any loss resulting from any deposits or investments made pursuant to this Section 4.2, other than as a result of the fraud, gross negligence, bad faith or willful misconduct of the Escrow Agent.
4.3. Accounting. The Escrow Agent shall provide monthly reports of transactions and holdings to resTORbio and each Investor as of the end of each month, at the address provided by resTORbio and each Investor.
4.4. Notices. Any notice, request for consent, report, or any other communication required or permitted in this Escrow Agreement shall be in writing and shall be deemed to have been given when delivered by electronic mail to the e-mail address given below, provided that written confirmation of receipt is obtained promptly from the recipient after completion of the electronic mail transmission.
If to the Escrow Agent:
PNC Bank, National Association
Attn: Heather Kelly; Rachel Stastny
80 South 8th Street, Suite 3715
Minneapolis, Minnesota 55402
Email: hkelly @pnc.com; Rachel.stastny@pnc.com
pncpaidadmin@pnc.com
Phone: 612-268-7307
If to resTORbio:
resTORbio, Inc.
500 Boylston Street, 13th Floor
Boston, Massachusetts
Attention: Chen Schor
Email: cschor@restorbio.com
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with a copy (which shall not constitute notice) to each of:
Morrison & Foerster LLP
12531 High Bluff Drive, Suite 100
San Diego, CA 92011
Attention: James M. Krenn
Email: jkrenn@mofo.com
Goodwin Procter LLP
100 Northern Avenue
Boston, Massachusetts 02210
Attention: Andrew H. Goodman
Email: agoodman@goodwinlaw.com
If to any Investor: To the email and address set forth on such Investors signature page hereto.
Any party may unilaterally designate a different address by giving notice of each change in the manner specified above to each other party. In all cases, the Escrow Agent shall be entitled to rely on a copy or electronic transmission of any document with the same legal effect as if it were the original of such document. Business Day shall mean any day other than a Saturday, Sunday or any other day on which banking institutions located in Pennsylvania are authorized or obligated by law or executive order to close. The parties acknowledges that there are certain security, corruption, transmission error and access availability risks associated with using open networks such as the internet and Parties assumes such risks and acknowledges that the security procedures set forth herein are commercially reasonable.
4.5. Governing Law. This Escrow Agreement shall be governed by and construed according to the laws of the State of Delaware, without regard to principles of conflicts of law. The parties hereto consent to the exclusive jurisdiction of the state and federal courts sitting in the state of Delaware and consent to personal jurisdiction of and venue in such courts with respect to any and all matters or disputes arising out of this Escrow Agreement.
4.6. Waiver of Jury Trial. TO THE EXTENT NOT PROHIBITED BY APPLICABLE LAW THAT CANNOT BE WAIVED, EACH PARTY HEREBY WAIVES, AND COVENANTS THAT IT WILL NOT ASSERT (WHETHER AS PLAINTIFF, DEFENDANT OR OTHERWISE), ANY RIGHT TO TRIAL BY JURY IN ANY FORUM IN RESPECT OF ANY ISSUE, CLAIM, DEMAND, ACTION OR CAUSE OF ACTION ARISING IN WHOLE OR IN PART UNDER, RELATED TO, BASED ON OR IN CONNECTION WITH THIS ESCROW AGREEMENT OR THE SUBJECT MATTER HEREOF, WHETHER NOW EXISTING OR HEREAFTER ARISING AND WHETHER SOUNDING IN TORT OR CONTRACT OR OTHERWISE. ANY PARTY HERETO MAY FILE AN ORIGINAL COUNTERPART OR A COPY OF THIS SECTION 4.6 WITH ANY COURT AS WRITTEN EVIDENCE OF THE CONSENT OF EACH SUCH PARTY TO THE WAIVER OF ITS RIGHT TO TRIAL BY JURY.
4.7. Assignment; Binding Effect. Except as permitted in Section 2.9, neither this Escrow Agreement nor any rights or obligations hereunder may be assigned by any party hereto without the express written consent of each of the other parties hereto. This Escrow Agreement shall inure to and be binding upon the parties hereto and their respective successors, heirs and permitted assigns.
4.8. Amendment and Waiver. The terms of this Escrow Agreement may be altered, amended, modified or revoked only by an instrument in writing signed by the Escrow Agent, resTORbio and the Requisite Investors. No course of conduct shall constitute a waiver of any terms or conditions of this
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Escrow Agreement, unless such waiver is specified in writing, and then only to the extent so specified. A waiver of any of the terms and conditions of this Escrow Agreement on one occasion shall not constitute a waiver of the other terms of this Escrow Agreement, or of such terms and conditions on any other occasion.
4.9. Severability. If any provision of this Escrow Agreement shall be held or deemed to be or shall in fact, be illegal, inoperative or unenforceable, the same shall not affect any other provision or provisions herein contained or render the same invalid, inoperative or unenforceable to any extent whatsoever.
4.10. Further Assurances. If at any time the Escrow Agent shall determine or be advised that any further agreements, assurances or other documents are reasonably necessary or desirable to carry out the provisions of this Escrow Agreement and the transactions contemplated by this Escrow Agreement, the parties shall execute and deliver any and all such agreements or other documents and do all things reasonably necessary or appropriate to carry out fully the provisions of this Escrow Agreement.
4.11. No Third Party Beneficiaries. This Escrow Agreement is for the sole benefit of the parties hereto, and their respective successors and permitted assigns, and nothing herein, express or implied, is intended to or shall confer upon any other person or entity any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Escrow Agreement. Additionally, any permitted assignee must also satisfy the Escrow Agents requirements set forth in Section 2.9.
4.12. Force Majeure. No party to this Escrow Agreement shall be liable to any other party hereto for losses due to, or if it is unable to perform its obligations under the terms of this Escrow Agreement because of, acts of God, fire, war, terrorism, floods, strikes, electrical outages, equipment or transmission failure, interruption or malfunctions of communications or power supplies, labor difficulties, actions of public authorities or other similar causes reasonably beyond its control.
4.13. Termination. This Escrow Agreement shall terminate upon the distribution by the Escrow Agent in accordance with this Escrow Agreement of all funds, equity and property held under this Escrow Agreement or upon the earlier Joint Written Direction.
4.14. Titles and Headings. All titles and headings in this Escrow Agreement are intended solely for convenience of reference and shall in no way limit or otherwise affect the interpretation of any of the provisions hereof.
4.15. Counterparts; Facsimile Execution. This Escrow Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Delivery of an executed signature page to this Escrow Agreement and agreements, certificates, instruments and documents entered into in connection herewith by facsimile or other electronic transmission (including Adobe PDF format) will be effective as delivery of a manually executed counterpart to this Escrow Agreement or such agreements, certificates, instruments and documents.
4.16. Entire Agreement; Effect of Definitive. This Escrow Agreement constitutes the entire agreement between the Escrow Agent and resTORbio and the Investors in connection with the subject matter of this Escrow Agreement, and no other agreement entered into between resTORbio and any Investor, or either of them, including, without limitation, and the Funding Agreement, shall be considered as adopted or binding, in whole or in part, upon the Escrow Agent notwithstanding that any such other agreement may be deposited with the Escrow Agent or the Escrow Agent may have knowledge thereof. The parties hereto acknowledge and agree that the Escrow Agent is not a party to, is not bound by, and has no duties or obligations under the Funding Agreement, that all references in this Escrow Agreement to the Funding Agreement are for convenience, and that the Escrow Agent shall have no implied duties beyond the express duties set forth in this Escrow Agreement.
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4.17. Procedures for Opening a New Account. IMPORTANT INFORMATION ABOUT PROCEDURES FOR OPENING A NEW ACCOUNT: To help the government fight the funding of terrorism and money laundering activities, Federal law requires all financial institutions to obtain, verify and record information that identifies each person who opens an account. When a party opens an account, the Escrow Agent must obtain each partys name, address, date of birth (as applicable), taxpayer or other government identification number or other appropriate information that will allow the Escrow Agent to identify such party. The Escrow Agent may also ask to see each partys drivers license, passport or other identifying documents. For parties that are business or other legal entities, the Escrow Agent may require such documents as it deems necessary to confirm the legal existence of the entity.
[Signature Page Follows]
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IN WITNESS WHEREOF, the parties hereto have caused this Escrow Agreement to be executed as of the date first above written.
PNC BANK, NATIONAL ASSOCIATION, as the | ||
Escrow Agent |
By: | /s/ Rachel Stastny |
Name: | Rachel Stastny |
Title: | Vice President |
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RESTORBIO, INC. |
By: | /s/ Chen Schor |
Name: | Chen Schor |
Title: | Chief Executive Officer |
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INVESTOR: | ||
By: | ||
By: | ||
By: |
| |
Name: |
| |
Title: |
| |
Address: | ||
Email: |
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Exhibit 10.2
CONTINGENT VALUE RIGHTS AGREEMENT
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH [***]. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
This CONTINGENT VALUE RIGHTS AGREEMENT (this Agreement), dated as of September 15, 2020 (the Effective Date), is entered into by and between (i) resTORbio, Inc., a Delaware corporation (Parent), and (ii) Computershare Inc., a Delaware corporation and its wholly owned subsidiary, Computershare Trust Company, N.A., a national banking association, jointly as Rights Agent (as defined below). Parent and Rights Agent agree, for the equal and proportionate benefit of all Holders (as hereinafter defined), as follows:
1. DEFINITIONS.
Capitalized terms used but not otherwise defined herein will have the meanings ascribed to them in the Merger Agreement (as defined below). As used in this Agreement, the following terms will have the following meanings:
1.1 Acting Holders means, at the time of determination, Holders of at least 20% of the outstanding CVRs.
1.2 Affiliate means, with respect to any Person, any other Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such Person. The term control (including the terms controlled by and under common control with) of any Person means the power to direct the management and policies of such Person, directly or indirectly, whether through the ownership of voting shares of the Person or actual control over the business and affairs of such Person.
1.3 Budget shall mean the budget attached hereto as Exhibit A.
1.4 Calendar Quarter means the successive periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect; provided, however that (a) the first Calendar Quarter shall commence on the Effective Date and shall end on the first September 30 thereafter, and (b) the last Calendar Quarter shall commence on the first day after the full Calendar Quarter immediately preceding the effective date of the termination or expiration of this Agreement and shall end on the effective date of the termination or expiration of this Agreement.
1.5 Clinical Trial means a clinical study conducted on certain numbers of human subjects (depending on the phase of the trial) that is designed to (a) establish that a pharmaceutical product is reasonably safe and tolerable for continued testing, (b) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed, or (c) support Marketing Approval of such pharmaceutical product or label expansion of such pharmaceutical product.
1.6 Clinical Trial Cap means US [***] less any fully burdened costs accrued or incurred by Parent or its Affiliates in connection with the CVR Clinical Trial(s), in accordance with the Budget, between the date of the Merger Agreement Date and the Effective Date.
1.7 Commercialize means to market, promote, distribute, import, export, offer to sell and/or sell the CVR Product, and Commercialization means commercialization activities related to the CVR Product, including activities relating to marketing, promoting, distributing, importing, exporting, offering for sale and/or selling the CVR Product.
1.8 Commercially Reasonable Efforts means the level of efforts consistent with the efforts that a Third Party of similar size and with similar resources as Parent, in the biopharmaceutical industry, typically devotes to a similar product of similar market potential, at a similar stage in its development or product life, taking into account development, commercial, legal and regulatory factors, such as efficacy, safety, patent and regulatory exclusivity, product profile, cost and availability of supply, the time and cost required to complete development, the competitiveness of the marketplace (including the proprietary position and anticipated market share of the product), the patent position with respect to such product (including the ability to obtain or enforce, or have obtained or enforced, such patent rights), the third-party patent landscape relevant to the product, the regulatory structure involved, the likelihood of obtaining Marketing Approval, the anticipated or actual profitability of the applicable product (but without taking into account the amount of any potential CVR Payments), anticipated or approved labeling, present and future market potential, competitive products and market conditions, pricing and reimbursement considerations, costs for development and costs for obtaining, prosecuting, maintaining and licensing relevant intellectual property rights, and other technical, commercial, legal, scientific, regulatory, and medical considerations, all based on conditions then prevailing. Notwithstanding anything to the contrary in this Agreement, (a) a Party makes no guarantee, and Commercially Reasonable Efforts does not mean, that such Party will actually accomplish the applicable task or objective or complete any particular phases of development or commercialization within any particular time horizons, (b) the use of Commercially Reasonable Efforts may, under certain circumstances, be consistent with the termination of the development, manufacture and/or Commercialization of the CVR Product, and (c) in no event shall the use of Commercially Reasonable Efforts require Parent to take or omit to take any action (including, without limitation, entering into any CVR Commercial Agreement) the approval of which would violate any fiduciary duties of Parents board of directors, as determined by Parents board of directors, acting reasonably and in good faith.
1.9 CVR(s) means the rights of Holders to receive contingent cash payments pursuant to the Merger Agreement and this Agreement.
1.10 CVR Clinical Trial(s) means the Planned Clinical Trial and the Proposed Clinical Trial.
1.11 CVR Commercial Agreement means a transaction or series of transactions between Parent or its Affiliates and any Partner that meets all of the following requirements:
(a) is memorialized in one or more binding, valid, and enforceable written agreements, the final form(s) of which (i) meets the requirements set forth in this Section 1.11 and are otherwise reasonably acceptable to Parent, and (ii) has been expressly approved by Parents board of directors, in its reasonable discretion;
(b) is entered into on or before September 30, 2021;
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(c) in which Parent or its Affiliate agrees to grant, sell, license or otherwise convey to Partner and/or its Affiliates the exclusive or co-exclusive rights to Commercialize the CVR Product in one or more fields of use in one or more countries or regions in the world;
(d) in which no proprietary technology, products or intangible tangible assets of Parent or its Affiliates (other than such proprietary technology, products or intangible tangible assets of Parent or its Affiliates regarding the CVR Product existing as of the Merger Agreement Date or generated pursuant to the Planned Protocol or the Proposed Protocol), including any rights associated therewith, are granted, sold, or otherwise conveyed by Parent or its Affiliates to Partner pursuant to the transaction;
(e) in which Partner or its Affiliate, collectively, is expressly obligated to reimburse Parents out-of-pocket and accrued costs and expenses incurred prior to the date of such transaction in connection with filing, prosecuting, and maintaining any patent rights relating to the CVR Product in the Partner Territory and in the Partner Field, to the extent such costs and expenses are not subject to reimbursement by any other Third Party;
(f) in which, from and after the date of such transaction, Partner or its Affiliate, collectively, shall be responsible for (i) preparing, filing, and prosecuting applications to obtain Marketing Approval for the CVR Product in the Partner Territory and directly paying all future costs and expenses incurred in connection therewith together with all accrued expenses of Parent and its Affiliates to facilitate the foregoing, and (ii) prosecuting and maintaining any patent rights relating to the CVR Product, in the Partner Territory and in the Partner Field (other than such patent rights as Partner or Parent may elect to abandon), on its own account or for the benefit of Parent or its Affiliate, and directly paying all future costs and expenses incurred in connection therewith together with all accrued expenses of Parent and its Affiliates to facilitate the foregoing;
(g) in which the payments received prior to the due date of the applicable Third-Party Payments by Parent from Partner or its Affiliate, collectively, for each CVR Payment Period shall not be less than the aggregate amounts of all Third-Party Payments owing for the same period;
(h) in which, from and after the effective date of such transaction, Partner or its Affiliate, collectively, shall be responsible for the development, manufacture, Marketing Approval, and Commercialization of the CVR Product in the relevant Partner Territory and directly paying all costs and expenses incurred in connection therewith; and
(i) in which the terms (i) provide that Parent and its Affiliates shall have no liability whatsoever regarding or in connection with the CVR Product or its the manufacture or use, (ii) make no representation and warranties on behalf of Parent and its Affiliates regarding or in connection with the CVR Product or its the manufacture or use, (iii) release Parent and its Affiliates from for all losses, liabilities, expenses, and damages incurred in connection with the CVR Product or its the manufacture or use, and (iv) require Partner to indemnify, defend, and hold harmless Parent and its Affiliates from any Third Party claims regarding or in connection with any of the foregoing.
1.12 CVR Payment means any payment under Section 2.4(a).
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1.13 CVR Payment Period means a period equal to a Calendar Quarter, prior to the expiration of the CVR Term, ending at any time after the effective date of the CVR Commercial Agreement.
1.14 CVR Payment Statement means, for a given CVR Payment Period during the CVR Term, a written statement of Parent, signed on behalf of Parent setting forth in reasonable detail the calculation of the applicable CVR Payment for such CVR Payment Period.
1.15 CVR Product means solely [***].
1.16 CVR Register has the meaning set forth in Section 2.3(b).
1.17 CVR Term means the period beginning on the Effective Date and ending upon (i) if a CVR Commercial Agreement is entered into prior to any expiration or termination of this Agreement, the latest date upon which Parent or any of its Affiliates is eligible to receive Gross Consideration under such CVR Commercial Agreement, or (ii) if a CVR Commercial Agreement is not entered into prior to any termination of this Agreement, the effective date of termination and/or expiration of this Agreement.
1.18 DTC means The Depository Trust Company or any successor thereto.
1.19 Finder means JMP Securities LLC or another Person that is a nationally recognized investment banking firm identified by the Company.
1.20 Finder Agreement means the Engagement Letter, dated as of September 10, 2020, between Parent and JMP Securities LLC, in the form agreed to with Company and Parent prior to the Effective Date.
1.21 FTE means the equivalent of one full-time employee or consultant of Parent or its Affiliate conducting the efforts described in Section 4.3(a) on behalf of Parent under this Agreement. In no event shall any one individual be counted as more than one (1) FTE.
1.22 Gross Consideration means the sum of all cash consideration actually received by Parent or its Affiliates during the CVR Term in consideration for the grant of rights to Commercialize the CVR Product under the CVR Commercial Agreement or any sublicense granted under such rights.
1.23 Holder means a Person in whose name a CVR is registered in the CVR Register at the applicable time.
1.24 IND means an investigational new drug application filed with the FDA for approval to commence Clinical Trials in the United States.
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1.25 Marketing Approval means, with respect to a pharmaceutical product, the registrations, authorizations and approvals of the applicable Regulatory Authority or other Governmental Authority in a particular country or region in the world that are necessary to market and sell or otherwise Commercialize such pharmaceutical product in such country or region.
1.26 Merger Agreement means that certain Agreement and Plan of Merger, dated as of April 28, 2020 (the Merger Agreement Date), as amended or restated from time to time, by and among Parent, Project Oasis Merger Sub, Inc., and Adicet Bio, Inc. (the Company).
1.27 Net Proceeds means, for any CVR Payment Period, Gross Consideration minus Permitted Deductions, all as calculated in accordance with Parents accounting practices and annual audited financial statements. For clarity, to the extent Permitted Deductions exceed Gross Consideration for any CVR Payment Period, any excess Permitted Deductions shall be applied against Gross Consideration in subsequent CVR Payment Periods.
1.28 Partner means any Third Party that enters into a transaction with Parent or its Affiliates for the Commercialization of the CVR Product as described in Section 4.3(a).
1.29 Partner Field means the field(s) of use in which a Partner is authorized to Commercialize the CVR Product pursuant to a CVR Commercial Agreement.
1.30 Partner Territory means the country(ies) and/or region(s) of the world in which a Partner is authorized to Commercialize the CVR Product pursuant to a CVR Commercial Agreement.
1.31 Party means Parent or the Rights Agent.
1.32 Payment Amount means, with respect to each CVR Payment and each Holder, an amount equal to such CVR Payment divided by the total number of CVRs and then multiplied by the total number of CVRs held by such Holder as reflected on the CVR Register (rounded downwards to the nearest whole cent).
1.33 Permitted Deductions means the sum of:
(a) applicable excise taxes, use taxes, tariffs, sales taxes and customs duties, and/or other government charges imposed on the Gross Consideration owed for the applicable CVR Payment Period;
(b) any offsets, credits, deductions, refunds, and chargebacks actually granted, allowed or incurred in connection with the CVR Product during the applicable CVR Payment Period;
(c) any applicable Third-Party Payments;
(d) any reasonable and documented out of pocket costs and expenses incurred for any ongoing efforts described in Section 4.3(a);
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(e) any reasonable and documented out-of-pocket costs incurred or accrued by Parent and its Affiliates in connection with the negotiation, entry into and closing of such CVR Commercial Agreement, including any accountant or attorneys fees;
(f) any aggregate losses, liabilities, damages, and expenses owing by Parent or its Affiliates arising out of any Third Party claims, demands, actions, or other proceedings relating to or in connection with the CVR Clinical Trial(s) and/or the CVR Product;
(g) any amounts paid or reimbursed by Parent pursuant to Section 3.2(g) or 3.2(i) or otherwise by Parent to the Rights Agent pursuant to or in connection with this Agreement, or incurred pursuant to Section 2.4(c); and
(h) an administration fee of 7.5% of all Gross Consideration received by Parent or its Affiliate for the applicable CVR Payment Period.
1.34 Permitted Transfer means a transfer of CVRs (a) upon death of a Holder by will or intestacy; (b) pursuant to a court order; (c) by operation of law (including by consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity; or (d) in the case of CVRs held in book-entry or other similar nominee form, from a nominee to a beneficial owner and, if applicable, through an intermediary, to the extent allowable by DTC.
1.35 Person shall mean any individual, partnership, joint venture, limited liability company, firm, corporation, unincorporated association or organization, trust or other entity, and shall include any successor (by merger or otherwise) of any of the foregoing.
1.36 Planned Clinical Trial means [***].
1.37 Planned Protocol means the protocol entitled [***].
1.38 Proposed Clinical Trial means [***].
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1.39 Proposed Protocol means [***].
1.40 Regulatory Authority means any national, regional, state or local regulatory authority, department, bureau, commission, council or other Governmental Authority within any country or region in the world (including the FDA) that is responsible for overseeing the development, use, manufacture, transport, storage or commercialization of the CVR Product in such country or region.
1.41 Rights Agent means the Rights Agent named in the first paragraph of this Agreement or any direct or indirect successor Rights Agent designated in accordance with the applicable provisions of this Agreement.
1.42 Third Party means any Person other than Parent, Rights Agent or their respective Affiliates.
1.43 Third-Party Payment(s) means all amounts owing by Parent or its Affiliates, including any applicable fees, success-based payments, milestone payments and/or royalties related thereto, to a Third Party that are related to the development, Marketing Approval, manufacture, or commercialization of the CVR Product, including, without limitation, all amounts owing by Parent under the Finder Agreement.
2. | CONTINGENT VALUE RIGHTS. |
2.1 CVRs. The CVRs represent the rights of Holders to receive contingent cash payments pursuant to this Agreement. The initial Holders will be the holders of Oasis Common Stock as of immediately prior to the Effective Time. One CVR will be issued with respect to each share of Oasis Common Stock that is outstanding as of immediately prior to the Effective Time (including, for the avoidance of doubt, those shares of Oasis Common Stock issued upon settlement of Oasis Restricted Stock Units pursuant to Section 6.8 of the Merger Agreement).
2.2 Nontransferable. The CVRs may not be sold, assigned, transferred, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than through a Permitted Transfer. The CVRs will not be listed on any quotation system or traded on any securities exchange.
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2.3 No Certificate; Registration; Registration of Transfer; Change of Address; CVR Distribution.
(a) The CVRs will be issued in book-entry form only and will not be evidenced by a certificate or other instrument.
(b) The Rights Agent shall create and maintain a register (the CVR Register) for the purpose of registering CVRs and Permitted Transfers. The CVR Register will be created, and CVRs will be distributed, pursuant to written instructions to the Rights Agent from Parent pursuant to Section 2.3(e). The CVR Register will initially show one position for Cede & Co. representing shares of Oasis Common Stock held by DTC on behalf of the street holders of the shares of Oasis Common Stock held by such holders as of immediately prior to the Effective Time. The Rights Agent will have no responsibility whatsoever directly to the street name holders with respect to transfers of CVRs. With respect to any payments to be made under Section 2.4 below, the Rights Agent will accomplish the payment to any former street name holders of shares Oasis Common Stock by sending one lump-sum payment to DTC. The Rights Agent will have no responsibilities whatsoever with regard to the distribution of payments by DTC to such street name holders.
(c) Subject to the restrictions on transferability set forth in Section 2.2, every request made to transfer a CVR must be in writing and accompanied by a written instrument of transfer in form reasonably satisfactory to the Rights Agent pursuant to its guidelines, including a guaranty of signature by an eligible guarantor institution that is a member or participant in the Securities Transfer Agents Medallion Program, duly executed by the Holder thereof, the Holders attorney duly authorized in writing, the Holders personal representative or the Holders survivor, and setting forth in reasonable detail the circumstances relating to the transfer. Upon receipt of such written notice, the Rights Agent shall, subject to its reasonable determination that the transfer instrument is in proper form and the transfer otherwise complies with the other terms and conditions of this Agreement (including the provisions of Section 2.2), register the transfer of the CVRs in the CVR Register. Parent and Rights Agent may require payment of a sum sufficient to cover any stamp or other tax or charge that is imposed in connection with any such registration of transfer. The Rights Agent shall have no duty or obligation to take any action under any section of this Agreement that requires the payment by a Holder of a CVR of applicable taxes or charges unless and until the Rights Agent is satisfied that all such taxes or charges have been paid. All duly transferred CVRs registered in the CVR Register will be the valid obligations of Parent and will entitle the transferee to the same benefits and rights under this Agreement as those held immediately prior to the transfer by the transferor. No transfer of a CVR will be valid until registered in the CVR Register.
(d) A Holder may make a written request to the Rights Agent to change such Holders address of record in the CVR Register. The written request must be duly executed by the Holder. Upon receipt of such written notice, the Rights Agent shall, subject to its reasonable determination that the written request is in proper form, promptly record the change of address in the CVR Register. The Acting Holders may, without duplication, make a written request to the Rights Agent for a list containing the names, addresses and number of CVRs of the Holders that are registered in the CVR Register. Upon receipt of such written request from the Acting Holders, the Rights Agent shall promptly deliver a copy of such list to the Acting Holders.
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(e) Parent will provide written instructions to the Rights Agent for the distribution of CVRs to holders of Oasis Common Stock as of immediately prior to the Effective Time (the Record Time). Subject to the terms and conditions of this Agreement and upon receipt of such instructions, which shall include a statement that the Effective Time has occurred, the Rights Agent shall effect the distribution of the CVRs, less any applicable tax withholding, to each holder of Oasis Common Stock as of the Record Time by the mailing of a statement of holding reflecting such CVRs.
2.4 Payment Procedures.
(a) Within sixty (60) days after the end of each CVR Payment Period during the CVR Term, commencing with the first CVR Payment Period in which Parent or its Affiliate receives Gross Consideration, Parent shall deliver to the Rights Agent a CVR Payment Statement for such CVR Payment Period. Concurrent with the delivery of each CVR Payment Statement, on the terms and conditions of this Agreement, Parent shall pay the Rights Agent in U.S. dollars an amount equal to one-hundred percent (100%) of the Net Proceeds (if any) for the applicable CVR Payment Period. For further clarity, any sale of CVR Products by Partner will not be included in Gross Consideration or Net Proceeds, and Parent shall not be obligated to make any payments to the Rights Agent regarding any proceeds based on such sales (it being understood that payments made by Partner to Parent or its Affiliates based on such sales will be included in Gross Consideration). Such amount of Net Proceeds will be transferred by wire transfer of immediately available funds to an account designated in writing by the Rights Agent not less than ten (10) Business Days prior to the date of the applicable payment. In the event that any Party determines that the calculation of Net Proceeds for a CVR Payment Period deviates from the amounts previously reported to the Rights Agent for any reason (such as, on account of additional amounts collected or product returns), Parent and the Rights Agent shall reasonably cooperate to reconcile any such deviations to the extent necessary under applicable legal or financial reporting requirements. Notwithstanding the foregoing and for the avoidance of doubt, the Rights Agent shall have no duty to verify the accuracy of any calculation by Parent of Net Proceeds for a CVR Payment Period, and the Rights Agent shall incur no liability for or in respect of any action taken, suffered or omitted to be taken by it under the provisions of this Agreement in reliance upon such calculation.
(b) The Rights Agent shall be solely responsible for the delivery of CVR Payment Statements and CVR Payments to each Holder and Parent shall have no responsibility or liability therefor, provided that the Rights Agent receives such Payment Statements and CVR Payments from Parent as contemplated herein. The Rights Agent shall promptly, and in any event within ten (10) Business Days after receipt of a CVR Payment Statement under Section 2.4(a), send each Holder at its address set forth in the CVR Register a copy of such statement. If the Rights Agent also receives any CVR Payment, then within ten (10) Business Days after the receipt of each CVR Payment, the Rights Agent shall also pay to each Holder, by check mailed to the address of each Holder as reflected in the CVR Register as of the close of business on the date of the receipt of the CVR Payment Statement, such Holders Payment Amount.
(c) All payments under this Agreement shall be made without any deduction or withholding for or on account of any tax or similar charge or levy, except as required by applicable law and as set forth in this Section 2.4(c). The Parties shall cooperate with one another and use
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reasonable efforts to minimize under applicable law obligations for any and all income or other taxes required by applicable law to be withheld or deducted from any payments made under this Agreement (Withholding Taxes), provided that notwithstanding anything to the contrary herein (i) the Rights Agent shall have no responsibilities with respect to tax withholding, reporting or payment except as required under applicable law or specifically instructed by Parent, and (ii) the Rights Agent shall be fully protected and incur no liability in relying on any instructions from Parent with respect to tax withholding, reporting or payment, or complying with its obligations under this Section 2.4(c). Parent shall, if required by applicable law, deduct or cause to be deducted from any amounts required to be paid under this Agreement an amount equal to such Withholding Taxes; provided that (i) Parent shall instruct the Rights Agent to solicit from each Holder an IRS Form W-9 or applicable IRS Form W-8 at such time or times as is necessary to permit any payment under this Agreement to be made without U.S. federal backup withholding, and (ii) in the event Parent becomes aware that a payment under this Agreement is subject to Withholding Taxes (other than U.S. federal backup withholding), Parent shall instruct the Rights Agent to use commercially reasonable efforts to provide written notice of such Withholding Taxes to the applicable Holders prior to paying such Withholding Taxes. For the avoidance of doubt, in the event that notice has been provided to an applicable Holder pursuant to clause (ii) of the immediately preceding sentence, no further notice shall be required to be given for any future payments of such Withholding Tax. Such Withholding Taxes shall be paid to the proper taxing authority by Parent for the applicable Holders account and, if available, evidence of such payment shall be secured and sent to the Rights Agent within thirty (30) days of such payment. Parent shall, at its sole cost and expense, as mutually agreed to with the other Parties, do all such lawful acts and things and sign all such lawful deeds and documents that Parent determines are reasonably necessary to enable Parent to avail itself of any applicable legal provision or any double taxation treaties with the goal of paying the sums due to the Holders hereunder without deducting any Withholding Taxes.
(d) If any funds delivered to the Rights Agent for payment to Holders as CVR Payments remain undistributed to the Holders on the date that is six (6) months after the date of the applicable CVR Payment Statement to which such CVR Payment relates, the Rights Agent will deliver to Parent or its designee any funds which had been made available to the Rights Agent in connection with such CVR Payment and not disbursed to the Holders, and, thereafter, such Holders shall be entitled to look to Parent (subject to abandoned property, escheat and other similar Laws) only as general creditors thereof with respect to such CVR Payments that may be payable (without interest).
(e) Neither Parent, the Rights Agent nor any of their affiliates shall be liable to any Holder for any CVR Payment delivered to a public official pursuant to any abandoned property, escheat or other similar laws. Any amounts remaining unclaimed by such Holders at such time at which such amounts would otherwise escheat to or become property of any governmental body shall become, to the extent permitted by applicable laws, the property of Parent or its designee, free and clear of all claims or interest of any Person previously entitled thereto. In addition to and not in limitation of any other indemnity obligation herein, Parent agrees to indemnify and hold harmless the Rights Agent with respect to any liability, penalty, cost or expense the Rights Agent may incur or be subject to in connection with transferring such property to Parent in accordance with the foregoing and applicable laws and regulations, except to the extent the foregoing has been determined by a final, non-appealable judgment of a court of competent jurisdiction to be a result of the Rights Agents gross negligence, bad faith or willful or intentional misconduct. The indemnification provided by this Section 2.4(e) shall survive the resignation, replacement or removal of the Rights Agent and the termination of this Agreement.
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2.5 No Voting, Dividends or Interest; No Equity or Ownership Interest in Parent.
(a) The CVRs will not have any voting or dividend rights, and interest will not accrue on any amounts payable on the CVRs to any Holder.
(b) The CVRs will not represent any equity or ownership interest in Parent or in any constituent company to the Merger. It is hereby acknowledged and agreed that a CVR shall not constitute a security of Parent.
(c) Nothing contained in this Agreement shall be construed as conferring upon any Holder, by virtue of the CVRs, any rights or obligations of any kind or nature whatsoever as a stockholder or member of Parent, the Company or any of their respective subsidiaries, as applicable, either at law or in equity. The rights of any Holder and the obligations of Parent and its Affiliates and their respective officers, directors and controlling Persons are contract rights limited to those expressly set forth in this Agreement.
3. | THE RIGHTS AGENT. |
3.1 Appointment of Rights Agents; Certain Duties and Responsibilities. Parent hereby appoints the Rights Agent to act as agent for Parent in accordance with the express terms and conditions hereof, and the Rights Agent hereby accepts such appointment. The Rights Agent shall not have any liability for any actions taken or not taken in connection with this Agreement, except to the extent of its willful misconduct, bad faith or gross negligence (in each case as determined by a final, non-appealable judgment of a court of competent jurisdiction).
3.2 Limitation on Duties and Responsibilities of Rights Agent. The Rights Agent undertakes to perform such duties and only such duties as are specifically set forth in this Agreement, and no implied covenants or obligations will be read into this Agreement against the Rights Agent. In addition:
(a) the Rights Agent may rely on and will be protected and incur no liability in acting or refraining from acting upon any resolution, certificate, statement, instrument, opinion, report, notice, request, direction, consent, order or other paper or document believed by it in the absence of bad faith to be genuine and to have been signed or presented by the proper party or parties;
(b) whenever the Rights Agent will deem it desirable that a matter be proved or established prior to taking, suffering or omitting any action hereunder, the Rights Agent may rely upon an officers certificate, which certificate shall be full authorization and protection to the Rights Agent, and the Rights Agent shall incur no liability and, except to the extent of its willful misconduct, bad faith or gross negligence as determined by a final, non-appealable judgment of a court of competent jurisdiction, be held harmless by Parent for or in respect of any action taken, suffered or omitted to be taken by it under the provisions of this Agreement in reliance upon such certificate;
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(c) the Rights Agent may engage and consult with counsel of its selection and the advice of such counsel or any opinion of counsel will be full and complete authorization and protection and will incur no liability in respect of any action taken, suffered or omitted by it hereunder in the absence of bad faith and in reliance thereon;
(d) the permissive rights of the Rights Agent to do things enumerated in this Agreement will not be construed as a duty;
(e) the Rights Agent will not be required to give any note or surety in respect of the execution of such powers or otherwise in respect of the premises;
(f) the Rights Agent will have no liability in respect of the validity of this Agreement or the execution and delivery hereof (except the due execution and delivery hereof by the Rights Agent and the enforceability of this Agreement against the Rights Agent assuming the due execution and delivery hereof by Parent); nor shall it be responsible for any breach by Parent or any other Person of any covenant or condition contained in this Agreement;
(g) Parent agrees to indemnify Rights Agent for, and hold Rights Agent harmless against, any loss, liability, damage, claim, judgment, fine, penalty, claim, demands, suits or expense (including the reasonable expenses and counsel fees and other disbursements) arising out of or in connection with Rights Agents preparation, delivery, negotiation, amendment, administration and execution of this Agreement and the exercise and performance of its duties hereunder, including the costs and expenses of defending Rights Agent against any claims, charges, demands, suits or loss, except to the extent such loss has been determined by a final, non-appealable judgment of a court of competent jurisdiction to be a result of Rights Agents gross negligence, bad faith or willful or intentional misconduct. The reasonable out-of-pocket costs and expenses incurred by the Rights Agent in enforcing this right of indemnification shall be paid by Parent;
(h) notwithstanding anything in this Agreement to the contrary, (i) the Rights Agent shall not be liable for special, punitive, indirect, incidental or consequential loss or damages of any kind whatsoever (including, without limitation, lost profits), even if the Rights Agent has been advised of the likelihood of such loss or damages, and regardless of the form of action, and (ii) any liability of the Rights Agent under this Agreement will be limited to the aggregate amount of fees (but not reimbursed expenses) paid or payable by Parent to the Rights Agent during the twelve (12) months immediately preceding the event for which recovery from the Rights Agent is being sought;
(i) Parent agrees to (i) pay the documented out-of-pocket fees and expenses of the Rights Agent in connection with this Agreement as agreed upon in writing by the Rights Agent and Parent on or prior to the date hereof, and (ii) reimburse the Rights Agent for all taxes and charges, reasonable expenses and other similar charges incurred by the Rights Agent in the execution of this Agreement (other than taxes imposed on or measured by the Rights Agents net income and franchise or similar taxes imposed on it). The Rights Agent will also be entitled to reimbursement from Parent for all reasonable and necessary out-of-pocket expenses paid or incurred by it in connection with the administration by the Rights Agent of its duties hereunder. No provision of this Agreement shall require the Rights Agent to expend or risk its own funds or
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otherwise incur any financial liability in the performance of any of its duties hereunder or in the exercise of its rights if there shall be reasonable grounds for believing that repayment of such funds or adequate indemnification against such risk or liability is not reasonably assured to it;
(j) the Rights Agent may execute and exercise any of the rights or powers hereby vested in it or perform any duty hereunder either itself or by or through its attorneys or agents, and the Rights Agent shall not be answerable or accountable for any act, omission, default, neglect or misconduct of any such attorneys or agents or for any loss to Parent, to the holders of the CVRs or any other Person resulting from any such act, omission, default, neglect or misconduct, absent gross negligence or bad faith in the selection and continued employment thereof (which gross negligence or bad faith must be determined by a final, non-appealable judgment of a court of competent jurisdiction);
(k) the Rights Agent and any stockholder, affiliate, member, director, officer, agent, representative or employee of the Rights Agent may buy, sell or deal in any of the securities of Parent or become pecuniarily interested in any transaction in which Parent may be interested, or contract with or lend money to Parent or otherwise act in accordance with applicable laws and regulations as fully and freely as though it were not the Rights Agent under this Agreement. Nothing herein shall preclude the Rights Agent or any such stockholder, affiliate, director, member, officer, agent, representative or employee from acting in any other capacity for Parent or for any other Person;
(l) the Rights Agent shall not be deemed to have knowledge of any event of which it was supposed to receive notice thereof hereunder, and the Rights Agent shall incur no liability for failing to take action in connection therewith, unless and until it has received such notice in writing;
(m) the Rights Agent shall not be subject to, nor be required to comply with, or determine whether any Person has complied with, the Merger Agreement or any other agreement between or among Parent or any Holder, even though reference thereto may be made in this Agreement, or to comply with any notice, instruction, direction, request or other communication, paper or document other than as expressly set forth in this Agreement;
(n) the Rights Agent shall not be liable for or by reason of any of the statements of fact or recitals contained in this Agreement or be required to verify the same, but all such statements and recitals are and shall be deemed to have been made by Parent only;
(o) the Rights Agent shall not have any duty or responsibility in the case of the receipt of any written demand from any Holder with respect to any action or default by Parent, including, without limiting the generality of the foregoing, any duty or responsibility to initiate or attempt to initiate any proceedings at law or otherwise or to make any demand upon Parent; and
(p) the provisions of this Section 3.2 shall survive the expiration of the CVRs and the termination of this Agreement and the resignation, replacement or removal of the Rights Agent.
3.3 Resignation and Removal; Appointment of Successor.
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(a) The Rights Agent may resign at any time by giving written notice thereof to Parent specifying a date when such resignation will take effect, which notice will be sent at least thirty (30) days prior to the date so specified. Parent may, in its sole discretion, remove the Rights Agent at any time by notice specifying a date when such removal will take effect. Such notice of removal will be given by Parent to the Rights Agent, which notice will be sent at least thirty (30) days prior to the date so specified.
(b) If the Rights Agent provides notice of its intent to resign, is removed or becomes incapable of acting, Parent shall as soon as is reasonably possible appoint a qualified successor Rights Agent who shall be a stock transfer agent of national reputation or the corporate trust department of a commercial bank. The successor Rights Agent so appointed will, forthwith upon its acceptance of such appointment in accordance with Section 3.4, become the successor Rights Agent.
(c) Parent shall use commercially reasonable efforts to give written notice of each resignation and each removal of a Rights Agent and each appointment of a successor Rights Agent to the Holders in accordance with Section 5.2. Each notice will include the name and address of the successor Rights Agent. If Parent fails to send such notice within ten days after acceptance of appointment by a successor Rights Agent, the successor Rights Agent will cause the notice to be mailed.
3.4 Acceptance of Appointment by Successor. Every successor Rights Agent appointed hereunder will execute, acknowledge and deliver to Parent and to the retiring Rights Agent an instrument accepting such appointment and a counterpart of this Agreement, and thereupon such successor Rights Agent, without any further act, deed or conveyance, will become vested with all the rights, powers, trusts and duties of the retiring Rights Agent. On request of Parent or the successor Rights Agent, the retiring Rights Agent will execute and deliver an instrument transferring to the successor Rights Agent all the rights (except such rights of predecessor rights agent which survive pursuant to Section 3.2 of this Agreement), powers and trusts of the retiring Rights Agent.
4. | COVENANTS. |
4.1 List of Holders. Parent shall furnish or cause to be furnished to the Rights Agent in such form as Parent receives from Parents transfer agent (or other agent performing similar services for Parent), the names and addresses of the Holders within thirty (30) Business Days of the Effective Time. Until such list of Holders is furnished to the Rights Agent, the Rights Agent shall have no duties, responsibilities or obligations with respect to such Holders.
4.2 CVR Clinical Trial(s).
(a) From the Effective Date through September 30, 2021, and subject to any limitations set forth in this Agreement, Parent shall, or shall cause its Affiliates to, use Commercially Reasonable Efforts to perform the key tasks necessary to (i) continue the Planned Clinical Trial in strict accordance with the Planned Protocol, and (ii) conduct the Proposed Clinical Trial in strict accordance with the Proposed Protocol.
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(b) Parent shall have no obligation to pay any fees and expenses for the CVR Clinical Trial(s) in the aggregate in excess of the Clinical Trial Cap. In the event that the total fees and expenses incurred by Parent to conduct the CVR Clinical Trials(s) exceed, in the aggregate, the Clinical Trial Cap, Parent may, in its sole discretion and upon written notice to the Rights Agent, terminate this Agreement without liability, whereupon Parent shall use commercially reasonable efforts to promptly notify the Holders in writing, and Parent shall be relieved of any and all obligations contained herein (other than obligations that expressly survive the termination of this Agreement). Without limiting the foregoing, in the event Parent anticipates that the total fees and expenses reasonably necessary to conduct the CVR Clinical Trial(s) will exceed, in the aggregate, the Clinical Trial Cap, Parent shall use commercially reasonable efforts to promptly notify the Rights Agent and the Holders in writing.
(c) Parent has no obligation to conduct any tasks relating to the CVR Clinical Trial(s) after September 30, 2021. In the event (i) the CVR Clinical Trial(s) are not completed by September 30, 2021, for any reason, or (ii) an applicable Regulatory Authority requires or requests additional testing or information beyond that which is in the possession and control of Parent prior to the Merger Agreement Date or produced (or expected to be produced) after the Merger Agreement Date pursuant to the Planned Protocol or the Proposed Protocol; Parent may, in its sole discretion and upon written notice to the Rights Agent, terminate its obligations under this Agreement with respect to Section 4.2(a) without liability whereupon Parent shall use commercially reasonable efforts to promptly notify the Holders in writing, and Parent shall be relieved of any and all obligations contained in Section 4.2(a).
(d) Parent has no obligation to make any modifications, improvements, alterations, or other changes to the CVR Product or the process of manufacture thereof. In the event the CVR Product or the process of manufacture thereof, requires any modifications, Parent may, in its sole discretion and upon written notice to the Rights Agent, terminate this Agreement without liability whereupon Parent shall use commercially reasonable efforts to promptly notify the Holders in writing, and Parent shall be relieved of any and all obligations contained herein (other than obligations that expressly survive the termination of this Agreement).
(e) Subject to the terms and conditions of this Agreement Parent shall have no obligation under this Agreement to develop any additional technology, conduct any additional Clinical Trials, or be responsible for any filings, approvals, and requests for information from any Regulatory Authority, for any reason related to the CVR Product.
(f) Parent shall have no obligation to take (or refrain from taking) any action which would trigger any payment owing to [***] or its Affiliates under that certain [***], between [***] and Parent, as may be amended from time to time, unless such payment is directly paid by a Partner or its Affiliates prior to the applicable due date.
4.3 CVR Commercial Agreement.
(a) Subject to Parents termination rights set forth in this Agreement, Parent shall, or shall cause its Affiliates to, use Commercially Reasonable Efforts to, through September 30, 2021, reasonably support Finder pursuant to the Finder Agreement in Finders efforts to
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identify one or more Partners and negotiate and complete a CVR Commercial Agreement with such Partner for the Commercialization of the CVR Product by Partner in one or more countries or regions in the world. Parent shall have no obligation to enter into any agreement for the Commercialization of the CVR Product that is not a CVR Commercial Agreement or to commit the use, in connection with its activities under this Section 4.3(a), of more than the budgeted FTE(s) specified for such activities in the Budget.
(b) Parent has no obligation to support Finder after September 30, 2021. If a CVR Commercial Agreement is not mutually agreed, duly executed, and delivered prior September 30, 2021, Parent may terminate, in its sole discretion and upon written notice to the Rights Agent, this Agreement without liability whereupon Parent shall use commercially reasonable efforts to promptly notify the Holders in writing, and Parent shall be relieved of any and all obligations contained herein (other than obligations that expressly survive the termination of this Agreement).
(c) Notwithstanding anything contained herein to the contrary, Parent shall not, and shall not permit its Affiliates to: (i) amend any CVR Commercial Agreement, or waive any right thereunder if such amendment or waiver materially and adversely affects the rights of the Holders to receive the CVR Payment hereunder, unless the Acting Holders consent to each such amendment or waiver, which shall not be unreasonably withheld, delayed, or conditioned; (ii) assign any CVR Commercial Agreement without the consent of the Acting Holders, which shall not be unreasonably withheld, delayed, or conditioned, unless such assignee agrees to assume all obligations under, and agrees to be bound in writing to the terms of, the CVR Commercial Agreement and this Agreement; or (iii) intentionally take any action for the principal purpose of reducing the amount of CVR Payment payable under this Agreement; provided, however, that Parent shall have no obligation to enforce the terms of the CVR Commercial Agreement against Partner or take any legal action against Partner in the event of an actual or alleged breach by Partner of the CVR Commercial Agreement.
(d) Prior to December 31, 2021 (the Outside Date), Parent shall not, and shall not permit its Affiliates to, grant, assign, transfer or otherwise convey any rights (including any option to obtain rights) to any Third Party to research, develop or Commercialize the CVR Product without obtaining the prior written consent of the Acting Holders, other than to (i) contract research, contract manufacturing and similar service providers engaged to perform services on Parent or its Affiliates behalf, (ii) a Partner pursuant to a CVR Commercial Agreement, or (iii) an Acquiror (as defined below) in connection with an Acquisition (as defined below).
(e) Parent shall promptly notify the Rights Agent and shall use commercially reasonable efforts to notify the Holders in writing of the execution of any CVR Commercial Agreement together with the latest date upon which Parent or any of its Affiliates is eligible to receive Gross Consideration under such CVR Commercial Agreement to the extent known. The Rights Agent may rely on such notice in carrying out its duties under this Agreement and shall not be deemed to have any knowledge of any CVR Commercial Agreement or whether Parent or any of its Affiliates is eligible to receive Gross Consideration under such CVR Commercial Agreement, unless and until it shall have received such notice.
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4.4 Books and Records. Parent shall, and shall cause its Affiliates to, keep true, complete and accurate records in sufficient detail to support the applicable Payment Amount payable hereunder in accordance with the terms specified in this Agreement.
4.5 Audits. Until the expiration or termination of this Agreement and for a period of one (1) year thereafter, Parent shall keep complete and accurate records in sufficient detail to support the accuracy of the payments due hereunder. The Acting Holders shall have the right to cause an independent internationally recognized accounting firm reasonably acceptable to Parent to audit such records for the sole purpose of confirming payments for a period covering not more than the preceding three (3) years. Parent may require such accounting firm to execute a reasonable confidentiality agreement with Parent prior to commencing the audit. The accounting firm shall disclose to the Acting Holders only whether the reports are correct or not and the specific details concerning any discrepancies. No other information shall be shared. Such audits may be conducted during normal business hours upon reasonable prior written notice to Parent, but no more than frequently than once per year. No accounting period of Parent shall be subject to audit more than one time hereunder unless after an accounting period has been audited by the Acting Holders, Parent restates its financial results for such accounting period, in which event the Acting Holders may conduct a second audit of such accounting period in accordance with this Section 4.5. Adjustments (including remittances of underpayments or overpayments disclosed by such audit) shall be made by the Parties to reflect the results of such audit, which adjustments shall be paid promptly following receipt of an invoice therefor. The Acting Holders causing such audit shall bear the full cost and expense of such audit unless such audit discloses an underpayment by Parent of twenty percent (20%) or more of the Payment Amount due under this Agreement, in which case Parent shall bear the full cost and expense of such audit.
5. OTHER PROVISIONS OF GENERAL APPLICATION.
5.1 Notices to Rights Agent, Parent. All requests, notices or other communications required or permitted to be given to the Parties hereto shall be given in writing, shall expressly reference the section(s) of this Agreement to which they pertain, and shall be delivered to the other Party, effective on receipt, at the appropriate address as set forth below or to such other addresses as may be designated in writing by the Parties from time to time during the term of this Agreement:
If to the Rights Agent, to it at:
Computershare Trust Company, N.A.
Computershare Inc.
150 Royall Street
Canton, MA 02021
Attn: Corporate Actions
With a copy to:
Computershare Trust Company, N.A.
Computershare Inc.
150 Royall Street
Canton, MA 02021
Attn: Legal Department
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If to Parent, to it at:
resTORbio, Inc.
500 Boylston Street, 13th Floor
Boston, Massachusetts 02116
Attn: Chen Schor, Chief Executive Officer
Email: cschor@restorbio.com
With copies to:
Goodwin Procter LLP
100 Northern Avenue Boston, Massachusetts 02210
Attn: Mitchel S. Bloom, Danielle M. Lauzon, Andrew H. Goodman
Email: mbloom@goodwinlaw.com, dlauzon@goodwinlaw.com,
agoodman@goodwinlaw.com
Morrison & Foerster LLP
12531 High Bluff Drive, Suite 100
San Diego, California 92130
Attention: James M. Krenn and John A. de Groot
Email: JKrenn@mofo.com, jdegroot@mofo.com
The Rights Agent or Parent may specify a different address or electronic mail address by giving notice in accordance with this Section 5.1.
5.2 Notice to Holders. Where this Agreement provides for notice to Holders, such notice will be sufficiently given (unless otherwise herein expressly provided) if in writing and mailed first-class postage prepaid, or sent by email, to each Holder affected by such event, at the Holders address as it appears in the CVR Register, not later than the latest date, and not earlier than the earliest date, if any, prescribed for the giving of such notice. In any case where notice to Holders is given by mail, neither the failure to mail such notice, nor any defect in any notice so mailed, to any particular Holder will affect the sufficiency of such notice with respect to other Holders.
5.3 Parent Successors and Assigns; Merger of Rights Agent.
(a) Parent may not assign this Agreement without the prior written consent of the Acting Holders, provided that (i) Parent may assign, in its sole discretion and without the consent of any other Party, any or all of its rights, interests and obligations hereunder to one or more Affiliates of Parent (each, an Assignee) provided that the Assignee agrees to assume and be bound by all of the terms of this Agreement, and (ii) Parent may assign this Agreement in its entirety without the consent of any other Party to its successor in interest in connection with the sale of all or substantially all of its assets or of its stock, or in connection with a merger, acquisition or similar transaction (such successor in interest, the Acquiror, and such transaction, the Acquisition). This Agreement will be binding upon, inure to the benefit of and be enforceable
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by Parents successors, acquirers and each Assignee. Each reference to Parent in this Agreement shall be deemed to include Parents successors, acquirers and all Assignees. Each of Parents successors, acquirers and assigns shall expressly assume by an instrument supplemental hereto, executed and delivered to the Rights Agent, the due and punctual payment of the CVR Payments and the due and punctual performance and observance of all of the covenants and obligations of this Agreement to be performed or observed by Parent.
(b) The Rights Agent may not assign this Agreement without the prior written consent of Parent, provided that the Rights Agent may assign this Agreement in its entirety without the consent of any other Parties to its successor in interest in connection with the sale of all or substantially all of its assets or of its stock, or in connection with a merger, acquisition or similar transaction. Any Person into which the Rights Agent or any successor Rights Agent may be merged or with which it may be consolidated, or any Person resulting from any merger or consolidation to which the Rights Agent or any successor Rights Agent shall be a party, or any Person succeeding to the stock transfer or other shareholder services business of the Rights Agent or any successor Rights Agent, shall be the successor to the Rights Agent under this Agreement without the execution or filing of any paper or any further act on the part of any of the Parties hereto, provided that such Person would be eligible for appointment as a successor Rights Agent under the provisions of the Agreement. The purchase of all or substantially all of the Rights Agents assets employed in the performance of transfer agent activities shall be deemed a merger or consolidation for purposes of this Section 5.3(b).
5.4 Benefits of Agreement. Nothing in this Agreement, express or implied, will give to any Person (other than the Rights Agent, Parent, Parents successors and assignees, and the Holders) any benefit or any legal or equitable right, remedy or claim under this Agreement or under any covenant or provision herein contained, all such covenants and provisions being for the sole benefit of the Rights Agent, Parent, Parents successors and assignees, and the Holders. The rights of Holders are limited to those expressly provided in this Agreement and the Merger Agreement. To the extent valid and binding under applicable law, all decisions of Acting Holders shall be final and binding on all Holders as if expressly confirmed and ratified by such Holders. Except for the rights of the Rights Agent set forth herein, the Acting Holders will have the sole right, on behalf of all Holders, by virtue of or under any provision of this Agreement, to (i) institute any action or proceeding at law or in equity with respect to this Agreement, (ii) negotiate and settle any dispute that arises under this Agreement after the Effective Time, (iii) confirm the satisfaction of Parents obligations under this Agreement and (iv) negotiate and settle matters with respect to the amounts to be paid to the Holders pursuant to this Agreement. For the avoidance of doubt, no individual Holder or other group of Holders (other than the Acting Holders) will be entitled to exercise such rights listed in the preceding sentence. Any recovery in connection with any action instituted by the Acting Holders shall be for the proportionate benefit of all the Holders. Each Holder agrees that such Holder shall not challenge or contest any action, inaction, determination or decision of the Acting Holders or the authority or power of the Acting Holders and shall not threaten, bring, commence, institute, maintain, prosecute or voluntarily aid any action, which challenges the validity of or seeks to enjoin the operation of any provision of this Agreement, including, without limitation, the provisions related to the authority of the Acting Holders to act on behalf of such Holder and all Holders as set forth in this Agreement (including, without limitation, with respect to any conflict any such Holder may have). Parent and the Rights Agent shall be entitled to rely upon, without independent investigation, any act, notice, instruction or
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communication from the Acting Holders and any document executed by the Acting Holders on behalf of any Holder and shall incur no liability in connection with any action or inaction taken or omitted to be taken in reliance thereon.
5.5 Severability. If any provision of this Agreement is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of this Agreement shall remain in full force and effect. Any provision of this Agreement held invalid or unenforceable only in part or degree shall remain in full force and effect to the extent not held invalid or unenforceable. The Parties further agree to replace such invalid or unenforceable provision of this Agreement with a valid and enforceable provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable provision; provided, however, that if such excluded provision shall affect the rights, immunities, liabilities, duties or obligations of the Rights Agent, the Rights Agent shall be entitled to resign immediately upon written notice to Parent.
5.6 Counterparts and Signature. This Agreement may be executed in two or more counterparts (including by electronic scan delivered by electronic mail), each of which shall be deemed an original but all of which together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each of the Parties hereto and delivered to the other Party, it being understood that the Parties need not sign the same counterpart.
5.7 Termination. Unless otherwise terminated earlier in accordance with this termination rights set forth in this Agreement, this Agreement will expire and be of no force or effect, the Parties hereto will have no liability hereunder (other than with respect to monies due and owing by Parent to Rights Agent or any other rights of the Rights Agent which expressly survive the termination of this Agreement), and no additional payments will be required to be made, upon the expiration or termination of the CVR Term; provided that the following provisions shall survive any termination or expiration of this Agreement and shall remain fully effective and enforceable thereafter: Section 2.4(e), Section 3.2, Section 4.3(c) (clause (iii) only), Section 4.3(d) (until the Outside Date) and Section 4.5 (for the one (1) year period specified therein).
5.8 Entire Agreement. Notwithstanding the reference to any other agreement hereunder, this Agreement contains the entire understanding of the Parties hereto and thereto with reference to the transactions and matters contemplated hereby and thereby and supersedes all prior agreements, written or oral, among the Parties with respect hereto and thereto. If and to the extent that any provision of this Agreement is inconsistent or conflicts with the Merger Agreement, this Agreement will govern and control.
5.9 Applicable Law; Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware, regardless of the laws that might otherwise govern under applicable principles of conflicts of laws. In any action or proceeding between the Parties arising out of or relating to this Agreement, each Party: (a) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the Court of Chancery of the State of Delaware or, to the extent such court does not have subject matter jurisdiction, the United States District Court for the District of Delaware or, to the extent that neither of the foregoing courts has jurisdiction, the Superior Court of the State of Delaware; (b) agrees that all claims in respect of such action or proceeding shall be heard and determined exclusively in accordance with clause (a) of this Section 5.9; (c) waives any objection to laying venue in any such action or proceeding in
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such courts; (d) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any such Party; and (e) agrees that service of process upon such Party in any such action or proceeding shall be effective if notice is given in accordance with Section 5.1 or Section 5.2 of this Agreement. In any action or proceeding between or among the Parties arising out of relating to this Agreement, each Party irrevocably and unconditionally waives the right to trial by jury.
5.10 Amendments. No amendment, modification or waiver of any provision of this Agreement shall be effective unless in writing and signed by duly authorized signatories of Parent and the Rights Agent; provided, however, that Parent and the Rights Agent may (without the consent of any other Person) amend this Agreement: (a) as may be necessary or appropriate to ensure that the CVRs are not subject to registration under the Securities Act, the Exchange Act or any applicable state securities or blue sky laws; (b) to evidence the succession of another Person to Parent and the assumption by such successor of the covenants of Parent herein; (c) to evidence the succession of another Person as a successor Rights Agent and the assumption by such successor of the covenants and obligations of the Rights Agent herein; (d) to cure any ambiguity, to correct or supplement any provision herein that may be defective or inconsistent with any other provision herein, or to make any other provisions with respect to matters or questions arising under this Agreement; provided that, in each case, such provisions do not adversely affect the interests of the Holders; or (e) any other amendments hereto for the purpose of adding, eliminating or changing any provisions of this Agreement, unless such addition, elimination or change is adverse to the interests of the Holders. Promptly after the execution by Parent and the Rights Agent of any amendment pursuant to subsections (a)-(e) of this Section 5.10, Parent will (or will cause the Rights Agent to) use commercially reasonable efforts to notify the Holders in general terms of the substance of such amendment in accordance with Section 5.2. The failure to deliver such notice, or any defect in such notice, shall not impair or affect the validity of such amendment to this Agreement. Upon the execution of any amendment under this Section 5.10, this Agreement will be modified in accordance therewith, such amendment will form a part of this Agreement for all purposes and each party and every Holder will be bound thereby. In executing any amendment permitted by this Section 5.10, the Rights Agent will be entitled to receive, and will incur no liability in relying upon, an opinion of counsel of Parent stating that the execution of such amendment is authorized or permitted by this Agreement. The Rights Agent may, but is not obligated to, enter into any such amendment that adversely affects the Rights Agents own rights, privileges, covenants or duties under this Agreement or otherwise. No supplement or amendment to this Agreement shall be effective unless duly executed by the Rights Agent.
5.11 Funds. All funds received by the Rights Agent under this Agreement that are to be distributed or applied by the Rights Agent in the performance of services hereunder (the Funds) shall be held by the Rights Agent as agent for Parent and deposited in one or more bank accounts to be maintained by the Rights Agent in its name as agent for Parent. Until paid pursuant to the terms of this Agreement, the Rights Agent will hold the Funds through such accounts in: deposit accounts of commercial banks with Tier 1 capital exceeding $1 billion or with an average rating above investment grade by S&P (LT Local Issuer Credit Rating), Moodys (Long Term Rating) and Fitch Ratings, Inc. (LT Issuer Default Rating) (each as reported by Bloomberg Finance L.P.). The Rights Agent shall have no responsibility or liability for any diminution of the Funds that may result from any deposit made by the Rights Agent in accordance with this paragraph, including any losses resulting from a default by any bank, financial institution or other Third Party. The
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Rights Agent may from time to time receive interest, dividends or other earnings in connection with such deposits. The Rights Agent shall not be obligated to pay such interest, dividends or earnings to Parent, any Holder or any other party.
5.12 Further Assurances. Each Party agrees that it will perform, execute, acknowledge and deliver or cause to be performed, executed, acknowledged and delivered all such further and other acts, instruments and assurances as may reasonably be necessary to effectuate the provisions of this Agreement.
5.13 Rules of Construction. Except as otherwise explicitly specified to the contrary, (a) references to a Section means a Section of this Agreement unless another agreement is specified, (b) the word including (in its various forms) means including without limitation, (c) references to a particular statute or regulation include all rules and regulations thereunder and any successor statute, rules or regulation, in each case as amended or otherwise modified from time to time, (d) words in the singular or plural form include the plural and singular form, respectively, (e) references to a particular Person include such Persons successors and assigns to the extent not prohibited by this Agreement and (f) all references to dollars or $ refer to United States dollars.
5.14 Force Majeure. Notwithstanding anything to the contrary contained herein, neither of the Rights Agent or Parent will be liable for any delays or failures in performance resulting from acts beyond its reasonable control including acts of God, pandemics (including COVID-19), terrorist acts, shortage of supply, breakdowns or malfunctions, interruptions or malfunctions of computer facilities, or loss of data due to power failures or mechanical difficulties with information storage or retrieval systems, labor difficulties, war or civil unrest.
{Remainder of page intentionally left blank}
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IN WITNESS WHEREOF, each of the Parties has caused this Contingent Value Rights Agreement to be executed on its behalf by its duly authorized officers, as of the day and year first above written.
RESTORBIO, INC. |
By: | /s/ Chen Schor |
Name: | Chen Schor | |
Title: | Chief Executive Officer |
COMPUTERSHARE TRUST COMPANY, N.A. and COMPUTERSHARE INC., | ||
On behalf of both entities |
By: | /s/ Collin Ekeogu |
Name: | Collin Ekeogu | |
Title: | Manager, Corporate Actions |
Exhibit A
Budget
(Attached).
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Exhibit B
Planned Protocol
(Attached).
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Exhibit 10.3
SECOND AMENDMENT
TO
LOAN AND SECURITY AGREEMENT
This Second Amendment to Loan and Security Agreement (this Amendment) is made and entered into as of September 14, 2020, by and between PACIFIC WESTERN BANK, a California state chartered bank (Bank), and ADICET BIO, INC. (Borrower).
RECITALS
Borrower and Bank are parties to that certain Loan and Security Agreement dated as of April 28, 2020 (as amended from time to time, the Agreement). The parties desire to amend the Agreement in accordance with the terms of this Amendment.
NOW, THEREFORE, the parties agree as follows:
1) | The following defined term in Exhibit A to the Agreement is hereby amended and restated, as follows: |
Credit Card Line means a Credit Extension of up to $250,000, to be used exclusively for the provision of Credit Card Services.
2) | Unless otherwise defined, all initially capitalized terms in this Amendment shall be as defined in the Agreement. The Agreement, as amended hereby, shall be and remain in full force and effect in accordance with its respective terms and hereby is ratified and confirmed in all respects. Except as expressly set forth herein, the execution, delivery, and performance of this Amendment shall not operate as a waiver of, or as an amendment of, any right, power, or remedy of Bank under the Agreement, as in effect prior to the date hereof. Borrower ratifies and reaffirms the continuing effectiveness of all agreements entered into in connection with the Agreement. |
3) | Borrower represents and warrants that the representations and warranties contained in the Agreement are true and correct as of the date of this Amendment. |
4) | This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument. |
5) | As a condition to the effectiveness of this Amendment, Bank shall have received, in form and substance satisfactory to Bank, the following: |
a) | this Amendment, duly executed by Borrower; |
b) | payment for all Bank Expenses incurred through the date of this Amendment, including Banks expenses for the documentation of this Amendment and any UCC, good standing or intellectual property search or filing fees, which may be debited from any of Borrowers accounts; and |
c) | such other documents and completion of such other matters, as Bank may reasonably deem necessary or appropriate. |
[Signature Page Follows]
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IN WITNESS WHEREOF, the undersigned have executed this Amendment as of the first date above written.
ADICET BIO, INC. | PACIFIC WESTERN BANK | |
By: /s/ Anil Singhal | By: /s/ Steve Kent | |
Name: Anil Singhal | Name: Steve Kent | |
Title: Chief Executive Officer | Title: Vice President |
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Exhibit 10.4
THIRD AMENDMENT TO
LOAN AND SECURITY AGREEMENT
This Third Amendment to Loan and Security Agreement (this Amendment) is entered into as of September 15, 2020, by and between PACIFIC WESTERN BANK, a California state chartered bank (Bank) and ADICET THERAPEUTICS, INC., a Delaware corporation formerly known as Adicet Bio, Inc. (Borrower).
RECITALS
Borrower and Bank are parties to that certain Loan and Security Agreement dated as of April 28, 2020 (as amended, restated, supplemented or otherwise modified from time to time, the Agreement). The parties desire to amend the Agreement in accordance with the terms of this Amendment.
NOW, THEREFORE, the parties agree as follows:
1) | Amendments. |
a) | A new Section 8.9 is added to the Agreement to read as follows: |
8.9 Guaranty. If any guaranty of all or a portion of the Obligations, including, without limitation, the Parent Guaranty (a Guaranty), ceases for any reason to be in full force and effect, or any guarantor fails to perform any obligation under any Guaranty or a security agreement securing any Guaranty (collectively, the Guaranty Documents), or any event of default occurs under any Guaranty Document or any guarantor revokes or purports to revoke a Guaranty, or any material misrepresentation or material misstatement exists now or hereafter in any warranty or representation set forth in any Guaranty Document or in any certificate delivered to Bank in connection with any Guaranty Document, or if any of the circumstances described in Sections 8.3 through 8.9 occur with respect to any guarantor.
b) | Exhibit A to the Agreement is amended by amending or restating, or adding, in appropriate alphabetical order, as applicable, the following defined terms to read as follows: |
Warrant means that certain Warrant to Purchase Stock issued by Guarantor to Bank dated as of September 15, 2020.
Guarantor means Adicet Bio, Inc., a Delaware corporation formerly named resTORbio, Inc., and its successors and assigns.
Parent Guaranty means that certain Unconditional Secured Guaranty executed by Guarantor in favor of Bank dated as of September 15, 2020.
2) | Unless otherwise defined, all initially capitalized terms in this Amendment shall be as defined in the Agreement. The Agreement, as amended hereby, shall be and remain in full force and effect in accordance with its terms. Except as expressly set forth herein, the execution, delivery, and performance of this Amendment shall not operate as a waiver of, or as an amendment of, any right, power, or remedy of Bank under the Agreement, as in effect prior to the date hereof. Borrower ratifies and reaffirms the continuing effectiveness of all agreements entered into in connection with the Agreement and the security interest as granted as of the Closing Date continues without novation. |
3) | Borrower represents and warrants that the representations and warranties contained in the Agreement are true and correct in all material respects as of the date of this Amendment (provided, that those representations and warranties expressly referring to another date shall be true and correct in all material respects as of such date, and provided further that any representation or warranty that contains a materiality qualification therein shall be true and correct in all respects). No Event of Default or failure of condition has occurred or exists, or |
would exist with notice or lapse of time or both under the Agreement or any other Loan Document. A true and correct copy of each of Borrowers and Guarantors certificate of incorporation and bylaws, as in effect as of the date of this Amendment have been delivered to Bank. |
4) | This Amendment and any documents executed in connection herewith or pursuant hereto contain the entire agreement between the parties with respect to the subject matter hereof and supersede all prior agreements, understandings, offers and negotiations, oral or written, with respect thereto and no extrinsic evidence whatsoever may be introduced in any judicial or arbitration proceeding, if any, involving this Amendment; except that any financing statements or other agreements or instruments filed by Bank with respect to Borrower shall remain in full force and effect. |
5) | This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument. |
6) | The terms of Article 11 of the Agreement are incorporated herein by this reference, mutatis mutandis. |
7) | As a condition to the effectiveness of this Amendment, Bank shall have received, in form and substance satisfactory to Bank, the following: |
a) | this Amendment, duly executed by Borrower and Bank; |
b) | the Warrant, duly executed by Guarantor and Bank; |
c) | the Parent Guaranty, duly executed by Guarantor, along with an officers certificate of Guarantor with respect to incumbency and resolutions authorizing the execution and delivery of the Parent Guaranty; |
d) | the Certificates for the Shares of Borrower, together with Assignment separate from Certificates, duly executed by Guarantor in blank; |
e) | duly executed copies of all agreements, documents and instruments entered in connection with that certain Agreement and Plan of Merger dated as of April 28, 2020; |
f) | a financing statement amendment (Form UCC-3) for Borrower; |
g) | a financing statement (Form UCC-1) for Guarantor; |
h) | updated Certificate of Incorporation and Bylaws for each of Borrower and Guarantor in connection with the name change; |
i) | payment of Bank Expenses, which may be debited from any of Borrowers deposit account maintained with Bank; and |
j) | such other documents and completion of such other matters, as Bank may reasonably deem necessary or appropriate. |
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
IN WITNESS WHEREOF, the undersigned have executed this Amendment as of the first date above written.
ADICET THERAPEUTICS, INC. | PACIFIC WESTERN BANK | |||||||
By: | /s/ Stewart Abbot |
By: | /s/ Steve Kent | |||||
Name: | Stewart Abbot |
Name: | Steve Kent | |||||
Title: | Chief Operating Officer and Chief Science Officer |
Title: | Vice President |
[SIGNATURE PAGE TO THIRD AMENDMENT TO LOAN AND SECURITY AGREEMENT]
Exhibit 10.5
THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED OR HYPOTHECATED IN THE ABSENCE OF A REGISTRATION STATEMENT IN EFFECT WITH RESPECT TO THE SECURITIES UNDER SUCH ACT OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED OR UNLESS SOLD PURSUANT TO RULE 144 OF SUCH ACT.
Issue Date: September 15, 2020
FORM OF WARRANT TO PURCHASE STOCK
THIS WARRANT TO PURCHASE STOCK (this Warrant) CERTIFIES THAT, for good and valuable consideration, Beech Hill Securities, Inc. (together with any successor or permitted assignee or transferee of this Warrant or of any shares issued upon exercise hereof, Holder) is entitled to purchase [●] shares (the Shares) of common stock (Common Stock) of Adicet Bio, Inc. (f/k/a resTORbio, Inc.), a Delaware corporation (the Company) at an exercise price per share (the Exercise Price) equal to $[●] per Share, subject to the provisions and upon the terms and conditions set forth in this Warrant.
This Warrant is issued pursuant to (i) Section 2(b)(i)(2) of that certain letter agreement among the Company, RM Global Partners, LLC (RMG) and Holder, dated February 19, 2019 and (ii) in connection with that certain Agreement and Plan of Merger, dated April 28, 2020, by and between the Company, Adicet Therapeutics, Inc. (f/k/a Adicet Bio, Inc.), a Delaware corporation, and Project Oasis Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of resTORbio (the Merger Agreement).
SECTION 1. EXERCISE.
1.1 Method of Exercise. Subject to the provisions hereof, Holder may at any time and from time to time exercise this Warrant during the Exercise Period (as defined below), in whole or in part:
a. | Cash Exercise Election. By delivering to the Company the original copy of this Warrant together with a duly executed Notice of Exercise in substantially the form attached hereto as Appendix 1 and a check, wire transfer of funds (to an account designated by the Company), or other form of payment acceptable to the Company in the amount obtained by multiplying the Exercise Price by the number of Shares being purchased as designated in the Notice of Exercise (the Aggregate Exercise Price). Such delivery shall be effective upon receipt by the Company. |
b. | Net Issue Election. Alternatively, in Holders sole discretion, by electing to receive, without payment by Holder of any additional consideration, shares of Common Stock equal to the value of the spread on the shares of Common Stock or any portion thereof by the surrender of this Warrant to the Company, together with a duly completed Net Issue Election Notice, in the form attached hereto as Appendix II, at the principal office of the Company, in which event the Company shall issue to Holder such number of shares of Common Stock as is computed using the following formula, rounded down to the nearest whole share: |
X = Y (A B)
A
Where: |
X= | The number of shares of Common Stock to be issued to Holder pursuant to the net issue election; | ||
Y= | The number of shares of Common Stock in respect of which the net issue election is made (inclusive of the shares of Common Stock surrendered to the Company in payment of the Aggregate Exercise Price); | |||
A= | The Fair Market Value (as determined below) of one share of Common Stock at the time the net issue election is made; and | |||
B= | The Exercise Price in effect under this Warrant as of the date of the net issue election. |
For purposes of this Section 1.1, Fair Market Value shall mean (i) if the Common Stock is traded regularly in a public market, the closing price of the Common Stock reported for the business day immediately before Holder delivers its Net Issue Election Notice to the Company and (ii) if the Common Stock is not traded regularly in a public market, the value most recently determined by the Companys Board of Directors (the Board) to represent the fair market value per share of Common Stock; and, if the Common Stock is not traded regularly in a public market, upon request of Holder, the Company shall promptly notify Holder of the Fair Market Value per share of the Common Stock subject to this Warrant. Notwithstanding the foregoing, if the Common Stock is not traded regularly in a public market and the Board has not made such a determination within the three-month period prior to the exercise date, then (1) the Board, in good faith, shall make a determination of the Fair Market Value per share of the Common Stock within 15 days of a request by Holder that it do so, and (2) the exercise of this Warrant pursuant to this Section 1.1(b) shall be delayed until such determination is made.
1.2 Exercise Period. Subject to the provisions hereof, this Warrant shall be exercisable at any time from and after the Issue Date listed above up to and including 5:00 p.m. (Pacific Time) on the first to occur of (a) the closing of any Acquisition, or (b) August 21, 2026 (such earlier date being referred to herein as the Expiration Date and such period, the Exercise Period). This Warrant shall terminate in its entirety on the Expiration Date. For the purposes of this Warrant, Acquisition means (a) any sale, license, or other disposition of all or substantially all of the assets (including intellectual property) of the Company and its subsidiaries taken as a whole, (b) any reorganization, consolidation, merger or sale of the voting securities of the Company or any other transaction where the holders of the Companys securities before the transaction beneficially own less than 50% of the outstanding voting securities of (1) the Company; (2) the surviving or resulting entity; or (3) if the surviving entity is a wholly owned subsidiary of another entity immediately following such transaction, the parent entity of such surviving or resulting entity (other than a bona fide equity financing principally for capital raising purposes in which the Company sells and issues equity securities to investors).
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1.3 Delivery of Certificate and New Warrant. Within a reasonable time after Holder exercises this Warrant in the manner set forth in Section 1.1 above, the Company shall (a)(x) provided that the Companys transfer agent is then participating in the Depository Trust Company (DTC) Deposit Withdrawal Agent Commission (DWAC) system, cause the Companys transfer agent to credit the number of Shares acquired to Holders account with DTC or (y) if the Companys transfer agent is not then participating in the DTC DWAC system, deliver to Holder a certificate representing the Shares issued to Holder upon such exercise and, if this Warrant has not been fully exercised and has not expired, a new warrant of like tenor representing the Shares not so acquired.
1.4 Replacement of Warrant. On receipt of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this Warrant and, in the case of loss, theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form, substance and amount to the Company or, in the case of mutilation, on surrender of this Warrant to the Company for cancellation, the Company shall, within a reasonable time, execute and deliver to Holder, in lieu of this Warrant, a new warrant of like tenor and amount.
1.5 Restrictions on Exercise; Compliance with Securities Laws. Notwithstanding anything to the contrary herein, this Warrant may only be exercised if (a) such exercise complies with applicable securities laws and (b) at the time of such exercise, Holder is an accredited investor within the meaning of Regulation D promulgated under the Act. Holder agrees to take such actions and execute such documents as reasonable requested by the Company to evidence the foregoing.
SECTION 2. ADJUSTMENTS TO THE SHARES AND EXERCISE PRICE.
2.1 Stock Splits or Combinations. If the Company subdivides the outstanding shares of Common Stock by reclassification or otherwise into a greater number of shares, the number of Shares purchasable hereunder (the Warrant Shares) shall be proportionately increased and the Exercise Price shall be proportionately decreased. If the outstanding shares of Common Stock are combined or consolidated, by reclassification or otherwise, into a lesser number of shares, the Exercise Price shall be proportionately increased and the number of Shares shall be proportionately decreased.
2.2 Reclassification, Exchange, Conversion or Substitution. Upon any event whereby all of the outstanding shares of Common Stock are reclassified, exchanged, converted, substituted, or replaced for, into, with or by Company securities of a different class and/or series, then from and after the consummation of such event, (i) this Warrant will be exercisable for the number, class and series of Company securities that Holder would have received had the Shares been outstanding on and as of the consummation of such event and (ii) if such event results in a change in the number of Company securities for which this Warrant is then exercisable into, the Exercise Price shall be proportionately adjusted, in each case subject to further adjustment thereafter from time to time in accordance with the provisions of this Warrant. The provisions of this Section 2.2 shall similarly apply to successive reclassifications, exchanges, conversions, substitutions or other similar events.
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2.3 Stock Dividend. If the Company shall, at any time or from time to time after the Issue Date, pay a dividend or make any other distribution upon the Common Stock or any other capital stock of the Company payable in shares of Common Stock, the Exercise Price in effect immediately prior to any such dividend or distribution shall be proportionately reduced and the number of Warrant Shares issuable upon exercise of this Warrant shall be proportionately increased. Any adjustment under this Section 2.3 shall become effective at the close of business on the date the dividend becomes effective.
2.4 Certain Events. If any event of the type contemplated by the provisions of this Section 2 but not expressly provided for by such provisions occurs, then the Board shall make an appropriate adjustment in the Exercise Price and the number of Warrant Shares issuable upon exercise of this Warrant so as to protect the rights of the Holder in a manner consistent with the provisions of this Section 2; provided, that no such adjustment pursuant to this Section 2.4 shall increase the Exercise Price or decrease the number of Warrant Shares issuable as otherwise determined pursuant to this Section 2.
2.5 No Fractional Share. No fractional Share shall be issuable upon exercise of this Warrant and the number of Shares to be issued shall be rounded down to the nearest whole Share.
2.6 Notice/Certificate as to Adjustments. Upon each adjustment of the Exercise Price and/or number of Shares, the Company shall notify Holder in writing within a reasonable time setting forth the adjustments to the Exercise Price and/or number of Shares and facts upon which such adjustment is based.
SECTION 3. INVESTMENT REPRESENTATIONS.
Holder hereby represents and warrants to the Company:
3.1 Purchase for Own Account. Holder is acquiring this Warrant and all equity securities issuable, directly or indirectly, upon exercise of the Warrants (collectively, the Securities) for Holders own account not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that Holder has no present intention of selling, granting any participation in, or otherwise distributing the same. The acquisition by Holder of any of the Securities shall constitute confirmation of the representation by Holder that Holder does not have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participations to such person or to any third person, with respect to any of the Securities.
3.2 Disclosure of Information. Holder further represents that it has had an opportunity to ask questions and receive answers from the Company regarding the terms and conditions of the offering of the Securities and the business, properties, prospects and financial condition of the Company. With respect to any projections of its future operations provided to Holder by the Company, Holder acknowledges that the Company makes no representations or warranties.
3.3 Investment Experience. Holder is an investor in securities of companies in the development stage and acknowledges that it is able to fend for itself, can bear the economic risk of its investment, and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment in the Securities. Holder
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acknowledges that any investment in the Securities involves a high degree of risk, and represents that it is able, without materially impairing its financial condition, to hold the Securities for an indefinite period of time and to suffer a complete loss of its investment.
3.4 Accredited Investor. Holder is an accredited investor within the meaning of SEC Rule 501 of Regulation D, as presently in effect and, for the purpose of Section 25102(f) of the California Corporations Code, Holder is excluded from the count of purchasers pursuant to Rule 260.102.13 thereunder.
3.5 Restricted Securities. Holder understands that the Securities are characterized as restricted securities under the federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Securities Act of 1933, as amended (the Securities Act) only in certain limited circumstances. In this connection, Holder represents that it is familiar with SEC Rule 144, as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act. HOLDER UNDERSTANDS AND ACKNOWLEDGES HEREIN THAT AN INVESTMENT IN THE COMPANYS SECURITIES INVOLVES AN EXTREMELY HIGH DEGREE OF RISK AND MAY RESULT IN A COMPLETE LOSS OF HIS, HER OR ITS INVESTMENT. Holder understands that the Securities have not been and will not be registered under the Securities Act and have not been and will not be registered or qualified in any state in which they are offered, and thus Holder will not be able to resell or otherwise transfer his, her or its Securities unless they are registered under the Securities Act and registered or qualified under applicable state securities laws, or an exemption from such registration or qualification is available. Holder has no immediate need for liquidity in connection with this investment, does not anticipate that the Investor will be required to sell his, her or its Securities in the foreseeable future.
3.6 Reliance by Company. Holder understands that the representations, warranties, covenants and acknowledgements set forth in this Section 3 constitute a material inducement to the Company entering into this Warrant.
3.7 Foreign Investors. If Holder is not a United States person (as defined by Section 7701(a)(30) of the Internal Revenue Code), Holder hereby represents that it has satisfied itself as to the full observance of the laws of its jurisdiction in connection with any invitation to subscribe for the Securities or any use of this Warrant, including (i) the legal requirements within its jurisdiction for the purchase of the Securities, (ii) any foreign exchange restrictions applicable to such purchase, (iii) any governmental or other consents that may need to be obtained, and (iv) the income tax and other tax consequences, if any, that may be relevant to the purchase, holding, redemption, sale, or transfer of the Securities. Holders subscription and payment for and continued beneficial ownership of the Securities will not violate any applicable securities or other laws of Holders jurisdiction.
3.8 Residence. If Holder is an individual, then Holder resides in the state or province identified in the address of Holder set forth on the signature pages hereto; if Holder is a partnership, corporation, limited liability company or other entity, then the office or offices of Holder in which its principal place of business is identified in the address or addresses of Holder set forth on the signature pages hereto.
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3.9 No Bad Actor Disqualification Events. Neither (i) Holder, (ii) any of its directors, executive officers, other officers that may serve as a director or officer of any company in which it invests, general partners or managing members, nor (iii) any beneficial owner of the Companys voting equity securities (in accordance with Rule 506(d) of the Securities Act) held by Holder is subject to any of the bad actor disqualifications described in Rule 506(d)(1)(i) through (viii) under the Securities Act.
SECTION 4. MISCELLANEOUS.
4.1 [Reserved].
4.2 Governing Law. This Warrant is to be construed in accordance with and governed by the internal laws of the State of Delaware without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of Delaware to the rights and duties of the parties.
4.3 Dispute Resolution. The parties hereby irrevocably and unconditionally (a) submit to the jurisdiction of the federal and state courts located within the geographical boundaries of the United States District Court for the Northern District of California for the purpose of any suit, action or other proceeding arising out of or based upon this Warrant, (b) agree not to commence any suit, action or other proceeding arising out of or based upon this Warrant except in the federal and state courts located within the geographical boundaries of the United States District Court for the Northern District of California, and (c) hereby waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Warrant or the subject matter hereof may not be enforced in or by such court.
4.4 Waiver of Right to Jury Trial. EACH OF HOLDER AND THE COMPANY, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY AS TO ANY ISSUE RELATING HERETO IN ANY ACTION, PROCEEDING OR COUNTERCLAIM ARISING OUT OF OR RELATING TO THIS NOTE.
4.5 Counterparts. This Warrant may be executed in several counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including PDF or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., DocuSign) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes
4.6 Titles and Subtitles. The titles and subtitles used in this Warrant are used for convenience only and are not to be considered in construing or interpreting this Warrant.
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4.7 Notices.
(a) Except as may be otherwise provided herein, all notices, requests, waivers and other communications made pursuant to this Warrant shall be in writing and shall be conclusively deemed to have been duly given (i) when hand delivered to the other party; (ii) when sent by facsimile to the number set forth below if sent between 8:00 a.m. and 5:00 p.m. recipients local time on a business day, or on the next business day if sent by facsimile to the number set forth below if sent other than between 8:00 a.m. and 5:00 p.m. recipients local time on a business day, or when sent by electronic mail to the address set forth below if sent between 8:00 am and 5:00 pm recipients local time on a business day, or on the next business day if sent by electronic mail other than between 8:00 am and 5:00 pm recipients local time; (iii) three business days after deposit in the U.S. mail with first class or certified mail receipt requested postage prepaid and addressed to the other party at the address set forth below; or (iv) the next business day after deposit with a national overnight delivery service, postage prepaid, addressed to the parties as set forth below with next business day delivery guaranteed, provided that the sending party receives a confirmation of delivery from the delivery service provider. Each person making a communication hereunder by facsimile or electronic mail shall promptly attempt to confirm by telephone to the person to whom such communication was addressed each communication made by it by facsimile or electronic mail pursuant hereto but the absence of such confirmation shall not affect the validity of any such communication. A party may change or supplement the addresses given above, or designate additional addresses, for purposes of this Section 4.7 by giving the other party written notice of the new address in the manner set forth above.
(b) The Company agrees to provide no less than fifteen (15) calendar days advance written notice to Holder of any Acquisition to enable Holder to elect to exercise this Warrant as provided herein.
4.8 Transfer. This Warrant and the Shares issuable upon exercise of this Warrant may not be transferred or assigned in whole or in part except (i) with the prior written consent of the Company; provided, that such consent shall not be required in connection with (a) a transfer to any affiliate of Holder, (b) a transfer to RMG or its affiliates or (c) subject to compliance with Section 4.1, a transfer of the Shares (or the securities issuable, directly or indirectly, upon conversion of the Shares, if any) following the Closing Date (as defined in the Merger Agreement) and (ii) in each case in compliance with applicable securities laws by the transferor and the transferee (including, without limitation, the delivery of investment representation letters and legal opinions reasonably satisfactory to the Company, as reasonably requested by the Company). Any subsequent transferee shall agree in writing with the Company to be bound by all of the terms and conditions of this Warrant and make to the Company each of the representations and warranties set forth in Section 3 of this Warrant as of the date of such transfer.
4.9 [Reserved].
4.10 Legends. The Securities shall have such legends as deemed required by the Company for applicable securities laws, the Companys organizational documents, and any other agreement the Securities are subject to.
4.11 No Stockholder Rights. Holder, as a Holder of this Warrant, will not have any rights as a stockholder of the Company until the exercise of this Warrant.
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4.12 Modification and Waiver. Any term of this Warrant may be amended and the observance of any term of this Warrant may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the written consent of the Company and Holder.
[Balance of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, the parties have caused this Warrant to Purchase Stock to be executed by their duly authorized representatives effective as of the Issue Date written above.
COMPANY: | ||
ADICET BIO, INC. | ||
By: |
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Name: | Chen Schor | |
Title: | Chief Executive Officer | |
Address: | 200 Constitution Drive | |
Menlo Park, CA 94025 | ||
Attention: Chen Schor | ||
Facsimile: |
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Email: |
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HOLDER: | ||
BEECH HILL SECURITIES, INC. | ||
By: |
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Name: |
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Title: |
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Address: |
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Email: |
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APPENDIX 1
NOTICE OF EXERCISE
1. The undersigned Holder hereby exercises its right to purchase ___________ shares of the Common Stock of Adicet Bio, Inc. (f/k/a resTORbio, Inc.), a Delaware corporation (the Company) in accordance with the attached Warrant to Purchase Stock (the Warrant), and tenders payment of the Aggregate Exercise Price (as defined in the Warrant) for such shares as follows:
[ ] check in the amount of $ payable to order of the Company enclosed herewith.
[ ] Wire transfer of immediately available funds to the Companys account.
2. By its execution below and for the benefit of the Company, Holder hereby restates each of the representations and warranties in Section 3 of the Warrant as of the date hereof.
HOLDER: | ||
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By: |
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Name: |
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Title: |
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Address: |
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Date: |
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APPENDIX II
NOTICE OF NET ISSUE ELECTION NOTICE
(To be signed only on net issue exercise of the Warrant)
1. The undersigned, the holder of the within Warrant (as defined below), hereby irrevocably elects to exercise this Warrant with respect to shares of Common Stock of Adicet Bio, Inc. (f/k/a resTORbio, Inc.), a Delaware corporation (the Company), in accordance with the attached Warrant to Purchase Stock (the Warrant), and tenders payment of the Aggregate Exercise Price pursuant to the net issue election provisions set forth in Section 1.1(b) of the Warrant.
2. By its execution below and for the benefit of the Company, Holder hereby restates each of the representations and warranties in Section 3 of the Warrant as of the date hereof.
HOLDER: | ||
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By: |
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Name: |
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Title: |
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Address: |
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Date: |
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Exhibit 10.6
THIS WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE SOLD, PLEDGED OR OTHERWISE TRANSFERRED EXCEPT IN ACCORDANCE WITH THE TERMS OF THIS WARRANT AND APPLICABLE LAW.
WARRANT TO PURCHASE STOCK
Corporation: | ADICET BIO, INC. | |
Number of Shares: | See below. | |
Class of Stock: | Common Stock | |
Initial Exercise Price: | $11.32 per share | |
Issue Date: | September 15, 2020 | |
Expiration Date: | April 28, 2027 |
THIS WARRANT CERTIFIES THAT, for good and valuable consideration, the receipt of which is hereby acknowledged, PACWEST BANCORP or its assignee or transferee (Holder) is entitled to purchase the number of fully paid and nonassessable shares of the class of securities (the Shares) of the corporation (the Company) at the initial exercise price per Share (the Warrant Price) all as set forth above and as adjusted pursuant to Article 2 of this warrant, subject to the provisions and upon the terms and conditions set forth in this warrant. This warrant shall be exercisable for 5,301 Shares on the Issue Date and shall be exercisable for an additional number of Shares equal to (a) 1.00% of the aggregate original principal amount of all Term Loans made pursuant to the Loan and Security Agreement (the Loan Agreement), dated as of April 28, 2020, between Adicet Therapeutics, Inc. (f/k/a Adicet Bio, Inc.) and Pacific Western Bank, as may be amended from time to time, divided by (b) the Warrant Price (subject to appropriate adjustment in the event of a stock dividend, stock split or other similar event affecting the Shares). For the avoidance of doubt, in no event shall this warrant be exercisable for more than 15,904 Shares (subject to appropriate adjustment in the event of a stock dividend, stock split or other similar event affecting the Shares).
ARTICLE 1
EXERCISE
1.1 Method of Exercise. Holder may exercise this warrant by delivering this warrant and a duly executed Notice of Exercise in substantially the form attached as Appendix 1 to the principal office of the Company. Unless Holder is exercising the conversion right set forth in Section 1.2, Holder shall also deliver to the Company a check, a wire transfer (to an account designated by the Company) or other form of payment acceptable to the Company for the aggregate Warrant Price for the Shares being purchased.
1.2 Conversion Right. In lieu of exercising this warrant as specified in Section 1.1, Holder may from time to time convert this warrant, in whole or in part, into a number of Shares determined by dividing (a) the aggregate fair market value of the Shares or other securities otherwise issuable upon exercise of this warrant minus the aggregate Warrant Price of such Shares by (b) the fair market value of one Share. The fair market value of the Shares shall be determined pursuant to Section 1.3.
1.3 Fair Market Value. If the Shares are traded regularly in a public market, the fair market value of the Shares shall be the closing price of the Shares reported for the business day immediately before Holder delivers its Notice of Exercise to the Company. If the Shares are not regularly traded in a public market, the Board of Directors of the Company shall determine fair market value in its reasonable good faith judgment.
1.4 Delivery of Certificate and New Warrant. Promptly after Holder exercises or converts this warrant, the Company shall (a)(x) provided that the Companys transfer agent is then participating in the Depository Trust Company (DTC) Deposit Withdrawal Agent Commission (DWAC) system, cause the Companys transfer agent to credit the number of Shares acquired to Holders account with DTC or (y) if the Companys transfer agent is not then participating in the DTC DWAC system, deliver to Holder certificates for the Shares acquired and (b) if this warrant has not been fully exercised or converted and has not expired, a new warrant representing the Shares not so acquired.
1.5 Replacement of Warrants. On receipt of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this warrant and, in the case of loss, theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form and amount to the Company or, in the case of mutilation, on surrender and cancellation of this warrant, the Company at its expense shall execute and deliver, in lieu of this warrant, a new warrant of like tenor.
1.6 Treatment of Warrant Upon Acquisition of the Company.
1.6.1 Acquisition. For the purpose of this warrant, Acquisition means (a) any sale, license, or other disposition of all or substantially all of the assets (including intellectual property) of the Company, (b) any reorganization, consolidation, merger or sale of the voting securities of the Company or any other transaction where the holders of the Companys securities before the transaction beneficially own less than 50% of the outstanding voting securities of (1) the Company; (2) the surviving or resulting entity; or (3) if the surviving entity is a wholly owned subsidiary of another entity immediately following such transaction, the parent entity of such surviving or resulting entity (other than a bona fide equity financing principally for capital raising purposes in which the Company sells and issues equity securities to investors).
1.6.2 Exercise Upon Acquisition. Upon the closing of any Acquisition, if the fair market value of the consideration per Share to be received by the Companys stockholders consists of cash, marketable securities, or a combination of both cash and marketable securities (as determined pursuant to Section 1.3) and is greater than the Warrant Price, this warrant shall be deemed to have been automatically converted pursuant to Section 1.2, without any further action by the Holder, even if this warrant is not surrendered and without the issuance of any certificate for Shares hereunder, and thereafter Holder shall participate in the Acquisition on the same terms as other holders of the same class of securities of the Company; provided, however, that if the fair market value of the Shares, as determined pursuant to Section 1.3, in connection with such Acquisition is less than the aggregate Warrant Price, then this warrant shall terminate without exercise or conversion immediately prior, and subject, to the closing of such Acquisition.
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1.6.3 Assumption of Warrant. Upon the closing of any Acquisition not referred to in Section 1.6.2, the successor entity shall assume the obligations of this warrant, and this warrant shall thereafter be exercisable for the same securities and/or other property as would have been paid for the Shares issuable upon exercise of the unexercised portion of this warrant as if such Shares were outstanding on and as of the closing of such Acquisition, subject to further adjustment from time to time in accordance with the provisions of this warrant.
1.7 Rule 144. With a view to making available to Holder the benefits of Rule 144 (or its successor rule) (Rule 144) promulgated under the Securities Act of 1933, as amended (the Securities Act) to sell Shares delivered to Holder upon exercise of this warrant, the Company agrees, at the Companys sole expense, to:
(a) use its commercially reasonable efforts to file with the SEC in a timely manner (or obtain extensions in respect thereof and file within the applicable grace period) all reports and other documents (other than Current Reports on Form 8-K) required of the Company under Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, (the Exchange Act) so long as (1) the Company remains subject to such requirements under Section 13 or 15(d) of the Exchange Act, (2) the filing of such reports and other documents is required to satisfy the current public information requirements of Rule 144(c)(1) and (3) and it is necessary for the Company to satisfy the current public information requirements of Rule 144(c)(1) for the Holder to offer, sell or otherwise transfer such Shares pursuant to Rule 144 (assuming the Holder is not an affiliate (as defined in Rule 144) of the Companys, and that has not been an affiliate (as defined in Rule 144) of the Companys during the immediately preceding three months);
(b) promptly upon request of the Holder furnish to Holder, (i) a written statement by the Company that it has complied in all material respects with the requirements of Rule 144(c)(1)(i) and (ii), and (ii) such other information, if any, as may be reasonably requested to permit Holder to sell such securities pursuant to Rule 144 without registration, in each case, so long as (1) Holder owns such Shares, (2) the Company is required to file with the SEC reports and other documents under Section 13 or 15(d) of the Exchange Act, (3) the filing of such reports and other documents is required to satisfy the current public information requirements of Rule 144(c)(1) and (4) and it is necessary for the Company to satisfy the current public information requirements of Rule 144(c)(1) for the Holder to offer, sell or otherwise transfer such Shares pursuant to Rule 144 (assuming the Holder is not an affiliate (as defined in Rule 144) of the Companys, and that has not been an affiliate (as defined in Rule 144) of the Companys during the immediately preceding three months); and
(c) take such additional action as is reasonably requested by Holder to enable Holder to sell the Shares pursuant to Rule 144, including, without limitation, delivering all such legal opinions consents, certificates, resolutions and instructions to the Companys transfer agent as may be reasonably requested from time to time by Holder.
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ARTICLE 2
ADJUSTMENTS TO THE SHARES
2.1 Stock Dividends, Splits, Etc. If the Company declares or pays a dividend on its common stock payable in common stock, or other securities, or subdivides the outstanding common stock into a greater amount of common stock, then upon exercise of this warrant, for each Share acquired, Holder shall receive, without cost to Holder, the total number and kind of securities to which Holder would have been entitled had Holder owned the Shares of record as of the date the dividend or subdivision occurred.
2.2 Reclassification, Exchange or Substitution. Upon any reclassification, exchange, substitution, or other event that results in a change of the number and/or class of the securities issuable upon exercise or conversion of this warrant (including, without limitation, in any Permitted Transaction (as defined in the Loan Agreement)), Holder shall be entitled to receive, upon exercise or conversion of this warrant, the number and kind of securities and property that Holder would have received for the Shares if this warrant had been exercised immediately before such reclassification, exchange, substitution, or other event. The Company, its parent entity or its successor shall promptly issue to Holder a new warrant for such new securities or other property. The new warrant shall provide for adjustments which shall be as nearly equivalent as may be practicable to the adjustments provided for in this Article 2 including, without limitation, adjustments to the Warrant Price and to the number of securities or property issuable upon exercise of the new warrant. The provisions of this Section 2.2 shall similarly apply to successive reclassifications, exchanges, substitutions, or other events as described in this Section 2.2.
2.3 Adjustments for Combinations, Etc. If the outstanding Shares are combined or consolidated, by reclassification or otherwise, into a lesser number of shares, the Warrant Price shall be proportionately increased. If the outstanding Shares are combined or consolidated, by reclassification or otherwise, into a greater number of shares, the Warrant Price shall be proportionately decreased.
2.4 Certificate as to Adjustments. Upon each adjustment of the Warrant Price, the Company at its expense shall promptly compute such adjustment, and furnish Holder with a certificate of its Chief Financial Officer setting forth such adjustment and the facts upon which such adjustment is based. The Company shall, upon written request, furnish Holder a certificate setting forth the Warrant Price in effect upon the date thereof and the series of adjustments leading to such Warrant Price.
2.5 Fractional Shares. No fractional Shares shall be issuable upon exercise or conversion of the warrant and the Number of Shares to be issued shall be rounded down to the nearest whole Share. If a fractional share interest arises upon any exercise or conversion of the warrant, the Company shall eliminate such fractional share interest by paying Holder the amount computed by multiplying the fractional interest by the fair market value of a full Share.
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ARTICLE 3
REPRESENTATIONS AND COVENANTS OF THE COMPANY
3.1 Representations and Warranties. The Company hereby represents and warrants to the Holder as follows:
(a) All Shares which may be issued upon the exercise of the purchase right represented by this warrant, and all securities, if any, issuable upon conversion of the Shares, shall, upon issuance, be duly authorized, validly issued, fully paid and nonassessable, and free of any liens and encumbrances except for restrictions on transfer provided for herein or under applicable federal and state securities laws.
3.2 Notice of Certain Events. The Company shall provide Holder with not less than 10 days prior written notice of, including a description of the material facts surrounding, any of the following events: (a) declaration of any dividend or distribution upon its common stock, whether in cash, property, stock, or other securities and whether or not a regular cash dividend; (b) offering for subscription pro rata to the holders of any class or series of its stock any additional shares of stock of any class or series or other rights; (c) effecting any reclassification or recapitalization of common stock; or (d) the merger or consolidation with or into any other corporation, or sale, lease, license, or conveyance of all or substantially all of its assets, or liquidation, dissolution or winding up.
ARTICLE 4
REPRESENTATIONS AND COVENANTS OF HOLDER
Holder hereby represents, warrants and covenants to the Company:
4.1 Purchase for Own Account. Holder is acquiring this warrant and all equity securities issuable, directly or indirectly, upon exercise of the warrant (collectively, the Securities) for Holders own account not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that Holder has no present intention of selling, granting any participation in, or otherwise distributing the same.
4.2 Disclosure of Information. Holder further represents that it has had an opportunity to ask questions and receive answers from the Company regarding the terms and conditions of the offering of the Securities and the business, properties, prospects and financial condition of the Company. With respect to any projections of its future operations provided to Holder by the Company, Holder acknowledges that the Company makes no representations or warranties.
4.3 Investment Experience. Holder has experience as an investor in securities of companies in the development stage and acknowledges that it is able to fend for itself, can bear the economic risk of its investment, and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment in the Securities. Holder acknowledges that any investment in the Securities involves a high degree of risk, and represents that it is able, without materially impairing its financial condition, to hold the Securities for an indefinite period of time and to suffer a complete loss of its investment.
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4.4 Accredited Investor. Holder is an accredited investor within the meaning of SEC Rule 501 of Regulation D, as presently in effect.
4.5 Restricted Securities. Holder understands that the Securities are characterized as restricted securities under the federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Securities Act only in certain limited circumstances. In this connection, Holder represents that it is familiar with Rule 144, as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act. Holder understands that the Securities have not been and will not be registered under the Securities Act and have not been and will not be registered or qualified in any state in which they are offered, and thus Holder will not be able to resell or otherwise transfer his, her or its Securities unless they are registered under the Securities Act and registered or qualified under applicable state securities laws, or an exemption from such registration or qualification is available.
4.6 Residence. If Holder is a partnership, corporation, limited liability company or other entity, then the office or offices of Holder in which its principal place of business is identified in the address or addresses of Holder set forth in Section 5.5 hereof.
ARTICLE 5
MISCELLANEOUS
5.1 Term: Exercise Upon Expiration. Subject to Section 1.6, this warrant is exercisable in whole or in part, at any time and from time to time on or before the Expiration Date set forth above. If this warrant has not been exercised prior to the Expiration Date, this warrant shall be deemed to have been automatically exercised on the Expiration Date by cashless conversion pursuant to Section 1.2.
5.2 Legends. This warrant and the Shares shall be imprinted with such legends as deemed required by the Company for applicable securities laws, the Companys organizational documents, and any other agreements the Securities are subject to, including the following:
THIS SECURITY HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE SOLD, PLEDGED OR OTHERWISE TRANSFERRED EXCEPT IN ACCORDANCE WITH THIS WARRANT AND APPLICABLE LAW.
5.3 Compliance with Securities Laws on Transfer. This warrant and the Shares issuable upon exercise of this warrant (and the securities issuable, directly or indirectly, upon conversion of the Shares, if any) may not be transferred or assigned in whole or in part without compliance with applicable federal and state securities laws by the transferor and the transferee. The Company shall not require Holder to provide an opinion of counsel if there is no material question as to the availability of current information as referenced in Rule 144(c), Holder
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represents that it has complied with Rule 144 (d) and (e) in reasonable detail, the selling broker represents that it has complied with Rule 144(f), and the Company is provided with a copy of Holders notice of proposed sale. Any subsequent transferee shall be bound by all of the terms and conditions of this warrant and make to the Company each of the representations, warranties and covenants set forth in Article 4 of this warrant as of the date of such transfer.
5.4 Transfer Procedure. Subject to the provisions of Section 5.3, Holder may transfer all or part of this warrant or the Shares issuable upon exercise of this warrant (or the securities issuable, directly or indirectly, upon conversion of the Shares, if any) by giving the Company notice of the portion of the warrant being transferred setting forth the name, address and taxpayer identification number of the transferee and surrendering this warrant to the Company for reissuance to the transferee(s) (and Holder, if applicable); provided, however, that Holder shall not transfer all or part of this warrant or the Shares issuable upon exercise of this warrant (or the securities issuable, directly or indirectly, upon conversion of the Shares, if any) to any Person who is a direct competitor of the Company, whether as an operating company or direct or indirect parent with voting control over such operating company. No surrender or reissuance shall be required for a transfer to any other affiliate of Holder
5.5 Notices. All notices and other communications from the Company to the Holder, or vice versa, shall be deemed delivered and effective when given personally, emailed or mailed by first-class registered or certified mail, postage prepaid, at such address as may have been furnished to the Company or the Holder, as the case may be, in writing by the Company or such Holder from time to time. All notices to the Holder shall be addressed as follows:
PacWest Bancorp
Attn: Warrant Administrator
406 Blackwell Street, Suite 240
Durham, NC 27701
Email: warrants@pacwest.com
All notices to the Company shall be addressed as follows:
Adicet Bio, Inc.
Attention: Chen Schor, CEO
500 Boylston Street, 13th Floor
Boston, Massachusetts
Email: __________________
5.6 Amendments. This warrant and any term hereof may be changed, waived, discharged or terminated only by an instrument in writing signed by the party against which enforcement of such change, waiver, discharge or termination is sought.
5.7 Attorneys Fees. In the event of any dispute between the parties concerning the terms and provisions of this warrant, the party prevailing in such dispute shall be entitled to collect from the other party all costs incurred in such dispute, including reasonable attorneys fees.
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5.8 No Stockholder Rights. Holder, as a Holder of this warrant, will not have any rights as a stockholder of the Company until the exercise of this warrant.
5.9 Governing Law. This warrant shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to its principles regarding conflicts of law.
[Signature Page Follows]
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IN WITNESS WHEREOF, the undersigned has executed this Warrant to Purchase Stock as of the date set forth above.
ADICET BIO, INC. | ||
By: | /s/ Chen Schor | |
Name: | Chen Schor | |
Title: | Chief Executive Officer | |
Accepted and agreed: | ||
PACWEST BANCORP | ||
By: | /s/ Jeff Krumpoch | |
Name: | Jeff Krumpoch | |
Title: | Senior Corporate Controller |
[Signature Page to Warrant to Purchase Stock]
APPENDIX 1
NOTICE OF EXERCISE
1. The undersigned hereby elects to purchase ______________ shares of the ______________ stock of ADICET BIO, INC. pursuant to the terms of the attached warrant, and tenders herewith payment of the purchase price of such shares in full.
1. The undersigned hereby elects to convert the attached warrant into shares in the manner specified in the warrant. This conversion is exercised with respect to ______________ of the shares covered by the warrant.
[Strike paragraph that does not apply.]
2. Please issue a certificate or certificates representing said shares in the name of the undersigned or in such other name as is specified below:
(Holders Name) |
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(Address) |
3. The undersigned hereby confirms that the representations and warranties set forth in Section 4 of the warrant are true and correct in all respects as of the date hereof.
PACWEST BANCORP or Registered Assignee |
(Signature) |
(Date) |
Exhibit 10.7
UNCONDITIONAL SECURED GUARANTY
In connection with the Loan and Security Agreement, dated as of April 28, 2020 (as amended, restated, supplemented or otherwise modified from time to time, the Loan Agreement), by and between PACIFIC WESTERN BANK (Bank), and ADICET THERAPEUTICS, INC., a Delaware corporation formerly named Adicet Bio, Inc. (Borrower), ADICET BIO, INC., a Delaware corporation formerly named resTORbio, Inc. (Guarantor) hereby unconditionally and irrevocably guarantees (i) the prompt and complete payment of all Obligations (as defined in the Loan Agreement), and (ii) performance by Borrower of its obligations under the Loan Agreement, in each case in strict accordance with its terms (herein referred to as the Guaranteed Obligations). All terms used without definition in this Guaranty shall have the meaning assigned to them in the Loan Agreement or as defined in the Code. This Guaranty is executed effective as of September 15, 2020 (the Effective Date) and is a continuing guaranty, and the obligations guaranteed hereby include, without limitation, new obligations incurred by Borrower under the Loan Agreement after the Effective Date. Guarantor acknowledges it will receive a direct and material benefit from the loans made pursuant to the Loan Agreement and that Bank has required that this secured guaranty (as amended, restated, supplemented or otherwise modified, from time to time, this Guaranty) be entered into as a condition of the Loan Agreement.
1. Guaranty. If Borrower does not pay any amount or perform the Guaranteed Obligations, Guarantor shall immediately pay all amounts due under the Loan Agreement (including, without limitation, all principal, interest, and fees) and otherwise proceed to complete the same and satisfy all of Borrowers Obligations under the Loan Agreement. The obligations hereunder are independent of the Obligations of Borrower and any other person or entity, and a separate action or actions may be brought and prosecuted against Guarantor whether action is brought against Borrower or whether Borrower is joined in any such action or actions. Guarantor waives the benefit of any statute of limitations affecting its liability hereunder or the enforcement thereof, to the extent permitted by law. Guarantors liability under this Guaranty is not conditioned or contingent upon the genuineness, validity, regularity or enforceability of the Guaranteed Obligations.
2. Grant of Security Interest. To secure its obligations under this Guaranty, Guarantor hereby grants Bank a security interest in the assets described on Exhibit A hereto (the Collateral). The security interest granted herein is and shall at all times continue to be a first-priority perfected security interest in the Collateral (other than Permitted Liens, to the extent applicable to Guarantor, or other Liens as set forth in the schedule to this Guaranty). If Guarantor acquires a commercial tort claim with a potential recovery reasonably expected to be in excess of Two Hundred Fifty Thousand Dollars ($250,000), Guarantor shall promptly notify Bank in writing and deliver such other information and documents as Bank may reasonably require to perfect Banks security interest in such commercial tort claim. Guarantor authorizes Bank to file at any time financing statements, continuation statements and amendments thereto with all appropriate jurisdictions to perfect or protect Banks interest or rights hereunder. Guarantor shall not, without at least ten (10) days prior written notice to Bank (i) change its jurisdiction of organization, chief executive office, legal name, or organizational number (if any) assigned by its jurisdiction of organization. Guarantor shall execute any further instruments and take further action as Bank reasonably requests to perfect or continue Banks Lien in the Collateral or to effect the purposes of this Guaranty.
3. Pledge of Shares. Guarantor hereby pledges, assigns and grants to Bank a security interest in all the issued and outstanding capital stock, membership units or other securities owned or held of record by Guarantor in Borrower (the Shares), together with all proceeds and substitutions thereof, all cash, stock and other moneys and property paid thereon, all rights to subscribe for securities declared or granted in connection therewith, and all other cash and noncash proceeds of the foregoing, as security for the performance of the Guaranteed Obligations. On the Effective Date, the certificate or certificates for the Shares of Borrower will be delivered to Bank, accompanied by an instrument of assignment duly governing the Shares. Guarantor shall cause the books of Borrower and any transfer agent to reflect the pledge of the Shares. Upon the occurrence of an Event of Default hereunder, Bank may effect the transfer of any securities included in the Collateral (including but not limited to the Shares) into the name of Bank and cause new certificates representing such securities to be issued in the name of Bank or its transferee. Unless an Event of Default shall have occurred and be continuing, Guarantor shall be entitled to exercise any voting rights with respect to the Shares and to give consents, waivers and ratifications in respect thereof, provided that no vote shall be cast or consent, waiver or ratification given or action taken which would be inconsistent with any of the terms of this Guaranty or which would constitute or create any violation of any of such terms. All such rights to vote and give consents, waivers and ratifications shall terminate upon the occurrence and continuance of an Event of Default.
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4. Representations and Warranties. Guarantor represents and warrants to Bank that:
4.1 (i) Guarantor has taken all necessary and appropriate action to authorize the execution, delivery and performance of this Guaranty, (ii) the execution, delivery and performance of this Guaranty do not conflict with or result in a breach of or constitute a default under Guarantors organizational documents, nor will they constitute an event of default under any material agreement to which it is party or by which it is bound, (iii) after giving effect to this Guaranty, Guarantor is not insolvent or left with unreasonably small capital for the business or transactions in which Guarantor is presently engaged or plans to be engaged, and is able to pay its debts as they mature, and (iv) except as may be limited by bankruptcy, insolvency or other laws affecting the enforcement of creditors rights generally and by general principles of equity (regardless of whether enforcement is sought in equity or in law), this Guaranty constitutes a valid and binding obligation, enforceable against Guarantor in accordance with its terms.
4.2 Guarantor has good title to, rights in, and the power to transfer each item of the Collateral upon which it purports to grant a Lien hereunder, free and clear of any and all Liens, except Permitted Liens, to the extent applicable to Guarantor, or as otherwise set forth in the schedule to this Guaranty.
4.3 The information with respect to Guarantor and the Collateral set forth in that certain Borrower Information Certificate dated as of July 7, 2020 is true and correct in all material respects as of such date.
4.4 As of the date hereof, no Collateral consisting of promissory notes or equity interests is evidenced by an original instrument or share certificate, as applicable, except to the extent delivered to Bank as possessory collateral with appropriate allonges or stock powers in form satisfactory to Bank.
5. Landlord Waiver. Within one hundred twenty (120) days of the Effective Date, provided that Guarantor has not vacated possession of such premises (whether in connection with the execution of a sublease or otherwise), Guarantor shall exercise commercially reasonable efforts to deliver to Bank in form and substance satisfactory to Bank a duly executed landlord waiver in favor of Bank for the rental property located at 500 Boylston Street, 13th Floor, Boston, Massachusetts.
6. Insurance. Guarantor, at its expense, shall (i) keep the Collateral insured against loss or damage, and (ii) maintain liability and other insurance, in each case as ordinarily insured against by other owners in businesses similar to Guarantors. All such policies of insurance shall be in such form, with such companies, and in such amounts reasonably satisfactory to Bank. All policies of property insurance shall contain a lenders loss payable endorsement, in a form satisfactory to Bank, showing Bank as lenders loss payee. All liability insurance policies shall show, or have endorsements showing, Bank as an additional insured. Any such insurance policies shall specify that the insurer must give at least twenty (20) days notice to Bank before canceling its policy for any reason. Within thirty (30) days of the Effective Date, Bank shall have received in form and substance reasonably satisfactory to Bank evidence that the insurance policies required by this Section 6 are in full force and effect. Within thirty (30) days of the Effective Date, Guarantor shall cause to be furnished to Bank a copy of its policies including any endorsements covering Bank or showing Bank as an additional insured. Proceeds payable under any casualty policy will, at Guarantors option, be payable to Guarantor to replace the property subject to the claim, provided that any such replacement property shall be deemed Collateral in which Bank has been granted a first priority security interest, provided that if an event of default has occurred and is continuing, all proceeds payable under any such policy shall, at Banks option, be payable to Bank to be applied on account of the Guaranteed Obligations.
7. Primary Depository. Within sixty (60) days of the Effective Date, Guarantor shall maintain, and shall (subject to Borrowers obligations in Section 6.6 of the Loan Agreement) cause all of its Subsidiaries to maintain, all of its Cash in depository and operating accounts with Bank and all investment accounts with Bank or Banks affiliates; provided that prior to Guarantor maintaining any investment accounts with Banks affiliates, Guarantor, Bank, and any such affiliate shall have entered into a securities account control agreement with respect to any such investment accounts, in form and substance satisfactory to Bank, provided that, Guarantor shall be permitted to maintain an aggregate amount not to exceed $20,000 in one or more accounts outside of Bank.
8. Existing Letter of Credit. Notwithstanding anything herein to the contrary, Guarantor shall be permitted to maintain Guarantors existing cash collateral account at Wells Fargo Bank (the Collateral Account) securing that certain letter of credit for $245,442.50 in favor of 500 Boylston & 222 Berkeley Owner (DE) LLC (the Letter of Credit), provided that (x) the aggregate balance of the Collateral Account shall not exceed $245,442.50 at any time and (y) upon the earlier of (A) the outside expiration date of the Letter of Credit as of the Effective Date which is December 31, 2026, and (z) early termination of the Letter of Credit, the entire balance held in the Collateral Account shall immediately be transferred to Guarantors account at Bank. For the avoidance of doubt, the Letter of Credit shall not be renewed or extended so long as Bank shall have provided similar replacement letter of credit in favor of the existing beneficiary in such amount and on terms substantially similar to the terms of Letter of Credit, resulting in a replacement letter of credit that is reasonably acceptable to the applicable beneficiary.
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9. Affirmative Covenants. Until the final payment and performance in full of all of the Obligations (other than inchoate indemnification or reimbursement obligations), Guarantor shall do all of the following: (a) maintain its existence, remain in good standing in its jurisdiction of organization, and continue to qualify in its jurisdiction in which the failure to so qualify could have a material adverse effect on the financial condition, operations or business of Guarantor; (b) maintain in force all licenses, approvals and agreements, the loss of which could reasonably be expected have a material adverse effect on its financial condition, operations or business; (c) comply with all statutes, laws, ordinances, directives, orders, and government rules and regulations to which it is subject if non-compliance with such laws could reasonably be expected to have a material adverse effect on the financial condition, operations or business of Guarantor; and (d) at any time and from time to time Guarantor shall execute and deliver such further instruments and take such further action as may reasonably be requested by Bank to effect the purposes of this Guaranty.
10. Negative Covenants. Guarantor shall not do any of the following: (a) create, incur, assume or be or remain liable with respect to any Indebtedness, other than Permitted Indebtedness, to the extent applicable to Guarantor, or other Indebtedness as set forth in the Schedule to this Guaranty; (b) create, incur, assume or suffer to exist any Lien with respect to any of its property, other than Permitted Liens, to the extent applicable to Guarantor, or other Liens as set forth in the Schedule to this Guaranty; (c) transfer, assign, encumber, or otherwise dispose of any equity interest that Guarantor may now have or hereafter acquire in Borrower; and (d) dispose of any interest in the Collateral other than Permitted Transfers, to the extent applicable to Guarantor.
11. Waivers by Guarantor. Guarantor waives any right to require Bank to (a) proceed against Borrower, any guarantor, or any other person; (b) proceed against or exhaust any security held from Borrower; or (c) pursue any other remedy in Banks power whatsoever. Bank may, at each of its election, exercise or decline or fail to exercise any right or remedy it may have against Borrower or any security held by Bank, including without limitation the right to foreclose upon any such security by judicial or non-judicial foreclosure, without affecting or impairing in any way the liability of Guarantor hereunder. Guarantor waives any defense arising by reason of any disability or other defense of Borrower, or by reason of the cessation from any cause whatsoever of the liability of Borrower. Until all of the Guaranteed Obligations (other than inchoate indemnity obligations) have been paid in full, (a) Guarantor waives any defense that Guarantor may have against Bank arising out of the absence, impairment or loss of any right of reimbursement or subrogation or any other rights Guarantor has against Borrower, (b) Guarantor shall not exercise any rights against Borrower arising as a result of payment by Guarantor hereunder, by way of subrogation, reimbursement, restitution, contribution or otherwise and (c) Guarantor waives any right to enforce any remedy that Bank now has or may hereafter have against Borrower and waives all rights to participate in any security now or hereafter held by Bank. Guarantor waives all presentments, demands for performance, notices of nonperformance, protests, notices of protest, notices of dishonor, and notices of acceptance of this Guaranty and of the existence, creation, or incurring of new or additional indebtedness. Guarantor waives any setoff, defense or counterclaim that Borrower may have against Bank. Guarantor assumes the responsibility for being and keeping itself informed of the financial condition of Borrower and of all other circumstances bearing upon the risk of nonpayment of any indebtedness or nonperformance of any Obligation of Borrower and agrees that, absent a request for particular information by Guarantor, Bank shall not have any duty to advise Guarantor of information known to Bank regarding such condition or any such circumstances. Guarantor waives any defenses as a surety under applicable law, including without limitation, any suretyship defenses available to it under the Code or any other applicable law. Guarantor waives any benefits that it has that permit a subordinating creditor to assert suretyship or that give a subordinating creditor rights to require a senior creditor to marshal assets. Guarantor will not assert such a defense or right. In addition to the waivers set forth above, Guarantor expressly waives, to the extent permitted by North Carolina law, all of Guarantors rights under North Carolina General Statute Section 26-7 through Section 26-9, inclusive, or any similar or subsequent laws. Guarantor authorizes Bank, as applicable, in accordance with the terms of the Loan Agreement, without notice or demand and without affecting its liability hereunder, from time to time to, (a) renew, extend, or otherwise change the terms of the Loan Documents or any part hereof; (b) take and hold security for the payment of this Guaranty or the Guaranteed Obligations, and exchange, enforce, waive and release any such security; and (c) apply such security and direct the order or manner of sale thereof as provided in the Loan Agreement or, if not so provided, as Bank in its sole discretion may determine.
12. Borrowers Insolvency. If Borrower becomes insolvent or is adjudicated bankrupt or files a petition for reorganization, arrangement, composition or similar relief under any present or future provision of the United States Bankruptcy Code, or if such a petition is filed against Borrower, and in any such proceeding some or all of any indebtedness
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or obligations under the Loan Documents are terminated or rejected or any obligation of Borrower is modified or abrogated, or if Borrowers obligations are otherwise avoided for any reason, Guarantor agrees that Guarantors liability hereunder shall not thereby be affected or modified and such liability shall continue in full force and effect as if no such action or proceeding had occurred. This Guaranty shall continue to be effective or be reinstated, as the case may be, if any payment must be returned by Bank upon the insolvency, bankruptcy or reorganization of Borrower, Guarantor, any other guarantor, or otherwise, as though such payment had not been made.
13. Subordination of Borrowers Indebtedness. Any indebtedness of Borrower now or hereafter held by Guarantor is hereby subordinated to the Guaranteed Obligations; and upon notice of Bank following the occurrence and during the continuation of an Event of Default, such indebtedness of Borrower to Guarantor shall be collected, enforced and received by Guarantor as trustee for Bank and be paid over to Bank on account of the Guaranteed Obligations, but without reducing or affecting in any manner the liability of Guarantor under the other provisions of this Guaranty.
14. Event of Default. Each of the following shall constitute an event of default under this Guaranty: if this Guaranty ceases to be in full force and effect for any reason; if any material misrepresentation or material misstatement exists now or hereafter in any warranty or representation in this Guaranty; if Guarantor fails to perform any obligation required hereunder; if Guarantor purports to revoke or otherwise avoid any obligation under this Guaranty; or if an Event of Default occurs under the Loan Agreement.
15. Remedies and Related Provisions
15.1 Rights and Remedies. Upon the occurrence and during the continuance of an event of default under this Guaranty described in Section 14 hereof, Bank may, without notice or demand, do any or all of the following (in addition to any remedies pursuant to the Loan Agreement): (i) verify the amount of, demand payment of and performance under, and collect any Accounts and general intangibles, settle or adjust disputes and claims directly with account debtors for amounts on terms and in any order that Bank considers advisable, and notify any Person owing Guarantor money of Banks security interest in such funds; (ii) make any payments and do any acts it reasonably considers necessary or advisable to protect the Collateral and/or its security interest in the Collateral, and Guarantor shall assemble the Collateral if Bank requests and make it available as Bank designates, (iii) enter premises where the Collateral is located, take and maintain possession of any part of the Collateral, and pay, purchase, contest, or compromise any Lien which appears to be prior or superior to its security interest and pay all expenses incurred, and in furtherance of the foregoing, Guarantor grants Bank a license to enter and occupy any of its premises, without charge, to exercise any of Banks rights or remedies; (iv) apply to the Obligations any (A) balances and deposits of Guarantor that Bank holds, or (B) amounts held by Bank owing to or for the credit or the account of Guarantor; (v) ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell the Collateral, and solely in furtherance of the foregoing in connection with the exercise of its remedies hereunder, Guarantor hereby grants Bank a non-exclusive, royalty-free license or other right to use, without charge, Guarantors labels, patents, copyrights, mask works, rights of use of any name, trade secrets, trade names, trademarks, and advertising matter, or any similar property as it pertains to the Collateral, completing production of, advertising for sale, and selling any Collateral and, in connection with Banks exercise of its rights hereunder, and any rights of Guarantor under all licenses and all franchise agreements inure to Banks benefit; (vi) place a hold on any account maintained with Bank or deliver a notice of exclusive control, any entitlement order, or other directions or instructions pursuant to any account control agreement or similar agreements providing control of any Collateral; (vii) demand and receive possession of any Guarantors books and records; and (viii) exercise all rights and remedies available to Bank at law or equity, including all remedies provided under the Code (including sale of the Collateral pursuant to the terms thereof).
15.2 Power of Attorney. Guarantor hereby irrevocably appoints Bank (and any of Banks partners, managers, officers, agents or employees) as its lawful attorney-in-fact, with full power of substitution, exercisable solely upon the occurrence and during the continuance of an Event of Default, to: (a) send requests for verification of Accounts or notify account debtors of Banks security interest and Liens in the Collateral; (b) endorse Guarantors name on any checks or other forms of payment or security; (c) sign Guarantors name on any invoice or bill of lading for any Account or drafts against account debtors schedules and assignments of Accounts, verifications of Accounts, and notices to account debtors; (d) settle and adjust disputes and claims about the Accounts directly with account debtors, for amounts and on terms Bank determines reasonable; (e) make, settle, and adjust all claims under Guarantors insurance policies; (f) pay, contest or settle any Lien, charge, encumbrance, security interest, and adverse claim in or to the Collateral, or any judgment based thereon, or otherwise take any action to terminate or discharge the same; (g) transfer the Collateral into the name of Bank or a third party as the Code permits; and (h) dispose of the Collateral as the Code permits. Guarantor further hereby
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appoints Bank (and any of Banks partners, managers, officers, agents or employees) as its lawful attorney-in-fact, with full power of substitution, regardless of whether or not an Event of Default has occurred or is continuing to: (i) sign Guarantors name on any documents and other instrument necessary to perfect or continue the perfection of, or maintain the priority of, Banks security interest in the Collateral to the extent Guarantor does not promptly execute the same upon Banks written request, (ii) execute and do all such assurances, acts and things which Guarantor is required, but fails to do under the covenants and provisions hereof; (iii) take any and all such actions as Bank may reasonably determine to be necessary or advisable for the purpose of maintaining, preserving or protecting the Collateral or any of the rights, remedies, powers or privileges of Bank hereunder or the under the Loan Agreement. Banks foregoing appointment as Guarantors attorney in fact, and all of Banks rights and powers, coupled with an interest, are irrevocable until all Guaranteed Obligations (other than inchoate indemnity obligations) have been paid in full, in cash, and Bank is under no further obligation to make credit extensions to Borrower.
15.3 Protective Payments. If Guarantor fails to obtain the insurance required by this Guaranty or fails to pay any premium thereon or fails to pay any other amount which Guarantor is obligated to pay under this Guaranty, the Loan Agreement or which may be required to preserve the Collateral, Bank may obtain such insurance or make such payment, and all amounts so paid by Bank shall constitute Obligations and shall be immediately due and payable, bearing interest at the then highest rate applicable to the Obligations in accordance with the terms of the Loan Documents, and shall be secured by the Collateral. Bank will make reasonable efforts to provide Guarantor with notice of Bank obtaining such insurance at the time it is obtained or within a reasonable time thereafter. No payments by Bank are deemed an agreement to make similar payments in the future or Banks waiver of any event of default hereunder.
15.4 Banks Liability for Collateral. So long as Bank complies with commercially reasonable banking practices regarding the safekeeping of the Collateral in the possession or under the control of Bank, Bank shall not be liable or responsible for: (a) the safekeeping of the Collateral; (b) any loss or damage to the Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other Person. Subject to the foregoing, Guarantor shall bear all risk of loss, damage or destruction of the Collateral.
16. Miscellaneous.
16.1 Guarantor agrees to pay reasonable attorneys fees and all other reasonable out-of-pocket costs and expenses which may be incurred by Bank in the enforcement of this Guaranty.
16.2 No terms or provisions of this Guaranty may be changed, waived, revoked or amended except by written agreement between Guarantor and Bank.
16.3 Should any provision of this Guaranty be determined by a court of competent jurisdiction to be unenforceable, all of the other provisions shall remain effective.
16.4 This Guaranty, together with any agreement executed in connection with this Guaranty, embodies the entire agreement between the parties hereto with respect to the matters set forth herein, and supersedes all prior agreements between the parties with respect to the matters set forth herein.
16.5 No course of prior dealing among the parties, no usage of trade, and no parol or extrinsic evidence of any nature shall be used to supplement, modify or vary any of the terms hereof. Banks failure, at any time or times, to require strict performance by Guarantor of any provision of this Guaranty or any other Loan Document shall not waive, affect, or diminish any right of Bank thereafter to demand strict performance and compliance herewith or therewith. No waiver hereunder shall be effective unless signed by the party granting the waiver and then is only effective for the specific instance and purpose for which it is given. Banks rights and remedies under this Guaranty and the other Loan Documents are cumulative. Bank has all rights and remedies provided under the Code, by law, or in equity. Banks exercise of one right or remedy is not an election and shall not preclude Bank from exercising any other remedy under this Guaranty or other remedy available at law or in equity, and Banks waiver of any Event of Default is not a continuing waiver. Banks delay in exercising any remedy is not a waiver, election, or acquiescence.
16.6 There are no conditions to the full effectiveness of this Guaranty.
16.7 Bank may assign this Guaranty (or its rights thereunder) in connection with a permitted assignment of the Guaranteed Obligations in accordance with the Loan Agreement without in any way affecting Guarantors liability under it. This Guaranty shall inure to the benefit of Bank and its successors and assigns.
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16.8 This Guaranty may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one agreement. Executed copies of the signature pages of this Agreement sent by facsimile or transmitted electronically in Portable Document Format (PDF), or any similar format, shall be treated as originals, fully binding and with full legal force and effect, and the parties waive any rights they may have to object to such treatment.
16.9 Governing Law; Jurisdiction; Venue; Jury Trial Waiver. This Guaranty shall be governed by, and construed in accordance with, the internal laws of the State of North Carolina, without regard to principles of conflicts of law. Jurisdiction shall lie in the State of North Carolina. All disputes, controversies, claims, actions and similar proceedings arising with respect to Borrowers account or any related agreement or transaction shall be brought in the General Court of Justice of North Carolina sitting in Durham County, North Carolina, or the United States District Court for the Middle District of North Carolina, except as provided below with respect to arbitration of such matters. BANK AND GUARANTOR EACH ACKNOWLEDGE THAT THE RIGHT TO TRIAL BY JURY IS A CONSTITUTIONAL ONE, BUT THAT IT MAY BE WAIVED. EACH OF THEM, AFTER CONSULTING OR HAVING HAD THE OPPORTUNITY TO CONSULT, WITH COUNSEL OF THEIR CHOICE, KNOWINGLY, VOLUNTARILY AND INTENTIONALLY WAIVES ANY RIGHT ANY OF THEM MAY HAVE TO A TRIAL BY JURY IN ANY LITIGATION BASED UPON OR ARISING OUT OF THIS GUARANTY OR ANY RELATED INSTRUMENT OR LOAN DOCUMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS GUARANTY OR ANY COURSE OF CONDUCT, DEALING, STATEMENTS (WHETHER ORAL OR WRITTEN), OR ACTION OF ANY OF THEM. THESE PROVISIONS SHALL NOT BE DEEMED TO HAVE BEEN MODIFIED IN ANY RESPECT OR RELINQUISHED BY BANK OR GUARANTOR, EXCEPT BY A WRITTEN INSTRUMENT EXECUTED BY EACH OF THEM. If the jury waiver set forth in this Section 16.9 is not enforceable, then any dispute, controversy, claim, action or similar proceeding arising out of or relating to this Guaranty, the Loan Documents or any of the transactions contemplated therein shall be settled by final and binding arbitration held in Durham County, North Carolina in accordance with the then current Commercial Arbitration Rules of the American Arbitration Association by one arbitrator appointed in accordance with those rules. The arbitrator shall apply North Carolina law to the resolution of any dispute, without reference to rules of conflicts of law or rules of statutory arbitration. Judgment upon any award resulting from arbitration may be entered into and enforced by any state or federal court having jurisdiction thereof. Notwithstanding the foregoing, the parties may apply to any court of competent jurisdiction for preliminary or interim equitable relief, or to compel arbitration in accordance with this Section 16.9. The costs and expenses of the arbitration, including without limitation, the arbitrators fees and expert witness fees, and attorneys fees, incurred by the parties to the arbitration may be awarded to the prevailing party, in the discretion of the arbitrator, or may be apportioned between the parties in any manner deemed appropriate by the arbitrator. Unless and until the arbitrator decides that one party is to pay for all (or a share) of such costs and expenses, both parties shall share equally in the payment of the arbitrators fees as and when billed by the arbitrator.
16.10 Withholding. All payments made by Guarantor hereunder will be made free and clear of, and without deduction or withholding for, any present or future taxes, levies, imposts, duties, fees, assessments or other charges of whatever nature now or hereafter imposed by any governmental authority or by any political subdivision or taxing authority thereof or therein with respect to such payments (excluding taxes imposed on or measured by the net income of Bank) and all interest, penalties or similar liabilities with respect thereto (all such taxes, levies, imposts, duties, fees, assessments or other charges and as required by any governmental authority, applicable law, regulation or international agreement being referred to collectively as Taxes). If any Taxes are so levied or imposed, Guarantor agrees to pay the full amount of such Taxes, and such additional amounts as may be necessary so that every payment of all amounts due under this Guaranty, after withholding or deduction for or on account of any Taxes, will not be less than the amount required to be paid with respect to the Guaranteed Obligations. Notwithstanding the foregoing, Guarantor need not make any withholding payment if the amount or validity of such withholding payment is contested in good faith by appropriate and timely proceedings and as to which payment in full is bonded or reserved against by Guarantor.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, the undersigned Guarantor has duly executed this Guaranty as of the date set forth above.
ADICET BIO, INC., a Delaware corporation | ||
By: | /s/ Chen Schor | |
Name: | Chen Schor | |
Title: | Chief Executive Officer |
Exhibit A
Collateral Description
The Collateral consists of all of Guarantors right, title and interest in and to the following personal property wherever located, whether now owned or existing or hereafter acquired, created or arising:
All goods, Accounts (including health-care receivables), Equipment, Inventory, Shares, contract rights or rights to payment of money, leases, license agreements, franchise agreements, general intangibles (including goodwill and payment intangibles), commercial tort claims, documents, instruments (including any promissory notes), chattel paper (whether tangible or electronic), cash, deposit accounts, fixtures, letters of credit rights (whether or not the letter of credit is evidenced by a writing), securities, and all other investment property, supporting obligations, and financial assets, whether now owned or hereafter acquired, wherever located; and all such Guarantors books relating to the foregoing, and any and all claims, rights and interests in any of the above and all substitutions for, additions, attachments, accessories, accessions and improvements to and replacements, products, proceeds (both cash and non-cash) and insurance proceeds of any or all of the foregoing.
Notwithstanding the foregoing, the Collateral shall not include any of the intellectual property, in any medium, of any kind or nature whatsoever, now or hereafter owned or acquired or received by Guarantor, or in which Guarantor now holds or hereafter acquires or receives any right or interest (collectively, the Intellectual Property); provided, however, that the Collateral shall include all accounts and general intangibles that consist of rights to payment and proceeds from the sale, licensing or disposition of all or any part, or rights in, the foregoing (the Rights to Payment).
Notwithstanding the foregoing, if a judicial authority (including a U.S. Bankruptcy Court) holds that a security interest in the underlying Intellectual Property is necessary to have a security interest in the Rights to Payment, then the Collateral shall automatically, and effective as of September 15, 2020 include the Intellectual Property to the extent and only to the extent necessary to permit perfection of Banks security interest in the Rights to Payment, and further provided, however, that Banks enforcement rights with respect to any security interest in the Intellectual Property shall be absolutely limited to the Rights to Payment only, and Bank shall have no recourse whatsoever with respect to the underlying Intellectual Property.
SCHEDULE OF EXCEPTIONS
Liens existing as of Effective Date None.
Indebtedness existing as of the Effective Date None.
RESOLUTIONS TO GUARANTY AND WARRANT
Guarantor: ADICET BIO, INC., a Delaware corporation formerly named resTORbio, Inc.
The undersigned is the duly elected and qualified Secretary of ADICET BIO, INC., a Delaware corporation formerly named resTORbio, Inc. (the Guarantor), does hereby certify that the following is a true and correct copy of the resolutions adopted by the Guarantors Board of Directors in accordance with applicable law and the Guarantors bylaws, and that such resolutions are now unmodified and in full force and effect:
BE IT RESOLVED, that
1) Any one (1) of the following named persons, whose actual signatures are shown below is authorized to act for, on behalf of, and in the name of the Guarantor in connection with the resolutions below:
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In furtherance of the transactions contemplated by the Guaranty Documents (as defined below), such person, may, on behalf of the Guarantor and is hereby authorized and empowered to:
Guaranty Indebtedness. Guaranty all amounts borrowed from time to time from Bank by Borrower, pursuant to that certain Loan and Security Agreement between Borrower and Bank dated as of April 28, 2020 (the Loan Agreement), and any related agreements, each as amended from time to time.
Execute Guaranty. Execute and deliver to Bank that certain Unconditional Secured Guaranty of even date herewith in favor of Bank (the Guaranty), and any other agreement entered into between Guarantor and Bank in connection therewith, all as amended or extended from time to time (collectively, the Guaranty Documents), and also execute and deliver to Bank one or more affirmations, renewals, extensions, modifications, refinancings, consolidations, or substitutions for the Guaranty Documents, or any portion thereof.
Grant Security. Grant a security interest to Bank in the Collateral described in the Guaranty Documents, which security interest shall secure all of the Borrowers Obligations (as defined in the Loan Agreement).
Warrants. Issue a warrant or warrants to purchase the Guarantors capital stock;
Further Acts. Do and perform such other acts and things, pay any and all fees and costs, and execute and deliver such other documents and agreements as he or she may in his or her discretion deem reasonably necessary or proper in order to carry into effect the foregoing.
2) Any and all acts authorized pursuant to these resolutions and performed prior to the passage of these resolutions are hereby ratified and approved, that these resolutions shall remain in full force and effect and Bank may rely on these Resolutions until written notice of their revocation shall have been delivered to Bank. Any such notice shall not affect any of the Guarantors agreements or commitments in effect at the time such notice is given.
3) The officers, employees, and agents named above are duly elected, appointed, or employed by or for the Guarantor, as the case may be, and occupy the positions set forth opposite their respective names; the foregoing resolutions now stand of record on the books of the Guarantor; and the resolutions are in full force and effect and have not been modified or revoked in any manner whatsoever.
IN WITNESS WHEREOF, I have affixed my name as Secretary on September 15, 2020 and attest that the signatures set opposite the names listed above are such individuals genuine signatures.
CERTIFIED TO AND ATTESTED BY: | ||
By: |
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Title: Secretary |
Exhibit 10.9
Adicet Bio, Inc.
April 28, 2020
Anil Singhal
Re: | Transition Agreement |
Dear Anil,
This letter (the Transition Agreement) confirms the agreement between you and Adicet Bio, Inc. (the Company) (collectively, the parties) regarding the transition of your position with the Company on the following terms:
1. Transition. You acknowledge that, in the event that the proposed reverse triangular merger among the Company, a publicly traded company previously disclosed to you (Parent), and a wholly owned subsidiary of Parent (Merger Sub), pursuant to which Merger Sub will merge with and into the Company with the Company surviving as a wholly owned subsidiary of Parent (the Merger) pursuant to an agreement and plan of merger anticipated to be entered into shortly following the date hereof (the Merger Agreement), is consummated (the Closing), your employment with the Company as Chief Executive Officer, President, Treasurer and Secretary shall end effective as of the Closing (such date, the Resignation Date). You further acknowledge that on your Resignation Date you will receive your final paycheck, which includes your final wages and pay for any accrued but unused vacation or personal days through your last day of employment, less withholdings. You agree to submit any claims for reimbursement for unreimbursed business expenses within 10 days of the Resignation Date in accordance with the Companys normal procedures for reimbursement. The parties acknowledge that except as provided for in this Transition Agreement, all benefits and perquisites of employment cease as of your last day of employment, including any and all temporary housing and travel arrangements provided to you by the Company.
2. Future Service. The parties wish to provide for a smooth succession, including providing the Company time for you and the Company to transition knowledge, relationships, and other matters that you acquired in your years with the Company. Accordingly, you agree that following your Resignation Date you will continue to assist the Company and Parent in the transition to new management (the Services) as set out in the Independent Contractor Services Agreement (set forth in Attachment A) (the Independent Contractor Services Agreement).
3. Resignation. For purposes of this Transition Agreement, the parties acknowledge and agree that you have voluntarily elected to resign from your employment without Good Reason as defined in Section 3.c.iii of your Executive Employment Agreement, dated April 23, 2019, as amended, modified or restated from time to time (the Employment Agreement), and therefore you are not entitled to any Severance Benefits (as defined in the Employment Agreement), upon termination of your employment under Section 3.b of the Employment Agreement. You also acknowledge that effective as of the Resignation Date, you shall cease to hold, and be deemed to have resigned from (and hereby resign effective as of the Resignation Date from), any and all titles, positions and appointments you hold with the Company and/or any of its subsidiaries, whether as an officer, trustee, director, employee, trustee, committee member or otherwise. You further agree to execute any documents reasonably requested by the Company in connection with the actions contemplated by the preceding sentence. On and after your Resignation Date, you agree that you will not represent to anyone that you are still an employee or officer of the Company or any of its subsidiaries or affiliates or and you will not say or do anything purporting to bind the Company or any of its subsidiaries or affiliates.
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4. Consideration. Although you are not otherwise entitled to receive any additional consideration from the Company under the circumstances of your resignation, subject to, and in consideration for your providing the Company with an executed copy of this Transition Agreement and the Independent Contractor Services Agreement, and provided you continue in service as an employee of the Company through the Resignation Date and comply with all of the terms and conditions of this Transition Agreement, the Independent Contractor Services Agreement, the Employee Proprietary Information and Invention Assignment Agreement entered into by and between you and the Company (the Proprietary Information Agreement) and all applicable Company policies, the Company will provide you with the following (Consideration): (a) the consulting relationship set forth in the Independent Contractor Services Agreement and (b) the payments and benefits set forth in Section 6 (subject to the terms and conditions thereof).
5. Equity.
a. You acknowledge and agree that (i) you currently own options to purchase (A) 3,128,049 shares of the Common Stock of the Company pursuant to that certain Notice of Stock Option Award and Stock Option Award Agreement (Award Number 118), dated as of May 22, 2019, by and between you and the Company and the Companys 2015 Stock Incentive Plan, as amended (the Plan) and (B) 2,814,768 shares of the Common Stock of the Company pursuant to that certain Notice of Stock Option Award and Stock Option Award Agreement (Award Number 140), dated as of October 15, 2019, by and between you and the Company and the Plan (the Existing Options), (ii) you may become eligible to receive additional options to purchase up to 364,112 shares of the Common Stock of the Company in accordance with, and subject to the terms of the Employment Agreement (the Milestone Options) (the Existing Options and Milestone Options, collectively, the Options and the related option agreements for the Options, collectively, the Option Agreements) and (iii) other than the Options, and notwithstanding anything to the contrary, you do not have any right, title, claim or interest in or to any equity or other security of the Company, any security convertible or exercisable into any of the foregoing, or any right to purchase or receive any of the foregoing (whether presently, as a result of the passage of time or upon the occurrence of any events).
b. You and the Company acknowledge and agree that, notwithstanding anything to the contrary, including your service to the Company pursuant to the Independent Contractor Services Agreement or in any other capacity: (i) your transition from an employee to a consultant of the Company as contemplated hereby will not be deemed to be a termination of your Continuous Service for purposes of the Option Agreements (other than as provided for in subsection (iii) below); (ii) following such transition, Continuous Service for purposes of the Option Agreements shall refer solely to your continued service to the Company or its affiliates (including Parent) as a consultant pursuant to the Independent Contractor Services Agreement; (iii) following such transition, your Continuous Service for purposes of the Option Agreement shall be deemed to have been terminated upon the earliest of (the Vesting End Date): (1) the termination of your services pursuant to the Independent Contractor Services Agreement or (2) May 7, 2021; (iv) in no event shall you vest in any further shares under the Options following the Vesting End Date (notwithstanding any continuation in your Continuous Service for purposes of the Options); provided, however, that if the Company terminates your service under the Independent Contractor Services Agreement without ICSA Cause (as defined below) prior to May 7, 2021, you shall vest in all then unvested shares subject to the Options (the Unvested Shares) that would have vested from the date of such termination without ICSA Cause through May 7, 2021; (v) all Unvested Shares (including, for the avoidance of doubt, the Milestone Options and other than any Unvested Shares you may potentially vest in as a result of your service prior to May 7, 2021 pursuant to the Independent Contractor
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Services Agreement or pursuant to clause (iv) above) shall be deemed forfeited as of the Resignation Date and (vi) the acceleration provisions set forth in the Option Agreements shall terminate on the Resignation Date and shall thereafter be null and void. The Option Agreements are hereby amended to the extent necessary to reflect the foregoing.
c. ICSA Cause shall mean (i) your intentional performance of any act or failure to perform any act in bad faith and to the detriment of the Company or its affiliates, including, but not limited to, misappropriation of trade secrets, fraud or embezzlement; (ii) material breach by you of any written agreement with the Company or its affiliates; (iii) your conviction or plea of no-contest to any felony or any crime of moral turpitude, (iv) your willful refusal to implement or follow a lawful policy or directive of the Company or its affiliates; or (v) your engagement in misfeasance or malfeasance demonstrated by a pattern of failure to perform job duties diligently and professionally; provided, however, that except for an action, omission, failure, breach, refusal or other event which, by its nature, cannot reasonably be expected to be cured, you shall have twenty (20) days from the delivery of written notice by the Company within which to cure any acts constituting ICSA Cause; provided however, that, if the Company reasonably expects material injury from a delay of twenty (20) days, the Company may give you notice of such shorter period within which to cure as is reasonable under the circumstances, which may include the termination of the Independent Contractor Services Agreement without notice and with immediate effect.
d. Your further acknowledge and agree that any unexercised Options that are incentive stock options shall cease to be treated as incentive stock options and shall be treated for tax purposes as non-statutory stock options upon the effective date of this Transition Agreement.
e. The Options will remain subject to the terms and conditions of the following (as modified hereby, as applicable): (i) the Option Agreements, (ii) the Plan and (iii) the Companys Bylaws, in each case, as may be amended, modified or restated from time to time (collectively, the Equity Documents). The Equity Documents will remain in full force and effect and, to the extent applicable, will govern any shares of the Companys capital stock or other securities of the Company that you currently own or hereafter may acquire in the future (including, but not limited to, any shares you may receive upon exercise of the Options).
f. You expressly acknowledge and agree that the Merger and the related transactions shall not constitute a Liquidation for purposes of the Employment Agreement or any of the Options. Further, you acknowledge and agree that (i) you understand and agree to the treatment of the Options pursuant to the Merger Agreement, a draft of which has been provided to you prior to the date hereof, (ii) the Milestone Options may be granted to you following consummation of the Merger and (iii) in such event, (A) the Milestone Options would be for shares of Parents common stock under a Parent equity incentive plan, (B) the Milestone Options would be subject to the terms of Parents standard stock option agreement, (C) the Milestone Options would have a per share exercise price equal to the per share fair market value of Parents common stock on the date of grant, as determined by the board of directors of Parent (D) an adjustment would be made to the number of shares subject to the Milestone Options above based on the terms of the Merger Agreement, (E) your service under the Independent Contractor Services Agreement will qualify for purposes of the Milestone Options as remaining in continuous service as the Companys Chief Executive Officer.
6. Termination Consideration. Solely if either: (i) you continue to provide services as an employee of the Company through the Resignation Date and the Closing occurs or (ii) the Company terminates your employment prior to your Resignation Date other than (a) for Cause (as defined in the Employment Agreement), (b) as a result of your death or (c) as a result of your Disability (as defined in the Employment Agreement), the Company will provide you with the payments and benefits listed in this
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Section 6 (the Termination Consideration), subject to and contingent upon Section 8 of this Transition Agreement:
a. A payment of $470,000, payable in one lump sum within sixty (60) days following the Resignation Date.
b. An amount equal to the prorated portion of $211,500 based on the ratio that the number of days elapsed in calendar year 2020 prior to the Resignation Date bears to 365 (the 2020 Bonus Payment), payable in one lump sum within sixty (60) days following the Resignation Date.
c. A payment of $250,000, payable in one lump sum on January 1, 2021.
d. A payment of $24,000, payable in one lump sum within sixty (60) days following the Resignation Date.
e. The vesting of all Options then held by you shall be accelerated such that all Options shall be deemed vested as if you had remained continuously employed for twelve (12) months following the Resignation Date.
f. All vested Options then held by you as of the Resignation Date or that subsequently vest in accordance with Section 5 shall remain exercisable until the twelve (12) month anniversary of the termination of your services pursuant to the Independent Contractor Services Agreement; provided, however, that no such Option shall be exercisable after the expiration of its maximum term pursuant to the terms thereto.
g. Reimbursement for up to $15,000 of your reasonable and documented legal expenses incurred in connection with this Transition Agreement.
7. Early Resignation. You acknowledge and agree that if you resign from employment prior to the Resignation Date (an Early Resignation), you will not be entitled to any Termination Consideration, or any Severance Benefits under the Employment Agreement or any acceleration of vesting under any of the Options. You acknowledge and agree that, other than as set forth in Section 6 (and under the conditions set forth therein), you are not entitled to, or eligible for, any further bonus payment of any kind.
8. Eligibility. Your eligibility for the Termination Consideration is conditioned on (a) you having resigned from the Board and from all positions that you are then serving as a director, officer or in another similar capacity at the Companys direct and indirect subsidiaries and (b) you having first signed a release agreement in substantially the form attached as Attachment B, which may be adjusted by the Company in its discretion for changes in applicable laws, rules or regulations or customary practice (the Release) and such Release becoming effective pursuant to its terms no later than sixty (60) days following the date of termination of your employment (the Release Deadline). If the Release does not become effective and irrevocable by the Release Deadline, you forfeit any rights to the Termination Consideration. In no event will any Termination Consideration be paid under this this Agreement until the Release becomes effective and irrevocable and the Termination Consideration will commence or be provided once the Release becomes effective and irrevocable. You agree that the Company shall have a right of offset against the foregoing for amounts owed to the Company by you (unless the amounts owed are subject to a good faith dispute) to the fullest extent not prohibited by law. The Termination Consideration shall be in lieu of any other severance payments, severance benefits, and severance protections to which you may be entitled under the Employment Agreement (including the Severance Benefits) or any severance or termination policy, plan, program, practice or arrangement of the Company and its affiliates.
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9. Withholding. All amounts payable under this Transition Agreement shall be paid less all applicable state and federal tax withholdings and any other withholdings required by any applicable jurisdiction or authorized by you. You acknowledge and agree that other than (a) payment of salary and wages through the Resignation Date (the Remaining Employment Compensation) and (b) subject to the terms and conditions hereof and the payments and benefits set forth herein: (i) you have been timely paid all of your wages through the date hereof and, assuming the payment of the Remaining Employment Compensation, you will have been timely paid all of your wages earned through the Resignation Date, (ii) prior to the execution of this Transition Agreement, except for the Remaining Employment Compensation and standard employee benefits through the Resignation Date, you were not entitled to receive (or if entitled to receive, hereby waive, release and forever discharge) any further payments, equity grants, perks or benefits from the Company or any of its subsidiaries or affiliates and (iii) you are not entitled to (or if entitled, hereby waive, release and forever discharge) any further payments, equity grants, perks or benefits from the Company or any of its subsidiaries or affiliates after the Resignation Date (including, without limitation, under the Employment Agreement), except as set forth in this Transition Agreement and the Independent Contractor Services Agreement. You agree that you did not suffer an injury covered by workers compensation in the course and scope of your employment with the Company. You agree that, except as provided in this Transition Agreement, you are not and will not be entitled to any severance or acceleration benefits, including, without limitation, under the Option Agreements and the Employment Agreement, as a result of your resignation.
10. Section 409A. It is intended that the terms of this Transition Agreement comply with Section 409A of the Internal Revenue Code of 1986, as amended, the final regulations and any guidance promulgated thereunder (collectively, Section 409A) or an exemption therefrom, and the terms of this Transition Agreement will be interpreted accordingly; provided, however, that the Company, its affiliates, and their respective employees, officers, directors, agents and representatives (including, without limitation, legal counsel) will not have any liability to you with respect to any taxes, penalties, interest or other costs or expenses you or any related party may incur with respect to or as a result of Section 409A or for damages for failing to comply with Section 409A. Notwithstanding any provision to the contrary in this Transition Agreement, with respect to any amounts under this Transition Agreement that are determined to be deferred compensation for purposes of Section 409A and payable as a result of your termination of employment, you shall not be deemed to have terminated employment unless and until you have experienced a separation from service (as that term is used in Section 409A). Payments pursuant to this Transition Agreement are intended to constitute separate payments for purposes of Section 409A. To the extent you are a specified employee, as defined in Section 409A and any elections made by the Company in accordance therewith, notwithstanding the timing of payment provided in any other section of this Transition Agreement, to the extent required by Section 409A, no payment, distribution or benefit under this Transition Agreement that constitutes a distribution of deferred compensation (within the meaning of Section 409A) upon separation from service (as that term is used in Section 409A), after taking into account all available exemptions, that would otherwise be payable, distributable or settled during the six (6) month period after separation from service, will be made during such six (6) month period, and any such payment, distribution or benefit will instead be paid on the first business day after such six (6) month period, provided, however, that if you die following the date of termination and prior to the payment, distribution, settlement or provision of any payments, distributions or benefits delayed on account of Section 409A, such payments, distributions or benefits shall be paid or provided to the personal representative of your estate within thirty (30) days after the date of your death. To the extent that the payment of any amount hereunder constitutes nonqualified deferred compensation for purposes of Section 409A, if the applicable sixty (60) day period described in either Section 6 or Section 8 above spans calendar years, the payments will be made in the second calendar year. Any reimbursements or in-kind benefits provided to or for your benefit that constitute deferred compensation for purposes of Section 409A shall be provided in a manner that complies with Section 409A. Accordingly, (a) all such reimbursements will be made not later than the last day of the calendar year after the calendar year in which the expenses
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were incurred, (b) any right to such reimbursements or in-kind benefits will not be subject to liquidation or exchange for another benefit, and (c) the amount of the expenses eligible for reimbursement, or the amount of any in-kind benefit provided, during any taxable year will not affect the amount of expenses eligible for reimbursement, or the in-kind benefits provided, in any other taxable year.
11. Release. In exchange for the agreements contained in this Transition Agreement, which you acknowledge exceeds any amounts to which you otherwise may be entitled under the Companys policies and practices or applicable law, you on behalf of yourself and your heirs, executors, representatives and assigns, hereby fully acquits, releases, waives and discharges from and agree that you have not and will not file, cause to be filed or pursue against, the Company, its affiliates, related parties, parent or subsidiary companies, and its and their present and former directors, officers, employees, agents, committee members, attorneys and representatives, and each of the foregoings successors and assigns (including, without limitation, Parent) (the Released Parties) all claims obligations, liabilities, complaints, causes of action, charges, debts, and demands of any kind, known and unknown, in law or in equity, asserted or unasserted (Claims) which you may now have or have ever had against any of them, or arising out of your relationship with any of them, including all claims for compensation and bonuses, attorneys fees, and all claims arising from your employment with the Company or the termination of your employment, whether based on contract, tort, statute, local ordinance, rule, regulation or any comparable law in any jurisdiction (Released Claims).
Released Claims include, but are not limited to:
(i) all Claims arising from your employment with the Company or the termination of that employment, including Claims for wrongful termination or retaliation and the terms and conditions of employment;
(ii) all Claims related to your compensation or benefits from the Company, including salary, wages, bonuses, commissions, incentive compensation, profit sharing, retirement benefits, paid time off, vacation, sick leave, leaves of absence, expense reimbursements, equity, severance pay, and fringe benefits;
(iii) all Claims for breach of contract, breach of quasi-contract, promissory estoppel, detrimental reliance, and breach of the implied covenant of good faith and fair dealing;
(iv) all tort Claims, including Claims for fraud, defamation, slander, libel, disparagement, negligent or intentional infliction of emotional distress, personal injury, negligence, compensatory or punitive damages, negligent or intentional misrepresentation, and discharge in violation of public policy;
(v) all federal, state, and local statutory Claims, including Claims for discrimination, harassment, retaliation, attorneys fees, medical expenses, experts fees, costs and disbursements; and
(vi) any other Claims of any kind whatsoever, from the beginning of time until the date you sign this Transition Agreement, in each case whether based on contract, tort, statute, local ordinance, rule, regulation or any comparable law, public policy or common law in any jurisdiction.
By way of example and not limitation, Released Claims shall include any Claims arising under Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq.; the Civil Rights Act of 1991; the Civil Rights Acts of 1866 and/or 1871, 42 U.S.C. Section 1981; the Americans with Disabilities Act, 42 U.S.C. 12101 et seq., the Age Discrimination in Employment Act (ADEA), 29 U.S.C. § 621 et seq.; the Family Medical Leave Act, 29 U.S.C. § 2601 et seq.; the Employee Retirement Income Security Act of 1974, 29 U.S.C. § 1001 et seq.; the federal Worker Adjustment Retraining Notification Act, 29 U.S.C. § 2102 et seq., the California
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WARN Act, California Labor Code § 1400 et seq., the California Fair Employment and Housing Act, Cal. Gov. Code §12900 et seq., the California Labor Code, and the orders of the California Industrial Welfare Commission. The parties intend for this release to be enforced to the fullest extent permitted by law. You understand that you are not waiving any right or Claim that cannot be waived as a matter of law, such as workers compensation Claims, Claims for indemnification under California Labor Code Section 2802, Claims for unemployment insurance benefits, your right to vested equity or other vested benefits, or as otherwise set forth in this Transition Agreement. YOU UNDERSTAND AND AGREE THAT THIS TRANSITION AGREEMENT CONTAINS A GENERAL RELEASE OF ALL CLAIMS.
12. ADEA. You further specifically unconditionally release and forever discharge the Released Parties from any and all Claims that you may have as of the date you sign this Transition Agreement arising under the ADEA. By signing this Transition Agreement, you acknowledge and confirm that: (a) you have been advised by the Company to consult with an attorney of your choice before signing this Transition Agreement; (b) you were given no fewer than twenty-one (21) days to consider the terms of this Transition Agreement, although you may sign it sooner if desired; (c) you are providing this release in exchange for consideration in addition to that which you are already entitled; (d) you have seven (7) days from the date of signing this Transition Agreement to revoke this Transition Agreement by providing the Company with a written notice of revocation to the Companys Chairman of the Board at the Companys principal executive office located at 200 Constitution Drive, Menlo Park, CA 94025, before the end of such seven-day period (Revocation Period); (e) this Transition Agreement will not become effective, and you will not be entitled to the benefits of this Transition Agreement, until the Revocation Period passes without you revoking this Transition Agreement; (f) the release contained in this paragraph does not apply to rights and claims that may arise after the date on which you sign this Transition Agreement, and (g) you knowingly and voluntarily accept the terms of this Transition Agreement. You further agree that any change to this Transition Agreement, whether material or immaterial, will not restart the twenty-one (21) day period for you to consider the terms of this Transition Agreement.
13. Section 1542. You further agree that because this release specifically covers known and unknown claims, you waive your rights under Section 1542 of the California Civil Code, or under any comparable law of any other jurisdiction. Section 1542 states:
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS THAT THE CREDITOR OR RELEASING PARTY DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE AND THAT, IF KNOWN BY HIM OR HER, WOULD HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR OR RELEASED PARTY.
You intend for this release to be enforced to the fullest extent permitted by law. Notwithstanding the foregoing, you acknowledge and agree that you are not waiving or being required to waive any right that cannot be waived as a matter of law, including the right to file a charge, report an alleged violation of law or participate in an investigation by a governmental administrative agency, including your ability to file a charge or complaint with the Equal Employment Opportunity Commission, the National Labor Relations Board, the Occupational Safety and Health Administration, the Securities and Exchange Commission or any other federal, state or local government agency or commission (Government Agencies). You further understand that this General Release Agreement does not limit your ability to communicate with any Government Agencies or otherwise participate in any investigation or proceeding that may be conducted by any Government Agency, including providing documents or other information, without notice to the Company; provided, however, that you hereby disclaim and waive any right to share or participate in any monetary award resulting from the prosecution of such charge, report or investigation, except that you may receive and fully retain a monetary award from a government-administered whistleblower award program for providing information directly to a government agency. This General Release does not release any rights you may have pursuant to this Transition Agreement or Independent Contractor Services Agreement.
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14. Confidentiality. You further agree to maintain this Transition Agreement and its contents in the strictest confidence and agree that you will not disclose the terms of this Transition Agreement to any third party (other than your legal and financial advisors) without the prior written consent of the Company, unless otherwise required by law. If you are obligated under law to disclose the contents of this Transition Agreement, you agree, to the extent possible, to provide the Company at least five (5) days prior written notice of such obligation. You also agree that during your continued services with the Company and for five (5) years thereafter, you will not make or publish, either orally or in writing, any disparaging statement regarding any Released Parties. The Company agrees that during such period it shall instruct its executive officers and directors to refrain from making or publishing, either orally or in writing, any disparaging statements concerning you to any third parties; provided, however, that the Company shall be permitted to (a) respond truthfully to reference requests from your potential future employers, and (b) disclose the reasons for your departure to current and prospective equityholders, officers, directors, investors, financing sources, underwriters, acquirors, strategic partners or any representative or affiliate or the foregoing, and both parties may make disclosures necessary or advisable to comply with applicable law, rule, regulation, securities exchange requirement or court order. The parties further agree that you will refer any third party reference requests to the Companys Chief Human Resources Officer or the then highest ranking human resources employee, who will respond by confirming dates of employment and last position held.
15. Cooperation. You agree to use reasonable efforts to cooperate with the Company in connection with any business matters in which you were involved or any existing or potential claims, investigations, administrative proceedings, lawsuits or other legal and business matters which arose during your employment or thereafter as part of the Services or involving matters of which you have knowledge due to your position as Chief Executive Officer, President, Treasurer or Secretary. This includes being available to provide information or explain documents as requested by the Company and its counsel as well as disclosing to the Company and its counsel any facts you know which might be relevant and cooperating fully so as to enable the Company and its counsel to present any claim or defense which it may have relating to such matters. In addition, you agree not to counsel or assist any attorneys or their clients in the presentation or prosecution of any disputes, differences, grievances, claims, charges or complaints by any third party against the Company, unless under subpoena or other court or administrative order or legal process to do so.
16. Right to Disclose. Notwithstanding any other provision of this Transition Agreement to the contrary, you have the right to (a) disclose in confidence trade secrets to federal, state, and local government officials, or to an attorney, for the sole purpose of reporting or investigating a suspected violation of the law or (b) disclose trade secrets in a document filed in a lawsuit or other proceeding so long as that filing is made under seal and protected from public disclosure. Nothing in this Transition Agreement is intended to conflict with 18 U.S.C. § 1833(b) or create liability for disclosures of trade secrets that are expressly allowed by 18 U.S.C. § 1833(b).
17. Proprietary Information. You agree that, notwithstanding any other provision of this Transition Agreement to the contrary and without limiting in any manner the Proprietary Information Agreement, as a precondition of your eligibility for and receipt of the Consideration, you shall return to the Company all Company documents (and all copies thereof) and other Company property that you have had in your possession at any time, including, but not limited to, CDs, electronic files and/or storage devices, presentations; Company files, notes, drawings, records, business plans and forecasts, financial information, specifications, computer-recorded information, tangible property (including, but not limited to, computers, phones, credit cards, entry cards, identification badges and building and desk keys); and, any materials of
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any kind that contain or embody any proprietary or confidential information of the Company (and all reproductions thereof). You shall retain no copies of Company records after the date hereof. Any such records have been or will be returned to Company.
18. Arbitration. You and the Company further agree that the sole remedy for any and all disputes arising out of or based on the terms, interpretation, application, or alleged breach of this Transition Agreement, including any of the Released Claims, shall be binding arbitration, which shall be conducted in San Mateo County, California, before a single arbitrator, in accordance with the then applicable rules of the Judicial Arbitration and Mediation Service (JAMS) or by a non-JAMS process to which the parties may otherwise agree. By agreeing to arbitrate, the parties are waiving their respective rights to a jury trial with regard to any of the above-referenced claims.
19. Entire Agreement. This Transition Agreement constitutes the entire agreement and understanding between you and the Company concerning its subject matter, replaces and supersedes any and all prior agreements and understandings between us (other than the Proprietary Information Agreement, which shall remain in full force and effect), and may only be amended in writing signed by you and an authorized representative of the Company, and that, except for the Proprietary Information Agreement and the Independent Contractor Services Agreement, and except as otherwise expressly provided in this Transition Agreement, this Transition Agreement renders null and void any and all prior or contemporaneous representations, warranties or agreements between you and the Company or any affiliate of the Company. It is agreed that this Transition Agreement shall be governed by the laws of the State of California. If any provision of this Transition Agreement or the application thereof to any person, place, or circumstance shall be held by a court of competent jurisdiction or arbitrator to be invalid, unenforceable, or void, the remainder of this Transition Agreement and such provision as applied to other person, places, and circumstances shall remain in full force and effect. You understand and agree that this Transition Agreement is not an admission of guilt or wrongdoing by the Company and that the Company does not believe or admit that it has done anything wrong.
20. Acknowledgement. Finally, by your signature below, you acknowledge each of the following: (a) that you have read this Transition Agreement or have been afforded every opportunity to do so; (b) that you are fully aware of this Transition Agreements contents and legal effect; (c) that you have reviewed, or have had the opportunity to review, this Transition Agreement with legal counsel of your choosing; and (d) that you have chosen to enter into this Transition Agreement freely, without coercion and based upon your own judgment and not in reliance upon any promises made by Company other than those contained in this Transition Agreement.
21. Conditionality. Each party acknowledges and agrees that this Transition Agreement shall terminate in its entirety and be of no further force and effect if the Merger Agreement is: (a) not entered into prior to June 30, 2020 or (b) entered into and subsequently terminated prior to the Closing occurring.
[Remainder of Page Left Intentionally Blank]
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To accept this Transition Agreement, please sign and date this Transition Agreement and return it to me. Please indicate your agreement with the above terms by signing below.
Sincerely, | ||
Adicet Bio Inc. | ||
By: | /s/ Donald Santel | |
Name: | Donald Santel | |
Title: | Executive Chairman | |
Address for Notices: | ||
200 Constitution Drive | ||
Menlo Park, CA 94025 |
My agreement with the terms of this Transition Agreement is signified by my signature below. I confirm and acknowledge that I am not entitled to any severance under my Employment Agreement. Furthermore, I acknowledge that I have read and understand this Transition Agreement and that I sign this release of all claims voluntarily, with full appreciation that at no time in the future may I pursue any of the rights I have waived in this Transition Agreement.
Signed | /s/ Anil Singhal |
Dated: April 28, 2020 | ||||||
Anil Singhal |
Address for Notices:
Attachment A: | Independent Contractor Services Agreement | |
Attachment B: | Form of Release |
ATTACHMENT A
INDEPENDENT CONTRACTOR SERVICES AGREEMENT
[See Attached]
ATTACHMENT B
FORM OF RELEASE
[See Attached]
GENERAL RELEASE AGREEMENT
This General Release Agreement is executed by Anil Singhal (you), in accordance with your Transition Agreement, dated as of April 28, 2020, by and between you and Adicet Bio, Inc. (the Company), as amended, modified or restated from time to time (the Transition Agreement). Capitalized terms used but not otherwise defined herein shall have the meanings set forth in the Transition Agreement.
In accordance with the Transition Agreement, and in exchange for the Termination Consideration, which you acknowledge exceeds any amounts to which you otherwise may be entitled under the Companys policies and practices or applicable law, you on behalf of yourself and your heirs, executors, representatives and assigns, hereby fully acquits, releases, waives and discharges from and agree that you have not and will not file, cause to be filed or pursue against, the Company, its affiliates, related, parent or subsidiary companies, and its and their present and former directors, officers, employees, agents, committee members, attorneys and representatives, and each of the foregoings successors and assigns (including, without limitation, Parent) (the Released Parties) all claims obligations, liabilities, complaints, causes of action, charges, debts, and demands of any kind, known and unknown, in law or in equity, asserted or unasserted (Claims) which you may now have or have ever had against any of them, or arising out of your relationship with any of them, including all claims for compensation and bonuses, attorneys fees, and all claims arising from your employment with the Company or the termination of your employment, whether based on contract, tort, statute, local ordinance, rule, regulation or any comparable law in any jurisdiction (Released Claims).
Released Claims include, but are not limited to:
(i) all Claims arising from your employment with the Company or the termination of that employment, including Claims for wrongful termination or retaliation and the terms and conditions of employment;
(ii) all Claims related to your compensation or benefits from the Company, including salary, wages, bonuses, commissions, incentive compensation, profit sharing, retirement benefits, paid time off, vacation, sick leave, leaves of absence, expense reimbursements, equity, severance pay, and fringe benefits;
(iii) all Claims for breach of contract, breach of quasi-contract, promissory estoppel, detrimental reliance, and breach of the implied covenant of good faith and fair dealing;
(iv) all tort Claims, including Claims for fraud, defamation, slander, libel, disparagement, negligent or intentional infliction of emotional distress, personal injury, negligence, compensatory or punitive damages, negligent or intentional misrepresentation, and discharge in violation of public policy;
(v) all federal, state, and local statutory Claims, including Claims for discrimination, harassment, retaliation, attorneys fees, medical expenses, experts fees, costs and disbursements; and
(vi) any other Claims of any kind whatsoever, from the beginning of time until the date you sign this General Release Agreement, in each case whether based on contract, tort, statute, local ordinance, rule, regulation or any comparable law, public policy or common law in any jurisdiction.
By way of example and not limitation, Released Claims shall include any Claims arising under Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq.; the Civil Rights Act of 1991; the Civil Rights Acts of 1866 and/or 1871, 42 U.S.C. Section 1981; the Americans with Disabilities Act, 42 U.S.C. 12101 et seq., the Age Discrimination in Employment Act (ADEA), 29 U.S.C. § 621 et seq.; the Family Medical Leave
Act, 29 U.S.C. § 2601 et seq.; the Employee Retirement Income Security Act of 1974, 29 U.S.C. § 1001 et seq.; the federal Worker Adjustment Retraining Notification Act, 29 U.S.C. § 2102 et seq., the California WARN Act, California Labor Code § 1400 et seq., the California Fair Employment and Housing Act, Cal. Gov. Code §12900 et seq., the California Labor Code, and the orders of the California Industrial Welfare Commission. The parties intend for this release to be enforced to the fullest extent permitted by law. You understand that you are not waiving any right or Claim that cannot be waived as a matter of law, such as workers compensation Claims, Claims for indemnification under California Labor Code Section 2802, Claims for unemployment insurance benefits, your right to vested equity or other vested benefits, or as otherwise set forth in this General Release Agreement. YOU UNDERSTAND AND AGREE THAT THIS GENERAL RELEASE AGREEMENT CONTAINS A GENERAL RELEASE OF ALL CLAIMS.
You further agree that because this release specifically covers known and unknown claims, you waive your rights under Section 1542 of the California Civil Code, or under any comparable law of any other jurisdiction. Section 1542 states:
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS THAT THE CREDITOR OR RELEASING PARTY DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE AND THAT, IF KNOWN BY HIM OR HER, WOULD HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR OR RELEASED PARTY.
You intend for this release to be enforced to the fullest extent permitted by law. Notwithstanding the foregoing, you acknowledge and agree that you are not waiving or being required to waive any right that cannot be waived as a matter of law, including the right to file a charge, report an alleged violation of law or participate in an investigation by a governmental administrative agency, including your ability to file a charge or complaint with the Equal Employment Opportunity Commission, the National Labor Relations Board, the Occupational Safety and Health Administration, the Securities and Exchange Commission or any other federal, state or local government agency or commission (Government Agencies). You further understand that this General Release Agreement does not limit your ability to communicate with any Government Agencies or otherwise participate in any investigation or proceeding that may be conducted by any Government Agency, including providing documents or other information, without notice to the Company; provided, however, that you hereby disclaim and waive any right to share or participate in any monetary award resulting from the prosecution of such charge, report or investigation, except that you may receive and fully retain a monetary award from a government-administered whistleblower award program for providing information directly to a government agency. This General Release does not release any rights you may have pursuant to the Transition Agreement or Independent Contractor Services Agreement.
You further specifically unconditionally release and forever discharge the Released Parties from any and all Claims that you may have as of the date you sign this General Release Agreement arising under the ADEA. By signing this General Release Agreement, you acknowledge and confirm that: (i) you have been advised by the Company to consult with an attorney of your choice before signing this General Release Agreement; (ii) you were given no fewer than [twenty-one (21) or forty-five (45)] days to consider the terms of this General Release Agreement, although you may sign it sooner if desired; (iii) you are providing this release in exchange for consideration in addition to that which you are already entitled; (iv) you have seven (7) days from the date of signing this General Release Agreement to revoke this General Release Agreement by providing the Company with a written notice of revocation to the current [Chairman of the Board of Directors of the Company] at the Companys principal executive office located at [LOCATION], before the end of such seven-day period (Revocation Period); (v) this General Release Agreement will not become effective, and you will not be entitled to any Termination Consideration, until the Revocation Period passes without you revoking this General Release Agreement; (vi) the release contained in this
paragraph does not apply to rights and claims that may arise after the date on which you sign this General Release Agreement, and (vii) you knowingly and voluntarily accept the terms of this General Release Agreement. You further agree that any change to this General Release Agreement, whether material or immaterial, will not restart the [twenty-one (21) or forty-five (45)] day period for you to consider the terms of this General Release Agreement.
You affirm that you have not initiated, filed or caused to be filed and agree not to initiate, file or cause to be filed any Released Claims against any of the Released Parties. You further agree not to encourage any person, including any current or former Company employee, to file any kind of claim whatsoever against the Released Parties, or any of them, and not to solicit, assist, support or in any way cooperate in the initiation or prosecution of any action or proceeding brought against the Released Parties, or any of them, by a third party, except if compelled to do so by legal process which includes when compelled by court order, subpoena or written request by an administrative agency or the legislature to testify regarding alleged criminal conduct or alleged sexual harassment.
Notwithstanding anything to the contrary in this General Release Agreement, nothing in this General Release Agreement shall prohibit or interfere with you exercising protected rights to file a charge with or report to any Governmental Agency. You do not need the Companys advance permission to file any such charge or report or to participate in any such investigation. You do, however, waive any right to receive any monetary award or benefit resulting from such a charge, report, or investigation related to any Released Claims, except that you may receive and fully retain a monetary award from a government-administered whistleblower award program. You further acknowledge and agree that this General Release Agreement shall not be construed as a waiver of any rights that are not subject to waiver by private agreement or otherwise cannot be waived as a matter of law.
You represent and warrant that you have returned to the Companyand have not retained any copies ofall Company property, including, without limitation, all documents and data in whatever form maintained, confidential information, computer hardware or software, files, papers, memoranda, correspondence, client lists, employee information, financial records and information, credit cards, keys, access cards, tape recordings, pictures and any other items of any nature which were or are the property of the Company. You understand that you will not be eligible for any Termination Consideration, until you return all Company property.
You agree to reasonably cooperate with the Company in any pending or future litigation and/or administrative investigation in which the Company is a party and/or is the subject of an administrative investigation where you have relevant knowledge or information.
You agree that the Transition Agreement and this General Release Agreement contain all of the agreements and understandings between you and the Company with respect to their subject matter, and may not be contradicted by evidence of any prior or contemporaneous agreement; provided, however, that, the Proprietary Information Agreement shall not be modified in any way by this General Release Agreement and shall continue in full force and effect in accordance with its terms. This General Release Agreement shall be governed by the laws of the State of California. If any provision of this General Release Agreement or its application to any person, place, or circumstance is held by a court of competent jurisdiction to be invalid, unenforceable, or void, the remainder of this General Release Agreement and such provision as applied to other person, places, and circumstances will remain in full force and effect. Nothing in this General Release Agreement shall be construed as an admission by any party of any wrongdoing, violation of the Companys policies or procedures, or violations of any federal, state or local law.
Finally, by your signature below, you acknowledge each of the following: (a) you have read this General Release Agreement or have been afforded every opportunity to do so; (b) you are fully aware of this General
Release Agreements contents and legal effect; (c) you have reviewed, or have had the opportunity to review, this General Release Agreement with legal counsel of your choosing; and (d) you have chosen to enter into this General Release Agreement freely, without coercion and based upon your own judgment and not in reliance upon any promises made by the Company other than those contained in this General Release Agreement.
Please note that this General Release Agreement may be signed no earlier than your last date of employment with the Company, and that your eligibility for any Termination Consideration, is conditioned upon meeting the terms set forth in the Transition Agreement.
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Date: | |||||||
Anil Singhal |
Exhibit 10.10
INDEPENDENT CONTRACTOR SERVICES AGREEMENT
THIS INDEPENDENT CONTRACTOR SERVICES AGREEMENT (this Agreement) effective as of April 28, 2020 (the Effective Date), is entered into between Adicet Bio, Inc., a Delaware corporation (Adicet), and Anil Singhal (Contractor). The parties hereby agree as follows:
1. Engagement for Services. Subject to and contingent upon Contractor providing services as an employee of Adicet through the Resignation Date and the Closing occurring (each as defined in that certain letter agreement, dated on or about the date hereof, by and between Contractor and Adicet, as amended, modified or restated from time to time (the Transition Agreement)), Adicet hereby engages Contractor to perform the services (the Services) described on Exhibit A on the terms and conditions of this Agreement from and after the Resignation Date (the Start Date). Contractor hereby accepts such engagement, and shall perform the Services and otherwise act in strict accordance with the terms and conditions of this Agreement. Contractor shall comply with all applicable Adicet policies and procedures in the performance of the Services. Contractor shall perform the Services in accordance with all applicable laws, regulations and the highest professional industry standards. Except as otherwise provided herein, Adicet shall not control the manner or means by which Contractor performs the Services.
2. Place of Work. Contractor is generally free to perform Contractors Services at a location of Contractors choosing. Contractor understands that the Services must coordinate with Adicets established protocols and security requirements and may from time to time need to be performed at Adicets premises.
3. Compensation. Adicet shall pay Contractor the compensation set forth in Exhibit A in accordance with the payment schedule set forth therein. If provided for in Exhibit A, Adicet shall reimburse Contractors reasonable expenses in accordance with, and subject to the terms and conditions set forth on, Exhibit A. Upon termination of this Agreement for any reason, Contractor shall be (a) paid fees on the basis set forth in Exhibit A and (b) reimbursed only for expenses that are incurred prior to termination of this Agreement and in accordance with this Agreement.
4. Disclosure and Assignment of Work Product.
4.1 Work Product. Work Product shall mean all (a) deliverables, discoveries, inventions, designs, processes, formulae, developments, improvements, works of authorship, results, information, data, know-how, ideas, concepts, technology or intellectual property (in each case, whether or not protectable under patent, copyright or trade secret laws) and (b) patent rights, copyrights, trade secret rights, mask work rights, trademark rights, trade names, trade dress, trade secret rights, sui generis database rights and all other intellectual property rights of any sort throughout the world, in each case of any of the foregoing in (a) or (b), conceived, created, generated, made, derived, developed or reduced to practice, whether directly or indirectly or solely or jointly with others, from, using, or in connection with (i) the performance of the Services or (ii) any Confidential Information (as defined below).
4.2 Disclosure and Assignment of Work Product. Contractor shall maintain adequate and current records of all Work Product, which records shall be and remain the property of Adicet. Contractor shall promptly disclose and describe to Adicet all Work Product. Contractor shall, and hereby does, assign to Adicet, or Adicets designee, all of Contractors right, title and interest in and to any and all Work Product, all associated records, and all intellectual property rights therein and thereto. Contractor retains no rights to use the Work Product.
4.3 Further Assistance. Contractor shall perform, during and after the term of this Agreement, all acts that Adicet deems necessary or desirable to permit and assist Adicet in obtaining,
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perfecting and enforcing the full benefits, enjoyment, rights and title throughout the world in the Work Product. Such assistance shall include, without limitation, the maintenance of adequate and current records of any and all Work Product, the disclosure of all pertinent information and data relating to Work Product, the execution of all applications, specifications, oaths, and assignments, and all other instruments and papers that Adicet shall deem necessary to apply for and to assign or convey to Adicet, its successors, and assigns or nominees, the sole and exclusive right, title, and interest in such Work Product. If Adicet is unable for any reason to secure Contractors signature to any document required to file, prosecute, register, enforce or memorialize the assignment of any rights under any Work Product, Contractor hereby irrevocably designates and appoints Adicet as Contractors agent and attorney-in-fact to act for and on Contractors behalf and instead of Contractor to take all lawfully permitted acts to further the filing, prosecution, registration, memorialization of assignment, issuance and enforcement of rights under such Work Product, all with the same legal force and effect as if executed by Contractor. The foregoing is deemed a power coupled with an interest and is irrevocable.
4.4 License. To the extent any of the rights, title and interest in and to any Work Product cannot be assigned by Contractor to Adicet, Contractor hereby unconditionally and irrevocably grants to Adicet and Adicets designees and successors in interest an exclusive (even as to Contractor), royalty-free, transferable, irrevocable, perpetual, worldwide, fully paid-up license (with rights to sublicense through multiple tiers of sublicensees) to use, reproduce, distribute, display and perform (whether publicly or otherwise), prepare derivative works of and otherwise modify, make, sell, offer to sell, import and otherwise use and exploit (and have others exercise such rights on behalf of Adicet) all or any portion of such non-assignable rights, title and interest, in each case in any medium or format, whether now known or later developed, and in each case without notice to, the consent of, or accounting to Contractor. To the extent any of the rights, title and interest in and to any Work Product can neither be assigned nor licensed by Contractor to Adicet, Contractor hereby unconditionally and irrevocably waives and agrees never to assert such non-assignable and non-licensable rights, title and interest, and any associated claims or causes of action, against Adicet or any of Adicets designees or successors in interest. Contractor further waives any moral rights or other rights with respect to attribution of authorship or integrity of such Work Product that Contractor may have under any applicable law, whether under copyright, trademark, unfair competition, defamation, right of privacy, contract, tort or other legal theory.
4.5 Out-of-Scope Innovations. Contractor agrees not to use or incorporate into any Work Product any confidential or proprietary information, technology or intellectual property conceived, created, generated, made, derived, developed or reduced to practice (a) by Contractor other than in the course of performing the Services or (b) by any third party (collectively, the Out-of-Scope Innovations). To the extent Contractor uses, incorporates or permits to be incorporated into any Work Product any Out-of-Scope Innovations, then Contractor hereby grants to Adicet and Adicets designees and successors in interest a non-exclusive, royalty-free, transferable, irrevocable, perpetual, worldwide, fully paid-up license (with rights to sublicense through multiple tiers of sublicensees) to use, reproduce, distribute, display and perform (whether publicly or otherwise), prepare derivative works of and otherwise modify, make, sell, offer to sell, import and otherwise use and exploit (and have others exercise such rights on behalf of Adicet) all or any portion of such Out-of-Scope Innovations, in each case in any medium or format, whether now known or later developed, and without notice to, the consent of, or accounting to Contractor. To the extent any of the rights, title and interest in and to any Out-of-Scope Innovations cannot be licensed by Contractor to Adicet, Contractor hereby unconditionally and irrevocably waives and agrees never to assert such non-licensable rights, title and interest, and any associated claims or causes of action, against Adicet or any of Adicets designee or successors in interest.
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5. Confidentiality.
5.1 Confidential Information. Confidential Information shall mean (a) any and all data and information (and all tangible and intangible embodiments thereof), whether or not marked or identified as confidential or proprietary, of any type whatsoever, whether in writing, or in oral, graphic, electronic or any other form, related to Adicet, its technology, intellectual property, contracts, business relationships, products, product candidates, employees, business, assets, finances, operations or opportunities and/or the Services, (b) all Work Product and all associated records, (c) the existence of this Agreement and the nature and scope of the Services, the terms and conditions hereof and thereof, and the performance of the Services, and (d) any other data or information (and all tangible and intangible embodiments thereof), including any trade secrets, that may be provided, made accessible or made known to, Contractor from or in connection with the performance of the Services, including, without limitation, any such information that Adicet has received from others that Adicet is obligated to treat as confidential or proprietary. Notwithstanding the foregoing, Confidential Information shall not include (i) information that is or becomes publicly known through lawful means through no act or omission of Contractor; (ii) information that was rightfully known by Contractor without confidential or proprietary restriction before receipt from Adicet, as evidenced by Contractors contemporaneous written records; or (iii) information that is disclosed to Contractor without restriction by a third party who rightfully possesses the information and does not owe a duty of confidentiality to Adicet with respect to such information.
5.2 Nondisclosure and Nonuse. Except as permitted in this Section 5, Contractor shall maintain in confidence and not, directly or indirectly, use, disseminate or in any way disclose the Confidential Information to any third party, other than Adicet. Contractor may use the Confidential Information solely to perform the Services for the sole and exclusive benefit of Adicet and for no other purpose. Contractor shall treat all Confidential Information with the same degree of care as Contractor accords to Contractors own confidential information, but in no case shall Contractor use less than reasonable care. Contractor shall immediately give notice to Adicet of any unauthorized use or disclosure of the Confidential Information. Contractor shall assist Adicet in remedying any such unauthorized use or disclosure of the Confidential Information.
5.3 Permitted Disclosure. Contractors nondisclosure obligations under Section 5.2 shall not apply to the extent that Contractor is required to disclose information by applicable law, regulation or order of a governmental agency or a court of competent jurisdiction; provided, however, that Contractor shall provide advanced written notice thereof to Adicet, consult with Adicet with respect to such disclosure and provide Adicet sufficient opportunity to object to any such disclosure or to request confidential treatment thereof (if applicable) and reasonably cooperate with Adicet in objecting to or narrowing the scope of such disclosure and/or obtaining a protective order or confidential treatment of such disclosure.
5.4 Ownership and Return of Confidential Information and Adicet Property. All Confidential Information and any materials (including, without limitation, documents, drawings, papers, media, tapes, models, apparatus, sketches, designs and lists) relating thereto, as well as any other materials furnished by Adicet to Contractor in connection with this Agreement, and any copies or derivatives thereof (collectively, the Adicet Property), are and shall remain the sole and exclusive property of Adicet. Within five (5) days after any request by Adicet, Contractor shall destroy or deliver to Adicet, at Adicets option, (a) all Adicet Property and (b) all materials in Contractors possession or control that contain or disclose any Confidential Information. Nothing in this Section 5 is intended to limit any remedy of Adicet under the California Uniform Trade Secrets Act (California Civil Code Section 3426), or otherwise available under law.
5.5 Third Party Information. Contractor shall not disclose to Adicet, or bring onto Adicets premises or induce Adicet to use any confidential or proprietary information, technology or intellectual property that belongs to anyone other than Adicet or Contractor or otherwise take any action that may result in any Work Product being considered owned, in whole or in part, by any other third party.
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5.6 Privacy. Contractor acknowledges that Adicet may access all information and materials generated, received or maintained by or for Contractor on the premises or equipment of Adicet (including, without limitation, computer systems and electronic or voice mail systems), and Contractor hereby waives any privacy rights Contractor may have with respect to such information and materials. During the term of this Agreement and thereafter, Contractor shall adhere to any policies, guidelines or the like adopted by Adicet from time to time regarding treatment of personal information. Further, Contractor understands that there are laws in the United States and other countries that protect personal information, and agrees to comply with all applicable laws regarding the use and disclosure of any personal information.
6. Waiver of Rights and Constructive Trust. Contractor hereby waives any and all rights Contractor may have or hereafter acquire in or to the Work Product, the Confidential Information or the Adicet Property, or any other work product derived directly or indirectly therefrom. Without limiting the generality of any other provision of this Agreement, Contractor shall not copy, disclose, publish or otherwise disseminate (including without limitation in the form of any book, movie, television show, video, article, interview, blog, tweet, website posting or other public disclosure or use of any type whatsoever) the Work Product, the Confidential Information or the Adicet Property, or any other work product derived directly or indirectly therefrom. Any and all proceeds (in cash, in kind or otherwise) directly or indirectly resulting from any violation of this Agreement shall be held in constructive trust for the sole and exclusive benefit of Adicet, and Contractor immediately shall pay or deliver to Adicet any and all of such proceeds.
7. Independent Contractor Relationship. Contractors relationship with Adicet is that of an independent contractor, and nothing in this Agreement is intended to, or shall be construed to, create a partnership, agency, joint venture, employment or similar relationship. Neither Contractor nor, if Contractor is an entity, any employee of Contractor (which for purposes of this Section 7 shall be included in the term Contractor) shall be entitled to any benefits accorded to Adicets employees, including workers compensation, disability insurance, retirement plans, or vacation or sick pay. Contractors exclusion from benefit programs maintained by Adicet is a material component of the terms of compensation negotiated by the parties, and is not premised on Contractors status as a non-employee with respect to Adicet. To the extent that Contractor may become eligible for any benefit programs maintained by Adicet (regardless of the timing of or reason for eligibility), Contractor hereby waives Contractors right to participate in the programs. Contractors waiver is not conditioned on any representation or assumption concerning Contractors status under the common law test. Consistent with Contractors independent contractor status, Contractor shall not apply for any government-sponsored benefits that are intended to apply to employees, including, without limitation, unemployment benefits. Contractor is not authorized to make any representation, contract or commitment on behalf of Adicet unless specifically requested or authorized in writing to do so by Adicet. Contractor is solely responsible for, and shall file, on a timely basis, all tax returns and payments required to be filed with, or made to, any federal, state or local tax authority with respect to the performance of services and receipt of fees under this Agreement, and shall provide Adicet with proof of payment on demand. Contractor is solely responsible for, and must maintain adequate records of, expenses incurred in the course of performing services under this Agreement. No part of Contractors compensation shall be subject to withholding by Adicet for the payment of any social security, federal, state or any other employee payroll taxes. Contractor shall be responsible for providing, at Contractors expense and in Contractors name, disability, workers compensation, or other insurance as well as licenses and permits usual or necessary for performing the Services.
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8. Term and Termination.
8.1 Term. This Agreement is effective as of the Effective Date set forth above and shall terminate on the one (1) year anniversary of the Closing, unless terminated earlier as set forth below.
8.2 Termination. Either party may terminate this Agreement at any time, without cause, on ten (10) days prior express written notice of termination. Either party may terminate this Agreement immediately upon any material breach by the other party by express written notice of such termination.
8.3 Merger Termination. Each party acknowledges and agrees that this Agreement shall terminate in its entirety and be of no further force and effect if the Merger Agreement (as defined in the Transition Agreement) is: (1) not entered into prior to June 30, 2020 or (ii) entered into and subsequently terminated prior to the Closing occurring.
8.4 Effect of Expiration or Termination. Upon expiration or termination of this Agreement, Adicet shall pay Contractor for services performed under this Agreement as set forth in Section 2 and Exhibit A. The provisions of Sections 4, 5, 6, 7, 8.4, 10, 11 and 12 shall survive any termination or expiration of this Agreement.
9. Other Services; No Conflict of Interest. Contractor may represent, perform services for, or be employed by such additional persons or companies as Contractor sees fit, except to the extent that doing so causes Contractor to breach Contractors obligations under this Agreement. During the term of this Agreement, Contractor shall not accept work, enter into a contract or accept an obligation inconsistent or incompatible with Contractors obligations, or the Services to be rendered to Adicet, under this Agreement. Contractor represents and warrants that Contractor does not presently perform consulting or other services for, or engage in an employment relationship with, companies whose business or proposed business in any way involve products or services which would be competitive with Adicets products or services, or those products or services proposed or in development by Adicet during the term of the Agreement. If, however, Contractor decides to do so, Contractor agrees that, (a) Contractor shall continue to abide by the terms of this Agreement, and (b) in advance of accepting such work, Contractor will promptly notify Adicet in writing, specifying the organization with which Contractor proposes to consult, provide services, or become employed by to allow Adicet to determine if such work would conflict with the terms of this Agreement, the interests of Adicet or further services which Adicet might request of Contractor hereunder and (c) Adicet shall have the right to immediately terminate this Agreement by written notice to Contractor.
10. Contractors Representations and Warranties; Indemnification.
10.1 Contractor represents and warrants to Adicet that (a) Contractor has the qualifications and ability to perform the Services in accordance with the terms of this Agreement, without the advice, control or supervision of Adicet, (b) Contractor shall be solely responsible for the professional performance of the Services and shall receive no assistance, direction or control from Adicet, (c) Contractor has good title to any Work Product and the right to assign Work Product to Adicet free of any proprietary rights of any other party or any other encumbrance whatsoever, (d) neither the Work Product nor any element thereof will infringe or misappropriate any intellectual property or proprietary right of any person or entity, whether contractual, statutory or common law, (e) Contractor has never been debarred by the United States Food and Drug Administration, or other applicable governing health authority (or authorities), under any existing or prior law or regulation and (f) (i) Contractor has all necessary power and capacity (if Contractor is an individual) or authority (if Contractor is an entity) to enter into and perform this Agreement, (ii) this Agreement constitutes Contractors valid and binding obligation, enforceable in accordance with its terms, (iii) the execution and performance of this Agreement by Contractor do not (1) violate any
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provision of law applicable to Contractor, (2) conflict with or result in a default under any duty, document, agreement or instrument to which Contractor is a party or is otherwise subject to or (3) except for notices, approvals and consents that have been made or obtained, require that Contractor obtain any consent or approval of, or give notice to, any person. Contractor further represents and warrants that, following the Closing, Contractor will be engaged in an independently established trade, occupation, or business; maintains and operate or be employed by a business that is separate and independent from Adicets business; will hold himself or herself out to the public as independently competent and available to provide applicable services similar to the Services; may obtain and/or expect to obtain clients or customers other than Adicet for whom Contractor performs services or is employed; and will perform work for Adicet that Contractor understands is outside the usual course of Adicets business.
10.2 Contractor shall and does hereby indemnify, defend, and hold harmless Adicet, and Adicets officers, directors, equityholders, employees, agents, affiliates, subsidiaries, representatives, successors and assigns, from and against any and all claims, demands, losses, costs, expenses, obligations, liabilities, damages, settlements, judgments, recoveries, and deficiencies, including, without limitation, interest, penalties, and reasonable attorney fees and costs, that Adicet may incur or suffer to the extent resulting from or relating to any breach or failure of Contractor to perform any of its representations, warranties, and covenants in this Agreement or any actual or alleged breach by Contractor of any contract with or duty to any third party.
11. Non-Solicitation. Contractor acknowledges that, because of Contractors responsibilities at Adicet, Contractor will help to develop, and will be exposed to, Adicets business strategies, information on customers and clients, and other valuable Confidential Information and trade secrets, and that use or disclosure of such Confidential Information and trade secrets in breach of this Agreement would be extremely difficult to detect or prove. Contractor also acknowledges that Adicets relationships with its employees, customers, clients, vendors, and other persons are valuable business assets. Therefore, Contractor agrees that Contractor shall not, during Contractors engagement with Adicet pursuant to this Agreement, or for a period of one year following termination of Contractors engagement with Adicet for any reason, directly or indirectly solicit, induce, recruit, or encourage any officer, director, employee, independent contractor or consultant of Adicet who was employed by or affiliated with Adicet at the time of the termination of Contractors engagement with Adicet to leave Adicet or terminate his or her employment or relationship with Adicet.
12. Miscellaneous.
12.1 Successors and Assigns. Contractor may not subcontract or otherwise assign, transfer or delegate Contractors rights or obligations under this Agreement without Adicets prior written consent. Subject to the foregoing, this Agreement shall be binding upon and shall inure to the benefit of the parties and their respective heirs, legal representatives, successors, and permitted assigns, and shall not benefit any person or entity other than those enumerated above. Adicet may fully assign and transfer this Agreement in whole or part.
12.2 Counterparts; Signatures. This Agreement may be executed and delivered by in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Any signature page delivered by facsimile or e-mail transmission of images in Adobe PDF or similar format shall be binding to the same extent as an original signature page, with regard to any agreement subject to the terms hereof or any amendment thereto.
12.3 Injunctive Relief. Contractors obligations under this Agreement are of a unique character that gives them particular value; Contractors breach of any of such obligations shall result in irreparable and continuing damage to Adicet for which money damages are insufficient, and Adicet shall,
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in addition to any other remedies that may be available at law, in equity or otherwise, be entitled to injunctive relief and/or a decree for specific performance without the necessity of posting a bond. Contractor waives any claim or defense that there is an adequate remedy at law for such breach or threatened breach.
12.4 Attorneys Fees. If any legal action (including, without limitation, an action for arbitration or injunctive relief) is brought relating to this Agreement or the breach or alleged breach hereof, the prevailing party in any final judgment or arbitration award in any such action shall be entitled to receive from the other party the reasonable attorneys fees (and all related costs and expenses), and all other costs and expenses paid or incurred by such prevailing party in connection with such action or proceeding and in connection with enforcing any judgment or order with respect to such matter.
12.5 Governing Law; Forum. This Agreement shall be governed by, interpreted and construed in accordance with the laws of the State of California, without regard to the conflicts of law principles thereof. The parties hereby irrevocably and unconditionally (a) submit to the jurisdiction of the federal and state courts located within the geographical boundaries of the United States District Court for the Northern District of California for the purpose of any suit, action or other proceeding arising out of or based upon this Agreement, (b) agree not to commence any suit, action or other proceeding arising out of or based upon this Agreement except in the federal and state courts located within the geographical boundaries of the United States District Court for the Northern District of California, and (c) hereby waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court.
12.6 Notices. All notices, requests, waivers and other communications made pursuant to this Agreement shall be in writing and shall be conclusively deemed to have been duly given (a) when hand delivered to the other party; (b) when sent by electronic mail to the address set forth on the signature pages hereto if sent between 8:00 am and 5:00 pm recipients local time on a business day, or on the next business day if sent by electronic mail other than between 8:00 am and 5:00 pm recipients local time; (c) three business days after deposit in the U.S. mail with first class or certified mail receipt requested postage prepaid and addressed to the other party at the address set forth on the signature pages hereto; or (d) the next business day after deposit with a national overnight delivery service, postage prepaid, addressed to the parties as set forth on the signature pages hereto with next business day delivery guaranteed, provided that the sending party receives a confirmation of delivery from the delivery service provider. A party may change or supplement the addresses given above, or designate additional addresses, for purposes of this Section 11.7 by giving the other party written notice of the new address in the manner set forth above.
12.7 Further Assurances. Adicet and Contractor shall from time to time and at all times hereafter make, do, execute, or cause or procure to be made, done and executed such further acts, deeds, conveyances, consents and assurances without further consideration, which may reasonably be required to effect the transactions contemplated by this Agreement.
12.8 Enforceability; Severability. The parties hereto agree that each provision of this Agreement shall be interpreted in such a manner as to be effective and valid under applicable law. If one or more provisions of this Agreement are held to be unenforceable under applicable law, (a) such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement, and (b) the balance of the Agreement shall be interpreted as if such provision were so modified and shall be enforceable in accordance with its terms.
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12.9 Amendments; Waivers. This Agreement shall not be varied, altered, modified, changed or in any way amended except by an instrument in writing executed by Contractor and a duly authorized representative of Adicet. No waiver by a party of a breach of or obligation under this Agreement shall constitute a waiver of any other or subsequent breach or obligation.
12.10 18 U.S.C. § 1833(b) Notice. Contractor understands that 18 U.S.C. § 1833(b) states as follows:
An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that-(A) is made-(i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.
Accordingly, notwithstanding anything to the contrary in this Agreement, Contractor understands that Contractor has the right to disclose in confidence trade secrets to Federal, State, and local government officials, or to an attorney, for the sole purpose of reporting or investigating a suspected violation of law. Contractor understands that Contractor also has the right to disclose trade secrets in a document filed in a lawsuit or other proceeding, but only if the filing is made under seal and protected from public disclosure. Contractor understands and acknowledges that nothing in this Agreement is intended to conflict with 18 U.S.C. § 1833(b) or create liability for disclosures of trade secrets that are expressly allowed by 18 U.S.C. § 1833(b).
12.11 Acknowledgement; Interpretation. The parties acknowledge that: (a) they have each had the opportunity to consult with independent counsel of their own choice concerning this Agreement and have done so to the extent they deem necessary, and (b) they each have read and understand the Agreement, are fully aware of its legal effect, and have entered into it voluntarily and freely based on their own judgment and not on any promises or representations other than those contained in the Agreement. This Agreement shall be construed as a whole, according to its fair meaning, and not in favor of or against any party. By way of example and not in limitation, this Agreement shall not be construed in favor of the party receiving a benefit nor against the party responsible for any particular language in this Agreement. Captions are used for reference purposes only and should be ignored in the interpretation of this Agreement.
12.12 Entire Agreement. This Agreement, together with the Transition Agreement, constitute the entire agreement between the parties relating to this subject matter and supersede all prior or contemporaneous representations, warranties or agreements concerning such subject matter, written or oral; provided, however, that, notwithstanding the foregoing, this Agreement shall in no way supersede or effect the enforceability of that certain Employee Proprietary Information and Inventions Assignment Agreement, dated as of May 6, 2019, by and between Adicet and Contractor, which shall continue in full force and effect.
[Remainder of Page Left Intentionally Blank]
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the Effective Date.
ADICET BIO, INC. | ||
By: | /s/ Donald Santel | |
Name: | Donald Santel | |
Title: | Executive Chairman | |
Address for Notices: | ||
200 Constitution Drive | ||
Menlo Park, CA 94025 | ||
ANIL SINGHAL | ||
By: | /s/ Anil Singhal | |
Name: | Anil Singhal | |
Address for Notices: |
SIGNATURE PAGE TO INDEPENDENT CONTRACTOR SERVICES AGREEMENT
EXHIBIT A
SERVICES AND COMPENSATION
Description of Services.
Contractor will serve as a senior advisor to Adicet and provide strategic advice and such other services, all as related to Adicet business, as requested by Adicet from time to time.
Contractor agrees to be available and to devote as requested up to 40 hours per month to performing Contractors obligations to Adicet pursuant to this Agreement (or such greater amount as mutually agreed to from time to time by Contractor and Adicet). Without Contractors consent, Contractor has no duty or obligation to ever work more than 40 hours in any given month.
Adicet shall not supervise Contractor in the day-to-day performance of the Services. All of the services to be performed by Contractor, including but not limited to the Services, will be as agreed between Contractor and the Board or the Boards designee. Contractor will be required to report to the Board or the Boards designee concerning the Services performed under this Agreement. The nature and frequency of these reports will be in the discretion of the Board or the Boards designee.
Contractor shall be free to choose the location at which Contractor provides the Services; provided, however, that Contractor shall be available to provide the Services at Adicets San Francisco Bay Area offices at least one day a week if requested by the Board or the Boards designee upon reasonable advance notice.
Compensation and Payment Terms.
Adicet shall pay Contractor $12,500.00 per month during the term of this Agreement commencing on the Start Date, pro-rated for any partial month of service hereunder. Such amounts shall be paid within thirty (30) days of the end of each month during the term of this Agreement. Any additional hours beyond 40 hours in any given month shall be compensated at the rate of $312.50 per hour, pro-rated for any partial hour of service hereunder.
Contractor shall not be authorized to incur on behalf of Adicet any expenses and will be responsible for all expenses incurred while performing the Services unless otherwise agreed to in advance by the Board or the Boards designee in writing (Approved Expenses). Adicet shall reimburse Approved Expenses no later than thirty (30) days after Adicets receipt of Contractors invoice, provided that reimbursement for Approved Expenses may be delayed until such time as Contractor has furnished reasonable documentation for Approved Expenses as Adicet may reasonably request. Contractor shall submit to Adicet all statements for Approved Expenses incurred on a monthly basis in a form prescribed by Adicet.
A-1
Exhibit 10.13
ADICET BIO, INC.
2015 STOCK INCENTIVE PLAN
1. Purposes of the Plan. The purposes of this Plan are to attract and retain the best available personnel, to provide additional incentives to Employees, Directors and Consultants and to promote the success of the Companys business.
2. Definitions. The following definitions shall apply as used herein and in the individual Award Agreements except as defined otherwise in an individual Award Agreement. In the event a term is separately defined in an individual Award Agreement, such definition shall supersede the definition contained in this Section 2.
(a) Administrator means the Board or any of the Committees appointed to administer the Plan.
(b) Applicable Laws means the legal requirements relating to the Plan and the Awards under applicable provisions of federal and state securities laws, the corporate laws of California and, to the extent other than California, the corporate law of the state of the Companys incorporation, the Code, the rules of any applicable stock exchange or national market system, and the rules of any non-U.S. jurisdiction applicable to Awards granted to residents therein.
(c) Assumed means that pursuant to a Corporate Transaction either (i) the Award is expressly affirmed by the Company or (ii) the contractual obligations represented by the Award are expressly assumed (and not simply by operation of law) by the successor entity or its Parent in connection with the Corporate Transaction with appropriate adjustments to the number and type of securities of the successor entity or its Parent subject to the Award and the exercise or purchase price thereof which at least preserves the compensation element of the Award existing at the time of the Corporate Transaction as determined in accordance with the instruments evidencing the agreement to assume the Award.
(d) Award means the grant of an Option, SAR, Dividend Equivalent Right, Restricted Stock, Restricted Stock Unit or other right or benefit under the Plan.
(e) Award Agreement means the written agreement evidencing the grant of an Award executed by the Company and the Grantee, including any amendments thereto.
(f) Board means the Board of Directors of the Company.
(g) Cause means, with respect to the termination by the Company or a Related Entity of the Grantees Continuous Service, that such termination is for Cause as such term (or word of like import) is expressly defined in a then-effective written agreement between the Grantee and the Company or such Related Entity, or in the absence of such then-effective written agreement and definition, is based on, in the determination of the Administrator, the Grantees: (i) performance of any act or failure to perform any act in bad faith and to the detriment of the Company or a Related Entity; (ii) dishonesty, intentional misconduct or material breach of any agreement with the Company or a Related Entity; or (iii) commission of a crime
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involving dishonesty, breach of trust, or physical or emotional harm to any person; provided, however, that with regard to any agreement that defines Cause on the occurrence of or in connection with a Corporate Transaction, such definition of Cause shall not apply until a Corporate Transaction actually occurs.
(h) Code means the Internal Revenue Code of 1986, as amended.
(i) Committee means any committee composed of members of the Board appointed by the Board to administer the Plan.
(j) Common Stock means the common stock of the Company.
(k) Company means Adicet Bio, Inc., a Delaware corporation, or any successor entity that adopts the Plan in connection with a Corporate Transaction.
(l) Consultant means any person (other than an Employee or a Director, solely with respect to rendering services in such persons capacity as a Director) who is engaged by the Company or any Related Entity to render consulting or advisory services to the Company or such Related Entity.
(m) Continuous Service means that the provision of services to the Company or a Related Entity in any capacity of Employee, Director or Consultant is not interrupted or terminated. In jurisdictions requiring notice in advance of an effective termination as an Employee, Director or Consultant, Continuous Service shall be deemed terminated upon the actual cessation of providing services to the Company or a Related Entity notwithstanding any required notice period that must be fulfilled before a termination as an Employee, Director or Consultant can be effective under Applicable Laws. A Grantees Continuous Service shall be deemed to have terminated either upon an actual termination of Continuous Service or upon the entity for which the Grantee provides services ceasing to be a Related Entity. Continuous Service shall not be considered interrupted in the case of (i) any approved leave of absence, (ii) transfers among the Company, any Related Entity, or any successor, in any capacity of Employee, Director or Consultant, or (iii) any change in status as long as the individual remains in the service of the Company or a Related Entity in any capacity of Employee, Director or Consultant (except as otherwise provided in the Award Agreement). Notwithstanding the foregoing, except as otherwise determined by the Administrator, in the event of any spin-off of a Related Entity, service as an Employee, Director or Consultant for such Related Entity following such spin-off shall be deemed to be Continuous Service for purposes of the Plan and any Award under the Plan. An approved leave of absence shall include sick leave, military leave, or any other authorized personal leave. For purposes of each Incentive Stock Option granted under the Plan, if such leave exceeds three (3) months, and reemployment upon expiration of such leave is not guaranteed by statute or contract, then the Incentive Stock Option shall be treated as a Non-Qualified Stock Option on the day three (3) months and one (1) day following the expiration of such three (3) month period.
(n) Corporate Transaction means any of the following transactions, provided, however, that the Administrator shall determine under parts (iv) and (v) whether multiple transactions are related, and its determination shall be final, binding and conclusive:
(i) a merger or consolidation in which the Company is not the surviving entity, except for a transaction the principal purpose of which is to change the state in which the Company is incorporated;
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(ii) the sale, transfer or other disposition of all or substantially all of the assets of the Company;
(iii) the complete liquidation or dissolution of the Company;
(iv) any reverse merger or series of related transactions culminating in a reverse merger (including, but not limited to, a tender offer followed by a reverse merger) in which the Company is the surviving entity but (A) the shares of Common Stock outstanding immediately prior to such merger are converted or exchanged by virtue of the merger into other property, whether in the form of securities, cash or otherwise, or (B) in which securities possessing more than fifty percent (50%) of the total combined voting power of the Companys outstanding securities are transferred to a person or persons different from those who held such securities immediately prior to such merger or the initial transaction culminating in such merger, but excluding any such transaction or series of related transactions that the Administrator determines shall not be a Corporate Transaction; or
(v) acquisition in a single or series of related transactions by any person or related group of persons (other than the Company or by a Company-sponsored employee benefit plan) of beneficial ownership (within the meaning of Rule 13d-3 of the Exchange Act) of securities possessing more than fifty percent (50%) of the total combined voting power of the Companys outstanding securities but excluding any such transaction or series of related transactions that the Administrator determines shall not be a Corporate Transaction.
(o) Covered Employee means an Employee who is a covered employee under Section 162(m)(3) of the Code.
(p) Director means a member of the Board or the board of directors of any Related Entity.
(q) Disability means as defined under the long-term disability policy of the Company or the Related Entity to which the Grantee provides services regardless of whether the Grantee is covered by such policy. If the Company or the Related Entity to which the Grantee provides service does not have a long-term disability plan in place, Disability means that a Grantee is unable to carry out the responsibilities and functions of the position held by the Grantee by reason of any medically determinable physical or mental impairment for a period of not less than ninety (90) consecutive days. A Grantee will not be considered to have incurred a Disability unless he or she furnishes proof of such impairment sufficient to satisfy the Administrator in its discretion.
(r) Dividend Equivalent Right means a right entitling the Grantee to compensation measured by dividends paid with respect to Common Stock.
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(s) Employee means any person, including an Officer or Director, who is in the employ of the Company or any Related Entity, subject to the control and direction of the Company or any Related Entity as to both the work to be performed and the manner and method of performance. The payment of a directors fee by the Company or a Related Entity shall not be sufficient to constitute employment by the Company.
(t) Exchange Act means the Securities Exchange Act of 1934, as amended.
(u) Fair Market Value means, as of any date, the value of Common Stock determined as follows:
(i) If the Common Stock is listed on one or more established stock exchanges or national market systems, including without limitation The NASDAQ Global Select Market, The NASDAQ Global Market or The NASDAQ Capital Market of The NASDAQ Stock Market LLC, its Fair Market Value shall be the closing sales price for such stock (or the closing bid, if no sales were reported) as quoted on the principal exchange or system on which the Common Stock is listed (as determined by the Administrator) on the date of determination (or, if no closing sales price or closing bid was reported on that date, as applicable, on the last trading date such closing sales price or closing bid was reported), as reported in The Wall Street Journal or such other source as the Administrator deems reliable;
(ii) If the Common Stock is regularly quoted on an automated quotation system (including the OTC Bulletin Board) or by a recognized securities dealer, its Fair Market Value shall be the closing sales price for such stock as quoted on such system or by such securities dealer on the date of determination, but if selling prices are not reported, the Fair Market Value of a share of Common Stock shall be the mean between the high bid and low asked prices for the Common Stock on the date of determination (or, if no such prices were reported on that date, on the last date such prices were reported), as reported in The Wall Street Journal or such other source as the Administrator deems reliable; or
(iii) In the absence of an established market for the Common Stock of the type described in (i) and (ii), above, the Fair Market Value thereof shall be determined by the Administrator in good faith and in a manner consistent with Applicable Laws.
(v) Grantee means an Employee, Director or Consultant who receives an Award under the Plan.
(w) Immediate Family means any child, stepchild, grandchild, parent, stepparent, grandparent, spouse, former spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in law, daughter-in-law, brother-in-law, or sister-in-law, including adoptive relationships, any person sharing the Grantees household (other than a tenant or employee), a trust in which these persons (or the Grantee) have more than fifty percent (50%) of the beneficial interest, a foundation in which these persons (or the Grantee) control the management of assets, and any other entity in which these persons (or the Grantee) own more than fifty percent (50%) of the voting interests.
(x) Incentive Stock Option means an Option intended to qualify as an incentive stock option within the meaning of Section 422 of the Code.
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(y) Non-Qualified Stock Option means an Option not intended to qualify as an Incentive Stock Option.
(z) Officer means a person who is an officer of the Company or a Related Entity within the meaning of Section 16 of the Exchange Act and the rules and regulations promulgated thereunder.
(aa) Option means an option to purchase Shares pursuant to an Award Agreement granted under the Plan.
(bb) Parent means a parent corporation, whether now or hereafter existing, as defined in Section 424(e) of the Code.
(cc) Performance-Based Compensation means compensation qualifying as performance-based compensation under Section 162(m) of the Code.
(dd) Plan means this 2015 Stock Incentive Plan.
(ee) Post-Termination Exercise Period means the period specified in the Award Agreement of not less than thirty (30) days commencing on the date of termination (other than termination by the Company or any Related Entity for Cause) of the Grantees Continuous Service, or such longer period as may be applicable upon death or Disability.
(ff) Registration Date means the first to occur of: (i) the closing of the first sale to the general public pursuant to a registration statement filed with and declared effective by the Securities and Exchange Commission under the Securities Act of 1933, as amended, of (A) the Common Stock or (B) the same class of securities of a successor corporation (or its Parent) issued pursuant to a Corporate Transaction in exchange for or in substitution of the Common Stock; or (ii) in the event of a Corporate Transaction, the date of the consummation of the Corporate Transaction if the same class of securities of the successor corporation (or its Parent) issuable in such Corporate Transaction shall have been sold to the general public pursuant to a registration statement filed with and declared effective by the Securities and Exchange Commission under the Securities Act of 1933, as amended, on or prior to the date of consummation of such Corporate Transaction.
(gg) Related Entity means any Parent or Subsidiary of the Company.
(hh) Replaced means that pursuant to a Corporate Transaction the Award is replaced with a comparable stock award or a cash incentive program of the Company, the successor entity (if applicable) or Parent of either of them which preserves the compensation element of such Award existing at the time of the Corporate Transaction and provides for subsequent payout in accordance with the same (or a more favorable) vesting schedule applicable to such Award. The determination of Award comparability shall be made by the Administrator and its determination shall be final, binding and conclusive.
(ii) Restricted Stock means Shares issued under the Plan to the Grantee for such consideration, if any, and subject to such restrictions on transfer, rights of first refusal, repurchase provisions, forfeiture provisions, and other terms and conditions as established by the Administrator.
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(jj) Restricted Stock Units means an Award which may be earned in whole or in part upon the passage of time or the attainment of performance criteria established by the Administrator and which may be settled for cash, Shares or other securities or a combination of cash, Shares or other securities as established by the Administrator.
(kk) Rule 16b-3 means Rule 16b-3 promulgated under the Exchange Act or any successor thereto.
(ll) SAR means a stock appreciation right entitling the Grantee to Shares or cash compensation, as established by the Administrator, measured by appreciation in the value of Common Stock.
(mm) Share means a share of the Common Stock.
(nn) Subsidiary means a subsidiary corporation, whether now or hereafter existing, as defined in Section 424(f) of the Code.
3. Stock Subject to the Plan.
(a) Subject to the provisions of Section 10 below, the maximum aggregate number of Shares which may be issued pursuant to all Awards (including Incentive Stock Options) is 21,594,044 Shares. The Shares may be authorized, but unissued, or reacquired Common Stock.
(b) Any Shares covered by an Award (or portion of an Award) which is forfeited, canceled or expires (whether voluntarily or involuntarily) shall be deemed not to have been issued for purposes of determining the maximum aggregate number of Shares which may be issued under the Plan. Shares that actually have been issued under the Plan pursuant to an Award shall not be returned to the Plan and shall not become available for future issuance under the Plan, except that if unvested Shares are forfeited or repurchased by the Company, such Shares shall become available for future grant under the Plan. To the extent not prohibited by the listing requirements of The NASDAQ Stock Market LLC (or other established stock exchange or national market system on which the Common Stock is traded) or Applicable Laws, any Shares covered by an Award which are surrendered: (i) in payment of the Award exercise or purchase price (including pursuant to the net exercise of an option pursuant to Section 7(b)(vi)); or (ii) in satisfaction of tax withholding obligations incident to the exercise of an Award shall be deemed not to have been issued for purposes of determining the maximum number of Shares which may be issued pursuant to all Awards under the Plan, unless otherwise determined by the Administrator.
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4. Administration of the Plan.
(a) Plan Administrator.
(i) Administration with Respect to Directors and Officers. Prior to the Registration Date, with respect to grants of Awards to Directors or Employees who are also Officers or Directors of the Company, the Plan shall be administered by (A) the Board or (B) a Committee designated by the Board, which Committee shall be constituted in such a manner as to satisfy the Applicable Laws. On or after the Registration Date, with respect to grants of Awards to Directors or Employees who are also Officers or Directors of the Company, the Plan shall be administered by (A) the Board or (B) a Committee designated by the Board, which Committee shall be constituted in such a manner as to satisfy the Applicable Laws and to permit such grants and related transactions under the Plan to be exempt from Section 16(b) of the Exchange Act in accordance with Rule 16b-3. Once appointed, such Committee shall continue to serve in its designated capacity until otherwise directed by the Board.
(ii) Administration With Respect to Consultants and Other Employees. With respect to grants of Awards to Employees or Consultants who are neither Directors nor Officers of the Company, the Plan shall be administered by (A) the Board or (B) a Committee designated by the Board, which Committee shall be constituted in such a manner as to satisfy the Applicable Laws. Once appointed, such Committee shall continue to serve in its designated capacity until otherwise directed by the Board.
(iii) Administration With Respect to Covered Employees. Notwithstanding the foregoing, as of and after the date that the exemption for the Plan under Section 162(m) of the Code expires, as set forth in Section 19 below, grants of Awards to any Covered Employee intended to qualify as Performance-Based Compensation shall be made only by a Committee (or subcommittee of a Committee) which is comprised solely of two or more Directors eligible to serve on a committee making Awards qualifying as Performance-Based Compensation. In the case of such Awards granted to Covered Employees, references to the Administrator or to a Committee shall be deemed to be references to such Committee or subcommittee.
(b) Multiple Administrative Bodies. The Plan may be administered by different bodies with respect to Directors, Officers, Consultants, and Employees who are neither Directors nor Officers.
(c) Powers of the Administrator. Subject to Applicable Laws and the provisions of the Plan (including any other powers given to the Administrator hereunder), and except as otherwise provided by the Board, the Administrator shall have the authority, in its discretion:
(i) to select the Employees, Directors and Consultants to whom Awards may be granted from time to time hereunder;
(ii) to determine whether and to what extent Awards are granted hereunder;
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(iii) to determine the number of Shares or the amount of other consideration to be covered by each Award granted hereunder;
(iv) to approve forms of Award Agreements for use under the Plan;
(v) to determine the terms and conditions of any Award granted hereunder;
(vi) to establish additional terms, conditions, rules or procedures to accommodate the rules or laws of applicable non-U.S. jurisdictions and to afford Grantees favorable treatment under such rules or laws; provided, however, that no Award shall be granted under any such additional terms, conditions, rules or procedures with terms or conditions which are inconsistent with the provisions of the Plan;
(vii) to amend the terms of any outstanding Award granted under the Plan, provided that any amendment that would adversely affect the Grantees rights under an outstanding Award shall not be made without the Grantees written consent, provided, however, that an amendment or modification that may cause an Incentive Stock Option to become a Non-Qualified Stock Option shall not be treated as adversely affecting the rights of the Grantee. Notwithstanding the foregoing, (A) the reduction or increase of the exercise price of any Option awarded under the Plan and the base appreciation amount of any SAR awarded under the Plan and (B) canceling an Option or SAR at a time when its exercise price or base appreciation amount (as applicable) exceeds the Fair Market Value of the underlying Shares, in exchange for another Option, SAR, Restricted Stock, or other Award or for cash, in each case, shall not be subject to stockholder approval;
(viii) to construe and interpret the terms of the Plan and Awards, including without limitation, any notice of award or Award Agreement, granted pursuant to the Plan; and
(ix) to take such other action, not inconsistent with the terms of the Plan, as the Administrator deems appropriate.
The express grant in the Plan of any specific power to the Administrator shall not be construed as limiting any power or authority of the Administrator; provided that the Administrator may not exercise any right or power reserved to the Board. Any decision made, or action taken, by the Administrator or in connection with the administration of this Plan shall be final, conclusive and binding on all persons having an interest in the Plan.
(d) Indemnification. In addition to such other rights of indemnification as they may have as members of the Board or as Officers or Employees of the Company or a Related Entity, members of the Board and any Officers or Employees of the Company or a Related Entity to whom authority to act for the Board, the Administrator or the Company is delegated shall be defended and indemnified by the Company to the extent permitted by law on an after-tax basis against all reasonable expenses, including attorneys fees, actually and necessarily incurred in connection with the defense of any claim, investigation, action, suit or proceeding, or in connection with any appeal therein, to which they or any of them may be a party by reason of any action taken or failure to act under or in connection with the Plan, or any Award granted
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hereunder, and against all amounts paid by them in settlement thereof (provided such settlement is approved by the Company) or paid by them in satisfaction of a judgment in any such claim, investigation, action, suit or proceeding, except in relation to matters as to which it shall be adjudged in such claim, investigation, action, suit or proceeding that such person is liable for gross negligence, bad faith or intentional misconduct; provided, however, that within thirty (30) days after the institution of such claim, investigation, action, suit or proceeding, such person shall offer to the Company, in writing, the opportunity at the Companys expense to defend the same.
5. Eligibility. Awards other than Incentive Stock Options may be granted to Employees, Directors and Consultants. Incentive Stock Options may be granted only to Employees of the Company or a Parent or a Subsidiary of the Company. An Employee, Director or Consultant who has been granted an Award may, if otherwise eligible, be granted additional Awards. Awards may be granted to such Employees, Directors or Consultants who are residing in non-U.S. jurisdictions as the Administrator may determine from time to time.
6. Terms and Conditions of Awards.
(a) Types of Awards. The Administrator is authorized under the Plan to award any type of arrangement to an Employee, Director or Consultant that is not inconsistent with the provisions of the Plan and that by its terms involves or might involve the issuance of (i) Shares, (ii) cash or (iii) an Option, a SAR, or similar right with a fixed or variable price related to the Fair Market Value of the Shares and with an exercise or conversion privilege related to the passage of time, the occurrence of one or more events, or the satisfaction of performance criteria or other conditions. Such awards include, without limitation, Options, SARs, sales or bonuses of Restricted Stock, Restricted Stock Units or Dividend Equivalent Rights, and an Award may consist of one such security or benefit, or two (2) or more of them in any combination or alternative.
(b) Designation of Award. Each Award shall be designated in the Award Agreement. In the case of an Option, the Option shall be designated as either an Incentive Stock Option or a Non-Qualified Stock Option. However, notwithstanding such designation, an Option will qualify as an Incentive Stock Option under the Code only to the extent the $100,000 limitation of Section 422(d) of the Code is not exceeded. The $100,000 limitation of Section 422(d) of the Code is calculated based on the aggregate Fair Market Value of the Shares subject to Options designated as Incentive Stock Options which become exercisable for the first time by a Grantee during any calendar year (under all plans of the Company or any Parent or Subsidiary of the Company). For purposes of this calculation, Incentive Stock Options shall be taken into account in the order in which they were granted, and the Fair Market Value of the Shares shall be determined as of the grant date of the relevant Option. In the event that the Code or the regulations promulgated thereunder are amended after the date the Plan becomes effective to provide for a different limit on the Fair Market Value of Shares permitted to be subject to Incentive Stock Options, then such different limit will be automatically incorporated herein and will apply to any Options granted after the effective date of such amendment.
(c) Conditions of Award. Subject to the terms of the Plan, the Administrator shall determine the provisions, terms, and conditions of each Award including, but not limited to,
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the Award vesting schedule, repurchase provisions, rights of first refusal, forfeiture provisions, form of payment (cash, Shares, or other consideration) upon settlement of the Award, payment contingencies, and satisfaction of any performance criteria. The performance criteria established by the Administrator may be based on any one of, or combination of, increase in share price, earnings per share, total stockholder return, return on equity, return on assets, return on investment, net operating income, cash flow, revenue, economic value added, personal management objectives, or other measure of performance selected by the Administrator. Partial achievement of the specified criteria may result in a payment or vesting corresponding to the degree of achievement as specified in the Award Agreement. In addition, the performance criteria shall be calculated in accordance with generally accepted accounting principles, but excluding the effect (whether positive or negative) of any change in accounting standards and any extraordinary, unusual or nonrecurring item, as determined by the Administrator, occurring after the establishment of the performance criteria applicable to the Award intended to be performance-based compensation. Each such adjustment, if any, shall be made solely for the purpose of providing a consistent basis from period to period for the calculation of performance criteria in order to prevent the dilution or enlargement of the Grantees rights with respect to an Award intended to be performance-based compensation.
(d) Acquisitions and Other Transactions. The Administrator may issue Awards under the Plan in settlement, assumption or substitution for, outstanding awards or obligations to grant future awards in connection with the Company or a Related Entity acquiring another entity, an interest in another entity or an additional interest in a Related Entity whether by merger, stock purchase, asset purchase or other form of transaction.
(e) Deferral of Award Payment. The Administrator may establish one or more programs under the Plan to permit selected Grantees the opportunity to elect to defer receipt of consideration upon exercise of an Award, satisfaction of performance criteria, or other event that absent the election would entitle the Grantee to payment or receipt of Shares or other consideration under an Award. The Administrator may establish the election procedures, the timing of such elections, the mechanisms for payments of, and accrual of interest or other earnings, if any, on amounts, Shares or other consideration so deferred, and such other terms, conditions, rules and procedures that the Administrator deems advisable for the administration of any such deferral program.
(f) Separate Programs. The Administrator may establish one or more separate programs under the Plan for the purpose of issuing particular forms of Awards to one or more classes of Grantees on such terms and conditions as determined by the Administrator from time to time.
(g) Individual Limitations on Awards.
(i) Individual Option and SAR Limit. Following the date that the exemption from application of Section 162(m) of the Code described in Section 19 (or any exemption having similar effect) ceases to apply to Awards, the maximum number of Shares with respect to which Options and SARs may be granted to any Grantee in any calendar year shall be 4,000,000 Shares. In connection with a Grantees commencement of Continuous Service, a Grantee may be granted Options and SARs for up to an additional 100,000 Shares
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which shall not count against the limit set forth in the previous sentence. The foregoing limitations shall be adjusted proportionately in connection with any change in the Companys capitalization pursuant to Section 10, below. To the extent required by Section 162(m) of the Code or the regulations thereunder, in applying the foregoing limitations with respect to a Grantee, if any Option or SAR is canceled, the canceled Option or SAR shall continue to count against the maximum number of Shares with respect to which Options and SARs may be granted to the Grantee. For this purpose, the repricing of an Option (or in the case of a SAR, the base amount on which the stock appreciation is calculated is reduced to reflect a reduction in the Fair Market Value of the Common Stock) shall be treated as the cancellation of the existing Option or SAR and the grant of a new Option or SAR.
(ii) Individual Limit for Restricted Stock and Restricted Stock Units. Following the date that the exemption from application of Section 162(m) of the Code described in Section 19 (or any exemption having similar effect) ceases to apply to Awards, for awards of Restricted Stock and Restricted Stock Units that are intended to be Performance-Based Compensation, the maximum number of Shares with respect to which such Awards may be granted to any Grantee in any calendar year shall be 4,000,000 Shares. The foregoing limitation shall be adjusted proportionately in connection with any change in the Companys capitalization pursuant to Section 10, below.
(h) Early Exercise. The Award Agreement may, but need not, include a provision whereby the Grantee may elect at any time while an Employee, Director or Consultant to exercise any part or all of the Award prior to full vesting of the Award. Any unvested Shares received pursuant to such exercise may be subject to a repurchase right in favor of the Company or a Related Entity or to any other restriction the Administrator determines to be appropriate.
(i) Term of Award. The term of each Award shall be the term stated in the Award Agreement, provided, however, that the term shall be no more than ten (10) years from the date of grant thereof. However, in the case of an Incentive Stock Option granted to a Grantee who, at the time the Option is granted, owns stock representing more than ten percent (10%) of the voting power of all classes of stock of the Company or any Parent or Subsidiary of the Company, the term of the Incentive Stock Option shall be five (5) years from the date of grant thereof or such shorter term as may be provided in the Award Agreement. Notwithstanding the foregoing, the specified term of any Award shall not include any period for which the Grantee has elected to defer the receipt of the Shares or cash issuable pursuant to the Award.
(j) Transferability of Awards. Incentive Stock Options may not be sold, pledged, assigned, hypothecated, transferred, or disposed of in any manner other than by will or by the laws of descent or distribution and may be exercised, during the lifetime of the Grantee, only by the Grantee. Other Awards shall be transferable (i) by will and by the laws of descent and distribution and (ii) during the lifetime of the Grantee, to the extent and in the manner authorized by the Administrator by gift or pursuant to a domestic relations order to members of the Grantees Immediate Family. Notwithstanding the foregoing, the Grantee may designate one or more beneficiaries of the Grantees Award in the event of the Grantees death on a beneficiary designation form provided by the Administrator.
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(k) Time of Granting Awards. The date of grant of an Award shall for all purposes be the date on which the Administrator makes the determination to grant such Award, or such other later date as is determined by the Administrator.
7. Award Exercise or Purchase Price, Consideration and Taxes.
(a) Exercise or Purchase Price. The exercise or purchase price, if any, for an Award shall be as follows:
(i) In the case of an Incentive Stock Option:
(A) granted to an Employee who, at the time of the grant of such Incentive Stock Option owns stock representing more than ten percent (10%) of the voting power of all classes of stock of the Company or any Parent or Subsidiary of the Company, the per Share exercise price shall be not less than one hundred ten percent (110%) of the Fair Market Value per Share on the date of grant; or
(B) granted to any Employee other than an Employee described in the preceding paragraph, the per Share exercise price shall be not less than one hundred percent (100%) of the Fair Market Value per Share on the date of grant.
(ii) In the case of a Non-Qualified Stock Option, the per Share exercise price shall be not less than one hundred percent (100%) of the Fair Market Value per Share on the date of grant.
(iii) In the case of SARs, the base appreciation amount shall not be less than one hundred percent (100%) of the Fair Market Value per Share on the date of grant.
(iv) In the case of Awards intended to qualify as Performance-Based Compensation, the exercise or purchase price, if any, shall be not less than one hundred percent (100%) of the Fair Market Value per Share on the date of grant.
(v) In the case of the sale of Shares, the per Share purchase price, if any, shall be such price as is determined by the Administrator.
(vi) In the case of other Awards, such price as is determined by the Administrator.
(vii) Notwithstanding the foregoing provisions of this Section 7(a), in the case of an Award issued pursuant to Section 6(d), above, the exercise or purchase price for the Award shall be determined in accordance with the provisions of the relevant instrument evidencing the agreement to issue such Award.
(b) Consideration. Subject to Applicable Laws, the consideration to be paid for the Shares to be issued upon exercise or purchase of an Award including the method of payment, shall be determined by the Administrator. In addition to any other types of consideration the Administrator may determine, the Administrator is authorized to accept as consideration for Shares issued under the Plan the following provided that the portion of the
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consideration equal to the par value of the Shares must be paid in cash or other legal consideration permitted by the Delaware General Corporation Law:
(i) cash;
(ii) check;
(iii) delivery of Grantees promissory note with such recourse, interest, security, and redemption provisions as the Administrator determines as appropriate (but only to the extent that the acceptance or terms of the promissory note would not violate an Applicable Law);
(iv) surrender of Shares held for the requisite period, if any, necessary to avoid a charge to the Companys earnings for financial reporting purposes, or delivery of a properly executed form of attestation of ownership of Shares as the Administrator may require which have a Fair Market Value on the date of surrender or attestation equal to the aggregate exercise price of the Shares as to which said Award shall be exercised;
(v) with respect to Options, if the exercise occurs on or after the Registration Date, payment through a broker-dealer sale and remittance procedure pursuant to which the Grantee (A) shall provide written instructions to a Company designated brokerage firm to effect the immediate sale of some or all of the purchased Shares and remit to the Company sufficient funds to cover the aggregate exercise price payable for the purchased Shares and (B) shall provide written directives to the Company to deliver the certificates for the purchased Shares directly to such brokerage firm in order to complete the sale transaction;
(vi) with respect to Options, payment through a net exercise such that, without the payment of any funds, the Grantee may exercise the Option and receive the net number of Shares equal to (i) the number of Shares as to which the Option is being exercised, multiplied by (ii) a fraction, the numerator of which is the Fair Market Value per Share (on such date as is determined by the Administrator) less the exercise price per Share, and the denominator of which is such Fair Market Value per Share (the number of net Shares to be received shall be rounded down to the nearest whole number of Shares); or
(vii) any combination of the foregoing methods of payment.
The Administrator may at any time or from time to time, by adoption of or by amendment to the standard forms of Award Agreement described in Section 4(c)(iv), or by other means, grant Awards which do not permit all of the foregoing forms of consideration to be used in payment for the Shares or which otherwise restrict one or more forms of consideration.
(c) Taxes. No Shares shall be delivered under the Plan to any Grantee or other person until such Grantee or other person has made arrangements acceptable to the Administrator for the satisfaction of any non-U.S., federal, state, or local income and employment tax withholding obligations, including, without limitation, obligations incident to the receipt of Shares. Upon exercise or vesting of an Award the Company shall withhold or collect from the Grantee an amount sufficient to satisfy such tax obligations, including, but not limited to, by surrender of the whole number of Shares covered by the Award sufficient to satisfy
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the minimum applicable tax withholding obligations incident to the exercise or vesting of an Award (reduced to the lowest whole number of Shares if such number of Shares withheld would result in withholding a fractional Share with any remaining tax withholding settled in cash).
8. Exercise of Award.
(a) Procedure for Exercise; Rights as a Stockholder.
(i) Any Award granted hereunder shall be exercisable at such times and under such conditions as determined by the Administrator under the terms of the Plan and specified in the Award Agreement.
(ii) An Award shall be deemed to be exercised when written notice of such exercise has been given to the Company in accordance with the terms of the Award by the person entitled to exercise the Award and full payment for the Shares with respect to which the Award is exercised has been made, including, to the extent selected, use of the broker-dealer sale and remittance procedure to pay the purchase price as provided in Section 7(b)(v).
(b) Exercise of Award Following Termination of Continuous Service. In the event of termination of a Grantees Continuous Service for any reason other than Disability or death (but not in the event of a Grantees change of status from Employee to Consultant or from Consultant to Employee), such Grantee may, but only during the Post-Termination Exercise Period (but in no event later than the expiration date of the term of such Award as set forth in the Award Agreement), exercise the portion of the Grantees Award that was vested at the date of such termination or such other portion of the Grantees Award as may be determined by the Administrator. The Grantees Award Agreement may provide that upon the termination of the Grantees Continuous Service for Cause, the Grantees right to exercise the Award shall terminate concurrently with the termination of Grantees Continuous Service. In the event of a Grantees change of status from Employee to Consultant, an Employees Incentive Stock Option shall convert automatically to a Non-Qualified Stock Option on the day three (3) months and one day following such change of status. To the extent that the Grantees Award was unvested at the date of termination, or if the Grantee does not exercise the vested portion of the Grantees Award within the Post-Termination Exercise Period, the Award shall terminate.
(c) Disability of Grantee. In the event of termination of a Grantees Continuous Service as a result of his or her Disability, such Grantee may, but only within twelve (12) months from the date of such termination (or such longer period as specified in the Award Agreement but in no event later than the expiration date of the term of such Award as set forth in the Award Agreement), exercise the portion of the Grantees Award that was vested at the date of such termination; provided, however, that if such Disability is not a disability as such term is defined in Section 22(e)(3) of the Code, in the case of an Incentive Stock Option such Incentive Stock Option shall automatically convert to a Non-Qualified Stock Option on the day three (3) months and one day following such termination. To the extent that the Grantees Award was unvested at the date of termination, or if Grantee does not exercise the vested portion of the Grantees Award within the time specified herein, the Award shall terminate.
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(d) Death of Grantee. In the event of a termination of the Grantees Continuous Service as a result of his or her death, or in the event of the death of the Grantee during the Post-Termination Exercise Period or during the twelve (12) month period following the Grantees termination of Continuous Service as a result of his or her Disability, the Grantees estate or a person who acquired the right to exercise the Award by bequest or inheritance may exercise the portion of the Grantees Award that was vested as of the date of termination, within twelve (12) months from the date of death (or such longer period as specified in the Award Agreement but in no event later than the expiration of the term of such Award as set forth in the Award Agreement). To the extent that, at the time of death, the Grantees Award was unvested, or if the Grantees estate or a person who acquired the right to exercise the Award by bequest or inheritance does not exercise the vested portion of the Grantees Award within the time specified herein, the Award shall terminate.
(e) Extension if Exercise Prevented by Law. Notwithstanding the foregoing, if the exercise of an Award within the applicable time periods set forth in this Section 8 is prevented by the provisions of Section 9 below, the Award shall remain exercisable until one (1) month after the date the Grantee is notified by the Company that the Award is exercisable, but in any event no later than the expiration of the term of such Award as set forth in the Award Agreement and only in a manner and to the extent permitted under Code Section 409A.
9. Conditions Upon Issuance of Shares.
(a) If at any time the Administrator determines that the delivery of Shares pursuant to the exercise, vesting or any other provision of an Award is or may be unlawful under Applicable Laws, the vesting or right to exercise an Award or to otherwise receive Shares pursuant to the terms of an Award shall be suspended until the Administrator determines that such delivery is lawful and shall be further subject to the approval of counsel for the Company with respect to such compliance. The Company shall have no obligation to effect any registration or qualification of the Shares under federal or state laws.
(b) As a condition to the exercise of an Award, the Company may require the person exercising such Award to represent and warrant at the time of any such exercise that the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation is required by any Applicable Laws.
10. Adjustments Upon Changes in Capitalization. Subject to any required action by the stockholders of the Company and Section 11 below, the number of Shares covered by each outstanding Award, and the number of Shares which have been authorized for issuance under the Plan but as to which no Awards have yet been granted or which have been returned to the Plan, the exercise or purchase price of each such outstanding Award, the maximum number of Shares with respect to which Awards may be granted to any Grantee in any calendar year, as well as any other terms that the Administrator determines require adjustment shall be proportionately adjusted for: (i) any increase or decrease in the number of issued Shares resulting from a stock split, reverse stock split, stock dividend, recapitalization, combination or reclassification of the Shares, or similar transaction affecting the Shares; (ii) any other increase or decrease in the number of issued Shares effected without receipt of consideration by the Company; or (iii) any
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other transaction with respect to Common Stock including a corporate merger, consolidation, acquisition of property or stock, separation (including a spin-off or other distribution of stock or property), reorganization, liquidation (whether partial or complete) or any similar transaction; provided, however that conversion of any convertible securities of the Company shall not be deemed to have been effected without receipt of consideration. In the event of any distribution of cash or other assets to stockholders other than a normal cash dividend, the Administrator shall also make such adjustments as provided in this Section 10 or substitute, exchange or grant Awards to effect such adjustments (collectively adjustments). Any such adjustments to outstanding Awards will be effected in a manner that precludes the enlargement of rights and benefits under such Awards. In connection with the foregoing adjustments, the Administrator may, in its discretion, prohibit the exercise of Awards or other issuance of Shares, cash or other consideration pursuant to Awards during certain periods of time. Except as the Administrator determines, no issuance by the Company of shares of any class, or securities convertible into shares of any class, shall affect, and no adjustment by reason hereof shall be made with respect to, the number or price of Shares subject to an Award.
11. Corporate Transactions.
(a) Termination of Award to Extent Not Assumed in Corporate Transaction. Effective upon the consummation of a Corporate Transaction, all outstanding Awards under the Plan shall terminate. However, all such Awards shall not terminate to the extent they are Assumed in connection with the Corporate Transaction.
(b) Acceleration of Award Upon Corporate Transaction. The Administrator shall have the authority, exercisable either in advance of any actual or anticipated Corporate Transaction or at the time of an actual Corporate Transaction and exercisable at the time of the grant of an Award under the Plan or any time while an Award remains outstanding, to provide for the full or partial automatic vesting and exercisability of one or more outstanding unvested Awards under the Plan and the release from restrictions on transfer and repurchase or forfeiture rights of such Awards in connection with a Corporate Transaction, on such terms and conditions as the Administrator may specify. The Administrator also shall have the authority to condition any such Award vesting and exercisability or release from such limitations upon the subsequent termination of the Continuous Service of the Grantee within a specified period following the effective date of the Corporate Transaction.
(c) Effect of Acceleration on Incentive Stock Options. Any Incentive Stock Option accelerated under this Section 11 in connection with a Corporate Transaction shall remain exercisable as an Incentive Stock Option under the Code only to the extent the $100,000 limitation of Section 422(d) of the Code is not exceeded.
12. Effective Date and Term of Plan. The Plan shall become effective upon the earlier to occur of its adoption by the Board or its approval by the stockholders of the Company. It shall continue in effect for a term of ten (10) years unless sooner terminated. Subject to Section 17 below, and Applicable Laws, Awards may be granted under the Plan upon its becoming effective.
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13. Amendment, Suspension or Termination of the Plan.
(a) The Board may at any time amend, suspend or terminate the Plan. To the extent necessary to comply with Applicable Laws, the Company shall obtain stockholder approval of any Plan amendment in such a manner and to such a degree as required.
(b) No Award may be granted during any suspension of the Plan or after termination of the Plan.
(c) No suspension or termination of the Plan (including termination of the Plan under Section 12, above) shall adversely affect any rights under Awards already granted to a Grantee.
14. Reservation of Shares.
(a) The Company, during the term of the Plan, will at all times reserve and keep available such number of Shares as shall be sufficient to satisfy the requirements of the Plan.
(b) The inability of the Company to obtain authority from any regulatory body having jurisdiction, which authority is deemed by the Companys counsel to be necessary to the lawful issuance and sale of any Shares hereunder, shall relieve the Company of any liability in respect of the failure to issue or sell such Shares as to which such requisite authority shall not have been obtained.
15. No Effect on Terms of Employment/Consulting Relationship. The Plan shall not confer upon any Grantee any right with respect to the Grantees Continuous Service, nor shall it interfere in any way with his or her right or the right of the Company or any Related Entity to terminate the Grantees Continuous Service at any time, including, but not limited to, for Cause or without Cause, and with or without notice. The ability of the Company or any Related Entity to terminate the employment of a Grantee who is employed at will is in no way affected by its determination that the Grantees Continuous Service has been terminated for Cause for the purposes of this Plan.
16. No Effect on Retirement and Other Benefit Plans. Except as specifically provided in a retirement or other benefit plan of the Company or a Related Entity, Awards shall not be deemed compensation for purposes of computing benefits or contributions under any retirement plan of the Company or a Related Entity, and shall not affect any benefits under any other benefit plan of any kind or any benefit plan subsequently instituted under which the availability or amount of benefits is related to level of compensation. The Plan is not a Pension Plan or Welfare Plan under the Employee Retirement Income Security Act of 1974, as amended.
17. Stockholder Approval. Continuance of the Plan shall be subject to approval by the stockholders of the Company within twelve (12) months before or after the date the Plan is adopted. Such stockholder approval shall be obtained in the degree and manner required under Applicable Laws. Any Award exercised before stockholder approval is obtained shall be rescinded if stockholder approval is not obtained within the time prescribed, and Shares issued on the exercise of any such Award shall not be counted in determining whether stockholder approval is obtained.
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18. Information to Grantees. To the extent required by Applicable Laws, the Company shall provide to each Grantee, during the period for which such Grantee has one or more Awards outstanding, copies of financial statements at least annually. The Company shall not be required to provide such information to persons whose duties in connection with the Company assure them access to equivalent information.
19. Effect of Section 162(m) of the Code. Section 162(m) of the Code does not apply to the Plan prior to the Registration Date or such earlier time that the Company first becomes subject to the reporting obligations of Section 12 of the Exchange Act. Following the Registration Date or such earlier time that the Company first becomes subject to the reporting obligations of Section 12 of the Exchange Act, the Plan, and all Awards (except Awards of Restricted Stock that vest over time) issued thereunder, are intended to be exempt from the application of Section 162(m) of the Code, which restricts under certain circumstances the Federal income tax deduction for compensation paid by a public company to named executives in excess of $1 million per year. The exemption is based on Treasury Regulation Section 1.162-27(f), in the form existing on the effective date of the Plan, with the understanding that such regulation generally exempts from the application of Section 162(m) of the Code compensation paid pursuant to a plan that existed before a company becomes publicly held. Under such Treasury Regulation, this exemption is available to the Plan for the duration of the period that lasts until the earliest of (i) the expiration of the Plan, (ii) the material modification of the Plan, (iii) the exhaustion of the maximum number of shares of Common Stock available for Awards under the Plan, as set forth in Section 3(a), (iv) the first meeting of stockholders at which directors are to be elected that occurs after the close of the third calendar year following the calendar year in which the Company first becomes subject to the reporting obligations of Section 12 of the Exchange Act, or (v) such other date required by Section 162(m) of the Code and the rules and regulations promulgated thereunder. To the extent that the Administrator determines as of the date of grant of an Award that (i) the Award is intended to qualify as Performance-Based Compensation and (ii) the exemption described above is no longer available with respect to such Award, such Award shall not be effective until any stockholder approval required under Section 162(m) of the Code has been obtained.
20. Unfunded Obligation. Grantees shall have the status of general unsecured creditors of the Company. Any amounts payable to Grantees pursuant to the Plan shall be unfunded and unsecured obligations for all purposes, including, without limitation, Title I of the Employee Retirement Income Security Act of 1974, as amended. Neither the Company nor any Related Entity shall be required to segregate any monies from its general funds, or to create any trusts, or establish any special accounts with respect to such obligations. The Company shall retain at all times beneficial ownership of any investments, including trust investments, which the Company may make to fulfill its payment obligations hereunder. Any investments or the creation or maintenance of any trust or any Grantee account shall not create or constitute a trust or fiduciary relationship between the Administrator, the Company or any Related Entity and a Grantee, or otherwise create any vested or beneficial interest in any Grantee or the Grantees creditors in any assets of the Company or a Related Entity. The Grantees shall have no claim against the Company or any Related Entity for any changes in the value of any assets that may be invested or reinvested by the Company with respect to the Plan.
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21. Construction. Captions and titles contained herein are for convenience only and shall not affect the meaning or interpretation of any provision of the Plan. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
22. Nonexclusivity of the Plan. Neither the adoption of the Plan by the Board, the submission of the Plan to the stockholders of the Company for approval, nor any provision of the Plan will be construed as creating any limitations on the power of the Board to adopt such additional compensation arrangements as it may deem desirable, including, without limitation, the granting of Awards otherwise than under the Plan, and such arrangements may be either generally applicable or applicable only in specific cases.
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Exhibit 10.14
ADICET BIO, INC.
ISRAELI SUB-PLAN
TO THE ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
1. | GENERAL. |
This Adicet Bio, Inc. Israeli Sub-Plan (this Sub-Plan) is to be read as an integral part of the Adicet Bio, Inc. 2015 Stock Incentive Plan (the Company, and the Plan respectively), and the Plan together with this Sub-Plan shall be deemed one integrated document. The provisions of the Plan shall apply to Awards (as defined below) granted under this Sub-Plan, subject to the modifications set forth below. In the event of any conflict between the Plan and this Sub-Plan, the terms of this Sub-Plan shall govern with respect to Awards granted to Israeli Grantees (as defined below). This Sub-Plan shall only apply to, and modify Awards granted to, Israeli Grantees so that such Awards will be governed by the terms of this Sub-Plan and comply with the requirements of Israeli law generally, and specifically with the provisions of Section 102 and Section 3(i) of the Ordinance (as defined below). For the avoidance of doubt, this Sub-Plan shall not modify the Plan with respect of any other category of Grantees.
Unless otherwise defined in this Sub-Plan, all capitalized terms used herein shall have the meaning given to them in the Plan. Capitalized terms used herein that are the plural forms or singular forms of defined terms shall have the corresponding plural or singular meanings of the corresponding defined terms. The following terms shall have the meanings set forth below, unless the context clearly requires a different meaning:
(a) 3(i) Award means an Award granted pursuant to Section 3(i) of the Ordinance to any person who is an Israeli Non-Employee Grantee.
(b) 102 Award means an Award granted pursuant to Section 102 of the Ordinance to any person who is an Israeli Employee Grantee.
(c) 102 Capital Gains Award means a Trustee 102 Award elected and designated by the Employing Company to qualify for Capital Gains tax treatment in accordance with the provisions of Section 102(b)(2) of the Ordinance.
(d) 102 Ordinary Income Award means a Trustee 102 Award elected and designated by the Employing Company to qualify for ordinary income tax treatment in accordance with the provisions of Section 102(b)(1) of the Ordinance.
(e) Affiliate means any employing company within the meaning of Section 102(a) of the Ordinance.
(f) Approved 102 Award means an Award granted pursuant to Section 102(b) of the Ordinance and held in trust by a Trustee for the benefit of an Employee.
(g) Award means the grant of an Option, SAR, Dividend Equivalent Right, Restricted Stock, Restricted Stock Unit or other right or benefit under the Plan.
(h) Award Agreement means the written agreement evidencing the grant of an Award executed by the Company and the Grantee, including any amendments thereto.
(i) Board means the Board of Directors of the Company.
(j) Controlling Shareholder shall have the meaning ascribed to it in Section 32(9) of the Ordinance.
(k) Committee means any committee composed of members of the Board appointed by the Board to administer the Plan.
(l) Employing Company shall have the meaning ascribed to it in Section 102(a) of the Ordinance.
(m) Israeli Employee Grantee means a person who is a resident of the state of Israel or who is deemed to be a resident of the state of Israel for the payment of tax, and who is an employee or an Office Holder (Noseh Missra) of the Company, or any Affiliate of the Company, in each case excluding a person who is a Controlling Shareholder prior to the issuance of the relevant Award or as a result thereof.
(n) Israeli Non-Employee Grantee means a person who is a resident of the state of Israel or who is deemed to be a resident of the state of Israel for the payment of tax, and who is (i) a consultant, adviser or service provider of the Company, or any Affiliate of the Company, who is not an Israeli Employee Grantee, or (ii) a Controlling Shareholder (whether or not an employee of the Company or any Affiliate of the Company).
(o) Israeli Grantee means Israeli Employee Grantees and Israeli Non-Employee Grantees.
(p) ITA means the Israeli Income Tax Authorities.
(q) Lockup Period means the requisite period prescribed by the Ordinance and the Rules, or such other period as may be required by the ITA, with respect to 102 Trustee Grants, during which Awards or Shares issued thereunder, and all rights resulting from them, including bonus Shares, must be held by the Trustee.
(r) Non-Trustee 102 Award means an Award granted to an Israeli Grantee pursuant to Section 102(c) of the Ordinance, which is not required to be held in trust by a Trustee.
(s) Ordinance means the Income Tax Ordinance [New Version] 5721-1961 or any successor statute, as amended from time to time.
(t) Rules means the Income Tax Rules (Tax Relief in the Issuance of Shares to Employees), 5763-2003.
(u) Section 102 means Section 102 of the Ordinance and any regulations, rules, orders or procedures promulgated thereunder as now in effect or as amended or replaced from time to time.
(v) Tax means any tax (including, without limitation, any income tax, capital gains tax, value added tax, sales tax, property tax, gift tax, or estate tax), levy, assessment, tariff, duty (including any customs duty), deficiency, or other fee, and any related charge or amount (including any fine, penalty, interest, linkage differentials or addition to tax), imposed, assessed, or collected by or under the authority of any governmental body.
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(w) Trustee means any person or entity appointed by the Company or any of its Affiliates, as applicable, and approved by the ITA, to serve as a trustee, all in accordance with the provisions of Section 102(a) of the Ordinance.
(x) Trustee 102 Award means an Award granted pursuant to Section 102(b) of the Ordinance which is held in trust by a Trustee for the benefit of the Grantee.
(y) Unapproved 102 Award means an Award granted pursuant to Section 102(c) of the Ordinance which is not held in trust by a Trustee.
2. | ISSUANCE OF AWARDS. |
(a) (i) Israeli Employee Grantees may be granted only 102 Awards; and (ii) Israeli Non-Employee Grantees may be granted only 3(i) Awards. In each case, such Awards shall be subject to the terms and conditions of the Ordinance.
(b) The Employing Company may, pursuant to Section 102, designate 102 Awards granted to Israeli Employee Grantees as Non-Trustee 102 Awards or as Trustee 102 Awards. The Employing Company may seek any tax ruling as it may reasonably consider in connection with the application of Section 102 on any Awards granted by the Company.
(c) The Employing Company shall have the absolute discretion to decide whether Awards granted pursuant to Section 3(i) of the Ordinance shall be held by the Trustee for any period.
(d) Any trustee, including, without limitation, the Trustee, holding Awards or Shares issued upon the exercise thereof, or rights resulting therefrom, including bonus Shares, shall not be liable for any good faith determination, act or omission in connection with the Plan, any Sub-Plan, any Award or any agreement entered into between such Trustee and the Company or any Affiliate.
(e) The grant of Approved 102 Awards shall be made under this Sub-Plan not earlier than 30 days from the date it was submitted to the ITA.
(f) Approved 102 Awards may either be classified as 102 Capital Gains Award or 102 Ordinary Income Award.
(g) No Approved 102 Awards may be granted under this Sub-Plan to any eligible Israeli Employee Grantee, unless and until, the Companys election of the type of Approved 102 Awards as 102 Capital Gains Award or as 102 Ordinary Income Award granted to Israeli Employee Grantee (the Election), is appropriately filed with the ITA. Such Election shall become effective as of the date of grant of an Approved 102 Award under this Sub-Plan and shall remain in effect until the end of the year following the year during which the Company first granted Approved 102 Awards. The Election shall obligate the Company to grant only the type of Approved 102 Award it has elected, and shall apply to all Israeli Grantees who were granted Approved 102 Awards during the period indicated herein above, all in accordance with the provisions of Section 102(g) of the Ordinance. For the avoidance of doubt, such Election shall not prevent the Company from granting Unapproved 102 Awards or 3(i) Awards simultaneously.
(h) All Approved 102 Awards must be held in trust by a Trustee, as described in Section 3 below.
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(i) For the avoidance of doubt, the designation of Unapproved 102 Awards and Approved 102 Awards shall be subject to the terms and conditions set forth in Section 102.
3. | TRUSTEE 102 AWARDS. |
(a) Awards granted pursuant to this Section are intended to constitute Trustee 102 Awards and are subject to the provisions of Section 102 and the general terms and conditions specified in the Plan, except for such provisions of the Plan applying to Awards under a different tax law or regulation.
(b) Trustee 102 Awards may be granted only to Israeli Employee Grantees.
(c) Trustee 102 Awards shall be classified as either 102 Capital Gains Awards or 102 Ordinary Income Awards, subject to the terms and conditions of Section 102 and the provisions of the Plan and this Sub-Plan.
(d) No Trustee 102 Awards may be granted under this Sub-Plan, unless and until the Election is appropriately filed with the ITA. The Board or the Committee, as the case may be, shall have the right to determine whether the Election of the Trustee 102 Awards be 102 Capital Gains Awards or 102 Ordinary Income Awards. After the Election is made, the Company may grant only the type of Trustee 102 Awards it had elected (i.e., 102 Capital Gains Awards or 102 Ordinary Income Awards), and the Election shall apply to all grants to Israeli Employee Grantees of Trustee 102 Awards until such Election is changed pursuant to the provisions of Section 102(g) of the Ordinance. The Employing Company may change such Election only after the lapse of the minimum time period prescribed by Section 102. For the avoidance of doubt, such Election shall not prevent the Company from granting Non-Trustee 102 Awards or 3(i) Awards.
(e) The grant of Trustee 102 Awards shall be conditioned upon the approval (or the deemed approval pursuant to the provisions of Section 102(a) of the Ordinance) of the Plan, this Sub-Plan and the Trustee by the ITA.
(f) Trustee 102 Awards may be granted only after the passage of thirty days (or a shorter period as, and if, approved by the ITA) following the delivery by the appropriate Employing Company to the ITA of a request for approval of the Plan (including this Sub-Plan) and the Trustee in accordance with Section 102. Notwithstanding the foregoing paragraph and pursuant to any applicable law, if within ninety (90) days of delivery of the abovementioned request, the appropriate ITA officer notifies the Employing Company of his or her decision not to approve the Plan (including this Sub-Plan) or the Trustee, then the Awards that were intended to be granted as a Trustee 102 Awards shall be deemed to be Non-Trustee 102 Awards, unless (i) otherwise determined by the ITA officer or (ii) pursuant to applicable law, elected otherwise by the Company.
(g) Anything herein to the contrary notwithstanding, all Trustee 102 Awards granted under this Plan shall be granted or issued to a Trustee. The Trustee shall hold each such Trustee 102 Award, all Shares issued upon exercise thereof, and all other rights resulting from such Trustee 102 Award or Shares, including bonus Shares, in trust for the benefit of the Israeli Employee Grantee to which such Award was granted. All certificates representing Awards or Shares issued to the Trustee under the Plan shall be issued in the Trustees name, deposited with the Trustee, and shall be held by the Trustee until such time that such Awards or Shares are released from the trust.
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(h) With respect to 102 Capital Gains Awards and 102 Ordinary Income Awards, such Awards or any Shares issued upon the exercise thereof and all rights resulting from such Awards or Shares, including bonus Shares, will be held by the Trustee, from the date such Awards or Shares were deposited with the Trustee until the end of the applicable Lockup Period (currently at least 24 months in case of 102 Capital Gains Awards and 12 months in case of 102 Ordinary Income Awards) or such shorter period as approved by the ITA, under the terms set forth in Section 102.
(i) Notwithstanding anything to the contrary, the Trustee shall not release any Shares allocated or issued upon exercise or vesting of Approved 102 Awards prior to the full payment of the Israeli Employee Grantees tax liabilities, if any, or to the full satisfaction of the trustee that such applicable tax payments will be made, arising from Approved 102 Awards which were granted to him or her and/or any Shares allocated or issued upon exercise or vesting of such Awards.
(j) In accordance with Section 102, the Israeli Employee Grantee shall not sell, cause the release from trust, or otherwise dispose of, any Trustee 102 Award, any Share issued upon the exercise thereof, or any rights resulting from such Award or Share, including bonus Shares, until the end of the applicable Lockup Period. Notwithstanding the foregoing but without derogating from the provisions of the Plan and the terms and conditions set forth in the Award Agreement, if any such sale, release, or disposition occurs during the Lockup Period, then the provisions of Section 102 relating to non-compliance with the Lockup Period will apply and all sanctions and liability under Section 102 shall be borne by the Israeli Employee Grantee. The Israeli Employee Grantee will indemnify the Company, the Trustee and any other party which incurs any liability as a result of such sale, release or disposition.
(k) In the event that the requirements for the Trustee 102 Awards are not met, then the Trustee 102 Awards shall be deemed Non-Trustee 102 Awards.
(l) Upon receipt of a Trustee 102 Award, the Israeli Employee Grantee will sign an Award Agreement under which such Grantee will agree to be subject to the trust agreement between the Company or its Affiliate and the Trustee, stating, inter alia, that the Trustee will be released from any liability in respect of any action or decision taken or executed in good faith with respect to this Sub-Plan, or any Trustee 102 Award or Share issued to him or her thereunder, or right resulting therefrom, including bonus Shares.
(m) The validity of any order given to the Trustee by an Israeli Employee Grantee shall be subject to the approval of the Employing Company. The Employing Company shall render its decision regarding whether to approve orders given by any Israeli Employee Grantee to the Trustee within a reasonable period of time. The Employing Company shall not be required to approve any order which is incomplete, is not in accordance with the provisions of the Plan, this Sub-Plan and the applicable Award Agreement or which the Employing Company believes should not be executed for any reasonable reason. The Employing Company shall notify the Israeli Employee Grantee of the reason for not approving his order. Approval by the Employing Company of any order given to the Trustee by an Israeli Employee Grantee shall not constitute proof of the Employing Companys recognition of any right of such Israeli Employee Grantee.
(n) Without derogating from the above, the Employing Company shall have the authority to determine the specific procedures and conditions of the trusteeship with the Trustee in a separate agreement between the Employing Company and the Trustee.
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(o) In the case of 102 Awards, the Trustee shall have no rights as a Shareholder of the Company with respect to the Shares covered by such Award until the Trustee becomes the record holder of such Shares for the Israeli Employee Grantees benefit, and the Israeli Employee Grantee shall have no rights as a Shareholder of the Company with respect to the Shares covered by the Award until the date of the release of such Shares from the Trustee to the Israeli Employee Grantee and the transfer of record ownership of such Shares to the Israeli Employee Grantee.
4. | NON-TRUSTEE 102 AWARDS. |
(a) Awards granted pursuant to this Section are intended to constitute Non-Trustee 102 Awards and are subject to the provisions of Section 102 and the general terms and conditions specified in the Plan, except for such provisions of the Plan applying to Awards granted under a different tax law or regulations.
(b) Non-Trustee 102 Awards may be granted only to Israeli Employee Grantees.
(c) Non-Trustee 102 Awards that shall be granted pursuant to the Plan and may be issued directly to the Israeli Employee Grantee or to a trustee appointed by the Board or the Committee, as the case may be, in the Board or the Committee, as the case may be, at their sole discretion. In the event that the Board or the Committee, as the case may be, determines that Non-Trustee 102 Awards, or Shares issued upon the exercise thereof, or rights resulting therefore, including bonus Shares, shall be deposited with a trustee, the provisions of Section (f) of this Sub-Plan shall apply, mutatis mutandis.
(d) In the event that an Israeli Employee Grantee was granted a Non-Trustee 102 Award and thereafter such Israeli Employee Grantees employment by the Company, or any Affiliate thereof, terminates for any reason, such Israeli Employee Grantee will be obligated to provide his or her employer, upon the termination of employment, with a security or guarantee to cover any future tax obligation resulting from the grant, exercise or disposition of the Award, the Shares issuable upon the exercise thereof, or any rights resulting therefrom, in a form satisfactory to such employer in such employers sole discretion.
5. | 3(I) AWARDS. |
(a) Awards granted pursuant to this Section are intended to constitute 3(i) Awards and are subject to the provisions of Section 3(i) of the Ordinance and the general terms and conditions specified the Plan, except for provisions of the Plan applying to Awards granted under a different tax law or regulations.
(b) 3(i) Awards may be granted only to Israeli Non-Employee Grantees.
(c) 3(i) Awards that shall be granted pursuant to the Plan and may be issued directly to the Israeli Non-Employee Grantee or to a trustee appointed by the Board or the Committee, as the case may be, in their sole discretion. In the event that the Board or the Committee, as the case may be, determines that 3(i) Awards or Shares issued upon the exercise thereof, or rights resulting therefrom, including bonus Shares, shall be deposited with a trustee, the provisions of Section 3 of this Sub-Plan shall apply, mutatis mutandis.
(d) In the event that an Israeli Non-Employee Grantee was granted a 3(i) Award and thereafter such Israeli Non-Employee Grantees employment by the Company, or any Affiliate thereof, terminates for any reason, such Israeli Non-Employee Grantee will be obligated to
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provide his or her employer, upon the termination of his or her employment, with a security or guarantee to cover any future tax obligation resulting from the grant, exercise or disposition of the Award, the Shares issuable upon the exercise thereof, or any rights resulting therefrom, in a form satisfactory to such employer in such employers sole discretion.
6. | THE AWARD AGREEMENT. |
The terms and conditions upon which the Awards shall be issued and exercised shall be as specified in an Award Agreement to be executed pursuant to the Plan and this Sub-Plan. Each Award Agreement shall state, inter alia, the number of Shares granted under the Award, the type of Award granted thereunder (whether such Award is a Trustee 102 Award, and if so, whether it is a 102 Capital Gains Award or 102 Ordinary Income Award, or a Non-Trustee 102 Award, or a 3(i) Award), the vesting provisions, the term of the Award, and the exercise price. Any grant of Awards shall be conditioned upon the Israeli Grantees undertaking to be subject to the provisions of Section 102 or Section 3(i) of the Ordinance, as applicable.
7. | FAIR MARKET VALUE FOR ISRAELI TAX PURPOSES. |
Without derogating from Section 1(u) of the Plan and solely for the purpose of determining the tax liability pursuant to Section 102(b)(3) of the Ordinance, if at the date of grant of a 102 Capital Gains Award the Companys Shares are listed on any established stock exchange or anational market system, or if the Companys Shares are registered for trading within ninety (90) days following the date of grant of the 102 Capital Gains Award, the fair market value of the Shares at the date of grant shall be determined in accordance with the average value of theCompanys Shares on the thirty (30) trading days preceding the date of grant or on the thirty (30) trading days following the date of registration for trading, as the case may be.
8. | EXERCISE OF AWARDS. |
Awards that represent options to purchase Shares shall be exercised by the Israeli Grantee by giving a written or electronic notice to the Company and/or to any third party designated by the Company (the Representative), in such form and method as may be determined by the Company and, when applicable, by the Trustee, in accordance with the requirements of Section 102 or Section 3(i), which exercise shall be effective upon receipt of such notice by the Company and/or the Representative and the payment of the exercise price for the number of Shares with respect to which the Award is being exercised and the payment of the tax, at the Companys or the Representatives principal office. The notice shall specify the number of Shares with respect to which the Award is being exercised.
Other Awards shall be exercised in such form and method as may be determined by the Company and, when applicable, by the Trustee, in accordance with the requirements of Section 102 or Section 3(i), which exercise shall be effective upon receipt of the payment of the tax in case of exercise of 3(i) Awards.
For the avoidance of doubt it is hereby clarified that no exercise of 3(i) Awards shall be affective if the applicable tax was not paid to the Company or its Representative.
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9. | INTEGRATION OF SECTION 102 AND TAX ASSESSING OFFICERS PERMIT. |
(a) With respect to Trustee 102 Awards, the provisions of the Plan, this Sub-Plan and the Award Agreement shall be subject to the provisions of Section 102 and the Tax Assessing Officers permit (to the extent that such permit is issued) and/or any pre-ruling obtained by the ITA (the Permit), and the provisions of the Permit shall be deemed integrated with, and a part of, the Plan, this Sub-Plan and the Award Agreement.
(b) Any provision of Section 102 or the Permit which is necessary in order to obtain or preserve any tax benefit pursuant to Section 102, which is not expressly specified in the Plan, this Sub-Plan, or the Award Agreement, shall be deemed to have been automatically incorporated into this Sub-Plan and binding upon the Company and the Grantees who are Israeli Grantees.
10. | DIVIDENDS. |
Without derogating from the provisions of the Plan, an Israeli Grantee shall be entitled to receive dividends with respect to Shares issued upon the exercise of his or her Awards, whether such Shares are held by the Israeli Grantee or by the Trustee (entitled dividends with respect to Shares held by the Trustee, shall be received by the Trustee) for his or her benefit, in accordance with the provisions of the Companys Certificate of Incorporation (including all amendments thereto), subject to any applicable taxation on distribution of dividends and, when applicable, subject to the provisions of Section 102.
11. | TAX CONSEQUENCES. |
(a) Any liability for any Tax arising with respect to the Awards and the Shares, including, but not limited to, as a result of the grant of Awards, the exercise of an Award for Shares, the receipt of cash, the transfer, waiver, or expiration of Awards or Shares or the disposal of Shares, shall be borne solely by the Israeli Grantees, and in the event of their death, by their estates or heirs. Neither the Company nor any Affiliate nor the Trustee shall be required to pay such Taxes, directly or indirectly, nor shall they be required to gross up such Taxes in the Israeli Grantees salaries or remuneration. The applicable Tax may be deducted from any cash to be provided to the Israeli Grantee or from the proceeds of the disposal of the Shares or shall be paid to the Trustee or to the Company or its Affiliates by the Israeli Grantees at their request, or may be provided via any combination of the above.
(b) The Company, its Affiliates and the Trustee shall be entitled to withhold Taxes according to the requirements of any applicable laws, rules, and regulations, including by withholding Taxes at source and specifically under Rule 7(b) of the Rules.
(c) The Israeli Grantees undertake to indemnify the Company, its Affiliates and the Trustee, immediately upon their request, for any Tax for which the Israeli Grantee is liable under any applicable law, under the Plan or this Sub-Plan, and which was paid by the Company or the Trustee, or which the Company or the Trustee are required to pay and hold them harmless against and from any and all liability for any such tax or interest or penalty or indexation thereon, including without limitation, liabilities relating to the necessity to withhold, or to have withhold any such tax from payments made to the Israeli Grantee. The Company may exercise its right to such indemnification by deducting the Tax subject to indemnification from Grantees salary or remuneration.
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(d) The Board (or the Committee, as the case may be), or when applicable, the Trustee shall not be required to release any Awards, Shares, rights resulting therefrom, including bonus Shares, or share certificates, to an Israeli Grantee until all required Tax payments and other payments to be borne by such Israeli Grantee have been fully made.
(e) Notwithstanding any other provision no Israeli Grantee shall have any of the rights of a Shareholder with respect to any Shares until Grantee pays all payments (including Tax) required to be paid under this Section with respect to such Shares.
(f) The ramifications of any future modification of any applicable law with respect to the taxation of Awards or Shares granted to Grantees shall apply to the Israeli Grantees accordingly and the Israeli Grantees shall bear the full cost thereof, unless such laws, as modified, mandatorily provide otherwise. For the avoidance of doubt, should the applicability of such taxing arrangements to the Plan, this Sub-Plan or to securities issued hereunder or thereunder be conditioned on a decision by the Company or by the Trustee that such arrangements shall apply, the Company shall be entitled to decide, at its absolute discretion, whether to apply such taxing arrangements and to instruct the Trustee to act accordingly.
(g) With respect to Unapproved 102 Award, if the Israeli Grantee ceases to be employed by the Company or any Affiliate, the Israeli Grantee shall extend to the Company and/or its Affiliate a security or guarantee for the payment of tax due at the time of sale of Shares, all in accordance with the provisions of Section 102 and the rules, regulation or orders promulgated thereunder.
(h) Each Grantee agrees to, and undertakes to comply with, any ruling, settlement, closing agreement or other similar agreement or arrangement with any tax authority in connection with the foregoing which is approved by the Company.
12. | VOTING RIGHTS. |
SUBJECT TO THE PROVISIONS OF THE PLAN, FOR AS LONG AS ANY SHARES ARE ISSUED TO THE TRUSTEE ON BEHALF OF AN ISRAELI GRANTEE UNDER THIS SUB-PLAN, SUCH SHARES SHALL BE VOTED BY THE TRUSTEE, UNLESS THE TRUSTEE IS DIRECTED OTHERWISE BY THE BOARD OR THE COMMITTEE, AS THE CASE MAY BE, IN THE SAME PROPORTION AS THE RESULT OF THE SHAREHOLDER VOTE AT THE SHAREHOLDERS MEETING OR WRITTEN CONSENT IN RESPECT OF WHICH THE SHARES HELD BY THE TRUSTEE ARE BEING VOTED. HOWEVER, THE TRUSTEE SHALL NOT BE OBLIGATED TO EXERCISE SUCH VOTING RIGHTS NOR NOTIFY THE ISRAELI GRANTEE OF ANY MEETING OF THE COMPANYS SHAREHOLDERS.
13. | GOVERNING LAW & JURISDICTION. |
THIS SUB-PLAN SHALL BE GOVERNED BY AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH THE LAWS OF THE STATE OF ISRAEL, WITHOUT GIVING EFFECT TO THE PRINCIPLES OF CONFLICT OF LAWS. THE COMPETENT COURTS IN TEL-AVIV SHALL HAVE SOLE JURISDICTION IN ANY MATTERS PERTAINING TO THIS SUB-PLAN.
* * *
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Exhibit 10.15
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
NOTICE OF STOCK OPTION AWARD
Grantees Name and Address: |
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You (the Grantee) have been granted an option to purchase shares of Common Stock, subject to the terms and conditions of this Notice of Stock Option Award (the Notice), the Adicet Bio, Inc. 2015 Stock Incentive Plan, as amended from time to time (the Plan) and the Stock Option Award Agreement (the Option Agreement) attached hereto, as follows. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Notice.
Award Number |
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Date of Award |
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Vesting Commencement Date |
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Exercise Price per Share |
$ | |
Total Number of Shares Subject to the Option (the Shares) |
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Total Exercise Price |
$ | |
Type of Option: |
Incentive Stock Option | |
Non-Qualified Stock Option | ||
Expiration Date: |
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Post-Termination Exercise Period: |
Three (3) Months |
Vesting Schedule:
This Option is immediately exercisable although the Shares issued upon exercise of the Option will be subject to the restrictions on transfer and a right of repurchase at the Exercise Price per Share, in favor of the Company, as described in Section 16 of the Option Agreement (the Repurchase Right). For purposes of this Notice and the Option Agreement, the term vest shall mean, with respect to any Shares, that such Shares (whether subject to the Option or acquired upon exercise of the Option) are no longer subject to the Repurchase Right, provided, however, that such Shares shall remain subject to other restrictions on transfer set forth in the Option Agreement or the Plan. Shares that have not vested are deemed Restricted Shares. If the Grantee would become vested in a fraction of a Share, such Share shall not vest until the Grantee becomes vested in the entire Share.
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Subject to the Grantees Continuous Service and the other limitations set forth in this Notice, the Plan and the Option Agreement, the Repurchase Right shall lapse in accordance with the following schedule:
[25% of the Shares subject to the Option shall vest twelve (12) months after the Vesting Commencement Date, and 1/36th of the remaining unvested Shares subject to the Option shall vest on each of the next thirty-six (36) monthly anniversaries of the Vesting Commencement Date thereafter.]1
[1/48th of the Shares subject to the Option shall vest on each monthly anniversary of the Vesting Commencement Date.]2
During any authorized leave of absence, the vesting of the Shares shall be suspended after the leave of absence exceeds a period of three (3) months. Vesting of the Shares shall resume upon the Grantees termination of the leave of absence and return to Continuous Service. The Vesting Schedule of the Shares shall be extended by the length of the suspension.
In the event of termination of the Grantees Continuous Service for Cause, the Grantees right to exercise the Option shall terminate concurrently with the termination of the Grantees Continuous Service, except as otherwise determined by the Administrator.
[Remainder of Page Left Intentionally Blank]
1 | Insert for new-hire grants. |
2 | Insert for refresh grants. |
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IN WITNESS WHEREOF, the Company and the Grantee have executed this Notice and agree that the Option is to be governed by the terms and conditions of this Notice, the Plan, and the Option Agreement.
ADICET BIO, INC., | ||
a Delaware corporation | ||
By: |
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Name: |
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Title: |
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[Remainder of Page Left Intentionally Blank]
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THE GRANTEE ACKNOWLEDGES AND AGREES THAT THE SHARES SUBJECT TO THE OPTION SHALL VEST, IF AT ALL, ONLY DURING THE PERIOD OF THE GRANTEES CONTINUOUS SERVICE (NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED THE OPTION OR ACQUIRING SHARES HEREUNDER). THE GRANTEE FURTHER ACKNOWLEDGES AND AGREES THAT NOTHING IN THIS NOTICE, THE OPTION AGREEMENT, OR THE PLAN SHALL CONFER UPON THE GRANTEE ANY RIGHT WITH RESPECT TO FUTURE AWARDS OR CONTINUATION OF THE GRANTEES CONTINUOUS SERVICE, NOR SHALL IT INTERFERE IN ANY WAY WITH THE GRANTEES RIGHT OR THE RIGHT OF THE COMPANY OR RELATED ENTITY TO WHICH THE GRANTEE PROVIDES SERVICES TO TERMINATE THE GRANTEES CONTINUOUS SERVICE, WITH OR WITHOUT CAUSE, AND WITH OR WITHOUT NOTICE. THE GRANTEE ACKNOWLEDGES THAT UNLESS THE GRANTEE HAS A WRITTEN EMPLOYMENT AGREEMENT WITH THE COMPANY TO THE CONTRARY, THE GRANTEES STATUS IS AT WILL.
The Grantee acknowledges receipt of a copy of the Plan and the Option Agreement, and represents that he or she is familiar with the terms and provisions thereof, and hereby accepts the Option subject to all of the terms and provisions hereof and thereof. The Grantee has reviewed this Notice, the Plan, and the Option Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Notice, and fully understands all provisions of this Notice, the Plan and the Option Agreement. The Grantee hereby agrees that all questions of interpretation and administration relating to this Notice, the Plan and the Option Agreement shall be resolved by the Administrator in accordance with Section 23 of the Option Agreement. The Grantee further agrees to the venue selection in accordance with Section 24 of the Option Agreement. The Grantee further agrees to notify the Company upon any change in the residence address indicated in this Notice.
Dated: | Signed: | |
Grantee |
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Award Number:
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
IMMEDIATELY EXERCISABLE STOCK OPTION AWARD AGREEMENT
1. Grant of Option. Adicet Bio, Inc., a Delaware corporation (the Company), hereby grants to the Grantee (the Grantee) named in the Notice of Stock Option Award (the Notice), an option (the Option) to purchase the Total Number of Shares of Common Stock subject to the Option (the Shares) set forth in the Notice, at the Exercise Price per Share set forth in the Notice (the Exercise Price) subject to the terms and provisions of the Notice, this Stock Option Award Agreement (the Option Agreement) and the Companys 2015 Stock Incentive Plan, as amended from time to time (the Plan), which are incorporated herein by reference. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Option Agreement.
If designated in the Notice as an Incentive Stock Option, the Option is intended to qualify as an Incentive Stock Option as defined in Section 422 of the Code. However, notwithstanding such designation, the Option will qualify as an Incentive Stock Option under the Code only to the extent the $100,000 dollar limitation of Section 422(d) of the Code is not exceeded. The $100,000 limitation of Section 422(d) of the Code is calculated based on the aggregate Fair Market Value of the Shares subject to options designated as Incentive Stock Options which become exercisable for the first time by the Grantee during any calendar year (under all plans of the Company or any Parent or Subsidiary of the Company). For purposes of this calculation, Incentive Stock Options shall be taken into account in the order in which they were granted, and the Fair Market Value of the shares subject to such options shall be determined as of the grant date of the relevant option.
2. Exercise of Option.
(a) Right to Exercise. The Option shall be immediately exercisable during its term in accordance with the applicable provisions of the Plan and this Option Agreement. The Option shall be subject to the provisions of Section 11 of the Plan relating to the exercisability or termination of the Option in the event of a Corporate Transaction. The Grantee shall be subject to reasonable limitations on the number of requested exercises during any monthly or weekly period as determined by the Administrator. In no event shall the Company issue fractional Shares.
(b) Method of Exercise. The Option shall be exercisable by delivery of an exercise notice (a form of which is attached as Exhibit A) or by such other procedure as specified from time to time by the Administrator which shall state the election to exercise the Option, the whole number of Shares in respect of which the Option is being exercised, and such other provisions as may be required by the Administrator. The exercise notice shall be delivered in person, by certified mail, or by such other method (including electronic transmission) as determined from time to time by the Administrator to the Company accompanied by payment of the Exercise Price and all applicable income and employment taxes required to be withheld. The
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Option shall be deemed to be exercised upon receipt by the Company of such notice accompanied by the Exercise Price and all applicable withholding taxes, which, to the extent selected, shall be deemed to be satisfied by use of the broker-dealer sale and remittance procedure to pay the Exercise Price provided in Section 4(d), below, to the extent such procedure is available to the Grantee at the time of exercise and such an exercise would not violate any Applicable Law.
(c) Taxes. No Shares will be delivered to the Grantee or other person pursuant to the exercise of the Option until the Grantee or other person has made arrangements acceptable to the Administrator for the satisfaction of applicable income tax and employment tax withholding obligations, including, without limitation, such other tax obligations of the Grantee incident to the receipt of Shares. Upon exercise of the Option, the Company or the Grantees employer may offset or withhold (from any amount owed by the Company or the Grantees employer to the Grantee) or collect from the Grantee or other person an amount sufficient to satisfy such tax withholding obligations. Furthermore, in the event of any determination that the Company has failed to withhold a sum sufficient to pay all withholding taxes due in connection with the Option, the Grantee agrees to pay the Company the amount of such deficiency in cash within five (5) days after receiving a written demand from the Company to do so, whether or not the Grantee is an employee of the Company at that time.
3. Grantees Representations. The Grantee understands that neither the Option nor the Shares exercisable pursuant to the Option have been registered under the Securities Act of 1933, as amended or any United States securities laws. In the event the Shares purchasable pursuant to the exercise of the Option have not been registered under the Securities Act of 1933, as amended, at the time the Option is exercised, the Grantee shall, if requested by the Company, concurrently with the exercise of all or any portion of the Option, deliver to the Company his or her Investment Representation Statement in the form attached hereto as Exhibit B.
4. Method of Payment. Payment of the Exercise Price shall be made by any of the following, or a combination thereof, at the election of the Grantee; provided, however, that such exercise method does not then violate any Applicable Law and, provided further, that the portion of the Exercise Price equal to the par value of the Shares must be paid in cash or other legal consideration permitted by the Delaware General Corporation Law:
(a) cash;
(b) check;
(c) if the exercise occurs on or after the Registration Date, surrender of Shares held for the requisite period, if any, necessary to avoid a charge to the Companys earnings for financial reporting purposes, or delivery of a properly executed form of attestation of ownership of Shares as the Administrator may require which have a Fair Market Value on the date of surrender or attestation equal to the aggregate Exercise Price of the Shares as to which the Option is being exercised; or
(d) if the exercise occurs on or after the Registration Date, payment through a broker-dealer sale and remittance procedure pursuant to which the Grantee (i) shall provide
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written instructions to a Company-designated brokerage firm to effect the immediate sale of some or all of the purchased Shares and remit to the Company sufficient funds to cover the aggregate exercise price payable for the purchased Shares and (ii) shall provide written directives to the Company to deliver the certificates for the purchased Shares directly to such brokerage firm in order to complete the sale transaction.
5. Restrictions on Exercise. The Option may not be exercised if the issuance of the Shares subject to the Option upon such exercise would constitute a violation of any Applicable Laws. In addition, the Option may not be exercised until such time as the Plan has been approved by the stockholders of the Company. If the exercise of the Option within the applicable time periods set forth in Sections 6, 7 and 8 of this Option Agreement is prevented by the provisions of this Section 5, the Option shall remain exercisable until one (1) month after the date the Grantee is notified by the Company that the Option is exercisable, but in any event no later than the Expiration Date set forth in the Notice.
6. Termination or Change of Continuous Service. In the event the Grantees Continuous Service terminates, other than for Cause, the Grantee may, but only during the Post-Termination Exercise Period, exercise the portion of the Option that was vested at the date of such termination (the Termination Date). The Post-Termination Exercise Period shall commence on the Termination Date. In the event of termination of the Grantees Continuous Service for Cause, the Grantees right to exercise the Option shall, except as otherwise determined by the Administrator, terminate concurrently with the termination of the Grantees Continuous Service (also the Termination Date). In no event, however, shall the Option be exercised later than the Expiration Date set forth in the Notice. In the event of the Grantees change in status from Employee, Director or Consultant to any other status of Employee, Director or Consultant, the Option shall remain in effect and the Option shall continue to vest in accordance with the Vesting Schedule set forth in the Notice; provided, however, with respect to any Incentive Stock Option that shall remain in effect after a change in status from Employee to Director or Consultant, such Incentive Stock Option shall cease to be treated as an Incentive Stock Option and shall be treated as a Non-Qualified Stock Option on the day three (3) months and one (1) day following such change in status. Except as provided in Sections 7 and 8 below, to the extent that the Option was unvested on the Termination Date, or if the Grantee does not exercise the vested portion of the Option within the Post-Termination Exercise Period, the Option shall terminate.
7. Disability of Grantee. In the event the Grantees Continuous Service terminates as a result of his or her Disability, the Grantee may, but only within twelve (12) months commencing on the Termination Date (but in no event later than the Expiration Date), exercise the portion of the Option that was vested on the Termination Date; provided, however, that if such Disability is not a disability as such term is defined in Section 22(e)(3) of the Code and the Option is an Incentive Stock Option, such Incentive Stock Option shall cease to be treated as an Incentive Stock Option and shall be treated as a Non-Qualified Stock Option on the day three (3) months and one (1) day following the Termination Date. To the extent that the Option was unvested on the Termination Date, or if the Grantee does not exercise the vested portion of the Option within the time specified herein, the Option shall terminate. Section 22(e)(3) of the Code provides that an individual is permanently and totally disabled if he or she is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than twelve (12) months.
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8. Death of Grantee. In the event of the termination of the Grantees Continuous Service as a result of his or her death, or in the event of the Grantees death during the Post-Termination Exercise Period or during the twelve (12) month period following the Grantees termination of Continuous Service as a result of his or her Disability, the person who acquired the right to exercise the Option pursuant to Section 9 may exercise the portion of the Option that was vested at the date of termination within twelve (12) months commencing on the date of death (but in no event later than the Expiration Date). To the extent that the Option was unvested on the date of death, or if the vested portion of the Option is not exercised within the time specified herein, the Option shall terminate.
9. Transferability of Option. The Option, if an Incentive Stock Option, may not be transferred in any manner other than by will or by the laws of descent and distribution and may be exercised during the lifetime of the Grantee only by the Grantee. The Option, if a Non-Qualified Stock Option, may not be transferred in any manner other than by will or by the laws of descent and distribution, provided, however, that a Non-Qualified Stock Option may be transferred during the lifetime of the Grantee by gift or pursuant to a domestic relations order to members of the Grantees Immediate Family to the extent and in the manner determined by the Administrator. Notwithstanding the foregoing, the Grantee may designate one or more beneficiaries of the Grantees Incentive Stock Option or Non-Qualified Stock Option in the event of the Grantees death on a beneficiary designation form provided by the Administrator. Following the death of the Grantee, the Option, to the extent provided in Section 8, may be exercised (a) by the person or persons designated under the deceased Grantees beneficiary designation or (b) in the absence of an effectively designated beneficiary, by the Grantees legal representative or by any person empowered to do so under the deceased Grantees will or under the then applicable laws of descent and distribution. The terms of the Option shall be binding upon the executors, administrators, heirs, successors and transferees of the Grantee.
10. Term of Option. The Option must be exercised no later than the Expiration Date set forth in the Notice or such earlier date as otherwise provided herein. After the Expiration Date or such earlier date, the Option shall be of no further force or effect and may not be exercised.
11. Transfer Restrictions for Unvested Shares. The Shares sold to the Grantee hereunder may not be sold, transferred by gift, pledged, hypothecated, or otherwise transferred or disposed of by the Grantee prior to the date that the Shares become vested pursuant to the Vesting Schedule set forth in the Notice. Any attempt to transfer Shares in violation of this Section 11 will be null and void and will be disregarded. After the Shares vest, the Shares will remain subject to the Companys Right of First Refusal as set forth in Section 12.
12. Companys Right of First Refusal. The Grantee acknowledges and agrees that the Shares are subject to a right of first refusal (Right of First Refusal) as set forth in the Bylaws of the Company, which Right of First Refusal is incorporated herein by reference irrespective of whether the Bylaws are amended at some future date to remove the Right of First Refusal therefrom, and that, except in compliance with such Right of First Refusal, neither the Grantee nor a transferee (either being sometimes referred to herein as the Holder) shall sell, hypothecate, encumber or otherwise transfer any Shares or any right or interest therein.
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13. Escrow of Stock. For purposes of facilitating the enforcement of the provisions of this Option Agreement, the Grantee agrees, immediately upon receipt of the certificate(s) for the Shares, to deliver such certificate(s), together with an Assignment Separate from Certificate in the form attached hereto as Exhibit C, executed in blank by the Grantee with respect to each such stock certificate, to the Secretary or Assistant Secretary of the Company, or their designee, to hold in escrow for so long as such Shares have not vested pursuant to the Vesting Schedule set forth in the Notice or are subject to the Companys Right of First Refusal, with the authority to take all such actions and to effectuate all such transfers and/or releases as may be necessary or appropriate to accomplish the objectives of this Option Agreement in accordance with the terms hereof. The Grantee hereby acknowledges that the appointment of the Secretary or Assistant Secretary of the Company (or their designee) as the escrow holder hereunder with the stated authorities is a material inducement to the Company to make this Option Agreement and that such appointment is coupled with an interest and is accordingly irrevocable. The Grantee agrees that the Restricted Shares may be held electronically in a book entry system maintained by the Companys transfer agent or other third-party and that all the terms and conditions of this Section 13 applicable to certificated Restricted Shares will apply with the same force and effect to such electronic method for holding the Restricted Shares. The Grantee agrees that such escrow holder shall not be liable to any party hereto (or to any other party) for any actions or omissions unless such escrow holder is grossly negligent relative thereto. The escrow holder may rely upon any letter, notice or other document executed by any signature purported to be genuine and may resign at any time. Upon the vesting of all Shares and termination of the Companys Right of First Refusal, the escrow holder will, upon request, transmit to the Grantee the certificate evidencing such Shares.
14. Additional Securities. Any securities or cash received (other than a regular cash dividend) as the result of ownership of the Shares (the Additional Securities), including, but not by way of limitation, warrants, options and securities received as a stock dividend or stock split, or as a result of any transaction described in Section 10 or 11 of the Plan, shall be subject to the same conditions and restrictions as the Shares with respect to which they were issued, including, without limitation, the Vesting Schedule set forth in the Notice, Right of First Refusal and the Repurchase Right and retained in escrow in the same manner as the Shares with respect to which they relate. The Grantee shall be entitled to direct the Company to exercise any warrant or option received as Additional Securities upon supplying the funds necessary to do so, in which event the securities so purchased shall constitute Additional Securities, but the Grantee may not direct the Company to sell any such warrant or option. If Additional Securities consist of a convertible security, the Grantee may exercise any conversion right, and any securities so acquired shall constitute Additional Securities. Appropriate adjustments to reflect the distribution of Additional Securities shall be made to the price per share to be paid upon the exercise of the Repurchase Right in order to reflect the effect of any such transaction upon the Companys capital structure. In the event of any change in certificates evidencing the Shares or the Additional Securities by reason of any recapitalization, reorganization or other transaction that results in the creation of Additional Securities, the escrow holder is authorized to deliver to the issuer the certificates evidencing the Shares or the Additional Securities in exchange for the certificates of the replacement securities.
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15. Distributions. Subject to Section 14 and Section 16(e), the Company shall disburse to the Grantee all regular cash dividends with respect to the Shares and Additional Securities (whether vested or not), less any applicable withholding obligations.
16. Companys Repurchase Right.
(a) Grant of Repurchase Right. The Company is hereby granted the right (the Repurchase Right), exercisable at any time during the nine (9) month period following the Termination Date, to repurchase all or any portion of the Shares that have not vested pursuant to the terms of the Vesting Schedule purchased upon exercise of the Option (the Share Repurchase Period).
(b) Exercise of the Repurchase Right. The Repurchase Right shall be exercisable by written notice delivered to the Grantee prior to the expiration of the Share Repurchase Period. The notice shall indicate the number of Shares to be repurchased and the date on which the repurchase is to be effected, such date to be not later than the last day of the Share Repurchase Period. On the date on which the repurchase is to be effected, the Company and/or its assigns shall pay to the Grantee in cash or cash equivalents (including the cancellation of any purchase-money indebtedness) an amount equal to the lesser of the Exercise Price per Share previously paid by the Grantee to the Company for such Shares and the Fair Market Value per Share on the date on which the repurchase is to be effected. Upon such payment or deposit into escrow for the benefit of the Grantee, the Company and/or its assigns shall become the legal and beneficial owner of the Shares being repurchased and all rights and interest thereon or related thereto, and the Company shall have the right to transfer to its own name or its assigns the number of Shares being repurchased, without further action by the Grantee.
(c) Assignment. Whenever the Company shall have the right to purchase Shares under this Repurchase Right, the Company may designate and assign one or more employees, officers, directors or stockholders of the Company or other persons or organizations, to exercise all or a part of the Companys Repurchase Right.
(d) Termination of the Repurchase Right. The Repurchase Right shall terminate with respect to any Shares for which it is not timely exercised.
(e) Additional Shares or Substituted Securities. In the event of any transaction described in Sections 10 or 11 of the Plan, the Repurchase Right shall apply to the new capital stock or other property (including cash paid other than as a regular cash dividend) received in exchange for the Shares in consummation of any such transaction and such stock or property shall be deemed Additional Securities for purposes of this Option Agreement, but only to the extent the Shares are at the time covered by such Repurchase Right. Appropriate adjustments shall be made to the price per share payable upon exercise of the Repurchase Right to reflect the effect of any such transaction.
17. Stop-Transfer Notices. In order to ensure compliance with the restrictions on transfer set forth in this Option Agreement, the Notice or the Plan, the Company may issue appropriate stop transfer instructions to its transfer agent, if any, and, if the Company transfers its own securities, it may make appropriate notations to the same effect in its own records.
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18. Refusal to Transfer. The Company shall not be required (i) to transfer on its books any Shares that have been sold or otherwise transferred in violation of any of the provisions of this Option Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.
19. Tax Consequences.
(a) The Grantee may incur tax liability as a result of the Grantees purchase or disposition of the Shares. THE GRANTEE SHOULD CONSULT A TAX ADVISER BEFORE EXERCISING THE OPTION OR DISPOSING OF THE SHARES.
(b) Notwithstanding the Companys good faith determination of the Fair Market Value of the Companys Common Stock for purposes of determining the Exercise Price Per Share of the Option as set forth in the Notice, the taxing authorities may assert that the Fair Market Value of the Common Stock on the Date of Award was greater than the Exercise Price Per Share. If designated in the Notice as an Incentive Stock Option, the Option may fail to qualify as an Incentive Stock Option if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award. In addition, under Section 409A of the Code, if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award, the Option may be treated as a form of deferred compensation and the Grantee may be subject to an acceleration of income recognition, an additional 20% tax, plus interest and possible penalties. The Company makes no representation that the Option will comply with Section 409A of the Code and makes no undertaking to prevent Section 409A of the Code from applying to the Option or to mitigate its effects on any deferrals or payments made in respect of the Option. The Grantee is encouraged to consult a tax adviser regarding the potential impact of Section 409A of the Code.
20. Lock-Up Agreement.
(a) Agreement. The Grantee, if requested by the Company and the lead underwriter of any public offering of the Common Stock (the Lead Underwriter), hereby irrevocably agrees not to sell, contract to sell, grant any option to purchase, transfer the economic risk of ownership in, make any short sale of, pledge or otherwise transfer or dispose of any interest in any Common Stock or any securities convertible into or exchangeable or exercisable for or any other rights to purchase or acquire Common Stock (except Common Stock included in such public offering or acquired on the public market after such offering) during the 180-day period following the effective date of a registration statement of the Company filed under the Securities Act of 1933, as amended, or such shorter or longer period of time as the Lead Underwriter shall specify. The Grantee further agrees to sign such documents as may be requested by the Lead Underwriter to effect the foregoing and agrees that the Company may impose stop-transfer instructions with respect to such Common Stock subject to the lock-up period until the end of such period. The Company and the Grantee acknowledge that each Lead Underwriter of a public offering of the Companys stock, during the period of such offering and for the lock-up period thereafter, is an intended beneficiary of this Section 20.
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(b) No Amendment Without Consent of Underwriter. During the period from identification of a Lead Underwriter in connection with any public offering of the Companys Common Stock until the earlier of (i) the expiration of the lock-up period specified in Section 20(a) in connection with such offering or (ii) the abandonment of such offering by the Company and the Lead Underwriter, the provisions of this Section 20 may not be amended or waived except with the consent of the Lead Underwriter.
21. Entire Agreement: Governing Law. The Notice, the Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Grantee with respect to the subject matter hereof, and may not be modified adversely to the Grantees interest except by means of a writing signed by the Company and the Grantee. Nothing in the Notice, the Plan and this Option Agreement (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties. The Notice, the Plan and this Option Agreement are to be construed in accordance with and governed by the internal laws of the State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California to the rights and duties of the parties. Should any provision of the Notice, the Plan or this Option Agreement be determined to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
22. Construction. The captions used in the Notice and this Option Agreement are inserted for convenience and shall not be deemed a part of the Option for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
23. Administration and Interpretation. Any question or dispute regarding the administration or interpretation of the Notice, the Plan or this Option Agreement shall be submitted by the Grantee or by the Company to the Administrator. The resolution of such question or dispute by the Administrator shall be final and binding on all persons.
24. Venue. The Company, the Grantee, and the Grantees assignees pursuant to Section 9 (the parties) agree that any suit, action, or proceeding arising out of or relating to the Notice, the Plan or this Option Agreement shall be brought in the United States District Court for the Northern District of California (or should such court lack jurisdiction to hear such action, suit or proceeding, in a California state court in the County of San Francisco) and that the parties shall submit to the jurisdiction of such court. The parties irrevocably waive, to the fullest extent permitted by law, any objection the party may have to the laying of venue for any such suit, action or proceeding brought in such court. If any one or more provisions of this Section 24 shall for any reason be held invalid or unenforceable, it is the specific intent of the parties that such provisions shall be modified to the minimum extent necessary to make it or its application valid and enforceable.
25. Notices. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an
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internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown in these instruments, or to such other address as such party may designate in writing from time to time to the other party.
26. Confidentiality. To the extent required by Applicable Law, the Company shall provide to the Grantee, during the period the Option is outstanding, copies of financial statements of the Company at least annually. The Grantee understands and agrees that such financial statements are confidential and shall not be disclosed by the Grantee, to any entity or person, for any reason, at any time, without the prior written consent of the Company, unless required by law. If disclosure of such financial statements is required by law, whether through subpoena, request for production, deposition, or otherwise, the Grantee promptly shall provide written notice to Company, including copies of the subpoena, request for production, deposition, or otherwise, within five (5) business days of their receipt by the Grantee and prior to any disclosure so as to provide Company an opportunity to move to quash or otherwise to oppose the disclosure. Notwithstanding the foregoing, the Grantee may disclose the terms of such financial statements to his or her spouse or domestic partner, and for legitimate business reasons, to legal, financial, and tax advisors.
END OF AGREEMENT
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EXHIBIT A
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
EXERCISE NOTICE
[COMPANY ADDRESS]
Attention: Secretary
1. Effective as of today, the undersigned (the Grantee) hereby elects to exercise the Grantees option to purchase shares of the Common Stock (the Shares) of Adicet Bio, Inc. (the Company) under and pursuant to the Companys 2015 Stock Incentive Plan, as amended from time to time (the Plan) and the [ ] Incentive [ ] Non-Qualified Stock Option Award Agreement (the Option Agreement) and Notice of Stock Option Award (the Notice) dated . Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Exercise Notice.
2. Representations of the Grantee. The Grantee acknowledges that the Grantee has received, read and understood the Notice, the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
3. Rights as Stockholder. Until the stock certificate evidencing such Shares is issued (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to vote or receive dividends or any other rights as a stockholder shall exist with respect to the Shares, notwithstanding the exercise of the Option. The Company shall issue (or cause to be issued) such stock certificate promptly after the Option is exercised. No adjustment will be made for a dividend or other right for which the record date is prior to the date the stock certificate is issued, except as provided in Section 10 of the Plan.
The Grantee shall enjoy rights as a stockholder until such time as the Grantee disposes of the Shares or the Company and/or its assignee(s) exercises the Right of First Refusal or the Repurchase Right. Upon such exercise, the Grantee shall have no further rights as a holder of the Shares so purchased except the right to receive payment for the Shares so purchased in accordance with the provisions of the Option Agreement, and the Grantee shall forthwith cause the certificate(s) evidencing the Shares so purchased to be surrendered to the Company for transfer or cancellation.
4. Delivery of Payment. The Grantee herewith delivers to the Company the full Exercise Price for the Shares, which, to the extent selected, shall be deemed to be satisfied by use of the broker-dealer sale and remittance procedure to pay the Exercise Price provided in Section 4(d) of the Option Agreement.
5. Tax Consultation. The Grantee understands that the Grantee may suffer adverse tax consequences as a result of the Grantees purchase or disposition of the Shares. The Grantee represents that the Grantee has consulted with any tax consultants the Grantee deems advisable in connection with the purchase or disposition of the Shares and that the Grantee is not relying on the Company for any tax advice.
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6. Tax Election; Taxes. The Grantee shall provide the Company with a copy of any timely filed 83(b) Election relating to the purchase of the Shares. If the Grantee makes a timely 83(b) Election, the Grantee shall immediately pay the Company (or the Related Entity that employs the Grantee) the amount necessary to satisfy any applicable federal, state, and local income and employment tax withholding obligations. If the Grantee does not make a timely 83(b) Election, the Grantee shall, either at the time that the restrictions lapse under the Option Agreement and the Plan or at the time withholding is otherwise required by Applicable Law, pay the Company (or the Related Entity that employs the Grantee) the amount necessary to satisfy any applicable federal, state, and local income and employment tax withholding obligations. In addition, the Grantee agrees to satisfy all other applicable federal, state and local income and employment tax withholding obligations and herewith delivers to the Company the full amount of such obligations or has made arrangements acceptable to the Company to satisfy such obligations. In the case of an Incentive Stock Option, the Grantee also agrees, as partial consideration for the designation of the Option as an Incentive Stock Option, to notify the Company in writing within thirty (30) days of any disposition of any shares acquired by exercise of the Option if such disposition occurs within two (2) years from the Date of Award or within one (1) year from the date the Shares were transferred to the Grantee.
7. Restrictive Legends. The Grantee understands and agrees that the Company shall cause the legends set forth below or legends substantially equivalent thereto, to be placed upon any certificate(s) evidencing ownership of the Shares together with any other legends that may be required by the Company or by state or federal securities laws:
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE ACT) OR ANY STATE SECURITIES LAWS AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER THE ACT OR, IN THE OPINION OF COUNSEL SATISFACTORY TO THE ISSUER OF THESE SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS IN COMPLIANCE THEREWITH.
THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER, A RIGHT OF FIRST REFUSAL AND A REPURCHASE RIGHT HELD BY THE ISSUER OR ITS ASSIGNEE(S) AS SET FORTH IN THE OPTION AGREEMENT BETWEEN THE ISSUER AND THE ORIGINAL HOLDER OF THESE SHARES, A COPY OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE ISSUER. SUCH TRANSFER RESTRICTIONS, RIGHT OF FIRST REFUSAL AND REPURCHASE RIGHT ARE BINDING ON TRANSFEREES OF THESE SHARES.
8. Successors and Assigns. The Company may assign any of its rights under this Exercise Notice to single or multiple assignees, and this agreement shall inure to the benefit of
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the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth, this Exercise Notice shall be binding upon the Grantee and his or her heirs, executors, administrators, successors and assigns.
9. Construction. The captions used in this Exercise Notice are inserted for convenience and shall not be deemed a part of this agreement for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
10. Administration and Interpretation. The Grantee hereby agrees that any question or dispute regarding the administration or interpretation of this Exercise Notice shall be submitted by the Grantee or by the Company to the Administrator. The resolution of such question or dispute by the Administrator shall be final and binding on all persons.
11. Governing Law; Severability. This Exercise Notice is to be construed in accordance with and governed by the internal laws of the State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California to the rights and duties of the parties. Should any provision of this Exercise Notice be determined by a court of law to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
12. Notices. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown below beneath its signature, or to such other address as such party may designate in writing from time to time to the other party.
13. Further Instruments. The parties agree to execute such further instruments and to take such further action as may be reasonably necessary to carry out the purposes and intent of this agreement.
14. Entire Agreement. The Notice, the Plan and the Option Agreement are incorporated herein by reference and together with this Exercise Notice constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Grantee with respect to the subject matter hereof, and may not be modified adversely to the Grantees interest except by means of a writing signed by the Company and the Grantee. Nothing in the Notice, the Plan, the Option Agreement and this Exercise Notice (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties.
[Remainder of Page Left Intentionally Blank]
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Submitted by: | Accepted by: | |||||||
GRANTEE: | ADICET BIO, INC. | |||||||
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Title: |
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Address: | Address: | |||||||
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EXHIBIT B
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
INVESTMENT REPRESENTATION STATEMENT
GRANTEE: |
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COMPANY: | ADICET BIO, INC. | |||
SECURITY: | COMMON STOCK | |||
NUMBER OF SHARES: |
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DATE: |
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In connection with the purchase of the above-listed Securities, the undersigned Grantee represents to the Company the following:
(a) Grantee is aware of the Companys business affairs and financial condition and has acquired sufficient information about the Company to reach an informed and knowledgeable decision to acquire the Securities. Grantee is acquiring these Securities for investment for Grantees own account only and not with a view to, or for resale in connection with, any distribution thereof within the meaning of the Securities Act of 1933, as amended (the Securities Act).
(b) Grantee acknowledges and understands that the Securities constitute restricted securities under the Securities Act and have not been registered under the Securities Act in reliance upon a specific exemption therefrom, which exemption depends upon among other things, the bona fide nature of Grantees investment intent as expressed herein. Grantee further understands that the Securities must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available. Grantee further acknowledges and understands that the Company is under no obligation to register the Securities. Grantee understands that the certificate evidencing the Securities will be imprinted with a legend which prohibits the transfer of the Securities unless they are registered or such registration is not required in the opinion of counsel satisfactory to the Company.
(c) Grantee is familiar with the provisions of Rule 701 and Rule 144, each promulgated under the Securities Act, which, in substance, permit limited public resale of restricted securities acquired, directly or indirectly from the issuer thereof, in a non-public offering subject to the satisfaction of certain conditions. Rule 701 provides that if the issuer qualifies under Rule 701 at the time of the grant of the Option to the Grantee, the exercise will be exempt from registration under the Securities Act. In the event the Company becomes subject to the reporting requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, ninety (90) days thereafter (or such longer period as any market stand-off agreement may require) the Securities exempt under Rule 701 may be resold, except in the case of affiliates, such Securities may be resold subject to the satisfaction of the applicable conditions specified by Rule 144, including: (1) the availability of certain public information about the Company, (2) the amount of Securities being sold during any three month period not exceeding specified limitations, (3) the resale being made in an unsolicited brokers transaction, in transactions directly with a market maker or riskless principal transactions (as said terms are defined under the Securities Exchange Act of 1934) and (4) the timely filing of a Form 144, if applicable.
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In the event that the Company does not qualify under Rule 701 at the time of the grant of the Option, then the Securities may be resold in certain limited circumstances subject to the provisions of Rule 144, which may require: the availability of current public information about the Company; the resale to occur more than a specified period after the purchase and full payment (within the meaning of Rule 144) for the Securities; and, in the case of the sale of Securities by an affiliate, the satisfaction of the conditions set forth in sections (2), (3) and (4) of the paragraph immediately above.
(d) Grantee further understands that in the event all of the applicable requirements of Rule 701 or 144 are not satisfied, registration under the Securities Act, compliance with Regulation A, or some other registration exemption will be required; and that, notwithstanding the fact that Rules 144 and 701 are not exclusive, the Staff of the Securities and Exchange Commission has expressed its opinion that persons proposing to sell private placement securities other than in a registered offering and otherwise than pursuant to Rules 144 or 701 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales, and that such persons and their respective brokers who participate in such transactions do so at their own risk. Grantee understands that no assurances can be given that any such other registration exemption will be available in such event.
(e) Grantee represents that Grantee is a resident of the state of .
Signature of Grantee: |
By: |
Date: |
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EXHIBIT C
STOCK ASSIGNMENT SEPARATE FROM CERTIFICATE
[Please sign this document but do not date it. The date and information of the transferee will be completed if and when the shares are assigned.]
FOR VALUE RECEIVED, hereby sells, assigns and transfers unto , ( ) shares of the Common Stock of Adicet Bio, Inc., a Delaware corporation (the Company), standing in his name on the books of, represented by Certificate No. herewith, and does hereby irrevocably constitute and appoint the Secretary of the Company attorney to transfer the said stock in the books of the Company with full power of substitution.
DATED:
By: |
(Signature) |
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EXHIBIT D
ELECTION UNDER SECTION 83(b)
OF THE INTERNAL REVENUE CODE OF 1986
The undersigned taxpayer hereby elects, pursuant to the Internal Revenue Code, to include in gross income for calendar year the amount of any compensation taxable in connection with the taxpayers receipt of the property described below:
1. The name, address, taxpayer identification number and taxable year of the undersigned are:
TAXPAYERS NAME |
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TAXPAYERS SOCIAL SECURITY NO.: |
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TAXABLE YEAR: |
Calendar Year | |
ADDRESS: |
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2. The property which is the subject of this election is shares of common stock of Adicet Bio, Inc.
3. The property was transferred to the undersigned on , .
4. The property is subject to the following restrictions: The property is subject to a repurchase right pursuant to which the issuer has the right to acquire the property at the lesser of the original purchase price or the fair market value of the property if for any reason taxpayers employment or service with the issuer is terminated. The issuers repurchase right lapses in a series of periodic installments.
5. The fair market value of the property at the time of transfer (determined without regard to any restriction other than a restriction which by its terms will never lapse) is: $ per share x shares = $ .
6. The undersigned paid $ per share x shares for the property transferred or a total of $ .
The undersigned has submitted a copy of this statement to the person for whom the services were performed in connection with the undersigneds receipt of the above-described property. The undersigned taxpayer is the person performing the services in connection with the transfer of said property.
The undersigned will file this election with the Internal Revenue Service office to which the undersigned files the undersigneds annual income tax return not later than 30 days after the date of transfer of the property. Additionally, the undersigned will include a copy of the election with the undersigneds income tax return for the taxable year in which the property is transferred.
Dated: |
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Taxpayer |
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The property described in the above Section 83(b) election is comprised of shares of common stock acquired pursuant to the exercise of an incentive stock option under Section 422 of the Internal Revenue Code (the Code). Accordingly, the purpose of this election is to have the alternative minimum taxable income attributable to the purchased shares measured by the amount by which the fair market value of such shares at the time of their transfer to the Taxpayer exceeds the purchase price paid for the shares. In the absence of this election, such alternative minimum taxable income would be measured by the spread between the fair market value of the purchased shares and the purchase price which exists on the various lapse dates in effect for the forfeiture restrictions applicable to such shares.
THIS PAGE 2 IS TO BE ATTACHED TO ANY SECTION 83(b) ELECTION FILED IN CONNECTION WITH THE EXERCISE OF AN INCENTIVE STOCK OPTION.
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Exhibit 10.16
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
NOTICE OF STOCK OPTION AWARD
Grantees Name and Address: |
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You (the Grantee) have been granted an option to purchase shares of Common Stock, subject to the terms and conditions of this Notice of Stock Option Award (the Notice), the Adicet Bio, Inc. 2015 Stock Incentive Plan, as amended from time to time (the Plan) and the Stock Option Award Agreement (the Option Agreement) attached hereto, as follows. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Notice.
Award Number |
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Date of Award |
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Vesting Commencement Date |
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Exercise Price per Share |
$ | |||
Total Number of Shares Subject to the Option (the Shares) |
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Total Exercise Price |
$ | |||
Type of Option: |
Incentive Stock Option | |||
Non-Qualified Stock Option | ||||
Expiration Date: |
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Post-Termination Exercise Period: Three (3) Months |
Vesting Schedule:
Subject to the Grantees Continuous Service and the other limitations set forth in this Notice, the Plan and the Option Agreement, the Option may be exercised, in whole or in part, in accordance with the following schedule:
[25% of the Shares subject to the Option shall vest twelve (12) months after the Vesting Commencement Date, and 1/36th of the remaining unvested Shares subject to the Option shall vest on each of the next thirty-six (36) monthly anniversaries of the Vesting Commencement Date thereafter.]1
[1/48th of the Shares subject to the Option shall vest on each monthly anniversary of the Vesting Commencement Date.]2
1 | Insert for new-hire grants. |
2 | Insert for refresh grants. |
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During any authorized leave of absence, the vesting of the Shares shall be suspended after the leave of absence exceeds a period of three (3) months. Vesting of the Shares shall resume upon the Grantees termination of the leave of absence and return to Continuous Service. The Vesting Schedule of the Shares shall be extended by the length of the suspension.
In the event of termination of the Grantees Continuous Service for Cause, the Grantees right to exercise the Option shall terminate concurrently with the termination of the Grantees Continuous Service, except as otherwise determined by the Administrator.
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IN WITNESS WHEREOF, the Company and the Grantee have executed this Notice and agree that the Option is to be governed by the terms and conditions of this Notice, the Plan, and the Option Agreement.
ADICET BIO, INC., | ||
a Delaware corporation | ||
By: |
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Name: |
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Title: |
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THE GRANTEE ACKNOWLEDGES AND AGREES THAT THE SHARES SUBJECT TO THE OPTION SHALL VEST, IF AT ALL, ONLY DURING THE PERIOD OF THE GRANTEES CONTINUOUS SERVICE (NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED THE OPTION OR ACQUIRING SHARES HEREUNDER). THE GRANTEE FURTHER ACKNOWLEDGES AND AGREES THAT NOTHING IN THIS NOTICE, THE OPTION AGREEMENT, OR THE PLAN SHALL CONFER UPON THE GRANTEE ANY RIGHT WITH RESPECT TO FUTURE AWARDS OR CONTINUATION OF THE GRANTEES CONTINUOUS SERVICE, NOR SHALL IT INTERFERE IN ANY WAY WITH THE GRANTEES RIGHT OR THE RIGHT OF THE COMPANY OR RELATED ENTITY TO WHICH THE GRANTEE PROVIDES SERVICES TO TERMINATE THE GRANTEES CONTINUOUS SERVICE, WITH OR WITHOUT CAUSE, AND WITH OR WITHOUT NOTICE. THE GRANTEE ACKNOWLEDGES THAT UNLESS THE GRANTEE HAS A WRITTEN EMPLOYMENT AGREEMENT WITH THE COMPANY TO THE CONTRARY, THE GRANTEES STATUS IS AT WILL.
The Grantee acknowledges receipt of a copy of the Plan and the Option Agreement, and represents that he or she is familiar with the terms and provisions thereof, and hereby accepts the Option subject to all of the terms and provisions hereof and thereof. The Grantee has reviewed this Notice, the Plan, and the Option Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Notice, and fully understands all provisions of this Notice, the Plan and the Option Agreement. The Grantee hereby agrees that all questions of interpretation and administration relating to this Notice, the Plan and the Option Agreement shall be resolved by the Administrator in accordance with Section 18 of the Option Agreement. The Grantee further agrees to the venue selection in accordance with Section 19 of the Option Agreement. The Grantee further agrees to notify the Company upon any change in the residence address indicated in this Notice.
Dated: | Signed: | |
Grantee |
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Award Number:
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
STOCK OPTION AWARD AGREEMENT
1. Grant of Option. Adicet Bio, Inc., a Delaware corporation (the Company), hereby grants to the Grantee (the Grantee) named in the Notice of Stock Option Award (the Notice), an option (the Option) to purchase the Total Number of Shares of Common Stock subject to the Option (the Shares) set forth in the Notice, at the Exercise Price per Share set forth in the Notice (the Exercise Price) subject to the terms and provisions of the Notice, this Stock Option Award Agreement (the Option Agreement) and the Companys 2015 Stock Incentive Plan, as amended from time to time (the Plan), which are incorporated herein by reference. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Option Agreement.
If designated in the Notice as an Incentive Stock Option, the Option is intended to qualify as an Incentive Stock Option as defined in Section 422 of the Code. However, notwithstanding such designation, the Option will qualify as an Incentive Stock Option under the Code only to the extent the $100,000 dollar limitation of Section 422(d) of the Code is not exceeded. The $100,000 limitation of Section 422(d) of the Code is calculated based on the aggregate Fair Market Value of the Shares subject to options designated as Incentive Stock Options which become exercisable for the first time by the Grantee during any calendar year (under all plans of the Company or any Parent or Subsidiary of the Company). For purposes of this calculation, Incentive Stock Options shall be taken into account in the order in which they were granted, and the Fair Market Value of the shares subject to such options shall be determined as of the grant date of the relevant option.
2. Exercise of Option.
(a) Right to Exercise. The Option shall be exercisable during its term in accordance with the Vesting Schedule set out in the Notice and with the applicable provisions of the Plan and this Option Agreement. The Option shall be subject to the provisions of Section 11 of the Plan relating to the exercisability or termination of the Option in the event of a Corporate Transaction. The Grantee shall be subject to reasonable limitations on the number of requested exercises during any monthly or weekly period as determined by the Administrator. In no event shall the Company issue fractional Shares.
(b) Method of Exercise. The Option shall be exercisable by delivery of an exercise notice (a form of which is attached as Exhibit A) or by such other procedure as specified from time to time by the Administrator which shall state the election to exercise the Option, the whole number of Shares in respect of which the Option is being exercised, and such other provisions as may be required by the Administrator. The exercise notice shall be delivered in person, by certified mail, or by such other method (including electronic transmission) as determined from time to time by the Administrator to the Company accompanied by payment of the Exercise Price and all applicable income and employment taxes required to be withheld. The
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Option shall be deemed to be exercised upon receipt by the Company of such notice accompanied by the Exercise Price and all applicable withholding taxes, which, to the extent selected, shall be deemed to be satisfied by use of the broker-dealer sale and remittance procedure to pay the Exercise Price provided in Section 4(d) below to the extent such procedure is available to the Grantee at the time of exercise and such an exercise would not violate any Applicable Law.
(c) Taxes. No Shares will be delivered to the Grantee or other person pursuant to the exercise of the Option until the Grantee or other person has made arrangements acceptable to the Administrator for the satisfaction of applicable income tax and employment tax withholding obligations, including, without limitation, such other tax obligations of the Grantee incident to the receipt of Shares. Upon exercise of the Option, the Company or the Grantees employer may offset or withhold (from any amount owed by the Company or the Grantees employer to the Grantee) or collect from the Grantee or other person an amount sufficient to satisfy such tax withholding obligations. Furthermore, in the event of any determination that the Company has failed to withhold a sum sufficient to pay all withholding taxes due in connection with the Option, the Grantee agrees to pay the Company the amount of such deficiency in cash within five (5) days after receiving a written demand from the Company to do so, whether or not the Grantee is an employee of the Company at that time.
3. Grantees Representations. The Grantee understands that neither the Option nor the Shares exercisable pursuant to the Option have been registered under the Securities Act of 1933, as amended or any United States securities laws. In the event the Shares purchasable pursuant to the exercise of the Option have not been registered under the Securities Act of 1933, as amended, at the time the Option is exercised, the Grantee shall, if requested by the Company, concurrently with the exercise of all or any portion of the Option, deliver to the Company his or her Investment Representation Statement in the form attached hereto as Exhibit B.
4. Method of Payment. Payment of the Exercise Price shall be made by any of the following, or a combination thereof, at the election of the Grantee; provided, however, that such exercise method does not then violate any Applicable Law and, provided further, that the portion of the Exercise Price equal to the par value of the Shares must be paid in cash or other legal consideration permitted by the Delaware General Corporation Law:
(a) cash;
(b) check;
(c) if the exercise occurs on or after the Registration Date, surrender of Shares held for the requisite period, if any, necessary to avoid a charge to the Companys earnings for financial reporting purposes, or delivery of a properly executed form of attestation of ownership of Shares as the Administrator may require which have a Fair Market Value on the date of surrender or attestation equal to the aggregate Exercise Price of the Shares as to which the Option is being exercised; or
(d) if the exercise occurs on or after the Registration Date, payment through a broker-dealer sale and remittance procedure pursuant to which the Grantee (i) shall provide
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written instructions to a Company-designated brokerage firm to effect the immediate sale of some or all of the purchased Shares and remit to the Company sufficient funds to cover the aggregate exercise price payable for the purchased Shares and (ii) shall provide written directives to the Company to deliver the certificates for the purchased Shares directly to such brokerage firm in order to complete the sale transaction.
5. Restrictions on Exercise. The Option may not be exercised if the issuance of the Shares subject to the Option upon such exercise would constitute a violation of any Applicable Laws. In addition, the Option may not be exercised until such time as the Plan has been approved by the stockholders of the Company. If the exercise of the Option within the applicable time periods set forth in Sections 6, 7 and 8 of this Option Agreement is prevented by the provisions of this Section 5, the Option shall remain exercisable until one (1) month after the date the Grantee is notified by the Company that the Option is exercisable, but in any event no later than the Expiration Date set forth in the Notice.
6. Termination or Change of Continuous Service. In the event the Grantees Continuous Service terminates, other than for Cause, the Grantee may, but only during the Post-Termination Exercise Period, exercise the portion of the Option that was vested at the date of such termination (the Termination Date). The Post-Termination Exercise Period shall commence on the Termination Date. In the event of termination of the Grantees Continuous Service for Cause, the Grantees right to exercise the Option shall, except as otherwise determined by the Administrator, terminate concurrently with the termination of the Grantees Continuous Service (also the Termination Date). In no event, however, shall the Option be exercised later than the Expiration Date set forth in the Notice. In the event of the Grantees change in status from Employee, Director or Consultant to any other status of Employee, Director or Consultant, the Option shall remain in effect and the Option shall continue to vest in accordance with the Vesting Schedule set forth in the Notice; provided, however, with respect to any Incentive Stock Option that shall remain in effect after a change in status from Employee to Director or Consultant, such Incentive Stock Option shall cease to be treated as an Incentive Stock Option and shall be treated as a Non-Qualified Stock Option on the day three (3) months and one (1) day following such change in status. Except as provided in Sections 7 and 8 below, to the extent that the Option was unvested on the Termination Date, or if the Grantee does not exercise the vested portion of the Option within the Post-Termination Exercise Period, the Option shall terminate.
7. Disability of Grantee. In the event the Grantees Continuous Service terminates as a result of his or her Disability, the Grantee may, but only within twelve (12) months commencing on the Termination Date (but in no event later than the Expiration Date), exercise the portion of the Option that was vested on the Termination Date; provided, however, that if such Disability is not a disability as such term is defined in Section 22(e)(3) of the Code and the Option is an Incentive Stock Option, such Incentive Stock Option shall cease to be treated as an Incentive Stock Option and shall be treated as a Non-Qualified Stock Option on the day three (3) months and one (1) day following the Termination Date. To the extent that the Option was unvested on the Termination Date, or if the Grantee does not exercise the vested portion of the Option within the time specified herein, the Option shall terminate. Section 22(e)(3) of the Code provides that an individual is permanently and totally disabled if he or she is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than twelve (12) months.
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8. Death of Grantee. In the event of the termination of the Grantees Continuous Service as a result of his or her death, or in the event of the Grantees death during the Post-Termination Exercise Period or during the twelve (12) month period following the Grantees termination of Continuous Service as a result of his or her Disability, the person who acquired the right to exercise the Option pursuant to Section 9 may exercise the portion of the Option that was vested at the date of termination within twelve (12) months commencing on the date of death (but in no event later than the Expiration Date). To the extent that the Option was unvested on the date of death, or if the vested portion of the Option is not exercised within the time specified herein, the Option shall terminate.
9. Transferability of Option. The Option, if an Incentive Stock Option, may not be transferred in any manner other than by will or by the laws of descent and distribution and may be exercised during the lifetime of the Grantee only by the Grantee. The Option, if a Non-Qualified Stock Option, may not be transferred in any manner other than by will or by the laws of descent and distribution; provided, however, that a Non-Qualified Stock Option may be transferred during the lifetime of the Grantee by gift or pursuant to a domestic relations order to members of the Grantees Immediate Family to the extent and in the manner determined by the Administrator. Notwithstanding the foregoing, the Grantee may designate one or more beneficiaries of the Grantees Incentive Stock Option or Non-Qualified Stock Option in the event of the Grantees death on a beneficiary designation form provided by the Administrator. Following the death of the Grantee, the Option, to the extent provided in Section 8, may be exercised (a) by the person or persons designated under the deceased Grantees beneficiary designation or (b) in the absence of an effectively designated beneficiary, by the Grantees legal representative or by any person empowered to do so under the deceased Grantees will or under the then applicable laws of descent and distribution. The terms of the Option shall be binding upon the executors, administrators, heirs, successors and transferees of the Grantee.
10. Term of Option. The Option must be exercised no later than the Expiration Date set forth in the Notice or such earlier date as otherwise provided herein. After the Expiration Date or such earlier date, the Option shall be of no further force or effect and may not be exercised.
11. Companys Right of First Refusal. The Grantee acknowledges and agrees that the Shares are subject to a right of first refusal (Right of First Refusal) as set forth in the Bylaws of the Company, which Right of First Refusal is incorporated herein by reference irrespective of whether the Bylaws are amended at some future date to remove the Right of First Refusal therefrom, and that, except in compliance with such Right of First Refusal, neither the Grantee nor a transferee (either being sometimes referred to herein as the Holder) shall sell, hypothecate, encumber or otherwise transfer any Shares or any right or interest therein.
12. Stop-Transfer Notices. In order to ensure compliance with the restrictions on transfer set forth in this Option Agreement, the Notice or the Plan, the Company may issue appropriate stop transfer instructions to its transfer agent, if any, and, if the Company transfers its own securities, it may make appropriate notations to the same effect in its own records.
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13. Refusal to Transfer. The Company shall not be required (i) to transfer on its books any Shares that have been sold or otherwise transferred in violation of any of the provisions of this Option Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.
14. Tax Consequences.
(a) The Grantee may incur tax liability as a result of the Grantees purchase or disposition of the Shares. THE GRANTEE SHOULD CONSULT A TAX ADVISER BEFORE EXERCISING THE OPTION OR DISPOSING OF THE SHARES.
(b) Notwithstanding the Companys good faith determination of the Fair Market Value of the Companys Common Stock for purposes of determining the Exercise Price Per Share of the Option as set forth in the Notice, the taxing authorities may assert that the Fair Market Value of the Common Stock on the Date of Award was greater than the Exercise Price Per Share. If designated in the Notice as an Incentive Stock Option, the Option may fail to qualify as an Incentive Stock Option if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award. In addition, under Section 409A of the Code, if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award, the Option may be treated as a form of deferred compensation and the Grantee may be subject to an acceleration of income recognition, an additional 20% tax, plus interest and possible penalties. The Company makes no representation that the Option will comply with Section 409A of the Code and makes no undertaking to prevent Section 409A of the Code from applying to the Option or to mitigate its effects on any deferrals or payments made in respect of the Option. The Grantee is encouraged to consult a tax adviser regarding the potential impact of Section 409A of the Code.
15. Lock-Up Agreement.
(a) Agreement. The Grantee, if requested by the Company and the lead underwriter of any public offering of the Common Stock (the Lead Underwriter), hereby irrevocably agrees not to sell, contract to sell, grant any option to purchase, transfer the economic risk of ownership in, make any short sale of, pledge or otherwise transfer or dispose of any interest in any Common Stock or any securities convertible into or exchangeable or exercisable for or any other rights to purchase or acquire Common Stock (except Common Stock included in such public offering or acquired on the public market after such offering) during the 180-day period following the effective date of a registration statement of the Company filed under the Securities Act of 1933, as amended, or such shorter or longer period of time as the Lead Underwriter shall specify. The Grantee further agrees to sign such documents as may be requested by the Lead Underwriter to effect the foregoing and agrees that the Company may impose stop-transfer instructions with respect to such Common Stock subject to the lock-up period until the end of such period. The Company and the Grantee acknowledge that each Lead Underwriter of a public offering of the Companys stock, during the period of such offering and for the lock-up period thereafter, is an intended beneficiary of this Section 15.
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(b) No Amendment Without Consent of Underwriter. During the period from identification of a Lead Underwriter in connection with any public offering of the Companys Common Stock until the earlier of (i) the expiration of the lock-up period specified in Section 15(a) in connection with such offering or (ii) the abandonment of such offering by the Company and the Lead Underwriter, the provisions of this Section 15 may not be amended or waived except with the consent of the Lead Underwriter.
16. Entire Agreement: Governing Law. The Notice, the Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Grantee with respect to the subject matter hereof, and may not be modified adversely to the Grantees interest except by means of a writing signed by the Company and the Grantee. Nothing in the Notice, the Plan and this Option Agreement (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties. The Notice, the Plan and this Option Agreement are to be construed in accordance with and governed by the internal laws of the State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California to the rights and duties of the parties. Should any provision of the Notice, the Plan or this Option Agreement be determined to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
17. Construction. The captions used in the Notice and this Option Agreement are inserted for convenience and shall not be deemed a part of the Option for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
18. Administration and Interpretation. Any question or dispute regarding the administration or interpretation of the Notice, the Plan or this Option Agreement shall be submitted by the Grantee or by the Company to the Administrator. The resolution of such question or dispute by the Administrator shall be final and binding on all persons.
19. Venue. The Company, the Grantee, and the Grantees assignees pursuant to Section 9 (the parties) agree that any suit, action, or proceeding arising out of or relating to the Notice, the Plan or this Option Agreement shall be brought in the United States District Court for the Northern District of California (or should such court lack jurisdiction to hear such action, suit or proceeding, in a California state court in the County of San Francisco) and that the parties shall submit to the jurisdiction of such court. The parties irrevocably waive, to the fullest extent permitted by law, any objection the party may have to the laying of venue for any such suit, action or proceeding brought in such court. If any one or more provisions of this Section 19 shall for any reason be held invalid or unenforceable, it is the specific intent of the parties that such provisions shall be modified to the minimum extent necessary to make it or its application valid and enforceable.
20. Notices. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an
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internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown in these instruments, or to such other address as such party may designate in writing from time to time to the other party.
21. Confidentiality. To the extent required by Applicable Law, the Company shall provide to the Grantee, during the period the Option is outstanding, copies of financial statements of the Company at least annually. The Grantee understands and agrees that such financial statements are confidential and shall not be disclosed by the Grantee, to any entity or person, for any reason, at any time, without the prior written consent of the Company, unless required by law. If disclosure of such financial statements is required by law, whether through subpoena, request for production, deposition, or otherwise, the Grantee promptly shall provide written notice to Company, including copies of the subpoena, request for production, deposition, or otherwise, within five (5) business days of their receipt by the Grantee and prior to any disclosure so as to provide Company an opportunity to move to quash or otherwise to oppose the disclosure. Notwithstanding the foregoing, the Grantee may disclose the terms of such financial statements to his or her spouse or domestic partner, and for legitimate business reasons, to legal, financial, and tax advisors.
END OF AGREEMENT
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EXHIBIT A
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
EXERCISE NOTICE
[COMPANY ADDRESS]
Attention: Secretary
1. Effective as of today, , the undersigned (the Grantee) hereby elects to exercise the Grantees option to purchase shares of the Common Stock (the Shares) of Adicet Bio, Inc., (the Company) under and pursuant to the Companys 2015 Stock Incentive Plan, as amended from time to time (the Plan) and the [ ] Incentive [ ] Non-Qualified Stock Option Award Agreement (the Option Agreement) and Notice of Stock Option Award (the Notice) dated . Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Exercise Notice.
2. Representations of the Grantee. The Grantee acknowledges that the Grantee has received, read and understood the Notice, the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
3. Rights as Stockholder. Until the stock certificate evidencing such Shares is issued (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to vote or receive dividends or any other rights as a stockholder shall exist with respect to the Shares, notwithstanding the exercise of the Option. The Company shall issue (or cause to be issued) such stock certificate promptly after the Option is exercised. No adjustment will be made for a dividend or other right for which the record date is prior to the date the stock certificate is issued, except as provided in Section 10 of the Plan.
The Grantee shall enjoy rights as a stockholder until such time as the Grantee disposes of the Shares or the Company and/or its assignee(s) exercises the Right of First Refusal. Upon such exercise, the Grantee shall have no further rights as a holder of the Shares so purchased except the right to receive payment for the Shares so purchased in accordance with the provisions of the Option Agreement, and the Grantee shall forthwith cause the certificate(s) evidencing the Shares so purchased to be surrendered to the Company for transfer or cancellation.
4. Delivery of Payment. The Grantee herewith delivers to the Company the full Exercise Price for the Shares, which, to the extent selected, shall be deemed to be satisfied by use of the broker-dealer sale and remittance procedure to pay the Exercise Price provided in Section 4(d) of the Option Agreement.
5. Tax Consultation. The Grantee understands that the Grantee may suffer adverse tax consequences as a result of the Grantees purchase or disposition of the Shares. The Grantee represents that the Grantee has consulted with any tax consultants the Grantee deems advisable in connection with the purchase or disposition of the Shares and that the Grantee is not relying on the Company for any tax advice.
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6. Taxes. The Grantee agrees to satisfy all applicable federal, state and local income and employment tax withholding obligations and herewith delivers to the Company the full amount of such obligations or has made arrangements acceptable to the Company to satisfy such obligations. In the case of an Incentive Stock Option, the Grantee also agrees, as partial consideration for the designation of the Option as an Incentive Stock Option, to notify the Company in writing within thirty (30) days of any disposition of any shares acquired by exercise of the Option if such disposition occurs within two (2) years from the Date of Award or within one (1) year from the date the Shares were transferred to the Grantee.
7. Restrictive Legends. The Grantee understands and agrees that the Company shall cause the legends set forth below or legends substantially equivalent thereto, to be placed upon any certificate(s) evidencing ownership of the Shares together with any other legends that may be required by the Company or by state or federal securities laws:
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE ACT) OR ANY STATE SECURITIES LAWS AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER THE ACT OR, IN THE OPINION OF COUNSEL SATISFACTORY TO THE ISSUER OF THESE SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS IN COMPLIANCE THEREWITH.
THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER AND A RIGHT OF FIRST REFUSAL HELD BY THE ISSUER OR ITS ASSIGNEE(S) AS SET FORTH IN THE OPTION AGREEMENT BETWEEN THE ISSUER AND THE ORIGINAL HOLDER OF THESE SHARES, A COPY OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE ISSUER. SUCH TRANSFER RESTRICTIONS AND RIGHT OF FIRST REFUSAL ARE BINDING ON TRANSFEREES OF THESE SHARES.
8. Successors and Assigns. The Company may assign any of its rights under this Exercise Notice to single or multiple assignees, and this agreement shall inure to the benefit of the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth, this Exercise Notice shall be binding upon the Grantee and his or her heirs, executors, administrators, successors and assigns.
9. Construction. The captions used in this Exercise Notice are inserted for convenience and shall not be deemed a part of this agreement for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
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10. Administration and Interpretation. The Grantee hereby agrees that any question or dispute regarding the administration or interpretation of this Exercise Notice shall be submitted by the Grantee or by the Company to the Administrator. The resolution of such question or dispute by the Administrator shall be final and binding on all persons.
11. Governing Law; Severability. This Exercise Notice is to be construed in accordance with and governed by the internal laws of the State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California to the rights and duties of the parties. Should any provision of this Exercise Notice be determined by a court of law to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
12. Notices. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown below beneath its signature, or to such other address as such party may designate in writing from time to time to the other party.
13. Further Instruments. The parties agree to execute such further instruments and to take such further action as may be reasonably necessary to carry out the purposes and intent of this agreement.
14. Entire Agreement. The Notice, the Plan and the Option Agreement are incorporated herein by reference and together with this Exercise Notice constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Grantee with respect to the subject matter hereof, and may not be modified adversely to the Grantees interest except by means of a writing signed by the Company and the Grantee. Nothing in the Notice, the Plan, the Option Agreement and this Exercise Notice (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties.
[Remainder of Page Left Intentionally Blank]
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Submitted by: | Accepted by: | |||||||
GRANTEE: | ADICET BIO, INC. | |||||||
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EXHIBIT B
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
INVESTMENT REPRESENTATION STATEMENT
GRANTEE: | ||
COMPANY: | ADICET BIO, INC. | |
SECURITY: | COMMON STOCK | |
NUMBER OF SHARES: | ||
DATE: |
In connection with the purchase of the above-listed Securities, the undersigned Grantee represents to the Company the following:
(a) Grantee is aware of the Companys business affairs and financial condition and has acquired sufficient information about the Company to reach an informed and knowledgeable decision to acquire the Securities. Grantee is acquiring these Securities for investment for Grantees own account only and not with a view to, or for resale in connection with, any distribution thereof within the meaning of the Securities Act of 1933, as amended (the Securities Act).
(b) Grantee acknowledges and understands that the Securities constitute restricted securities under the Securities Act and have not been registered under the Securities Act in reliance upon a specific exemption therefrom, which exemption depends upon among other things, the bona fide nature of Grantees investment intent as expressed herein. Grantee further understands that the Securities must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available. Grantee further acknowledges and understands that the Company is under no obligation to register the Securities. Grantee understands that the certificate evidencing the Securities will be imprinted with a legend which prohibits the transfer of the Securities unless they are registered or such registration is not required in the opinion of counsel satisfactory to the Company.
(c) Grantee is familiar with the provisions of Rule 701 and Rule 144, each promulgated under the Securities Act, which, in substance, permit limited public resale of restricted securities acquired, directly or indirectly from the issuer thereof, in a non-public offering subject to the satisfaction of certain conditions. Rule 701 provides that if the issuer qualifies under Rule 701 at the time of the grant of the Option to the Grantee, the exercise will be exempt from registration under the Securities Act. In the event the Company becomes subject to the reporting requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, ninety (90) days thereafter (or such longer period as any market stand-off agreement may require) the Securities exempt under Rule 701 may be resold, except in the case of affiliates, such Securities may be resold subject to the satisfaction of the applicable conditions specified by Rule 144, including: (1) the availability of certain public information about the Company, (2) the amount of Securities being sold during any three month period not exceeding specified limitations, (3) the resale being made in an unsolicited brokers transaction, in transactions directly with a market maker or riskless principal transactions (as said terms are defined under the Securities Exchange Act of 1934) and (4) the timely filing of a Form 144, if applicable.
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In the event that the Company does not qualify under Rule 701 at the time of the grant of the Option, then the Securities may be resold in certain limited circumstances subject to the provisions of Rule 144, which may require: the availability of current public information about the Company; the resale to occur more than a specified period after the purchase and full payment (within the meaning of Rule 144) for the Securities; and, in the case of the sale of Securities by an affiliate, the satisfaction of the conditions set forth in sections (2), (3) and (4) of the paragraph immediately above.
(d) Grantee further understands that in the event all of the applicable requirements of Rule 701 or 144 are not satisfied, registration under the Securities Act, compliance with Regulation A, or some other registration exemption will be required; and that, notwithstanding the fact that Rules 144 and 701 are not exclusive, the Staff of the Securities and Exchange Commission has expressed its opinion that persons proposing to sell private placement securities other than in a registered offering and otherwise than pursuant to Rules 144 or 701 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales, and that such persons and their respective brokers who participate in such transactions do so at their own risk. Grantee understands that no assurances can be given that any such other registration exemption will be available in such event.
(e) Grantee represents that Grantee is a resident of the state of .
Signature of Grantee: | ||
By: |
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Date: |
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Exhibit 10.17
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
NOTICE OF STOCK OPTION AWARD
Grantees Name and Address: |
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You (the Grantee) have been granted an option to purchase shares of Common Stock, subject to the terms and conditions of this Notice of Stock Option Award (the Notice), the Adicet Bio, Inc. 2015 Stock Incentive Plan, as amended from time to time (the Plan), the Adicet Bio, Inc. Israeli Sub-Plan to the Plan (the Israeli Sub-Plan) and the Stock Option Award Agreement (the Option Agreement) attached hereto, as follows. Unless otherwise defined herein, the terms defined in the Plan or in the Israeli Sub-Plan, as the case may be, shall have the same defined meanings in this Notice.
Award Number |
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Date of Award |
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Vesting Commencement Date |
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Exercise Price per Share |
$ | |||
Total Number of Shares Subject to the Option (the Shares) |
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Total Exercise Price |
$ | |||
Tax Route: |
Section 3(i) of the Ordinance | |||
Expiration Date: |
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Post-Termination Exercise Period: |
Three (3) Months |
Vesting Schedule:
Subject to the Grantees Continuous Service and the other limitations set forth in this Notice, the Plan and the Option Agreement, the Option may be exercised, in whole or in part, in accordance with the following schedule:
[25% of the Shares subject to the Option shall vest twelve (12) months after the Vesting Commencement Date, and 1/36th of the remaining unvested Shares subject to the Option shall vest on each of the next thirty-six (36) monthly anniversaries of the Vesting Commencement Date thereafter.]1
1 | Insert for new-hire grants. |
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[1/48th of the Shares subject to the Option shall vest on each monthly anniversary of the Vesting Commencement Date.]2
During any authorized leave of absence, the vesting of the Shares shall be suspended after the leave of absence exceeds a period of three (3) months. Vesting of the Shares shall resume upon the Grantees termination of the leave of absence and return to Continuous Service. The Vesting Schedule of the Shares shall be extended by the length of the suspension.
In the event of termination of the Grantees Continuous Service for Cause, the Grantees right to exercise the Option shall terminate concurrently with the termination of the Grantees Continuous Service, except as otherwise determined by the Administrator.
[Remainder of Page Left Intentionally Blank]
2 | Insert for refresh grants. |
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IN WITNESS WHEREOF, the Company and the Grantee have executed this Notice and agree that the Option is to be governed by the terms and conditions of this Notice, the Plan, the Israeli Sub-Plan and the Option Agreement.
ADICET BIO, INC., | ||
a Delaware corporation | ||
By: |
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Name: |
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Title: |
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[Remainder of Page Left Intentionally Blank]
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THE GRANTEE ACKNOWLEDGES AND AGREES THAT THE SHARES SUBJECT TO THE OPTION SHALL VEST, IF AT ALL, ONLY DURING THE PERIOD OF THE GRANTEES CONTINUOUS SERVICE (NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED THE OPTION OR ACQUIRING SHARES HEREUNDER). THE GRANTEE FURTHER ACKNOWLEDGES AND AGREES THAT NOTHING IN THIS NOTICE, THE OPTION AGREEMENT, OR THE PLAN (INCLUDING THE ISRAELI SUB-PLAN) SHALL CONFER UPON THE GRANTEE ANY RIGHT WITH RESPECT TO FUTURE AWARDS OR CONTINUATION OF THE GRANTEES CONTINUOUS SERVICE, NOR SHALL IT INTERFERE IN ANY WAY WITH THE GRANTEES RIGHT OR THE RIGHT OF THE COMPANY OR RELATED ENTITY TO WHICH THE GRANTEE PROVIDES SERVICES TO TERMINATE THE GRANTEES CONTINUOUS SERVICE, WITH OR WITHOUT CAUSE, AND WITH OR WITHOUT NOTICE. THE GRANTEE ACKNOWLEDGES THAT UNLESS THE GRANTEE HAS A WRITTEN EMPLOYMENT AGREEMENT WITH THE COMPANY TO THE CONTRARY, THE GRANTEES STATUS IS AT WILL.
The Grantee acknowledges receipt of a copy of the Plan, the Israeli Sub-Plan, the trust agreement between the Company and the Trustee (the Trust Agreement), the Option Agreement, and represents that he or she is familiar with the terms and provisions thereof, and hereby accepts the Option subject to all of the terms and provisions hereof and thereof. The Grantee has reviewed this Notice, the Plan, the Israeli Sub-Plan and the Option Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Notice, and fully understands all provisions of this Notice, the Plan, the Israeli Sub-Plan and the Option Agreement. The Grantee hereby agrees that all questions of interpretation and administration relating to this Notice, the Plan and the Option Agreement shall be resolved by the Administrator in accordance with Section 18 of the Option Agreement. The Grantee further agrees to the venue selection in accordance with Section 19 of the Option Agreement. The Grantee further agrees to notify the Company upon any change in the residence address indicated in this Notice.
Grantee represents that Grantee is a resident of the State of Israel for tax purposes on the date of allocation and agrees to notify the Company upon any change in the residence address indicated above and acknowledges that if Grantee ceases to be an Israeli resident or if Grantees engagement with the Company is terminated, the Option and/or Shares shall remain subject to Section 3(i) of the Ordinance, the Trust Agreement, the Plan, the Israeli Sub-Plan and this Option Agreement.
Grantee declares that she/he is familiar with Section 3(i) of the Ordinance and the regulations and rules promulgated thereunder, including without limitations the provisions of the applicable tax route, and agrees to comply with such provisions, as amended from time to time. The Grantee authorizes the Company to provide the trustee with any information required for the purpose of executing its obligations under the Ordinance, including without limitation information about the Option and the Shares, income tax rates, salary bank account, contact details and identification number. The Grantee warrants and undertakes that at the time of grant of the Option herein, or as a consequence of the grant, the Grantee is not and will not become a holder of a controlling interest in the Company, as such term is defined in Section 32(9) of the Ordinance.
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Dated: | Signed: |
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Grantee |
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Award Number:
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
STOCK OPTION AWARD AGREEMENT
1. Grant of Option. Adicet Bio, Inc., a Delaware corporation (the Company), hereby grants to the Grantee (the Grantee) named in the Notice of Stock Option Award (the Notice), an option (the Option) to purchase the Total Number of Shares of Common Stock subject to the Option (the Shares) set forth in the Notice, at the Exercise Price per Share set forth in the Notice (the Exercise Price) subject to the terms and provisions of the Notice, this Stock Option Award Agreement (the Option Agreement) and the Companys 2015 Stock Incentive Plan, as amended from time to time (the Plan) and the Adicet Bio, Inc. Israeli Sub-Plan to the Plan (the Israeli Sub-Plan), which are incorporated herein by reference. Unless otherwise defined herein, the terms defined in the Plan and/or in the Israeli Sub-Plan, as the case may be, shall have the same defined meanings in this Option Agreement.
Your Option shall be issued to a trustee. The trustee will hold in trust the Options, the Shares and all other securities received following any exercise or realization of rights, including bonus stock, dividend (whether in cash or in kind), or other rights issued or distributed in connection with the Option or the Shares, until the full payment of all requisite taxes by you, as shall be determined by the Company and the trustee in their sole discretion.
2. Exercise of Option.
(a) Right to Exercise. The Option shall be exercisable during its term in accordance with the Vesting Schedule set out in the Notice and with the applicable provisions of the Plan and this Option Agreement. The Option shall be subject to the provisions of Section 11 of the Plan relating to the exercisability or termination of the Option in the event of a Corporate Transaction. The Grantee shall be subject to reasonable limitations on the number of requested exercises during any monthly or weekly period as determined by the Administrator. In no event shall the Company issue fractional Shares.
(b) Method of Exercise. The Option shall be exercisable by delivery of an exercise notice (a form of which is attached as Exhibit A) or by such other procedure as specified from time to time by the Administrator which shall state the election to exercise the Option, the whole number of Shares in respect of which the Option is being exercised, and such other provisions as may be required by the Administrator. The exercise notice shall be delivered in person, by certified mail, or by such other method (including electronic transmission) as determined from time to time by the Administrator to the Company accompanied by payment of the Exercise Price and all applicable income and employment taxes required to be withheld. The Option shall be deemed to be exercised upon receipt by the Company of such notice accompanied by the Exercise Price and all applicable withholding taxes, which, to the extent selected, shall be deemed to be satisfied by use of the broker-dealer sale and remittance procedure to pay the Exercise Price provided in Section 4(d) below to the extent such procedure is available to the Grantee at the time of exercise and such an exercise would not violate any Applicable Law.
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(c) Taxes. Subject to the approval of the Israeli Sub-Plan by the ITA, you shall be taxed in Israel in accordance with the provisions under Section 3(i) of the Ordinance, including the provisions the regulations and any tax ruling or agreement obtained by the Company with regard to the Plan. No Shares will be delivered to the Grantee or other person pursuant to the exercise of the Option until the Grantee or other person has made arrangements acceptable to the Administrator for the satisfaction of applicable income tax and employment tax withholding obligations, including, without limitation, such other tax obligations of the Grantee incident to the receipt of Shares. Upon exercise of the Option, the Company or the Grantees employer may offset or withhold (from any amount owed by the Company or the Grantees employer to the Grantee) or collect from the Grantee or other person an amount sufficient to satisfy such tax withholding obligations. Furthermore, in the event of any determination that the Company has failed to withhold a sum sufficient to pay all withholding taxes due in connection with the Option, the Grantee agrees to pay the Company the amount of such deficiency in cash within five (5) days after receiving a written demand from the Company to do so, whether or not the Grantee is an employee of the Company at that time.
3. Grantees Representations. The Grantee understands that neither the Option nor the Shares exercisable pursuant to the Option have been registered under the Securities Act of 1933, as amended or any United States securities laws. In the event the Shares purchasable pursuant to the exercise of the Option have not been registered under the Securities Act of 1933, as amended, at the time the Option is exercised, the Grantee shall, if requested by the Company, concurrently with the exercise of all or any portion of the Option, deliver to the Company his or her Investment Representation Statement in the form attached hereto as Exhibit B.
4. Method of Payment. Payment of the Exercise Price shall be made by any of the following, or a combination thereof, at the election of the Grantee; provided, however, that such exercise method does not then violate any Applicable Law (including the Ordinance) and, provided further, that the portion of the Exercise Price equal to the par value of the Shares must be paid in cash or other legal consideration permitted by the Delaware General Corporation Law:
(a) cash;
(b) check;
(c) if the exercise occurs on or after the Registration Date, surrender of Shares held for the requisite period, if any, necessary to avoid a charge to the Companys earnings for financial reporting purposes, or delivery of a properly executed form of attestation of ownership of Shares as the Administrator may require which have a Fair Market Value on the date of surrender or attestation equal to the aggregate Exercise Price of the Shares as to which the Option is being exercised; or
(d) if the exercise occurs on or after the Registration Date, payment through a broker-dealer sale and remittance procedure pursuant to which the Grantee (i) shall provide written instructions to a Company-designated brokerage firm to effect the immediate sale of
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some or all of the purchased Shares and remit to the Company sufficient funds to cover the aggregate exercise price payable for the purchased Shares and (ii) shall provide written directives to the Company to deliver the certificates for the purchased Shares directly to such brokerage firm in order to complete the sale transaction.
5. Restrictions on Exercise. The Option may not be exercised if the issuance of the Shares subject to the Option upon such exercise would constitute a violation of any Applicable Laws. In addition, the Option may not be exercised until such time as the Plan has been approved by the stockholders of the Company, and the Israeli Sub-Plan has been approved by the ITA. If the exercise of the Option within the applicable time periods set forth in Sections 6, 7 and 8 of this Option Agreement is prevented by the provisions of this Section 5, the Option shall remain exercisable until one (1) month after the date the Grantee is notified by the Company that the Option is exercisable, but in any event no later than the Expiration Date set forth in the Notice.
6. Termination or Change of Continuous Service. In the event the Grantees Continuous Service terminates, other than for Cause, the Grantee may, but only during the Post-Termination Exercise Period, exercise the portion of the Option that was vested at the date of such termination (the Termination Date). The Post-Termination Exercise Period shall commence on the Termination Date. In the event of termination of the Grantees Continuous Service for Cause, the Grantees right to exercise the Option shall, except as otherwise determined by the Administrator, terminate concurrently with the termination of the Grantees Continuous Service (also the Termination Date). In no event, however, shall the Option be exercised later than the Expiration Date set forth in the Notice. In the event of the Grantees change in status from Employee, Director or Consultant to any other status of Employee, Director or Consultant, the Option shall remain in effect and the Option shall continue to vest in accordance with the Vesting Schedule set forth in the Notice; provided, however, that the Option may be subject to a different tax route, following such change in status. Except as provided in Sections 7 and 8 below, to the extent that the Option was unvested on the Termination Date, or if the Grantee does not exercise the vested portion of the Option within the Post-Termination Exercise Period, the Option shall terminate.
7. Disability of Grantee. In the event the Grantees Continuous Service terminates as a result of his or her Disability, the Grantee may, but only within twelve (12) months commencing on the Termination Date (but in no event later than the Expiration Date), exercise the portion of the Option that was vested on the Termination Date. To the extent that the Option was unvested on the Termination Date, or if the Grantee does not exercise the vested portion of the Option within the time specified herein, the Option shall terminate. Section 22(e)(3) of the Code provides that an individual is permanently and totally disabled if he or she is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than twelve (12) months.
8. Death of Grantee. In the event of the termination of the Grantees Continuous Service as a result of his or her death, or in the event of the Grantees death during the Post-Termination Exercise Period or during the twelve (12) month period following the Grantees termination of Continuous Service as a result of his or her Disability, the person who acquired the right to exercise the Option pursuant to Section 9 may exercise the portion of the Option that
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was vested at the date of termination within twelve (12) months commencing on the date of death (but in no event later than the Expiration Date). To the extent that the Option was unvested on the date of death, or if the vested portion of the Option is not exercised within the time specified herein, the Option shall terminate.
9. Transferability of Option. Prior to the payment of the tax applicable under law, including under Section 3(i) of the Ordinance (the Applicable Tax), the Options and/or the Shares or rights arising therefrom shall not be transferable or assignable, shall not be subject to any mortgage, liens, attachment or other encumbrance, and no power or attorney or note of transfer shall be issued in respect thereof, whether such instrument enter into force immediately or at future date, excluding transfer by power of a last will or under law and all subject to the terms of the Plan and the Israeli Sub-Plan. Should the Options or Shares have been transferred pursuant to the provisions of a last testamentary instrument or under applicable law, Section 3(i) of the Ordinance shall apply to the heirs or transferees of the deceased Grantee. Notwithstanding the foregoing, the Grantee may designate one or more beneficiaries of the Grantees Option in the event of the Grantees death on a beneficiary designation form provided by the Administrator. Following the death of the Grantee, the Option, to the extent provided in Section 8, may be exercised (a) by the person or persons designated under the deceased Grantees beneficiary designation or (b) in the absence of an effectively designated beneficiary, by the Grantees legal representative or by any person empowered to do so under the deceased Grantees will or under the then applicable laws of descent and distribution. Notwithstanding the foregoing, no Option may be transferred in violation of Applicable Law, including any applicable securities exemption. The terms of the Option shall be binding upon the executors, administrators, heirs, successors and transferees of the Grantee.
10. Term of Option. The Option must be exercised no later than the Expiration Date set forth in the Notice or such earlier date as otherwise provided herein. After the Expiration Date or such earlier date, the Option shall be of no further force or effect and may not be exercised.
11. Companys Right of First Refusal. The Grantee acknowledges and agrees that the Shares are subject to a right of first refusal (Right of First Refusal) as set forth in the Bylaws of the Company, which Right of First Refusal is incorporated herein by reference irrespective of whether the Bylaws are amended at some future date to remove the Right of First Refusal therefrom, and that, except in compliance with such Right of First Refusal, neither the Grantee nor a transferee (either being sometimes referred to herein as the Holder) shall sell, hypothecate, encumber or otherwise transfer any Shares or any right or interest therein.
12. Stop-Transfer Notices. In order to ensure compliance with the restrictions on transfer set forth in this Option Agreement, the Notice or the Plan, the Company may issue appropriate stop transfer instructions to its transfer agent, if any, and, if the Company transfers its own securities, it may make appropriate notations to the same effect in its own records.
13. Refusal to Transfer. The Company shall not be required (i) to transfer on its books any Shares that have been sold or otherwise transferred in violation of any of the provisions of this Option Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.
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14. Tax Consequences.
(a) The Grantee may incur tax liability as a result of the Grantees purchase or disposition of the Shares. THE GRANTEE SHOULD CONSULT A TAX ADVISER BEFORE EXERCISING THE OPTION OR DISPOSING OF THE SHARES.
(b) Notwithstanding the Companys good faith determination of the Fair Market Value of the Companys Common Stock for purposes of determining the Exercise Price Per Share of the Option as set forth in the Notice, the taxing authorities may assert that the Fair Market Value of the Common Stock on the Date of Award was greater than the Exercise Price Per Share. Under Section 409A of the Code, if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award, the Option may be treated as a form of deferred compensation and the Grantee, if a U.S. taxpayer, may be subject to an acceleration of income recognition, an additional 20% tax, plus interest and possible penalties. The Company makes no representation that the Option will comply with Section 409A of the Code and makes no undertaking to prevent Section 409A of the Code from applying to the Option or to mitigate its effects on any deferrals or payments made in respect of the Option. The Grantee, if a U.S. taxpayer, is encouraged to consult a tax adviser regarding the potential impact of Section 409A of the Code.
15. Lock-Up Agreement.
(a) Agreement. The Grantee, if requested by the Company and the lead underwriter of any public offering of the Common Stock (the Lead Underwriter), hereby irrevocably agrees not to sell, contract to sell, grant any option to purchase, transfer the economic risk of ownership in, make any short sale of, pledge or otherwise transfer or dispose of any interest in any Common Stock or any securities convertible into or exchangeable or exercisable for or any other rights to purchase or acquire Common Stock (except Common Stock included in such public offering or acquired on the public market after such offering) during the 180-day period following the effective date of a registration statement of the Company filed under the Securities Act of 1933, as amended, or such shorter or longer period of time as the Lead Underwriter shall specify. The Grantee further agrees to sign such documents as may be requested by the Lead Underwriter to effect the foregoing and agrees that the Company may impose stop-transfer instructions with respect to such Common Stock subject to the lock-up period until the end of such period. The Company and the Grantee acknowledge that each Lead Underwriter of a public offering of the Companys stock, during the period of such offering and for the lock-up period thereafter, is an intended beneficiary of this Section 15.
(b) No Amendment Without Consent of Underwriter. During the period from identification of a Lead Underwriter in connection with any public offering of the Companys Common Stock until the earlier of (i) the expiration of the lock-up period specified in Section 15(a) in connection with such offering or (ii) the abandonment of such offering by the Company and the Lead Underwriter, the provisions of this Section 15 may not be amended or waived except with the consent of the Lead Underwriter.
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16. Entire Agreement: Governing Law. The Notice, the Plan, the Israeli Sub-Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Grantee with respect to the subject matter hereof, and may not be modified adversely to the Grantees interest except by means of a writing signed by the Company and the Grantee. Nothing in the Notice, the Plan, the Israeli Sub-Plan and this Option Agreement (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties. The Notice, the Plan and this Option Agreement are to be construed in accordance with and governed by the internal laws of the State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California to the rights and duties of the parties. The Israeli Sub-Plan is to be construed in accordance with and governed by the internal laws of the State of Israel, in all tax related matters. Should any provision of the Notice, the Plan, the Israeli Sub-Plan or this Option Agreement be determined to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
17. Construction. The captions used in the Notice and this Option Agreement are inserted for convenience and shall not be deemed a part of the Option for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
18. Administration and Interpretation. Any question or dispute regarding the administration or interpretation of the Notice, the Plan, the Israeli Sub-Plan or this Option Agreement shall be submitted by the Grantee or by the Company to the Administrator. The resolution of such question or dispute by the Administrator shall be final and binding on all persons.
19. Venue. The Company, the Grantee, and the Grantees assignees pursuant to Section 9 (the parties) agree that any suit, action, or proceeding arising out of or relating to the Notice, the Plan or this Option Agreement shall be brought in the United States District Court for the Northern District of California (or should such court lack jurisdiction to hear such action, suit or proceeding, in a California state court in the County of San Francisco) and that the parties shall submit to the jurisdiction of such court. The parties irrevocably waive, to the fullest extent permitted by law, any objection the party may have to the laying of venue for any such suit, action or proceeding brought in such court. If any one or more provisions of this Section 19 shall for any reason be held invalid or unenforceable, it is the specific intent of the parties that such provisions shall be modified to the minimum extent necessary to make it or its application valid and enforceable. Notwithstanding, any suit, action, or proceeding arising out of or relating directly and specifically to the Israeli Sub-Plan shall be brought in the competent Israeli District Court and that the parties shall submit to the jurisdiction of such court.
20. Notices. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown in these instruments, or to such other address as such party may designate in writing from time to time to the other party.
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21. Confidentiality. To the extent required by Applicable Law, the Company shall provide to the Grantee, during the period the Option is outstanding, copies of financial statements of the Company at least annually. The Grantee understands and agrees that such financial statements are confidential and shall not be disclosed by the Grantee, to any entity or person, for any reason, at any time, without the prior written consent of the Company, unless required by law. If disclosure of such financial statements is required by law, whether through subpoena, request for production, deposition, or otherwise, the Grantee promptly shall provide written notice to Company, including copies of the subpoena, request for production, deposition, or otherwise, within five (5) business days of their receipt by the Grantee and prior to any disclosure so as to provide Company an opportunity to move to quash or otherwise to oppose the disclosure. Notwithstanding the foregoing, the Grantee may disclose the terms of such financial statements to his or her spouse or domestic partner, and for legitimate business reasons, to legal, financial, and tax advisors.
END OF AGREEMENT
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EXHIBIT A
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
EXERCISE NOTICE
[COMPANY ADDRESS]
Attention: Secretary
1. Effective as of today, , the undersigned (the Grantee) hereby elects to exercise the Grantees option to purchase shares of the Common Stock (the Shares) of Adicet Bio, Inc., (the Company) under and pursuant to the Companys 2015 Stock Incentive Plan, as amended from time to time (the Plan), the Adicet Bio, Inc. Israeli Sub-Plan to the Plan (the Israeli Sub-Plan) and the Stock Option Award Agreement (the Option Agreement) and Notice of Stock Option Award (the Notice) dated . Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Exercise Notice.
2. Representations of the Grantee. The Grantee acknowledges that the Grantee has received, read and understood the Notice, the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
3. Rights as Stockholder. Until the stock certificate evidencing such Shares is issued (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to vote or receive dividends or any other rights as a stockholder shall exist with respect to the Shares, notwithstanding the exercise of the Option. The Company shall issue (or cause to be issued) such stock certificate promptly after the Option is exercised. No adjustment will be made for a dividend or other right for which the record date is prior to the date the stock certificate is issued, except as provided in Section 10 of the Plan.
The Grantee shall enjoy rights as a stockholder until such time as the Grantee disposes of the Shares or the Company and/or its assignee(s) exercises the Right of First Refusal. Upon such exercise, the Grantee shall have no further rights as a holder of the Shares so purchased except the right to receive payment for the Shares so purchased in accordance with the provisions of the Option Agreement, and the Grantee shall forthwith cause the certificate(s) evidencing the Shares so purchased to be surrendered to the Company for transfer or cancellation.
4. Delivery of Payment. The Grantee herewith delivers to the Company the full Exercise Price for the Shares, which, to the extent selected, shall be deemed to be satisfied by use of the broker-dealer sale and remittance procedure to pay the Exercise Price provided in Section 4(d) of the Option Agreement.
5. Tax Consultation. The Grantee understands that the Grantee may suffer adverse tax consequences as a result of the Grantees purchase or disposition of the Shares. The Grantee represents that the Grantee has consulted with any tax consultants the Grantee deems advisable in connection with the purchase or disposition of the Shares and that the Grantee is not relying on the Company for any tax advice.
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6. Taxes. The Grantee agrees to satisfy all applicable federal, state and local income and employment tax withholding obligations and herewith delivers to the Company the full amount of such obligations or has made arrangements acceptable to the Company to satisfy such obligations. Restrictive Legends. The Grantee understands and agrees that the Company shall cause the legends set forth below or legends substantially equivalent thereto, to be placed upon any certificate(s) evidencing ownership of the Shares together with any other legends that may be required by the Company or by state or federal securities laws:
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE ACT) OR ANY STATE SECURITIES LAWS AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER THE ACT OR, IN THE OPINION OF COUNSEL SATISFACTORY TO THE ISSUER OF THESE SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS IN COMPLIANCE THEREWITH.
THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER AND A RIGHT OF FIRST REFUSAL HELD BY THE ISSUER OR ITS ASSIGNEE(S) AS SET FORTH IN THE OPTION AGREEMENT BETWEEN THE ISSUER AND THE ORIGINAL HOLDER OF THESE SHARES, A COPY OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE ISSUER. SUCH TRANSFER RESTRICTIONS AND RIGHT OF FIRST REFUSAL ARE BINDING ON TRANSFEREES OF THESE SHARES.
7. Successors and Assigns. The Company may assign any of its rights under this Exercise Notice to single or multiple assignees, and this agreement shall inure to the benefit of the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth, this Exercise Notice shall be binding upon the Grantee and his or her heirs, executors, administrators, successors and assigns.
8. Construction. The captions used in this Exercise Notice are inserted for convenience and shall not be deemed a part of this agreement for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
9. Administration and Interpretation. The Grantee hereby agrees that any question or dispute regarding the administration or interpretation of this Exercise Notice shall be submitted by the Grantee or by the Company to the Administrator. The resolution of such question or dispute by the Administrator shall be final and binding on all persons.
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10. Governing Law; Severability. This Exercise Notice is to be construed in accordance with and governed by the Applicable Laws. Should any provision of this Exercise Notice be determined by a court of law to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
11. Notices. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown below beneath its signature, or to such other address as such party may designate in writing from time to time to the other party.
12. Further Instruments. The parties agree to execute such further instruments and to take such further action as may be reasonably necessary to carry out the purposes and intent of this agreement.
13. Entire Agreement. The Notice, the Plan and the Option Agreement are incorporated herein by reference and together with this Exercise Notice constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Grantee with respect to the subject matter hereof, and may not be modified adversely to the Grantees interest except by means of a writing signed by the Company and the Grantee. Nothing in the Notice, the Plan, the Option Agreement and this Exercise Notice (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties.
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Submitted by: | Accepted by: | |||||||
GRANTEE: | ADICET BIO, INC. | |||||||
By: |
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By: |
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Name: |
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Name: |
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Title: |
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Address: | Address: | |||||||
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EXHIBIT B
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
INVESTMENT REPRESENTATION STATEMENT
GRANTEE: |
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COMPANY: | ADICET BIO, INC. | |||
SECURITY: | COMMON STOCK | |||
NUMBER OF SHARES: |
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DATE: |
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In connection with the purchase of the above-listed Securities, the undersigned Grantee represents to the Company the following:
(a) Grantee is aware of the Companys business affairs and financial condition and has acquired sufficient information about the Company to reach an informed and knowledgeable decision to acquire the Securities. Grantee is acquiring these Securities for investment for Grantees own account only and not with a view to, or for resale in connection with, any distribution thereof within the meaning of the Securities Act of 1933, as amended (the Securities Act).
(b) Grantee acknowledges and understands that the Securities constitute restricted securities under the Securities Act and have not been registered under the Securities Act in reliance upon a specific exemption therefrom, which exemption depends upon among other things, the bona fide nature of Grantees investment intent as expressed herein. Grantee further understands that the Securities must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available. Grantee further acknowledges and understands that the Company is under no obligation to register the Securities. Grantee understands that the certificate evidencing the Securities will be imprinted with a legend which prohibits the transfer of the Securities unless they are registered or such registration is not required in the opinion of counsel satisfactory to the Company.
(c) Grantee is familiar with the provisions of Rule 701 and Rule 144, each promulgated under the Securities Act, which, in substance, permit limited public resale of restricted securities acquired, directly or indirectly from the issuer thereof, in a non-public offering subject to the satisfaction of certain conditions. Rule 701 provides that if the issuer qualifies under Rule 701 at the time of the grant of the Option to the Grantee, the exercise will be exempt from registration under the Securities Act. In the event the Company becomes subject to the reporting requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, ninety (90) days thereafter (or such longer period as any market stand-off agreement may require) the Securities exempt under Rule 701 may be resold, except in the case of affiliates, such Securities may be resold subject to the satisfaction of the applicable conditions specified by Rule 144, including: (1) the availability of certain public information about the Company, (2) the amount of Securities being sold during any three month period not exceeding specified limitations, (3) the resale being made in an unsolicited brokers transaction, in transactions directly with a market maker or riskless principal transactions (as said terms are defined under the Securities Exchange Act of 1934) and (4) the timely filing of a Form 144, if applicable.
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In the event that the Company does not qualify under Rule 701 at the time of the grant of the Option, then the Securities may be resold in certain limited circumstances subject to the provisions of Rule 144, which may require: the availability of current public information about the Company; the resale to occur more than a specified period after the purchase and full payment (within the meaning of Rule 144) for the Securities; and, in the case of the sale of Securities by an affiliate, the satisfaction of the conditions set forth in sections (2), (3) and (4) of the paragraph immediately above.
(d) Grantee further understands that in the event all of the applicable requirements of Rule 701 or 144 are not satisfied, registration under the Securities Act, compliance with Regulation A, or some other registration exemption will be required; and that, notwithstanding the fact that Rules 144 and 701 are not exclusive, the Staff of the Securities and Exchange Commission has expressed its opinion that persons proposing to sell private placement securities other than in a registered offering and otherwise than pursuant to Rules 144 or 701 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales, and that such persons and their respective brokers who participate in such transactions do so at their own risk. Grantee understands that no assurances can be given that any such other registration exemption will be available in such event.
(e) Grantee represents that Grantee is a resident of the state of the State of Israel.
Signature of Grantee: | ||
By: |
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Date: |
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Exhibit 10.18
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
NOTICE OF STOCK OPTION AWARD
Grantees Name and Address: | ||
You (the Grantee) have been granted an option to purchase shares of Common Stock, subject to the terms and conditions of this Notice of Stock Option Award (the Notice), the Adicet Bio, Inc. 2015 Stock Incentive Plan, as amended from time to time (the Plan), the Adicet Bio, Inc. Israeli Sub-Plan to the Plan (the Israeli Sub-Plan) and the Stock Option Award Agreement (the Option Agreement) attached hereto, as follows. Unless otherwise defined herein, the terms defined in the Plan or in the Israeli Sub-Plan, as the case may be, shall have the same defined meanings in this Notice.
Award Number | ||
Date of Award | ||
Vesting Commencement Date | ||
Exercise Price per Share | $ | |
Total Number of Shares Subject to the Option (the Shares) | ||
Total Exercise Price | $ | |
Tax Route: | Capital Gain | |
Expiration Date: | ||
Post-Termination Exercise Period: Three (3) Months |
Vesting Schedule:
Subject to the Grantees Continuous Service and the other limitations set forth in this Notice, the Plan, the Israeli Sub-Plan and the Option Agreement, the Option may be exercised, in whole or in part, in accordance with the following schedule:
[25% of the Shares subject to the Option shall vest twelve (12) months after the Vesting Commencement Date, and 1/36th of the remaining unvested Shares subject to the Option shall vest on each of the next thirty-six (36) monthly anniversaries of the Vesting Commencement Date thereafter.]1
1 | Insert for new-hire grants. |
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[1/48th of the Shares subject to the Option shall vest on each monthly anniversary of the Vesting Commencement Date.]2
During any authorized leave of absence, the vesting of the Shares shall be suspended after the leave of absence exceeds a period of three (3) months. Vesting of the Shares shall resume upon the Grantees termination of the leave of absence and return to Continuous Service. The Vesting Schedule of the Shares shall be extended by the length of the suspension.
In the event of termination of the Grantees Continuous Service for Cause, the Grantees right to exercise the Option shall terminate concurrently with the termination of the Grantees Continuous Service, except as otherwise determined by the Administrator.
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2 | Insert for refresh grants. |
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IN WITNESS WHEREOF, the Company and the Grantee have executed this Notice and agree that the Option is to be governed by the terms and conditions of this Notice, the Plan, the Israeli Sub-Plan and the Option Agreement.
ADICET BIO, INC., | ||
a Delaware corporation | ||
By: |
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Name: |
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Title: |
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[Remainder of Page Left Intentionally Blank]
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THE GRANTEE ACKNOWLEDGES AND AGREES THAT THE SHARES SUBJECT TO THE OPTION SHALL VEST, IF AT ALL, ONLY DURING THE PERIOD OF THE GRANTEES CONTINUOUS SERVICE (NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED THE OPTION OR ACQUIRING SHARES HEREUNDER). THE GRANTEE FURTHER ACKNOWLEDGES AND AGREES THAT NOTHING IN THIS NOTICE, THE OPTION AGREEMENT, OR THE PLAN (INCLUDING THE ISRAELI SUB-PLAN) SHALL CONFER UPON THE GRANTEE ANY RIGHT WITH RESPECT TO FUTURE AWARDS OR CONTINUATION OF THE GRANTEES CONTINUOUS SERVICE, NOR SHALL IT INTERFERE IN ANY WAY WITH THE GRANTEES RIGHT OR THE RIGHT OF THE COMPANY OR RELATED ENTITY TO WHICH THE GRANTEE PROVIDES SERVICES TO TERMINATE THE GRANTEES CONTINUOUS SERVICE, WITH OR WITHOUT CAUSE, AND WITH OR WITHOUT NOTICE. THE GRANTEE ACKNOWLEDGES THAT UNLESS THE GRANTEE HAS A WRITTEN EMPLOYMENT AGREEMENT WITH THE COMPANY TO THE CONTRARY, THE GRANTEES STATUS IS AT WILL.
The Grantee acknowledges receipt of a copy of the Plan, the Israeli Sub-Plan, the trust agreement between the Company and the Trustee (the Trust Agreement) the Option Agreement, and represents that he or she is familiar with the terms and provisions thereof, and hereby accepts the Option subject to all of the terms and provisions hereof and thereof. The Grantee has reviewed this Notice, the Plan, the Israeli Sub-Plan and the Option Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Notice, and fully understands all provisions of this Notice, the Plan the Israeli Sub-Plan and the Option Agreement. The Grantee hereby agrees that all questions of interpretation and administration relating to this Notice, the Plan, the Israeli Sub-Plan and the Option Agreement shall be resolved by the Administrator in accordance with Section 18 of the Option Agreement. The Grantee further agrees to the venue selection in accordance with Section 19 of the Option Agreement. The Grantee further agrees to notify the Company upon any change in the residence address indicated in this Notice.
Grantee represents that Grantee is a resident of the State of Israel for tax purposes on the date of allocation and agrees to notify the Company upon any change in the residence address indicated above and acknowledges that if Grantee ceases to be an Israeli resident or if Grantees engagement with the Company is terminated, the Option and/or Shares shall remain subject to Section 102, the Trust Agreement, the Plan, the Israeli Sub-Plan and this Option Agreement.
Grantee declares that she/he is familiar with Section 102 of the Ordinance and the regulations and rules promulgated thereunder, including without limitations the provisions of the applicable tax route, and agrees to comply with such provisions, as amended from time to time. The Grantee authorizes the Company to provide the Trustee with any information required for the purpose of executing its obligations under the Ordinance, including without limitation information about the Option and the Shares, income tax rates, salary bank account, contact details and identification number. The Grantee warrants and undertakes that at the time of grant of the Option herein, or as a consequence of the grant, the Grantee is not and will not become a holder of a controlling interest in the Company, as such term is defined in Section 32(9) of the Ordinance.
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Dated: | Signed: | |||||||
Grantee |
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Award Number:
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
STOCK OPTION AWARD AGREEMENT
1. Grant of Option. Adicet Bio, Inc., a Delaware corporation (the Company), hereby grants to the Grantee (the Grantee) named in the Notice of Stock Option Award (the Notice), an option (the Option) to purchase the Total Number of Shares of Common Stock subject to the Option (the Shares) set forth in the Notice, at the Exercise Price per Share set forth in the Notice (the Exercise Price) subject to the terms and provisions of the Notice, this Stock Option Award Agreement (the Option Agreement), the Companys 2015 Stock Incentive Plan, as amended from time to time (the Plan) and the Adicet Bio, Inc. Israeli Sub-Plan to the Plan (the Israeli Sub-Plan), and the Trust Agreement, which are incorporated herein by reference. Unless otherwise defined herein, the terms defined in the Plan and/or in the Israeli Sub-Plan, as the case may be, shall have the same defined meanings in this Option Agreement.
The Shares shall be held in trust under the terms and conditions of the capital gain route under Section 102 of the Ordinance during the Lock-Up Period.
2. Exercise of Option.
(a) Right to Exercise. The Option shall be exercisable during its term in accordance with the Vesting Schedule set out in the Notice and with the applicable provisions of the Plan, the Israeli Sub-Plan and this Option Agreement. The Option shall be subject to the provisions of Section 11 of the Plan relating to the exercisability or termination of the Option in the event of a Corporate Transaction. The Grantee shall be subject to reasonable limitations on the number of requested exercises during any monthly or weekly period as determined by the Administrator. In no event shall the Company issue fractional Shares.
(b) Method of Exercise. The Option shall be exercisable by delivery of an exercise notice (a form of which is attached as Exhibit A) or by such other procedure as specified from time to time by the Administrator which shall state the election to exercise the Option, the whole number of Shares in respect of which the Option is being exercised, and such other provisions as may be required by the Administrator. The exercise notice shall be delivered in person, by certified mail, or by such other method (including electronic transmission) as determined from time to time by the Administrator to the Company accompanied by payment of the Exercise Price and all applicable income and employment taxes required to be withheld. The Option shall be deemed to be exercised upon receipt by the Company of such notice accompanied by the Exercise Price and all applicable withholding taxes, which, to the extent selected, shall be deemed to be satisfied by use of the broker-dealer sale and remittance procedure to pay the Exercise Price provided in Section 4(d) below to the extent such procedure is available to the Grantee at the time of exercise and such an exercise would not violate any Applicable Law.
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(c) Taxes. The Grantee shall be taxed in Israel in accordance with the provisions under Section 102 of the Ordinance, including the provisions the regulations and any tax ruling or agreement obtained by the Company with regard to the Plan. No Shares will be delivered to the Grantee or other person pursuant to the exercise of the Option until the Grantee or other person has made arrangements acceptable to the Administrator for the satisfaction of applicable income tax and employment tax withholding obligations, including, without limitation, such other tax obligations of the Grantee incident to the receipt of Shares. Upon exercise of the Option, the Company or the Grantees employer may offset or withhold (from any amount owed by the Company or the Grantees employer to the Grantee) or collect from the Grantee or other person an amount sufficient to satisfy such tax withholding obligations. Furthermore, in the event of any determination that the Company has failed to withhold a sum sufficient to pay all withholding taxes due in connection with the Option, the Grantee agrees to pay the Company the amount of such deficiency in cash within five (5) days after receiving a written demand from the Company to do so, whether or not the Grantee is an employee of the Company at that time.
3. Grantees Representations. The Grantee understands that neither the Option nor the Shares exercisable pursuant to the Option have been registered under the Securities Act of 1933, as amended or any United States securities laws. In the event the Shares purchasable pursuant to the exercise of the Option have not been registered under the Securities Act of 1933, as amended, at the time the Option is exercised, the Grantee shall, if requested by the Company, concurrently with the exercise of all or any portion of the Option, deliver to the Company his or her Investment Representation Statement in the form attached hereto as Exhibit B.
4. Method of Payment. Payment of the Exercise Price shall be made by any of the following, or a combination thereof, at the election of the Grantee; provided, however, that such exercise method does not then violate any Applicable Law (including the Ordinance) and, provided further, that the portion of the Exercise Price equal to the par value of the Shares must be paid in cash or other legal consideration permitted by the Delaware General Corporation Law:
(a) cash;
(b) check;
(c) if the exercise occurs on or after the Registration Date, surrender of Shares held for the requisite period, if any, necessary to avoid a charge to the Companys earnings for financial reporting purposes, or delivery of a properly executed form of attestation of ownership of Shares as the Administrator may require which have a Fair Market Value on the date of surrender or attestation equal to the aggregate Exercise Price of the Shares as to which the Option is being exercised; or
(d) if the exercise occurs on or after the Registration Date, payment through a broker-dealer sale and remittance procedure pursuant to which the Grantee (i) shall provide written instructions to a Company-designated brokerage firm to effect the immediate sale of some or all of the purchased Shares and remit to the Company sufficient funds to cover the aggregate exercise price payable for the purchased Shares and (ii) shall provide written directives to the Company to deliver the certificates for the purchased Shares directly to such brokerage firm in order to complete the sale transaction.
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5. Restrictions on Exercise. The Option may not be exercised if the issuance of the Shares subject to the Option upon such exercise would constitute a violation of any Applicable Laws. In addition, the Option may not be exercised until such time as the Plan has been approved by the stockholders of the Company, and the Israeli Sub-Plan has been approved by the ITA. If the exercise of the Option within the applicable time periods set forth in Sections 6, 7 and 8 of this Option Agreement is prevented by the provisions of this Section 5, the Option shall remain exercisable until one (1) month after the date the Grantee is notified by the Company that the Option is exercisable, but in any event no later than the Expiration Date set forth in the Notice.
6. Termination or Change of Continuous Service. In the event the Grantees Continuous Service terminates, other than for Cause, the Grantee may, but only during the Post-Termination Exercise Period, exercise the portion of the Option that was vested at the date of such termination (the Termination Date). The Post-Termination Exercise Period shall commence on the Termination Date. In the event of termination of the Grantees Continuous Service for Cause, the Grantees right to exercise the Option shall, except as otherwise determined by the Administrator, terminate concurrently with the termination of the Grantees Continuous Service (also the Termination Date). In no event, however, shall the Option be exercised later than the Expiration Date set forth in the Notice. In the event of the Grantees change in status from Employee, Director or Consultant to any other status of Employee, Director or Consultant, the Option shall remain in effect and the Option shall continue to vest in accordance with the Vesting Schedule set forth in the Notice, provided however, that the Option may be subject to a different tax route, following such change in status. Except as provided in Sections 7 and 8 below, to the extent that the Option was unvested on the Termination Date, or if the Grantee does not exercise the vested portion of the Option within the Post-Termination Exercise Period, the Option shall terminate.
7. Disability of Grantee. In the event the Grantees Continuous Service terminates as a result of his or her Disability, the Grantee may, but only within twelve (12) months commencing on the Termination Date (but in no event later than the Expiration Date), exercise the portion of the Option that was vested on the Termination Date. To the extent that the Option was unvested on the Termination Date, or if the Grantee does not exercise the vested portion of the Option within the time specified herein, the Option shall terminate. Section 22(e)(3) of the Code provides that an individual is permanently and totally disabled if he or she is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than twelve (12) months.
8. Death of Grantee. In the event of the termination of the Grantees Continuous Service as a result of his or her death, or in the event of the Grantees death during the Post-Termination Exercise Period or during the twelve (12) month period following the Grantees termination of Continuous Service as a result of his or her Disability, the person who acquired the right to exercise the Option pursuant to Section 9 may exercise the portion of the Option that was vested at the date of termination within twelve (12) months commencing on the date of death (but in no event later than the Expiration Date). To the extent that the Option was unvested on the date of death, or if the vested portion of the Option is not exercised within the time specified herein, the Option shall terminate.
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9. Transferability of Option. Prior to the payment of the tax applicable under law, including under Section 102 (the Applicable Tax), the Options and/or the Shares or rights arising therefrom shall not be transferable or assignable, shall not be subject to any mortgage, liens, attachment or other encumbrance, and no power or attorney or note of transfer shall be issued in respect thereof, whether such instrument enter into force immediately or at future date, excluding transfer by power of a last will or under law and all subject to the terms of the Plan and the Israeli Sub-Plan. Should the Options or Shares have been transferred pursuant to the provisions of a last testamentary instrument or under applicable law, Section 102 shall apply to the heirs or transferees of the deceased Grantee. Subject to Section 102, the Trustee shall not transfer the Options and/or the Shares to the Grantees name, and shall not transfer the consideration received from the sale of the Shares to the Grantee, unless one of the following conditions shall be fulfilled: (a) the Grantee provided the Trustee with a certificate from the Assessing Officer that the Applicable Tax has been paid; or (b) the Grantee paid the Trustee an amount equaling to the amount of tax applicable in accordance with Section 102 (the Taxable Consideration) for such sale, and the Trustee checked the manner of calculating the payable amount, at its sole discretion, and was fully satisfied that the calculation was performed accurately and lawfully; or (c) the Trustee deducted the applicable tax in accordance with Section 102 of the Taxable Consideration, or any other amount as shall be approved by the Assessing Officer, from the consideration it received from the sale of the Option and/or the Shares. Notwithstanding the foregoing, the Grantee may designate one or more beneficiaries of the Grantees Option in the event of the Grantees death on a beneficiary designation form provided by the Administrator. Following the death of the Grantee, the Option, to the extent provided in Section 8, may be exercised (a) by the person or persons designated under the deceased Grantees beneficiary designation or (b) in the absence of an effectively designated beneficiary, by the Grantees legal representative or by any person empowered to do so under the deceased Grantees will or under the then applicable laws of descent and distribution. Notwithstanding the foregoing, no Option may be transferred in violation of Applicable Law, including any applicable securities exemption. The terms of the Option shall be binding upon the executors, administrators, heirs, successors and transferees of the Grantee.
10. Term of Option. The Option must be exercised no later than the Expiration Date set forth in the Notice or such earlier date as otherwise provided herein. After the Expiration Date or such earlier date, the Option shall be of no further force or effect and may not be exercised.
11. Companys Right of First Refusal. The Grantee acknowledges and agrees that the Shares are subject to a right of first refusal (Right of First Refusal) as set forth in the Bylaws of the Company, which Right of First Refusal is incorporated herein by reference irrespective of whether the Bylaws are amended at some future date to remove the Right of First Refusal therefrom, and that, except in compliance with such Right of First Refusal, neither the Grantee nor a transferee (either being sometimes referred to herein as the Holder) shall sell, hypothecate, encumber or otherwise transfer any Shares or any right or interest therein.
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12. Stop-Transfer Notices. In order to ensure compliance with the restrictions on transfer set forth in this Option Agreement, the Notice the Plan, or the Israeli Sub-Plan, the Company may issue appropriate stop transfer instructions to its transfer agent, if any, and, if the Company transfers its own securities, it may make appropriate notations to the same effect in its own records.
13. Refusal to Transfer. The Company shall not be required (i) to transfer on its books any Shares that have been sold or otherwise transferred in violation of any of the provisions of this Option Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.
14. Tax Consequences.
(a) The Grantee may incur tax liability as a result of the Grantees purchase or disposition of the Shares. THE GRANTEE SHOULD CONSULT A TAX ADVISER BEFORE EXERCISING THE OPTION OR DISPOSING OF THE SHARES.
(b) Notwithstanding the Companys good faith determination of the Fair Market Value of the Companys Common Stock for purposes of determining the Exercise Price Per Share of the Option as set forth in the Notice, the taxing authorities may assert that the Fair Market Value of the Common Stock on the Date of Award was greater than the Exercise Price Per Share. Under Section 409A of the Code, if the Exercise Price Per Share of the Option is less than the Fair Market Value of the Common Stock on the Date of Award, the Option may be treated as a form of deferred compensation and the Grantee, if a U.S. taxpayer, may be subject to an acceleration of income recognition, an additional 20% tax, plus interest and possible penalties. The Company makes no representation that the Option will comply with Section 409A of the Code and makes no undertaking to prevent Section 409A of the Code from applying to the Option or to mitigate its effects on any deferrals or payments made in respect of the Option. The Grantee, if a U.S. taxpayer, is encouraged to consult a tax adviser regarding the potential impact of Section 409A of the Code.
15. Lock-Up Agreement.
(a) Agreement. The Grantee, if requested by the Company and the lead underwriter of any public offering of the Common Stock (the Lead Underwriter), hereby irrevocably agrees not to sell, contract to sell, grant any option to purchase, transfer the economic risk of ownership in, make any short sale of, pledge or otherwise transfer or dispose of any interest in any Common Stock or any securities convertible into or exchangeable or exercisable for or any other rights to purchase or acquire Common Stock (except Common Stock included in such public offering or acquired on the public market after such offering) during the 180-day period following the effective date of a registration statement of the Company filed under the Securities Act of 1933, as amended, or such shorter or longer period of time as the Lead Underwriter shall specify. The Grantee further agrees to sign such documents as may be requested by the Lead Underwriter to effect the foregoing and agrees that the Company may impose stop-transfer instructions with respect to such Common Stock subject to the lock-up period until the end of such period. The Company and the Grantee acknowledge that each Lead Underwriter of a public offering of the Companys stock, during the period of such offering and for the lock-up period thereafter, is an intended beneficiary of this Section 15.
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(b) No Amendment Without Consent of Underwriter. During the period from identification of a Lead Underwriter in connection with any public offering of the Companys Common Stock until the earlier of (i) the expiration of the lock-up period specified in Section 15(a) in connection with such offering or (ii) the abandonment of such offering by the Company and the Lead Underwriter, the provisions of this Section 15 may not be amended or waived except with the consent of the Lead Underwriter.
16. Entire Agreement: Governing Law. The Notice, the Plan, the Israeli Sub-Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Grantee with respect to the subject matter hereof, and may not be modified adversely to the Grantees interest except by means of a writing signed by the Company and the Grantee. Nothing in the Notice, the Plan, the Israeli Sub-Plan and this Option Agreement (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties. The Notice, the Plan and this Option Agreement are to be construed in accordance with and governed by the internal laws of the State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California to the rights and duties of the parties. The Israeli Sub-Plan is to be construed in accordance with and governed by the laws of the State of Israel, in all tax related matters. Should any provision of the Notice, the Plan, the Israeli Sub-Plan or this Option Agreement be determined to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
17. Construction. The captions used in the Notice and this Option Agreement are inserted for convenience and shall not be deemed a part of the Option for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
18. Administration and Interpretation. Any question or dispute regarding the administration or interpretation of the Notice, the Plan, the Israeli Sub-Plan, or this Option Agreement shall be submitted by the Grantee or by the Company to the Administrator. The resolution of such question or dispute by the Administrator shall be final and binding on all persons.
19. Venue. The Company, the Grantee, and the Grantees assignees pursuant to Section 9 (the parties) agree that any suit, action, or proceeding arising out of or relating to the Notice, the Plan or this Option Agreement shall be brought in the United States District Court for the Northern District of California (or should such court lack jurisdiction to hear such action, suit or proceeding, in a California state court in the County of San Francisco) and that the parties shall submit to the jurisdiction of such court. The parties irrevocably waive, to the fullest extent permitted by law, any objection the party may have to the laying of venue for any such suit, action or proceeding brought in such court. If any one or more provisions of this Section 19
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shall for any reason be held invalid or unenforceable, it is the specific intent of the parties that such provisions shall be modified to the minimum extent necessary to make it or its application valid and enforceable. Notwithstanding, any suit, action, or proceeding arising out of or relating directly and specifically to the Israeli Sub-Plan shall be brought in the competent Israeli District Court and that the parties shall submit to the jurisdiction of such court.
20. Notices. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown in these instruments, or to such other address as such party may designate in writing from time to time to the other party.
21. Confidentiality. To the extent required by Applicable Law, the Company shall provide to the Grantee, during the period the Option is outstanding, copies of financial statements of the Company at least annually. The Grantee understands and agrees that such financial statements are confidential and shall not be disclosed by the Grantee, to any entity or person, for any reason, at any time, without the prior written consent of the Company, unless required by law. If disclosure of such financial statements is required by law, whether through subpoena, request for production, deposition, or otherwise, the Grantee promptly shall provide written notice to Company, including copies of the subpoena, request for production, deposition, or otherwise, within five (5) business days of their receipt by the Grantee and prior to any disclosure so as to provide Company an opportunity to move to quash or otherwise to oppose the disclosure. Notwithstanding the foregoing, the Grantee may disclose the terms of such financial statements to his or her spouse or domestic partner, and for legitimate business reasons, to legal, financial, and tax advisors.
END OF AGREEMENT
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EXHIBIT A
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
EXERCISE NOTICE
[COMPANY ADDRESS]
Attention: Secretary
1. Effective as of today, , the undersigned (the Grantee) hereby elects to exercise the Grantees option to purchase shares of the Common Stock (the Shares) of Adicet Bio, Inc., (the Company) under and pursuant to the Companys 2015 Stock Incentive Plan, as amended from time to time (the Plan), the Adicet Bio, Inc. Israeli Sub-Plan to the Plan (the Israeli Sub-Plan) and the Stock Option Award Agreement (the Option Agreement) and Notice of Stock Option Award (the Notice) dated . Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Exercise Notice.
2. Representations of the Grantee. The Grantee acknowledges that the Grantee has received, read and understood the Notice, the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
3. Rights as Stockholder. Until the stock certificate evidencing such Shares is issued (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to vote or receive dividends or any other rights as a stockholder shall exist with respect to the Shares, notwithstanding the exercise of the Option. The Company shall issue (or cause to be issued) such stock certificate promptly after the Option is exercised. No adjustment will be made for a dividend or other right for which the record date is prior to the date the stock certificate is issued, except as provided in Section 10 of the Plan.
The Grantee shall enjoy rights as a stockholder until such time as the Grantee disposes of the Shares or the Company and/or its assignee(s) exercises the Right of First Refusal. Upon such exercise, the Grantee shall have no further rights as a holder of the Shares so purchased except the right to receive payment for the Shares so purchased in accordance with the provisions of the Option Agreement, and the Grantee shall forthwith cause the certificate(s) evidencing the Shares so purchased to be surrendered to the Company for transfer or cancellation.
4. Delivery of Payment. The Grantee herewith delivers to the Company the full Exercise Price for the Shares, which, to the extent selected, shall be deemed to be satisfied by use of the broker-dealer sale and remittance procedure to pay the Exercise Price provided in Section 4(d) of the Option Agreement.
5. Tax Consultation. The Grantee understands that the Grantee may suffer adverse tax consequences as a result of the Grantees purchase or disposition of the Shares. The Grantee represents that the Grantee has consulted with any tax consultants the Grantee deems advisable in connection with the purchase or disposition of the Shares and that the Grantee is not relying on the Company for any tax advice.
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6. Taxes. The Grantee agrees to satisfy all applicable federal, state and local income and employment tax withholding obligations and herewith delivers to the Company the full amount of such obligations or has made arrangements acceptable to the Company to satisfy such obligations.
7. Restrictive Legends. The Grantee understands and agrees that the Company shall cause the legends set forth below or legends substantially equivalent thereto, to be placed upon any certificate(s) evidencing ownership of the Shares together with any other legends that may be required by the Company or by state or federal securities laws:
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE ACT) OR ANY STATE SECURITIES LAWS AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER THE ACT OR, IN THE OPINION OF COUNSEL SATISFACTORY TO THE ISSUER OF THESE SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS IN COMPLIANCE THEREWITH.
THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER AND A RIGHT OF FIRST REFUSAL HELD BY THE ISSUER OR ITS ASSIGNEE(S) AS SET FORTH IN THE OPTION AGREEMENT BETWEEN THE ISSUER AND THE ORIGINAL HOLDER OF THESE SHARES, A COPY OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE ISSUER. SUCH TRANSFER RESTRICTIONS AND RIGHT OF FIRST REFUSAL ARE BINDING ON TRANSFEREES OF THESE SHARES.
8. Successors and Assigns. The Company may assign any of its rights under this Exercise Notice to single or multiple assignees, and this agreement shall inure to the benefit of the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth, this Exercise Notice shall be binding upon the Grantee and his or her heirs, executors, administrators, successors and assigns.
9. Construction. The captions used in this Exercise Notice are inserted for convenience and shall not be deemed a part of this agreement for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
10. Administration and Interpretation. The Grantee hereby agrees that any question or dispute regarding the administration or interpretation of this Exercise Notice shall be submitted by the Grantee or by the Company to the Administrator. The resolution of such question or dispute by the Administrator shall be final and binding on all persons.
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11. Governing Law; Severability. This Exercise Notice is to be construed in accordance with and governed by the Applicable Laws. Should any provision of this Exercise Notice be determined by a court of law to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
12. Notices. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown below beneath its signature, or to such other address as such party may designate in writing from time to time to the other party.
13. Further Instruments. The parties agree to execute such further instruments and to take such further action as may be reasonably necessary to carry out the purposes and intent of this agreement.
14. Entire Agreement. The Notice, the Plan and the Option Agreement are incorporated herein by reference and together with this Exercise Notice constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Grantee with respect to the subject matter hereof, and may not be modified adversely to the Grantees interest except by means of a writing signed by the Company and the Grantee. Nothing in the Notice, the Plan, the Option Agreement and this Exercise Notice (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties.
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Submitted by: | Accepted by: | |||||||
GRANTEE: | ADICET BIO, INC. | |||||||
By: |
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By: |
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Name: |
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Title: |
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Address: | Address: | |||||||
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EXHIBIT B
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
INVESTMENT REPRESENTATION STATEMENT
GRANTEE: | ||
COMPANY: | ADICET BIO, INC. | |
SECURITY: | COMMON STOCK | |
NUMBER OF SHARES: | ||
DATE: |
In connection with the purchase of the above-listed Securities, the undersigned Grantee represents to the Company the following:
(a) Grantee is aware of the Companys business affairs and financial condition and has acquired sufficient information about the Company to reach an informed and knowledgeable decision to acquire the Securities. Grantee is acquiring these Securities for investment for Grantees own account only and not with a view to, or for resale in connection with, any distribution thereof within the meaning of the Securities Act of 1933, as amended (the Securities Act).
(b) Grantee acknowledges and understands that the Securities constitute restricted securities under the Securities Act and have not been registered under the Securities Act in reliance upon a specific exemption therefrom, which exemption depends upon among other things, the bona fide nature of Grantees investment intent as expressed herein. Grantee further understands that the Securities must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available. Grantee further acknowledges and understands that the Company is under no obligation to register the Securities. Grantee understands that the certificate evidencing the Securities will be imprinted with a legend which prohibits the transfer of the Securities unless they are registered or such registration is not required in the opinion of counsel satisfactory to the Company.
(c) Grantee is familiar with the provisions of Rule 701 and Rule 144, each promulgated under the Securities Act, which, in substance, permit limited public resale of restricted securities acquired, directly or indirectly from the issuer thereof, in a non-public offering subject to the satisfaction of certain conditions. Rule 701 provides that if the issuer qualifies under Rule 701 at the time of the grant of the Option to the Grantee, the exercise will be exempt from registration under the Securities Act. In the event the Company becomes subject to the reporting requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, ninety (90) days thereafter (or such longer period as any market stand-off agreement may require) the Securities exempt under Rule 701 may be resold, except in the case of affiliates, such Securities may be resold subject to the satisfaction of the applicable conditions specified by Rule 144, including: (1) the availability of certain public information about the Company, (2) the amount of Securities being sold during any three month period not exceeding specified limitations, (3) the resale being made in an unsolicited brokers transaction, in transactions directly with a market maker or riskless principal transactions (as said terms are defined under the Securities Exchange Act of 1934) and (4) the timely filing of a Form 144, if applicable.
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In the event that the Company does not qualify under Rule 701 at the time of the grant of the Option, then the Securities may be resold in certain limited circumstances subject to the provisions of Rule 144, which may require: the availability of current public information about the Company; the resale to occur more than a specified period after the purchase and full payment (within the meaning of Rule 144) for the Securities; and, in the case of the sale of Securities by an affiliate, the satisfaction of the conditions set forth in sections (2), (3) and (4) of the paragraph immediately above.
(d) Grantee further understands that in the event all of the applicable requirements of Rule 701 or 144 are not satisfied, registration under the Securities Act, compliance with Regulation A, or some other registration exemption will be required; and that, notwithstanding the fact that Rules 144 and 701 are not exclusive, the Staff of the Securities and Exchange Commission has expressed its opinion that persons proposing to sell private placement securities other than in a registered offering and otherwise than pursuant to Rules 144 or 701 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales, and that such persons and their respective brokers who participate in such transactions do so at their own risk. Grantee understands that no assurances can be given that any such other registration exemption will be available in such event.
(e) Grantee represents that Grantee is a resident of the State of Israel.
Signature of Grantee: | ||
By: |
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Date: |
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Exhibit 10.19
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
NOTICE OF RESTRICTED STOCK PURCHASE AWARD
Grantees Name and Address: |
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You (the Grantee) have been granted the right to purchase shares of Common Stock, subject to the terms and conditions of this Notice of Restricted Stock Purchase Award (the Notice), the Adicet Bio, Inc. 2015 Stock Incentive Plan, as amended from time to time (the Plan) and the Restricted Stock Purchase Award Agreement (the Agreement) attached hereto, as follows. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Notice.
Award Number |
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Date of Purchase |
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Date Award Approved by Board |
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Vesting Commencement Date |
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Purchase Price per Share |
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Total Number of Shares of Common Stock Awarded (the Shares) |
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Total Purchase Price |
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Vesting Schedule:
For purposes of this Notice and the Agreement, the term vest shall mean, with respect to any Shares, that such Shares are no longer subject to repurchase at the Purchase Price per Share, as described in Section 9 of the Agreement (the Repurchase Right); provided, however, that such Shares shall remain subject to other restrictions on transfer set forth in the Agreement or the Plan. Shares that have not vested are deemed Restricted Shares. If the Grantee would become vested in a fraction of a Share, such Share shall not vest until the Grantee becomes vested in the entire Share.
Subject to the Grantees Continuous Service and the other limitations set forth in this Notice, the Plan and the Agreement, the Repurchase Right shall lapse in accordance with the following schedule:
[25% of the Shares shall vest twelve (12) months after the Vesting Commencement Date, and 1/36th of the remaining unvested Shares shall vest on each of the next thirty-six (36) monthly anniversaries of the Vesting Commencement Date thereafter.]1
1 | Insert for new-hire grants. |
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[1/48th of the Shares shall vest on each monthly anniversary of the Vesting Commencement Date.]2
During any authorized leave of absence, the vesting of the Shares shall be suspended after the leave of absence exceeds a period of three (3) months. Vesting of the Shares shall resume upon the Grantees termination of the leave of absence and return to Continuous Service. The Vesting Schedule of the Shares shall be extended by the length of the suspension.
[Remainder of Page Left Intentionally Blank]
2 | Insert for refresh grants. |
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IN WITNESS WHEREOF, the Company and the Grantee have executed this Notice and agree that the Award is to be governed by the terms and conditions of this Notice, the Plan, and the Agreement.
ADICET BIO, INC., a Delaware corporation | ||
By: |
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Name: |
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Title: |
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[Remainder of Page Left Intentionally Blank]
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THE GRANTEE ACKNOWLEDGES AND AGREES THAT THE SHARES SHALL VEST, IF AT ALL, ONLY DURING THE PERIOD OF THE GRANTEES CONTINUOUS SERVICE (NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED THIS AWARD OR ACQUIRING SHARES HEREUNDER). THE GRANTEE FURTHER ACKNOWLEDGES AND AGREES THAT NOTHING IN THIS NOTICE, THE AGREEMENT, OR THE PLAN, SHALL CONFER UPON THE GRANTEE ANY RIGHT WITH RESPECT TO FUTURE AWARDS OR CONTINUATION OF THE GRANTEES CONTINUOUS SERVICE, NOR SHALL IT INTERFERE IN ANY WAY WITH THE GRANTEES RIGHT OR THE RIGHT OF THE COMPANY OR RELATED ENTITY TO WHICH THE GRANTEE PROVIDES SERVICES TO TERMINATE THE GRANTEES CONTINUOUS SERVICE, WITH OR WITHOUT CAUSE, AND WITH OR WITHOUT NOTICE. THE GRANTEE ACKNOWLEDGES THAT UNLESS THE GRANTEE HAS A WRITTEN EMPLOYMENT AGREEMENT WITH THE COMPANY TO THE CONTRARY, THE GRANTEES STATUS IS AT WILL.
The Grantee acknowledges receipt of a copy of the Plan and the Agreement and represents that he or she is familiar with the terms and provisions thereof, and hereby accepts the Award subject to all of the terms and provisions hereof and thereof. The Grantee has reviewed this Notice, the Plan, and the Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to executing this Notice and fully understands all provisions of this Notice, the Plan, and the Agreement. The Grantee hereby agrees that all questions of interpretation and administration relating to this Notice, the Plan and the Agreement shall be resolved by the Administrator in accordance with Section 17 of the Agreement. The Grantee further agrees to the venue selection in accordance with Section 18 of the Agreement. The Grantee further agrees to notify the Company upon any change in the residence address indicated in this Notice. TO ACCEPT THIS AWARD AND PURCHASE THE SHARES, THE GRANTEE MUST EXECUTE AND DELIVER THIS SIGNED NOTICE AND AGREEMENT TO THE COMPANY ACCOMPANIED WITH PAYMENT OF THE TOTAL PURCHASE PRICE (PAID IN ACCORDANCE WITH SECTION 2 OF THE AGREEMENT) WITHIN 60 DAYS OF RECEIPT OF THIS NOTICE FROM THE COMPANY. THE DATE OF DELIVERY OF THE SIGNED NOTICE AND AGREEMENT TOGETHER WITH PAYMENT OF THE TOTAL PURCHASE PRICE SHALL CONSTITUTE THE DATE OF PURCHASE OF THE SHARES.
Dated: |
Signed: | |||||
Grantee |
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Award Number:
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
RESTRICTED STOCK PURCHASE AWARD AGREEMENT
1. Purchase of Shares. Adicet Bio, Inc., a Delaware corporation (the Company), agrees to issue and sell to the Grantee (the Grantee) named in the Notice of Restricted Stock Purchase Award (the Notice), the Total Number of Shares of Common Stock Awarded set forth in the Notice (the Shares) for a Purchase Price per Share set forth in the Notice (the Total Purchase Price), subject to the Notice, this Restricted Stock Purchase Award Agreement (the Agreement) and the Companys 2015 Stock Incentive Plan, as amended from time to time (the Plan), which are incorporated herein by reference. Payment for the Shares in the amount of the Total Purchase Price set forth in the Notice shall be made to the Company upon execution of the Notice. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Agreement. All Shares sold hereunder will be deemed issued to the Grantee as fully paid and nonassessable shares, and the Grantee will have the right to vote the Shares at meetings of the Companys stockholders. The Company shall pay any applicable stock transfer taxes imposed upon the issuance of the Shares to the Grantee hereunder.
2. Method of Payment. Payment of the Total Purchase Price shall be by any of the following, or a combination thereof, at the election of the Grantee; provided, however, that such payment method does not then violate any Applicable Law and, provided further, that the portion of the Total Purchase Price equal to the par value of the Shares must be paid in cash or other legal consideration permitted by the Delaware General Corporation Law:
(a) cash; or
(b) check.
3. Transfer Restrictions for Unvested Shares. The Shares sold to the Grantee hereunder may not be sold, transferred by gift, pledged, hypothecated, or otherwise transferred or disposed of by the Grantee prior to the date that the Shares become vested pursuant to the Vesting Schedule set forth in the Notice. Any attempt to transfer Shares in violation of this Section 3 will be null and void and will be disregarded. After the Shares vest, the Shares will remain subject to the Companys Right of First Refusal as set forth in Section 8 below.
4. Escrow of Stock. For purposes of facilitating the enforcement of the provisions of this Agreement, the Grantee agrees, immediately upon receipt of the certificate(s) for the Shares, to deliver such certificate(s), together with an Assignment Separate from Certificate in the form attached hereto as Exhibit A, executed in blank by the Grantee with respect to each such stock certificate, to the Secretary or Assistant Secretary of the Company, or their designee, to hold in escrow for so long as such Shares have not vested pursuant to the Vesting Schedule set forth in the Notice or are subject to the Companys Right of First Refusal, with the authority to take all
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such actions and to effectuate all such transfers and/or releases as may be necessary or appropriate to accomplish the objectives of this Agreement in accordance with the terms hereof. The Grantee hereby acknowledges that the appointment of the Secretary or Assistant Secretary of the Company (or their designee) as the escrow holder hereunder with the stated authorities is a material inducement to the Company to make this Agreement and that such appointment is coupled with an interest and is accordingly irrevocable. The Grantee agrees that the Restricted Shares may be held electronically in a book entry system maintained by the Companys transfer agent or other third-party and that all the terms and conditions of this Section 4 applicable to certificated Restricted Shares will apply with the same force and effect to such electronic method for holding the Restricted Shares. The Grantee agrees that such escrow holder shall not be liable to any party hereto (or to any other party) for any actions or omissions unless such escrow holder is grossly negligent relative thereto. The escrow holder may rely upon any letter, notice or other document executed by any signature purported to be genuine and may resign at any time. Upon the vesting of all Shares and termination of the Companys Right of First Refusal, the escrow holder will, upon request, transmit to the Grantee the certificate evidencing such Shares, subject, however, to satisfaction of any withholding obligations provided in Section 6 below.
5. Distributions. Except as set forth in Section 9(e), the Company shall disburse to the Grantee all regular cash dividends with respect to the Shares and Additional Securities (whether vested or not), less any applicable withholding obligations.
6. Section 83(b) Election and Withholding of Taxes. The Grantee shall provide the Administrator with a copy of any timely election made pursuant to Section 83(b) of the Internal Revenue Code or similar provision of state law (collectively, an 83(b) Election), a form of which is attached hereto as Exhibit B. If the Grantee makes a timely 83(b) Election, the Grantee shall immediately pay the Company the amount necessary to satisfy any applicable foreign, federal, state, and local income and employment tax withholding obligations. If the Grantee does not make a timely 83(b) Election, the Grantee shall, as Restricted Shares shall vest or at the time withholding is otherwise required by any Applicable Law, pay the Company the amount necessary to satisfy any applicable foreign, federal, state, and local income and employment tax withholding obligations. The Grantee hereby represents that he or she understands (a) the contents and requirements of the 83(b) Election, (b) the application of Section 83(b) to the receipt of the Shares by the Grantee pursuant to this Agreement, (c) the nature of the election to be made by the Grantee under Section 83(b), and (d) the effect and requirements of the 83(b) Election under relevant state and local tax laws. The Grantee further represents that he or she intends to file an election pursuant to Section 83(b) with the Internal Revenue Service within thirty (30) days following the date of this Agreement, and submit a copy of such election to the Company and with his or her federal tax return for the calendar year in which the date of this Agreement falls.
7. Additional Securities. Any securities or cash received (other than a regular cash dividend) as the result of ownership of the Shares (the Additional Securities), including, but not by way of limitation, warrants, options and securities received as a stock dividend or stock split, or as a result of any transaction described in Section 10 or 11 of the Plan, shall be subject to the same conditions and restrictions as the Shares with respect to which they were issued, including, without limitation, the Vesting Schedule set forth in the Notice, Right of First Refusal and the Repurchase Right and retained in escrow in the same manner as the Shares with respect
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to which they relate. The Grantee shall be entitled to direct the Company to exercise any warrant or option received as Additional Securities upon supplying the funds necessary to do so, in which event the securities so purchased shall constitute Additional Securities, but the Grantee may not direct the Company to sell any such warrant or option. If Additional Securities consist of a convertible security, the Grantee may exercise any conversion right, and any securities so acquired shall constitute Additional Securities. Appropriate adjustments to reflect the distribution of Additional Securities shall be made to the price per share to be paid upon the exercise of the Repurchase Right in order to reflect the effect of any such transaction upon the Companys capital structure. In the event of any change in certificates evidencing the Shares or the Additional Securities by reason of any recapitalization, reorganization or other transaction that results in the creation of Additional Securities, the escrow holder is authorized to deliver to the issuer the certificates evidencing the Shares or the Additional Securities in exchange for the certificates of the replacement securities.
8. Companys Right of First Refusal. The Grantee acknowledges and agrees that the Shares are subject to a right of first refusal (Right of First Refusal) as set forth in the Bylaws of the Company, which Right of First Refusal is incorporated herein by reference irrespective of whether the Bylaws are amended at some future date to remove the Right of First Refusal therefrom, and that, except in compliance with such Right of First Refusal, neither the Grantee nor a transferee shall sell, hypothecate, encumber or otherwise transfer any Shares or any right or interest therein.
9. Companys Repurchase Right.
(a) Grant of Repurchase Right. The Company is hereby granted the right (the Repurchase Right), exercisable at any time during the nine (9) month period (the Share Repurchase Period) following the date the Grantees Continuous Service terminates for any reason, with or without cause (including death or disability) (the Termination Date) to repurchase all or any portion of the Shares that are deemed Restricted Shares.
(b) Exercise of the Repurchase Right. The Repurchase Right shall be exercisable by written notice delivered to the Grantee prior to the expiration of the Share Repurchase Period. The notice shall indicate the number of Shares to be repurchased and the date on which the repurchase is to be effected, such date to be not later than the last day of the Share Repurchase Period. On the date on which the repurchase is to be effected, the Company and/or its assigns shall pay to the Grantee in cash or cash equivalents (including the cancellation of any purchase-money indebtedness) an amount equal to the lesser of the Purchase Price per Share previously paid by the Grantee to the Company for such Shares and the Fair Market Value per Share on the date on which the repurchase is to be effected. Upon such payment or deposit into escrow for the benefit of the Grantee, the Company and/or its assigns shall become the legal and beneficial owner of the Shares being repurchased and all rights and interest thereon or related thereto, and the Company shall have the right to transfer to its own name or its assigns the number of Shares being repurchased, without further action by the Grantee.
(c) Assignment. Whenever the Company shall have the right to purchase Shares under this Repurchase Right, the Company may designate and assign one or more employees, officers, directors or stockholders of the Company or other persons or organizations, to exercise all or a part of the Companys Repurchase Right.
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(d) Termination of the Repurchase Right. The Repurchase Right shall terminate with respect to any Shares for which it is not timely exercised.
(e) Additional Shares or Substituted Securities. In the event of any transaction described in Sections 10 or 11 of the Plan, the Repurchase Right shall apply to the new capital stock or other property (including cash paid other than as a regular cash dividend) received in exchange for the Shares in consummation of any such transaction and such stock or property shall be deemed Additional Securities for purposes of this Agreement, but only to the extent the Shares are at the time covered by such Repurchase Right. Appropriate adjustments shall be made to the price per share payable upon exercise of the Repurchase Right to reflect the effect of any such transaction.
10. Stop-Transfer Notices. In order to ensure compliance with the restrictions on transfer set forth in this Agreement, the Notice or the Plan, the Company may issue appropriate stop transfer instructions to its transfer agent, if any, and, if the Company transfers its own securities, it may make appropriate notations to the same effect in its own records.
11. Refusal to Transfer. The Company shall not be required (i) to transfer on its books any Shares that have been sold or otherwise transferred in violation of any of the provisions of this Agreement or (ii) to treat as owner of such Shares or to accord the right to vote or pay dividends to any purchaser or other transferee to whom such Shares shall have been so transferred.
12. Restrictive Legends. The Grantee understands and agrees that the Company shall cause the legends set forth below or legends substantially equivalent thereto, to be placed upon any certificate(s) evidencing ownership of the Shares together with any other legends that may be required by the Company or by state or federal securities laws:
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE ACT) AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER THE ACT OR, IN THE OPINION OF COUNSEL SATISFACTORY TO THE ISSUER OF THESE SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION IS IN COMPLIANCE THEREWITH.
THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER, A RIGHT OF FIRST REFUSAL AND A REPURCHASE RIGHT HELD BY THE ISSUER OR ITS ASSIGNEE(S) AS SET FORTH IN THE RESTRICTED STOCK PURCHASE AGREEMENT BETWEEN THE ISSUER AND THE ORIGINAL HOLDER OF
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THESE SHARES, A COPY OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE ISSUER. SUCH TRANSFER RESTRICTIONS, RIGHT OF FIRST REFUSAL AND REPURCHASE RIGHT ARE BINDING ON TRANSFEREES OF THESE SHARES.
13. Lock-Up Agreement.
(a) Agreement. The Grantee, if requested by the Company and the lead underwriter of any public offering of the Common Stock (the Lead Underwriter), hereby irrevocably agrees not to sell, contract to sell, grant any option to purchase, transfer the economic risk of ownership in, make any short sale of, pledge or otherwise transfer or dispose of any interest in any Common Stock or any securities convertible into or exchangeable or exercisable for or any other rights to purchase or acquire Common Stock (except Common Stock included in such public offering or acquired on the public market after such offering) during the 180-day period following the effective date of a registration statement of the Company filed under the Securities Act of 1933, as amended, or such shorter or longer period of time as the Lead Underwriter shall specify. The Grantee further agrees to sign such documents as may be requested by the Lead Underwriter to effect the foregoing and agrees that the Company may impose stop-transfer instructions with respect to such Common Stock subject to the lock-up period until the end of such period. The Company and the Grantee acknowledge that each Lead Underwriter of a public offering of the Companys stock, during the period of such offering and for the lock-up period thereafter, is an intended beneficiary of this Section 13.
(b) No Amendment Without Consent of Underwriter. During the period from identification of a Lead Underwriter in connection with any public offering of the Companys Common Stock until the earlier of (i) the expiration of the lock-up period specified in Section 13(a) in connection with such offering or (ii) the abandonment of such offering by the Company and the Lead Underwriter, the provisions of this Section 13 may not be amended or waived except with the consent of the Lead Underwriter.
14. Grantees Representations. The Grantee shall, concurrently with the purchase of the Shares, deliver to the Company his or her Investment Representation Statement in the form attached hereto as Exhibit C.
15. Entire Agreement: Governing Law. The Notice, the Plan and this Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and the Grantee with respect to the subject matter hereof, and may not be modified adversely to the Grantees interest except by means of a writing signed by the Company and the Grantee. Nothing in the Notice, the Plan and this Agreement (except as expressly provided therein) is intended to confer any rights or remedies on any persons other than the parties. The Notice, the Plan and this Agreement are to be construed in accordance with and governed by the internal laws of the State of California without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of the State of California to the rights and duties of the parties. Should any provision of the Notice, the Plan or this Agreement be determined to be illegal or unenforceable, such provision shall be enforced to the fullest extent allowed by law and the other provisions shall nevertheless remain effective and shall remain enforceable.
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16. Construction. The captions used in the Notice and this Agreement are inserted for convenience and shall not be deemed a part of the Agreement for construction or interpretation. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term or is not intended to be exclusive, unless the context clearly requires otherwise.
17. Administration and Interpretation. Any question or dispute regarding the administration or interpretation of the Notice, the Plan or this Agreement shall be submitted by the Grantee or by the Company to the Administrator. The resolution of such question or dispute by the Administrator shall be final and binding on all persons.
18. Venue. The Company, the Grantee, and the Grantees assignees pursuant to Section 3 (the parties) agree that any suit, action, or proceeding arising out of or relating to the Notice, the Plan or this Agreement shall be brought in the United States District Court for the Northern District of California (or should such court lack jurisdiction to hear such action, suit or proceeding, in a California state court in the County of San Francisco) and that the parties shall submit to the jurisdiction of such court. The parties irrevocably waive, to the fullest extent permitted by law, any objection the party may have to the laying of venue for any such suit, action or proceeding brought in such court. If any one or more provisions of this Section 18 shall for any reason be held invalid or unenforceable, it is the specific intent of the parties that such provisions shall be modified to the minimum extent necessary to make it or its application valid and enforceable.
19. Notices. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery, upon deposit for delivery by an internationally recognized express mail courier service or upon deposit in the United States mail by certified mail (if the parties are within the United States), with postage and fees prepaid, addressed to the other party at its address as shown in these instruments, or to such other address as such party may designate in writing from time to time to the other party.
END OF AGREEMENT
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EXHIBIT A
STOCK ASSIGNMENT SEPARATE FROM CERTIFICATE
[Please sign this document but do not date it. The date and information of the transferee will be completed if and when the shares are assigned.]
FOR VALUE RECEIVED, hereby sells, assigns and transfers unto , ( ) shares of the Common Stock of Adicet Bio, Inc., a Delaware corporation (the Company), standing in his name on the books of, represented by Certificate No. herewith, and does hereby irrevocably constitute and appoint the Secretary of the Company attorney to transfer the said stock in the books of the Company with full power of substitution.
DATED:
By: |
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(Signature) |
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EXHIBIT B
ELECTION UNDER SECTION 83(b)
OF THE INTERNAL REVENUE CODE OF 1986
The undersigned taxpayer hereby elects, pursuant to the Internal Revenue Code, to include in gross income for calendar year the amount of any compensation taxable in connection with the taxpayers receipt of the property described below:
1. The name, address, taxpayer identification number and taxable year of the undersigned are:
TAXPAYERS NAME |
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TAXPAYERS SOCIAL SECURITY NO.: |
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TAXABLE YEAR: | Calendar Year | |||
ADDRESS: |
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2. The property which is the subject of this election is shares of common stock of Adicet Bio, Inc.
3. The property was transferred to the undersigned on , .
4. The property is subject to the following restrictions: The property is subject to a repurchase right pursuant to which the issuer has the right to acquire the property at the lesser of the original purchase price or the fair market value of the property if for any reason taxpayers employment or service with the issuer is terminated. The issuers repurchase right lapses in a series of periodic installments.
5. The fair market value of the property at the time of transfer (determined without regard to any restriction other than a restriction which by its terms will never lapse) is: $ per share x shares = $ .
6. The undersigned paid $ per share x shares for the property transferred or a total of $ .
The undersigned has submitted a copy of this statement to the person for whom the services were performed in connection with the undersigneds receipt of the above-described property. The undersigned taxpayer is the person performing the services in connection with the transfer of said property.
The undersigned will file this election with the Internal Revenue Service office to which the undersigned files the undersigneds annual income tax return not later than 30 days after the date of transfer of the property. Additionally, the undersigned will include a copy of the election with the undersigneds income tax return for the taxable year in which the property is transferred.
Dated: |
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Taxpayer |
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EXHIBIT C
ADICET BIO, INC. 2015 STOCK INCENTIVE PLAN
INVESTMENT REPRESENTATION STATEMENT
GRANTEE: |
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COMPANY: | ADICET BIO, INC. | |||
SECURITY: | COMMON STOCK | |||
NUMBER OF SHARES: |
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DATE: |
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In connection with the purchase of the above-listed Securities, the undersigned Grantee represents to the Company the following:
(a) Grantee is aware of the Companys business affairs and financial condition and has acquired sufficient information about the Company to reach an informed and knowledgeable decision to acquire the Securities. Grantee is acquiring these Securities for investment for Grantees own account only and not with a view to, or for resale in connection with, any distribution thereof within the meaning of the Securities Act of 1933, as amended (the Securities Act).
(b) Grantee acknowledges and understands that the Securities constitute restricted securities under the Securities Act and have not been registered under the Securities Act in reliance upon a specific exemption therefrom, which exemption depends upon among other things, the bona fide nature of Grantees investment intent as expressed herein. Grantee further understands that the Securities must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available. Grantee further acknowledges and understands that the Company is under no obligation to register the Securities. Grantee understands that the certificate evidencing the Securities will be imprinted with a legend which prohibits the transfer of the Securities unless they are registered or such registration is not required in the opinion of counsel satisfactory to the Company.
(c) Grantee is familiar with the provisions of Rule 701 and Rule 144, each promulgated under the Securities Act, which, in substance, permit limited public resale of restricted securities acquired, directly or indirectly from the issuer thereof, in a non-public offering subject to the satisfaction of certain conditions. Rule 701 provides that if the issuer qualifies under Rule 701 at the time of the sale of the Shares to Grantee, the sale will be exempt from registration under the Securities Act. In the event the Company becomes subject to the reporting requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, ninety (90) days thereafter (or such longer period as any market stand-off agreement may require) the Securities exempt under Rule 701 may be resold, except in the case of affiliates, such Securities may be resold subject to the satisfaction of the applicable conditions specified by Rule 144, including: (1) the availability of certain public information about the Company, (2) the amount of Securities being sold during any three month period not exceeding specified
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limitations, (3) the resale being made in an unsolicited brokers transaction, in transactions directly with a market maker or riskless principal transactions (as said terms are defined under the Securities Exchange Act of 1934) and (4) the timely filing of a Form 144, if applicable.
In the event that the Company does not qualify under Rule 701 at the time of sale of the Securities, then the Securities may be resold in certain limited circumstances subject to the provisions of Rule 144, which may require: the availability of current public information about the Company; the resale to occur more than a specified period after the purchase and full payment (within the meaning of Rule 144) for the Securities; and, in the case of the sale of Securities by an affiliate, the satisfaction of the conditions set forth in sections (2), (3) and (4) of the paragraph immediately above.
(d) Grantee further understands that in the event all of the applicable requirements of Rule 701 or 144 are not satisfied, registration under the Securities Act, compliance with Regulation A, or some other registration exemption will be required; and that, notwithstanding the fact that Rules 144 and 701 are not exclusive, the Staff of the Securities and Exchange Commission has expressed its opinion that persons proposing to sell private placement securities other than in a registered offering and otherwise than pursuant to Rules 144 or 701 will have a substantial burden of proof in establishing that an exemption from registration is available for such offers or sales, and that such persons and their respective brokers who participate in such transactions do so at their own risk. Grantee understands that no assurances can be given that any such other registration exemption will be available in such event.
(e) Grantee represents that Grantee is a resident of the state of .
Signature of Grantee: | ||
By: |
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Date: |
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Exhibit 10.20
APPLIED IMMUNE TECHNOLOGIES LTD.
(the Company)
SHARE OPTION PLAN (2014)
Adopted by the Board of Directors on 2014
TABLE OF CONTENTS
1. |
Preamble |
3 | ||||
2. |
Schedules, Headings and Definitions |
3 | ||||
3. |
Shares Subject to Plan; Issuance of Options |
5 | ||||
4. |
Terms of the Options |
6 | ||||
5. |
Manner of Exercising the Option |
8 | ||||
6. |
Trust |
10 | ||||
7. |
Taxes |
11 | ||||
8. |
Registration of the Exercise Shares |
11 | ||||
9. |
The rights attached to the Exercise Shares |
12 | ||||
10. |
Changes to the Plan and in the Companys Share Capital |
13 | ||||
11. |
Notices; Documentation |
15 | ||||
12. |
Governing Law |
16 | ||||
Schedule A: Form of Exercise Notice |
17 | |||||
Schedule B: Proxy. |
18 |
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1. | Preamble | |||
This plan, as amended from time to time, shall be known as the Applied Immune Technologies Ltd. Share Option Plan (2014) (the Plan). The purpose of the Plan is to provide incentives to certain employees of the Company and others whose identities shall be determined by the Board (the Offerees), from time to time, by offering one or more of such Offerees the opportunity to purchase ordinary shares in the Company, NIS 0.01 par value each (the Ordinary Shares). | ||||
2. | Schedules, Headings and Definitions | |||
2.1 | The Schedules hereto constitute an integral part of the Plan. | |||
2.2 | The section headings are intended solely for the readers convenience and in no event shall they constitute a basis for the interpretation of the Plan. | |||
2.3 | In this Plan, the following terms shall have the meanings set forth beside them: | |||
102 Provisions | The provisions of section 102 of the Ordinance and of the Income Tax Rules (Tax Relief in Allocating Shares to Employees), 5763-2003, as they shall apply from time to time to shares and options issued hereunder; | |||
3(i) Option | An Option granted under the rules of Section 3(i) of the Ordinance, as amended, or any law or regulations, which shall replace Section 3(i); | |||
Applicable Laws | The requirements relating to the administration of share option plans under Israeli law, any stock exchange or quotation system on which the Ordinary Shares are listed or quoted and the applicable laws of any other country or jurisdiction where Options are granted under the Plan; | |||
Board | The Companys Board of Directors, or any committees lawfully empowered by the Board; | |||
Cause | Any of the following: (i) the Offerees theft, dishonesty, or falsification of any Company documents or records; (ii) the Offerees improper use or disclosure of the Companys confidential or proprietary information; (iii) any action by the Offeree which has a detrimental effect on the Companys reputation or business; (iv) any material breach of the Offeree of any agreement between the Offeree and the Company; (v) the Offerees conviction (including any guilty plea or plea of nolo contendere) of any criminal act which impairs the Offerees ability to perform his or her duties with the Company; (vi) a breach of the non compete commitment.
For purposes of the definition of Cause, Company shall include the parent or subsidiary employing or engaging the services of the Offeree; |
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Consultant | Any person who is engaged by the Company or any Parent or Subsidiary to render consulting or advisory services to such entity, including any employees of such person and including a non-Employee Director of the Company or any Related Company thereof. An Offeree shall not cease to be a Consultant in case of any temporary interruption in such persons availability to provide services to the Company, any Related Company, or any successor, which has been authorized in writing by the engaging company (or by the Parent or Subsidiary) prior to its commencement; | |||
Controlling Shareholder | Shall have the meaning ascribed to it in Section 32(i) of the Ordinance; | |||
Effective Date | A date to be determined separately for each offer to each Offeree, from which the Offerees entitlement to the Options shall begin to vest; | |||
Exercise Date | As defined in section 5.2 below; | |||
Exercise Price | A price to be determined separately for each Offeree under section 3.4 below and set out in such Offerees Notice of Share Option Grant; | |||
Exercise Shares | As defined in section 3.2 below; | |||
IPO | Initial public offering of the Companys shares; | |||
Lockup Period | As defined in section 6.1 below; | |||
Notice Of Share Option Grant | A Notice setting out each Offerees separate terms and conditions including but not limited to the Offerees Options Exercise Price, Vesting Schedule etc.; | |||
Number of Vested Options | A number to be calculated separately for each Offeree in accordance with such Offerees vesting schedule determined under section 3.4 below and set out in such Offerees Notice of Share Option Grant; | |||
Options | As defined in section 3.2 below; | |||
Ordinance | The Israeli Income Tax Ordinance [New Version], 5721-1961 as amended, the rules promulgated thereunder, or any law or regulations which shall replace the Ordinance or Sections 3(i) or 102 Provisions; | |||
Related Company | A company in which the Company is a Controlling Shareholder or a company which is a Controlling Shareholder in the Company; | |||
Significant Event | Any Deemed Liquidation Event (as defined in the Companys Articles of Association, as amended from time to time), including, without limitation, any of the following: | |||
(a) An acquisition of all or substantially all of the Companys assets, or |
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(b) the registration of the Companys shares for trade on the Stock Exchange, or
(c) a change of the Companys structure and any arrangement between the Company and its shareholders and/or creditors and/or holders of options on the Companys shares, or
(d) a statutory merger or statutory spin-off or an arrangement which economically amounts to a merger or a spin-off, or
(e) a transaction or a series of consecutive transactions within a period of 12 months, in which all or substantially all of the issued and outstanding share capital of the company are sold to a third party; | ||||
Successor Company | Any entity with which the Company is merged, or which acquires the Company, following which the Company is not the surviving entity; | |||
Stock Exchange | Any established stock exchange or a national market system, including a foreign stock exchange; | |||
Termination Date | The earlier of the date of notice of dismissal of, or resignation by the Offeree in question and the date the employee-employer relationship between the Offeree and the Company or a subsidiary thereof is terminated, as the case may be; | |||
Trustee | The trustee specified in the Notice of Share Option Grant of the relevant Offeree and any other trustee who shall replace the same for the purposes of this Plan. |
3. | Shares Subject to Plan; Issuance of Options |
3.1 | The Company, during the term of this Plan will at all times reserve and keep available such number of Ordinary Shares as shall be sufficient to satisfy the vested portion of Options granted under the Plan and any other share and option plans which may be adopted by the Company in the future, subject to any adjustment provided below. Such Ordinary Shares may consist, in whole or in part, of authorized and unissued shares or treasury shares. Any shares that are subject to Options that, for any reason, expire or are terminated unexercised shall again become available for issuance under the Plan. In the event of any merger, reorganization, consolidation, recapitalization, share dividend, share distribution, stock split, spin off, combination or reclassification of shares or any other change in corporate structure affecting the number of authorized Ordinary Shares, an adjustment in the number of shares to be covered by the Plan shall be made by the Board, consistent with its determinations under section 4, below. |
3.2 | The Company shall offer the Offerees, for consideration to be determined separately for each Offeree, non-marketable and non transferable (excluding transfer to heirs in the event of death, as provided for in section 4.4 below or in circumstances as provided in section 9.5) options, the exact number of which is to be determined by the Board from time to time, subject to the provisions of section 3.1 above (the Options), each convertible into one Ordinary Share (the Exercise Shares), all as provided below. In the event that any Option |
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granted under the Plan shall expire, terminate or be cancelled for any reason without having been exercised in full, and to such extent not exercised, such Exercise Shares subject thereto shall again be available for the purposes of the Plan. |
3.3 | Under the Plan, the Options shall be offered to the Offerees, whose identities shall be determined at the Boards sole discretion. The Options shall be offered on an individual and personal basis, at the recommendation of the Companys CEO and subject to the Boards approval in respect of each and every Offeree. |
3.4 | In respect of each individual Offeree, the Board shall, determine in its sole discretion: (i) the number of Options to be granted to such Offeree under this Plan, (ii) the Exercise Price of each Option, (iii) the Effective Date, (iv) the vesting schedule and conditions in respect of the Options granted to such Offeree, including the acceleration of such vesting schedule and (v) any other matter which is necessary or desirable for, or incidental to, the administration of the Plan. |
3.5 | With respect to Israeli Offerees, the Options shall be issued under the Trustees name, and shall be held in trust by the Trustee for the benefit of such Offerees, as provided for in section 6 below. |
3.6 | The Plan shall be administered by the Board and the Board shall have, in addition to the powers and authorities vested in it under the Plan, all the powers and authorities to efficiently administer the Plan as well as to construe and interpret the terms of the Plan and awards granted pursuant to the Plan. |
3.7 | Upon or within a reasonable time following the issuance of the Options to an Offeree (or in favour thereof), the Company shall provide such Offeree with a notice of such issuance (the Notice of Share Option Grant). The Notice of Share Option Grant shall be signed by the Offeree and the Company and shall include, among others, the following details: |
(a) | The number of Options granted to the Offeree or in favour thereof; |
(b) | The Exercise Price of each Option; |
(c) | The Effective Date; |
(d) | The vesting schedule and conditions in respect of the Options granted to such Offeree; |
(e) | The applicable tax route chosen by the Company; |
(f) | The expiration date of the Options; and |
(g) | Any further provision determined by the Board under the provisions of this Plan. |
4. | Terms of the Options |
4.1 | Each Option shall entitle the Offeree holding such Option to receive, upon exercise of the Option, one fully paid-up Ordinary Share. |
4.2 | If the Ordinary Shares of the Company shall at any time be changed or exchanged by declaration of a stock dividend (bonus stock), stock split, combination or exchange of stock, recapitalization, or any other like event by or of the Company, and as often as the same shall occur, then the number and class of the Exercised Shares underlying the Options subject to the Plan and the Exercise Price shall be appropriately and equitably adjusted so as to maintain the proportionate equity portion represented by the Options and the total Exercise |
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Price of the Options, provided, however, that no adjustment shall be made by reason of the distribution of subscription rights (rights offering) on outstanding Ordinary Shares or other issuance of shares by the Company. Except as expressly provided herein, no issuance by the Company of stock of any class, or securities convertible into stock of any class, shall affect, and no adjustment by reason thereof shall be made with respect to, the number or price of Shares underlying an Option. Any adjustment according to this section shall be subject to the receipt of a tax ruling or approval from the tax authorities, if and as necessary. |
4.3 | In the event that the employee-employer relationship between an Offeree and the Company or a subsidiary of the Company, as applicable, shall terminate, the following provisions shall apply: |
4.3.1 | In the event that such employee-employer relationship shall terminate without Cause prior to the Offerees exercise of an Option granted to him/her in whole or in part, the Offeree shall be entitled to exercise the Option during a period of up to 3 months (unless otherwise determined in each Offerees Notice of Share Option Grant) commencing on the Termination Date according to the number of Options the right to the exercise of which had vested by the Termination Date. In the event that such Offeree shall not exercise such Option by the end of such period, such Option, and the right to acquire such shares shall terminate, all interests and rights of the Offeree in and to the same shall ipso facto expire. Options which the Offeree shall not have been entitled to exercise upon the Termination Date shall expire automatically on the Termination Date and shall have no value whatsoever. It is clarified that during such period of up to 3 month the Offerees entitlement to exercise Options shall not continue to vest. |
The Board, at its sole and absolute discretion and without such act constituting a precedent in respect of any other Offeree, shall be entitled to extend the period during which the Offeree shall be entitled to exercise the Option, by a period to be fixed by the Board.
4.3.2 | In case the Offeree will be employed by the Company in a continuous period of less then a full calendar year, the Offeree will be entitled to receive a relative part of the Options which are vested in that same year, according to the number of the continuous month in which the Offeree was employed by the Company in that same calendar year; For the purpose of demonstration only (and under the assumption that the vesting period was defined as one year for each quantum) in case where the Offerees employment by the Company will terminate after eightteen (18) month from the grant of the Options, then the Offeree will be entitled to exercise the first quantum and half of the second quantum. |
4.3.3 | Notwithstanding the provisions of sections 4.3.1 and 4.3.2 above, in the event that such employee-employer relationship shall terminate with Cause, all the Options granted to such Offeree, and the right to acquire such Exercise Shares shall terminate, all interests and rights of the Offeree in and to the same shall ipso facto expire on the Termination Date. Any Options which were immediately exercisable on the Termination Date shall also expire automatically and such Options shall have no value whatsoever. |
4.3.4 | For the avoidance of doubt, it is hereby clarified that a dismissed Offeree shall not be entitled to claim against the Company that he/she was prevented from continuing to receive vested Options from the date of his/her dismissal. Such dismissed Offeree shall not be entitled to any compensation in respect of the Options which would have vested in his/her favour had he/she not been dismissed. |
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4.4 | The provisions of Section 4.3 above shall apply, mutatis mutandis, to the termination of relationship between Consultant and the Company or a subsidiary of the Company. |
4.5 | The Options shall not be transferable or marketable in any manner, save for a transfer to an Offerees heirs in the event of such Offerees death (provided that upon the demise of such Offeree, such Options shall have been in force), and may be exercised, during the lifetime of the Offeree, only by the Offeree. |
Options inherited by heirs shall be exercisable by such heirs or by the Executor of the Offerees estate, in such portion vested up to the date of Offerees death. Such exercise shall take place within twelve (12) month of the date of death or until the last date on which the deceased would have been entitled to exercise such Options, whichever is later. For the avoidance of doubt, it is clarified that the Offerees entitlement to Options shall not continue to vest after his/her death.
Options inherited by heirs which are not exercisable by the heirs within the time specified herein, shall terminate and the Exercise Shares covered by such Options shall revert to the Plan. In addition to the foregoing and without derogating therefrom, any right to acquire Exercise Shares shall terminate all interests and rights in and to the same shall ipso facto expire.
4.6 | Notwithstanding the provisions of section 4.3.1 above, the provisions of section 4.4 above shall apply, mutatis mutandis, to the Offeree if his/her employment or engagement was terminated due to his/her total and permanent disability or retirement after the age of 67. |
4.7 | Should the Company grant Options to a particular Offeree on several Effective Dates, the Offerees vesting schedule and entitlement to exercise a portion of the Options granted on a particular Effective Date shall be calculated on the basis of such particular Effective Date and separately from the rest of the Options granted to such Offeree. |
4.8 | The Board shall have the sole authority to extend the exercise periods detailed in sections 4.3-4.5 above at its sole discretion |
5. | Manner of Exercising the Option |
5.1 | The options shall be exercisable, at any time, subject to the satisfaction of all vesting terms and conditions, set out in this Plan and in the Offerees Notice of Share Option Grant. |
Without derogating from the above after Termination Date and regarding the relevant Offeree (or his/her heirs) alone during the period such Offeree may exercise the Options in accordance with the provisions of section 4 above;
5.2 | Should an Offeree wish to exercise the Options available to him/her for exercise and to convert such Options to Exercise Shares, the Offeree shall submit to the Company a written request, on a form as attached hereto as Schedule A or as otherwise prescribed by the Company, for an issuance of Exercise Shares in respect of the Options, the details of which to be specified in the request (the Exercise Notice). The Offeree shall attach to the Exercise Notice an amount that equals the Exercise Price multiplied by the Number of Vested Options which the Offeree wishes to exercise (the Exercise Amount). The Exercise Notice shall be deemed to have been received by the Company following the Offerees actual payment to the Company of the Exercise Amount, including without limitation, by cash or check, in respect of the Options to be exercised. The date of receipt by the Company of the Exercise Notice shall for all purposes be deemed as the exercise date (the Exercise Date). |
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In the case of an Israeli Offeree, the Company shall also transfer the Exercise Notice to the Trustee. The Trustee shall be entitled to set additional exercising procedures as the Trustee shall see fit, provided that the Trustee gives the Company prior written notice, of any such procedures.
5.3 | Exercise Notices which are submitted after the last date set for exercising the Options, or which were received by the Company under section 5.2 above but not during a period during which the Options may be exercised in accordance with section 5.1 above, or which specify Options which have not yet vested, or which do not contain all of the details which must be included in a Notice of Exercise - shall not be accepted and shall have no force whatsoever. |
The Offeree shall execute and deliver any document required under any law or by the Company or the Trustee for the purposes of issuance of the Exercise Shares, including any agreement between the Company and its shareholders setting forth certain obligations of the Companys shareholders and certain restrictions and limitations on the transfer shares of the Company including, without limitation, the terms of a bring along provision.
5.4 | After the date on which the Exercise Notice, together with the Exercise Amount, has been received by the Company, as provided for in section 5.2 above, the Company shall issue the Exercise Shares in respect of the Options specified in the Exercise Notice and shall register the Offeree as owner of the Exercise Shares in the Companys shareholders registry, and shall then deliver to the Offeree, at his/her express prior written demand, a share certificate in respect of the Exercise Shares. |
5.5 | Notwithstanding the above, in the case of an Israeli Offeree, the Exercise Shares shall be issued under the Trustees name and the Company shall register the Trustee as owner of the Exercise Shares in the Companys shareholders registry, and shall then deliver to the Trustee, at the Trustees express prior written demand, a share certificate in respect of the Exercise Shares. An option issuance certificate exercised in respect of all of the Options specified therein, shall expire and be void and shall not entitle its owner to any right. |
Should an option issuance certificate be exercised in respect of part of the Options specified therein - the option issuance certificate shall be void insofar as it concerns the exercised Options. Following the Exercise Date and against receipt of the option issuance certificate the Company shall deliver to the Offeree (and in the case of an Israeli Offeree to the Trustee) a new amended option note reflecting the number of Options to which the Offeree who had exercised Options and converted same to Exercise Shares is entitled.
5.6 | Notwithstanding the provisions of section 5 above: |
5.6.1 | Exercise Shares shall not be issued pursuant to the exercise of Options unless the exercise of such Options and the issuance and delivery of such Exercise Shares shall comply with any law and shall be further subject to the approval of the Company with respect to such compliance. |
5.6.2 | As a condition to the exercise of an Option, the Board may require the person exercising such Option to represent and warrant at the time of any such exercise that the Exercise Shares are being purchased only for investment and without any present intention to sell or distribute such Exercise Shares if, in the opinion of the Company, such a representation is required under any Applicable Laws. |
5.7 | Until the consummation of an IPO, the Exercise Shares shall be voted by an irrevocable proxy, attached hereto as Schedule B (the Proxy) pursuant to the directions of the Board, such Proxy to be assigned to the person or persons designated by the Board. Such person or |
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persons designated by the Board shall be indemnified and held harmless by the Company against any cost or expense (including counsel fees) reasonably incurred by him/her, or any liability (including any sum paid in settlement of a claim with the approval of the Company) arising out of any act or omission to act in connection with the voting of such Proxy unless arising out of such members own fraud or bad faith, to the extent permitted by applicable law. Such indemnification shall be in addition to any rights of indemnification the person(s) may have as a director or otherwise under the Companys Articles of Association, any agreement, any vote of shareholders or disinterested directors, insurance policy or otherwise |
5.8 | An Option not exercised within ten (10) years from the issuance of the Options to an Offeree shall expire automatically, and shall have no value whatsoever. |
6. | Trust |
The Options and/or Exercise Shares and/or other shares received subsequently following any realization of rights, including without limitation bonus shares, which are granted to an Israeli Offeree under the Plan shall be allocated or issued under the Trustees name and shall be held by the Trustee for the Offerees benefit, in accordance with the following terms and conditions:
6.1 | Subject to the provisions of sections 9.4 below, the Options and/or Exercise Shares which shall have been issued under the Trustees name for the Offerees benefit shall be the Trustee for a period not shorter than the period specified within section 102 for the tax route chosen by the Board or for a different period that shall be specified in accordance with the 102 Provisions from time to time (the Lockup Period). |
6.2 | Subject to the provisions of section 102, an Offeree shall not transfer or release from the control of the Trustee any Option or any Exercise Share, until the lapse of the Lockup Period. Notwithstanding the above, if any such release or Transfer occurs during the Lockup Period, the sanctions under section 102 shall apply to and shall be borne by such Offeree. |
6.3 | In the event that a stock split shall be effected or bonus shares shall be issued on account of the Exercise Shares which have been issued for the Offerees benefit, such new split or bonus shares shall be transferred by the Company to the Trustee to hold for such Offerees benefit. Such split or bonus shares issued in connection with Exercise Shares that are subject to the 102 Provisions, shall be subject to the 102 Provisions for all purposes. |
6.4 | In the event that an Offeree is no longer employed or engaged by the Company, as the case may be, then the Company may condition the holding of the Exercise Shares which are subject to such Option by the Trustee for the benefit of such Offeree in the participation of such Offeree in the Trustee fee. |
6.5 | The execution of any instructions given to the Trustee by an Offeree shall be subject to approval of such order by the Company. The Company shall approve instructions given by an Offeree to the Trustee within a reasonable period of time, provided that such instructions are in full compliance with the terms of the Plan. The approval by the Company of any instructions given to the Trustee by an Offeree shall not constitute proof of the Companys recognition or acknowledgement or acceptance of any right of such Offeree. |
6.6 | Subject to the provisions of this Plan, Options granted to Israeli Offerees and/or Exercise Shares shall not be released from the control of the Trustee nor shall they be transferred unless the Company and the Trustee are satisfied that the full amounts of Tax due by the applicable Offeree have been paid or will be paid. |
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6.7 | As long as the Options and any Exercise Shares are held by the Trustee for the benefit of the Offeree, all rights of the Offeree over such Options and Exercise Shares cannot be transferred other than by will or laws of descent and distribution. |
7. | Taxes |
7.1 | Any tax imposed in respect of the Options and/or the exercise of the Options into Exercise Shares and/or the sale and/or the transfer of the Options and/or the Exercise Shares shall be borne solely by the Offerees, and in the event of any Offerees death, by his/her heirs. The Company shall not be liable for the aforementioned taxes, directly or indirectly, nor shall they be required to pay such taxes indirectly by any increase in the Offerees salaries or remuneration. To the extent that the Company might be held responsible for such tax, the imposed tax shall be deducted, on the date such tax is payable, from the sale consideration or paid to the Trustee or to the tax authorities by the Offerees, as applicable. The Company may condition the exercise of Options or the transfer or the assignment of Options or Exercise Shares upon a withholding of such tax or upon receiving a confirmation, to the Companys satisfaction, that such tax has been paid by the Offeree. The Company may set procedures to ensure compliance with Applicable Laws. |
7.2 | Without derogating from the above, the Options and/or Exercise Shares which are granted to Israeli Offeree, who are not a controlling shareholders in the Company and/or a Consultant, shall be subject to the 102 Provisions, as shall apply from time to time, and the regulations promulgated thereunder. The Board shall have the absolute discretion to choose between any available tax routes to Employees under Section 102 of the Ordinance. Options allotted to Offerees, who are controlling shareholders in the Company, or to Consultants shall be subject to Section 3(i) of the Ordinance, as shall apply from time to time. The Board shall have the absolute discretion to decide whether Options granted pursuant to Section 3(i) of the Ordinance shall be held with the Trustee for any lockup period |
7.3 | The ramifications of any future modification of the Applicable Laws regarding the taxation of Options and/or shares granted to offerees shall apply to the Offerees accordingly and such Offerees shall bear the full cost thereof, unless such modified laws expressly provide otherwise. For the avoidance of doubt, should the applicability of such taxing arrangements to this Plan or to securities issued in the framework thereof be stipulated by an application by the Company or by the Trustee that same shall apply, the Company shall be entitled to decide, at its absolute discretion, whether to apply such taxing arrangements and to instruct the Trustee to act accordingly. |
7.4 | The Offerees shall indemnify the Company and the Trustee, immediately upon their so notifying the Offerees, for any tax amount (including interest and/or fines of any type and/or linkage differentials in respect of tax and/or withheld tax) payable by the Offerees under Applicable Laws (including under the 102 Provisions, if such provisions shall apply), and which has been paid by the Company or a subsidiary of the Company or the Trustee or which the Company, a subsidiary of the Company or the Trustee are required to pay to a local or foreign tax authority. The Company and the Trustee (if applicable) may exercise such indemnification by deducting the amount subject to indemnification from the Offerees salaries or remunerations. |
8. | Registration of the Exercise Shares |
8.1 | Should a reorganization or certain other arrangements regarding the Companys share capital be necessary prior to the issuance of the Companys shares on a Stock Exchange, Offerees hereby agree that the rights attached to the Options and/or Exercise Shares shall be adjusted accordingly. |
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8.2 | Should the Companys shares be traded on a Stock Exchange, each Offeree shall be entitled to sell the Exercise Shares, subject to the Lockup Period applicable to such Offeree, and to the provisions of sections 6 and 7 above and to any other applicable provision regarding such lockup of shares, as may be required under any applicable law, the rules of the Stock Exchange where the Companys shares are traded or by the underwriters involved in such issuance. |
8.3 | In the event that the Companys shares shall be registered for trade on a Stock Exchange, the Company does not undertake to register any Exercise Shares for trade on such Stock Exchange, or that such registration, if carried out at all at the Boards discretion, shall take place within a certain period of time following the public trading of the Companys shares. Without derogating from the foregoing however, the Company shall use its reasonable efforts to register the Exercise Shares for trade within a reasonable time following the date the Companys shares shall be traded on a Stock Exchange. |
8.4 | Subject to the provisions of section 7 above, the Company shall bear all expenses incurred in connection with the issuance and the registration of the Exercise Shares including stamp duty (if applicable). |
9. | The Rights Attached to the Exercise Shares |
9.1 | The Exercise Shares are Ordinary Shares of the Company, and they shall carry rights equal for all intents and purposes to the Ordinary Shares of the same class already included in the Companys share capital, but subject to (i) the restriction on the voting rights in the General Meetings by virtue of such shares until the consummation of an IPO as provided in section 5.7 above, (ii) the restrictions on sale of the Exercise Shares as provided in section 9.4 below and (iii) the Companys option to purchase the Exercise Shares as provided for in section 9.5 below. |
Exercise Shares shall be entitled to any dividend or other distributions of the Company provided that the record date used to determine the persons eligible for participation in such distribution shall occur on or after the Exercise Date. The Exercise Shares shall not be protected against their dilution in the Companys capital in any manner whatsoever.
9.2 | For the avoidance of doubt, it is hereby clarified that the Exercise Shares shall not constitute a separate class of shares, but shall be an integral part of the Companys Ordinary Shares. |
9.3 | Any change to the Companys Memorandum or Articles of Association which affects the rights attached to the Companys shares, shall also apply to the Options and the Exercise Shares. The provisions of the Plan shall remain applicable, with the necessary modifications arising from any such change. |
9.4 | At the end of the Lockup Period, each Offeree shall be entitled to sell or transfer the Exercise Shares, subject to the provisions of sections 9.5-9.6 below. |
9.5 | Notwithstanding the provisions of sections 4.4, 6.1 and 9.4 above, the Company shall have the right to purchase from any Offeree all or part of his/her Exercise Shares and all or part of his Options, vested or unvested, at a price determined by the Board in good faith to reflect the fair market value of such shares or options (the Purchase Consideration). |
Without derogating from other provisions of this Plan, the Company shall not be entitled to purchase such Exercise Shares under this section 9.5 during any of the following periods:
(a) | As long as the Companys shares shall be listed on a Stock Exchange. |
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(b) | The first six months following the exercise of the Options into Exercise Shares regarding such Exercise Shares only. |
The Company shall be entitled to assign its rights under this section 9.5, with regards to any or all of the Exercise Shares or Options, without being required to obtain the consent of any Offeree and such assignee and any of its assignees shall have the right to reassign the said rights.
9.6 | Notwithstanding anything to the contrary in the Articles of Association of the Company, none of the Offerees shall have a right of first refusal in relation with any sale of shares in the Company. |
9.7 | Unless otherwise determined by the Board, until such time as the Company shall complete an IPO, the sale of Shares by the Offeree shall be subject to a right of first refusal on the part of the Repurchaser(s). |
Repurchaser(s) means (i) the Company, if permitted by applicable law, (ii) if the Company is not permitted by applicable law, then any affiliate of the Company designated by the Board; or (iii) if no decision is reached by the Board, then the Companys existing shareholders (save, for avoidance of doubt, for other Offerees who received Options under the Plan), pro rata in accordance with their shareholding. The Offeree shall give a notice of sale (hereinafter the Notice) to the Company in order to offer the Shares to the Repurchaser(s).
9.8 | The Notice shall specify the name of each proposed purchaser or other transferee (hereinafter the Proposed Transferee), the number of Exercise Shares offered for sale, the price per Share and the payment terms. The Repurchaser(s) will be entitled for thirty (30) days from the day of receipt of the Notice (hereinafter the Notice Period), to purchase all or part of the offered Shares on a pro rata basis based upon their respective holdings in the Company. |
9.9 | If by the end of the Notice Period not all of the offered Shares have been purchased by the Repurchaser(s), the Offeree shall be entitled to sell the remainder of the Exercise Shares at any time during the ninety (90) days following the end of the Notice Period on terms not more favourable than those set out in the Notice, provided that the Proposed Transferee agrees in writing that the provisions of this section shall continue to apply to the Shares in the hands of such Proposed Transferee. Any sale of Shares exercised from Options issued under the Plan by the Offeree that is not made in accordance with the Plan or the Notice of Share Option Grant shall be null and void. |
10. | Changes to the Plan and in the Companys Share Capital |
10.1 | The Company shall be entitled, from time to time, to update and/or change the terms of this Plan, in whole or in part, at its sole discretion, provided that such change shall not substantially financially derogate from the rights attached to the Options (whether vested or unvested) as of the date of such modification or update or the rights attached to the Exercise Shares issued under this Plan as of such date. |
10.2 | Notwithstanding the provisions of section 10.1 above, upon the occurrence of a Significant Event: |
10.2.1 | The Board shall be entitled (but not obliged), at its sole discretion, to adjust the rights of an Offeree under the Plan, including by any of the following (a) |
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provide an Offeree with substitute securities or rights of the Successor Company as is reasonable in the opinion of the Board; the grant of any such substitute shall be considered as full compliance with the terms of this Plan; (b) provide for an exchange of Options or Shares for a monetary compensation (including both vested and unvested Options and including for avoidance of doubt a cash out of the Option for the net value), as shall be determined in good faith solely by the Board, which shall also have full authority to select the method for determining the payment (and such determination may provide that payment shall be set at zero if the value of Shares is determined to be less than the Exercise price or in respect of Exercised Shares which would not otherwise be exercisable or vested or that payment may be made only in excess of the Exercise price); (c) decide that every unvested Option and unexercised vested Options shall expire automatically, and shall have no value whatsoever; (d) provide for the Optionees to have the right to exercise all vested Options within a set time period and sell all of their Exercise Shares on the same terms and conditions as applicable to the other shareholders selling their Ordinary Shares as part of the Significant Event; (e) provide for the acceleration of vesting of such Options, as to all or part of the Exercised Shares covered by the Options which would not otherwise be exercisable or vested, under such terms and conditions to be determined by the Board. |
10.2.2 | The Board may determine that any payments made in respect of the Options shall be made or delayed to the same extent that payment of consideration to the holders of the Ordinary Shares in connection with the Significant Event is made or delayed as a result of escrows, indemnification, earn outs, holdbacks or any other contingencies, and the terms and conditions applying to the payment made to the Offeree, including participation in escrow, indemnification, releases, earn-outs, holdbacks or any other contingencies. |
10.2.3 | Notwithstanding the foregoing, in the event of a Significant Event, the Board may determine, in its sole discretion that the terms of any Option be otherwise amended, modified or terminated, without any liability to the Company or its Affiliates and to their respective its officers, directors, employees and representatives and the respective successors and assigns of any of the foregoing in connection with the method of treatment or chosen course of action permitted hereunder. |
10.2.4 | Neither the authorities and powers of the Board under this Section 10.2, nor the exercise or implementation thereof, shall (i) be restricted or limited in any way by any adverse consequences (tax or otherwise) that may result to any Offeree, and (ii) as, inter alia, being a feature of the Option upon its grant, be deemed to constitute a change or an amendment of the rights of such holder under this Plan, nor shall any such adverse consequence be deemed to constitute a change or an amendment of the rights of such holder under this Plan, and may be effected without consent of any Offeree and without any liability to the Company or its Affiliates and to their respective its officers, directors, employees and representatives and the respective successors and assigns of any of the foregoing. |
10.2.5 | The Board may determine different treatment of Options within the scope of a Significant Event such that the Board may take different actions with respect to the vested and unvested portions of an Option, may determine an amount or type of consideration to be received or distributed in a Significant Event which may differ as among the Offerees, and as between the Offerees and any other holders of shares of the Company. |
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10.2.6 | The Boards determinations pursuant to this Section 10.2 shall be conclusive and binding on all Participants. |
10.2.7 | If determined by the Board, the Offerees shall be subject to the definitive agreement(s) in connection with the Significant Event as applying to holders of Shares including such terms, conditions, representations, undertakings, liabilities, limitations, releases, indemnities, participating in transaction expenses and escrow arrangement. Each Participant shall execute such separate agreement(s) or instruments as may be requested by the Company, the Successor Company or the acquirer in connection with such in such Significant Event and in the form required by them. The execution of such separate agreement(s) may be a condition to the receipt of assumed or substituted securities, payment in lieu of the Option or the exercise of any Option. Without de4rogatinf from the above, each Optionee acknowledges and agrees that the Board shall be entitled to authorize any one of its members to sign share transfer deeds in customary form in respect of the Exercise Shares held by such Optionee and that such share transfer deed shall bind the Optionee; |
10.3 | The Board shall be entitled, from time to time, to determine that the granting of Options to any Offeree or any particular type of Offerees under this Plan shall be carried out subject to any changes, additions and conditions to be determined by the Board at its absolute discretion, including providing for sub-plans for certain types of Offerees, and in respect of such Offerees the Plan shall be deemed to include the provisions of any such determination or sub-plan, as well. |
10.4 | This Plan (together with the Notice of Share Options Grant signed by the Company and the Offeree) supersedes all of the agreements and/or understandings reached prior to the date of granting of Options to such Offeree between the Company or any subsidiary thereof and any of the Offerees in connection with issuance of shares of the Company or options on shares of the Company. Any representation and/or promise and/or undertaking made and/or given by the Company and/or by any subsidiary thereof or by whomsoever on their behalf, which have not been expressed herein, shall have no force and effect. |
10.5 | The issuance of the Options and the Exercise Shares under this Plan shall not restrict the Company in any way regarding the future creation of additional and/or other classes of shares, including classes of shares that may in any manner be preferred over the currently existing Ordinary Shares that are offered to the Offerees under this Plan. This issuance of the Options and Exercise Shares under this Plan shall also not grant any of the Offerees the right to any compensation in the event of such creation of an additional class of shares or equalling of rights between classes of shares. |
10.6 | In the event of the proposed dissolution or liquidation of the Company, any or all outstanding Options will expire immediately prior to the consummation of such proposed action, unless otherwise determined by the Board. |
11. | Notices; Documentation |
11.1 | Notices and requests regarding this Plan shall be sent in writing to the addresses of the Company and the Offeree as follows: The Company Applied Immune Technologies Ltd.. (Attn.: CEO, only) Gutwirth Industrial Park, Technion City, Haifa 32000,Israel, PO Box 39; The Offeree - to the Offerees address as registered in records of the Company or a subsidiary of the Company, as applicable. Such notices shall be deemed received at the addressee as follows: if sent by registered mail - within 5 days of their being deposited for mailing at a post office in Israel, and if hand-delivered - on the day of delivery. |
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11.2 | Until the Companys shares are traded on a Stock Exchange, the Company shall have the right to request from any or all the Offerees, and such Offerees shall provide or execute, any certificate, declaration or other document which in the Companys reasonable opinion shall be necessary or desirable pursuant to Applicable Laws including without limitation any certificate or agreement which the Company shall reasonably require from such Offerees as members of a class of the Companys shareholders, or any certificate, declaration or other document deemed by the Board in its reasonable opinion to be appropriate or necessary or desirable for the purposes of (i) raising capital for the Company, (ii) the reorganization of the Company, including, in the event of a consolidation or merger of the Company (whether or not the Company is the surviving entity pursuant to such merger), or any sale, lease, exchange, transfer, or other dispositions of all or substantially all of the assets or shares of the Company, or (iii) the sale or exchange of any Exercise Shares held by such Offerees as may be deemed necessary or desirable by the Board. |
12. | Governing Law |
The Plan and all instruments issued thereunder shall be governed by and construed in accordance with the laws of the State of Israel, without giving effect to the principles of conflict of laws. The competent courts of Tel-Aviv, Israel shall have exclusive jurisdiction in any matters pertaining to the Plan.
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Schedule A
SHARE OPTION PLAN (2014)
FORM OF EXERCISE NOTICE
To
[Name and address of the Trustee]
I, the undersigned Offeree, hereby state as follows:
1. | I am the beneficial owner of Option(s) to purchase Ordinary Shares of Applied Immune Technologies Ltd. (the Company), each having a par value of NIS 0.01 (respectively: the Options; the Shares). The Option(s) are held in trust by you, in accordance with the Trust Agreement between you and the Company, the Companys Share Option Plan (2014) under which the Options were granted and the Notice of Share Option Grant signed between myself and the Company (the plan and the notice shall be referred to, collectively, as the Plan) and with Applicable Laws (as defined in the Plan). |
2. | I wish to exercise my Option(s) as follows: number of Option(s) to be exercised for a total of Shares. |
3. | I acknowledge that I have received, read and understood the Plan and I agree to abide by and be bound by its terms and conditions. |
4. | Until the issuance of the Shares (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to receive dividends or any other rights as a shareholder shall exist with respect to the Shares, notwithstanding the exercise of the Option. Until the consummation of an IPO, the Exercise Shares shall be voted by an irrevocable proxy attached hereto (the Proxy), pursuant to the directions of the Board. |
5. | Offeree understands that Offeree may suffer adverse tax consequences as a result of Offerees purchase or disposition of the Shares. Offeree represents that Offeree has consulted with any tax consultants Offeree deems advisable in connection with the purchase or disposition of the Shares and that Offeree is not relying on the Company or any subsidiary of the Company for any tax advice. |
Submitted by: | Accepted by: | |||||
OFFEREE: | Applied Immune Technologies Ltd. | |||||
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Signature | By: |
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Title: | ||||||
Print Name: | ||||||
Address: | ||||||
Social Security/I.D. Number: |
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Date Received: |
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Schedule B
PROXY
I, the undersigned, as record holder of securities of Applied Immune Technologies Ltd. (the Company) hereby irrevocably appoints the person who holds the office of the chairman of the board of directors of the Company, at any time, or any other person designated for such purpose by the Companys board of directors, as my proxy to attend all shareholders meetings and to vote, execute consents, and otherwise represent me with respect to the shares received from Options granted pursuant to the Companys Share Option Plan (2014), in the same manner and with the same effect as if the undersigned were personally present at any such meeting or voting such securities or personally acting on any matters submitted to shareholders for approval or consent.
I hereby irrevocably waive any right to receive notice in connection with any such meeting of the Shareholders of the Company, whether Regular or Extraordinary, adjourned or otherwise.
This proxy is made pursuant the Applied Immune Technologies Ltd. Share Option Plan (2014) dated, .
The proxy-holder shall waive any preemptive right, right of first refusal, right of first offer, co-sale right or any other similar participation right or restriction to which I will be entitled by virtue of the securities whether offered by the Company or any shareholder thereof.
The Shares shall be voted by the proxy holder in the same proportion as the votes of the other shareholders of the Company.
This proxy is irrevocable as it may effect rights of third parties.
The irrevocable proxy will remain in full force and effect until the consummation of an IPO, upon which it will terminate automatically.
This proxy shall be signed exactly as the shareholders name appears on his share certificate.
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DATE | NAME | |||
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SIGNATURE |
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NOTICE TO THE ISRAELI EMPLOYEES OF THE COMPANY
Applied Immune Technologies Ltd.
(the Company)
To:
Notice of Share Option Grant
You (the Offeree) have been granted options, pursuant to of the Applied Immune Technologies Ltd. Share Option Plan (2014) attached hereto as Exhibit A (the Plan) and this Notice of Share Option Grant, to purchase shares of the Companys Ordinary Shares as follows:
Effective Date |
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Exercise Price per Option: |
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Total Number of Options Granted: |
The Trustee |
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The Tax route |
Capital Gain |
1. | All terms not expressly defined herein shall have the meaning assigned to them in the Plan, unless such interpretation does not conform with the circumstances or context of the issue. |
2. | Your entitlement to the Exercise Shares by virtue of the Options hereby granted shall vest (the Number of Vested Options) at the following rates and dates: |
Amount of vested Options |
Vesting Date | |
Total |
Nothing of the foregoing shall be construed so as to derogate from the Lockup Period provided under the 102 Provisions or the restrictions on the exercise of Options provided in the Plan.
For the purpose of calculating your entitlement to the Options, you shall not be deemed to be employed in the Company during periods for which you shall not be entitled to severance pay pursuant to section 10 of the Severance Pay Regulations (Severance Pay Calculation and Resignation that shall be deemed to be Dismissal), 5724-1964.
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3. | Any exercise of your right to purchase shares according to your Number of Vested Options shall not derogate from your right to purchase the remainder of the Exercise Shares to which you shall be entitled by virtue of the Options granted to you, if and when, such remainder shall vest. |
4. | Your Options/ Exercise Shares shall be held in trust under the terms and conditions of the capital gains route under Section 102 of the Ordinance. The trust period will commence upon the date of allotment of the Option and will terminate after 24 months from the date in which the Option was granted or any other period determined under the Ordinance with respect to the capital gain route or determined by the Israeli Income Tax Authorities (the Lock-Up Period). |
5. | The following provisions shall apply to the Options: |
5.1 | The Options shall be exercisable, in whole or in part, immediately upon the vesting of the right to exercise the Options as described in section 2 above. |
5.2 | Exercising the Options to Exercise Shares shall be contingent upon payment to the Company of the Exercise Price per each Option, as provided for in section 5 of the Plan. |
5.3 | An Option not exercised within ten (10) years from the issuance of the Options to an Offeree shall expire automatically, and shall have no value whatsoever. |
5.4 | The Company and its shareholders shall have certain rights in the Exercise Shares as specified in the Plan, including the Companys right to purchase such shares set out in section 9.5 of the Plan and the right of the shareholders of the Company to require the Offeree sell his/her Exercise Shares set out in section 10.2 of the Plan. |
5.5 | Until the consummation of an IPO, the Exercise Shares shall be voted by an irrevocable proxy attached to the Plan as Schedule B (the Proxy) pursuant to the directions of the Board, such Proxy to be assigned to the person or persons designated by the Board. |
6. | Notwithstanding any provision of the Plan: |
6.1 | Prior to the payment of the tax applicable under law, including under the 102 Provisions (the Applicable Tax), the Options and/or the Exercise Shares or rights arising therefrom shall not be transferable or assignable, shall not be subject to any mortgage, liens, attachment or other encumbrance, and no power of attorney or note of transfer shall be issued in respect thereof, whether such instrument enter into force immediately or at a future date, excluding transfer by power of a last will or under law and all subject to the terms of the Plan. |
6.2 | Should the Options or Exercise Shares have been transferred pursuant to the provisions of a last testamentary instrument or under applicable law, the 102 Provisions shall apply to the heirs or transferees of the deceased Offeree. |
6.3 | Subject to the approval of the Plan by the Income Tax Authority, you shall be taxed in Israel in accordance with the provisions of the capital gain route under Section 102 of the Ordinance, including the provisions the regulations and any tax ruling or agreement obtained by the company with regard to the Plan. |
In accordance with Section 102(b)(4) of the Ordinance, if you sell Exercise Shares (or release the Option or the Exercise Shares from the Trust) before the termination of the Lock-Up Period, you will be liable to pay tax at your marginal income tax rate, in addition to social security and health tax contributions.
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By your signature on this Notice of Share Option Grant you herby take upon yourself to comply with the conditions set under Section 102 of the Ordinance with regard to the capital gain route and the Regulations.
6.4 | Subject to the 102 Provisions, the Trustee shall not transfer the Options and/or the Exercise Shares to the Offeree name, and shall not transfer the consideration received from the sale of the Exercise Shares to the Offeree, unless one of the following conditions shall be fulfilled: |
6.4.1 | the Offeree provided the Trustee with a certificate from the Assessing Officer that the Applicable Tax has been paid; or |
6.4.2 | the Offeree paid the Trustee an amount equalling to the amount of tax applicable in accordance with the 102 Provisions of the consideration, as defined in section 102 of the Ordinance (the Taxable Consideration) for such sale, and the Trustee checked the manner of calculating the payable amount, at his/her sole discretion, and was fully satisfied that the calculation was performed accurately and lawfully; or |
6.4.3 | The Trustee deducted the applicable tax in accordance with the 102 Provisions of the Taxable Consideration, or any other amount as shall be approved by the Assessing Officer, from the consideration he/she received from the sale of the Options and/or the Exercise Shares. |
7. | The Options shall not be transferable or marketable in any manner, save for a transfer to an Offerees heirs in the event of such Offerees death or transfer under the provisions of sections 9.5 and 10.2 of the Plan. |
8. | It is hereby clarified that the Options and/or the Exercise Shares are extraordinary, one-time benefits granted to the Offerees, and are not and shall not be deemed a salary component for any purpose whatsoever, including in connection with calculating severance compensation under the Severance Compensation Law, 5723-1963 and the regulations promulgated thereunder. |
9. | THE OFFEREE ACKNOWLEDGES AND AGREES THAT THE VESTING OF SHARES PURSUANT TO SECTION 2 ABOVE IS EARNED ONLY BY CONTINUING EMPLOYMENT AT THE WILL OF THE COMPANY OR THE RELEVANT SUBSIDARY. |
THE OFFEREE FURTHER ACKNOWLEDGES AND AGREES THAT THIS NOTICE AND THE TRANSACTIONS CONTEMPLATED HEREUNDER DO NOT CONSTITUTE AN EXPRESS OR IMPLIED PROMISE OF CONTINUED EMPLOYMENT FOR THE VESTING PERIOD, FOR ANY PERIOD, OR AT ALL, AND SHALL NOT INTERFERE IN ANY WAY WITH OFFEREES RIGHT OR THE RIGHT OF THE COMPANY OR RELEVANT SUBSIDIARY TO TERMINATE OFFEREES EMPLOYMENT AT ANY TIME, WITH OR WITHOUT CAUSE.
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10. | By the Offerees signature below she/he hereby: |
(a) acknowledges receipt of a copy of the Plan and accepts the Options and/or Exercise Shares subject to all of the terms and provisions of the Plan and this Notice and declares that he/she has reviewed the Plan and this Notice in their entirety.
(b) declares that he/she has had an opportunity to obtain the advice of counsel prior to executing this Option Agreement, and fully understand all provisions of this Notice and the Plan.
(c) agrees to accept as binding, conclusive and final all decisions or interpretations of the board upon any questions relating to the Plan and this Notice.
(d) declares that she/he is familiar with Section 102 and the regulations and rules promulgated thereunder, including without limitations the provisions of the applicable tax route, and agrees to comply with such provisions, as amended from time to time.
(e) agrees to the terms and conditions of the trust deed signed between the Trustee and the Company and/or the applicable Affiliate, attached hereto as Exhibit [] including but not limited to the control of the Options and/or Exercise Shares by the Trustee.
(f) acknowledges that releasing the Options and/or Exercise Shares from the control of the Trustee prior to the termination of the Holding Period constitutes a violation of the terms of Section 102 and agrees to bear the relevant sanctions.
(g) authorizes the Company to provide the Trustee with any information required for the purpose of executing its obligations under the Ordinance, the trust deed and the trust agreement, including without limitation information about his/her Options and/or Exercise Shares, income tax rates, salary bank account, contact details and identification number.
(h) declares that he/she is a resident of the state of Israel for tax purposes on the date of allocation and agrees to notify the Company upon any change in the residence address indicated above and acknowledges that if he/she ceases to be an Israeli resident or if his/her engagement with the Company is terminated, the Options and/or Exercise Shares shall remain subject to Section 102, the trust agreement, the Plan and this Notice.
(i) The Offeree warrants and undertakes that at the time of grant of the Options herein, or as a consequence of the grant, the Offeree is not and will not become a holder of a controlling interest in the Company, as such term is defined in Section 32(9) of the Ordinance.
By your signature and the signature of the Companys representative below, you and the Company agree that the Options are granted under and governed by the terms and conditions of the Plan and this Notice of Share Option Grant.
OFFEREE | Applied Immune Technologies Ltd. Ltd. | |||
I.D./ Passport No. | By: | |||
Date: | Date: |
This notice shall enter into force only upon the approval of the Plan by the Israeli Income Tax Authorities in accordance with the 102 provisions and at the date on which the Company will notify you of such approval, and from that date only. The Options will be issued at the name of the Trustee on or after such approval shall be granted.
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Exhibit 10.21
AMENDMENT TO
THE APPLIED IMMUNE TECHNOLOGIES LTD. SHARE OPTION PLAN (2014)
January 24, 2016
This AMENDMENT TO THE APPLIED IMMUNE TECHNOLOGIES LTD. SHARE OPTION PLAN (2014) (this Amendment) is effective as of the date first set forth above, such Amendment having been approved by the requisite parties in accordance with the terms of the Applied Immune Technologies Ltd. Share Option Plan (2014) and applicable law (as amended, the Plan). Capitalized terms not otherwise defined herein shall have the meanings set forth in the Plan.
1. Amendment to the definition of Significant Event in Section 2.3 of the Plan. The definition of Significant Event in Section 2.3 of the Plan is hereby amended by deleting such definition in its entirety and replacing it with the following:
Significant Event | Any of the following transactions, provided, however, that the Board shall determine under parts (iv) and (v) whether multiple transactions are related, and its determination shall be final, binding and conclusive: | |
(i) a merger or consolidation in which the Company is not the surviving entity, except for a transaction the principal purpose of which is to change the jurisdiction in which the Company is incorporated; | ||
(ii) the sale, transfer or other disposition of all or substantially all of the assets of the Company; | ||
(iii) the complete liquidation or dissolution of the Company; | ||
(iv) any reverse merger or series of related transactions culminating in a reverse merger (including, but not limited to, a tender offer followed by a reverse merger) in which the Company is the surviving entity but (A) the shares of Common Stock outstanding immediately prior to such merger are converted or exchanged by virtue of the merger into other property, whether in the form of securities, cash or otherwise, or (B) in which securities possessing more than fifty percent (50%) of the total combined voting power of the Companys outstanding securities are transferred to a person or persons different from those who held such securities immediately prior to such merger or the initial transaction culminating in such merger, but |
excluding any such transaction or series of related transactions that the Board determines shall not be a Significant Event; or | ||
(v) acquisition in a single or series of related transactions by any person or related group of persons (other than the Company or by a Company-sponsored employee benefit plan) of beneficial ownership (within the meaning of Rule 13d-3 of the Securities Exchange Act of 1934, as amended) of securities possessing more than fifty percent (50%) of the total combined voting power of the Companys outstanding securities but excluding any such transaction or series of related transactions that the Board determines shall not be a Significant Event. |
[Remainder of Page Left Intentionally Blank]
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IN WITNESS WHEREOF, the undersigned, being a duly elected and acting officer of Adicet Bio, Inc. (the Company), hereby certifies that the foregoing Amendment was duly approved and adopted in accordance with the Plan and all applicable laws by the Board of Directors of the Company and the stockholders of the Company, effective as of the date first referenced above.
By: | /s/ Aya Jakobovits | |
Name: | Dr. Aya Jakobovits | |
Title: | Chief Executive Officer |
AMENDMENT TO
THE APPLIED IMMUNE TECHNOLOGIES LTD. SHARE OPTION PLAN (2014)
Exhibit 10.22
NOTICE TO THE ISRAELI EMPLOYEES OF THE COMPANY
Applied Immune Technologies Ltd.
(the Company)
To:
Notice of Share Option Grant
You (the Offeree) have been granted options, pursuant to of the Applied Immune Technologies Ltd. Share Option Plan (2014) attached hereto as Exhibit A (the Plan) and this Notice of Share Option Grant, to purchase shares of the Companys Ordinary Shares as follows:
Effective Date | ||
Exercise Price per Option: | ||
Total Number of Options Granted: | ||
The Trustee | ||
The Tax route | Capital Gain |
1. | All terms not expressly defined herein shall have the meaning assigned to them in the Plan, unless such interpretation does not conform with the circumstances or context of the issue. |
2. | Your entitlement to the Exercise Shares by virtue of the Options hereby granted shall vest (the Number of Vested Options) at the following rates and dates: |
Amount of vested Options |
Vesting Date | |
Total |
Nothing of the foregoing shall be construed so as to derogate from the Lockup Period provided under the 102 Provisions or the restrictions on the exercise of Options provided in the Plan.
For the purpose of calculating your entitlement to the Options, you shall not be deemed to be employed in the Company during periods for which you shall not be entitled to severance pay pursuant to section 10 of the Severance Pay Regulations (Severance Pay Calculation and Resignation that shall be deemed to be Dismissal), 5724-1964.
3. | Any exercise of your right to purchase shares according to your Number of Vested Options shall not derogate from your right to purchase the remainder of the Exercise Shares to which you shall be entitled by virtue of the Options granted to you, if and when, such remainder shall vest. |
4. | Your Options/ Exercise Shares shall be held in trust under the terms and conditions of the capital gains route under Section 102 of the Ordinance. The trust period will commence upon the date of allotment of the Option and will terminate after 24 months from the date in which the Option was granted or any other period determined under the Ordinance with respect to the capital gain route or determined by the Israeli Income Tax Authorities (the Lock-Up Period). |
5. | The following provisions shall apply to the Options: |
5.1 | The Options shall be exercisable, in whole or in part, immediately upon the vesting of the right to exercise the Options as described in section 2 above. |
5.2 | Exercising the Options to Exercise Shares shall be contingent upon payment to the Company of the Exercise Price per each Option, as provided for in section 5 of the Plan. |
5.3 | An Option not exercised within ten (10) years from the issuance of the Options to an Offeree shall expire automatically, and shall have no value whatsoever. |
5.4 | The Company and its shareholders shall have certain rights in the Exercise Shares as specified in the Plan, including the Companys right to purchase such shares set out in section 9.5 of the Plan and the right of the shareholders of the Company to require the Offeree sell his/her Exercise Shares set out in section 10.2 of the Plan. |
5.5 | Until the consummation of an IPO, the Exercise Shares shall be voted by an irrevocable proxy attached to the Plan as Schedule B (the Proxy) pursuant to the directions of the Board, such Proxy to be assigned to the person or persons designated by the Board. |
6. | Notwithstanding any provision of the Plan: |
6.1 | Prior to the payment of the tax applicable under law, including under the 102 Provisions (the Applicable Tax), the Options and/or the Exercise Shares or rights arising therefrom shall not be transferable or assignable, shall not be subject to any mortgage, liens, attachment or other encumbrance, and no power of attorney or note of transfer shall be issued in respect thereof, whether such instrument enter into force immediately or at a future date, excluding transfer by power of a last will or under law and all subject to the terms of the Plan. |
6.2 | Should the Options or Exercise Shares have been transferred pursuant to the provisions of a last testamentary instrument or under applicable law, the 102 Provisions shall apply to the heirs or transferees of the deceased Offeree. |
6.3 | Subject to the approval of the Plan by the Income Tax Authority, you shall be taxed in Israel in accordance with the provisions of the capital gain route under Section 102 of the Ordinance, including the provisions the regulations and any tax ruling or agreement obtained by the company with regard to the Plan. |
In accordance with Section 102(b)(4) of the Ordinance, if you sell Exercise Shares (or release the Option or the Exercise Shares from the Trust) before the termination of the Lock-Up Period, you will be liable to pay tax at your marginal income tax rate, in addition to social security and health tax contributions.
By your signature on this Notice of Share Option Grant you herby take upon yourself to comply with the conditions set under Section 102 of the Ordinance with regard to the capital gain route and the Regulations.
6.4 | Subject to the 102 Provisions, the Trustee shall not transfer the Options and/or the Exercise Shares to the Offeree name, and shall not transfer the consideration received from the sale of the Exercise Shares to the Offeree, unless one of the following conditions shall be fulfilled: |
6.4.1 | the Offeree provided the Trustee with a certificate from the Assessing Officer that the Applicable Tax has been paid; or |
6.4.2 | the Offeree paid the Trustee an amount equalling to the amount of tax applicable in accordance with the 102 Provisions of the consideration, as defined in section 102 of the Ordinance (the Taxable Consideration) for such sale, and the Trustee checked the manner of calculating the payable amount, at his/her sole discretion, and was fully satisfied that the calculation was performed accurately and lawfully; or |
6.4.3 | The Trustee deducted the applicable tax in accordance with the 102 Provisions of the Taxable Consideration, or any other amount as shall be approved by the Assessing Officer, from the consideration he/she received from the sale of the Options and/or the Exercise Shares. |
7. | The Options shall not be transferable or marketable in any manner, save for a transfer to an Offerees heirs in the event of such Offerees death or transfer under the provisions of sections 9.5 and 10.2 of the Plan. |
8. | It is hereby clarified that the Options and/or the Exercise Shares are extraordinary, one-time benefits granted to the Offerees, and are not and shall not be deemed a salary component for any purpose whatsoever, including in connection with calculating severance compensation under the Severance Compensation Law, 5723-1963 and the regulations promulgated thereunder. |
9. | THE OFFEREE ACKNOWLEDGES AND AGREES THAT THE VESTING OF SHARES PURSUANT TO SECTION 2 ABOVE IS EARNED ONLY BY CONTINUING EMPLOYMENT AT THE WILL OF THE COMPANY OR THE RELEVANT SUBSIDARY. |
THE OFFEREE FURTHER ACKNOWLEDGES AND AGREES THAT THIS NOTICE AND THE TRANSACTIONS CONTEMPLATED HEREUNDER DO NOT CONSTITUTE AN EXPRESS OR IMPLIED PROMISE OF CONTINUED EMPLOYMENT FOR THE VESTING PERIOD, FOR ANY PERIOD, OR AT ALL, AND SHALL NOT INTERFERE IN ANY WAY WITH OFFEREES RIGHT OR THE RIGHT OF THE COMPANY OR RELEVANT SUBSIDIARY TO TERMINATE OFFEREES EMPLOYMENT AT ANY TIME, WITH OR WITHOUT CAUSE.
10. | By the Offerees signature below she/he hereby: |
(a) acknowledges receipt of a copy of the Plan and accepts the Options and/or Exercise Shares subject to all of the terms and provisions of the Plan and this Notice and declares that he/she has reviewed the Plan and this Notice in their entirety.
(b) declares that he/she has had an opportunity to obtain the advice of counsel prior to executing this Option Agreement, and fully understand all provisions of this Notice and the Plan.
(c) agrees to accept as binding, conclusive and final all decisions or interpretations of the board upon any questions relating to the Plan and this Notice.
(d) declares that she/he is familiar with Section 102 and the regulations and rules promulgated thereunder, including without limitations the provisions of the applicable tax route, and agrees to comply with such provisions, as amended from time to time.
(e) agrees to the terms and conditions of the trust deed signed between the Trustee and the Company and/or the applicable Affiliate, attached hereto as Exhibit [] including but not limited to the control of the Options and/or Exercise Shares by the Trustee.
(f) acknowledges that releasing the Options and/or Exercise Shares from the control of the Trustee prior to the termination of the Holding Period constitutes a violation of the terms of Section 102 and agrees to bear the relevant sanctions.
(g) authorizes the Company to provide the Trustee with any information required for the purpose of executing its obligations under the Ordinance, the trust deed and the trust agreement, including without limitation information about his/her Options and/or Exercise Shares, income tax rates, salary bank account, contact details and identification number.
(h) declares that he/she is a resident of the state of Israel for tax purposes on the date of allocation and agrees to notify the Company upon any change in the residence address indicated above and acknowledges that if he/she ceases to be an Israeli resident or if his/her engagement with the Company is terminated, the Options and/or Exercise Shares shall remain subject to Section 102, the trust agreement, the Plan and this Notice.
(i) The Offeree warrants and undertakes that at the time of grant of the Options herein, or as a consequence of the grant, the Offeree is not and will not become a holder of a controlling interest in the Company, as such term is defined in Section 32(9) of the Ordinance.
By your signature and the signature of the Companys representative below, you and the Company agree that the Options are granted under and governed by the terms and conditions of the Plan and this Notice of Share Option Grant.
OFFEREE Ltd. | Applied Immune Technologies Ltd. | |||
I.D./ Passport No. | By: |
| ||
Date: | Date: |
This notice shall enter into force only upon the approval of the Plan by the Israeli Income Tax Authorities in accordance with the 102 provisions and at the date on which the Company will notify you of such approval, and from that date only. The Options will be issued at the name of the Trustee on or after such approval shall be granted.
|
Exhibit 10.23
LEASE AGREEMENT
By and Between
WESTPORT OFFICE PARK, LLC,
a California limited liability company
(Landlord)
and
ADICET BIO, INC., a Delaware corporation
(Tenant)
October 31, 2018
Page | ||||
ARTICLE 1. PREMISES; COMMON AREAS |
4 | |||
ARTICLE 2. TERM AND CONDITION OF PREMISES |
5 | |||
ARTICLE 3. USE, NUISANCE, OR HAZARD |
7 | |||
ARTICLE 4. RENT |
8 | |||
ARTICLE 5. RENT ADJUSTMENT |
10 | |||
ARTICLE 6. SERVICES TO BE PROVIDED BY LANDLORD |
19 | |||
ARTICLE 7. REPAIRS AND MAINTENANCE BY LANDLORD |
21 | |||
ARTICLE 8. REPAIRS AND CARE OF PREMISES BY TENANT |
22 | |||
ARTICLE 9. TENANTS EQUIPMENT AND INSTALLATIONS |
23 | |||
ARTICLE 10. FORCE MAJEURE |
23 | |||
ARTICLE 11. CONSTRUCTION, MECHANICS AND MATERIALMANS LIENS |
24 | |||
ARTICLE 12. ARBITRATION |
24 | |||
ARTICLE 13. INSURANCE |
25 | |||
ARTICLE 14. QUIET ENJOYMENT |
27 | |||
ARTICLE 15. ALTERATIONS |
27 | |||
ARTICLE 16. FURNITURE, FIXTURES, AND PERSONAL PROPERTY |
30 | |||
ARTICLE 17. PERSONAL PROPERTY AND OTHER TAXES |
31 | |||
ARTICLE 18. ASSIGNMENT AND SUBLETTING |
32 | |||
ARTICLE 19. DAMAGE OR DESTRUCTION |
37 | |||
ARTICLE 20. CONDEMNATION |
40 | |||
ARTICLE 21. HOLD HARMLESS |
41 | |||
ARTICLE 22. DEFAULT BY TENANT |
42 | |||
ARTICLE 23. INTENTIONALLY OMITTED |
46 | |||
ARTICLE 24. INTENTIONALLY OMITTED |
46 | |||
ARTICLE 25. ATTORNEYS FEES |
46 | |||
ARTICLE 26. NON-WAIVER |
46 | |||
ARTICLE 27. RULES AND REGULATIONS |
47 | |||
ARTICLE 28. ASSIGNMENT BY LANDLORD; RIGHT TO LEASE |
47 | |||
ARTICLE 29. LIABILITY OF LANDLORD |
47 | |||
ARTICLE 30. SUBORDINATION AND ATTORNMENT |
48 |
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ARTICLE 31. HOLDING OVER |
50 | |||
ARTICLE 32. SIGNS |
50 | |||
ARTICLE 33. HAZARDOUS AND BIOLOGICAL MATERIALS |
52 | |||
ARTICLE 34. COMPLIANCE WITH LAWS AND OTHER REGULATIONS |
56 | |||
ARTICLE 35. SEVERABILITY |
57 | |||
ARTICLE 36. NOTICES |
57 | |||
ARTICLE 37. OBLIGATIONS OF, SUCCESSORS, PLURALITY, GENDER |
58 | |||
ARTICLE 38. ENTIRE AGREEMENT |
58 | |||
ARTICLE 39. CAPTIONS |
58 | |||
ARTICLE 40. CHANGES |
59 | |||
ARTICLE 41. AUTHORITY |
59 | |||
ARTICLE 42. BROKERAGE |
59 | |||
ARTICLE 43. EXHIBITS |
59 | |||
ARTICLE 44. APPURTENANCES |
60 | |||
ARTICLE 45. PREJUDGMENT REMEDY, REDEMPTION, COUNTERCLAIM, AND JURY |
60 | |||
ARTICLE 46. RECORDING |
60 | |||
ARTICLE 47. MORTGAGEE PROTECTION |
61 | |||
ARTICLE 48. OTHER LANDLORD CONSTRUCTION |
61 | |||
ARTICLE 49. PARKING |
62 | |||
ARTICLE 50. ELECTRICAL CAPACITY |
62 | |||
ARTICLE 51. OPTION TO EXTEND LEASE |
63 | |||
ARTICLE 52. TELECOMMUNICATIONS LINES AND EQUIPMENT |
66 | |||
ARTICLE 53. ERISA |
66 | |||
ARTICLE 54. INTENTIONALLY OMITTED |
67 | |||
ARTICLE 55. TENANTS ROOFTOP RIGHTS |
67 | |||
ARTICLE 56. GENERATOR |
69 | |||
ARTICLE 57. LETTER OF CREDIT |
70 | |||
ARTICLE 58. REASONABLE APPROVALS |
74 |
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LEASE AGREEMENT
THIS LEASE AGREEMENT, (this Lease) is made and entered into as of October 31, 2018 by and between WESTPORT OFFICE PARK, LLC, a California limited liability company (Landlord), and Tenant identified in the Basic Lease Information below.
BASIC LEASE INFORMATION
Tenant: ADICET BIO, INC., a Delaware corporation
Premises: The entire 1st floor and entire 2nd floor of the Building, each as outlined in Exhibit B to this Lease. The Premises shall consist of 50,305 square feet of rentable area in the aggregate.
Building: The Building commonly known as 1000 Bridge Parkway, Redwood City, California 94065. The rentable area of the Building is 50,305 square feet.
Base Rent:
Months |
Base Rent Per Year | Base Rent Per Month | ||||||
09/01/2019 - 02/29/2020 |
N/A | $ | 211,281.00 | (*Abated) | ||||
03/01/2020 - 08/31/2020 |
N/A | $ | 211,281.00 | |||||
09/01/2020 - 08/31/2021 |
$ | 2,611,433.16 | $ | 217,619.43 | ||||
09/01/2021 - 08/31/2022 |
$ | 2,689,776.15 | $ | 224,148.01 | ||||
09/01/2022 - 08/31/2023 |
$ | 2,770,469.44 | $ | 230,872.45 | ||||
09/01/2023 - 08/31/2024 |
$ | 2,853,583.52 | $ | 237,798.63 | ||||
09/01/2024 - 08/31/2025 |
$ | 2,939,191.03 | $ | 244,932.59 | ||||
09/01/2025 - 08/31/2026 |
$ | 3,027,366.76 | $ | 252,280.56 | ||||
09/01/2026 - 08/31/2027 |
$ | 3,118,187.76 | $ | 259,848.98 | ||||
09/01/2027 - 08/31/2028 |
$ | 3,211,733.39 | $ | 267,644.45 | ||||
09/01/2028 - 08/31/2029 |
$ | 3,308,085.40 | $ | 275,673.78 | ||||
09/01/2029 - 02/28/2030 |
N/A | $ | 283,944.00 |
* | As an inducement to Tenant entering into this Lease, Base Rent in the amount of $211,281.00 per month shall be abated (the Rent Abatement) for the first six (6) months commencing as of the Commencement Date, or if the Commencement Date is other than the first day of a calendar month, commencing as of the first day of the first full calendar month of the Term (the Abatement Period). During such Abatement Period, Tenant shall still be responsible for the payment of all of its other monetary obligations under the Lease. If, by reason of any other provision in this Lease, Tenant would otherwise be entitled to receive an abatement of Base Rent during a period coinciding with the Abatement Period (such as by reason of a casualty or condemnation), then in such event the Abatement Period shall be extended on a day-for-day basis by the period that such other abatement coincided with the Abatement Period so as to assure |
1
Tenant the benefit of the full amount of the Rent Abatement. If an Event of Default by Tenant under the terms of the Lease occurs at a time when the Rent Abatement would otherwise be applied, Tenants right to receive the Rent Abatement shall be stayed until that Event of Default is cured. |
Security Deposit Amount: $0.00.
Letter of Credit Required Amount: $4,131,719.96.
Rent Payable Upon Execution: $271,647.00.
Tenants Building Only Percentage: 100%.
Tenants Common Area Building Percentage: 5.05%.
Commencement Date: September 1, 2019, but such date shall be extended by one day for every one day in delay in Substantial Completion (as defined in the Tenant Work Letter attached hereto as Exhibit C (the Tenant Work Letter)) of the Premises (as such date of Substantial Completion is adjusted under Section 5.2 of the Tenant Work Letter) after September 1, 2019, caused by (i) Landlord Delays (as defined in the Tenant Work Letter) and/or (ii) any one or more Force Majeure Delays (as defined in the Tenant Work Letter).
Expiration Date: The date that is the day prior to the day that is one hundred twenty six (126) months after the Commencement Date. If the Expiration Date falls on a day other than the last day of the calendar month, then, the Expiration Date shall be extended to the last day of the calendar month in which the day that the Term of this Lease would otherwise end but for this proviso occurs, and the Term of this Lease shall be extended accordingly.
Landlords Address:
c/o PGIM Real Estate
101 California Street, 40th Floor
San Francisco, CA 94111
Attn: PRISA II Asset Management
With a copy by the same method to:
c/o PGIM Real Estate
7 Giralda Farms
Madison, New Jersey 07940
Attention: Legal Department
2
With a copy by the same method to:
Harvest Properties, Inc.
6425 Christie Avenue, Suite 220
Emeryville, California 94608
Attention: Joss Hanna
Address for rental payment:
Payments via FedEx/UPS/Courier:
JP Morgan Chase
2710 Media Center Dr.
Building #6, Suite #120
Los Angeles, CA 90065
Attn: PREIs Westport Office Park/100170
Payments via regular mail (lockbox address):
Remit to: PREIs Westport Office Park #171201
P. O. Box 100170
Pasadena, CA 91189-0170
Payments via either FED wire or ACH wire:
Bank Account Name:
Harvest Properties, Inc. LLC,
as agent for PREIs Westport Office Park
Bank Account Number 921254751
Bank Name: JP Morgan Chase Bank, N.A.
Bank City & State Location: Baton Rouge, LA
ABA Routing Number: 071000013
Tenants Address:
200 Constitution Drive
Menlo Park, California 94025
Attention: Brian Hogan
(If on or after the Commencement Date to the Premises)
Attention: Brian Hogan
Landlords Broker: Cushman & Wakefield.
Tenants Broker: T3 Advisors.
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Maximum Parking Allocation: one hundred sixty-six (166), which is based on a parking ratio of 3.3 non-exclusive parking spaces per one thousand (1,000) square feet of rentable space in the Premises.
Tenant Improvement Allowance: $3,018,300.00.
Additional Allowance: $3,018,300.00.
Space Planning Allowance: $7,545.75.
The Basic Lease Information is incorporated into and made part of this Lease. Each reference in this Lease to any Basic Lease Information shall mean the applicable information set forth in the Basic Lease Information, except that in the event of any conflict between an item in the Basic Lease Information and this Lease, this Lease shall control. Additional defined terms used in the Basic Lease Information shall have the meanings given those terms in this Lease.
ARTICLE 1.
PREMISES ; COMMON AREAS
1.1 Subject to all of the terms and conditions hereinafter set forth, Landlord hereby leases to Tenant and Tenant hereby leases from Landlord the Premises. The property shown on Exhibit A to this Lease and all improvements thereon and appurtenances on that land thereto, including, but not limited to, the Building, other office buildings, access roadways, and all other related areas, shall be collectively hereinafter referred to as the Project. Tenant acknowledges and agrees that Landlord may elect to sell one or more of the buildings within the Project and that upon any such sale Tenants pro-rata share of those Operating Expenses and Taxes (each as defined below) allocated to the areas of the Project other than buildings may be adjusted accordingly by Landlord. The parties hereto hereby acknowledge that the purpose of Exhibit A and Exhibit B are to show the approximate location of the Premises in the Building and the general layout of the Project and such Exhibits are not meant to constitute an agreement, representation or warranty as to the construction of the Premises, the Building or the Project, the precise area of the Premises, the Building or the Project or the specific location of the Building, Common Areas, as that term is defined in Section 1.3, below, or the elements thereof or of the accessways to the Premises, or the Project, or the identity or existence of any other tenant or occupant of the Project.
1.2 For purposes of this Lease, (1) rentable area and usable area shall be calculated pursuant to the Standard Method for Measuring Floor Area in Office Buildings (ANSI/BOMA Z65.1, 1996); (2) rentable square feet and rentable footage shall have the same meaning as the term rentable area; and (3) usable square feet and usable square footage shall have the same meaning as the term usable area. Notwithstanding anything to the contrary in this Lease, the recital of the rentable area herein above set forth is for descriptive purposes only. Tenant shall have no right to terminate this Lease or receive any adjustment or rebate of any Base Rent or Additional Rent (as hereinafter defined) payable hereunder if said recital is incorrect. Tenant has inspected the Premises and is fully familiar with the scope and size thereof and agrees to pay the full Base Rent and Additional Rent set forth herein in consideration for the use and occupancy of said space, regardless of the actual number of square feet contained therein.
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1.3 Tenant shall have the non-exclusive right to use in common with other tenants in the Project, and subject to the reasonable, non-discriminatory rules and regulations referred to in Article 27 of this Lease, those portions of the Project outside the Premises which are provided, from time to time, for use in common by Landlord, Tenant and any other tenants of the Project (such areas, are collectively referred to herein as the Common Areas). The Common Areas shall consist of the portion of the Project reasonably designated as such by Landlord. The manner in which the Common Areas are maintained and operated shall be at the reasonable discretion of Landlord and the use thereof shall be subject to such reasonable, non-discriminatory rules, regulations and restrictions as Landlord may make from time to time. Landlord reserves the right to close temporarily, make alterations or additions to, or change the location of elements of the Project and the Common Areas; provided that in the event of any such Common Area closure, change, alteration or modification, except in emergency situations as reasonably determined by Landlord, Landlord shall exercise commercially reasonable efforts to perform the same in a manner that is reasonably designed to minimize interference with Tenants access to and permitted use of the Premises consistent with Comparable Buildings (as defined below). Subject to Applicable Laws, as that term is defined in Section 5.1(a) of this Lease, except when and where Tenants right of access is specifically excluded in this Lease, and except in the event of an emergency, Tenant shall have the right of access to the Premises, the Building, the Common Area and the parking facilities servicing the Building twenty-four (24) hours per day, seven (7) days per week during the Term, as that term is defined in Section 2.1, below.
ARTICLE 2.
TERM AND CONDITION OF PREMISES
2.1 The term of this Lease (the Term) shall commence on the Commencement Date and end on the Expiration Date, unless sooner terminated (the Termination Date) as hereinafter provided. The Commencement Date of this Lease and the obligation of Tenant to pay Base Rent, Additional Rent and all other charges hereunder shall not be delayed or postponed by reason of any delay by Tenant in performing changes or alterations in the Premises not required to be performed by Landlord. In the event the Term shall commence on a day other than the first day of a month, then the Base Rent shall be immediately paid for such partial month prorated in accordance with Section 4.4 below. In the event that the Commencement Date is a date which is other than the date set forth in the Basic Lease Information, within a reasonable period of time after the actual Commencement Date Landlord shall deliver to Tenant an amendment to lease in the form as set forth in Exhibit E, attached hereto, wherein the parties shall specify such different Commencement Date and the Expiration Date, and which amendment Tenant shall execute and return to Landlord within ten (10) business days of receipt thereof. In the event that the Substantial Completion of the Premises does not occur by the Outside Commencement Date (as defined below), then Tenant shall be entitled by notice in writing to Landlord within ten (10) days thereafter to cancel this Lease, in which event the parties shall be discharged from all obligations hereunder; provided further, however, that if such written notice of Tenant is not given to Landlord within such ten (10) day period, Tenants right to cancel this Lease hereunder shall terminate and be of no further force or
5
effect. If Tenant elects to terminate this Lease under this Section 2.1 then such termination of this Lease shall be effective on the date which is thirty (30) days after delivery of notice of termination to Landlord, unless the Substantial Completion of the Premises occurs within thirty (30) days of delivery of Tenants notice hereunder. The term Outside Commencement Date initially means March 1, 2020, but shall be extended by one day for every one day in delay in Substantial Completion of the Premises caused by (i) Tenant Delays (as defined in the Tenant Work Letter), (ii) inability to obtain or delays in obtaining necessary permits, and/or (iii) any other one or more Force Majeure Events (as defined in Article 10).
2.2 Except as expressly set forth in this Lease and in the Tenant Work Letter, Landlord shall not be obligated to provide or pay for any improvement, remodeling or refurbishment work or services related to the improvement, remodeling or refurbishment of the Premises, and Tenant shall accept the Premises in its As Is condition on the Commencement Date.
2.3 The taking of possession of the Premises by Tenant shall be conclusive evidence that the Premises and the Building were in good and satisfactory condition at such time, except for latent defects. As used in this Lease, a latent defect is a design or construction defect or error in the Premises which is not apparent upon an ordinary and reasonable inspection of the Premises. Neither Landlord nor Landlords agents have made any representations or promises with respect to the condition of the Building, the Premises, the land upon which the Building is constructed, or any other matter or thing affecting or related to the Building or the Premises, except as herein expressly set forth, and no rights, easements or licenses are acquired by Tenant by implication or otherwise except as expressly set forth in this Lease.
2.4 Notwithstanding Section 2.3 above, Landlord warrants that the roof, structural components of the Building, HVAC system, electrical and plumbing systems, elevator, parking lot or site lighting (the Covered Items), other than those constructed by Tenant, shall be in good operating condition on the date of Substantial Completion of the Premises. If a non-compliance with such warranty exists as of such date, or if one of such Covered Items should malfunction or fail within sixty (60) days after such date, Landlord shall, as Landlords sole obligation with respect to such matter, promptly after receipt of written notice from Tenant setting forth in reasonable detail the nature and extent of such non-compliance, malfunction or failure, rectify the same at Landlords expense. If Tenant does not give Landlord the required notice within sixty (60) days after the date of Substantial Completion of the Premises, Landlord shall have no obligation with respect to that warranty other than obligations regarding the Covered Items set forth elsewhere in this Lease.
2.5 Tenant may move into and commence business operations at the Premises prior to the Commencement Date. The period from that commencement of business operations to the Commencement Date shall be referred to herein as the Beneficial Occupancy Period and such period shall be governed by the terms of this Section 2.5. Tenant shall not be required to pay Base Rent during the Beneficial Occupancy Period, however, all other terms and conditions of this Lease and obligations of Landlord and Tenant hereunder shall apply throughout the Beneficial Occupancy Period. Without limiting the generality of the foregoing, Tenant shall pay for Tenants Share of Operating Expenses (as those terms are defined below), Tenants Tax Share of Taxes (as those terms are defined below) and any above-standard services such as after-hours HVAC charges (as described in Article 6 hereof, but excluding any such services provided in connection with the performance of the Tenant Improvements) throughout the Beneficial Occupancy Period.
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ARTICLE 3.
USE, NUISANCE, OR HAZARD
3.1 The Premises shall be used and occupied by Tenant solely for general office, research and development, biological research, laboratory and general administrative purposes consistent with a first-class office building and for no other purposes without the prior written consent of Landlord. Notwithstanding the foregoing, Tenant may construct a Vivarium (as defined in Exhibit I attached hereto) containing not more than 2,500 square feet of rentable area within the Premises as part of the Tenant Improvements. The use and construction of the Vivarium shall be subject to all of the terms and conditions of this Lease and, in addition, the provisions of Exhibit I attached hereto. Tenant shall design and construct the Tenant Improvements (and any alterations thereof pursuant to Article 15, below) for the laboratory area and the Vivarium such that they include fire detection and extinguishing systems, air filtration systems and containment (including without limitation chemical storage areas) design and systems appropriate for such uses, including without limitation those required by Applicable Laws.
3.2 Tenant shall not use, occupy, or permit the use or occupancy of the Premises for any purpose which Landlord, in its reasonable discretion, deems to be illegal, immoral, or dangerous; permit any public or private nuisance; do or permit any act or thing which may disturb the quiet enjoyment of any other tenant of the Project; keep any substance or carry on or permit any operation which might introduce offensive odors or conditions into other portions of the Project, use any apparatus which might make undue noise or set up vibrations in or about the Project; permit anything to be done which would increase the premiums paid by Landlord for special causes of loss form property insurance on the Project or its contents or cause a cancellation of any insurance policy covering the Project or any part thereof or any of its contents; or permit anything to be done which is prohibited by or which shall in any way conflict with any law, statute, ordinance, or governmental rule, regulation or covenants, conditions and restrictions affecting the Project, including without limitation the CC&Rs (as defined below) now or hereinafter in force. Should Tenant do any of the foregoing without the prior written consent of Landlord, and the same is not cured within ten (10) business days after notice from Landlord (which ten (10) business day period shall be subject to extension if the nature of the breach is such that it is not possible to cure the same within such ten (10) business day period so long as the Tenant commences the cure of such breach within such ten (10) business day period and diligently prosecutes the same to completion) it shall constitute an Event of Default (as hereinafter defined) and shall enable Landlord to resort to any of its remedies hereunder.
3.3 The ownership, operation, maintenance and use of the Project may in the future be subject to certain conditions and restrictions contained in an instrument (CC&Rs) recorded or to be recorded against title to the Project. Tenant agrees that regardless of when those CC&Rs are so recorded, this Lease and all provisions hereof shall be subject and subordinate thereto and Tenant shall comply therewith, provided that such CC&Rs do not materially increase Tenants costs or obligations or materially decrease Tenants rights or
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privileges under this Lease. Accordingly, as a consequence of that subordination, during any period in which the entire Project is not owned by Landlord, (a) the portion of Operating Expenses and Taxes for the Common Areas shall be allocated among the owners of the Project as provided in the CC&Rs, and (b) the CC&Rs shall govern the maintenance and insuring of the portions of the Project not owned by Landlord. Tenant shall, promptly upon request of Landlord, sign all documents reasonably required to carry out the foregoing into effect.
ARTICLE 4.
RENT
4.1 Tenant hereby agrees to pay Landlord the Base Rent. For purposes of Rent adjustment under the Lease, the number of months is measured from the first day of the calendar month in which the Commencement Date falls. Each monthly installment (the Monthly Rent) shall be payable by check or by money order on or before the first day of each calendar month. In addition to the Base Rent, Tenant also agrees to pay Tenants Share of Operating Expenses and Taxes, and any and all other sums of money as shall become due and payable by Tenant to Landlord as set forth in this Lease, all of which shall constitute additional rent under this Lease (the Additional Rent). Landlord expressly reserves the right to apply any payment received to Base Rent or any other items of Rent that are not paid by Tenant. The Base Rent, the Monthly Rent and the Additional Rent are sometimes hereinafter collectively called Rent and shall be paid when due in lawful money of the United States without demand, deduction, abatement, or offset (except as otherwise expressly provided in this Lease) to the addresses for the rental payment set forth in the Basic Lease Information, or as Landlord may designate from time to time.
4.2 In the event any Monthly or Additional Rent or other amount payable by Tenant to Landlord hereunder is not paid within five (5) days after its due date, Tenant shall pay to Landlord a one-time late charge (the Late Charge), as Additional Rent, in an amount of five percent (5%) of the amount of such late payment. Failure to pay any Late Charge shall be deemed a Monetary Default (as hereinafter defined). Provision for the Late Charge shall be in addition to all other rights and remedies available to Landlord hereunder, at law or in equity, and shall not be construed as liquidated damages or limiting Landlords remedies in any manner. Failure to charge or collect such Late Charge in connection with any one (1) or more such late payments shall not constitute a waiver of Landlords right to charge and collect such Late Charges in connection with any other similar or like late payments. Notwithstanding the foregoing provisions of this Section 4.2, the Late Charge shall not be imposed with respect to the first late payment in the twelve (12) months following the Commencement Date or with respect to the first late payment in any succeeding twelve (12) month period during the Term unless the applicable payment due from Tenant is not received by Landlord within five (5) days following written notice from Landlord that such payment was not received when due. Following the first such written notice from Landlord in the twelve (12) months following the Commencement Date and the first such written notice in any succeeding twelve (12) month period during the Term (but regardless of whether such payment has been received within such five (5) day period), the Late Charge will be imposed without notice for any subsequent payment due from Tenant during such applicable twelve (12) month period which is not received within five (5) days after its due date.
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4.3 Simultaneously with the execution hereof, Tenant shall deliver to Landlord (i) the Rent Payable Upon Execution as payment of Base Rent for the seventh full month of the Term and Monthly Escalation Payment and Monthly Tax Payment for the first full month of the Term due hereunder and (ii) an amount equal to the Security Deposit Amount to be held by Landlord as security for Tenants faithful performance of all of the terms, covenants, conditions, and obligations required to be performed by Tenant hereunder (the Security Deposit). The Security Deposit shall be held by Landlord as security for the performance by Tenant of all of the covenants of this Lease to be performed by Tenant and Tenant shall not be entitled to interest thereon. The Security Deposit is not an advance rent deposit, an advance payment of any other kind, or a measure of Landlords damages in any case of Tenants default. If Tenant fails to perform any of the covenants of this Lease to be performed by Tenant, including without limitation the provisions relating to payment of Rent, the removal of property at the end of the Term, the repair of damage to the Premises caused by Tenant, and the cleaning of the Premises upon termination of the tenancy created hereby, then Landlord shall have the right, but no obligation, to apply the Security Deposit, or so much thereof as may be necessary, for the payment of any Rent or any other sum in default and/or to cure any other such failure by Tenant. If Landlord applies the Security Deposit or any part thereof for payment of such amounts or to cure any such other failure by Tenant, then Tenant shall immediately pay to Landlord the sum necessary to restore the Security Deposit to the full amount then required by this Section 4.3. Landlords obligations with respect to the Security Deposit are those of a debtor and not a trustee. Landlord shall not be required to maintain the Security Deposit separate and apart from Landlords general or other funds and Landlord may commingle the Security Deposit with any of Landlords general or other funds. Upon termination of the original Landlords or any successor owners interest in the Premises or the Building, the original Landlord or such successor owner shall be released from further liability with respect to the Security Deposit upon the original Landlords or such successor owners transfer of the Security Deposit to the successor owner and otherwise complying with California Civil Code Section 1950.7. Subject to the foregoing, Tenant hereby waives the provisions of Section 1950.7 of the California Civil Code, and all other provisions of law, now or hereafter in force, which (a) establish a time frame within which a landlord must refund a security deposit under a lease, and/or (b) provide that Landlord may claim from a security deposit only those sums reasonably necessary to remedy defaults in the payment of Rent, to repair damage caused by Tenant or to clean the Premises, it being agreed that Landlord may, in addition, claim those sums reasonably necessary to compensate Landlord for any other loss or damage caused by the default of Tenant under this Lease, including without limitation all damages or Rent due upon termination of this Lease pursuant to Section 1951.2 of the California Civil Code. If no Event of Default exists, the unused portion of the Security Deposit shall be returned to Tenant or the last assignee of Tenants interest under this Lease within thirty (30) days following expiration or termination of the Term of this Lease.
4.4 If the Term commences on a date other than the first day of a calendar month or expires or terminates on a date other than the last day of a calendar month, the Rent for any such partial month shall be prorated to the actual number of days in such partial month.
4.5 All Rents and any other amount payable by Tenant to Landlord hereunder, if not paid when due, shall bear interest from the date due until paid at a rate equal to the prime commercial rate established from time to time by Bank of America, plus four percent (4%) per
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annum; but not in excess of the maximum legal rate permitted by law. Failure to charge or collect such interest in connection with any one (1) or more delinquent payments shall not constitute a waiver of Landlords right to charge and collect such interest in connection with any other or similar or like delinquent payments.
4.6 Intentionally omitted.
4.7 No Rent or other payment in respect of the Premises shall be based in any way upon net income or profits from the Premises. Tenant may not enter into or permit any sublease or license or other agreement in connection with the Premises which provides for a rental or other payment based on net income or profit.
ARTICLE 5.
RENT ADJUSTMENT
5.1 Definitions.
(a) Operating Expenses, as said term is used herein, shall mean all reasonable expenses, costs, and disbursements of every kind and nature which Landlord shall actually pay because of or in connection with the ownership, operation, management, security, repair, restoration, replacement, or maintenance of the Project, or any portion thereof. Operating Expenses shall be computed in accordance with generally accepted real estate practices, consistently applied, and shall include, but not be limited to, the items as listed below:
(i) Wages, salaries, other compensation and any and all taxes, insurance and benefits of, the Project manager and of all other employees of Landlord below the level of Project manager engaged in the operation, maintenance and security of the Project (reasonably prorated for employees who do not work one hundred percent (100%) at the Project);
(ii) Payments under any equipment rental agreements or management agreements, including without limitation the cost of any actual or charged management fee and all expenses for the Project management office including rent, office supplies, and materials therefor;
(iii) Costs of all supplies, equipment, materials, and tools and amortization (including interest on the unamortized cost) of the cost of acquiring or the rental expense of personal property to the extent used in the maintenance, operation and repair of the Project, or any portion thereof;
(iv) All costs incurred in connection with the operation, maintenance, and repair of the Project including without limitation, the following: (A) the cost of operation, repair, maintenance and replacement of all systems and equipment and components thereof of the Project; (B) the cost of janitorial, alarm, security and other services, replacement of wall and floor coverings, ceiling tiles and fixtures in common areas, maintenance and replacement of curbs and walkways, repair to roofs and re-roofing; (C) the cost of licenses, certificates, permits and inspections and the cost of contesting any governmental enactments which are reasonably anticipated by Landlord to increase Operating Expenses, and the cost
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incurred in connection with a transportation system management program or similar program; and (D) the cost of landscaping, decorative lighting, and relamping, the cost of maintaining fountains, sculptures, bridges; and (E) costs, fees, charges or assessments imposed by, or resulting from any mandate imposed on Landlord by, any federal, state or local government for fire and police protection, trash removal, community services, or other services which do not constitute Taxes as that term is defined below.
(v) The cost of supplying all utilities, the cost of operating, maintaining, repairing, replacing, renovating and managing the utility systems, mechanical systems, sanitary, storm drainage systems, communication systems and escalator and elevator systems, and the cost of supplies, tools, and equipment and maintenance and service contracts in connection therewith.
(vi) Costs and expenses of complying with, or participating in, conservation, recycling, sustainability, energy efficiency, waste reduction or other programs or practices implemented or enacted from time to time at the Building, including, without limitation, in connection with any LEED (Leadership in Energy and Environmental Design) rating or compliance system or program, including that currently coordinated through the U.S. Green Building council or Energy Star rating and/or compliance system or program (collectively, Conservation Costs);
(vii) The cost of all insurance carried by Landlord in connection with the Project as reasonably determined by Landlord, including without limitation commercial general liability insurance, physical damage insurance covering damage or other loss caused by fire, earthquake, flood or other water damage, explosion, vandalism and malicious mischief, theft or other casualty, rental interruption insurance and such insurance as may be required by any lessor under any present or future ground or underlying lease of the Building or Project or any unaffiliated, institutional holder of a mortgage, deed of trust or other encumbrance now or hereafter in force against the Building or Project or any portion thereof, and any deductibles payable thereunder; including, without limitation, Landlords cost of any self-insurance deductible or retention; provided that Landlords cost of any self-insurance shall not exceed the cost that would have been payable for a policy covering the same risks as to which Landlord is self-insuring;
(viii) Capital improvements made to or capital assets acquired for the Project, or any portion thereof, after the Commencement Date that (1) are intended to reduce Operating Expenses, or (2) are necessary for the health, safety and/or security of the Project, its occupants and visitors and are deemed advisable in the reasonable judgment of Landlord, or (3) are Conservation Costs, or (4) are required under any and all applicable laws, statutes, codes, ordinances, orders, rules, regulations, conditions of approval and requirements of all federal, state, county, municipal and governmental authorities and all administrative or judicial orders or decrees and all permits, licenses, approvals and other entitlements issued by governmental entities, and rules of common law, relating to or affecting the Project, the Premises or the Building or the use or operation thereof, whether now existing or hereafter enacted, including, without limitation, the Americans with Disabilities Act of 1990, 42 USC 12111 et seq. (the ADA) as the same may be amended from time to time, all Environmental Requirements (as hereinafter defined), and any CC&Rs, or any corporation, committee or association formed in
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connection therewith, or any supplement thereto recorded in any official or public records with respect to the Project or any portion thereof (collectively, Applicable Laws) (except for capital repairs, replacements or other improvements to remedy a condition existing prior to the Commencement Date which an applicable governmental authority, if it had knowledge of such condition prior to the Commencement Date, would have then required to be remedied pursuant to then-current governmental laws or regulations in their form existing as of the Commencement Date and pursuant to the then-current interpretation of such governmental laws or regulations by the applicable governmental authority as of the Commencement Date), which capital costs, or an allocable portion thereof, shall be amortized over the useful life of the capital improvement in question as reasonably determined by Landlord, together with interest on the unamortized balance at a rate reasonably determined by Landlord;
(ix) fees, charges and other costs, including management fees (or amounts in lieu thereof), consulting fees, legal fees and accounting fees, of all contractors, engineers, consultants and other persons engaged by Landlord or otherwise incurred by or charged by Landlord in connection with the management, operation, maintenance and repair of the Buildings and the Project; and
(x) payments, fees or charges under the CC&Rs and any easement, license, operating agreement, declaration, restricted covenant, or instrument pertaining to the sharing of costs by the Project, or any portion thereof.
Expressly excluded from Operating Expenses are the following items:
(xi) Repairs and restoration paid for by the proceeds of any insurance policies or amounts otherwise reimbursed to Landlord or paid by any other source (other than by tenants paying their share of Operating Expenses);
(xii) Principal, interest, and other costs directly related to financing the Project or ground lease rental or depreciation;
(xiii) The cost of special services to tenants (including Tenant) for which a special charge is made;
(xiv) The costs of repair of casualty damage or for restoration following condemnation to the extent covered by insurance proceeds or condemnation awards;
(xv) The costs of any capital expenditures except as expressly permitted to be included in Operating Expenses as provided under clauses (vii), and (viii) above;
(xvi) Advertising and leasing commissions; costs, including permit, license and inspection costs and supervision fees, incurred with respect to the installation of tenant improvements within the Project or incurred in renovating or otherwise improving, decorating, painting or redecorating vacant space within the Project or promotional or other costs in order to market space to potential tenants;
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(xvii) The legal fees and related expenses and legal costs incurred by Landlord (together with any damages awarded against Landlord) due to the bad faith violation by Landlord or any tenant of the terms and conditions of any lease of space in the Project;
(xviii) Costs incurred: (x) to comply with Applicable Laws with respect to any Biological Materials (as defined below) or Hazardous Materials (as defined below) which were in existence in, on, under or about the Project (or any portion thereof) prior to the Commencement Date; and/or (y) with respect to Biological Materials or Hazardous Materials which are disposed of or otherwise introduced into, on, under or about the Project after the date hereof by Landlord or Landlords affiliates or their agents, employees, contractors or invitees; provided, however, Operating Expenses shall include costs incurred in connection with the clean-up, remediation, monitoring, management and administration of (and defense of claims related to) the presence of (1) Hazardous Materials used by Landlord (provided such use is not negligent and is in compliance with Applicable Laws) in connection with the operation, repair and maintenance of the Project to perform Landlords obligations under this Lease (such as, without limitation, fuel oil for generators, cleaning solvents, and lubricants) and which are customarily found or used in Comparable Buildings and (2) Biological Materials or Hazardous Materials created, released or placed in the Premises, Building or the Project by Tenant (or Tenants affiliates or their tenants, contractors, employees or agents) prior to or after the Commencement Date;
(xix) The attorneys fees in connection with the negotiation and preparation of letters, deal memos, letters of intent, leases, subleases and/or assignments, space planning costs, and other costs and expenses incurred in connection with lease, sublease and/or assignment negotiations and transactions with present or prospective tenants or other occupants of the Project;
(xx) The expenses in connection with services or other benefits which are not available to Tenant;
(xxi) The overhead and profit paid to Landlord or to subsidiaries or affiliates of Landlord for goods and/or services in the Project to the extent the same exceeds the costs of such goods and/or services rendered by qualified, unaffiliated third parties on a competitive basis;
(xxii) The costs arising from Landlords charitable or political contributions;
(xxiii) The costs (other than ordinary maintenance and insurance) for sculpture, paintings and other objects of art;
(xxiv) The interest and penalties resulting from Landlords failure to pay any items of Operating Expense when due;
(xxv) The Landlords general corporate overhead and general and administrative expenses, costs of entertainment, dining, automobiles or travel for Landlords employees, and costs associated with the operation of the business of the partnership or entity which constitutes Landlord as the same are distinguished from the costs of the operation of the
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Project, including partnership accounting and legal matters, costs of defending any lawsuits with any mortgagee, costs of selling, syndicating, financing, mortgaging or hypothecating any of Landlords interest in the Project, costs of any disputes between Landlord and its employees (if any) not engaged in the operation of the Project, disputes of Landlord with management, or outside fees paid in connection with disputes with other Project tenants or occupants (except to the extent such dispute is based on Landlords good faith efforts to benefit Tenant or meet Landlords obligations under this Lease);
(xxvi) The costs arising from the gross negligence or willful misconduct of Landlord or its affiliates or their agents, employees, contractors or invitees;
(xxvii) The management office rental to the extent such rental exceeds the fair market rental for such space;
(xxviii) The costs of correction of any defects in the Project to the extent covered by warranties, indemnities or service contracts;
(xxix) The costs of Landlords membership in professional organizations (such as, by way of example and without limitation, BOMA) in excess of $2,500.00 per year.
(xxx) Depreciation, amortization and interest payments, except on materials, tools, supplies and vendor-type equipment purchased by Landlord to enable Landlord to supply services Landlord might otherwise contract for with a third party to the extent such depreciation, amortization and interest payments would otherwise have been included in the charge for such third parties services and any interest expressly included in Section 5.1(a)(viii);
(xxxi) Insurance deductibles or self-insurance retention or uninsured casualty damage which in any Lease Year exceed $50,000 with respect to the Building; provided, however, if the amount of the deductible exceeds that annual limitation, Landlord may carry over the unrecovered portion of any deductible into the subsequent lease years and recover them from Tenant subject to the annual limitation provided for in this Section 5.1(a)(xxxi);
(xxxii) Management fees retained by Landlord or its affiliates in excess of an amount equal to four percent (4%) of all gross receipts for the Project;
(xxxiii) Any costs or expenses of any kind or nature which are exclusively related to or for any other building forming part of the Project (other than the Building); and
(xxxiv) Reserves for future expenses; provided, however, the foregoing shall not prohibit Landlord from passing through to Tenant (as an Operating Expense) items includable in Operating Expenses pursuant to the Lease once such items have been purchased from an existing reserve or once the expenses covered by such reserve have been incurred.
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(b) Taxes shall mean all real property taxes, ad valorem taxes, personal property taxes, and all other taxes, assessments, embellishments, use and occupancy taxes, transit taxes, water, sewer and pure water charges not included in Section 5.1.(a)(v) above, excises, levies, license fees or taxes, and all other similar charges, levies, penalties, or taxes, if any, which are levied, assessed, or imposed, by any Federal, State, county, or municipal authority, whether by taxing districts or authorities presently in existence or by others subsequently created, upon, or due and payable in connection with, or a lien upon, all or any portion of the Project, or facilities used in connection therewith, and rentals or receipts therefrom and all taxes of whatsoever nature that are imposed in substitution for or in lieu of any of the taxes, assessments, or other charges included in its definition of Taxes, and any costs and expenses of contesting the validity of same. Taxes shall include, without limitation: (i) Any tax on the gross rent, right to rent or other income from the Project, or any portion thereof, or as against the business of leasing the Project, or any portion thereof; (ii) Any assessment, tax, fee, levy or charge in addition to, or in substitution, partially or totally, of any assessment, tax, fee, levy or charge previously included within the definition of real property tax, it being acknowledged by Tenant and Landlord that Proposition 13 was adopted by the voters of the State of California in the June 1978 election (Proposition 13) and that assessments, taxes, fees, levies and charges may be imposed by governmental agencies for such services as fire protection, street, sidewalk and road maintenance, refuse removal and for other governmental services formerly provided without charge to property owners or occupants, and, in further recognition of the decrease in the level and quality of governmental services and amenities as a result of Proposition 13, Taxes shall also include any governmental or private assessments or the Projects contribution towards a governmental or private cost-sharing agreement for the purpose of augmenting or improving the quality of services and amenities normally provided by governmental agencies; (iii) Any assessment, tax, fee, levy, or charge allocable to or measured by the area of the Premises, the tenant improvements in the Premises, or the Rent payable hereunder, including, without limitation, any business or gross income tax or excise tax with respect to the receipt of such rent, or upon or with respect to the possession, leasing, operating, management, maintenance, alteration, repair, use or occupancy by Tenant of the Premises, or any portion thereof; (iv) Any assessment, tax, fee, levy or charge, upon this transaction or any document to which Tenant is a party, creating or transferring an interest or an estate in the Premises; (v) All of the real estate taxes and assessments imposed upon or with respect to the Buildings and all of the real estate taxes and assessments imposed on the land and improvements comprising the Project, and (vi) assessments attributable to the Project by any governmental or quasi-governmental agency that Landlord is required to pay. Notwithstanding anything to the contrary contained in this Section 5.1(b), there shall be excluded from Taxes (1) all excess profits taxes, franchise taxes, documentary transfer taxes, gift taxes, capital stock taxes, inheritance and succession taxes, estate taxes, federal and state net income taxes, and other taxes to the extent applicable to Landlords net income (as opposed to rents, receipts or income attributable to operations at the Project), (2) any items included as Operating Expenses, and (3) any items paid by Tenant under Section 17.1 of this Lease, (4) tax penalties, fines, interest or charges incurred as a result of Landlords failure to make payments and/or to file any tax or informational returns when due, and (5) any taxes or assessment expenses or any increase therein (A) in excess of the amount which would be payable if such tax or assessment expense were paid in installments over the longest possible term or (B) imposed on land or improvements other than the Project.
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(c) Lease Year shall mean the twelve (12) month period commencing January 1st and ending December 31st.
(d) Tenants Building Percentage shall mean Tenants percentage of the entire Building as determined by dividing the rentable area of the Premises by the total rentable area of the Building. If there is a change in the total Building rentable area as a result of an addition to the Building, partial destruction, modification or similar cause, which event causes a reduction or increase on a permanent basis, Landlord shall cause adjustments in the computations as shall be necessary to provide for any such changes. Landlord shall, at Landlords option, have the right to segregate Operating Expenses into two (2) separate categories, one (1) such category, to be applicable only to Operating Expenses incurred for the Building and the other category applicable to Operating Expenses incurred for the Common Areas and/or the Project as a whole. If Landlord so segregates Operating Expenses into two (2) categories, two (2) Tenants Building Percentages shall apply, one (1) such Tenants Building Percentage shall be calculated by dividing the rentable area of the Premises by the total Rentable area in the Building (Tenants Building Only Percentage), and the other Tenants Building Percentage to be calculated by dividing the rentable area of the Premises by the total rentable area of all buildings in the Project (Tenants Common Area Building Percentage). Consequently, if Landlord elects to so segregate Operating Expenses into two (2) categories, any reference in this Lease to Tenants Building Percentage shall mean and refer to both Tenants Building Only Percentage and Tenants Common Area Building Percentage of Operating Expenses.
(e) Tenants Tax Percentage shall mean the percentage determined by dividing the rentable area of the Premises by the total rentable area of all buildings in the Project.
(f) Market Area shall mean the Redwood Shores submarket of Redwood City, California (the City).
(g) Comparable Buildings shall mean comparable Class A office/R&D use buildings owned by institutions in the Market Area.
5.2 Tenant shall pay to Landlord, as Additional Rent, Tenants Share (as hereinafter defined) of the Operating Expenses. Tenants Share shall be determined by multiplying Operating Expenses for any Lease Year or pro rata portion thereof, by Tenants Building Percentage. Landlord shall, in advance of each Lease Year, estimate what Tenants Share will be for such Lease Year based, in part, on Landlords operating budget for such Lease Year, and Tenant shall pay Tenants Share as so estimated each month (the Monthly Escalation Payments). The Monthly Escalation Payments shall be due and payable at the same time and in the same manner as the Monthly Rent.
5.3 Landlord shall, within one hundred fifty (150) days after the end of each Lease Year, or as soon thereafter as reasonably possible, provide Tenant with a written statement of the actual Operating Expenses incurred during such Lease Year for the Project and such statement shall set forth Tenants Share of such Operating Expenses. Tenant shall pay Landlord, as Additional Rent, the difference between Tenants Share of Operating Expenses and the amount of Monthly Escalation Payments made by Tenant attributable to said Lease Year, such
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payment to be made within thirty (30) days of the date of Tenants receipt of said statement (except as provided in Section 5.4 below); similarly, Tenant shall receive a credit if Tenants Share of Operating Expenses is less than the amount of Monthly Escalation Payments collected by Landlord during said Lease Year, such credit to be applied to future Rent to become due hereunder. If utilities, janitorial services or any other components of Operating Expenses increase during any Lease Year, Landlord may revise Monthly Escalation Payments due during such Lease Year by giving Tenant written notice to that effect; and thereafter, Tenant shall pay, in each of the remaining months of such Lease Year, a sum equal to the amount of the revised difference in Operating Expenses multiplied by Tenants Building Percentage divided by the number of months remaining in such Lease Year.
5.4 Within ninety (90) days following Tenants receipt of the Operating Expense statement or Taxes statement, Tenant may give Landlord notice (the Review Notice) stating that Tenant elects to review Landlords calculation of the amount of Operating Expenses or Taxes payable by Tenant for the Lease Year to which such statement applies and identifying with reasonable specificity the records of Landlord reasonably relating to such matters that Tenant desires to review. Tenant may not deliver more than one (1) Review Notice with respect to any Lease Year. If Tenant fails to give Landlord such a Review Notice within that ninety (90) day period, Tenant shall be deemed to have approved the applicable statement. If Tenant timely gives the Review Notice, Tenant shall be entitled to conduct or require an audit to be conducted, provided that (a) not more than one (1) such audit may be conducted during any Lease Year of the Term, (b) the records for each Lease Year may be audited only once, (c) such audit is commenced within ninety (90) days following Tenants receipt of the applicable statement, and (d) such audit is completed and a copy thereof is delivered to Landlord within one hundred eighty (180) days following Tenants receipt of the applicable statement. Tenants auditor must be a member of a nationally recognized accounting firm and must not charge a fee based on the amount that the accountant is able to save Tenant by the inspection. As a condition precedent to any inspection by Tenants accountant, Tenant shall deliver to Landlord a copy of Tenants written agreement with such accountant, which agreement shall include provisions which state that (i) Landlord is an intended third party beneficiary of such agreement, (ii) such accountant will not in any manner solicit any other tenant of the Project with respect to an audit or other review of Landlords accounting records at the Project, and (iii) such accountant shall maintain in strict confidence any and all information obtained in connection with the review and shall not disclose such information to any person or entity other than to the management personnel of Tenant. An overcharge of Operating Expenses or Taxes by Landlord shall not entitle Tenant to terminate this Lease. No subtenant shall have the right to audit. Any assignees audit right will be limited to the period after the effective date of the assignment. No audit shall be permitted if an Event of Default by Tenant has occurred and is continuing under this Lease, including without limitation any failure by Tenant to pay any amount due under this Article 5. If Landlord responds to any such audit with an explanation of any issues raised in the audit, such issues shall be deemed resolved unless Tenant responds to Landlord with further written objections within thirty (30) days after receipt of Landlords response to the audit. In no event shall payment of Rent ever be contingent upon the performance of such audit. For purposes of any audit, Tenant or Tenants duly authorized representative, at Tenants sole cost and expense, shall have the right, upon ten (10) days written notice to Landlord, to inspect Landlords books and records pertaining to Operating Expenses and Taxes at the offices of Landlord or Landlords managing agent during ordinary business hours, provided that such audit must be conducted so as not to
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interfere with Landlords business operations and must be reasonable as to scope and time. If actual Operating Expenses or Taxes are finally determined (by agreement of the parties or arbitration) to have been overstated or understated by Landlord for any calendar year, then the parties shall within thirty (30) days thereafter make such adjustment payment or refund as is applicable, and if actual Operating Expenses and Taxes are finally determined (by agreement of the parties or arbitration) to have been overstated by Landlord for any calendar year by in excess of seven percent (7%), then Landlord shall pay the reasonable cost of Tenants audit, not to exceed $3,000.00.
5.5 If the occupancy of the Building during any part of any Lease Year is less than one hundred percent (100%), Landlord shall make an appropriate adjustment of the variable components of Operating Expenses for that Lease Year, as reasonably determined by Landlord using sound accounting and management principles, to determine the amount of Operating Expenses that would have been incurred had the Building been one hundred percent (100%) occupied. This amount shall be considered to have been the amount of Operating Expenses for that Lease Year. For purposes of this Section 5.5, variable components include only those component expenses that are affected by variations in occupancy levels.
5.6 Tenant shall pay to Landlord, as Additional Rent, Tenants Tax Share (as hereinafter defined) of the Taxes. Tenants Tax Share shall be determined by multiplying Taxes for any Lease Year or pro rata portion thereof, by Tenants Tax Percentage. Landlord shall, in advance of each Lease Year, estimate what Tenants Tax Share will be for such Lease Year and Tenant shall pay Tenants Tax Share as so estimated each month (the Monthly Tax Payments). The Monthly Tax Payments shall be due and payable at the same time and in the same manner as the Monthly Rent.
5.7 Landlord shall, within one hundred fifty (150) days after the end of each Lease Year, or as soon thereafter as reasonably possible, provide Tenant with a written statement of the actual Taxes incurred during such Lease Year for the Project and such statement shall set forth Tenants Tax Share of such Taxes. Tenant shall pay Landlord, as Additional Rent, the difference between Tenants Tax Share of Taxes and the amount of Monthly Tax Payments made by Tenant attributable to said Lease Year, such payment to be made within thirty (30) days of the date of Tenants receipt of said statement; similarly, Tenant shall receive a credit if Tenants Tax Share is less than the amount of Monthly Tax Payments collected by Landlord during said Lease Year, such credit to be applied to future Rent to become due hereunder. If Taxes increase during any Lease Year, Landlord may revise Monthly Tax Payments due during such Lease Year by giving Tenant written notice to that effect; and, thereafter, Tenant shall pay, in each of the remaining months of such Lease Year, a sum equal to the amount of revised difference in Taxes multiplied by Tenants Tax Percentage divided by the number of months remaining in such Lease Year. Despite any other provision of this Article 5, Landlord may adjust Operating Expenses and/or Taxes and submit a corrected statement to account for Taxes or other government public-sector charges (including utility charges) that are for that given year but that were first billed to Landlord after the date that is ten (10) business days before the date on which the statement was furnished.
5.8 If the Taxes for any Lease Year are changed as a result of protest, appeal or other action taken by a taxing authority, the Taxes as so changed shall be deemed the Taxes
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for such Lease Year. Any expenses incurred by Landlord in attempting to protest, reduce or minimize Taxes shall be included in Taxes in the Lease Year in which those expenses are paid. Landlord shall have the exclusive right to conduct such contests, protests and appeals of the Taxes as Landlord shall determine is appropriate in Landlords sole discretion.
5.9 Tenants obligation with respect to Additional Rent and the payment of Tenants Share of Operating Expenses and Tenants Tax Share of Taxes shall survive the Expiration Date or Termination Date of this Lease.
ARTICLE 6.
SERVICES TO BE PROVIDED BY LANDLORD
6.1 Subject to Articles 5 and 10 herein, under this Lease, Landlord agrees to furnish or cause to be furnished to the Premises the utilities and services described in the Standards for Utilities and Services, attached hereto as Exhibit G, subject to the conditions and in accordance with the standards set forth herein.
6.2 Landlord shall not be liable for any loss or damage arising or alleged to arise in connection with the failure, stoppage, or interruption of any such services; nor shall the same be construed as an eviction of Tenant, work an abatement of Rent, entitle Tenant to any reduction in Rent, or relieve Tenant from the operation of any covenant or condition herein contained; it being further agreed that Landlord reserves the right to discontinue temporarily such services or any of them at such times as may be necessary by reason of repair or capital improvements performed within the Project, accident, unavailability of employees, repairs, alterations or improvements, or whenever by reason of strikes, lockouts, riots, acts of God, or any other happening or occurrence beyond the reasonable control of Landlord. In the event of any such failure, stoppage or interruption of services, Landlord shall use reasonable diligence to have the same restored. Neither diminution nor shutting off of light or air or both, nor any other effect on the Project by any structure erected or condition now or hereafter existing on lands adjacent to the Project, shall affect this Lease, abate Rent, or otherwise impose any liability on Landlord. Furthermore, Landlord shall not be liable under any circumstances for a loss of, or injury to, property or for injury to, or interference with, Tenants business, including, without limitation, loss of profits, however occurring, through or in connection with or incidental to a failure to furnish any of the services or utilities as set forth in this Article 6.
6.3 Landlord shall have the right to reduce heating, cooling, or lighting within the Premises and in the public area in the Building as required by any fuel or energy-saving program mandated by Applicable Law.
6.4 Unless otherwise provided by Landlord, Tenant shall separately arrange with the applicable local public authorities or utilities, as the case may be, for the furnishing of and payment of all telephone and facsimile services as may be required by Tenant in the use of the Premises. Tenant shall directly pay for such telephone and facsimile services as may be required by Tenant in the use of the Premises, including the establishment and connection thereof, at the rates charged for such services by said authority or utility; and the failure of Tenant to obtain or to continue to receive such services for any reason whatsoever shall not relieve Tenant of any of its obligations under this Lease.
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6.5 Landlord shall have the exclusive right, but not the obligation, to provide any locksmithing services, and Landlord shall also have the non-exclusive right, but not the obligation, to provide any additional services which may be required by Tenant, including without limitation additional repairs and maintenance, provided that Tenant shall pay to Landlord upon billing, the sum of all reasonable costs to Landlord of such additional services plus an administration fee agreed upon in advance by Landlord and Tenant (provided that the administrative fee for Landlords locksmithing services shall not exceed three percent (3%) of the actual out-of-pocket costs of such services). If Tenant requests the Landlord provide locksmithing services and Landlord declines, then Tenant shall not be obligated to use Landlords locksmithing services. Charges for any utilities or service for which Tenant is required to pay from time to time hereunder, shall be deemed Additional Rent hereunder and shall be billed on a monthly basis.
6.6 At all times during the Term Landlord shall have the right to select the utility company or companies that shall provide electric, telecommunication and/or other utility services to the Premises and, subject to all Applicable Laws, Landlord shall have the right at any time and from time to time during the Term to either (a) contract for services from electric, telecommunication and/or other utility service provider(s) other than the provider with which Landlord has a contract as of the date of this Lease (the Current Provider), or (b) continue to contract for services from the Current Provider. The cost of such utility services and any energy management and procurements services in connection therewith shall be Operating Expenses.
6.7 If Tenant is billed directly by a public utility with respect to Tenants electrical usage at the Premises, upon request from time to time, Tenant shall provide monthly electrical utility usage for the Premises to Landlord for the period of time requested by Landlord (in electronic or paper format) or, at Landlords option, provide any written authorization or other documentation required for Landlord to request information regarding Tenants electricity usage with respect to the Premises directly from the applicable utility company; provided that Landlord shall keep such information confidential.
6.8 Notwithstanding anything to the contrary in Section 6.2 or elsewhere in this Lease, if (a) Landlord fails to provide Tenant with the utility services or elevator service described in Section 6.1, (b) such failure is not due to any one or more Force Majeure Events or to an event covered by Article 19, (c) Tenant has given Landlord reasonably prompt written notice that such failure is unreasonably interfering with Tenants use of the Premises and (d) as a result of such failure all or any part of the Premises are rendered not reasonably usable by Tenant (and, as a result, all or such part of the Premises are not used by Tenant during the applicable period) for more than five (5) consecutive business days, then Tenant shall be entitled to an abatement of Rent proportional to the extent to which the Premises are thereby rendered unusable by Tenant, commencing with the later of (i) the sixth (6th) business day during which such unusability continues or (ii) the sixth (6th) business day after Landlord receives such notice from Tenant, until the Premises (or part thereof affected) are again reasonably usable or until Tenant again uses the Premises (or part thereof rendered unusable) in its business, whichever first occurs. The foregoing rental abatement shall be Tenants exclusive remedy therefor. Notwithstanding the foregoing, the provisions of Article 19 below and not the provisions of this subsection shall govern in the event of casualty damage to the Premises or Project and the provisions of Article 20 below and not the provisions of this subsection shall govern in the event of condemnation of all or a part of the Premises or Project.
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ARTICLE 7.
REPAIRS AND MAINTENANCE BY LANDLORD
7.1 Landlord shall provide for the cleaning and maintenance of the public portions of the Project in keeping with the ordinary standard for Comparable Buildings as part of Operating Expenses. Unless otherwise expressly stipulated herein, Landlord shall not be required to make any improvements or repairs of any kind or character to the Premises during the Term, except such repairs as may be required to the exterior walls, corridors, windows, roof, integrated Building utility and mechanical systems and other Base Building (as defined below) elements and other structural elements and equipment of the Project, and subject to Section 13.4, below, such additional maintenance as may be necessary because of the damage caused by persons other than Tenant, its agents, employees, licensees, or invitees. As used in this Lease, the Base Building shall include the structural portions of the Building, and the public restrooms, elevators, exit stairwells and the systems and equipment located in the internal core of the Building.
7.2 Landlord or Landlords officers, agents, and representatives (subject to any security regulations imposed by any governmental authority) shall have the right to enter all parts of the Premises at all reasonable hours upon reasonable prior notice to Tenant (which notice shall not be less than twenty-four (24) hours in advance, except in an emergency) to inspect, clean, make repairs, alterations, and additions to the Project or the Premises which it may deem necessary or desirable, to make repairs to adjoining spaces, to cure any defaults of Tenant hereunder that Landlord elects to cure pursuant to Section 22.5, below, to post notices of nonresponsibility, to show the Premises to prospective tenants (during the final nine (9) months of the Term or at any time after the occurrence of an Event of Default that remains uncured), mortgagees or purchasers of the Building, or to provide any service which it is obligated or elects to furnish to Tenant; and Tenant shall not be entitled to any abatement or reduction of Rent by reason thereof. Landlord shall have the right to enter the Premises at any time and by any means in the case of an emergency. In connection with any entry into the Premises except in the case of an emergency or after the entry of judgment in favor of Landlord for unlawful detainer due to an Event of Default by Tenant, Landlord shall comply with Tenants reasonable security measures and operating procedures and shall use reasonable efforts to minimize any disruption to Tenant. Furthermore, notwithstanding anything to the contrary contained in this Lease, Tenant reserves right to require that a representative of the Tenant accompany the Landlord and all such other parties at all times while gaining access to the Premises; provided that Tenants failure to make a Tenant employee available at the time of Landlords entry into the Premises shall not limit Landlords or Landlords officers, agents, representatives right to enter the Premises.
7.3 Except as otherwise expressly provided in this Lease, Landlord shall not be liable for any failure to make any repairs or to perform any maintenance and there shall be no abatement of rent and no liability of Landlord by reason of any injury to or interference with Tenants business arising from the making of any repairs, alterations or improvements in or to any portion of the Project, Building or the Premises or in or to fixtures, and equipment therein. Tenant hereby waives all rights it would otherwise have under California Civil Code
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Sections 1932(1) and 1942(a), or any similar law, statute or ordinance now or hereafter in effect, to make repairs at Landlords expense, to deduct repair costs from Rent and/or terminate this Lease as the result of any failure by Landlord to maintain or repair.
ARTICLE 8.
REPAIRS AND CARE OF PREMISES BY TENANT
8.1 If the Building, the Project, or any portion thereof, including but not limited to, the elevators, boilers, engines, pipes, and other apparatus, or members of elements of the Building (or any of them) used for the purpose of climate control of the Building or operating of the elevators, or of the water pipes, drainage pipes, electric lighting, or other equipment of the Building or the roof or outside walls of the Building and also the Premises improvements, including but not limited to, the carpet, wall coverings, doors, and woodwork, become damaged or are destroyed through the negligence, or intentional misuse of Tenant, its servants, agents, employees, or anyone permitted by Tenant to be in the Building, or through it or them, then the reasonable cost of the necessary repairs, replacements, or alterations shall be borne by Tenant who shall pay the same to Landlord as Additional Rent within ten (10) business days after demand, subject to Section 13.4 below. Landlord shall have the exclusive right, but not the obligation, to make any repairs necessitated by such damage. In performing such repairs, Landlord shall use its reasonable efforts to minimize any disruption to Tenant.
8.2 Subject to Section 13.4 below, Tenant agrees, at its sole cost and expense, to repair or replace any damage or injury done to the Project, or any part thereof, caused by the negligence or willful misconduct of Tenant, Tenants agents, employees, licensees, or invitees which Landlord elects not to repair. Tenant shall not injure the Project or the Premises and, at Tenants sole cost and expense, shall maintain the Premises, including without limitation all improvements, fixtures and furnishings therein, and the floor or floors on which the Premises are located, in good order, repair and condition at all times during the Term. Notwithstanding the foregoing, Landlord shall perform and construct, and Tenant shall have no responsibility to perform or construct, any repair, maintenance or improvements (i) required as a consequence of any violation of any Laws or construction defects in the Premises, the Building or the Project as of the Commencement Date, (ii) which could be treated as a capital expenditure under generally accepted accounting principles, except to the extent the capital expenditure is required due to a Trigger Event (as defined in Section 34.1 below), and (iii) to any portion of the Building or the Project outside of the demising walls of the Premises; provided that (a) the cost to Landlord of such repair, maintenance or improvements shall be included in Operating Expenses, subject to the terms of Article 5, and (b) to the extent any repair, maintenance or improvements are required to any portion of the Building or the Project outside of the demising walls of the Premises due to a Trigger Event, Tenant shall be solely responsible for the cost thereof. If an Event of Default occurs because Tenant fails to keep such elements of the Premises in such good order, condition, and repair as required hereunder to the satisfaction of Landlord, Landlord may restore the Premises to such good order and condition and make such repairs without liability to Tenant for any loss or damage that may accrue to Tenants property or business by reason thereof, and within ten (10) business days after completion thereof, Tenant shall pay to Landlord, as Additional Rent, upon demand, the cost of restoring the Premises to such good order and condition and of the making of such repairs, plus an additional charge of ten percent (10%) thereof. Upon the Expiration Date or the Termination Date, Tenant shall surrender and deliver up
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the Premises to Landlord in the same condition in which it existed at the Commencement Date, excepting only ordinary wear and tear, Alterations that Tenant is not required to remove hereunder, and damage arising from any cause not required to be repaired by Tenant (including casualty and condemnation). Upon the Expiration Date or the Termination Date, Landlord shall have the right to re-enter and take possession of the Premises.
8.3 Tenant shall provide its own janitorial and cleaning services to the Premises at Tenants sole cost and expense. Landlord is not obligated to provide any janitorial or cleaning services to the Premises.
ARTICLE 9.
TENANTS EQUIPMENT AND INSTALLATIONS
9.1 If heat-generating machines or equipment, including telephone equipment, cause the temperature in the Premises, or any part thereof, to exceed the temperatures the Buildings air conditioning system would be able to maintain in such Premises were it not for such heat-generating equipment, then Landlord reserves the right to install supplementary air conditioning units in the Premises, and the reasonable cost thereof, including the cost of installation and the cost of operation and maintenance thereof, including water, shall be paid by Tenant to Landlord within thirty (30) days after demand by Landlord.
9.2 Except for desk or table-mounted typewriters, adding machines, office calculators, dictation equipment, personal computers, servers, photocopiers, printers and other similar office equipment consistent with first-class general office use in Comparable Buildings, Tenant shall not install within the Premises any fixtures, equipment, facilities, or other improvements without the specific written consent of Landlord, subject to Article 15, below. Tenant shall not, without the specific written consent of Landlord (which consent shall not be unreasonably withheld, conditioned, or delayed), install or maintain any apparatus or device within the Premises which shall increase the usage of electrical power or water for the Premises to an amount greater than would be normally required for general office use for space of comparable size in the Market Area; and if any such apparatus or device is so installed, Tenant agrees to furnish Landlord a written agreement to pay for any additional costs of utilities as the result of said installation. Notwithstanding anything to the contrary contained in this Lease except Section 50.1, Tenant shall have the right to install and maintain such fixtures, equipment, facilities, or other improvements as are reasonably necessary for conduct of Tenants business at the Premises.
ARTICLE 10.
FORCE MAJEURE
10.1 It is understood and agreed that with respect to any service or other obligation to be furnished or obligations to be performed by either party, in no event shall either party be liable for failure to furnish or perform the same when prevented from doing so by strike, lockout, breakdown, accident, supply, or inability by the exercise of reasonable diligence to obtain supplies, parts, or employees necessary to furnish such service or meet such obligation; or because of war or other emergency; or for any cause beyond the reasonable control with the party obligated for such performance; or for any cause due to any act or omission in violation of
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this Lease of the other party or its agents, employees, licensees, invitees, or any persons claiming by, through, or under the other party (each, a Party Caused Event); or because of the failure of any public utility to furnish services; or because of order or regulation of any federal, state, county or municipal authority (collectively, Force Majeure Events). Nothing in this Section 10.1 shall limit or otherwise modify or waive Tenants obligation to pay Base Rent and Additional Rent as and when due pursuant to the terms of this Lease.
ARTICLE 11.
CONSTRUCTION, MECHANICS AND MATERIALMANS LIENS
11.1 Tenant shall not suffer or permit any construction, mechanics or materialmans lien to be filed against the Premises or any portion of the Project by reason of work, labor services, or materials supplied or claimed to have been supplied to Tenant. Nothing herein contained shall be deemed or construed in any way as constituting the consent or request of Landlord, expressed or implied, by inference or otherwise, for any contractor, subcontractor, laborer, or materialman to perform any labor or to furnish any materials or to make any specific improvement, alteration, or repair of or to the Premises or any portion of the Project; nor of giving Tenant any right, power, or authority to contract for, or permit the rendering of, any services or the furnishing of any materials that could give rise to the filing of any construction, mechanics or materialmans lien against the Premises or any portion of the Project.
11.2 If any such construction, mechanics or materialmans lien shall at any time be filed against the Premises or any portion of the Project as the result of any act or omission of Tenant, Tenant covenants that it shall, within twenty (20) days after Tenant has notice of the claim for lien, procure the discharge thereof by payment or by giving security or in such other manner as is or may be required or permitted by law or which shall otherwise satisfy Landlord. If Tenant fails to take such action, Landlord, in addition to any other right or remedy it may have, may take such action as may be reasonably necessary to protect its interests. Any amounts paid by Landlord in connection with such action, all other expenses of Landlord incurred in connection therewith, including reasonable attorneys fees, court costs, and other necessary disbursements shall be repaid by Tenant to Landlord within ten (10) business days after demand.
ARTICLE 12.
ARBITRATION
12.1 In the event that a dispute arises under Section 5.3 above, the same shall be submitted to arbitration in accordance with the provisions of applicable state law, if any, as from time to time amended. Arbitration proceedings, including the selection of an arbitrator, shall be conducted pursuant to the rules, regulations, and procedures from time to time in effect as promulgated by the American Arbitration Association (the Association). Prior written notice of application by either party for arbitration shall be given to the other at least ten (10) business days before submission of the application to the said Associations office in the city wherein the Building is situated (or the nearest other city having an Association office). The arbitrator shall hear the parties and their evidence. The decision of the arbitrator may be entered in the appropriate court of law; and the parties consent to the jurisdiction of such court and further agree that any process or notice of motion or other application to the court or a judge thereof may
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be served outside the state wherein the Building is situated by registered mail or by personal service, provided a reasonable time for appearance is allowed. The costs and expenses of each arbitration hereunder and their apportionment between the parties shall be determined by the arbitrator in his or her award or decision, subject to the penultimate sentence of this section. No arbitrable dispute shall be deemed to have arisen under this Lease (a) prior to the expiration of the period of twenty (20) days after the date of the giving of written notice by the party asserting the existence of the dispute, together with a description thereof sufficient for an understanding thereof, and (b) where Tenant disputes the amount of a Tenant payment required hereunder (e.g., Operating Expenses under Section 5.3 hereof), prior to Tenant paying in full the amount billed by Landlord, including the disputed amount. The prevailing party in such arbitration shall be reimbursed for its expenses, including reasonable attorneys fees. Notwithstanding the foregoing, in no event shall this Article 12 affect or delay Landlords unlawful detainer rights under California law.
ARTICLE 13.
INSURANCE
13.1 Landlord shall maintain, as a part of Operating Expenses, to the extent permitted under Section 5.1(a), special causes of loss form property insurance on the Project (excluding, at Landlords option, the property required to be insured by Tenant pursuant to Section 13.2(e), below) in an amount equal to the full replacement cost of the Project, subject to such deductibles as Landlord may determine. Landlord shall not be obligated to insure, and shall not assume any liability of risk of loss for, any of Tenants furniture, equipment, machinery, goods, supplies, improvements or alterations upon the Premises. Such insurance shall be maintained with an insurance company selected, and in amounts desired, by Landlord or Landlords mortgagee, and payment for losses thereunder shall be made solely to Landlord subject to the rights of the holder of any mortgage or deed of trust which may now or hereafter encumber the Project. Additionally Landlord may maintain such additional insurance, including, without limitation, earthquake insurance, flood insurance, liability insurance and/or rent insurance, as Landlord may in its sole discretion elect. Subject to Section 5.1(a), the cost of all such additional insurance shall also be part of the Operating Expenses. Any or all of Landlords insurance may be provided by blanket coverage maintained by Landlord or any affiliate of Landlord under its insurance program for its portfolio of properties or by Landlord or any affiliate of Landlords program of self-insurance, and in such event Operating Expenses shall include subject to Section 5.1(a), the portion of the reasonable cost of blanket insurance or self-insurance that is allocated to the Project.
13.2 Tenant, at its own expense, shall maintain with insurers authorized to do business in the State of California and which are rated A- or better and have a financial size category of at least VIII in the most recent Bests Key Rating Guide, or any successor thereto (or if there is none, an organization having a national reputation), (a) commercial general liability insurance, including Broad Form Property Damage and Contractual Liability with the following minimum limits: Each Occurrence $1,000,000.00 and General Aggregate $2,000,000.00; Personal and Advertising Injury $1,000,000.00; Medical Payments $5,000.00 per person, (b) Umbrella/Excess Liability on a following form basis with the following minimum limits: General Aggregate $5,000,000.00; Each Occurrence $5,000,000.00, excess above the General Liability, Employers Liability and Auto Liability coverage; (c) Workers Compensation with
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statutory limits; (d) Employers Liability insurance with the following limits: Bodily injury by disease per person $1,000,000.00; Bodily injury by accident policy limit $1,000,000.00; Bodily injury by disease policy limit $1,000,000.00; (e) property insurance on special causes of loss insurance form covering (i) all office furniture, business and trade fixtures, office equipment, free-standing cabinet work, movable partitions, merchandise and all other items of Tenants property on the Premises installed by, for, or at the expense of Tenant, (ii) the Tenant Improvements and any other improvements which exist in the Premises as of the Commencement Date (excluding the Base Building) (the Original Improvements), and (iii) all other improvements, alterations and additions to the Premises (such insurance shall be for the full replacement cost value (subject to reasonable deductible amounts) new without deduction for depreciation of the covered items and in amounts that meet any co-insurance clauses of the policies of insurance and shall include coverage for damage or other loss caused by fire or other peril including, but not limited to, vandalism and malicious mischief, theft, water damage of any type, including sprinkler leakage, bursting or stoppage of pipes, and explosion); and (f) business auto liability insurance having a combined single limit of not less than One Million Dollars ($1,000,000.00) per occurrence and insuring Tenant against liability for claims arising out of ownership, maintenance or use of any owned, hired or non-owned automobiles. At all times during the Term, such insurance shall be maintained, and Tenant shall cause a current and valid certificate of such policies to be deposited with Landlord. If Tenant fails to have a current and valid certificate of such policies on deposit with Landlord at all times during the Term and such failure is not cured within five (5) business days following Tenants receipt of notice thereof from Landlord, Landlord shall have the right, but not the obligation, to obtain such an insurance policy, and Tenant shall be obligated to pay Landlord the amount of the premiums applicable to such insurance within ten (10) business days after Tenants receipt of Landlords request for payment thereof. Said policy of liability insurance shall name Landlord, Landlords affiliates and subsidiaries reasonably designated by Landlord, and Landlords managing agent as additional insureds and Tenant as the insured and shall be noncancellable with respect to Landlord except after thirty (30) days written notice from the insurer to Landlord.
13.3 Tenant shall adjust (but not more than once every three years) the amount of coverage established in Section 13.2 hereof to such amount as in Landlords reasonable opinion, adequately protects Landlords interest; provided the same is consistent with the amount of coverage customarily required of comparable tenants in Comparable Buildings.
13.4 Notwithstanding anything in this Lease to the contrary, Landlord and Tenant each hereby waives any and all rights of recovery, claim, action, or cause of action against the other, its agents, employees, licensees, or invitees for any loss or damage to or at the Premises or the Project or any personal property of such party therein or thereon by reason of fire, the elements, or any other cause which would be insured against under the terms of special causes of loss form property insurance, regardless of cause or origin, including omission of the other party hereto, its agents, employees, licensees, or invitees. Landlord and Tenant covenant that no insurer shall hold any right of subrogation against either of such parties with respect thereto. This waiver shall be ineffective against any insurer of Landlord or Tenant to the extent that such waiver is prohibited by the laws and insurance regulations of the State of California. The parties hereto agree that any and all such insurance policies required to be carried by either shall be endorsed with a subrogation clause, substantially as follows: This insurance shall not be invalidated should the insured waive, in writing prior to a loss, any and all right of recovery
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against any party for loss occurring to the property described therein, and shall provide that such partys insurer waives any right of recovery against the other party in connection with any such loss or damage.
13.5 In the event Tenants particular occupancy or conduct of business in or on the Premises, whether or not Landlord has consented to the same, results in any increase in premiums for the insurance carried from time to time by Landlord with respect to the Building, Tenant shall pay any such increase in premiums as Rent within ten (10) business days after bills for such additional premiums shall be rendered by Landlord. In determining whether increased premiums are a result of Tenants use or occupancy of the Premises, a schedule issued by the organization computing the insurance rate on the Building showing the various components of such rate, shall be conclusive evidence of the several items and charges which make up such rate. Tenant shall promptly comply with all reasonable requirements of the insurance authority or of any insurer now or hereafter in effect relating to the Premises.
ARTICLE 14.
QUIET ENJOYMENT
14.1 So long as no Event of Default shall have occurred under this Lease, Tenant shall peaceably and quietly hold and enjoy the Premises for the Term, without hindrance by Landlord, subject to the provisions and conditions set forth in this Lease.
ARTICLE 15.
ALTERATIONS
15.1 Tenant agrees that it shall not make or allow to be made any alterations, physical additions, or improvements in or to the Premises without first obtaining the written consent of Landlord in each instance. As used herein, the term Minor Alteration refers to an alteration that (a) does not affect the outside appearance of the Building and is not visible from the Common Areas, (b) is non-structural and does not impair the strength or structural integrity of the Building, and (c) does not materially or adversely affect the mechanical, electrical, HVAC or other systems of the Building. Landlord agrees not to unreasonably withhold condition or delay its consent to any Alteration. Notwithstanding the foregoing, Landlord consents to any repainting, recarpeting, or other purely cosmetic changes or upgrades to the Premises, so long as (i) the aggregate cost of such work is less than $50,000.00 per project (provided that Tenant has not artificially segregated an alteration which by its nature is a single unit or event into smaller increments for purposes of avoiding the necessity of obtaining Landlords consent), (ii) such work constitutes a Minor Alteration (iii) no building permit is required in connection therewith, and (iv) such work conforms to the then existing Building standards. At the time of said request, Tenant shall submit to Landlord plans and specifications of the proposed alterations, additions, or improvements; and Landlord shall have a period of thirty (30) days therefrom in which to review and approve or disapprove said plans; provided that if Landlord determines in good faith that Landlord requires a third party to assist in reviewing such plans and specifications, Landlord shall instead have a period of forty-five (45) days in which to review and approve or disapprove said plans. Tenant shall pay to Landlord upon demand the actual third-party cost and expense of Landlord in (A) reviewing said plans and specifications, and (B) inspecting the alterations, additions, or improvements to determine whether the same are being performed in accordance
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with the approved plans and specifications and all laws and requirements of public authorities, including, without limitation, the fees of any architect or engineer employed by Landlord for such purpose. In any instance where Landlord grants such consent, and permits Tenant to use its own contractors, laborers, materialmen, and others furnishing labor or materials for Tenants construction (collectively, Tenants Contractors), Landlords consent shall be deemed conditioned upon each of Tenants Contractors (1) working in harmony and not interfering with any laborer utilized by Landlord, Landlords contractors, laborers, or materialmen; and (2) furnishing Landlord with evidence of acceptable liability insurance, workers compensation coverage and if required by Landlord for projects costing over $100,000, completion bonding, and if at any time such entry by one or more persons furnishing labor or materials for Tenants work shall cause such disharmony or interference, Tenant shall suspend such work until such harmony is restored or such interference abates. If Tenant is using Tenants Contractors for Tenants construction, the contract with such Tenants Contractor(s) shall be fully executed and delivered by Tenant and Tenants Contractor(s) prior to the commencement of construction. Tenant, at its expense, shall obtain all necessary governmental permits and certificates for the commencement and prosecution of alterations, additions, or improvements and for final approval thereof upon completion, and shall cause any alterations, additions, or improvements to be performed in compliance therewith and with all Applicable Laws (including without limitation, California Energy Code, Title 24) and all requirements of public authorities and with all applicable requirements of insurance bodies. All alterations, additions, or improvements shall be diligently performed in a good and workmanlike manner, using new materials and equipment at least equal in quality and class to be better than (a) the original installations of the Building, or (b) the then standards for the Comparable Building. Upon the completion of work and upon request by Landlord, Tenant shall provide Landlord copies of all waivers or releases of lien from each of Tenants Contractors. No alterations, modifications, or additions to the Project or the Premises shall be removed by Tenant either during the Term or upon the Expiration Date or the Termination Date without the express written approval of Landlord. Tenant shall not be entitled to any reimbursement or compensation resulting from its payment of the cost of constructing all or any portion of said improvements or modifications thereto unless otherwise expressly agreed by Landlord in writing. Notwithstanding anything to the contrary in this Lease, Landlord shall be deemed to have acted reasonably in disapproving plans or designs if Landlord determines in good faith that the matter disapproved constitutes or would create a Design Problem (as defined below). As used herein, a Design Problem shall mean (i) adverse effect on the structural integrity of the Building; (ii) reasonably likely damage to the Buildings systems; (iii) non-compliance with applicable codes; (iv) adverse effect on the exterior appearance of the Building; (v) reasonably likely creation of unusual expenses to be incurred upon the removal of the alteration or improvement and the restoration of the Premises upon termination of this Lease, unless Tenant agrees to pay for the incremental removal costs caused by the non-typical alterations; (vi) reasonably likely creation of unusual expenses to be incurred in connection with the maintenance by Landlord of the alteration or improvement, unless Tenant agrees to pay for the incremental maintenance costs caused by the non-typical alterations, (vii) a material adverse effect any other tenant or occupant of the Building, (viii) creation of an obligation to make other alterations, additions or improvements to the Premises or Common Areas in order to comply with applicable laws (including, without limitation, the Americans with Disabilities Act) unless Tenant agrees to pay for such changes, (ix) adverse effect on the LEED rating of the Building, or (x) reasonably likely increase in the premiums for property or liability insurance carried by Landlord, unless Tenant agrees to pay for the incremental increase in cost.
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15.2 Landlords approval of Tenants plans for work shall create no responsibility or liability on the part of Landlord for their completeness, design sufficiency, or compliance with all laws, rules, and regulations of governmental agencies or authorities, including, but not limited to, the Americans with Disabilities Act. Landlord may, at its option, at Tenants expense, require that Landlords contractors be engaged for any work upon the integrated Building mechanical or electrical systems.
15.3 At least five (5) days prior to the commencement of any work permitted to be done by persons requested by Tenant on the Premises, Tenant shall notify Landlord of the proposed work and the names and addresses of Tenants Contractors. During any such work on the Premises, Landlord, or its representatives, shall have the right to go upon and inspect the Premises at all reasonable times, and shall have the right to post and keep posted thereon building permits and notices of non-responsibility or to take any further action which Landlord may deem to be proper for the protection of Landlords interest in the Premises.
15.4 During such times as Tenant is performing work or having work or services performed in or to the Premises, Tenant shall require its contractors, and their subcontractors of all tiers, to obtain and maintain commercial general liability, automobile, workers compensation, employers liability, builders risk, and equipment/property insurance in such amounts and on such terms as are customarily required of such contractors and subcontractors on similar projects. The amounts and terms of all such insurance are subject to Landlords written approval, which approval shall not be unreasonably withheld. The commercial general liability and auto insurance carried by Tenants contractors and their subcontractors of all tiers pursuant to this section shall name Landlord, Landlords managing agent, and such other persons as Landlord may reasonably request from time to time as additional insureds with respect to liability arising out of or related to their work or services (collectively, Additional Insureds). Such insurance shall provide primary coverage without contribution from any other insurance carried by or for the benefit of Landlord, Landlords managing agent, or other Additional Insureds. Such property insurance shall also waive any right of subrogation against each Additional Insured. Tenant shall obtain and submit to Landlord, prior to the earlier of (i) the entry onto the Premises by such contractors or subcontractors or (ii) commencement of the work or services, certificates of insurance evidencing compliance with the requirements of this section. All of such alterations shall be insured by Tenant pursuant to Article 13 of this Lease immediately upon completion thereof.
15.5 Tenants initial improvement of the Premises shall be governed by Exhibit C and not the provisions of this Article 15 (other than Section 15.4).
15.6 Landlord may require Tenant to remove all or any part of any non-standard fixtures or improvements (e.g., vaults, kitchens, raised floors, auditoriums, internal stairways, hoods, chemical storage areas and the Vivarium) installed by Tenant and any alterations which include above or non-standard fixtures or improvements, in which event Tenant shall remove the foregoing from the Premises before the end of the Term at Tenants expense and shall repair and restore the Premises to its condition before such installation and
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repair any damage resulting from such removal, including repairing and patching cracks and holes left by such removal. Upon submission of any plans for Landlords approval, Tenant may request prior to the installation of specific non-standard fixtures, equipment or improvements in the Premises that Landlord agree not to require Tenant to remove such items upon expiration or termination of the Lease or agree to permit Tenant to remove any item it may otherwise not be permitted to remove under the terms of this Lease. Such consent, which may be granted or denied in Landlords reasonable discretion, must be granted in writing prior to the installation of the subject items in order to be binding against Landlord. Landlord hereby agrees that, subject to Landlords right to cause Tenant to remove certain Lines as provided in Section 52.1 below, Tenant shall not be obligated to remove any of its initial Tenant Improvements other than the Vivarium. Landlord hereby further agrees that Tenant may remove above-standard installations (e.g., generators, UPS, and raised floors) constructed as part of the Tenant Improvements or subsequently added to the Improvements in the Premises as alterations.
ARTICLE 16.
FURNITURE, FIXTURES, AND PERSONAL PROPERTY
16.1 Tenant, at its sole cost and expense, may remove its trade fixtures, supplies and moveable furniture and equipment not permanently attached to the Project or Premises provided:
(a) Such removal is made prior to the Expiration Date or the Termination Date; and
(b) Tenant promptly repairs all damage caused by such removal.
16.2 If Tenant does not remove its trade fixtures, office supplies, and moveable furniture and equipment as herein above provided prior to the Expiration Date or the Termination Date (unless prior arrangements have been made with Landlord and Landlord has agreed in writing to permit Tenant to leave such items in the Premises for an agreed period), then, in addition to its other remedies, at law or in equity, Landlord shall have the right to have such items removed and stored at Tenants sole cost and expense and all damage to the Project or the Premises resulting from said removal shall be repaired at the cost of Tenant. All other property in the Premises, any alterations, or additions to the Premises (including wall-to-wall carpeting, paneling, wall covering, specially constructed or built-in cabinetry or bookcases), and any other article permanently attached or affixed to the floor, wall, or ceiling of the Premises shall become the property of Landlord and shall remain upon and be surrendered with the Premises as a part thereof at the Expiration or Termination Date regardless of who paid therefor; and Tenant hereby waives all rights to any payment or compensation therefor, subject to the last sentence of this Section 16.2. If, however, Landlord so requests, in writing, Tenant shall remove, prior to the Expiration Date or the Termination Date, any and all alterations, additions, fixtures, equipment, and property placed or installed in the Premises and shall repair any damage caused by such removal. In addition, if any alterations performed by Tenant do not use materials that conform to the building standards used by Landlord at the time of the particular alteration or if Tenant requests any initial improvements to the Premises pursuant to Exhibit C, if any, that use materials that do not conform to the building standards used by Landlord at the time of that work, Tenant shall at Tenants sole cost and expense, no later than the expiration of the Term (or
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no later than fifteen (15) days after the earlier termination of the Term) cause the improvements in the Premises to be restored to conform to Landlords building standard at Tenants sole cost and expense. Prior to commencing any alteration, Tenant may request that Landlord notify Tenant whether or not the proposed alteration will be required by Landlord to be removed at the end of the Term; provided that, if Landlord fails to notify Tenant of Landlords waiver or nonwaiver of Tenants obligation to remove such addition, alteration or improvement at the end of the Term within ten (10) days after Tenants written request for that waiver, Tenant shall have the right to provide Landlord with a second written request for waiver (a Second Request) that specifically identifies the applicable in addition, alteration or improvement as to which it is seeking that waiver and contains the following statement in bold and capital letters: THIS IS A SECOND REQUEST FOR WAIVER OF THE OBLIGATION TO REMOVE CERTAIN ADDITIONS, ALTERATIONS OR IMPROVEMENTS PURSUANT TO THE PROVISIONS OF SECTION 16.2 OF THE LEASE. IF LANDLORD FAILS TO RESPOND WITHIN FIVE (5) BUSINESS DAYS AFTER RECEIPT OF THIS NOTICE, THEN LANDLORD SHALL BE DEEMED TO HAVE WAIVED THE OBLIGATION OF TENANT TO REMOVE THE ADDITION, ALTERATION OR IMPROVEMENT DESCRIBED HEREIN. If Landlord fails to respond to such Second Request within five (5) business days after receipt by Landlord, Landlord shall be deemed to have waived the right to require Tenant to remove such addition, alteration or improvement at the end of the Term.
16.3 All the furnishings, fixtures, equipment, effects, and property of every kind, nature, and description of Tenant and of all persons claiming by, through, or under Tenant which, during the continuance of this Lease or any occupancy of the Premises by Tenant or anyone claiming under Tenant, may be on the Premises or elsewhere in the Project shall be at the sole risk and hazard of Tenant, and if the whole or any part thereof shall be destroyed or damaged by fire, water, or otherwise, or by the leakage or bursting of water pipes, steam pipes, or other pipes, by theft, or from any other cause, no part of said loss or damage is to be charged to or be borne by Landlord unless due to the negligence or willful misconduct of Landlord or its employees, agents, or contractors.
ARTICLE 17.
PERSONAL PROPERTY AND OTHER TAXES
17.1 During the Term hereof, Tenant shall pay, prior to delinquency, all business and other taxes, charges, notes, duties, and assessments levied, and rates or fees imposed, charged, or assessed against or in respect of the personal property, trade fixtures, furnishings, equipment, and all other personal and other property of Tenant contained in the Project (including without limitation taxes and assessments attributable to the cost or value of any leasehold improvements made in or to the Premises by or for Tenant (to the extent that the assessed value of those leasehold improvements exceeds the assessed value of standard improvements in other space in the Project regardless of whether title to those improvements is vested in Tenant or Landlord)), and shall hold Landlord harmless from and against all payment of such taxes, charges, notes, duties, assessments, rates, and fees, and against all loss, costs, charges, notes, duties, assessments, rates, and fees, and any and all such taxes. Tenant shall cause said fixtures, furnishings, equipment, and other personal property to be assessed and billed separately from the real and personal property of Landlord. In the event any or all of Tenants fixtures, furnishings, equipment, and other personal property shall be assessed and taxed with
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Landlords real property, Tenant shall pay to Landlord Tenants share of such taxes within ten (10) business days after delivery to Tenant by Landlord of a statement in writing setting forth the amount of such taxes applicable to Tenants property. In addition, Tenant shall be liable for and shall pay ten (10) days before delinquency any (i) rent tax, gross receipts tax, or sales tax, service tax, transfer tax or value added tax, or any other applicable tax on the rent or services herein or otherwise respecting this Lease; or (ii) taxes assessed upon or with respect to the possession, leasing, operation, management, maintenance, alteration, repair, use or occupancy by Tenant of the Premises or any portion of the Project. If any of such taxes are billed to Landlord or included in bills to Landlord for taxes, then Tenant shall pay to Landlord all such amounts within thirty (30) days after receipt of Landlords invoice therefor.
ARTICLE 18.
ASSIGNMENT AND SUBLETTING
18.1 Tenant shall not, without the prior written consent of Landlord, which consent shall not be unreasonably withheld (except that Landlord shall in no event be obligated to consent to an encumbrance of this Lease or any transfer by operation of law): (a) assign, convey, mortgage or otherwise transfer this Lease or any interest hereunder, or sublease the Premises, or any part thereof, whether voluntarily or by operation of law; or (b) permit the use of the Premises or any part thereof by any person other than Tenant and its employees. Any such transfer, sublease or use described in the preceding sentence (a Transfer) occurring without the prior written consent of Landlord shall, at Landlords option, be void and of no effect. Landlords consent to any Transfer shall not constitute a waiver of Landlords right to withhold its consent to any future Transfer. Landlord may require as a condition to its consent to any assignment of this Lease that the assignee execute an instrument in which such assignee assumes the remaining obligations of Tenant hereunder; provided that the acceptance of any assignment of this Lease by the applicable assignee shall automatically constitute the assumption by such assignee of all of the remaining obligations of Tenant that accrue following such assignment. The voluntary or other surrender of this Lease by Tenant or a mutual cancellation hereof shall not work a merger and shall, at the option of Landlord, terminate all or any existing sublease or may, at the option of Landlord, operate as an assignment to Landlord of Tenants interest in any or all such subleases.
18.2 For purposes of this Lease, the term Transfer shall also include (i) if a Tenant is a partnership or limited liability company, the withdrawal or change, voluntary, involuntary or by operation of law, of fifty percent (50%) or more of the partners, members or managers thereof, or transfer of twenty-five percent (25%) or more of partnership or membership interests therein within a twelve (12) month period, or the dissolution of the partnership or the limited liability company without immediate reconstitution thereof, and (ii) if Tenant is a corporation whose stock is not publicly held and not traded through an exchange or over the counter or any other form of entity, (A) the dissolution, merger, consolidation or other reorganization of Tenant, the sale or other transfer of more than an aggregate of fifty percent (50%) of the voting shares or other interests of or in Tenant (other than to immediate family members by reason of gift or death), within a twelve (12) month period, or (B) the sale, mortgage, hypothecation or pledge of more than an aggregate of fifty percent (50%) of the value of the unencumbered assets of Tenant (other than in connection with a bona fide transaction with a third party that is not entered into as a subterfuge to avoid the obligation to obtain Landlords consent under this Article 18) within a twelve (12) month period.
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18.3 If Tenant desires the consent of Landlord to a Transfer, Tenant shall submit to Landlord, at least thirty (30) days prior to the proposed effective date of the Transfer, a written notice (the Transfer Notice) which includes (a) the name of the proposed sublessee or assignee, (b) the nature of the proposed sublessees or assignees business, (c) the terms and provisions of the proposed sublease or assignment, and (d) current financial statements and information on the proposed sublessee or assignee. Upon receipt of the Transfer Notice, Landlord may reasonably request additional information concerning the Transfer or the proposed sublessee or assignee (the Additional Information). Subject to Landlords rights under Section 18.6, Landlord shall not unreasonably withhold its consent to any assignment or sublease (excluding an encumbrance or transfer by operation of law), which consent or lack thereof shall be provided within thirty (30) days of receipt of Tenants Transfer Notice; provided, however, Tenant hereby agrees that it shall be a reasonable basis for Landlord to withhold its consent if Landlord has not received the Additional Information requested by Landlord. Without limiting any other reasonable basis for Landlord to withhold its consent to the proposed Transfer, Landlord and Tenant agree that for purposes of this Lease and any Applicable Law, Landlord shall not be deemed to have unreasonably withheld its consent if, in the reasonable judgment of Landlord: (i) the transferee is of a character or engaged in a business which is not in keeping with the standards or criteria used by Landlord in leasing the Project, or the general character or quality of the Project; (ii) the financial condition of the transferee is such that it may not be able to perform its obligations in connection with this Lease (or otherwise does not satisfy Landlords standards for financial standing with respect to tenants under direct leases of comparable economic scope); (iii) the transferee, or any person or entity which directly or indirectly controls, is controlled by, or is under common control with, the transferee, is a tenant of or negotiating for space in the Project occupies space in the Project or has negotiated with Landlord within the preceding ninety (90) days (or is currently negotiating with Landlord) to lease space in the Project, (iv) the transferee has the power of eminent domain, is a governmental agency or an agency or subdivision of a foreign government; (v) an Event of Default by Tenant has occurred and is uncured at the time Tenant delivers the Transfer Notice to Landlord; (vi) in the good faith judgment of Landlord, such a Transfer would violate any term, condition, covenant, or agreement of Landlord involving the Project or any other tenants lease within it or would give an occupant of the Project a right to cancel or modify its lease; (vii) [Intentionally Omitted]; (viii) in Landlords reasonable judgment, the use of the Premises by the proposed transferee would not be comparable to the types of use by other tenants in the Project, would entail any alterations which would materially lessen the value of the tenant improvements in the Premises, would result in more than a reasonable density of occupants per square foot of the Premises, would materially increase the burden on elevators or other Building systems or equipment over the burden thereon prior to the proposed Transfer, would require materially increased services by Landlord or would require any alterations to the Project to comply with applicable laws; (ix) the transferee intends to use the space for purposes which are not permitted under this Lease; (x) the terms of the proposed Transfer would allow the transferee to exercise a right of renewal, right of expansion, right of first offer, or other similar right held by Tenant (or will allow the transferee to occupy space leased by Tenant pursuant to any such right); (xi) the proposed Transfer would result in more than three subleases per each full floor of the Premises being in effect at any one time during the Term; or (xii) any ground lessor or mortgagee unaffiliated with Landlord, whose consent to such Transfer is required fails to consent thereto. Tenant hereby waives any right to terminate the Lease as remedies for Landlord wrongfully withholding its consent to any Transfer.
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18.4 Landlord and Tenant agree that, in the event of any approved assignment or subletting, the rights of any such assignee or sublessee of Tenant herein shall be subject to all of the terms, conditions, and provisions of this Lease, including, without limitation, restriction on use, assignment, and subletting and the covenant to pay Rent. Upon any Event of Default by Tenant, Landlord may collect the rent owing by the assignee or sublessee directly from such assignee or sublessee and apply the amount so collected to the Rent herein reserved. No such consent to or recognition of any such assignment or subletting shall constitute a release of Tenant or any guarantor of Tenants performance hereunder from further performance by Tenant or such guarantor of covenants undertaken to be performed by Tenant herein. Tenant and any such guarantor shall remain liable and responsible for all Rent and other obligations herein imposed upon Tenant, and Landlord may condition its consent to any Transfer upon the receipt of a written reaffirmation from each such guarantor in a form reasonably acceptable to Landlord (which shall not be construed to imply that the occurrence of a Transfer without such a reaffirmation would operate to release any guarantor). Consent by Landlord to a particular assignment, sublease, or other transaction shall not be deemed a consent to any other or subsequent transaction. In any case where Tenant desires to assign, sublease or enter into any related or similar transaction, whether or not Landlord consents to such assignment, sublease, or other transaction, Tenant shall pay any reasonable attorneys fees incurred by Landlord in connection with such assignment, sublease or other transaction, including, without limitation, fees incurred in reviewing documents relating to, or evidencing, said assignment, sublease, or other transaction; provided that those costs shall not exceed $2,500.00 with respect to any single Transfer so long as Tenant and the proposed transferee execute Landlords form of consent document without negotiation requiring more than four (4) hours of Landlords attorneys time.
18.5 Tenant shall be bound and obligated to pay Landlord a portion of any sums or economic consideration payable to Tenant by any sublessee, assignee, licensee, or other transferee with regard to such Transfer, within ten (10) business days following receipt thereof by Tenant from such sublessee, assignee, licensee, or other transferee, as the case might be, as follows:
(a) In the case of an assignment, fifty percent (50%) of any sums or other economic consideration received by Tenant as a result of such assignment shall be paid to Landlord after first deducting the unamortized cost of leasehold improvements paid for by Tenant in connection with such assignment and reasonable cost of any real estate commissions incurred by Tenant in connection with such assignment.
(b) In the case of a subletting, fifty percent (50%) of any sums or economic consideration received by Tenant as a result of such subletting shall be paid to Landlord after first deducting (i) the Rent due hereunder prorated to reflect only Rent allocable to the sublet portion of the Premises, (ii) the cost of tenant improvements made to the sublet portion of the Premises by Tenant at Tenants expense (without reimbursement out of any allowance provided by Landlord) for the specific benefit of the sublessee, and (iii) the reasonable cost of any real estate commissions incurred by Tenant in connection with such subletting.
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(c) Tenant shall provide Landlord with a detailed statement setting forth any sums or economic consideration Tenant either has or will derive from such Transfer, the deductions permitted under (a) and (b) of this Section 18.5, and the calculation of the amounts due Landlord under this Section 18.5. In addition, Landlord or its representative shall have the right at all reasonable times to audit the books and records of Tenant with respect to the calculation of the Transfer profits. If such inspection reveals that the amount paid to Landlord was incorrect, then within ten (10) days of Tenants receipt of the results of such audit, Tenant shall pay Landlord the deficiency and (if Tenant has underpaid Landlord by more than seven percent (7%)) the cost of Landlords audit.
18.6 If this Lease is assigned to any person or entity pursuant to the provisions of the Bankruptcy Code, 11 U.S.C. Section 101 et seq. or any successor or substitute therefor (the Bankruptcy Code), any and all monies or other consideration payable or otherwise to be delivered in connection with such assignment shall be paid or delivered to Landlord, shall be and remain the exclusive property of Landlord, and shall not constitute property of Tenant or of the estate of Tenant within the meaning of the Bankruptcy Code. Any such monies or other consideration not paid or delivered to Landlord shall be held in trust for the benefit of Landlord and shall be promptly paid or delivered to Landlord. Any person or entity to whom this Lease is so assigned shall be deemed, without further act or deed, to have assumed all of the remaining obligations arising under this Lease as of the date of such assignment. Any such assignee shall, upon demand therefor, execute and deliver to Landlord an instrument confirming such assumption.
18.7 Landlord shall have the following option with respect to any assignment of this Lease or a Triggering Subletting (as defined below) proposed by Tenant:
(a) Notwithstanding any other provision of this Article, Landlord has the option, by written notice to Tenant (the Recapture Notice) within thirty (30) days after receiving any Transfer Notice to recapture the space covered by the proposed sublease or the entire Premises in the case of an assignment (the Subject Space) by terminating this Lease for the Subject Space. A timely Recapture Notice terminates this Lease, effective as of the date specified in the Transfer Notice. After such termination, Landlord may (but shall not be obligated to) enter into a lease with the party to the sublease or assignment proposed by Tenant. Notwithstanding the foregoing, if Landlord elects to recapture the Subject Space in accordance with this Section 18.7(a), Tenant shall have the right, by written notice given within ten (10) business days after Tenants receipt of Landlords Recapture Notice, to rescind Tenants Transfer Notice, in which event Landlords recapture right shall be rendered null and void, and this Lease shall continue in full force and effect as though Tenant had not delivered a Transfer Notice. As used herein, Triggering Subletting means subleasing of fifty percent (50%) or more of the Premises and/or a full floor of the Premises, either in a single transaction or, in the aggregate, following a series of transactions, for a term or terms expiring during the last year of the Term.
(b) To determine the new Base Rent under this Lease in the event Landlord recaptures the Subject Space without terminating this Lease, (i) the original Base Rent under the Lease shall be multiplied by a fraction, the numerator of which is the rentable square feet of the Premises retained by Tenant after Landlords recapture and the denominator of which is the total rentable square feet in the Premises before Landlords recapture, (ii) the Additional
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Rent, to the extent that it is calculated on the basis of the rentable square feet within the Premises, shall be reduced to reflect Tenants proportionate share based on the rentable square feet of the Premises retained by Tenant after Landlords recapture, and (iii) this Lease as so amended shall continue thereafter in full force and effect. Either party may require a written confirmation of the amendments to this Lease necessitated by Landlords recapture of the Subject Space. If Landlord recaptures the Subject Space, Landlord shall, at Landlords sole expense, construct any partitions required to segregate the Subject Space from the remaining Premises retained by Tenant; provided, however, that Landlord shall use reasonable efforts to minimize any interference with Tenants operations at the Premises.
18.8 Notwithstanding the foregoing, Tenant may Transfer all or part of its interest in this Lease or all or part of the Premises (a Permitted Transfer) to the following types of entities (a Permitted Transferee) without the written consent of Landlord and without being subject to Section 18.5 or Section 18.7 of this Lease: (a) any parent, subsidiary or affiliate corporation which Controls (as defined below), is Controlled by or is under common Control with Tenant (collectively, an Affiliate); (b) any corporation, limited partnership, limited liability partnership, limited liability company or other business entity in which or with which Tenant, an Affiliate of Tenant, or their respective corporate successors or assigns, is merged or consolidated, in accordance with applicable statutory provisions governing merger and consolidation of business entities, so long as (i) in both cases (a) and (b), Tenants obligations hereunder are assumed by the Permitted Transferee; and (ii) in the case of clause (b), the Permitted Transferee satisfies the Net Worth Threshold as of the effective date of the Permitted Transfer; or (c) any corporation, limited partnership, limited liability partnership, limited liability company or other business entity which acquires all or substantially all of Tenants assets and/or ownership interests, or Tenant in the case of a deemed Transfer under Section 18.2, if the Transferee satisfies the Net Worth Threshold as of the effective date of the Transfer. Tenant shall notify Landlord in writing of any such Permitted Transfer. Tenant shall remain liable for the performance of all of the obligations of Tenant hereunder, or if Tenant no longer exists because of a merger, consolidation, or acquisition, the surviving or acquiring entity shall expressly assume in writing, the obligations of Tenant hereunder. Additionally, any Permitted Transferee constituting an assignee of Tenants entire interest under the Lease shall comply with all of the terms and conditions of this Lease, whether accruing prior to and/or from and after the consummation of the Transfer. No later than ten (10) days prior to the effective date of any Permitted Transfer, Tenant agrees to furnish Landlord with (1) copies of the instrument effecting any of the foregoing Transfers, (2) documentation establishing Tenants satisfaction of the requirements set forth above applicable to any such Transfer, and (3) evidence of insurance as required under this Lease with respect to the Permitted Transferee. To the extent that legal requirements or confidentiality requirements do not permit Tenant to give Landlord prior notice of a Permitted Transfer, then Tenant may in lieu of the prior notice required under this Section give Landlord notice within ten (10) days after the effective date of the Permitted Transfer, together with the name of the transferee and a written certification from an officer of Tenant certifying that the assignment or sublease qualifies as a Permitted Transfer. The occurrence of a Permitted Transfer shall not waive Landlords rights as to any subsequent Transfers. As used herein, the term Net Worth Threshold shall mean the proposed Permitted Transferee has a tangible net worth equal to or greater than (x) that of Tenant immediately prior to such transaction, and (y) that of the originally named Tenant as of December 31 of the year prior to the Commencement Date (determined in accordance with generally accepted accounting
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principles consistently applied and excluding from the determination of total assets all assets which would be classified as intangible assets under generally accepted accounting principles, including, without limitation, goodwill, licenses, trademarks, trade names, copyrights and franchises), and as evidenced by financial statements certified by the Transferors chief financial officer or audited by a certified public accounting firm (if available). The term Control shall mean the possession of the power to direct or cause the direction of the management and policy of such corporation, partnership, limited liability company or other entity, whether through the ownership of voting securities, by statute or by contract, and whether directly or indirectly through Affiliates. In addition, Landlords consent shall not be required with respect to the infusion of additional equity capital in Tenant or an initial public offering of equity securities of Tenant under the Securities Act of 1933, as amended, which results in Tenants stock being traded on a national securities exchange, including, but not limited to, the NYSE, the NASDAQ Stock Market or the NASDAQ Small Cap Market System or any sale thereafter of such equity securities on such national securities exchanges.
ARTICLE 19.
DAMAGE OR DESTRUCTION
19.1 If the Premises or Building should be damaged or destroyed by fire or other casualty, Tenant shall give prompt written notice to Landlord. If the Premises or any common areas of the Building or Project serving or providing access to the Premises shall be damaged by fire or other casualty, Landlord shall promptly and diligently, subject to reasonable delays for insurance adjustment or other matters beyond Landlords reasonable control, and subject to all other terms of this Article 19, restore the base, shell, and core of the Premises and such common areas. Such restoration shall be to substantially the same condition of the base, shell, and core of the Premises and common areas prior to the casualty, except for modifications required by zoning and building codes and other laws or by the holder of a mortgage on the Project, or the lessor of a ground or underlying lease with respect to the Project and/or the Building, or any other modifications to the common areas deemed desirable by Landlord, subject to Section 1.3 and provided access to the Premises and any common restrooms serving the Premises shall not be materially impaired. Landlord shall not be liable for any inconvenience or annoyance to Tenant or its visitors, or injury to Tenants business resulting in any way from such damage or the repair thereof; provided however, that if such fire or other casualty shall have damaged the Premises or common areas necessary to Tenants occupancy. Landlord shall allow Tenant a proportionate abatement of Base Rent and Tenants Share of Operating Expenses and Tenants Tax Share of Taxes, during the time and to the extent the Premises are unfit for occupancy for the purposes permitted under this Lease, and not occupied by Tenant as a result thereof; provided, however, if the damage or destruction was caused by the negligence or willful misconduct of Tenant or Tenants employees, contractors, licensees, subtenants or invitees, such abatement shall occur only to the extent rental abatement insurance proceeds are received by Landlord (or would have been received by Landlord if Landlord had carried rental abatement insurance with a coverage period of twelve months).
19.2 Within sixty (60) days following the date of discovery of the damage, Landlord shall deliver to Tenant a written estimate from Landlords contractor of the time needed to rebuild and/or restore the Premises and/or the Building (the Restoration Notice). Notwithstanding the terms of Section 19.1 of this Lease, Landlord may elect not to rebuild
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and/or restore the Premises, the Building and/or any other portion of the Project and instead terminate this Lease by notifying Tenant in writing of such termination within sixty (60) days after the date of Landlords discovery of such damage (the Damage Discovery Date), such notice to include a termination date giving Tenant ninety (90) days to vacate the Premises, but Landlord may so elect only if the Building shall be damaged by fire or other casualty or cause, whether or not the Premises are affected, and one or more of the following conditions is present: (i) repairs cannot reasonably be completed within two hundred seventy (270) days of the Damage Discovery Date (when such repairs are made without the payment of overtime or other premiums); (ii) the holder of any mortgage on the Project or ground or underlying lessor with respect to the Project and/or the Building shall require that the insurance proceeds or any portion thereof be used to retire the mortgage debt, or shall terminate the ground or underlying lease, as the case may be; or (iii) the damage is not fully covered (except for deductible amounts in the case of a casualty other than earthquake or flood) by Landlords insurance policies (or would not have been so covered if Landlord had carried the insurance required to be covered by Landlord under this Lease); provided, however, that Landlord shall not have the right to terminate this Lease if the damage to the Building is relatively minor (e.g., repair or restoration would cost less than five percent (5%) of the replacement cost of the Building) or Landlord actually intends to restore the damage in the following two hundred seventy (270) day period. In addition, if the Premises or the Building is destroyed or damaged to any substantial extent during the last twelve (12) months of the Term, Tenant has not exercised the Extension Option provided in Section 51.1, and such damage cannot reasonably be repaired within 90 days, then notwithstanding anything contained in this Article 19, Landlord and Tenant shall each have the option to terminate this Lease by giving written notice to the other of the exercise of such option within thirty (30) days after the Damage Discovery Date, in which event this Lease shall cease and terminate as of the date of such notice. Upon any such termination of this Lease pursuant to this Section 19.2, Tenant shall pay the Base Rent and Additional Rent, properly apportioned up to such date of termination, and both parties hereto shall thereafter be freed and discharged of all further obligations hereunder, except as provided for in provisions of this Lease which by their terms survive the expiration or earlier termination of the Term.
19.3 If there is an occurrence of any damage to the Premises that does not result in the termination of this Lease pursuant to this Article 19, then upon notice (the Landlord Repair Notice) to Tenant from Landlord, Tenant shall assign to Landlord (or to any party designated by Landlord) all insurance proceeds payable to Tenant under Tenants insurance required under Sections 13.2(e)(ii) and (iii) above with respect to any improvements in the Premises required to be insured by Tenant hereunder (excluding proceeds for Tenants Property), and Landlord shall repair any injury or damage to the Tenant Improvements, alterations and the Original Improvements installed in the Premises and shall return such Tenant Improvements, alterations and Original Improvements to substantially their original condition; provided that if the cost of such repair by Landlord exceeds the sum of (A) amount of insurance proceeds received by Landlord from Tenants insurance carrier, as assigned by Tenant, plus (B) any insurance proceeds received by Landlord with respect to such Tenant Improvements, alterations and Original Improvements (it being acknowledged and agreed that Tenants insurance as to the Tenant Improvements, Alterations and Original Improvements is primary in nature and Landlords insurance, if any, with respect to same is secondary in nature), the cost of such repairs in excess of such insurance proceeds shall be paid by Tenant to Landlord prior to Landlords commencement of repair of the damage. Tenant may elect to make reasonable value-engineering
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modifications to the plans for the restoration work to the extent necessary to minimize or eliminate any costs in excess of the insurance proceeds available for such restoration, except to the extent such shortfall of insurance proceeds is due to Tenants failure to carry the insurance Tenant is obligated to carry under this Lease or to any deductible under such insurance policy Tenant carries or is obligated to carry under this Lease. In the event that Landlord does not deliver the Landlord Repair Notice within sixty (60) days following the Damage Discovery Date, Tenant shall, at its sole cost and expense, repair any injury or damage to the Tenant Improvements, alterations, and the Original Improvements installed in the Premises and shall return such Tenant Improvements, alterations, and Original Improvements to their immediately prior condition. Whether or not Landlord delivers a Landlord Repair Notice, prior to the commencement of construction, Tenant shall submit to Landlord, for Landlords review and approval, all plans, specifications and working drawings relating thereto, and Landlord shall select the contractors to perform such improvement work.
19.4 If (i) Landlord does not elect to terminate this Lease pursuant to Landlords termination right as provided hereinabove, (ii) the damage constitutes a Tenant Damage Event (as defined below), and either (a) the repairs cannot, in the reasonable opinion of Landlords contractor, be completed within two hundred seventy (270) days after the date of the casualty, or (b) the damage occurs during the last twelve (12) months of the Term and will reasonably require in excess of ninety (90) days to repair, Tenant may elect, no earlier than sixty (60) days after the date of the damage and not later than ninety (90) days after the date of such damage (or within thirty (30) days after receipt of the Restoration Notice, if later), to terminate this Lease by written notice to Landlord effective as of the date specified in the notice, which date shall not be less than thirty (30) days nor more than sixty (60) days after the date such notice is given by Tenant (prior to which Tenant shall be entitled to an abatement of Rent as provided in Section 19.1). In the event of a Tenant Damage Event, and if the Lease does not terminate pursuant to the other provisions of this Article 19, then if Landlord fails to substantially complete the repair of such damage comprising a Tenant Damage Event on or before the date (the Outside Restoration Completion Date) which is three (3) months after the date estimated for completion of such repair by landlords contractor in the Restoration Notice, then Tenant shall have the option, exercisable by written notice to Landlord within thirty (30) days after the Outside Restoration Completion Date, to terminate this Lease (Tenants Second Termination Option). The Outside Restoration Completion Date shall be extended by delays in the completion of the repair of the damage comprising a Tenant Damage Event to the extent caused by Force Majeure Events (other than the casualty that caused the damage) for up to ninety (90) days or by Tenant, its agents, employees or contractors. If Tenant exercises Tenants Second Termination Option, the Lease shall terminate as of a date specified in Tenants termination notice which is not less than thirty (30) days nor more than sixty (60) days after Tenants notice to Landlord of the exercise of Tenants Second Termination Option. As used herein, a Tenant Damage Event shall mean damage to all or any part of the Premises or any Common Areas necessary to Tenants occupancy of the Premises by fire or other casualty, which damage (A) is not the result of the willful misconduct of Tenant or any of the Tenant Parties (as defined below), (B) substantially interferes with Tenants use of or access to the Premises and (C) would entitle Tenant to an abatement of Base Rent and Tenants Share of Operating Expenses and Tenants Tax Share of Taxes, pursuant to Section 19.1 above.
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19.5 In the event this Lease is terminated in accordance with the terms of this Article 19, Tenant shall assign to Landlord (or to any party designated by Landlord) all insurance proceeds payable to Tenant under Tenants insurance required under Sections 13.2(e)(ii) and (iii), provided, however, that Tenant shall retain all such proceeds equal to the unamortized amount of all costs paid by Tenant for all Tenant Improvements and alterations (including the Over-Allowance Amount).
19.6 The provisions of this Lease, including this Article 19, constitute an express agreement between Landlord and Tenant with respect to damage to, or destruction of, all or any portion of the Premises or the Project, and any statute or regulation of the State of California, including without limitation Sections 1932(2) and 1933(4) of the California Civil Code, with respect to any rights or obligations concerning damage or destruction in the absence of an express agreement between the parties (and any other statute or regulation now or hereafter in effect with respect to such rights or obligations), shall have no application to this Lease or to any damage or destruction to all or any portion of the Premises or the Project.
ARTICLE 20.
CONDEMNATION
20.1 If all of the Premises is condemned by eminent domain, inversely condemned or sold under threat of condemnation for any public or quasi-public use or purpose (Condemned), this Lease shall terminate as of the earlier of the date the condemning authority takes title to or possession of the Premises, and Rent shall be adjusted to the date of termination.
20.2 If any material portion of the Premises or Building is Condemned and such partial condemnation materially impairs Tenants ability to use the Premises for Tenants business, Landlord and Tenant shall each have the option in their sole and absolute discretion to terminate this Lease as of the earlier of the date title vests in the condemning authority or as of the date an order of immediate possession is issued and Rent shall be adjusted to the date of termination. If such partial condemnation does not materially impair Tenants ability to use the Premises for the business of Tenant, Landlord shall promptly restore the Premises to the extent of any condemnation proceeds recovered by Landlord, excluding the portion thereof lost in such condemnation, and this Lease shall continue in full force and effect except that after the date of such title vesting or order of immediate possession Rent shall be equitably adjusted as reasonably determined by Landlord.
20.3 If the Premises are wholly or partially Condemned, Landlord shall be entitled to the entire award paid for such condemnation, and Tenant waives any claim to any part of the award from Landlord or the condemning authority; provided, however, Tenant shall have the right to recover from the condemning authority such compensation as may be separately awarded to Tenant in connection with costs in removing Tenants merchandise, furniture, fixtures, leasehold improvements and equipment to a new location. No condemnation of any kind shall be construed to constitute an actual or constructive eviction of Tenant or a breach of any express or implied covenant of quiet enjoyment. Tenant hereby waives the effect of Sections 1265.120 and 1265.130 of the California Code of Civil Procedure.
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20.4 In the event of a temporary condemnation not extending beyond the Term, this Lease shall remain in effect, Tenant shall continue to pay Rent and Tenant shall receive any award made for such condemnation except damages to any of Landlords property. If a temporary condemnation is for a period which extends beyond the Term, this Lease shall terminate as of the date of initial occupancy by the condemning authority and any such award shall be distributed in accordance with the preceding section. If a temporary condemnation remains in effect at the expiration or earlier termination of this Lease, Tenant shall pay Landlord the reasonable cost of performing any obligations required of Tenant with respect to the surrender of the Premises.
ARTICLE 21.
HOLD HARMLESS
21.1 Tenant agrees to defend, with counsel reasonably approved by Landlord, all actions against Landlord, any member, partner, trustee, stockholder, officer, director, employee, or beneficiary of Landlord (collectively, Landlord Parties), holders of mortgages secured by the Premises or the Project and any other party having an interest therein (collectively with Landlord Parties, the Indemnified Parties) with respect to, and to pay, protect, indemnify, and save harmless, to the extent permitted by law, all Indemnified Parties from and against, any and all liabilities, losses, damages, costs, expenses (including reasonable attorneys fees and expenses), causes of action, suits, claims, demands, or judgments of any nature to which any Indemnified Party is subject because of its estate or interest in the Premises or the Project arising from (a) injury to or death of any person, or damage to or loss of property on the Premises, or the use, condition, or occupancy of the Premises by Tenant, except to the extent, if any, caused by the negligence or willful misconduct of Landlord or any Indemnified Parties and not insured (or required to be insured) by Tenant under this Lease, (b) any violation of this Lease by or attributable to Tenant, or (c) subject to Section 13.4, any wrongful act, fault, omission, or other misconduct of Tenant or its agents, contractors, licensees, sublessees, or invitees. Tenant agrees to use and occupy the Premises and other facilities of the Project at its own risk, and hereby releases the Indemnified Parties from any and all claims for any damage or injury to the fullest extent permitted by law, except in each case, to the extent, if any, caused by the gross negligence or willful misconduct of Landlord or any Indemnified Parties and not covered by insurance carried by Tenant (or that would have been covered under insurance that Tenant is obligated to carry under this Lease).
21.2 Except to the extent caused by the gross negligence or willful misconduct of Landlord or any Landlord Parties in providing access to the Premises, Tenant agrees that (i) Landlord shall not be responsible or liable to Tenant, its agents, employees, or invitees for fatal or non-fatal bodily injury or property damage occasioned by the acts or omissions of any other tenant, or such other tenants agents, employees, licensees, or invitees, of the Project and (ii) Landlord shall not be liable to Tenant for losses to property due to theft or burglary, or damages from criminal acts, done by any persons on the Project other than Landlord or its employees or agents.
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ARTICLE 22.
DEFAULT BY TENANT
22.1 The term Event of Default refers to the occurrence of any one (1) or more of the following:
(a) Failure of Tenant to pay when due any Rent required to be paid hereunder (the Monetary Default) within five (5) days of receipt of written notice from Landlord; provided, however, that after the first failure to pay any Rent required to be paid hereunder in any calendar year, in the event that Tenant fails a second time to pay within five (5) days of when due any sum required to be paid hereunder during such calendar year, such failure shall be deemed to automatically constitute a Monetary Default without any obligation on Landlord to provide any additional written notice, and provided further that Tenant acknowledges that any such written notice provided hereunder shall be in lieu of, and not in addition to, any notice to pay rent or quit pursuant to any applicable statutes (provided, that such notice is given in the manner provided in California Code of Civil Procedure Section 1162);
(b) Failure of Tenant, after thirty (30) days written notice thereof, to perform any of Tenants obligations, covenants, or agreements except a Monetary Default, provided that if the cure of any such failure is not reasonably susceptible of performance within such thirty (30) day period, then an Event of Default of Tenant shall not be deemed to have occurred so long as Tenant has promptly commenced and thereafter diligently prosecutes such cure to completion;
(c) Tenant, or any guarantor of Tenants obligations under this Lease (the Guarantor), admits in writing that it cannot meet its obligations as they become due; or is declared insolvent according to any law; or assignment of Tenants or Guarantors property is made for the benefit of creditors; or a receiver or trustee is appointed for Tenant or Guarantor or its property; or the interest of Tenant or Guarantor under this Lease is levied on under execution or other legal process; or any petition is filed by or against Tenant or Guarantor to declare Tenant bankrupt or to delay, reduce, or modify Tenants debts or obligations; or any petition filed or other action taken to reorganize or modify Tenants or Guarantors capital structure if Tenant is a corporation or other entity. Any such levy, execution, legal process, or petition filed against Tenant or Guarantor shall not constitute a breach of this Lease provided Tenant or Guarantor shall diligently contest the same by appropriate proceedings and shall remove or vacate the same within ninety (90) days from the date of its creation, service, or filing;
(d) The abandonment (as defined in California Civil Code section 1951.3) of the Premises by Tenant;
(e) The discovery by Landlord that any financial statement given by Tenant or any of its assignees, successors-in-interest, or Guarantors was materially false; or
(f) If Tenant or any Guarantor shall die, cease to exist as a corporation or partnership (except in a Permitted Transfer) where Tenant is not the surviving entity, or be otherwise dissolved or liquidated or become insolvent, or shall make a transfer in fraud of creditors.
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22.2 In the event of any Event of Default by Tenant, Landlord, at its option, may pursue one or more of the following remedies without notice or demand in addition to all other rights and remedies provided for at law or in equity:
(a) Landlord may continue this Lease in full force and effect, and this Lease shall continue in full force and effect as long as Landlord does not terminate this Lease, and Landlord shall have the right to collect Rent when due. Tenant shall pay to Landlord the Rent and other sums due under this Lease on the dates the Rent is due. No act by Landlord allowed by this Section 22.2(a) shall terminate this Lease unless Landlord notifies Tenant in writing that Landlord elects to terminate this Lease.
The lessor has the remedy described in Civil Code Section 1951.4 (lessor may continue the lease in effect after lessees breach and abandonment and recover rent as it becomes due, if lessee has the right to sublet or assign subject only to reasonable limitations).
(b) Landlord may terminate this Lease at any time by giving written notice to that effect. No act by Landlord other than giving written notice to Tenant shall terminate this Lease. Acts of maintenance, efforts to relet the Premises or the appointment of a receiver on Landlords initiative to protect Landlords interest under this Lease shall not constitute a termination of Tenants right to possession. On termination, Landlord shall have the right to remove all personal property of Tenant and store it at Tenants cost and to recover from Tenant as damages: (i) the worth at the time of award of unpaid Rent and other sums due and payable which had been earned at the time of termination; plus (ii) the worth at the time of award of the amount by which the unpaid Rent and other sums due and payable which would have been payable after termination until the time of award exceeds the amount of the Rent loss that Tenant proves could have been reasonably avoided; plus (iii) the worth at the time of award of the amount by which the unpaid Rent and other sums due and payable for the balance of the Term after the time of award exceeds the amount of the Rent loss that Tenant proves could be reasonably avoided; plus (iv) any other amount necessary to compensate Landlord for all the detriment proximately caused by Tenants failure to perform Tenants obligations under this Lease, or which, in the ordinary course of things, would be likely to result therefrom, including, without limitation, any costs or expenses incurred by Landlord: (A) in retaking possession of the Premises, including reasonable attorneys fees and costs therefor; (B) maintaining or preserving the Premises, including repairs; (C) leasing commissions; (D) any other costs necessary or appropriate to restore the Premises to the condition required by this Lease; and (E) at Landlords election, such other amounts in addition to or in lieu of the foregoing as may be permitted from time to time by the laws of the State of California.
The worth at the time of award of the amounts referred to in Sections 22.2(b)(i) and 22.2(b)(ii) shall be calculated by allowing interest at the lesser of ten percent (10%) per annum or the maximum rate permitted by law, on the unpaid Rent and other sums due and payable from the termination date through the date of award. The worth at the time of award of the amount referred to in Section 22.2(b)(iii) shall be calculated by discounting the amount at the discount rate of the Federal Reserve Bank of San Francisco at the time of award, plus one percent (1%). Tenant waives redemption or relief from forfeiture under California Code of Civil Procedure Sections 1174 and 1179, or under any other present or future law, if Tenant is evicted or
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Landlord takes possession of the Premises by reason of any Event of Default by Tenant. For purposes of this Section 2.2(b), Rent shall exclude any Amortization Rent, Landlord acknowledging that Landlords sole remedy for unpaid Amortization Rent upon any termination of this Lease shall be provided in Section 2.4 of the Tenant Work Letter.
22.3 If Landlord shall exercise any one or more remedies hereunder granted or otherwise available, it shall not be deemed to be an acceptance or surrender of the Premises by Tenant whether by agreement or by operation of law; it is understood that such surrender can be effected only by the written agreement of Landlord and Tenant. No alteration of security devices and no removal or other exercise of dominion by Landlord over the property of Tenant or others in the Premises shall be deemed unauthorized or constitute a conversion, Tenant hereby consenting to the aforesaid exercise of dominion over Tenants property within the Premises after any Event of Default.
22.4 Each right and remedy provided for in this Lease shall be cumulative and shall be in addition to every other right or remedy provided for in this Lease or now or hereafter existing at law or in equity or by statute or otherwise, including, but not limited to, suits for injunctive relief and specific performance. Notwithstanding any contrary provision herein, Tenant shall not be liable under any circumstances for any indirect or consequential damages or any injury or damage to, or interference with, Landlords business, including but not limited to, loss of profits, loss of rents or other revenues, loss of business opportunity, loss of goodwill or loss of use, in each case, however occurring, except as specifically provided in Article 31; provided that Tenant hereby acknowledges and agrees that the foregoing shall not prevent Landlord from recovering any and all damages to which Landlord is entitled pursuant to California Civil Code Sections 1951.2 and 1951.4 following an Event of Default by Tenant hereunder. The exercise or beginning of the exercise by Landlord of any one or more of the rights or remedies provided for in this Lease or now or hereafter existing at law or in equity, or by statute or otherwise shall not preclude the simultaneous or later exercise by Landlord for any or all other rights or remedies provided for in this Lease or now or hereafter existing at or in equity or by statute or otherwise. All such rights and remedies shall be considered cumulative and non-exclusive. All costs incurred by Landlord in connection with collecting any Rent or other amounts and damages owing by Tenant pursuant to the provisions of this Lease, or to enforce any provision of this Lease, including reasonable attorneys fees from the date such matter is turned over to an attorney, whether or not one or more actions are commenced by Landlord, shall also be recoverable by Landlord from Tenant. If any notice and grace period required under subparagraphs 22.1(a) or (b) was not previously given, a notice to pay rent or quit, or to perform or quit, as the case may be, given to Tenant under any statute authorizing the forfeiture of leases for unlawful detainer shall also constitute the applicable notice for grace period purposes required by subparagraphs 22.1(a) or (b). In such case, the applicable grace period under subparagraphs 22.1(a) or (b) and under the unlawful detainer statute shall run concurrently after the one such statutory notice, and the failure of Tenant to cure the default within the greater of the two (2) such grace periods shall constitute both an unlawful detainer and an Event of Default entitling Landlord to the remedies provided for in this Lease and/or by said statute.
22.5 If Tenant should fail to make any payment or cure any default hereunder within the time herein permitted and such failure constitutes an Event of Default (except in the
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case where if Landlord in good faith believes that action prior to the expiration of any cure period under Section 22.1 is necessary to prevent damage to persons or property, in which case Landlord may act without waiting for such cure period to expire), Landlord, without being under any obligation to do so and without thereby waiving such default, may make such payment and/or remedy such default for the account of Tenant (and enter the Premises for such purpose), and thereupon, Tenant shall be obligated and hereby agrees to pay Landlord, upon demand, all reasonable costs, expenses, and disbursements, plus ten percent (10%) overhead cost incurred by Landlord in connection therewith.
22.6 Intentionally omitted.
22.7 Nothing contained in this Article 22 shall limit or prejudice the right of Landlord to prove and obtain as damages in any bankruptcy, insolvency, receivership, reorganization, or dissolution proceeding, an amount equal to the maximum allowed by any statute or rule of law governing such a proceeding and in effect at the time when such damages are to be proved, whether or not such amount be greater, equal, or less than the amounts recoverable, either as damages or Rent, referred to in any of the preceding provisions of this Article 22. Notwithstanding anything contained in this Article to the contrary, any such proceeding or action involving bankruptcy, insolvency, reorganization, arrangement, assignment for the benefit of creditors, or appointment of a receiver or trustee, as set forth above, shall be considered to be an Event of Default only when such proceeding, action, or remedy shall be taken or brought by or against the then holder of the leasehold estate under this Lease.
22.8 Landlord is entitled to accept, receive, in check or money order, and deposit any payment made by Tenant for any reason or purpose or in any amount whatsoever, and apply them at Landlords option to any obligation of Tenant, and such amounts shall not constitute payment of any amount owed, except that to which Landlord has applied them. No endorsement or statement on any check or letter of Tenant shall be deemed an accord and satisfaction or recognized for any purpose whatsoever. The acceptance of any such check or payment shall be without prejudice to Landlords rights to recover any and all amounts owed by Tenant hereunder and shall not be deemed to cure any other default nor prejudice Landlords rights to pursue any other available remedy, Landlords acceptance of partial payment of Rent does not constitute a waiver of any rights, including without limitation any right Landlord may have to recover possession of the Premises.
22.9 Intentionally omitted.
22.10 Tenant waives the right to terminate this Lease on Landlords default under this Lease. Tenants sole remedy on Landlords default is an action for damages or injunctive or declaratory relief. Landlords failure to perform any of its obligations under this Lease shall constitute a default by Landlord under this Lease if the failure continues for thirty (30) days after written notice of the failure from Tenant to Landlord. If the required performance cannot be completed within thirty (30) days, Landlords failure to perform shall constitute a default under the Lease unless Landlord undertakes to cure the failure within thirty (30) days and diligently and continuously attempts to complete this cure as soon as reasonably possible. All obligations of each party hereunder shall be construed as covenants, not conditions.
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ARTICLE 23.
INTENTIONALLY OMITTED
ARTICLE 24.
INTENTIONALLY OMITTED
ARTICLE 25.
ATTORNEYS FEES
25.1 All costs and expenses, including reasonable attorneys fees (whether or not legal proceedings are instituted), involved in collecting rents, enforcing the obligations of Tenant, or protecting the rights or interests of Landlord under this Lease, whether or not an action is filed, including without limitation the cost and expense of instituting and prosecuting legal proceedings or recovering possession of the Premises after the occurrence of an Event of Default by Tenant or upon expiration or sooner termination of this Lease, shall be due and payable by Tenant on demand, as Additional Rent. In addition, and notwithstanding the foregoing, if either party hereto shall file any action or bring any proceeding against the other party arising out of this Lease or for the declaration of any rights hereunder, the prevailing party in such action shall be entitled to recover from the other party all costs and expenses, including reasonable attorneys fees incurred by the prevailing party, as determined by the trier of fact in such legal proceeding. For purposes of this provision, the terms attorneys fees or attorneys fees and costs, or costs and expenses shall mean the fees and expenses of legal counsel (including external counsel and in-house counsel) of the parties hereto, which include printing, photocopying, duplicating, mail, overnight mail, messenger, court filing fees, costs of discovery, and fees billed for law clerks, paralegals, investigators and other persons not admitted to the bar for performing services under the supervision and direction of an attorney. For purposes of determining in-house counsel fees, the same shall be considered as those fees normally applicable to an attorney in a law firm with like experience in such field. In addition, the prevailing party shall be entitled to recover reasonable attorneys fees and costs incurred in enforcing any judgment arising from a suit or proceeding under this Lease, including without limitation post-judgment motions, contempt proceedings, garnishment, levy and debtor and third party examinations, discovery and bankruptcy litigation, without regard to schedule or rule of court purporting to restrict such award. This post-judgment award of attorneys fees and costs provision shall be severable from any other provision of this Lease and shall survive any judgment/award on such suit or arbitration and is not to be deemed merged into the judgment/award or terminated with the Lease.
ARTICLE 26.
NON-WAIVER
26.1 Neither acceptance of any payment by Landlord from Tenant nor, failure by Landlord to complain of any action, non-action, or default of Tenant shall constitute a waiver of any of Landlords rights hereunder. Time is of the essence with respect to the performance of every obligation of each party under this Lease in which time of performance is a factor. Waiver by either party of any right or remedy arising in connection with any default of the other party shall not constitute a waiver of such right or remedy or any other right or remedy arising in connection with either a subsequent default of the same obligation or any other default. No right
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or remedy of either party hereunder or covenant, duty, or obligation of any party hereunder shall be deemed waived by the other party unless such waiver is in writing, signed by the other party or the other partys duly authorized agent.
ARTICLE 27.
RULES AND REGULATIONS
27.1 Such reasonable rules and regulations applying to all lessees in the Project for the safety, care, and cleanliness of the Project and the preservation of good order thereon are hereby made a part hereof as Exhibit D, and Tenant agrees to comply with all such rules and regulations. Landlord shall have the right at all times to change such rules and regulations or to amend them in any reasonable and non-discriminatory manner as may be deemed advisable by Landlord, all of which changes and amendments shall be sent by Landlord to Tenant in writing and shall be thereafter carried out and observed by Tenant. Landlord shall not have any liability to Tenant for any failure of any other lessees of the Project to comply with such rules and regulations.
ARTICLE 28.
ASSIGNMENT BY LANDLORD; RIGHT TO LEASE
28.1 Landlord shall have the right to transfer or assign, in whole or in part, all its rights and obligations hereunder and in the Premises and the Project. In such event, no liability or obligation shall accrue or be charged to Landlord with respect to the period from and after such transfer or assignment and assumption of Landlords obligations by the transferee or assignee.
28.2 Landlord reserves the absolute right to effect such other tenancies in the Project as Landlord in the exercise of its sole business judgment shall determine to best promote the interests of the Buildings or Project. Tenant does not rely on the fact, nor does Landlord represent, that any specific tenant or type or number of tenants shall, during the Lease Term, occupy any space in the Buildings or Project.
ARTICLE 29.
LIABILITY OF LANDLORD
29.1 It is expressly understood and agreed that the obligations of Landlord under this Lease shall be binding upon Landlord and its successors and assigns and any future owner of the Project only with respect to events occurring during its and their respective ownership of the Project. In addition, Tenant agrees to look solely to Landlords interest in the Project for recovery of any judgment against Landlord arising in connection with this Lease, it being agreed that neither Landlord nor any successor or assign of Landlord nor any future owner of the Project, nor any partner, shareholder, member, or officer of any of the foregoing shall ever be personally liable for any such judgment. For purposes hereof, Landlords interest in the Project shall include rents due from tenants, proceeds from any sale of the Project, insurance proceeds, and proceeds from condemnation or eminent domain proceedings (prior to the distribution of same to any member, partner or shareholder of Landlord in the ordinary course of Landlords business). The limitations of liability contained in this Section 29.1 shall inure to the
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benefit of Landlords and the Landlord Parties present and future partners, beneficiaries, officers, directors, trustees, shareholders, agents and employees, and their respective partners, heirs, successors and assigns. Under no circumstances shall any present or future partner of Landlord (if Landlord is a partnership), or trustee or beneficiary (if Landlord or any partner of Landlord is a trust), have any liability for the performance of Landlords obligations under this Lease. Notwithstanding any contrary provision herein, neither Landlord nor the Landlord Parties shall be liable under any circumstances for any indirect or consequential damages or any injury or damage to, or interference with, Tenants business, including but not limited to, loss of profits, loss of rents or other revenues, loss of business opportunity, loss of goodwill or loss of use, in each case, however occurring.
ARTICLE 30.
SUBORDINATION AND ATTORNMENT
30.1 This Lease, at Landlords option, shall be subordinate to any present or future mortgage, ground lease or declaration of covenants regarding maintenance and use of any areas contained in any portion of the Building, and to any and all advances made under any present or future mortgage and to all renewals, modifications, consolidations, replacements, and extensions of any or all of same. Tenant agrees, with respect to any of the foregoing documents, that no documentation other than this Lease shall be required to evidence such subordination. If any holder of a mortgage shall elect for this Lease to be superior to the lien of its mortgage and shall give written notice thereof to Tenant, then this Lease shall automatically be deemed prior to such mortgage whether this Lease is dated earlier or later than the date of said mortgage or the date of recording thereof. Tenant agrees to execute such commercially reasonable documents as may be further required to evidence such subordination or to make this Lease prior to the lien of any mortgage or deed of trust, as the case may be within ten (10) business days after written request by Landlord. If Tenant fails to do so within ten (10) days after a second written demand, such failure shall, if Landlord so elects, constitute an Event of Default. Tenant hereby attorns to all successor owners of the Building, whether or not such ownership is acquired as a result of a sale through foreclosure or otherwise.
30.2 Tenant shall, at such time or times as Landlord may request, upon not less than ten (10) business days prior written request by Landlord, sign and deliver to Landlord an estoppel certificate, which shall be substantially in the form of Exhibit E, attached hereto (or such other commercially reasonable form as may be required by any prospective mortgagee or purchaser of the Project, or any portion thereof), indicating therein any exceptions thereto that may exist at that time, and shall also contain such other information and agreements as may be reasonably requested, it being intended that any such statement delivered pursuant to this Article may be relied upon by Landlord and by any prospective purchaser of all or any portion of the Project, or a holder or prospective holder of any mortgage encumbering the Project, or any portion thereof. Tenants failure to deliver such statement within five (5) days after Landlords second written request therefor shall constitute an Event of Default (as that term is defined elsewhere in this Lease) and shall conclusively be deemed to be an admission by Tenant of the matters set forth in the request for an estoppel certificate.
30.3 Tenant shall deliver to Landlord prior to the execution of this Lease and thereafter at any time upon Landlords request, Tenants current audited financial statements,
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including a balance sheet and profit and loss statement for the most recent prior year (collectively, the Statements), which Statements shall accurately and completely reflect the financial condition of Tenant. Landlord shall have the right to deliver the same to any proposed purchaser of the Building or the Project, and to any encumbrancer of all or any portion of the Building or the Project. If audited financial statements are not then available, Tenant may instead provide unaudited financial statements certified by an officer of Tenant as accurately and completely reflecting the financial condition of Tenant. Landlord further agrees to keep the Tenants financials delivered to Landlord pursuant to Section 30.3 and identified by Tenant in writing as confidential (the Confidential Information) in confidence for its information only and not to disclose the Confidential Information to anyone else, except (a) to the directors, officers, employees, affiliates and advisors (including attorneys, counsels, consultants and financial advisors) of Landlord who agree to keep such information confidential; (b) as required by law; (c) to any regulators having jurisdiction over Landlords businesses; (d) to any purchaser or prospective purchaser of Landlords property in which Tenant is a tenant or subtenant and any lender holding a lien secured by such property who agrees to keep such information confidential; (e) in connection with any litigation between Tenant on the one hand and Landlord on the other; and (f) to any investor or pension fund for which Landlord holds title to the property who agrees to keep such information confidential. Landlord agrees not to use such information for any other purposes unless it shall have first entered into a further written agreement with Tenant relating to that other use of the Confidential Information proposed by the Landlord. Notwithstanding the foregoing, Landlord shall be free to use any of the following information obtained lawfully from others: (i) information which is, at the time of disclosure, in the public domain; (ii) information which, after disclosure, enters the public domain, except where such entry is the result of a breach of this Lease; (iii) information which, prior to the disclosure, was already known to Landlord; and; (iv) information which is rightfully received by Landlord from a third party. The provisions of this Section 30.3 with respect to confidentiality supersede any prior confidentiality or nondisclosure agreements executed for the benefit of Tenant or its affiliates by on or behalf of the Landlord or any of its members.
30.4 Tenant acknowledges that Landlord is relying on the Statements in its determination to enter into this Lease, and Tenant represents to Landlord, which representation shall be deemed made on the date of this Lease and again on the Commencement Date, that no material change in the financial condition of Tenant, as reflected in the Statements, has occurred since the date Tenant delivered the Statements to Landlord. The Statements are represented and warranted by Tenant to be correct and to accurately and fully reflect in all material respects Tenants true financial condition as of the date of submission of any Statements to Landlord.
30.5 As of the date of this Lease, there is no (a) deed of trust or mortgage encumbering the Project or (b) ground lease affecting the Building.
30.6 As a condition to the subordination in Section 30.1 of this Lease to its mortgage or deed of trust, any future mortgagee, beneficiary or ground lessor shall deliver to Tenant a written subordination and non-disturbance agreement in recordable form acceptable to such mortgagee, beneficiary, or in its sole discretion ground lessor providing that so long as no Event of Default by Tenant exists, Tenants possession and rights under this Lease shall not be disturbed or impaired and Tenant shall not be joined by the holder of any mortgage or deed of trust or ground lessor in any action or proceeding to foreclose or terminate thereunder, except
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where such is necessary for jurisdictional or procedural reasons. Landlord agrees to use commercially reasonable efforts to obtain a written subordination and non-disturbance agreement from such mortgagee, beneficiary or ground lessor in a form reasonably acceptable to Tenant; provided that Tenant shall pay all reasonable out-of-pocket costs incurred by Landlord in obtaining that subordination and non-disturbance agreement. Commercially reasonable efforts of Landlord shall not require Landlord to incur any material out-of-pocket cost, expense or liability to obtain such agreement, it being agreed that Tenant shall be responsible for any fee or review costs charged by such mortgagee or beneficiary. Landlords failure to obtain a non-disturbance, subordination and attornment agreement for Tenant in a form reasonably acceptable to Tenant shall have no effect on the rights, obligations and liabilities of Landlord and Tenant or be considered to be a default by Landlord hereunder.
ARTICLE 31.
HOLDING OVER
31.1 In the event Tenant, or any party claiming under Tenant, retains possession of the Premises after the Expiration Date or Termination Date, such possession shall be that of a tenant at sufferance and an unlawful detainer. No tenancy or interest shall result from such possession, and such parties shall be subject to immediate eviction and removal. Tenant or any such party shall pay Landlord, as Base Rent for the period of such holdover, a monthly amount equal to one hundred fifty percent (150%) of (a) the Base Rent for the last period prior to the date of such termination plus (b) Additional Rent attributable to Operating Expenses and Taxes as provided in Article 5 of this Lease during the time of holdover, together with all other Additional Rent and other amounts payable pursuant to the terms of this Lease. Notwithstanding the foregoing, Tenant shall not be required to pay during any holdover period any amounts attributable to the Additional Allowance or the Amortization Rate. Such tenancy at sufferance shall be subject to every other applicable term, covenant and agreement contained herein. Tenant shall also be liable for any and all damages sustained by Landlord as a result of such holdover. Tenant shall vacate the Premises and deliver same to Landlord immediately upon Tenants receipt of notice from Landlord to so vacate. The Rent during such holdover period shall be payable to Landlord on demand. Landlords acceptance of Rent if and after Tenant holds over shall not convert Tenants tenancy at sufferance to any other form of tenancy or result in a renewal or extension of the Term of this Lease, unless otherwise specified by notice from Landlord to Tenant.
ARTICLE 32.
SIGNS
32.1 No sign, symbol, or identifying marks shall be put upon the Project, Building, in the halls, elevators, staircases, entrances, parking areas, or upon the doors or walls, without the prior written approval of Landlord in its sole discretion. Should such approval ever be granted, all signs or lettering shall conform in all respects to the sign and/or lettering criteria established by Landlord and comply with all Applicable Laws. Landlord, at Landlords sole cost and expense, reserves the right to change the door plaques as Landlord deems reasonably desirable.
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32.2 Landlord shall, at Tenants sole cost and expense, install only signage (the Monument Signage) on the Building monument sign identifying only Tenants name. The graphics, materials, color, design, lettering, size and specifications of Tenants Monument Signage shall be subject to the reasonable approval of Landlord and all applicable governmental authorities and shall conform to Landlords approved sign plan for the Building. At the expiration or earlier termination of this Lease or termination of Tenants sign rights as provided below, Landlord shall, at Tenants sole cost and expense, cause the Monument Signage to be removed and the area of the monument sign affected by the Monument Signage to be restored to the condition existing prior to the installation of Tenants Monument Signage. The right to Monument Signage is personal to the initially named Tenant in this Lease (Original Tenant) and any Permitted Transferee who is an assignee of Tenants entire interest in this Lease or a subtenant of at least 50% of the Premises. To the extent Tenant desires to change the name and/or logo set forth on the Monument Signage, such name and/or logo shall not have a name which relates to an entity which is of a character or reputation, or is associated with a political faction or orientation, which is inconsistent with the quality of the Project, or which would otherwise reasonably offend a landlord of the Comparable Buildings. All of Tenants rights to install and maintain Monument Signage on the monument sign in accordance with this Section 32.2 shall terminate upon notice from Landlord for so long as Tenant ceases to occupy at least one entire floor of the Building.
32.3 Landlord shall, at Tenants sole cost and expense, install standard signage at the entrance to the Premises, and signage at the top of the Building (the Building-top Signage) identifying only Tenants name and logo. The graphics, materials, color, design, lettering, size and specifications of Tenants Building-top Signage shall be subject to the reasonable approval of Landlord and all applicable governmental authorities and shall conform to Landlords approved sign plan for the Building. The costs of the actual signs comprising the Building-top Signage and the installation, design, construction, and any and all other costs associated with the Building-top Signage including, without limitation, utility charges and hook-up fees, permits, and maintenance and repairs, shall be the sole responsibility of Tenant. Should the Building-top Signage require repairs and/or maintenance, as determined in Landlords reasonable judgment, Landlord shall have the right to provide notice thereof to Tenant and Tenant (except as set forth above) shall cause such repairs and/or maintenance to be performed within fifteen (15) business days after receipt of such notice from Landlord, at Tenants sole cost and expense; provided, however, if such repairs and/or maintenance are reasonably expected to require longer than fifteen (15) business days to perform, Tenant shall commence such repairs and/or maintenance within such fifteen (15) business day period and shall diligently prosecute such repairs and maintenance to completion. Should Tenant fail to perform such repairs and/or maintenance within the periods described in the immediately preceding sentence, Landlord shall, upon the delivery of an additional five (5) business days prior written notice, have the right to cause such work to be performed and to charge Tenant as Additional Rent for the cost of such work. At the expiration or earlier termination of this Lease or termination of Tenants sign rights as provided below, Landlord shall, at Tenants sole cost and expense, cause the Building-top Signage to be removed and the area of the top of the Building affected by the Building-top Signage to be restored to the condition existing prior to the installation of Tenants Building-top Signage. The right to Building-top Signage is personal to Original Tenant and any Permitted Transferee of the Original Tenant who is an assignee of that Original Tenants entire interest in this Lease or a subtenant of the entire Premises. To the extent Tenant desires to change the name
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and/or logo set forth on the Building-top Signage, such name and/or logo shall not have a name which relates to an entity which is of a character or reputation, or is associated with a political faction or orientation, which is inconsistent with the quality of the Project, or which would otherwise reasonably offend a landlord of the Comparable Buildings. All of Tenants rights to install and maintain the Building-top Signage at the top of the Building in accordance with this Section 32.3 shall terminate upon notice from Landlord during any period in which Tenant or a Permitted Transferee ceases to occupy at least one entire floor of the Building.
32.4 Landlord, at Tenants sole cost and expense, shall provide Tenant with Building standard lobby and suite signage.
ARTICLE 33.
HAZARDOUS AND BIOLOGICAL MATERIALS
33.1 Except for Hazardous Materials and Biological Materials contained in products used by Tenant for ordinary cleaning and office purposes (such as printer toner and copier toner) in quantities not violative of applicable Environmental, Public and Animal Welfare Requirements and those materials listed on Exhibit J attached hereto, Tenant shall not permit or cause any party to bring any Hazardous Materials or Biological Materials upon the Premises and/or the Project or transport, store, use, generate, manufacture, dispose, or release any Hazardous Materials or Biological Materials on or from the Premises and/or the Project without Landlords prior written consent. Tenant, at its sole cost and expense, shall operate its business in the Premises in strict compliance with all Environmental, Public and Animal Welfare Requirements (as defined below) and all requirements of this Lease. Tenant shall complete and certify to commercially reasonable disclosure statements as reasonably requested by Landlord from time to time relating to Tenants transportation, storage, use, generation, manufacture, or release of Hazardous Materials or Biological Materials on the Premises, and Tenant shall promptly deliver to Landlord a copy of any notice of violation relating to the Premises or the Project of any Environmental, Public and Animal Welfare Requirements. Without limiting the generality of the foregoing, Tenant shall, at such intervals as Landlord may reasonably require, provide to Landlord or its designated consultant a list of all Hazardous Materials and Biological Materials used by Tenant in the Premises. Tenant shall reimburse Landlord within thirty (30) days after demand for the actual costs and fees charged by Landlords consultant to review the list of chemicals and biological materials. Exhibit J shall also list applicable Environmental Protection Agency, US Center for Disease Control, National Institutes of Health and California Hazardous and Biological Materials codes for each of the Hazardous Materials or Biological Materials or waste. Tenant shall comply with any additional requirements listed on Exhibit J with respect to the Hazardous Materials and Biological Materials identified in Exhibit J.
33.2 The term Environmental Requirements means all applicable present and future statutes, regulations, ordinances, rules, codes, judgments, permits, authorizations, orders, policies or other similar requirements of any governmental authority, agency or court regulating or relating to health, safety, or environmental conditions on, under, or about the Premises or the environment, including without limitation, the following: the Comprehensive Environmental Response, Compensation and Liability Act; the Resource Conservation and Recovery Act; the Clean Air Act; the Clean Water Act; the Toxic Substances Control Act and all state and local counterparts thereto; all applicable California requirements, including, but not limited to,
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Sections 25115, 25117, 25122.7, 25140, 25249.8, 25281, 25316 and 25501 of the California Health and Safety Code and Title 22 of the California Code of Regulations, Division 4.5, Chapter 11, and any policies or rules promulgated thereunder as well as any County or City ordinances that may operate independent of, or in conjunction with, the State programs, and any common or civil law obligations including, without limitation, nuisance or trespass, and any other requirements of Article 3 of this Lease regarding the environment. The term Hazardous Materials means and includes any substance, material, waste, pollutant, or contaminant that is or could be regulated under any Environmental Requirement or that may adversely affect human health or the environment, including, without limitation, any solid or hazardous waste, hazardous substance, asbestos, petroleum (including crude oil or any fraction thereof, natural gas, synthetic gas, polychlorinated biphenyls (PCBs), and radioactive material). For purposes of Environmental Requirements, to the extent authorized by law, Tenant is and shall be deemed to be the responsible party, including without limitation, the owner and operator of Tenants facility and the owner of all Hazardous Materials and Biological Materials brought on the Premises by Tenant, its agents, employees, contractors or invitees, and the wastes, by-products, or residues generated, resulting, or produced therefrom by Tenant or any of the Tenant Parties. The term Public Welfare Requirements means and includes all applicable statutes, regulations and guidelines including but not limited to (to the extent applicable to Tenants operations) Title 45 of the Code of Federal Regulations as associated to all research or production involving Biological Materials conducted, supported or otherwise subject to regulation in accordance with the US HHS Biosafety in Microbiological and Biomedical Laboratories. The term Biological Materials means natural biocompatible materials that comprise a whole or a part of a living structure or biomedical device that performs, augments, or replaces a natural function. The term Animal Welfare Requirements means and includes (to the extent applicable to Tenants operations) 7 U.S.C. 21312159; 7 CFR 2.22, Laboratory Animal Welfare Act ; Public Law 99-158 and amendments and all Animal Research Laws (as defined in Exhibit I). The term Environmental, Public and Animal Welfare Requirements means, collectively, Environmental Requirements, Public Welfare Requirements and Animal Welfare Requirements. The term Environmental, Public or Animal Welfare Requirements means any of the Environmental Requirements, Public Welfare Requirements and/or Animal Welfare Requirements.
33.3 Tenant, at its sole cost and expense, shall remove all Hazardous Materials, Biological Materials and animals stored, disposed of or otherwise released by Tenant, its assignees, subtenants, agents, employees, contractors or invitees onto or from the Premises, in a manner and to a level satisfactory to Landlord in its reasonable discretion, but in no event to a level and in a manner less than that which complies with all Environmental, Public and Animal Welfare Requirements and does not limit any future uses of the Premises from those permitted by Applicable Laws as of the Commencement Date or require the recording of any deed restriction or notice regarding the Premises. Tenant shall perform such work at any time during the Term of the Lease upon written request by Landlord or, in the absence of a specific request by Landlord, before Tenants right to possession of the Premises terminates or expires. If an Event of Default exists because Tenant fails to perform such work within the time period specified by Landlord or before Tenants right to possession terminates or expires (whichever is earlier), Landlord may at its discretion, and without waiving any other remedy available under this Lease or at law or equity (including without limitation an action to compel Tenant to perform such work), perform such work at Tenants cost. Tenant shall pay all costs incurred by Landlord in performing such work within ten (10) business days after Landlords request
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therefor. Such work performed by Landlord is on behalf of Tenant and Tenant remains the owner, generator, operator, transporter, and/or arranger of the Hazardous Materials and Biological Materials for purposes of Environmental, Public and Animal Welfare Requirements. Tenant agrees not to enter into any agreement with any person, including without limitation any governmental authority, regarding the removal of Hazardous Materials and Biological Materials that have been disposed of or otherwise released onto or from the Premises without the written approval of Landlord.
33.4 Tenant shall indemnify, defend, and hold Landlord harmless from and against any and all losses (including, without limitation, diminution in value of the Premises or the Project and loss of rental income from the Project), claims, demands, actions, suits, damages (including, without limitation, punitive damages), expenses (including, without limitation, remediation, removal, repair, corrective action, or cleanup expenses), and costs (including, without limitation, actual attorneys fees, consultant fees or expert fees and including, without limitation, removal or management of any Hazardous Materials or Biological Materials brought into the Premises or (if the precise nature and location thereof has previously been disclosed in writing by Landlord to Tenant) disturbed in breach of the requirements of this Article 33, regardless of whether such removal or management is required by law) which are brought or recoverable against, or suffered or incurred by Landlord as a result of any release of Hazardous Materials or Biological Materials at the Premises or any breach of the requirements under this Article 33 by Tenant, its agents, employees, contractors, subtenants, assignees or invitees, regardless of whether Tenant had knowledge of such noncompliance. The obligations of Tenant under this Article 33 shall survive any termination of this Lease.
33.5 Landlord shall have access to, and a right to perform inspections and tests of, the Premises to determine Tenants compliance with Environmental, Public or Animal Welfare Requirements, its obligations under this Article 33, or the condition of the Premises. Access shall be granted to Landlord upon not less than two (2) business days prior written notice to Tenant and at such times so as to minimize, so far as may be reasonable under the circumstances, any disturbance to Tenants operations. Such inspections and tests shall be conducted at Landlords expense, unless such inspections or tests reveal that Tenant has not complied with any Environmental, Public or Animal Welfare Requirement to any material extent, in which case Tenant shall reimburse Landlord for the reasonable cost of such inspection and tests. Landlords receipt of or satisfaction with any assessment in no way waives any rights that Landlord holds against Tenant. Tenant shall promptly notify Landlord of any communication or report that Tenant makes to any governmental authority regarding any possible violation of Environmental, Public or Animal Welfare Requirements or release or threat of release of any Hazardous or Biological Materials onto or from the Premises. Tenant shall, within five (5) days of receipt thereof, provide Landlord with a copy of any documents or correspondence received from any governmental agency or other party relating to a possible violation of Environmental, Public or Animal Welfare Requirements or claim or liability associated with the release or threat of release of any Hazardous Materials or Biological Materials onto or from the Premises.
33.6 In addition to all other rights and remedies available to Landlord under this Lease or otherwise, Landlord may, in the event of a breach of the requirements of this Article 33 that is not cured within thirty (30) days following notice of such breach by Landlord,
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require Tenant to provide financial assurance (such as insurance, escrow of funds or third party guarantee) in an amount and form reasonably satisfactory to Landlord. The requirements of this Article 33 are in addition to and not in lieu of any other provision in the Lease.
33.7 Landlord hereby informs Tenant, and Tenant hereby acknowledges, that the Premises and adjacent properties overlie a former solid waste landfill site commonly known as the Westport Landfill (Former Landfill). Landlord further informs Tenant, and Tenant hereby acknowledges, that (i) prior testing has detected the presence of low levels of certain volatile and semi-volatile organic compounds and other chemical constituents in the groundwater, in the leachate from the landfilled solid waste, and/or in certain surface waters of the Project, as more fully described in the California Regional Water Quality Control Board, San Francisco Bay Regions (Regional Board) Order No. R2-2003-0074 (Updated Waste Discharge Requirements and Rescission of Order No. 94-181) (Order), (ii) methane gas is or may be generated by the landfilled solid waste (item i immediately preceding and this item ii are hereafter collectively referred to as the Landfill Condition), and (iii) the Premises and the Former Landfill are subject to the Order. The Order is attached hereto as Exhibit H. As evidenced by their initials on said Exhibit H, Tenant acknowledges that Landlord has provided Tenant with copies of the Order, and Tenant acknowledges that Tenant and Tenants experts (if any) have had ample opportunity to review the Order and that Tenant has satisfied itself as to the environmental conditions of the Property and the suitability of such conditions for Tenants intended use of the Property. Additional environmental reports are available for Tenants review at Landlords offices. In the event the Regional Board determines that the majority of the Premises cannot be occupied and/or Tenant cannot conduct its operations for a period in excess of thirty (30) days due to the any Hazardous Materials conditions related to the Landfill Condition, then, provided Tenant has not caused and/or materially contributed to the incident responsible for said occupancy restriction, Tenant may terminate this Lease provided Tenant gives Landlord written notice within ten (10) business days of Tenants receipt of notice that the Premises cannot be occupied for the purpose referenced in this Lease of its election to so terminate the Lease in the event Tenant cannot occupy and/or operate at the Premises at the conclusion of the thirty (30) day period. In the event said notice is received by Landlord as required herein and the majority of the Premises cannot be occupied or operated from as referenced above, this Lease shall thereafter terminate on the date of termination referenced in said Tenant notice (which date shall not be less than thirty (30) days from the date the Premises are deemed un-occupiable). Tenant agrees to cooperate (at no cost or liability to Tenant) and provide Landlord and the Regional Board or their authorized representatives, upon presentation of credentials, during normal business hours, immediate entry upon the Premises to assess any and all aspects of the environmental condition of the Project and its use, including, but not limited to, conducting any environmental assessment or audit, taking samples of soil, groundwater or other water, air or building materials, the inspection of treatment equipment, monitoring equipment or monitoring methods, or sampling of any discharge governed by the Order.
33.8 Notwithstanding any other provision in this Lease, Tenant shall not be responsible for any Hazardous Materials or Biological Materials in, on or under the Premises, Building or Project except for (a) any violations of the Order caused by Tenant or any of the Tenant Parties, (b) Hazardous Materials or Biological Materials introduced in, on or under the Premises, Building or Project due to the actions, negligence or willful misconduct of Tenant or
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any of the Tenant Parties, and (c) Hazardous Materials or Biological Materials present in, on or under the Premises, Building or Project disturbed by Tenant in breach of the requirements of Article 33 if the nature and location thereof has previously been disclosed in writing by Landlord to Tenant or is actually known by Tenant. As used herein, Tenant Parties means Tenant and the agents, contractors, employees, subtenants, licensees and invitees of Tenant.
33.9 Tenant acknowledges receipt of a copy of that certain Phase I Environmental Site Assessment, Westport Office Park, Bridge Parkway and Island Drive Redwood City, California 94065, No. 001 09412 00, dated August 10, 2005, prepared by LFR Levine-Fricke (collectively, Hazardous Substance Reports). Landlord acknowledges to Tenant that: (i) Landlord has not authorized any other studies for hazardous, biological or toxic materials at the Premises, Project or Building other than the Hazardous Substance Reports; and (ii) Landlord does not know of any surveys for toxic or Hazardous Materials or Biological Materials at the Premises, Project or the Building other than the Hazardous Substance Reports.
ARTICLE 34.
COMPLIANCE WITH LAWS AND OTHER REGULATIONS
34.1 Tenant, at its sole cost and expense, shall promptly comply with all laws, statutes, ordinances, and governmental rules, regulations, or requirements now in force or which may hereafter become in force, of federal, state, county, and municipal authorities, including without limitation the Americans with Disabilities Act and the California Energy Code, Title 24, with the requirements of any board of fire underwriters or other similar body now or hereafter constituted, and with any occupancy certificate issued pursuant to any law by any public officer or officers, which impose, any duty upon Landlord or Tenant, insofar as any thereof relate to or affect the condition, use, alteration, or occupancy of the Premises. Landlords approval of Tenants plans for any improvements shall create no responsibility or liability on the part of Landlord for their completeness, design sufficiency, or compliance with all laws, rules, and regulations of governmental agencies or authorities, including, but not limited to, the Americans with Disabilities Act. Tenant shall not be obligated to make any capital improvements to the Premises in order to comply with Applicable Laws, except to the extent the capital improvement is required due to a Trigger Event (as defined below). As used herein, the term Trigger Event means one or more of the following events or circumstances: (a) Tenants particular use of the Premises (other than normal office uses); (b) the manner of conduct of Tenants business or operation of its installations, equipment or other property outside those of normal office use; (c) the performance of any improvements or alterations or the installation of any Tenant systems; or (d) the breach of any of Tenants obligations under this Lease.
34.2 Tenant is not, and shall not during the term of this Lease become, a person or entity with whom Landlord is restricted from doing business under the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001, H.R. 3162, Public Law 107-56 (commonly known as the USA Patriot Act) and Executive Order Number 13224 on Terrorism Financing, effective September 24, 2001 and regulations promulgated pursuant thereto including without limitation persons and entities named on the Office of Foreign Asset Control Specially Designated Nationals and Blocked Persons List (collectively, Prohibited Persons). Tenant represents and warrants that to Tenants actual knowledge, Tenant is not currently engaged in any transactions or dealings, or
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otherwise associated with, any Prohibited Persons in connection with the use or occupancy of the Premises or the Building. Tenant will not, during the Term of this Lease, knowingly engage in any transactions or dealings, or be otherwise associated with, any Prohibited Persons in connection with the use or occupancy of the Premises or the Building. Landlord represents and warrants that to Landlords actual knowledge, Landlord is not currently engaged in any transactions or dealings, or otherwise associated with, any Prohibited Persons in connection with the use or occupancy of the Project. Landlord will not, during the Term of this Lease, knowingly engage in any transactions or dealings, or be otherwise associated with, any Prohibited Persons in connection with the use or occupancy of the Project.
34.3 Pursuant to California Civil Code Section 1938, Tenant is hereby notified that, as of the date hereof, the Project has not undergone an inspection by a Certified Access Specialist and except to the extent expressly set forth in this Lease, Landlord shall have no liability or responsibility to make any repairs or modifications to the Premises or the Project in order to comply with accessibility standards. The following disclosure is hereby made pursuant to applicable California law: A Certified Access Specialist (CASp) can inspect the subject premises and determine whether the subject premises comply with all of the applicable construction-related accessibility standards under state law. Although state law does not require a CASp inspection of the subject premises, the commercial property owner or lessor may not prohibit the lessee or tenant from obtaining a CASp inspection of the subject premises for the occupancy or potential occupancy of the lessee or tenant, if requested by the lessee or tenant. The parties shall mutually agree on the arrangements for the time and manner of the CASp inspection, the payment of the fee for the CASp inspection, and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within the premises. Tenant acknowledges that Landlord has made no representation regarding compliance of the Premises or the Project with accessibility standards. Any CASp inspection shall be conducted in compliance with reasonable rules in effect at the Building with regard to such inspections and shall be subject to Landlords prior written consent.
ARTICLE 35.
SEVERABILITY
35.1 This Lease shall be construed in accordance with the laws of the State of California. If any clause or provision of this Lease is illegal, invalid, or unenforceable under present or future laws effective during the Term, then it is the intention of the parties hereto that the remainder of this Lease shall not be affected thereby. It is also the intention of both parties that in lieu of each clause or provision that is illegal, or unenforceable, there is added as a part of this Lease a clause or provision as similar in terms to such illegal, invalid, or unenforceable clause or provision as may be possible and still be legal, valid, and enforceable.
ARTICLE 36.
NOTICES
36.1 All notices, demands, designations, approvals or other communications (collectively, Notices) given or required to be given by either party to the other hereunder or by law shall be in writing, shall be (i) sent by United States certified or registered mail, postage prepaid, return receipt requested (Mail), (ii) delivered by a nationally recognized overnight
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courier, or (iii) delivered personally. Any Notice shall be sent, transmitted, or delivered, as the case may be, to Tenant at the appropriate address set forth in the Basic Lease Information, or to such other place as Tenant may from time to time designate in a Notice to Landlord, or to Landlord at the addresses set forth in the Basic Lease Information, or to such other places as Landlord may from time to time designate in a Notice to Tenant. Any Notice will be deemed given (A) three (3) days after the date it is posted if sent by Mail, (B) the date the overnight courier delivery is made, or (C) the date personal delivery is made. Any Notice given by an attorney on behalf of Landlord or by Landlords managing agent shall be considered as given by Landlord and shall be fully effective.
ARTICLE 37.
OBLIGATIONS OF, SUCCESSORS, PLURALITY, GENDER
37.1 Landlord and Tenant agree that all the provisions hereof are to be construed as covenants and agreements as though the words imparting such covenants were used in each paragraph hereof, and that, except as restricted by the provisions hereof, shall bind and inure to the benefit of the parties hereto, their respective heirs, legal representatives, successors, and assigns. If two or more parties are designated herein as Tenant, then all such parties shall be jointly and severally liable for the obligations of Tenant hereunder. Whenever the singular or plural number, masculine or feminine or neuter gender is used herein, it shall equally include the other.
ARTICLE 38.
ENTIRE AGREEMENT
38.1 This Lease and any attached addenda or exhibits constitute the entire agreement between Landlord and Tenant. No prior or contemporaneous written or oral leases or representations shall be binding. This Lease shall not be amended, changed, or extended except by written instrument signed by Landlord and Tenant.
38.2 THE SUBMISSION OF THIS LEASE BY LANDLORD, ITS AGENT OR REPRESENTATIVE FOR EXAMINATION OR EXECUTION BY TENANT DOES NOT CONSTITUTE AN OPTION OR OFFER TO LEASE THE PREMISES UPON THE TERMS AND CONDITIONS CONTAINED HEREIN OR A RESERVATION OF THE PREMISES IN FAVOR OF TENANT, IT BEING INTENDED HEREBY THAT THIS LEASE SHALL ONLY BECOME EFFECTIVE UPON THE EXECUTION HEREOF BY LANDLORD AND DELIVERY OF A FULLY EXECUTED LEASE TO TENANT.
ARTICLE 39.
CAPTIONS
39.1 Paragraph captions are for Landlords and Tenants convenience only, and neither limit nor amplify the provisions of this Lease.
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ARTICLE 40.
CHANGES
40.1 Should any mortgagee require a modification of this Lease, which modification will not bring about any increased cost or expense to Tenant or in any other way materially and adversely change the rights and obligations of Tenant hereunder, then and in such event Tenant agrees that this Lease may be so modified.
ARTICLE 41.
AUTHORITY
41.1 All rights and remedies of Landlord under this Lease, or those which may be provided by law, may be exercised by Landlord in its own name individually, or in its name by its agent, and all legal proceedings for the enforcement of any such rights or remedies, including unlawful detainer, and any other legal or equitable proceedings may be commenced and prosecuted to final judgment and be executed by Landlord in its own name individually or in its name by its agent. Landlord and Tenant each represent to the other that each has full power and authority to execute this Lease and to make and perform the agreements herein contained, and Tenant expressly stipulates that any rights or remedies available to Landlord, either by the provisions of this Lease or otherwise, may be enforced by Landlord in its own name individually or in its name by its agent or principal.
ARTICLE 42.
BROKERAGE
42.1 Tenant represents and warrants to Landlord that it has dealt only with Tenants Broker and Landlords Broker, in negotiation of this Lease. Landlord shall make payment of the brokerage fee due the Landlords Broker pursuant to and in accordance with a separate agreement between Landlord and Landlords Broker. Landlords Broker shall pay a portion of its commission to Tenants Broker pursuant to a separate agreement between Landlords Broker and Tenants Broker. Except for amounts owing to Landlords Broker and Tenants Broker, each party hereby agrees to indemnify and hold the other party harmless of and from any and all damages, losses, costs, or expenses (including, without limitation, all attorneys fees and disbursements) by reason of any claim of or liability to any other broker or other person claiming through the indemnifying party and arising out of or in connection with the negotiation, execution, and delivery of this Lease. Additionally, except as may be otherwise expressly agreed upon by Landlord in writing, Tenant acknowledges and agrees that Landlord and/or Landlords agent shall have no obligation for payment of any brokerage fee or similar compensation to any person with whom Tenant has dealt or may in the future deal with respect to leasing of any additional or expansion space in the Building or renewals or extensions of this Lease.
ARTICLE 43.
EXHIBITS
43.1 Exhibits A through K are attached hereto and incorporated herein for all purposes and are hereby acknowledged by both parties to this Lease.
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ARTICLE 44.
APPURTENANCES
44.1 The Premises include the right of ingress and egress thereto and therefrom; however, Landlord reserves the right to make changes and alterations to the Building, fixtures and equipment thereof, in the street entrances, doors, halls, corridors, lobbies, passages, elevators, escalators, stairways, toilets and other parts thereof which Landlord may deem necessary or desirable; provided that Tenant at all times has a means of access to the Premises (subject to a temporary interruption due to Force Majeure Events or necessary maintenance that cannot reasonably be performed without such interruption of access). Neither this Lease nor any use by Tenant of the Building or any passage, door, tunnel, concourse, plaza or any other area connecting the garages or other buildings with the Building, shall give Tenant any right or easement of such use and the use thereof may, without notice to Tenant, be regulated or discontinued at any time and from time to time by Landlord without liability of any kind to Tenant and without affecting the obligations of Tenant under this Lease. In exercising its rights under this Section 44.1, Landlord shall make commercially reasonable efforts to minimize the disruption to Tenants business operations.
ARTICLE 45.
PREJUDGMENT REMEDY, REDEMPTION, COUNTERCLAIM, AND JURY
45.1 Tenant, for itself and for all persons claiming through or under it, hereby expressly waives any and all rights which are, or in the future may be, conferred upon Tenant by any present or future law to redeem the Premises, or to any new trial in any action for ejection under any provisions of law, after reentry thereupon, or upon any part thereof, by Landlord, or after any warrant to dispossess or judgment in ejection. If Landlord shall acquire possession of the Premises by summary proceedings, or in any other lawful manner without judicial proceedings, it shall be deemed a reentry within the meaning of that word as used in this Lease. In the event that Landlord commences any summary proceedings or action for nonpayment of Rent or other charges provided for in this Lease, Tenant shall not interpose any non-compulsory counterclaim of any nature or description in any such proceeding or action. Tenant and Landlord both waive a trial by jury of any or all issues arising in any action or proceeding between the parties hereto or their successors, under or connected with this Lease, or any of its provisions.
ARTICLE 46.
RECORDING
46.1 Tenant shall not record this Lease but will, at the request of Landlord, execute a memorandum or notice thereof in recordable form satisfactory to both Landlord and Tenant specifying the date of commencement and expiration of the Term of this Lease and other information required by statute. Either Landlord or Tenant may then record said memorandum or notice of lease at the cost of the recording party.
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ARTICLE 47.
MORTGAGEE PROTECTION
47.1 Tenant agrees to give any mortgagees and/or trust deed holders having a lien on Landlords interest in the Project, by registered mail, a copy of any notice of default served upon Landlord, provided that prior to such notice Tenant has been notified, in writing of the address of such mortgagees and/or trust deed holders. Tenant further agrees that if Landlord shall have failed to cure such default within the time provided for in this Lease, then such mortgagees and/or trust deed holders shall have an additional thirty (30) days within which to cure such default or if such default cannot be cured within that time, then such additional time as may be necessary to cure such default (including but not limited to commencement of receivership or foreclosure proceedings, if necessary to effect such cure) in which event this Lease shall not be terminated while such remedies are being so diligently pursued.
ARTICLE 48.
OTHER LANDLORD CONSTRUCTION
48.1 Tenant acknowledges that portions of the Project may be under construction following Tenants occupancy of the Premises, and that such construction may result in levels of noise, dust, odor, obstruction of access, etc. which are in excess of that present in a fully constructed project. Tenant hereby waives any and all rent offsets or claims of constructive eviction which may arise in connection with such construction. If any excavation or construction is made adjacent to, upon or within the Building, or any part thereof, Tenant shall afford to any and all persons causing or authorized to cause such excavation or construction (Landlords Construction Personnel) license to enter upon the Premises for the purpose of doing such work as such persons shall deem necessary to preserve the Building or any portion thereof from injury or damage and to support the same by proper foundations, braces and supports, without any claim for damages or indemnity or abatement of Rent (subject to the express provisions of this Lease), or of a constructive or actual eviction of Tenant. Notwithstanding anything to the contrary contained in this Lease, Landlord shall provide Tenant with written notice ten (10) days prior to any such entry of Landlords Construction Personnel onto the Premises.
48.2 It is specifically understood and agreed that Landlord has no obligation and has made no promises to alter, remodel, improve, renovate, repair or decorate the Premises, the Building, or any part thereof and that no representations respecting the condition of the Premises or the Building have been made by Landlord to Tenant except as specifically set forth herein or in the Tenant Work Letter. However, Tenant hereby acknowledges that Landlord is currently renovating or may during the Term of this Lease renovate, improve, alter, or modify (collectively, the Renovations) the Project, the Building and/or the Premises, including without limitation the Parking Facilities (as defined below), the Common Areas, and the systems and equipment, roof and structural portions of the same. Tenant hereby agrees that such Renovations and Landlords actions in connection with such Renovations shall in no way constitute a constructive eviction of Tenant nor entitle Tenant to any abatement of Rent. Landlord shall have no responsibility and shall not be liable to Tenant for any direct or indirect injury to or interference with Tenants business arising from the Renovations, nor shall Tenant be entitled to any compensation or damages from Landlord for loss of the use of the whole or any part of the
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Premises or of Tenants personal property or improvements resulting from the Renovations, or for any inconvenience or annoyance occasioned by such Renovations for Landlords actions in connection with such Renovations, or for any inconvenience or annoyance occasioned by such Renovations or Landlords actions in connection with such Renovations.
48.3 In exercising its rights under this Article 48, Landlord shall make commercially reasonable efforts to minimize the disruption to Tenants business operations and shall comply with Tenants reasonable security measures and operating procedures.
48.4 In addition, Landlords access to the Premises under this Article 48 shall be subject to the limitations provided for in Section 7.2, above.
ARTICLE 49.
PARKING
49.1 The use by Tenant, its employees and invitees, of the parking facilities of the Project (the Parking Facilities) shall be on the terms and conditions set forth in Exhibit D-1 attached hereto and by this reference incorporated herein and shall be subject to such other agreement between Landlord and Tenant as may hereinafter be established and to such other reasonable and nondiscriminatory rules and regulations as Landlord may establish. Tenant, its employees and invitees shall use no more than the Maximum Parking Allocation. Tenants right to use the Maximum Parking Allocation shall be without direct charge, other than Operating Expenses and Taxes otherwise payable under Article 5 of this Lease. Tenants use of the parking spaces shall be confined to the Project. If, in Landlords reasonable business judgment, it becomes necessary, Landlord shall exercise due diligence to cause the creation of cross-parking easements and such other agreements as are necessary to permit Tenant, its employees and invitees to use parking spaces on properties and buildings which are separate legal parcels from, but are in reasonable proximity to, the Project. Tenant acknowledges that other tenants of the Project and the tenants of the other buildings, their employees and invitees, may be given the right to park at the Project. Landlord reserves the right to change any existing or future parking area, roads, or driveways, or increase or decrease the size thereof and make any repairs or alterations it deems necessary to the parking area, roads and driveways and Landlord agrees to use commercially reasonable efforts to minimize any interference with Tenants parking in the course of such repairs or alterations. Landlord agrees not to grant rights to park in the Project that exceed the available parking spaces in the Project by more than is customary for parking for projects comparable to the Project.
ARTICLE 50.
ELECTRICAL CAPACITY
50.1 Tenant covenants and agrees that at all times, its use of electric energy shall never exceed the capacity of the existing feeders to the Building or the risers of wiring installation. Any riser or risers to supply Tenants electrical requirements upon written request of Tenant shall be installed by Landlord at the sole cost and expense of Tenant, if, in Landlords sole judgment, the same are necessary and will not cause or create a dangerous or hazardous condition or entail excess or unreasonable alterations, repairs or expense or interfere with or disrupt other tenants or occupants. In addition to the installation of such riser or risers, Landlord will also, at the sole cost and expense of Tenant, install all other equipment proper and necessary in connection therewith subject to the aforesaid terms and conditions.
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ARTICLE 51.
OPTION TO EXTEND LEASE
51.1 Extension Option. Tenant shall have the option to extend this Lease (the Extension Option) for one additional term of five (5) years (the Extension Period), upon the terms and conditions hereinafter set forth:
(a) If the Extension Option is exercised, then the Base Rent per annum for such Extension Period (the Option Rent) shall be an amount equal to the Fair Market Rental Value (as defined hereinafter) for the Premises as of the commencement of the Extension Option for such Extension Period.
(b) The Extension Option must be exercised by Tenant, if at all, only at the time and in the manner provided in this Section 51.1(b).
(i) If Tenant wishes to exercise the Extension Option, Tenant must, on or before the date occurring twelve (12) months before the expiration of the initial Lease Term (but not before the date that is fifteen (15) months before the expiration of the initial Lease Term), exercise the Extension Option by delivering written notice (the Exercise Notice) to Landlord. If Tenant timely and properly exercises its Extension Option, the Lease Term shall be extended for the Extension Period upon all of the terms and conditions set forth in the Lease, as amended, except that the Base Rent for the Extension Period shall be as provided in Section 51.1(a) and Tenant shall have no further options to extend the Lease Term.
(ii) If Tenant fails to deliver a timely Exercise Notice, Tenant shall be considered to have elected not to exercise the Extension Option.
(c) It is understood and agreed that the Extension Option hereby granted is personal to Original Tenant and is not transferable except to a Permitted Transferee in connection with an assignment of Tenants entire interest in this Lease. In the event of any assignment of this Lease or subletting of all of the Premises for a period ending in the last one hundred eighty (180) days of the Term thereof (other than to a Permitted Transferee), the Extension Option shall automatically terminate and shall thereafter be null and void.
(d) Tenants exercise of the Extension Option shall, if Landlord so elects in its absolute discretion, be ineffective in the event that (i) an Event of Default by Tenant remains uncured at the time of delivery of the Exercise Notice, or (ii) Tenant shall have reduced the size of the Premises below one (1) full floor of the Building by agreement with Landlord or pursuant to an express right in this Lease.
51.2 Fair Market Rental Value. The provisions of this Section shall apply in any instance in which this Lease provides that the Fair Market Rental Value is to apply.
(a) Fair Market Rental Value means the annual amount per square foot that a willing tenant would pay and a willing landlord would accept in arms length
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negotiations, without any additional inducements, for a lease of the applicable non-sublease, non-equity, unencumbered space on the applicable terms and conditions for the applicable period of time. Fair Market Rental Value shall be determined considering the most recent new direct leases (and market renewals, extensions and expansions, if applicable) in the Building and in Comparable Buildings in the Market Area.
(b) In determining the rental rate of comparable space, the parties shall include all escalations and take into consideration the following concessions:
(i) Rental abatement concessions, if any, being granted to tenants in connection with the comparable space; and
(ii) Tenant improvements or allowances provided or to be provided for the comparable space, taking into account the value of the existing improvements in the Premises, based on the age, quality, and layout of the improvements.
(c) If in determining the Fair Market Rental Value the parties determine that the economic terms of leases of comparable space include a tenant improvement allowance, Landlord may, at Landlords sole option, elect to do the following:
(i) Grant some or all of the value of the tenant improvement allowance as an allowance for the refurbishment of the Premises; and
(ii) Reduce the Base Rent component of the Fair Market Rental Value to be an effective rental rate that takes into consideration the total dollar value of that portion of the tenant improvement allowance that Landlord has elected not to grant to Tenant (in which case that portion of the tenant improvement allowance evidenced in the effective rental rate shall not be granted to Tenant).
51.3 Determination of Fair Market Rental Value. The determination of Fair Market Rental Value shall be as provided in this Section 51.3.
(a) Negotiated Agreement. Landlord and Tenant shall diligently attempt in good faith to agree on the Fair Market Rental Value on or before the date (the Outside Agreement Date) that is five (5) months prior to the date upon which the Extension Period is to commence.
(b) Parties Separate Determinations. If Landlord and Tenant fail to reach agreement on or before the Outside Agreement Date, Landlord and Tenant shall each make a separate determination of the Fair Market Rental Value and notify the other party of this determination within ten (10) business days after the Outside Agreement Date.
(i) Two Determinations. If each party makes a timely determination of the Fair Market Rental Value, those determinations shall be submitted to arbitration in accordance with subsection (c).
(ii) One Determination. If Landlord or Tenant fails to make a determination of the Fair Market Rental Value within the ten (10) business day period, that failure shall be conclusively considered to be that partys approval of the Fair Market Rental Value submitted within the ten (10) business day period by the other party.
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(c) Arbitration. If both parties make timely individual determinations of the Fair Market Rental Value under subsection (b), the Fair Market Rental Value shall be determined by arbitration under this subsection (c).
(i) Scope of Arbitration. The determination of the arbitrators shall be limited to the sole issue of whether Landlords or Tenants submitted Fair Market Rental Value is the closest to the actual Fair Market Rental Value as determined by the arbitrators, taking into account the requirements of Section 51.2.
(ii) Qualifications of Arbitrator(s). The arbitrators must be licensed real estate brokers who have been active in the leasing of commercial multi-story properties in the Market Area over the five-year period ending on the date of their appointment as arbitrator(s).
(iii) Parties Appointment of Arbitrators. Within twenty (20) days after the Outside Agreement Date, Landlord and Tenant shall each appoint one arbitrator and notify the other party of the arbitrators name and business address.
(iv) Appointment of Third Arbitrator. If each party timely appoints an arbitrator, the two (2) arbitrators shall, within ten (10) days after the appointment of the second arbitrator, agree on and appoint a third arbitrator (who shall be qualified under the same criteria set forth above for qualification of the initial two (2) arbitrators) and provide notice to Landlord and Tenant of the arbitrators name and business address.
(v) Arbitrators Decision. Within thirty (30) days after the appointment of the third arbitrator, the three (3) arbitrators shall decide whether the parties will use Landlords or Tenants submitted Fair Market Rental Value and shall notify Landlord and Tenant of their decision. The decision of the majority the three (3) arbitrators shall be binding on Landlord and Tenant.
(vi) If Only One Arbitrator is Appointed. If either Landlord or Tenant fails to appoint an arbitrator within twenty (20) days after the Outside Agreement Date, the arbitrator timely appointed by one of them shall reach a decision and notify Landlord and Tenant of that decision within thirty (30) days after the arbitrators appointment. The arbitrators decision shall be binding on Landlord and Tenant.
(vii) If Only Two Arbitrators Are Appointed. If each party appoints an arbitrator in a timely manner, but the two (2) arbitrators fail to agree on and appoint a third arbitrator within the required period, the arbitrators shall be dismissed without delay and the issue of Fair Market Rental Value shall be submitted to binding arbitration under the real estate arbitration rules of JAMS, subject to the provisions of this section.
(viii) If No Arbitrator Is Appointed. If Landlord and Tenant each fail to appoint an arbitrator in a timely manner, the matter to be decided shall be submitted without delay to binding arbitration under the real estate arbitration rules of JAMS subject the provisions of this Section 51.3(c).
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51.4 Cost of Arbitration. Each party shall pay the costs of its arbitrator and one-half of the cost of the third arbitrator, if applicable.
ARTICLE 52.
TELECOMMUNICATIONS LINES AND EQUIPMENT
52.1 Tenant may install, maintain, replace, remove or use any electrical, communications or computer wires and cables (collectively, the Lines) at the Building in or serving the Premises, provided that (i) Tenant shall obtain Landlords reasonable prior written consent, use an experienced and qualified contractor reasonably approved in writing by Landlord, and comply with all of the other provisions of Articles 8 and 15 of this Lease, (ii) an acceptable number of spare Lines and space for additional Lines shall be maintained for existing and future occupants of the Building, as determined in Landlords reasonable opinion, (iii) the Lines therefor (including riser cables) shall be appropriately insulated to prevent excessive electromagnetic fields or radiation, and shall be surrounded by a protective conduit reasonably acceptable to Landlord, (iv) any new or existing Lines servicing the Premises shall comply with all applicable governmental laws and regulations, (v) as a condition to permitting the installation of new Lines, Landlord may require that Tenant remove existing Lines located in or serving the Premises and repair any damage in connection with such removal, and (vi) Tenant shall pay all costs in connection therewith. Landlord reserves the right to require that Tenant remove any Lines located in or serving the Premises which are installed in violation of these provisions, or which are at any time in violation of any laws or represent a dangerous or potentially dangerous condition. Landlord further reserves the right to require that Tenant remove any and all additional Lines installed by Tenant and located in or serving the Premises upon the expiration of the Term or upon any earlier termination of this Lease.
ARTICLE 53.
ERISA
53.1 Tenant represents, warrants and covenants to Landlord that, as of the date hereof and throughout the term of this Lease, Tenant is not, and is not entering into this Lease on behalf of, (i) an employee benefit plan, (ii) a trust holding assets of such a plan or (iii) an entity holding assets of such a plan. Notwithstanding any terms to the contrary in this Lease, in no event may Tenant assign or transfer its interest under this Lease to a third party who is, or is entering into this Lease on behalf of, (i) an employee benefit plan, (ii) a trust holding assets of such a plan or (iii) an entity holding assets of such a plan if such transfer would could cause Landlord to incur any prohibited transaction excise tax penalties or other materially adverse consequences under the Employee Retirement Income Security Act of 1974, as amended, Section 4975 of the Internal Revenue Code of 1986, as amended or similar law. Tenant represents and warrants to Landlord that (i) neither Tenant nor any of its affiliates has the authority (A) to appoint or terminate PGIM, Inc. (PGIM) as investment manager of the PRISA II fund, (B) to negotiate the terms of a management agreement between PGIM and the PRISA II fund or (C) to cause an investment in or withdrawal from PRISA II fund and (ii) Tenant is not related to PGIM (within the meaning of Part VI(h) of Department of Labor Prohibited Transaction Exemption 84-14).
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ARTICLE 54.
INTENTIONALLY OMITTED
ARTICLE 55.
TENANTS ROOFTOP RIGHTS
55.1 Right to Install and Maintain Rooftop Equipment. During the Term and subject to the terms of this Article 55, Tenant may install on the roof of the Building telecommunications antennae, microwave dishes or other communication equipment, as necessary for the operation of Tenants business within the Premises, including any cabling or wiring necessary to connect this rooftop equipment to the Premises (collectively, the Rooftop Equipment). If Tenant wishes to install any Rooftop Equipment, Tenant shall first notify Landlord in writing, which notice shall fully describe the Rooftop Equipment, including, without limitation, its purpose, weight, size and desired location on the roof of the Building and its intended method of connection to the Premises. All of Tenants Rooftop Equipment must be located within a total aggregate area not to exceed 4 square feet, at locations reasonably approved by Landlord prior to any installation. Landlord hereby consents to the installation of Rooftop Equipment consisting of one (1) antennae and/or satellite dishes (the Initial Rooftop Equipment). Landlord also reserves the right to restrict the number and size of dishes, antennae and other Rooftop Equipment in addition to the Initial Rooftop Equipment installed on the roof of the Building in its sole discretion.
55.2 Additional Charges for Rooftop Equipment. Tenant will be solely responsible, at Tenants sole expense, for the installation, maintenance, repair and removal of the Rooftop Equipment, and Tenant shall at all times maintain the Rooftop Equipment in good condition and repair. Landlord agrees that the named Tenant hereunder shall not pay any rental charge for Tenants use of the rooftop pursuant to the terms of this Article 55 for the Initial Rooftop Equipment, provided, however, if any successor to the named Tenant, other than a Permitted Transferee, wishes to utilize rooftop space or if Tenant seeks to use rooftop space for Rooftop Equipment in addition to the Initial Rooftop Equipment, Landlord reserves the right to impose a charge for such use, which shall be consistent with market rates.
55.3 Conditions of Installation. The installation of the Rooftop Equipment shall constitute an alteration and shall be performed in accordance with and subject to the provisions of Article 15 of this Lease. Tenant shall comply with all applicable laws, rules and regulations relating to the installation, maintenance and operation of Rooftop Equipment at the Building (including, without limitation, all construction rules and regulations) and will pay all costs and expenses relating to such Rooftop Equipment, including the cost of obtaining and maintaining any necessary permits or approvals for the installation, operation and maintenance thereof in compliance with applicable laws, rules and regulations. The installation, operation and maintenance of the Rooftop Equipment at the Building shall not adversely affect the structure or operating systems of the Building or the business operations of any other tenant or occupant at the Building. For purposes of determining Landlords and Tenants respective rights and obligations with respect to the use of the roof, the portion of the roof affected by the Rooftop
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Equipment shall be deemed to be a portion of the Premises (provided that such portion shall not be measured for purposes of determining the area of the Premises and Tenant shall have no obligation to perform routine repair and maintenance thereof); consequently, all of the provisions of this Lease respecting Tenants obligations hereunder shall apply to the installation, use and maintenance of the Rooftop Equipment, including without limitation provisions relating to compliance with requirements as to insurance and indemnity. Tenant may install cabling and wiring through the Building interior conduits, risers, and pathways of the Building in accordance with Article 52 in order to connect Rooftop Equipment with the Premises.
55.4 Non-Exclusive Right. Tenants right to install and maintain Rooftop Equipment is non-exclusive and is subject to termination or revocation as set forth herein, including pursuant to Section 22.2(b) of this Lease. Landlord shall be entitled to all revenue from use of the roof other than revenue from the Rooftop Equipment installed by Tenant. Subject to the terms set forth below in this Section 55.4, Landlord at its election may require the relocation, reconfiguration or removal of the Rooftop Equipment, if in Landlords reasonable judgment the Rooftop Equipment is interfering with the use of the rooftop for the helipad or other Building operations (including without limitation maintenance, repairs and replacements of the roof) or the business operations of other tenants or occupants of the Building, causing damage to the Building or if Tenant otherwise fails to comply with the terms of this Article 55. If relocation or reconfiguration becomes necessary due to interference difficulties, Landlord and Tenant will reasonably cooperate in good faith to agree upon an alternative location or configuration that will permit the operation of the Rooftop Equipment for Tenants business at the Premises without interfering with other operations at the Building or communications uses of other tenants or occupants. If removal is required due to an Event of Default because of any breach or default by Tenant under the terms of this Article 55, Tenant shall remove the Rooftop Equipment upon thirty (30) days written notice from Landlord. Any relocation, removal or reconfiguration of the Rooftop Equipment as provided above shall be at Tenants sole cost and expense. In addition to the other rights of relocation and removal as set forth herein, Landlord reserves the right to require relocation of Tenants Rooftop Equipment at any time at its election at Landlords cost (but not more frequently than once per year) so long as Tenant is able to continue operating its Rooftop Equipment in substantially the same manner as it was operated prior to its relocation. In connection with any relocation of Tenants Rooftop Equipment at the request of or required by Landlord (other than in the case of an Event of Default by Tenant hereunder), Landlord shall provide Tenant with at least thirty (30) days prior written notice of the required relocation and will conduct the relocation in a commercially reasonable manner and in such a way that will, to the extent reasonably possible, prevent interference with the normal operation of Tenants Rooftop Equipment. In connection with any relocation, Landlord further agrees to work with Tenant in good faith to relocate Tenants Rooftop Equipment to a location that will permit its normal operation for Tenants business operations. Landlord acknowledges that relocation of Tenants Rooftop Equipment may be disruptive to Tenants business and, without limiting its rights to require such removal, confirms that it will not exercise its rights hereunder in a bad faith manner or for the purpose of harassing or causing a hardship to Tenant.
55.5 Costs and Expenses. If Tenant fails to comply with the terms of this Article 55 within thirty (30) days following written notice by Landlord (or such longer period as may be reasonably required to comply so long as Tenant is diligently attempting to comply), Landlord may take such action as may be necessary to comply with these requirements. In such
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event, Tenant agrees to reimburse Landlord for all costs incurred by Landlord to effect any such maintenance, removal or other compliance subject to the terms of this Article 55, including interest on all such amounts incurred at the Agreed Rate, accruing from the date which is ten 10) days after the date of Landlords demand until the date paid in full by Tenant, with all such amounts being Additional Rent under this Lease.
55.6 Indemnification; Removal. Tenant agrees to indemnify Landlord, its partners, agents, officers, directors, employees and representatives from and against any and all liability, expense, loss or damage of any kind or nature from any suits, claims or demands, including reasonable attorneys fees, arising out of Tenants installation, operation, maintenance, repair, relocation or removal of the Rooftop Equipment, except to the extent any such liability, expense, loss or damage results from the gross negligence or intentional misconduct of Landlord or its agents, partners, officers, directors, employees, contractors or representatives. At the expiration or earlier termination of the Lease, Tenant may and, upon request by Landlord, shall remove all of the Rooftop Equipment, including any wiring or cabling relating thereto, at Tenants sole cost and expense and will repair at Tenants cost any damage resulting from such removal. If Landlord does not require such removal, any Rooftop Equipment remaining at the Building after the expiration or earlier termination of this Lease which is not removed by Tenant shall be deemed abandoned and shall become the property of Landlord.
55.7 Roof Access; Rules and Regulations. Subject to compliance with the construction rules for the Building and Landlords reasonable and nondiscriminatory rules and regulations regarding access to the roof and, upon receipt of Landlords prior written consent to such activity (which shall not be unreasonably withheld, conditioned or delayed), Tenant and its representatives shall have access to and the right to go upon the roof of the Building, on a seven (7) day per week, twenty-four (24) hour basis, to exercise its rights and perform its obligations under this Article 55. Tenant acknowledges that, except in the case of an emergency or when a Building engineer is not made available to Tenant in sufficient time to allow Tenant to avoid or minimize interruption of use of the Rooftop Equipment, advance notice is required and a Building engineer must accompany all persons gaining access to the rooftop. Tenant may install Rooftop Equipment at the Building only in connection with its business operations at the Premises, and may not lease or license any rights or equipment to third parties or allow the use of any rooftop equipment by any party other than Tenant. Tenant acknowledges that Landlord has made no representation or warranty as to Tenants ability to operate Rooftop Equipment at the Building and Tenant acknowledges that helicopters, other equipment installations and other structures and activities at or around the Building may result in interference with Tenants Rooftop Equipment. Except as set forth in this Article 55, Landlord shall have no obligation to prevent, minimize or in any way limit or control any existing or future interference with Tenants Rooftop Equipment.
ARTICLE 56.
GENERATOR
56.1 Subject to the terms and conditions set forth below, Tenant shall have the right to install in such location adjacent to the Building as Landlord and Tenant shall reasonably and mutually agree, at Tenants sole expense, one back-up generator and related fuel storage, cabling and equipment (collectively, a UPS) to provide uninterrupted power to certain
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equipment in the Premises, provided that the UPS (i) does not adversely affect the safety of the Building or any warranty relating to the Building or adversely affect in any material respect any structural component of the Building, (ii) does not adversely affect any electrical, mechanical or any other system of the Building or the functioning thereof; (iii) does not materially interfere with the operation of the Building or the provision of services or utilities to the Building; (iv) complies with all Applicable Laws, and (v) is otherwise approved by Landlord in writing (which approval shall not be unreasonably, withheld, conditioned or delayed), including approval by Landlord of the exact location, type, style, dimensions, weight, plans and installation procedures for the UPS and the characteristics and type of fuel powering such UPS. Prior to the installation of the UPS by Tenant: (a) Tenant shall obtain Landlords reasonable approval of the contractor which shall undertake such installation; (b) Tenant shall obtain all permits and governmental approvals required for the installation of the UPS; (c) Tenant and the contractor approved by Landlord to undertake such installation shall obtain such insurance coverages as Landlord may reasonably require and, if requested by Landlord, cause Landlord to be named as an insured under such insurance policies; and (d) Tenant shall submit to Landlord for its reasonable approval, plans for the installation of the UPS, prepared by qualified engineers, showing all aesthetic, structural, mechanical and electrical details of the UPS, as well as all associated conduit and related equipment, all in accordance with all Applicable Laws, including without limitation all Environmental Requirements. Tenant shall ensure that the UPS does not interfere with any other equipment serving the Building or any portion thereof. At Tenants sole cost, the UPS shall be fully screened from view and sound in a manner reasonably acceptable to Landlord at the time that the UPS is approved by Landlord, which may include without limitation the installation of an additional screening wall and sound baffling. Throughout the Term, Tenant shall (A) ensure that the UPS complies with all Applicable Laws, including any Environmental Requirements; (B) cause engineers, including environmental engineers, reasonably acceptable to Landlord to inspect the UPS at least twice yearly to insure that such equipment is functioning properly and that no Hazardous Materials are emanating therefrom; (C) maintain the UPS in good order and repair; (D) maintain insurance coverages with respect thereto as are reasonably required by Landlord from time to time; and (E) maintain all permits and governmental approvals necessary for the operation of the UPS. Tenant shall promptly report to Landlord if Tenant determines that the UPS is not functioning properly, is leaking or is in violation of any Applicable Laws. At the end of the Term, if requested by Landlord, Tenant, at Tenants sole cost and expense, shall remove the UPS and restore the area in which it was located to its condition immediately prior to the installation of the UPS. Tenant shall obtain at Tenants expense all permits and governmental approvals necessary for such removal.
ARTICLE 57.
LETTER OF CREDIT
57.1 Letter of Credit. Tenant agrees to provide, at Tenants sole cost and expense, a Letter of Credit (as defined below) in the Letter of Credit Required Amount (as defined below) as additional security for the faithful performance and observance by Tenant of all of the provisions of this Lease, on the terms and conditions set forth below. The use, application or retention of the Letter of Credit, or any portion thereof, by Landlord shall not prevent Landlord from exercising any other right or remedy provided by this Lease or by law, it being intended that Landlord shall not first be required to proceed against the Letter of Credit and the Letter of Credit shall not operate as a limitation on any recovery to which Landlord may otherwise be entitled. As used herein the term Letter of Credit Required Amount initially means $4,131,719.96.
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57.2 Delivery of Letter of Credit. (a) Tenant shall cause a Letter of Credit, in the amount of the Letter of Credit Required Amount to be issued by the L/C Bank (as defined below) in favor of Landlord; (b) Tenant will cause the Letter of Credit to remain in full force and effect during the entire Term and thereafter until sixty (60) days after expiration or earlier termination of the Lease; and (c) the initial Letter of Credit will be delivered to Landlord upon the execution and delivery of this Lease by Tenant. So long as no Event of Default then exists, Landlord shall return the Letter of Credit to Tenant within sixty (60) days after the Expiration Date or the Termination Date. The specific requirements for the Letter of Credit and the rights of Landlord to make draws thereon will be as set forth in this Article 57.
57.3 Draws on the Letter of Credit. Immediately upon, and at any time or from time to time after, the occurrence of any one or more Draw Events (as defined below), Landlord will have the unconditional right to draw on the Letter of Credit in accordance with this Article 57. Upon the payment to Landlord of the Draw Proceeds, Landlord will hold the Draw Proceeds in its own name and for its own account, without liability for interest, to use and apply any and all of the Draw Proceeds only (a) to cure any Event of Default by Tenant; (b) to pay any other sum to which Landlord becomes obligated by reason of Tenants failure to carry out its obligations under this Lease; or (c) to compensate Landlord for any monetary loss or damage which Landlord suffers thereby arising from Tenants failure to carry out its obligations under this Lease. In addition, if the Draw Event is the failure of Tenant to renew the Letter of Credit as required hereunder, then Landlord shall be entitled to draw the entire Letter of Credit as a cash security deposit, held as a pledge under the California Uniform Commercial Code to secure Tenants obligations under this Lease. Following any such draw, however, Tenant shall have the right to deliver to Landlord a substitute Letter of Credit, whereupon Landlord shall refund to Tenant the entire amount of such cash security deposit. Among other things, it is expressly understood that the Draw Proceeds will not be considered an advance payment of Base Rent or Additional Rent or a measure of Landlords damages resulting from any Event of Default hereunder (past, present or future). Further, immediately upon the occurrence and during the continuance of any one or more Draw Events, Landlord may, from time to time and without prejudice to any other remedy, use the Draw Proceeds (whether from a contemporaneous or prior draw on the Letter of Credit) to the extent necessary to make good any arrearages of Base Rent or Additional Rent, to pay to Landlord any and all amounts to which Landlord is entitled in connection with the pursuit of any one or more of its remedies hereunder, and to compensate Landlord for any and all other damage, injury, expense or liability caused to Landlord by any and all such Events of Default. Any delays in Landlords draw on the Letter of Credit or in Landlords use of the Draw Proceeds as provided in this Article 57 will not constitute a waiver by Landlord of any of its rights hereunder with respect to the Letter of Credit or the Draw Proceeds. Following any such application of the Draw Proceeds, Tenant will either pay to Landlord on demand the cash amount so applied in order to restore the Draw Proceeds to the full amount thereof immediately prior to such application or cause the Letter of Credit to be replenished to its full amount thereunder. Failure to either pay that cash amount or cause the Letter of Credit to be replenished to its full amount thereunder within five (5) business days after Landlords written notice to Tenant of that application of the Draw Proceeds shall constitute an Event of Default without the right to any notice or cure period. Landlord will not be liable for any indirect,
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consequential, special or punitive damages incurred by Tenant arising from a claim that Landlord violated the bankruptcy codes automatic stay in connection with any draw by Landlord of any Draw Proceeds, Landlords liability (if any) under such circumstances being limited to the reimbursement of direct costs as and to the extent expressly provided in this Section 57.3. Nothing in this Lease or in the Letter of Credit will confer upon Tenant any property rights or interests in any Draw Proceeds; provided, however, that upon the expiration or earlier termination of this Lease, and so long as there then exist no Draw Events or Events of Default hereunder, Landlord agrees to return of any remaining unapplied balance of the Draw Proceeds then held by Landlord to Tenant, and the Letter of Credit itself (if and to the extent not previously drawn in full) to the L/C Bank. Landlord may draw on the Letter of Credit and/or apply any Security Deposit in any order.
57.4 Applicable Definitions.
Draw Event means each of the following events:
(a) the occurrence of any one or more of the following which shall have also been preceded, simultaneously accompanied, or succeeded by an Event of Default under this Lease regardless of the absence of any notice of default which might otherwise be required with respect to an Event of Default if the giving of notice to Tenant about such breach by Tenant is stayed or barred due to one of the following events: (i) Tenants filing of a petition under any chapter of the Bankruptcy Code, or under any federal, state or foreign bankruptcy or insolvency statute now existing or hereafter enacted, or Tenants making a general assignment or general arrangement for the benefit of creditors, (ii) the filing of an involuntary petition under any chapter of the Bankruptcy Code, or under any federal, state or foreign bankruptcy or insolvency statute now existing or hereafter enacted, or the filing of a petition for adjudication of bankruptcy or for reorganization or rearrangement, by or against Tenant and such filing not being dismissed within sixty (60) days, (iii) the entry of an order for relief under any chapter of the Bankruptcy Code, or under any federal, state or foreign bankruptcy or insolvency statute now existing or hereafter enacted, (iv) the appointment of a custodian, as such term is defined in the Bankruptcy Code (or of an equivalent thereto under any federal, state or foreign bankruptcy or insolvency statute now existing or hereafter enacted), for Tenant, or the appointment of a trustee or receiver to take possession of substantially all of Tenants assets located at the Premises or of Tenants interest in this Lease and possession not being restored to Tenant within sixty (60) days, or (v) the subjection of all or substantially all of Tenants assets located at the Premises or of Tenants interest in this Lease to attachment, execution or other judicial seizure and such subjection not being discharged within sixty (60) days;
(b) the failure of Tenant, not less than thirty (30) days prior to the stated expiration date of the Letter of Credit then in effect, to cause an extension, renewal or replacement issuance of the Letter of Credit, to be effected, which extension, renewal or replacement issuance will be made by the L/C Bank, will otherwise meet all of the requirements of the initial Letter of Credit hereunder;
(c) the failure of Tenant to make when due any payment of Rent within five (5) days after the amount is due; provided that in the event Tenant is entitled to a notice prior to the occurrence of an Event of Default for non-payment of Rent pursuant to
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Section 22.1(a), this Draw Event shall not be deemed to have occurred until expiration of five (5) days after that notice (or, if Landlord is prevented from giving notice by application of the bankruptcy codes automatic stay, any failure of Tenant to make when due any payment of Rent within five (5) days after the amount is due); and
(d) the payment by Landlord of any sum to cure a non-monetary Event of Default by Tenant hereunder (or, if Landlord is prevented from giving notice by application of the bankruptcy codes automatic stay, the payment of Landlord of any sum to cure a failure by Tenant to comply with any non-monetary obligation hereunder that Tenant has not cured within thirty (30) days from the date of the breach).
Draw Proceeds means the proceeds of any draw or draws made by Landlord under the Letter of Credit, together with any and all interest accruing thereon.
L/C Bank means any United States bank which is approved by Landlord in Landlords reasonable discretion. Landlord approves Silicon Valley Bank as an L/C Bank.
Letter of Credit means that certain one-year irrevocable letter of credit, in the Letter of Credit Required Amount, as such amount may be reduced pursuant to Section 57.8 below, issued by the L/C Bank, as required under Section 57.2 and, if applicable, as extended, renewed, replaced or modified from time to time in accordance with this Lease, which letter of credit will be transferable and in substantially the same form as attached Exhibit K.
57.5 Transfer of Letter of Credit. The Letter of Credit shall not be mortgaged, assigned or encumbered in any manner whatsoever by Tenant. Tenant acknowledges that Landlord has the right to transfer or mortgage its interest in the Premises and the Building and in this Lease and Tenant agrees that in the event of any such transfer or mortgage, Landlord shall have the right to transfer or assign the Letter of Credit and/or the Draw Proceeds to the transferee or mortgagee, and in such event, Tenant shall look solely to such transferee or mortgagee for return of the Letter of Credit and/or the Draw Proceeds so transferred. Tenant shall pay all fees and charges of the L/C Bank with respect to any transfer of the Letter of Credit. Tenant shall, within five (5) business days of request by Landlord, execute such further instruments or assurances as Landlord may reasonably deem necessary to evidence or confirm Landlords transfer or assignment of the Letter of Credit and/or the Draw Proceeds to such transferee or mortgagee.
57.6 Letter of Credit is Not Security Deposit. Landlord and Tenant acknowledge and agree that in no event or circumstance shall the Letter of Credit, any renewal thereof or substitute therefor or the proceeds thereof be (i) deemed to be or treated as a security deposit within the meaning of California Civil Code Section 1950.7, (ii) subject to the terms of such Section 1950.7, or (iii) intended to serve as a security deposit within the meaning of such Section 1950.7. The parties hereto (A) recite that the Letter of Credit is not intended to serve as a security deposit and such Section 1950.7 and any and all other laws, rules and regulations applicable to security deposits in the commercial context (Security Deposit Laws) shall have no applicability or relevancy thereto and (B) waive any and all rights, duties and obligations either party may now or, in the future, will have relating to or arising from the Security Deposit Laws. Notwithstanding the foregoing, to the extent California Civil Code 1950.7 in any way: (a) is
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determined to be applicable to this Lease or the Letter of Credit (or any proceeds thereof); or (b) controls Landlords rights to draw on the Letter of Credit or apply the proceeds of the Letter of Credit to any amounts due under this Lease or any damages Landlord may suffer following termination of this Lease, then Tenant fully and irrevocably waives the benefits and protections of Section 1950.7 of the California Civil Code, it being agreed that Landlord may recover from the Letter of Credit (or its proceeds) all of Landlords damages under this Lease and California law including, but not limited to, any damages accruing upon the termination of this Lease in accordance with this Lease and Section 1951.2 of the California Civil Code.
57.7 Substitute Letter of Credit. In the event the L/C Bank is declared insolvent by the FDIC or is closed for any reason, Tenant shall immediately provide a substitute Letter of Credit meeting the requirements of this Article 57 from another United States bank which is approved by Landlord in Landlords reasonable discretion.
57.8 Letter of Credit Reduction. So long as no material monetary Event of Default of Tenant then exists hereunder, as of the fourth (4th) anniversary of the Commencement Date (the LOC Reduction Date), Tenant shall have the right to deliver a new Letter of Credit, or amend the existing Letter of Credit, to reduce the amount of the Letter of Credit to Two Million Sixty-Five Thousand Eight Hundred Fifty-Nine and 98/100 Dollars ($2,065,859.98), provided that on or before the LOC Reduction Date either of the following (the LOC Reduction Conditions) shall have occurred: (i) both (a) an initial public offering of equity securities which results in Tenants stock being traded on a national securities exchange, including, without limitation, the NYSE, the NASDAQ Stock Market or the NASDAQ Small Cap Market System or any sale thereafter of equity securities on such a national securities exchange, and (b) Tenant has a market capitalization of not less than One Hundred Million Dollars ($100,000,000.00), or (ii) an infusion of not less than Seventy Million Dollars ($70,000,000.00), cumulatively and in the aggregate after the date of this Lease, of additional equity capital in Tenant as evidenced by Tenants audited financial statements. If a material monetary Event of Default of Tenant exists as of the LOC Reduction Date, Tenant shall have the right to deliver a new Letter of Credit or amend the existing Letter of Credit as described herein upon the cure of any such monetary Event of Default so long as at least one of the LOC Reduction Conditions is still then satisfied. Similarly, if neither of the LOC Reduction Conditions has been satisfied as of the LOC Reduction Date, then Tenant shall have the right to deliver a new Letter of Credit or amend the existing Letter of Credit as described herein upon the subsequent satisfaction of either of the LOC Reduction Conditions so long as no material monetary Event of Default then exists. Landlord shall cooperate reasonably with Tenant to effect the reduction in the amount of the Letter of Credit, including, without limitation, returning any existing Letter of Credit to Tenant for cancellation concurrently with Tenants delivery of a replacement or amended Letter of Credit to Landlord.
ARTICLE 58.
REASONABLE APPROVALS
58.1 Whenever this Lease grants Landlord or Tenant a right to take action, exercise discretion, or make an allocation, judgment or other determination (collectively, and Act), Landlord or Tenant shall act reasonably and in good faith (meaning that no action shall be taken which would materially contravene the reasonable expectations of a sophisticated
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landlord operating a first-class office building and a sophisticated tenant in a first-class office building concerning the benefits and rights granted under this Lease but not contravening the plain and clear intent of the specific language of this Lease governing the specific issue in question), and shall not take any action which might result in the frustration of the reasonable expectations of a sophisticated landlord and a sophisticated tenant concerning the benefits to be enjoyed under this Lease, provided, however, that:
(a) Wherever this Lease elsewhere provides another standard which specifically defines or limits Landlords or Tenants discretion with respect to any Act, such other standard and not this Article 58 shall then control as to such Act;
(b) Nothing in this Article 58 shall require Landlord to consent to (i) any use of the Premises for purposes other than those permitted in Article 3, (ii) any alterations to which Landlord is not otherwise required to consent under Section 15.1, or (iii) any proposed assignment of or subletting under this Lease to which Landlord is not otherwise required to consent under Article 18;
(c) Except for an obligation to act in good faith, and except for any action or determination expressly required to be reasonable or subject to a standard of reasonableness in Article 19 or Article 20, this Article 58 shall not apply to an election by Landlord or Tenant to terminate the Lease under Article 19 or Article 20 (but only if Landlord or Tenant (as applicable) strictly complies with the parameters for termination set forth in those Articles);
(d) This Article 58 shall not apply to an act taken by Landlord pursuant to Article 22 of this Lease; and
(e) Nothing contained in this Article 58 shall be deemed to limit the discretion of Landlord or Tenant with respect to any matter (including, without limitation, a proposal to amend or otherwise modify the Lease) which is not otherwise within the contemplation of the Lease.
[SIGNATURES FOLLOW]
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IN WITNESS WHEREOF, Landlord and Tenant, acting herein through duly authorized individuals, have caused these presents to be executed as of the date first above written.
TENANT: | ||
ADICET BIO, INC., a Delaware corporation | ||
By: | /s/ Brian Hogan | |
Brian Hogan, CFO | ||
[Printed Name and Title] | ||
By: |
| |
| ||
[Printed Name and Title] | ||
If Tenant is a corporation, this instrument must be executed by the chairman of the board, the president or any vice president and the secretary, any assistant secretary, the chief financial officer or any assistant financial officer or any assistant treasurer of such corporation, unless the bylaws or a resolution of the board of directors shall otherwise provide, in which case the bylaws or a certified copy of the resolution, as the case may be, must be attached to this instrument. | ||
Tenants NAICS Code: 541700 |
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LANDLORD: | ||||||
WESTPORT OFFICE PARK, LLC, a California limited liability company | ||||||
By: | PR II LHC Bayshore Technology Center, LLC, a Delaware limited liability company, its managing member | |||||
By: | PRISA II LHC, LLC, a Delaware limited liability company, its sole member | |||||
By: | /s/ Jeffrey D. Mills | |||||
Name: | Jeffrey D. Mills | |||||
Title: | Vice President |
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Exhibit 10.24
TENANT: ADICET BIO, INC.
LEASE
TABLE OF CONTENTS
ARTICLE TITLE | PAGE | |||
1 - Premises and Term |
1 | |||
2 - Rent |
4 | |||
3 - Landlords Work - Tenants Work |
7 | |||
4 - Streets |
10 | |||
5 - Utility Services |
10 | |||
6 - Assignment - Change of Ownership |
10 | |||
7 - Tenants Additional Agreements |
13 | |||
8 - Use of Premises |
16 | |||
9 - Indemnity and Public Liability Insurance |
17 | |||
10 - Fire Insurance and Casualty |
18 | |||
11 - Repair |
21 | |||
12 - Fixtures & Alterations |
23 | |||
13 - Remedies |
24 | |||
14 - Bankruptcy |
26 | |||
15 - Surrender of Premises |
26 | |||
16 - Eminent Domain |
27 | |||
17 - Real Property Taxes |
28 | |||
18 - Parking and Accommodation Areas |
29 | |||
19 - Miscellaneous |
32 |
9/30/2015
- 1 -
BUSINESS PARK LEASE
THIS LEASE is made this 30th day of September 2015, between DAVID D. BOHANNON ORGANIZATION, a California corporation, herein referred to as Landlord, and ADICET BIO, INC., a Delaware corporation, herein referred to as Tenant.
WITNESSETH:
ARTICLE 1 - Premises and Term
Section 1.1. Landlord hereby leases to Tenant and Tenant hereby leases from Landlord the demised premises consisting of the building located at 200 Constitution Drive in Menlo Park, California, as described in Exhibit A and located substantially as shown on Exhibit B attached hereto, upon and subject to the terms and provisions of this Lease for a demised term of seventy-four (74) months (plus any partial period prior to the commencement of the first full calendar month). Landlord shall deliver possession of the demised premises to Tenant upon execution and delivery of this Lease by the parties and Tenant shall commence the construction of the Tenant Improvements described in Section 3.2 promptly thereafter. The demised term and commencement of rent shall occur (the Commencement Date) on the earlier of (i) February 1, 2016, or (ii) the date Tenants Work has been substantially completed and Tenants business operations within the demised premises commence, and the demised term shall end on the last day of the seventy-fourth (74th) full calendar month (exclusive of any partial period prior to the commencement of the first full calendar month) after such commencement.
Upon execution and delivery of this Lease, Tenant shall have the right to access the demised premises for the purposes of performing the Tenant Improvements described in Section 3.2 and installing Tenants fixtures and equipment prior to the commencement of the demised term hereof, provided that Tenant does not unreasonably interfere with or delay Landlords work in the building or demised premises. Landlord agrees to use reasonable efforts to not unreasonably interfere with or delay Tenants Work in the demised premises. From and after the date Tenant first accesses any portion of the demised premises, all of the provisions of this Lease shall be applicable to said portion notwithstanding that the demised term has not yet commenced. Specifically, but without limitation, Tenants obligations with respect to insurance and indemnities shall be operable as of the date Tenant accesses any portion of the demised premises or building, and Tenant shall provide certificates of insurance for the insurance required of Tenant pursuant to Articles 9 and 10 of this Lease prior to accessing any portion thereof. Tenant shall not pay rent during such early access period; however, notwithstanding any other provision of this Lease to the contrary, Tenant shall pay for all utilities used by Tenant in the demised premises from and after the date Tenant first accesses any portion of the demised premises and throughout the entire demised term. Tenant shall indemnify Landlord against any and all claims arising out of Tenants access therein and/or construction work or other activity in the demised premises or building.
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Section 1.2. Landlord hereby notifies Tenant that neither the demised premises nor any portions of the building or Parking and Accommodation Areas have undergone inspection by a California Certified Access Specialist to determine if the demised premises, building or Parking and Accommodation Areas meet applicable accessibility standards with regard to the Americans With Disabilities Act (ADA). Landlord makes no warranty as to compliance with applicable codes, ordinances and laws, including the ADA, with respect to any improvements in the demised premises existing on the date Tenant first accesses the demised premises.
Section 1.3. Subject to Landlords termination right in subparagraph (g) of this Section 1.3 below, provided this Lease is in full force and effect and Tenant is not, at the time of giving the notice described below or at any time thereafter until commencement of the option term, in default beyond applicable notice and cure periods under any of the terms, conditions and covenants of this Lease, and subject to the terms and conditions set forth herein, Tenant shall be granted the option to extend the term of this Lease for one (1) consecutive period of five (5) years (the option term) as provided below:
A. Tenant shall notify Landlord in writing of Tenants exercise of the option to extend the Lease not less than nine (9), nor more than twelve (12), full calendar months prior to the expiration of the initial term;
B. The option term will commence on the day after the expiration of the initial term and shall terminate five (5) years later;
C. There shall be no further option to extend, there shall be no Landlord inducement, and Landlord shall not be required to perform any improvements in the demised premises or the building (other than items such as maintenance or restoration after a casualty as required under this Lease) prior to or during the option term;
D. The option to extend can be exercised only by Adicet Bio, Inc. or any Permitted Transferee (defined below) for its sole use of the demised premises and may not be transferred or assigned to any sublessee, assignee or other party other than a Permitted Transferee, nor may this option be exercised by Adicet Bio, Inc. for the use of the demised premises by any sublessee, assignee or party other than Adicet Bio, Inc. and any Permitted Transferee;
E. The then current payments for additional rent shall continue to be adjusted during the option term pursuant to the provisions of this Lease;
F. The base rent as described hereinbelow for each year of the option term shall (subject to the provisions hereof) equal the Fair Market Rental Value (hereinafter defined). Fair Market Rental Value shall mean the market rent, including annual increases (if any), being charged on the first day of the option term for similar space in buildings of comparable quality as the building on the demised premises which are located in similar areas of the Cities of Menlo Park, Palo Alto and Redwood City. In determining the Fair Market Rental Value comparable transactions shall be considered, including without limitation, length of lease term, landlord and tenant inducements and
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rent increases, if and to the extent then a part of market conditions. The rent on comparable leases shall be adjusted to reflect the value or cost of such inducements since neither Landlord nor Tenant shall have any obligation to pay or perform any such inducements (except for rent increases if applicable). For purposes of the determination of Fair Market Rental Value it shall be assumed the Landlord and Tenant are each ready, willing and able to enter into such a lease but are under no compulsion to do so.
Within twenty (20) calendar days after Tenants written notice of exercise, Tenant shall advise Landlord of its estimate of the Fair Market Rental Value for the demised premises. Landlord, within twenty (20) calendar days thereafter, shall advise Tenant in writing of its estimate of the Fair Market Rental Value. During the next twenty (20) calendar days the parties shall meet and confer for the purpose of agreeing upon Fair Market Rental Value. If the parties are then unable to agree, then the Fair Market Rental Value shall be determined by an appraisal as herein set forth and the Fair Market Rental Value as so determined shall be binding upon Landlord and Tenant. Within ninety (90) calendar days after the Tenants notice of exercise, Landlord and Tenant shall each appoint an appraiser and notify the other party in writing of its choice. Thereupon, the two appraisers so elected shall elect a third appraiser within thirty (30) calendar days of their appointment, unless during such period the two appraisers shall have agreed upon a Fair Market Rental Value, or have reconciled their appraisals to within ten percent (10%) of each other in which event the average of the two appraisals will be the Fair Market Rental Value, in which case their determination shall be final and binding. If the two appraisers shall be unable to agree upon a third appraiser, then the Landlord and Tenant shall immediately request the Presiding Judge of the San Mateo County Superior Court to make such selection. The three appraisers shall meet and confer for a period not to exceed sixty (60) calendar days and the determination of Fair Market Rental Value by a majority of the three shall be final and binding. In the event that a majority cannot agree, then the third (neutral) appraiser shall direct each of the party appraisers to review their appraisals for a period of seven (7) calendar days and return to a meeting of the three appraisers within five (5) calendar days thereafter with each respective party appraiser having indicated their final appraisal of Fair Market Rental Value in a sealed envelope and signed by that appraiser. The third appraiser will do the same. The envelopes will be opened in the presence of the three appraisers and the Fair Market Rental Value of the party appraiser which is closest to the Fair Market Rental Value of the third appraiser will be the final Fair Market Rental Value and binding on the parties. Each party shall bear the cost of the appraiser selected by it and the cost of the third appraiser shall be shared equally (including all costs associated with an appointment by the Superior Court of San Mateo, if applicable, regardless of which party filed the application). To be appointed as an appraiser the person so appointed shall hold the professional designation of MAI awarded by the American Institute of Real Estate Appraisers or such designation as may then be the preeminent professional designation, hold any licenses which may then be required by law, and have at least five (5) years current experience appraising commercial/light industrial properties in San Mateo County. The third (neutral) appraiser shall not have had any personal, social or business relationship with either party or any of its personnel during the preceding five (5) years.
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Notwithstanding the foregoing to the contrary, in no event shall the base rent for each year of the option term be reduced below the base rent payable by Tenant for the last year (or partial year) of the initial demised term.
When the base rent for the option term is determined pursuant to the above provisions, the parties shall promptly execute an amendment to this Lease stating the base rent to be paid during the option term. In the event Tenant has retained the services of a real estate broker to represent Tenant during the negotiations of the option term, it is expressly understood that Landlord shall have no obligation for the payment of all or any part of a real estate commission or other brokerage fee to Tenants real estate broker in connection therewith. Tenant shall be solely responsible for the payments of fees for services rendered to Tenant by such broker in connection with the option term.
G. Notwithstanding the foregoing, Landlord shall have the unilateral right to terminate this Lease at any time during the option term, or effective on the last day of the initial demised term of this Lease, by delivering to Tenant not less than twelve (12) months prior written notice if Landlord determines that it will require the demised premises for redevelopment or related purposes. For the avoidance of doubt, Landlords right to terminate this Lease in accordance with the provisions of this subparagraph (g) shall not be for purposes of leasing the demised premises in its existing configuration to a third party.
ARTICLE 2 - Rent
Section 2.1. Tenant covenants and agrees to pay to Landlord without set-off, recoupment, deduction or demand of any nature whatsoever, base rent for each year during the demised term as follows: for the first (1st) through the sixth (6th) full calendar months during the demised term the amount of Twenty Five Thousand One Hundred Sixty and 40/100 Dollars ($25,160.40) per month; for the seventh (7th) through twelfth (12th) full calendar months during the demised term the amount of Forty Three Thousand Three Hundred Eighty Dollars ($43,380.00) per month; for the thirteenth (13th) through twenty fourth (24th) full calendar months during the demised term the amount of Five Hundred Thirty Six Thousand One Hundred Seventy Six and 80/100 Dollars ($536,176.80) per annum, payable in twelve (12) equal monthly installments of Forty Four Thousand Six Hundred Eighty One and 40/100 Dollars ($44,681.40); for the twenty fifth (25th) through thirty sixth (36th) full calendar months during the demised term the amount of Five Hundred Fifty Two Thousand Two Hundred Sixty Two and 10/100 Dollars ($552,262.10) per annum, payable in twelve (12) equal monthly installments of Forty Six Thousand Twenty One and 84/100 Dollars ($46,021.84); for the thirty seventh (37th) through forty eighth (48th) full calendar months during the demised term the amount of Five Hundred Sixty Eight Thousand Eight Hundred Twenty Nine and 96/100 Dollars ($568,829.96) per annum, payable in twelve (12) equal monthly installments of Forty Seven Thousand Four Hundred Two and 50/100 Dollars ($47,402.50); for the forty ninth (49th) through sixtieth (60th) full calendar months during the demised term the amount of Five Hundred Eighty Five Thousand Eight Hundred Ninety Four and 86/100 Dollars ($585,894.86) per annum, payable in twelve (12) equal monthly installments of Forty Eight Thousand Eight Hundred Twenty Four and 57/100 Dollars ($48,824.57); for the sixty first (61st) through seventy
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second (72nd) full calendar months during the demised term the amount of Six Hundred Three Thousand Four Hundred Seventy One and 71/100 Dollars ($603,471.71) per annum, payable in twelve (12) equal monthly installments of Fifty Thousand Two Hundred Eighty Nine Thousand and 31/100 Dollars ($50,289.31); and for the seventy third (73rd) and seventy fourth (74th) full calendar months during the demised term the amount of Fifty One Thousand Seven Hundred Ninety Seven and 99/100 Dollars ($51,797.99) per month. Base rent shall be paid monthly in advance on the first (1st) day of each calendar month.
Section 2.2. For the purpose of this Lease, a year shall be twelve (12) calendar months, commencing with the first day of the first full calendar month of the demised term and the succeeding anniversaries thereof. For any period prior to the commencement of the first year or subsequent to the end of the last year of the demised term, rent shall be prorated on the basis of the rental rate then payable.
Section 2.3. All sums payable and all statements deliverable to Landlord by Tenant under this Lease shall be paid and delivered at Sixty 31st Avenue, San Mateo, California 94403-3404, or at such other place as Landlord may from time to time direct by notice to Tenant and all such sums shall be paid in lawful money of the United States.
Section 2.4. Upon execution of this Lease, Tenant shall pay to the Landlord the following:
A. Twenty Five Thousand One Hundred Sixty and 40/100 Dollars ($25,160.40) which shall be applied by Landlord to the first base rent to become due and payable under this Lease, and
B. Two Hundred Fifty Thousand Dollars ($250,000.00) which shall be held as a Security Deposit pursuant to the terms of Section 19.9.
In lieu of a cash Security Deposit, Tenant shall have the right to provide Landlord with an unconditional, clean, irrevocable, standby letter of credit (the Letter of Credit) payable on sight with the bearers draft in the amount of Two Hundred Fifty Thousand Dollars ($250,000.00) issued by and drawn on an institution acceptable to Landlord (the Issuing Bank) which shall be held by Landlord as a Security Deposit pursuant to the terms of Section 19.9. Landlord hereby approves Silicon Valley Bank as the Issuing Bank. Tenant shall provide Landlord with a draft letter of credit in advance for Landlords approval and the Letter of Credit shall be substantially in form attached hereto as Exhibit L. The Letter of Credit shall permit partial drawings and shall state that it shall be payable against sight drafts presented by Landlord, accompanied by Landlords statement that either (i) a default beyond any applicable notice and cure periods exists under the Lease, or (ii) the Letter of Credit is scheduled to expire within thirty (30) days of the date of Landlords statement and Landlord has not received a replacement Letter of Credit, or (iii) Tenant has been declared bankrupt, and that said drawing is in accordance with the terms and conditions of the Lease; no other document or certification from Landlord shall be required to negotiate the Letter of Credit. Landlord may designate any bank as Landlords advising bank for collection purposes and any sight drafts for the
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collection of the Letter of Credit may be presented by the advising bank on Landlords behalf. The Letter of Credit shall be for an initial term of at least one (1) year and shall be acceptable to Landlord in both form and substance. The Letter of Credit shall be automatically renewed, without amendment, for continuing consecutive one (1) year (or longer) periods unless, at least thirty (30) days prior to any such date of expiration, the issuer gives written notice to Landlord that the Letter of Credit will not be renewed, in which case, if Tenant does not provide a replacement letter of credit that complies with the terms hereof at least thirty (30) days prior to such expiration date, Landlord shall be able to draw the full amount of the Letter of Credit. The Letter of Credit shall not expire until the date which is at least ninety (90) days after the scheduled expiration date of the Lease, subject to the provisions of Section 19.9.
Upon a default beyond any applicable notice and cure period by Tenant under the Lease, Landlord shall be entitled to draw against the Letter of Credit in the amount of the delinquent base rent or additional rent or any other expense, loss or damage that Landlord may suffer because of Tenants default. Upon Tenants bankruptcy, Landlord shall be entitled to draw against the entire amount of the Letter of Credit and any excess amounts shall be held by Landlord as collateral for Lease obligations. Landlord shall not be required to exhaust its remedies against Tenant before having recourse to the Letter of Credit or to any other form of collateral held by Landlord or to any other remedy available to Landlord at law or in equity.
The beneficiary designation in the Letter of Credit shall include Landlord and Landlords successors and/or assigns as their interests may appear and the Letter of Credit shall be assignable and shall include the Issuing Banks acknowledgment and agreement that the Letter of Credit is assignable by Landlord and that, in such event, the Issuing Bank agrees to treat the assignee as a beneficiary thereunder, entitling such assignee to the same rights afforded to Landlord, as beneficiary thereunder.
Section 2.5. In addition to base rent under Section 2.1, all other payments to be made under this Lease by Tenant to Landlord shall be deemed to be and shall become additional rent hereunder, whether or not the same to be designated as such, and shall be included in the term rent wherever used in this Lease; and, unless another time shall be expressly provided for the payment thereof, all rent and additional rent shall be due and payable together with the next succeeding installment of base rent; and Landlord shall have the same remedies for failure to pay the same as for a nonpayment of base rent.
Section 2.6. Any amount due from Tenant to Landlord that is not paid when due shall bear interest at the lesser of ten percent (10%) per annum or the highest rate then permitted to be charged on late payments under leases under California law; provided, however, the payment of any such interest shall not excuse or cure the default upon which such interest accrued. Tenant acknowledges and agrees that payment of such interest on late payments is reasonable compensation to Landlord for the additional costs incurred by Landlord caused by such late payment, including, but not limited to, collection and administration expenses and the loss of the use of the money that was late in payment.
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ARTICLE 3 - Landlords Work - Tenants Work
Section 3.1.
A. Tenant accepts the demised premises in a so-called as-is condition and agrees that, except for the work described in Section 3.1.B and Section 3.1.C, Landlord shall not be required to perform any work whatsoever therein. In the event the Tenant Improvements require demolition of any existing improvements within the demised premises, Tenant agrees to undertake same at Tenants sole cost and expense as a portion of Tenants work.
B. Landlord shall replace the heating and air conditioning (HVAC) units described in Exhibit C-1 hereto and repair the remaining HVAC units which are necessary for Tenants use and occupancy of the demised premises to good working condition within ninety (90) days of the later of (i) the date Landlord has approved Tenants plans and specifications for the Tenant Improvements described in Section 3.2 below which plans shall include Tenants HVAC requirements, or (ii) the date this Lease has been fully executed and delivered by the parties. In addition, as of the commencement of the demised term hereof the existing electrical, lighting and plumbing systems serving the demised premises shall be in good working order. In the event Tenant provides written notice to Landlord of the need for maintenance or repair of the roof or any building systems or any HVAC units, electrical or plumbing items within ninety (90) days after commencement of the demised term hereof, Landlord shall, at Landlords sole expense (provided the need for such maintenance and repairs was not caused by Tenant), perform any such maintenance and repairs. After the end of such 90-day period, any maintenance, repair or replacement thereof shall be performed by Landlord, and the costs reimbursed by Tenant, pursuant to the provisions of Section 11.3 hereof, subject to Section 18.3. If, as a direct result of Landlords failure to perform the work in accordance with the provisions of Section 3.1.B and Section 3.1.C, Tenant is delayed in completing the Tenant Improvement work in the demised premises beyond the Commencement Date described in Section 1.1 such that Tenant cannot operate its business therein, then the Commencement Date shall be delayed by one (1) day for each one (1) day of delay, if any, caused thereby.
C. Landlord shall, at Landlords expense, perform any improvements required to make the exterior of the demised premises and the Parking and Accommodation Areas comply with the Americans with Disabilities Act (ADA) which are identified by the applicable governmental authorities as a condition of issuance of the building permits for the Tenant Improvements to be constructed by Tenant pursuant to Section 3.2. Tenant shall, at Tenants expense, perform any improvements required to make the demised premises comply with the ADA which are identified by the applicable governmental authorities as a condition of issuance of the building permits for the Tenant Improvements to be constructed by Tenant pursuant to Section 3.2. After completion of the Tenant Improvements and commencement of the demised term hereof, the responsibility for compliance with the ADA shall be as set forth in Section 7.5.
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Section 3.2. Tenant shall provide certain interior improvements in the demised premises that Tenant desires to construct in accordance with detailed plans and specifications therefor which shall include full construction drawings including without limitation architectural, structural, mechanical, plumbing and electrical drawings (herein, plans and specifications) which must be approved, in writing, by Landlord before work is commenced (collectively, the Tenant Improvements) and which plans and specifications, once approved, shall become Exhibit C hereto. Landlord acknowledges that Tenant may construct the Tenant Improvements in phases within twenty-four (24) months after Tenant first accesses the demised premises. All such Tenant Improvements shall be made at the sole cost of Tenant in accordance with Exhibit C hereto.
Landlord and Tenant hereby approve the preliminary plan for the Tenant Improvements shown on Exhibit E hereto; provided, however, that Landlords approval of the preliminary plan does not supersede or waive Tenants obligation to provide Landlord with the detailed plans and specifications for the Tenant Improvements nor does Landlords approval of the preliminary plan supersede or waive Landlords right to review and approve the plans and specifications for the Tenant Improvements in accordance with the provisions hereof. Subject to Landlords approval of the plans and specifications and subject to the provisions of Section 12.2 with regard to wiring, Landlord agrees that the improvements shown on Exhibit E may be surrendered at the expiration or sooner termination of the demised term of the Lease.
The Tenant Improvements will be constructed in accordance with the plans and specifications therefor to be prepared by a reputable licensed architect, under Tenants direction, which architect shall be approved by Landlord (the Architect), which approval shall not be unreasonably withheld, conditioned, or delayed. Landlord hereby approves DGA as an acceptable architect. Following approval of the plans and specifications, Tenant shall apply for all requisite building permits and approvals for construction of the Tenant Improvements. Following issuance of building permits, Tenant shall cause the Tenant Improvements to be constructed by a reputable general contractor licensed to do business in the State of California which contractor shall be approved by Landlord (the General Contractor) (which approval shall not be unreasonably withheld, conditioned, or delayed) and diligently prosecuted to completion in a good and workmanlike manner in accordance with the approved plans and specifications. Tenant shall have the right to make changes to the plans and specifications from time to time provided such changes are approved in advance in writing by Landlord, which approval shall not be unreasonably withheld, conditioned, or delayed. Landlord hereby approves MAI and CP Construction as acceptable General Contractors.
Landlord shall have the right to monitor the construction of the Tenant Improvements for conformance with the plans and specifications. Any deviations from the plans and specifications reported by Landlord to Tenant shall be corrected promptly. Tenant agrees to hold, or cause the General Contractor to hold, on site periodic construction meetings at a time made known to Landlords representative who shall have the right to attend such meetings for the purpose of monitoring the progress of the construction. Landlords representative shall also have access to the demised premises at all times during construction for the purpose of inspecting the work in progress.
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In connection with Tenants Work in the demised premises, including the Tenant Improvements, Tenant and its General Contractor agree to abide by the provisions of the Insurance Requirements, attached hereto as Exhibit D and made a part hereof. In addition, Tenant shall, during the course of Tenants Work, including the Tenant Improvements, obtain and maintain, at its expense, builders risk insurance for the amount of the completed value thereof on all-risk form, and flood insurance, insuring the interests of Tenant, Landlord, and any contractors and subcontractors.
Within ten (10) days following Tenants completion thereof, Tenant shall furnish Landlord with a complete set of the final For Construction plans therefor in AutoCAD format, including all x-refs, fonts and plot files.
Notwithstanding anything to the contrary herein, Tenant shall not be required to perform any Tenant Improvements and Tenant shall be entitled to reduce or eliminate the scope of the Tenant Improvements in its discretion, subject to compliance with applicable laws and Landlords approval of any revisions to the plans and specifications for such changes.
If Tenant finds that there was any Hazardous Material in the demised premises at the time of delivery of possession thereof to Tenant (and Tenant, its employees, agents, contractors and invitees were not responsible for bringing the same onto the demised premises), or if any seismic upgrades are required to the demised premises which are not required or triggered by the specific nature of (i) Tenants use of the demised premises or (ii) Tenants work (including the Tenant Improvements) or alterations (as opposed to seismic upgrades required for any general construction in the demised premises), or Tenants negligent acts or omissions or those of its employees, contractors, agents, invitees or servants, Tenant shall immediately notify Landlord in writing and it will be Landlords responsibility to perform whatever work is required by law to remove or render harmless such Hazardous Materials or perform such upgrades, any and all such work to be performed in a manner and by a procedure meeting the requirements of applicable federal, state and local laws, ordinances and regulations at no cost to Tenant. In the event of the presence of Hazardous Materials in the demised premises or if seismic upgrades are required, Landlord may by notice to Tenant (which may be verbal) require that Tenant immediately stop performing the Tenant Improvement work in the demised premises. If Tenant, in its reasonable business judgment or by notice from Landlord, is required to stop performing the Tenant Improvement work in the demised premises as a direct result of the presence of Hazardous Materials or requirement of such upgrades, and provided this Lease has not terminated pursuant to the provisions hereof, then the Commencement Date shall be delayed by one (1) day for each one (1) day of delay, if any, caused by Landlords Hazardous Materials removal work or such upgrade work. Notwithstanding anything contained in this Lease to the contrary, in the event the work required to remove or render harmless any Hazardous Materials and/or perform any seismic upgrade is estimated by Landlord to cost, in the aggregate, One Hundred Fifty Thousand Dollars ($150,000.00) or more, then Landlord shall have the right to either (a) terminate this Lease by written notice to Tenant, in which case Landlord shall reimburse Tenant for the following reasonable and actual out-of-pocket costs (up to the maximum amount of Ten Thousand Dollars [$10,000.00]): (i) attorneys fees incurred by
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Tenant in negotiating this Lease, and (ii) costs incurred by Tenant for designing and constructing the Tenant Improvements prior to the date Landlord required Tenant to stop work in the demised premises or the date Tenant actually stopped work if earlier, LESS the amount of the Inducement or any portion thereof which has been paid by Landlord to Tenant in accordance with Section 19.21 of this Lease, and such amount shall be payable within thirty (30) days after Tenant provides Landlord with all of the appropriate documentation to support and substantiate such costs, or (b) perform the work. In the event Landlord terminates this Lease, Landlord shall have no obligation to provide Tenant with the Inducement described in Section 19.21 or any portion thereof. Notwithstanding the foregoing, Landlord may not exercise option (a) in this paragraph if Tenant agrees, by written notice to Landlord within five (5) days after Landlords written termination notice, to pay for such Hazardous Materials or seismic upgrade costs in excess of One Hundred Fifty Thousand Dollars ($150,000.00).
Section 3.3. Any additional work to be performed during the demised term hereof shall be performed at the sole cost of Tenant in accordance with detailed plans and specifications therefor which must be approved, in writing, by Landlord or Landlords Architect before work is commenced and otherwise pursuant to the provisions of Section 3.2 above.
ARTICLE 4 - Streets
Section 4.1. Tenant agrees to use reasonable efforts to require employees, and to direct customers and other persons visiting Tenant, to park in the parking area provided in the Parking and Accommodation Areas and to allow Landlord to post the streets for no parking.
ARTICLE 5 - Utility Services
Section 5.1. Landlord has at its own cost and expense secured the installation of water, gas, sanitary sewers and electrical services to the demised premises and made all necessary connections thereof to the building. Tenant shall pay all meter or service charges made by public utilities companies and shall pay for the water, gas and/or electricity used on the demised premises and sewer use fees and charges whether ad valorum or not and any so called sewer connection charges based on increased wastewater discharge from the demised premises exclusively. Tenant shall maintain such connections of utilities to the demised premises and the building.
Section 5.2. Landlord shall not be liable to Tenant for the failure of any utility services.
ARTICLE 6 - Assignment - Change of Ownership
Section 6.1.
A. Except as otherwise provided herein, Tenant shall not, by operation of law or otherwise, transfer, assign, sublet, enter into license or concession agreements, mortgage or hypothecate this Lease or the Tenants interest in and to the demised
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premises without first procuring the written consent of Landlord. Any attempted transfer, assignment, subletting, license or concession agreement, mortgage or hypothecation without Landlords written consent shall be void and confer no rights upon any third person. Landlords consent to a proposed assignment or sublease shall not be unreasonably withheld, conditioned or delayed provided that the proposed assignee or sublessee shall have: (i) a net worth, at the time of the assignment or sublease, determined in accordance with good accounting principles, sufficient to perform its obligations under this Lease and the applicable transfer as determined by Landlord in Landlords sole but reasonable judgment, and (ii) a good reputation in the business community; provided further that Tenant shall give Landlord not less than thirty (30) days prior notice prior to the effective date of any such assignment or sublease, and Landlord shall have the option to terminate this Lease with respect to the space to be assigned or a sublease of all or substantially all of the demised premises for all or substantially all of the remaining Lease term (in each case, except with respect to a Permitted Transferee) by notice to Tenant given within thirty (30) days of Landlords receipt of Tenants notice. Nothing herein contained shall relieve Tenant from its covenants and obligations for the demised term. Tenant agrees to reimburse Landlord for Landlords reasonable outside attorneys fees incurred in conjunction with the processing and documentation of any such requested transfer, assignment, subletting, licensing or concession agreement, mortgage or hypothecation of this Lease or Tenants interest in and to the demised premises, not to exceed $1,000.00 per request. If Landlord consents to any assignment or sublease pursuant to this Article, Tenant shall pay Landlord, as additional rent:
(a) in the case of each and every assignment (except with respect to a Permitted Transferee), an amount equal to one-half (1/2) of all monies, property, and other consideration of every kind whatsoever paid or payable to Tenant by the assignee for such assignment and for all property of Tenant transferred to the assignee as part of the transaction (including, but not limited to, fixtures, other leasehold improvements, furniture, equipment, and furnishings), less the Transfer Costs, as defined below (with reference to an assignment rather than a sublease); and
(b) in the case of each and every sublease (except with respect to a Permitted Transferee), one-half (1/2) of the amount by which all rent, and/or other monies, property, and consideration of every kind whatsoever paid or payable to Tenant by the subtenant under the sublease exceeds the sum of:
(i) all base rent and additional rent under this Lease accruing during the term of the sublease in respect of the subleased space (as reasonably determined by Landlord, taking into account the useable area of the premises demised under the sublease); plus
(ii) attorneys fees up to $2,500.00 actually paid by Tenant to an independent outside attorney and commissions actually paid by Tenant in connection with the sublease to an independent third party licensed real estate broker; plus
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(iii) the actual cost of leasehold improvements undertaken by Tenant (subject to Landlords prior written consent) solely to prepare the sublease space for the subtenant, amortized over the period of the term of the sublease, commencing with the date on which the sublease commences (the foregoing clauses (ii) and (iii) are herein collectively referred to as the Transfer Costs).
B. Each transfer, assignment, subletting, license, concession agreement, mortgage and hypothecation to which there has been consent or for which no consent is required (other than to a Permitted Transferee where the Tenant is the surviving entity) shall be by an instrument in writing in form satisfactory to Landlord, and shall be executed by the transferor, assignor, sublessor, licensor, concessionaire, hypothecator or mortgagor and the transferee, assignee, sublessee, licensee, concessionaire or mortgagee in each instance, as the case may be; and each transferee, assignee, sublessee, licensee, concessionaire or mortgagee shall agree in writing for the benefit of Landlord herein to assume, to be bound by, and to perform the applicable terms, covenants and conditions of this Lease to be done, kept and performed by Tenant, including the payment of all applicable amounts due or to become due under this Lease directly to Landlord. One (1) executed copy of such written instrument shall be delivered to Landlord. Failure to first obtain in writing Landlords consent or failure to comply with the provisions of this Article shall operate to prevent any such transfer, assignment, subletting, license, concession agreement, mortgage, or hypothecation from becoming effective.
C. If Tenant hereunder is a corporation which, under the then current laws of the State of California, is not deemed a publicly traded corporation, as defined in California Corporations Code Section 1502.1 or any successor to such section, or is an unincorporated association or partnership, the transfer, assignment or hypothecation of any stock or interest in such corporation, association or partnership in the aggregate in excess of fifty percent (50%) shall be deemed an assignment within the meaning and provisions of this Section 6.1.
D. The consent of Landlord to any transfer, assignment, sublease, license or concession agreement, mortgage or hypothecation of this Lease is not and shall not operate as a consent to any future or further transfer, assignment, sublease, license or concession agreement, mortgage or hypothecation, and Landlord specifically reserves the right to refuse to grant any such consents except as otherwise provided in this Section 6.1.
E. Landlords rights to assign this Lease are and shall remain unqualified. Upon any sale of the demised premises and provided the purchaser assumes all obligations under this Lease, Landlord shall thereupon be entirely released of all obligations of Landlord hereunder and shall not be subject to any liability resulting from any act or omission or event occurring after such sale.
F. Notwithstanding anything to the contrary herein, Tenant may, without Landlords prior written consent, provided that (i) the rights granted to Tenant herein are not intended as a subterfuge to circumvent Landlords rights under this Article 6, and
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(ii) Tenant is not in default under this Lease beyond applicable notice and cure periods, and (iii) such assignee or sublessee shall comply with all of the terms and conditions of this Lease, without any modification of this Lease, sublet the demised premises or assign the Lease to a Permitted Transferee under the conditions contained herein. For the purposes hereof, a Permitted Transferee is defined as: (a) the parent corporation of Tenant or a subsidiary or affiliate of Tenant; or (b) any entity which results from a merger or consolidation (provided the surviving entity has financial capacity to fulfill the obligations under the Lease, as determined by Landlord in its sole, but reasonable, business judgment; and further provided that all of the assets then held by Tenant remain or become assets of the surviving entity); or (c) a purchaser of all or substantially all of Tenants assets or stock as a going concern; or (d) Tenant, following a change in control described in Section 6.1.0 above. Any such Permitted Transferee pursuant to clauses (a) and (c) above shall agree in writing, in form satisfactory to Landlord, to assume, to be bound by, and to perform the terms, covenants and conditions of this Lease to be done, kept and performed by Tenant, including the payment of all amounts due or to become due under this Lease directly to Landlord, without any modification of this Lease. Tenant shall provide Landlord with the following no later than ten (10) days after the effective date of the proposed transfer: (i) the name and address of the Permitted Transferee, and (ii) a copy of the proposed sublet or assignment agreement, and (iii) such reasonable information as may be requested by Landlord to substantiate that the proposed assignee or sublessee qualifies as a Permitted Transferee under the definition set forth hereinabove. Failure of Tenant to so provide Landlord with such information or a copy of the written instrument effecting the proposed sublease or assignment shall operate to prevent any such sublease or assignment from becoming effective and any such transaction shall be null and void. Nothing herein contained shall be construed as releasing Tenant from any of its liabilities or other obligations hereunder, including the payment of rent.
Notwithstanding anything herein to the contrary, the following shall not be deemed to constitute an assignment under this Lease: (i) the sale or issuance of stock by Tenant on a public exchange or in connection with a public offering or the subsequent sale of stock on a public exchange or the sale, transfer or issuance of stock by Tenant in a private financing intended to raise capital for Tenant and not intended to circumvent Landlords rights under this Article 6, or (ii) the transfer of stock among existing shareholders of Tenant, family members or for estate planning purposes.
None of the transactions permitted under this Section 6.F shall require the consent of Landlord but Tenant shall notify Landlord in writing of the same as provided hereinabove.
ARTICLE 7 - Tenants Additional Agreements
Section 7.1. Tenant agrees at all times during the demised term to: (A) Keep the demised premises in a neat and clean condition. (B) Promptly remove all waste, garbage or refuse from the demised premises. (C) Promptly comply with all laws and ordinances and all rules and regulations of duly constituted governmental authorities affecting the demised premises, and the cleanliness, safety, use and occupation thereof,
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but this clause (C) shall not be construed to require Tenant to comply with any such laws, ordinances, rules or regulations which require structural changes in the demised premises unless the same are made necessary by act or work or alterations performed by Tenant (including the Tenant Improvements, subject to Landlords obligations in Section 3.1.C) or the particular nature of Tenants business (other than general office use). (D) Prevent the escape from the demised premises of all fumes, odors and other substances which are offensive or may constitute a nuisance or interfere with other tenants.
Section 7.2. Tenant agrees that it will not at any time during the demised term without first obtaining the Landlords written consent: (A) Conduct or permit any fire, bankruptcy or auction sale in the demised premises. (B) Place on the exterior walls (including both interior and exterior surfaces of windows and doors), the roof of any buildings or any other part of the demised premises, any sign, symbol, advertisement, neon light, other light or other object or thing visible to public view outside of the demised premises. (C) Change the exterior color of the building on the demised premises, or any part thereof, or the color, size, location or composition of any sign, symbol or advertisement that may have been approved by Landlord. (D) Park, operate, load or unload, any truck or other delivery vehicle on any place other than the loading area designated for Tenants use. (E) Use the plumbing facilities for any purpose other than that for which they were constructed or dispose of any foreign substance therein. (F) Install any exterior lighting or plumbing facilities, shades or awnings, amplifiers or similar devices, or use any advertising medium which may be heard or experienced outside the demised premises, such as loudspeakers, phonographs, or radio broadcasts. (G) Deface any portion of the building or improvements on the demised premises, normal usage excepted. In the event any portion of the building is defaced or damaged, Tenant agrees to repair such damage. (H) Permit any rubbish or garbage to accumulate on the demised premises, or any part thereof, unless confined in metal containers so located as not to be visible to members of the public. (I) Install, maintain or operate any sign on the exterior of the building except as approved in writing by Landlord. (J) Store materials, supplies, equipment, finished products, raw materials or articles of any nature outside of the demised premises. (K) Use the demised premises for retail or residential purposes. (L) Use, store, generate or dispose of any hazardous material, hazardous substance or hazardous waste as those terms are defined from time to time under applicable laws and regulations (Hazardous Materials) except as are reasonably required for the conduct by Tenant of its business in the demised premises for the permitted use, provided that (i) Tenants indemnities set forth in this Lease shall not be affected or limited thereby, and (ii) any such Hazardous Materials shall be used with due care and in accordance with the instructions of the manufacturer of such products and used only strictly in accordance with all permits therefor and all applicable laws.
Landlord shall allow Tenant to install, at Tenants expense, Tenants signage on the monument sign for the building, subject to Landlords approval, in Landlords reasonable discretion, as to the size, type, installation procedure and location of the sign, and subject to approval by the City of Menlo Park; provided that, at the expiration or sooner termination of this Lease, at Landlords election, Tenant shall, at Tenants sole cost and expense, remove such signage and repair any damage caused by such removal.
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In addition, Tenant may install only such vinyl signage on the front windows of the building for which Tenant has received approval from the City of Menlo Park and also which have been approved in advance in writing by Landlord, which approval shall be in Landlords reasonable discretion.
Section 7.3. Tenant agrees that it will not at any time during the demised term: (A) Perform any act or carry on any practice which may injure the demised premises. (B) Burn anything in or about the demised premises. (C) Keep or display any merchandise or other object on or otherwise obstruct any sidewalks, walkways or areaways. (D) Use or permit the use of any portion of the demised premises as living quarters, sleeping apartments, lodging rooms, or for any unlawful purpose. (E) Use or permit the demised premises to be used for any purpose which is or shall not then be allowed under the Zoning Ordinance of the City of Menlo Park, California, in that area.
Section 7.4. Tenant shall, at its expense, comply with all applicable laws, regulations, rules and orders, regardless of when they become or became effective, including, without limitation, those relating to health, safety, noise, environmental protection, waste disposal, and water and air quality, and furnish satisfactory evidence of such compliance upon request of Landlord.
Should any discharge, leakage, spillage, emission or pollution of any type occur upon or from the demised premises due to Tenants use and occupancy thereof, Tenant, at its expense, shall be obligated to remedy the same to the reasonable satisfaction of Landlord and to the satisfaction of any governmental body having jurisdiction thereover or reasonably recommended by Landlords environmental consultant pursuant to the following paragraph. Tenant agrees to indemnify, hold harmless, and defend Landlord against all liability, cost, and expense (including without limitation any fines, penalties, judgments, litigation costs, and attorneys fees) incurred by Landlord as a result of Tenants breach of this section, or as a result of any such discharge, leakage, spillage, emission, or pollution, regardless of whether such liability, cost, or expense arises during or after the demised term, unless such liability, cost or expense is proximately caused solely by the active negligence of Landlord.
Tenant shall provide Landlord with a copy of its application(s) for all Hazardous Materials permits for Tenants operation of its business in the demised premises and shall provide Landlord with all information obtained by Tenant from, and/or provided to, the San Mateo County Department of Environmental Health or the Menlo Park Fire Protection District (MPFPD) (or other appropriate governmental authorities) pertaining to Tenants generation, discharge or use of Hazardous Materials in or from the demised premises. Landlord reserves the right to contract with an environmental consultant to perform walk throughs of the demised premises from time to time during the demised term, subject to the terms of Section 19.1, to review Tenants generation, discharge and/or use of Hazardous Materials in or from the demised premises and compliance with the applicable permits, and to make reasonable recommendations with respect thereto. Tenant shall undertake those activities necessary to timely comply with Landlords environmental consultants reasonable recommendations and all other activities required by the San Mateo County Department of Environmental Health or MPFPD or other governmental authorities responsible for Hazardous Materials, and shall provide Landlord with satisfactory evidence of such compliance.
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Tenant shall pay all amounts due Landlord under this section, as additional rent, within ten (10) days after any such amounts become due.
Tenant shall, at least thirty (30) days prior to the termination of the demised term, or any earlier termination of this Lease, submit a plan to the San Mateo County Department of Environmental Health or MPFPD in accordance with applicable provisions of the Uniform Fire Code (or other appropriate governmental authorities), with a copy to Landlord, demonstrating how any Hazardous Materials which were stored, dispensed, handled or used in, at or upon the demised premises will be transported, disposed of or reused at the expiration or sooner termination of the demised term of this Lease; and Tenant shall, at the expiration or sooner termination of the demised term, comply with all applicable laws, regulations, rules and orders of any governmental body having jurisdiction thereover (including without limitation the MPFPD or other appropriate governmental authorities) regarding the disposal of any such Hazardous Materials. In addition, at the expiration or earlier termination of the demised term Tenant shall close all Hazardous Materials permits with respect to the demised premises.
Tenants obligations under this Section 7.4 shall survive the expiration or earlier termination of this Lease, including without limitation any termination resulting from any default by Tenant under the Lease.
Section 7.5. Landlord and Tenant agree and acknowledge that, from and after the commencement of the demised term hereof, if the Parking and Accommodation Areas, or any portion thereof, are required to be modified to comply with the ADA, then Landlord shall make the improvements necessary to make any such areas comply with the provisions of the ADA and, except for Landlords obligations at Landlords sole cost under Section 3.1.C, the cost thereof shall be reimbursed by Tenant to Landlord as a portion of the management, maintenance and repair expenses of the Parking and Accommodation Areas pursuant to the provisions of Article 18. Tenant agrees and acknowledges that at any time during the demised term hereof (including if required as a condition of issuance of any building permit for the Tenant Improvements or subsequent improvements or alterations within the demised premises) that the demised premises are required to be modified to comply with the ADA, then Tenant shall, at Tenants sole cost and expense, make the improvements necessary to make the demised premises comply with the provisions of the ADA.
ARTICLE 8 - Use of Premises
Section 8.1. Tenant shall use the demised premises solely for general office, research and development, laboratory and pilot plant, and for no other purposes without Landlords written consent.
Section 8.2. Tenant covenants and agrees that it will not knowingly use or permit to be used the demised premises or any part thereof for any unlawful purpose whatsoever. Tenant shall obtain and maintain all governmental licenses and permits required for the lawful and proper conducting of Tenants business in the demised premises.
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ARTICLE 9 - Indemnity and Public Liability Insurance
Section 9.1. Tenant agrees to indemnify and save harmless Landlord from and against all claims arising from any act, omission or negligence of Tenant, or its contractors, licensees, agents, servants, invitees or employees, or arising from any accident, injury or damage whatsoever caused to any person, or to the property of any person occurring during the demised term in the demised premises and on the sidewalks (if any) in the Parking and Accommodation Areas adjoining the same, or arising in connection with Tenants use of generators, sheds and/or other improvements in accordance with Section 18.1 hereof, and from and against all costs, expenses and liabilities incurred in or in connection with any such claim or proceeding brought thereon, including, but not limited to, reasonable attorneys fees and court costs. Notwithstanding anything to the contrary herein, Landlord shall not be released or indemnified from, and shall indemnify, defend, protect and hold harmless Tenant from, all losses, damages, liabilities, claims, attorneys fees, costs and expenses to the extent arising from the gross negligence or willful misconduct of Landlord or its agents, contractors or licensees.
Section 9.2. Tenant agrees to maintain in full force during the demised term a policy of public liability and property damage insurance under which Landlord (and such other persons, firms or corporations as are designated by Landlord and are properly includible as additional insureds under the terms of any such policies of insurance) and Tenant are named as insureds, and the insurer agrees to indemnify and hold Landlord and Landlords said designees harmless from and against all cost, expense and/or liability arising out of or based upon any and all claims, accidents, injuries and damage mentioned in Section 9.1. All public liability and property damage policies shall contain a provision that Landlord, although named as an additional insured, shall nevertheless be entitled to recovery under said policies for any loss occasioned to it, its servants, agents and employees, by reason of the negligence of Tenant. Each such policy shall be approved as to form by Landlord, such approval not to be unreasonably withheld, be noncancelable with respect to the Landlord and Landlords said designees without advance written notice to the Landlord and Landlords said designees, and a duplicate original or certificate thereof shall be delivered to Landlord prior to commencement of the demised term and thereafter thirty (30) days prior to expiration of the term of each policy. The limits of liability of such comprehensive general liability insurance shall be Two Million Dollars ($2,000,000.00) for injury or death to one or more persons and damage to property, combined single limit.
Tenant shall maintain Pollution Legal Liability Insurance, which insurance shall cover Tenant against both Bodily Injury Liability and Property Damage Liability, with limits of $1,000,000.00 per occurrence and $2,000,000.00 in the aggregate. Such insurance shall cover Pollution Conditions on the Premises. Pollution Conditions means the discharge, disposal, release or escape of smoke, vapors, fumes, acids, alkalis, toxic chemicals, liquids or gases (including gasoline), waste materials, or other irritants,
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contaminants or pollutants into or upon land, the atmosphere, or any water course, groundwater or body of water. Landlord (and such other persons, firms or corporations as are designated by Landlord) shall be named as additional insured under said insurance.
All public liability, property damage, pollution legal liability insurance and other casualty policies shall be written as primary policies, not contributing with and not in excess of coverage which Landlord may carry. Notwithstanding anything contained herein to the contrary, all insurance carried by Tenant shall be issued by responsible insurance companies licensed to do business in the State of California with an A.M. Best Company rating of A-VIII or better.
If Tenant shall not comply with its covenants to maintain insurance made above, or if Tenant fails to provide duplicate originals or certificates thereof to Landlord as is provided above, Landlord may, but shall not be required to, obtain any such insurance; and if Landlord does obtain any such insurance, Tenant shall, on demand, reimburse Landlord for the premium for any such insurance.
Section 9.3. Tenant agrees to use and occupy the demised premises, the Parking and Accommodation Areas and to use all other portions of the Business Park (which it is herein given the right to use) at its own risk and hereby releases to the full extent permitted by law the Landlord, and its agents, servants, contractors, and employees, from all claims and demands of every kind resulting from any accident, damage or injury occurring therein. Landlord shall have no responsibility or liability for any loss of or damage to fixtures or other personal property of Tenant. The provisions of this Section shall apply during the whole of the demised term.
ARTICLE 10 - Fire Insurance and Casualty
Section 10.1. If the building on the demised premises should be damaged or destroyed during the demised term by any casualty insurable under Landlords standard fire and extended coverage insurance policies, Landlord shall (unless Landlord terminates the Lease in accordance with Subparagraph (g) of Section 1.3 and except as hereinafter provided) repair and/or rebuild the same to substantially the condition in which the same existed immediately prior to such damage or destruction. Landlords obligation under this Section shall in no event exceed either (A) the scope of the work existing as of the date of this Lease, or (B) the proceeds of any such insurance policy if Landlord keeps the building and the demised premises insured against loss or damage by such fire and extended coverage insurance to the extent of the full replacement value of the building if reasonably obtainable from responsible insurance companies licensed to do business in California, unless Landlord nevertheless elects to repair and/or rebuild the building and the demised premises. Tenant shall in the event of any such damage or destruction, unless this Lease shall be terminated as hereinafter provided, be responsible for replacing or repairing all exterior signs, trade fixtures, equipment, display cases, and other installations originally installed by the Tenant. Tenant shall have no interest in the proceeds of any insurance carried by Landlord.
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Section 10.2. Tenants base rent shall be abated proportionately during any period in which, by reason of any such damage or destruction, the building is rendered partially or totally untenantable. Such abatement shall continue for the period commencing with such destruction or damage and ending with the substantial completion by the Landlord of such work or repair and/or reconstruction as Landlord is obligated to do.
Section 10.3. If the building on the demised premises should be damaged or destroyed to the extent of 33-1/3% or more of the then monetary value thereof by an event described in Section 10.1, then Landlord may terminate this Lease by written notice to Tenant; provided, however, so long as there are at least three (3) years remaining in the demised term (excluding any option term) as of the date of such damage or destruction, Landlord may not terminate the Lease pursuant to this Section 10.3 or Section 10.7 below if Landlord (in its sole and unfettered discretion) intends to repair and/or rebuild the building to substantially the condition in which it existed immediately prior to such damage or destruction (including the same footprint), provided that Landlord actually completes such restoration within one (1) year (the Restoration Date) of the date of damage or destruction. If Landlord elects not to rebuild the existing building or does not complete the restoration of the building to substantially the condition in which it existed immediately prior to such damage or destruction (including the same footprint) by the Restoration Date, then Landlord may terminate the Lease by written notice to Tenant given within thirty (30) days after the Restoration Date.
If during the last four (4) years of the demised term hereof the demised premises should be damaged from any cause (excluding Tenants willful misconduct) and the time needed to repair and/or rebuild the same is reasonably estimated by Landlord to exceed two hundred seventy (270) days from the date Landlord receives permits, then Tenant may terminate this Lease by written notice to Landlord as follows:
Landlord shall notify Tenant within thirty (30) days following any damage to or destruction of the demised premises of the length of time Landlord reasonably estimates to be necessary for repair or restoration of the demised premises. Tenant shall have the right to terminate the Lease within fifteen (15) days following receipt of such notice if restoration or repair of the demised premises is estimated by Landlord to take more than two hundred seventy (270) days from the date Landlord receives permits for such restoration or repair. Tenant shall have the additional right to terminate the Lease if restoration or repair in fact takes longer (subject to Unavoidable Delays or delays caused by Tenant) than two hundred seventy (270) days (or such longer period of time as stated in Landlords original estimate) from the date Landlord received permits for such restoration or repair and Tenant notifies Landlord of its intention to terminate the Lease before the date that restoration and repair is actually completed.
If neither Landlord nor Tenant elects to terminate this Lease then Landlord shall repair and/or rebuild the same as provided in Section 10.1. If such damage or destruction occurs and this Lease is not so terminated, this Lease shall remain in full force and effect and the parties waive the provisions of any law to the contrary. The Landlords obligation under this Section shall in no event exceed the scope of the work existing as of the date of this Lease.
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Section 10.4. Tenant agrees to comply with all of the regulations and rules of the Insurance Service Office or any similar body and will not do, suffer, or permit an act to be done in or about the demised premises which will increase any insurance rate with respect thereto.
Section 10.5. Tenant agrees, in addition to any rent provided for herein, to pay to the Landlord the cost of the fire and extended coverage insurance policy carried by Landlord on the demised premises during the entire demised term or any renewal or extension thereof. Landlord shall carry standard fire and extended coverage policies to the extent of one hundred percent (100%) of the insurable value of the building.
Section 10.6. During the demised term, Tenant shall carry, at its expense, insurance against loss and damage by fire including Special Perils provisions for the full insurable value of Tenants merchandise and personal property, including wall coverings, carpeting and drapes, and the trade fixtures, furnishings and operating equipment in the demised premises, whether supplied by Tenant or existing in the demised premises upon commencement of the Lease. Landlord and Landlords mortgagee shall be named as additional insureds under said policy, which shall be noncancellable with respect to Landlord and Landlords mortgagee without prior written notice. A certificate evidencing such coverage shall be delivered to Landlord prior to commencement of the demised term and thereafter thirty (30) days prior to the expiration of the term of such policy. Such insurance shall be written as a primary policy, not contributing with and not in excess of coverage Landlord may carry. If Tenant shall not comply with its covenants to maintain said insurance, or if Tenant fails to provide a certificate thereof to Landlord, Landlord may, but shall not be required to, obtain any such insurance, and if Landlord does obtain any such insurance, Tenant shall, on demand, reimburse Landlord for the premium for any such insurance.
Section 10.7. In the event the building on the demised premises shall be damaged as a result of any flood, earthquake, act of war, nuclear reaction, nuclear radiation or radioactive contamination, or from any other casualty not covered by Landlords fire and extended coverage insurance, to any extent whatsoever, Landlord may within ninety (90) days following the date of such damage, commence repair, reconstruction or restoration of the building and prosecute the same diligently to completion, in which event this Lease shall continue in full force and effect, or within said ninety (90) day period elect not to so repair, reconstruct or restore the building, in which event this Lease shall cease and terminate. In either such event Landlord shall give Tenant written notice of its intention within said ninety-day period.
Section 10.8. Upon any termination of this Lease under the provisions of this Article 10, the rent shall be adjusted as of the date of such termination and the parties shall be released without further obligation to the other party upon the surrender of possession of the demised premises to Landlord, except for items that have been theretofore accrued and are then unpaid, and except for obligations that are designated as surviving such termination.
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Section 10.9. Notwithstanding anything in this Article 10 or elsewhere in this Lease to the contrary, Landlord may maintain any insurance on the demised premises that Landlord deems necessary or advisable, including, but not limited to, any rental insurance, owners protective liability insurance, pollution insurance, or any insurance required by any mortgagee of Landlord; and Landlord may include the amount of the premiums for such insurance in the total of the insurance premiums which Tenant is required to pay under the terms hereof.
Section 10.10. Notwithstanding anything to the contrary herein, the parties hereto release each other and their respective agents, employees, successors, assignees and subtenants from all liability for damage to any property that is caused by or results from a risk which is actually insured against or which is required to be insured against under this Lease, without regard to the negligence or willful misconduct of the entity so released. All of Landlords and Tenants repair and indemnity obligations under the Lease shall be subject to the waiver contained in this Section.
ARTICLE 11 - Repair
Section 11.1. Landlord agrees, at Landlords sole expense, to repair structural defects of the building on the demised premises throughout the life of the Lease. Structural defects and maintenance shall not be deemed to include cracks or fissures in walls or floors, nor the requirement of painting or caulking.
Section 11.2. Tenant agrees during the demised term or any extension thereof to maintain the interior of the building on the demised premises, and every part thereof, except as to work to be performed by Landlord under Sections 11.1 and 11.3. Tenant further agrees to clean, inside and out, all of the glass on the exterior of the building. If Tenant should fail to faithfully perform its maintenance obligations hereunder then Landlord shall, upon having given notice to Tenant of the need for said maintenance, have the right to perform, or cause to be performed, said maintenance and Tenant shall on demand reimburse Landlord for Landlords costs of providing such maintenance. Landlords reservation of the right to enter upon the demised premises to perform any repairs or maintenance or other work in, to, or about the demised premises which in the first instance is the Tenants obligation pursuant to this Lease shall not be deemed to impose any obligation on Landlord to do so, nor shall Landlord be rendered liable to Tenant or any third party for the failure to do so, and Tenant shall not be relieved from any obligation to indemnify Landlord as otherwise provided elsewhere in this Lease.
Section 11.3. Landlord shall provide the following services and Tenant shall, in addition to all other payments required to be made under other provisions of this Lease, reimburse Landlord, within twenty (20) days after demand therefor, for Landlords gross costs of the following, subject to the provisions of Section 11.5 and Section 18.3 of this Lease: (i) maintaining, repairing and replacing the roof; (ii) painting, maintaining and repairing the exterior of the building; (iii) maintaining, repairing and replacing the elevator
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and elevator equipment room (if any); (iv) maintenance and repair associated with the mechanical and electrical rooms and base utility systems of the building (including utility meters, pipes, conduits, fixtures and equipment within the demised premises); (v) maintenance and repair of the trash enclosure utilized in connection with the building; (vi) maintenance, repair and replacement of the glass on the exterior of the building; and (vii) any other maintenance and repair other than that which Landlord is required to perform at Landlords expense per Section 11.1. After the ninety (90) day notice period described in Section 3.1.B hereof has elapsed, subject to Section 11.5 below, Tenant shall also, on demand, reimburse Landlord for Landlords gross costs of maintaining, repairing and replacing the heating and air conditioning equipment serving the demised premises, whether furnished by Landlord or Tenant. Landlords said gross costs as used in this Section 11.3 shall include all costs and expenses of every kind or nature incurred by Landlord in the performance of such maintenance, repair or replacements and Landlords determination of the amount of said costs and expenses will be final.
Section 11.4. If during the term of this Lease Landlord or Landlords insurance carrier requires the installation of a specialized fire control system, or any fire detection device, because of the nature of the particular activities being carried on by Tenant in the demised premises (other than general office use), then said system or device shall be installed at the sole cost of the Tenant within the time specified.
Section 11.5. Notwithstanding the provisions of Section 11.3 and Section 18.3 hereof to the contrary, Tenants obligation to reimburse Landlord for (i) costs associated with the replacement (as opposed to repairs and maintenance) of the roof membrane and underlayment and the heating, ventilating and air-conditioning units furnished by Landlord and (ii) the cost of any capital improvement [not described in (i)] made by Landlord pursuant to Article 11 and/or Article 18 of this Lease during the demised term and typically amortized under good accounting practice (as used in this Section 11.5, the term capital improvement shall mean the replacement of an existing improvement or the addition of a permanent structural improvement costing in excess of Twelve Thousand Five Hundred Dollars ($12,500.00) for any one (1) individual replacement item), shall be limited to a proportionate share of such replacement or capital improvement costs (the Reimbursement Amounts) calculated as follows:
A. if such costs are incurred during the initial demised term of this Lease, by multiplying such replacement costs by a fraction, the numerator of which is the number of days in the original demised term and the denominator of which is the number of days in the estimated useful life of the replacement as determined in accordance with good accounting practices; and
B. if such costs are incurred during any option term or any holdover or extended term of this Lease, by multiplying such replacement costs by a fraction, the numerator of which is the number of days in the demised term of this Lease (including the extended term) and the denominator of which is the number of days in the estimated useful life of the replacement as determined in accordance with good accounting practices.
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If a Reimbursement Amount has been determined under subsection (a) above with respect to any replacement costs, and Tenant subsequently extends the term of this Lease, Tenant shall also be responsible for another Reimbursement Amount with respect to such replacement costs determined by multiplying such replacement costs by a fraction, the numerator of which is the number of days in the extended term of this Lease and the denominator of which is the number of days in the estimated useful life of the replacement.
The foregoing limitation shall not apply to equipment furnished by Tenant and maintained by Landlord. Tenant shall pay any Reimbursement Amounts, as additional rent, monthly on a straight-line basis amortized over the remaining demised term of the Lease using an interest rate equal to ten percent (10%) per annum.
The limitations on Tenants liability for expenses hereunder shall in no event apply to any costs for replacements occasioned by (x) Tenants negligent acts or omissions or those of its employees, contractors, agents, invitees or servants, or (y) the particular nature of Tenants business, all of which costs shall be borne solely by Tenant.
ARTICLE 12 - Fixtures & Alterations
Section 12.1. All trade fixtures owned by Tenant and installed in the demised premises shall remain the property of Tenant and may be removed from time to time and shall be removed at the expiration of the demised term. Tenant shall repair any damage to the demised premises caused by the removal of said fixtures. If Tenant fails to remove such fixtures on or before the last day of the demised term, all such fixtures shall become the property of Landlord, unless Landlord elects to require their removal, in which case Tenant shall promptly remove them and restore the demised premises to its condition prior to such removal. Landlord may also, at Landlords sole discretion, store such fixtures at Tenants expense.
Section 12.2. Tenant shall not make any alterations, additions or improvements in or to the demised premises or the building without submitting plans and specifications therefor for the prior written consent of Landlord, which consent shall not be unreasonably withheld, provided that the proposed alterations, additions or improvements do not impact the storefront, exterior walls, sprinkler and life support systems, or materially affect the mechanical/electrical system [including any increase in electrical service], or erect or increase the size of an existing mezzanine, or require or result in any penetration into or through the roof or the floor of the demised premises.
Any such alterations, additions or improvements shall comply with all applicable codes and standards, shall be consented to by Landlord, and shall be made at Tenants sole cost and expense in accordance with the plans and specifications therefor. Within ten (10) days following Tenants completion thereof, Tenant shall furnish Landlord with a complete set of the final For Construction plans therefor in AutoCAD format, including all x-refs, fonts and plot files. Tenant shall secure any and all governmental permits, approvals or authorizations required in connection with any such work, and shall hold Landlord harmless from any and all liability, costs, damages, expenses (including attorneys fees) and any and all liens resulting therefrom. All alterations, additions and
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improvements (and expressly including all light fixtures and floor coverings installed by Tenant), except furniture, removable paneling, wall fixtures, trade fixtures, appliances and equipment which do not become a part of the demised premises, shall be deemed to belong to Tenant, but shall be deemed to have been attached to the demised premises or the building and to have become the property of Landlord upon the termination of the demised term. Upon the expiration or sooner termination of the demised term hereof, Tenant shall, at Tenants sole cost and expense, forthwith remove (i) all alterations, decorations, additions or improvements installed by or for Tenant and designated by Landlord for removal at the time of Landlords consent thereto, and (ii) all wiring installed by or for Tenant in the demised premises and/or the building, unless excused from doing so in writing by Landlord, and Tenant shall forthwith at its sole cost and expense repair any damage to the demised premises or the building caused by such removal. In the event Tenant does not so remove all such alterations, decorations, additions, improvements and wiring from the demised premises and/or the building, or repair any damage caused by such removal, then Tenant agrees that Landlord may apply such sums from the Security Deposit, or recover such sums from Tenant by judgment if Tenant did not provide a Security Deposit, or if insufficient funds exist in the Security Deposit, to compensate Landlord for the removal and disposal of any of the same and/or repair of any damage therefrom to the demised premises or the building.
ARTICLE 13 - Remedies
Section 13.1. Should Tenant default in the performance of any of its obligations under this Lease with reference to the payment of rent and such default continue for five (5) days after the date Tenant receives written notice from Landlord that such payment is past-due, or should Tenant default in the performance of any other obligations under this Lease and such default continue for thirty (30) days after receipt of written notice from Landlord specifying such default or beyond the time reasonably necessary to cure if such default is of a nature to require more than thirty (30) days to remedy, then, in addition to all other rights and remedies Landlord may have under this Lease or under applicable law, Landlord shall have the following rights and remedies:
A. The Landlord has the remedy described in California Civil Code Section 1951.4 (Landlord may continue the lease in effect after Tenants breach and abandonment and recover Rent as it becomes due, if Tenant has the right to sublet or assign, subject only to reasonable limitations). If Tenant breaches any covenants of this Lease or if any event of default occurs, whether or not Tenant abandons the demised premises, this Lease shall continue in effect until Landlord terminates Tenants right to possession, and Tenant shall remain liable to perform all of its obligations under this Lease and Landlord may enforce all of Landlords rights and remedies, including the right to recover rent as it falls due. If Tenant abandons the demised premises or fails to maintain and protect the same as herein provided, Landlord shall have the right to do all things necessary or appropriate to maintain, preserve and protect the demised premises, including the installation of guards, and may do all things appropriate to a re-letting of the demised premises, and none of said acts shall be deemed to terminate Tenants right of possession, unless Landlord elects to terminate the same by written notice to Tenant to the extent permitted hereunder. Tenant agrees to reimburse Landlord on demand for all
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amounts reasonably expended by Landlord in maintaining, preserving and protecting the demised premises, together with interest on the amounts expended from time to time at the maximum legal rate. Landlord shall also have the right to repair, remodel and renovate the demised premises at the expense of Tenant and as deemed necessary by Landlord.
B. Landlord shall have the right to terminate this Lease and Tenants possession of the Premises, and if Tenants right to possession of the Premises is terminated by Landlord by reason of a breach of this Lease by Tenant, or by reason of the happening of an event of default, or by reason of abandonment of the Premises by Tenant, Landlord shall be entitled, at Landlords election, to recover damages in an amount as set forth in Section 1951.2 of the Civil Code of California as then in effect, which damages shall include (1) the worth at the time of award of any unpaid rent and additional rent which had been earned at the time of such termination; plus (2) the worth at the time of award of the amount by which the unpaid rent and additional rent which would have been earned after termination until the time of award exceeds the amount of such rental loss Tenant proves could have been reasonably avoided; plus (3) the worth at the time of award of the amount by which the unpaid rent and additional rent for the balance of the term after the time of award exceeds the amount of such rental loss that Tenant proves could be reasonably avoided; plus (4) all other amounts due Landlord from Tenant under the terms of this Lease, or necessary to compensate Landlord for all detriment caused by Tenants failure to perform its obligations under this Lease. The right to possession of the Premises by Tenant should not be deemed terminated until Landlord gives Tenant written notice of such termination or until Landlord re-lets all or a portion of the Premises. Landlord shall be required to mitigate damages by making a good faith effort to re-let the Premises.
As used in subparagraphs (1) and (2) above, the worth at the time of award is computed by allowing interest at the legal rate of ten percent (10%) per annum. As used in subparagraph (3) above, the worth at the time of award is computed by discounting such amount at the discount rate of the Federal Reserve Bank of San Francisco at the time of award plus one percent (1%).
C. No right or remedy herein conferred upon or reserved to Landlord is intended to be exclusive of any other right or remedy herein or by law, provided that each shall be cumulative and in addition to every other right or remedy given herein or now hereafter existing at law or in equity or by statute.
Section 13.2. Landlord shall in no event be in default in the performance of any of its obligations hereunder unless and until Landlord shall have failed to perform such obligations within thirty (30) days or such additional times as is reasonably required to correct any such default after notice by Tenant to the Landlord properly specifying wherein the Landlord has failed to perform any such obligation.
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ARTICLE 14 - Bankruptcy
Section 14.1. Tenant shall give written notice to Landlord of its intention to commence proceedings under any state or federal insolvency or bankruptcy law, or any comparable law that is now or hereafter may be in effect, whereby Tenant seeks to be, or would be, discharged of its debts or the payment of its debts is sought to be delayed, at least thirty (30) days prior to the commencement of such proceedings.
Section 14.2. If any of the following events occur:
A. The entry of an order for relief under Title 11 of the United States Code as to Tenant or its executors, administrators or assigns, if any, or the adjudication of Tenant or its executors, administrators or assigns, if any, as insolvent or bankrupt pursuant to the provisions of any state insolvency or bankruptcy act;
B. The appointment of a receiver, trustee or other custodian of the property of Tenant by reason of the insolvency or inability of Tenant to pay its debts;
C. The assignment of the property of Tenant for the benefit of creditors;
D. The commencement of any proceedings under any state or federal insolvency or bankruptcy law, or any comparable law that is now or hereafter may be in effect, whereby Tenant seeks to be, or would be, discharged of its debts or the payment of its debts is sought to be delayed;
E. The failure of Tenant to give written notice to Landlord provided for in Section 14.1 above;
then Landlord may, at any time thereafter, in addition to any and all other rights or remedies of Landlord under this Lease or under applicable law, upon written notice to Tenant, terminate this Lease, and upon such notice this Lease shall cease and terminate with the same force and effect as though the date set forth in said notice were the date originally set forth herein and fixed for the expiration of the demised term. Tenant shall thereupon vacate and surrender the demised premises, but shall remain liable as herein provided.
ARTICLE 15 - Surrender of Premises
Section 15.1. Tenant shall, upon termination of the demised term, or any earlier termination of this Lease, surrender to Landlord the demised premises, including, without limitation, all building equipment and apparatus, and fixtures (except as provided in Sections 12.1 and 12.2) then upon the demised premises without any damage, injury, or disturbance thereto, or payment therefor, except damages due to ordinary wear and tear, repairs and maintenance that are Landlords responsibility hereunder, acts of God, fire and other perils to the extent the demised premises are not required to be repaired or restored as hereinbefore provided, and Tenant shall dispose of any Hazardous Materials stored, dispensed, handled or used in, at or upon the demised premises due to Tenants use and occupancy of the demised premises in accordance with the provisions of Section 7.4.
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ARTICLE 16 - Eminent Domain
Section 16.1. If more than thirty-three percent (33%) of the floor area of the building on the demised premises shall be taken under the power of eminent domain and the portion not so taken will not be reasonably adequate for the operation of Tenants business after the Landlord completes such repairs or alterations as the Landlord is obligated or elects to make, Tenant shall have the right to elect either to terminate this Lease, or, subject to Landlords right to terminate the Lease pursuant to Section 16.4, to continue in possession of the remainder of the demised premises and shall notify Landlord in writing within ten (10) days after such taking of Tenants election. In the event less than thirty-three percent (33%) of the floor area of the building on the demised premises shall be taken or Tenant elects to remain in possession, as provided in the first sentence hereof, all of the terms herein provided shall continue in effect, except that the base rent shall be reduced in the same proportion that the floor area of the building on the demised premises taken bears to the original floor area of the building on the demised premises, and Landlord shall at its own cost and expense make all necessary repairs or alterations to the building so as to constitute the portion of the building not taken a complete architectural unit and the demised premises a complete unit for the purposes allowed by this Lease, but such work shall not exceed the scope of the work to be done by Landlord in originally constructing said building.
Section 16.2. Each party waives the provisions of Code of Civil Procedure Section 1265.130 allowing either party to petition the Superior Court to terminate this Lease in the event of a partial taking.
Section 16.3. All damages or awards for any taking under the power of eminent domain whether for the whole or a part of the demised premises shall belong to and be the property of Landlord whether such damages or awards shall be awarded as compensation for diminution in value to the leasehold or to the fee of the demised premises; provided however, that Landlord shall not be entitled to the award made to Tenant or Landlord for loss of business, depreciation to, and cost or removal of stock and fixtures and for leasehold improvements which have been installed by Tenant at its sole cost and expense less depreciation which is to be computed on the basis of completely depreciating such leasehold improvements during the initial term of this Lease, and any award made to Tenant in excess of the then depreciated value of leasehold improvements shall be payable to the Landlord.
Section 16.4. If more than thirty-three percent (33%) of the floor areas of the building on the demised premises shall be taken under power of eminent domain, or if any part of the Parking and Accommodation Areas shall be so taken, Landlord may, by written notice to Tenant delivered on or before the date of surrendering possession to the public authority pursuant to such taking, terminate this Lease as of such date.
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Section 16.5. If this Lease is terminated as provided in this Article, the rent shall be paid up to the day that possession is so taken by public authority and Landlord shall make a prorata refund of any rent and all deposits paid by Tenant in advance and not yet earned.
ARTICLE 17 - Real Property Taxes
Section 17.1. Tenant shall reimburse Landlord for all real property taxes, assessments and ongoing sewer fees applicable to the demised premises. Taxes shall be prorated to lease years for purpose of making this computation. Such payment shall be made by Tenant within thirty (30) days after receipt of Landlords written statement setting forth the amount of such computation thereof. If the demised term of this Lease shall not expire concurrently with the expiration date of the fiscal tax year, Tenants liability for taxes for the last partial lease year shall be prorated on an annual basis.
Tenant shall not be required to pay any tax or assessment or any increase therein imposed on land and improvements other than the demised premises, the Parking and Accommodation Areas and any improvements thereon. As to any special assessment that goes to bond or is bonded, Tenant shall be required to reimburse Landlord the portion thereof applicable to the demised premises which is charged on the Real Property Tax bill for any period applicable during the demised term. In addition, Tenant shall not be responsible for any increase in real property taxes due to transfers of the demised premises or ownership interests therein between Landlord and its affiliates, principals, shareholders, partners or investors or entities controlling, controlled by or under common control with Landlord or its affiliates, principals, shareholders, partners or investors.
Section 17.2. If the demised premises are not separately assessed, Tenants liability shall be an equitable proportion of the real property taxes for all of the land and improvements included within the tax parcel assessed, such proportion to be determined by Landlord from the respective valuations assigned in the assessors work sheets or such other information as may be reasonably available. Landlords reasonable determination thereof, in good faith, shall be conclusive.
Section 17.3. Tenant shall pay prior to delinquency all taxes assessed against and levied upon trade fixtures, furnishings, equipment and all other personal property contained in the demised premises or elsewhere. Tenant shall cause said trade fixtures, furnishings, equipment and all other personal property to be assessed and billed separately from the real property of Landlord.
If any of Tenants said personal property shall be assessed with Landlords real property, Tenant shall pay Landlord the taxes attributable to Tenant within ten (10) days after receipt of a written statement setting forth the taxes applicable to Tenants property.
Section 17.4. In addition to all other payments provided for herein, the Tenant shall on demand reimburse Landlord for any surcharges, fees, and any similar charges required to be paid by any instrumentality of local, state or federal government in connection with charged parking in the parking area, including policing; supervising with
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attendants; other costs in connection with providing charged parking; repairs, replacements and maintenance not properly chargeable to capital account under good accounting principles; interest and depreciation of the actual cost of modification or improvements to the areas, facilities and improvements maintained in this Article either (i) required by any instrumentality of local, state or federal government, or (ii) installed by Landlord on account of government requirements to facilitate payment of a parking charge by the general public for parking in the parking area, or both, and other similar costs (subject to the provisions of Section 11.5 with respect to a capital improvement therefor); and there shall be excluded (a) cost of construction of such improvements which is properly chargeable to capital account and (b) depreciation of the original cost of construction of all items not previously mentioned in this sentence. If Landlord shall on account of governmental requirements require the payment of a parking charge by the general public for parking in the parking area, then during any period in which such a charge is made the total revenue (after deducting excise and similar taxes thereon and taxes, fees or surcharges imposed by any agency or instrumentality of local, state or federal government) actually received in cash or its equivalent by Landlord for such parking charge shall be credited against said gross costs.
Section 17.5. Notwithstanding the provisions of Article 17 hereinabove, Tenant shall pay any increase in real property taxes resulting from any and all improvements of any kind whatsoever placed on or in the demised premises for the benefit of or at the request of Tenant regardless of whether said improvements were installed or constructed either by Landlord or Tenant.
Section 17.6. In addition to all other payments provided for herein, the Tenant shall on demand reimburse Landlord for any tax (excluding income tax) and/or business license fee or other levy that may be levied, assessed or imposed upon the rent or other payments provided for herein or on the square footage of the demised premises, on the act of entering into this Lease, or on the occupancy of the Tenant however described, as a direct substitution in whole or in part for, or in addition to, any real property taxes, whether pursuant to laws presently existing or enacted in the future.
ARTICLE 18 - Parking and Accommodation Areas
Section 18.1. Subject to the provisions herein, Landlord grants to Tenant during the demised term the exclusive right to use the parking facilities and other areas provided and designated as Parking and Accommodation Areas on Exhibit B hereto for the accommodation and parking of such automobiles of the Tenant, its officers, agents, employees and its customers while working or visiting Tenant. Landlord shall not be responsible to enforce such exclusive right to use the parking facilities and other areas in the Parking and Accommodation Areas, and the use of any such parking facilities and other areas by persons other than Tenant or its employees, contractors, agents and invitees shall not be deemed a breach by Landlord of any provision of this Lease. In addition, Tenant may use the generators, sheds and other improvements existing on the Parking and Accommodation Areas which were left by previous occupants and acknowledges and agrees to the following: (i) Landlord makes no warranty about the condition of the generators, sheds and other improvements for Tenants use thereof at
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the commencement of and during the demised term hereof, (ii) Tenant shall be solely responsible, at Tenants cost, for the maintenance, repair and replacement of such generators, sheds and other improvements to the extent Tenant desires to continue to use same, and (iii) Tenant hereby releases Landlord from any and all costs, expenses and liabilities incurred in connection with Tenants use thereof and acknowledges that Landlord has no liability with respect to the generators, sheds and other improvements or Tenants use thereof. Tenant agrees that its officers, agents and employees will park their automobiles only in the parking areas provided in the Parking and Accommodation Areas, and Tenant specifically agrees that such officers, agents and employees will not park on any public streets in the vicinity of the demised premises. Except as provided in Section 17.4, Landlord shall not charge parking fees for such right to use parking facilities.
Section 18.2. All parking areas and facilities furnished by Landlord including, but not limited to, pedestrian sidewalks, landscaped areas and parking areas shall at all times be subject to the control and management of Landlord so that Landlord will be in a position to make available efficient and convenient use thereof, and Landlord shall have the right from time to time to establish, modify and enforce reasonable rules and regulations with respect to all facilities and areas mentioned in this Article, and Tenant agrees to abide by and conform therewith. Landlord shall have the right to construct, maintain and operate lighting facilities on all of said areas and improvements, to police the same, from time to time to change the area, location and arrangement of parking areas and facilities, to restrict employee parking to employee parking areas, to construct surface, subterranean and/or elevated parking areas and facilities, to establish and from time to time change the level of parking surfaces, to close (if necessary) all or any portion of said areas or facilities to such extent as may in the opinion of Landlords counsel be legally sufficient to prevent a dedication thereof or the accrual of any rights of any person or of the public therein, and to do and perform such other acts in and to said areas and improvements respectively as in the use of good business judgment the Landlord shall determine to be advisable with a view to the improvement of the convenience and use thereof by Tenant, other lessees, and their respective employees and visitors.
Section 18.3. Tenant agrees during the demised term to pay to Landlord an annual charge which shall be Landlords actual gross costs of operating, maintaining and/or replacing all of the areas and facilities mentioned in this Article. The annual charge shall be an estimate computed on the basis of periods of twelve (12) consecutive calendar months, commencing and ending on such dates as may be designated by Landlord, and shall be paid in monthly installments on the first day of each calendar month in the amount estimated by Landlord. Within ninety (90) days after the end of each such annual period, Landlord will determine (and furnish to Tenant a statement showing in reasonable detail) the actual annual charge for such period and the amounts so estimated and paid during such period shall be adjusted within such ninety (90) days (including adjustments on a prorata basis of any partial such period at either end of the demised term) and one party shall pay to the other on demand whatever amount is necessary to effectuate such adjustment.
Landlords said gross costs shall consist of and include all costs and expenses of every kind or nature incurred by Landlord in the operation, maintenance and/or
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replacement of all of the areas, facilities and improvements mentioned in this Article determined in accordance with good accounting practice by an accountant employed by Landlord. The determination of such accountant shall be conclusive. Without otherwise limiting the generality of the foregoing, there shall be included in such gross costs public liability and property damage insurance, landscape maintenance, maintenance of utilities, water, cleaning of areas, facilities and improvements, operation of lighting, common area taxes and assessments determined in the same manner as taxes and assessments on the demised premises, policing and sweeping of parking areas, supervising with attendants, repairs, replacements and maintenance, and an amount equal to three percent (3%) of the total of all rent (i.e., base rent and additional rent) payable under this Lease for administration of the Parking and Accommodation Areas.
Tenant shall not be required to reimburse Landlord for any expenses or taxes otherwise due under this Lease if Landlord first notifies Tenant of such expenses in a statement received by Tenant more than twenty four (24) months after such expenses or taxes are incurred.
Notwithstanding anything to the contrary in this Lease, Tenant shall have no obligation to perform or to pay directly, or to reimburse Landlord for, the following costs and expenses (collectively, Costs):
A. Costs occasioned by the act, omission or violation of any law affecting the building by Landlord or Landlords agents, employees or contractors, and not covered by insurance carried or required to be carried under this Lease;
B. Costs occasioned by fire, acts of God, or other casualties (excluding deductibles which shall not be restricted, except as set forth below);
C. Costs to correct any construction defect in the demised premises or the building or to comply with any covenant, condition, restriction or law applicable to the demised premises or the building prior to the date of delivery of possession thereof to Tenant (unless required as a result of the Tenant Improvements or alterations or improvements performed by Tenant or the particular nature of Tenants use of the demised premises or building other than general office use), but Costs shall not include items for which Landlord is responsible under Section 3.1.C or the last paragraph of Section 3.2;
D. Reserves for anticipated future expenses to the extent not budgeted to be incurred within the year in which they are collected or the immediately following two (2) years during the demised term (including any option term);
E. Interest, charges and fees incurred on debt or mortgages;
F. Costs incurred in connection with Hazardous Materials which are present in the demised premises or building (except that Costs that are incurred by reason of the storage, use or disposal of Hazardous Materials by Tenant or any of its agents, employees, contractors, licensees, invitees, affiliates, sublessees, successors, assigns or other representatives shall be borne one hundred percent (100%) by Tenant); and
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G. insurance deductibles in excess of $25,000 per occurrence.
Section 18.4. The Parking and Accommodation Areas included for the purpose of this Article are those shown on Exhibit B outside of the building area.
Section 18.5. Tenant shall have the right no more than once annually to inspect the books and records of Landlord with respect to the operating and other costs referred to in Article 11 and this Article 18. Such inspections shall be completed in Landlords offices during normal business hours within one hundred twenty (120) days after delivery of Landlords annual report for said year setting forth such costs and shall be performed by a certified public accountant employed by Tenant, and the cost thereof shall be paid by Tenant. Tenant shall give Landlord no less than thirty (30) days advance written notice of its intent to inspect. Tenants right to inspect is conditioned upon Tenant, and Tenants accountant, executing and delivering to Landlord appropriate confidentiality agreements acceptable to Landlord agreeing to keep the results of any such inspection confidential. Upon completion thereof, Tenant shall deliver a copy of the inspection report and accompanying data to Landlord.
ARTICLE 19 - Miscellaneous
Section 19.1. Landlord and its designee shall have the right during reasonable business hours and upon at least 24 hours prior notice to enter the demised premises except restricted areas as established by or on behalf of the Federal Government for security purposes (and in emergencies at all times with no notice), (i) to inspect the same, (ii) for any purpose connected with Landlords rights or obligations under this Lease and, (iii) for all other lawful purposes. Any entry by Landlord and Landlords agents shall not impair Tenants operations more than reasonably necessary and shall to the extent practicable comply with Tenants reasonable security measures.
Section 19.2. Tenant shall not be entitled to make repairs at Landlords expense, and Tenant waives the provisions of Civil Code Sections 1941 and 1942 with respect to Landlords obligations for tenantability of the demised premises and Tenants right to make repairs and deduct the expenses of such repairs from rent.
Section 19.3. This Lease shall be governed exclusively by the provisions hereof and by the laws of the State of California as the same from time to time exist. This Lease expresses the entire understanding and all agreements of the parties hereto with each other and neither party hereto has made or shall be bound by any agreement or any representation to the other party which is not expressly set forth in this Lease. If any provision of this Lease shall be invalid, unenforceable or ineffective for any reason whatsoever, all other provisions hereof shall be and remain in full force and effect.
Section 19.4. If Tenant should hold over with Landlords consent after the demised term and any extension thereof as herein provided for, then such holding over shall be construed as a tenancy from month to month at a rent equal to 125% of that provided for under the last monthly rental of the principal term of this Lease. In the event of Tenants holdover without Landlords consent (and without prejudice to Landlords
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other remedies for such unlawful holdover), then the rent required to be paid hereunder shall be doubled. In no event shall any provision hereof be deemed Landlords consent permitting Tenant to retain possession of the demised premises after the expiration of the demised term or earlier termination thereof.
Section 19.5. Tenant agrees to maintain all toilet and washroom facilities within the demised premises in a neat, clean and sanitary condition.
Section 19.6. Landlord covenants and agrees that Tenant, subject to the terms and provisions of this Lease, on paying the rent and observing, keeping and performing all of the terms and provisions of this Lease on its part to be observed, kept and performed, shall lawfully, peaceably and quietly have, hold, occupy and enjoy the demised premises during the demised term without hindrance or ejection by any person lawfully claiming under or against the Landlord.
Section 19.7. Subject to Article 6, the terms and provisions hereof shall be construed as running with the land and shall be binding upon and inure to the benefit of heirs, executors, administrators, successors and assigns of Landlord and Tenant.
Section 19.8.
A. Tenant shall promptly pay all sums of money with respect to any labor, services, materials, supplies or equipment furnished or alleged to have been furnished to Tenant in, at or about the demised premises, or furnished to Tenants agents, employees, contractors or subcontractors, that may be secured by any mechanics, materialmens, suppliers or other liens against the demised premises or Landlords interest therein. In the event any such or similar liens shall be filed, Tenant shall, within three (3) days of receipt thereof, give notice to Landlord of such lien, and Tenant shall, within ten (10) days after receiving notice of the filing of the lien, discharge such lien by payment of the amount due to the lien claimant. However, Tenant may in good faith contest such lien provided that within such ten (10) day period Tenant provides Landlord with a surety bond from a company acceptable to Landlord, protecting against said lien in an amount at least one and one-half (1-1/2) times the amount claimed or secured as a lien or such greater amount as may be required by applicable law; and provided further that Tenant, if it should decide to contest such lien, shall agree to indemnify, defend and save harmless Landlord from and against all costs arising from or in connection with any proceeding with respect to such lien. Failure of Tenant to discharge the lien, or, if contested, to provide such bond and indemnification, shall constitute a default under this Lease and in, addition to any other right or remedy of Landlord, Landlord may, but shall not be obligated, to discharge or secure the release of any lien by paying the amount claimed to be due, and the amount so paid by Landlord, and all costs and expenses incurred by Landlord therewith, including, but not limited to, court costs and reasonable attorneys fees, shall be due and payable by Tenant to Landlord forthwith on demand.
B. At least fifteen (15) days before the commencement by Tenant of any material construction or remodeling work on the demised premises, Tenant shall give written notice thereof to Landlord. Landlord shall have the right to post and maintain on the demised premises such Notices of Non-Responsibility, or similar notices, provided for under applicable laws.
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Section 19.9.
A. Tenant shall deposit with Landlord the amount of $250,000.00 in cash or in the form of a Letter of Credit in strict accordance with the provisions of Section 2.4 hereof (as applicable, the Security Deposit). The Security Deposit shall be held by Landlord as security for the faithful performance of all the terms of this Lease to be observed and performed by Tenant. The Security Deposit shall not be mortgaged, assigned, transferred or encumbered by Tenant without the written consent of Landlord and any such act on the part of Tenant shall be without force and effect and shall not be binding upon Landlord.
Provided that (i) this Lease is in full force and effect, (ii) Tenant has completed the Tenant Improvements pursuant to the provisions of this Lease and the plans and specifications therefor as such have been approved by Landlord, and (iii) Tenant is not in default under any of the terms, conditions and covenants of this Lease beyond applicable notice and cure periods at the time of giving Tenants written notices(s) described herein, and subject to the terms and conditions set forth herein, (a) if Landlord is then holding a cash Security Deposit in the amount of $250,000.00, Landlord shall return a portion of the Security Deposit in the amount of One Hundred Thousand Dollars ($100,000.00) within thirty (30) days after Tenants written request to Landlord (herein, the Tenants First Notice), which Tenants First Notice may be given no earlier than the first day of the twenty fifth (25th) full calendar month after the commencement of the demised term of this Lease (and the Security Deposit to be held by Landlord pursuant to the provisions herein shall be the amount of One Hundred Fifty Thousand Dollars ($150,000.00)); and if Landlord is then holding a Letter of Credit in the amount of $250,000.00 as the Security Deposit, then no earlier than the first day of the twenty fifth (25th) full calendar month after the commencement of the demised term of this Lease, Tenant may deliver to Landlord a replacement Letter of Credit in the amount of $150,000.00, at which time (provided the replacement Letter of Credit complies with the provisions of Section 2.4) Landlord shall return the Letter of Credit in the amount of $250,000.00 to Tenant or to the issuing bank; and (b) if Landlord is then holding a cash Security Deposit, Landlord shall return an additional portion of the Security Deposit in the amount of One Hundred Thousand Dollars ($100,000.00) within thirty (30) days after Tenants written request to Landlord (herein, the Tenants Second Notice), which Tenants Second Notice may be given no earlier than the first day of the forty ninth (49th) full calendar month after the commencement of the demised term of this Lease (and upon the return of the amount of $100,000.00 to Tenant after Tenants First Notice and another $100,000.00 after Tenants Second Notice, the Security Deposit to be held by Landlord pursuant to the provisions herein shall be the amount of Fifty Thousand Dollars ($50,000.00)); and if Landlord is then holding a Letter of Credit as the Security Deposit, then no earlier than the first day of the forty ninth (49th) full calendar month after the commencement of the demised term of this Lease, Tenant may deliver to Landlord the amount of $50,000.00 in cash which shall be held by Landlord as a Security Deposit pursuant to the provisions herein, and Landlord shall return the Letter of Credit in Landlords possession to Tenant or to the issuing bank.
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B. If any of the rents herein reserved or any other sum payable by Tenant to Landlord shall be overdue and unpaid beyond applicable notice and cure periods, or should Landlord make payments on behalf of Tenant, or should Tenant fail to perform any of the terms of this Lease within applicable notice and cure periods, then Landlord may, at its option and without prejudice to any other remedy which Landlord may have on account thereof, apply the entire Security Deposit, or so much thereof as may be necessary, to compensate Landlord toward the payment of rent or additional rent, loss, or damage sustained by Landlord due to such breach on the part of Tenant, and Tenant shall forthwith upon demand restore said Security Deposit to the original sum deposited. Any portion of said Security Deposit remaining at the expiration of the demised term shall be returned in full to Tenant at the end of the demised term.
C. In the event of bankruptcy or other similar proceedings listed in Article 14 hereof, the Security Deposit shall be deemed to be applied first to the payment of rent and other charges due Landlord for all periods prior to the filing of such proceedings.
D. In the event Landlord delivers the Security Deposit to the purchaser of Landlords interest in the demised premises, Landlord, after written notice to Tenant of said delivery, shall be discharged from any further liability with respect to the Security Deposit. This provision shall also apply to any subsequent transferees.
Section 19.10. All notices, statements, demands, requests, consents, approvals, authorizations, offers, agreements, appointments or designations hereunder by either party to the other shall be in writing and shall be sufficiently given and served upon the other party if sent by United States certified mail, return receipt requested, postage prepaid, or overnight courier (provided a receipt is given), and addressed as follows:
If sent by mail to Tenant, the same shall be addressed to the Tenant at or at such other place as Tenant may from time to time designate by notice to Landlord.
If sent by mail to Landlord, the same shall be addressed to Landlord at Sixty 31st Avenue, San Mateo, California 94403-3404, or at such other place as Landlord may from time to time designate by notice to Tenant.
Any such notice when sent by certified mail as above provided shall be deemed duly served on the third business day following the date of such mailing. Any such notice when sent by overnight courier as above provided shall be deemed duly served on the first business day following the date of such mailing.
Section 19.11. As used in this Lease and when required by the context, each number (singular or plural) shall include all numbers, and each gender shall include all genders; and unless the context otherwise requires, the word person shall include corporation, firm or association.
Section 19.12. In case of litigation with respect to the mutual rights, obligations, or duties of the parties hereunder, the prevailing party shall be entitled to reimbursement from the other party of all costs and reasonable attorneys fees actually incurred.
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Section 19.13. Each term and each provision of this instrument performable by Tenant shall be construed to be both a covenant and a condition.
Section 19.14. Except as otherwise expressly stated, each payment provided herein to be made by Tenant to Landlord shall be in addition to and not in substitution for the other payments to be made by Tenant to Landlord.
Section 19.15. Time is and shall be of the essence of this Lease and all of the terms, provisions, covenants and conditions hereof.
Section 19.16. The Tenant warrants that it has not had any dealings with any realtor, broker, or agent in connection with the negotiation of this Lease excepting only Newmark Cornish & Carey, whom Landlord agrees to pay whatever commission may be due. Each party agrees to hold the other harmless from any cost, expense or liability for any compensation, commissions or charges claimed by any realtor, broker, or agent with respect to this Lease and/or the negotiation thereof with whom the other party has or purportedly has dealt.
Section 19.17. Tenant agrees that its interest in this Lease shall be subordinate to any mortgage, deed of trust and/or other security indenture hereafter placed upon the demised premises and to any and all advances made or to be made thereunder and to the interest thereon made and all renewals, replacements, and extensions thereof, but nothing herein contained shall be deemed to alter or limit Tenants rights as set forth in Section 19.6. Tenant shall, at the request of Landlord or any mortgagee, trustee or holder of any such security instrument, execute in writing an agreement subordinating its rights under this Lease to the lien of such mortgage, deed of trust and/or other security indenture. If any mortgagee, trustee or holder of such security instrument elects to have the Tenants interest in this Lease superior to any such instrument by notice to Tenant, then this Lease should be deemed superior to the lien of any such mortgage, deed of trust or security indenture whether this Lease was executed before or after said mortgage, deed of trust and/or security indenture.
Section 19.18. Landlord reserves the right during the last six months of the demised term of this Lease or the last six months of any extension hereof to enter the property during normal working hours for the purpose of showing the demised premises (except restricted areas established by, or on behalf of, the Federal Government for security purposes) to prospective tenants or purchasers and to place signs (for the last year) on the demised premises advertising the property for lease or sale.
Section 19.19. The following terms as used in this Lease shall have the following meaning:
A. Unavoidable Delay means any prevention, delay or stoppage due to strike(s), lockout(s), labor dispute(s), act(s) of God, inability to obtain labor or materials or reasonable substitutes therefor, governmental restrictions, governmental regulations, governmental controls, enemy or hostile governmental action, civil commotion, fire or other casualty, and other conditions or causes beyond the reasonable control of the party obligated to perform.
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Section 19.20. Tenant shall at any time during the demised term, within ten (10) days after written notice from Landlord, execute, acknowledge and deliver to Landlord or, at Landlords request, Landlords mortgagee, an estoppel certificate in writing (i) certifying that this Lease is unmodified and in full force and effect (or, if modified, stating the nature of such modification and certifying that this Lease, as so modified, is in full force and effect) and the date to which the rent and other charges are paid in advance, if any, (ii) acknowledging that there are not, to Tenants knowledge, any uncured defaults on the part of Landlord hereunder, or specifying such defaults, if any, are claimed, and (iii) ratifying and certifying any such other matters as may reasonably be requested. Any such certificate may be conclusively relied upon by any prospective purchaser or encumbrancer of the demised premises. Tenants failure to deliver such certificate within such time shall be conclusive upon Tenant that this Lease is in full force and effect, without modification except as may be represented by Landlord; that there are no uncured defaults in Landlords performance, and that not more than one months rent has been paid in advance.
Section 19.21. As an inducement to Tenant to lease the demised premises from Landlord, and subject to the provisions hereof, in consideration of Tenant performing its obligations as set forth in this Lease, Landlord agrees to provide to Tenant the lesser of (i) the amount of Seven Hundred Eighty Thousand Eight Hundred Forty Dollars ($780,840.00) or (ii) an amount equal to the actual costs of the design and construction of the Tenant Improvements referenced in Section 3.2 hereof which are performed by Tenant within the initial twenty four (24) months of the demised term hereof (the lesser amount being the Inducement), payable to Tenant in installments based on costs incurred to date as follows:
A. the first installment and each subsequent installment of the Inducement (up to an amount equal to ninety percent (90%) of that portion of the Inducement applicable to a given phase of the Tenant Improvement work) will be payable within thirty (30) days after all of the following conditions have been met: (i) the Lease has been executed and delivered by the parties and is in full force and effect; (ii) Tenant is not in default beyond applicable notice and cure periods under the terms of the Lease, including without limitation Section 19.8 hereof; (iii) Tenant has accepted delivery of the demised premises and commenced construction of the Tenant Improvements in accordance with the Landlord-approved plans and specifications therefor; (iv) Tenant has expended no less than the amount so requested with respect to the Tenant Improvements in the demised premises performed pursuant to Tenants plans as approved by Landlord and has provided Landlord with paid invoices, cancelled checks, contracts and other appropriate documentation to support and substantiate the cost of the Tenant Improvements and amounts actually expended by Tenant (including applicable AIA documents); (v) Tenant has provided Landlord with lien releases from Tenants general contractor(s), suppliers, materialmen, and all subcontractors who have done work on the demised premises to date, and no liens have been filed; and (vi) Tenant has provided Landlord with a written request therefor. Such requests shall be made not more often than once per calendar month.
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B. the final ten percent (10%) of that portion of the Inducement applicable to a given phase of the Tenant Improvement work will be payable within thirty (30) days after all of the following conditions are satisfied: (i) Tenant has satisfied, and continues to satisfy, the conditions contained in subparagraph (a) above; (ii) Tenant has completed the phase of the Tenant Improvements for which reimbursement has been requested in accordance with the Landlord-approved plans and specifications therefor and has provided Landlord with a copy of the building permit for the Tenant Improvements (if any) properly signed off by the government body having jurisdiction thereof; (iv) Tenant has, within ten days after the Tenant Improvements have been completed, recorded a Notice of Completion in the San Mateo County Recorders Office and has provided Landlord with a copy thereof (and if Tenant does not record a Notice of Completion in the San Mateo County Recorders Office within said ten day period, then the final ten percent (10%) of the Inducement shall not be paid to Tenant prior to a date which is ninety (90) days after the completion of the Tenant Improvements); (v) Tenant has provided Landlord with final unconditional lien releases from Tenants general contractor(s), suppliers, materialmen, and all subcontractors who have done work on the demised premises, and no liens have been filed; (vi) Tenants Architect has provided Landlord with a statement certifying and warranting that the demised premises have been constructed in complete compliance with the mutually approved plans and specifications; (vii) Tenant is in occupancy of the demised premises and conducting its business therein; (viii) Tenant has commenced the payment of base rent to Landlord; (ix) Tenant has advised Landlord in writing of Tenants actual cost of the Tenant Improvements including all necessary back-up documentation to substantiate the actual cost thereof, including copies of paid invoices, cancelled checks, contracts (including applicable AIA documents) and other appropriate documentation to support and substantiate said costs; and (x) Tenant has provided Landlord with a written request therefor. If any of the above conditions has not been met, or if Tenant does not provide Landlord with a written request for the Inducement or any portion thereof, within two (2) years after the date of this Lease, or in the event this Lease terminates prior to the date that the entire Inducement has been paid to Tenant, then Landlord shall have no obligation to pay the Inducement or such unpaid portion thereof.
The Inducement described above shall not exceed Tenants actual costs of the design and construction of the Tenant Improvements incurred in accordance with plans approved by Landlord and may include cabling and construction of building improvements (including flooring and paint) but the Inducement shall not include costs for Tenants fixtures, furniture, signage, equipment, inventory or other personal property (collectively, Tenants Fixtures).
In the event Tenant abandons the demised premises during the demised term of this Lease, or if this Lease terminates early as a result of Tenants default, then Tenant shall immediately repay Landlord the unamortized portion of said Inducement determined from the date of such abandonment or termination until the scheduled expiration of the demised term, without limiting any of Landlords other rights and remedies contained in this Lease.
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In the event Tenant has fulfilled the requirements set forth above and Landlord fails to pay any installment of the foregoing Inducement when due, then Tenant may provide written notice of such failure to Landlord (herein, Tenants notice of failure). In the event Landlord fails to make any such payment within thirty (30) days after Tenants notice of failure, then Tenant may offset the base rent thereafter due by Tenant under the Lease in the amount of the portion of said Inducement which remains unpaid by Landlord to Tenant. Tenants right to offset contained herein shall be Tenants sole and exclusive remedy for Landlords failure to pay any installment of the Inducement as provided herein.
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IN WITNESS WHEREOF, the parties have executed this instrument.
TENANT: | LANDLORD: | |||||||
ADICET BIO, INC., | DAVID D. BOHANNON ORGANIZATION, | |||||||
a Delaware corporation | a California corporation | |||||||
By: | /s/ Aya Jakobovits |
By: | /s/ Scott E. Bohannon | |||||
President | Senior Vice President | |||||||
By: | /s/ Aya Jakobovits |
By: | /s/ Ernest Lotti Jr. | |||||
Secretary | Secretary |
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Exhibit 10.25
FIRST AMENDMENT TO BUSINESS PARK LEASE
THIS FIRST AMENDMENT TO BUSINESS PARK LEASE (Amendment) is entered into as of September , 2019, by and between FACEBOOK, INC., a Delaware corporation (as successor-in-interest to David D. Bohannon Organization, a California corporation), herein called Landlord, and ADICET BIO, INC., a Delaware corporation, herein called Tenant.
RECITALS
A. Landlords predecessor-in-interest and Tenant entered into a written Lease, dated September 30, 2015, hereinafter referred to as the Lease, for the lease of certain premises currently identified as 200 Constitution Drive, and sometimes herein referred to as the Existing Premises, located in the City of Menlo Park, State of California.
B. Tenant wishes to expand the Existing Premises to include the building known as 175-177 Jefferson Drive (the Expansion Premises) in Menlo Park, California, consisting of approximately 7,973 rentable square feet and make certain other amendments to the Lease.
C. By this Amendment, Landlord and Tenant desire to amend the Lease in those particulars as hereinafter set forth.
AGREEMENT:
NOW, THEREFORE, for and in consideration of the Premises and the mutual agreements herein contained, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties agree as follows:
1. Definitions. Unless otherwise defined in this Amendment, all initially-capitalized terms used herein shall have the meanings described in the Lease.
2. Expansion Premises. Effective upon the Expansion Premises Commencement Date (as defined below), the Premises (as that term is used in the Lease) shall be amended to include the Expansion Premises. The Expansion Premises is more fully depicted on Exhibit A. Effective upon the Expansion Premises Commencement Date, the Existing Premises and the Expansion Premises shall be referred to collectively as the Premises. Tenant hereby accepts the Expansion Premises in its as is condition with all faults, and with no representations or warranties by Landlord nor any employee or agent of Landlord with respect to any portion of the Expansion Premises (including the exterior areas of the Building) including, without limitation, any representation or warranty with respect to the suitability or fitness of the Expansion Premises for the conduct of Tenants business. Without limiting the foregoing, Landlord is not required to perform or pay for any improvements in the Expansion Premises or otherwise, and is not offering any form of tenant improvement allowance, free rent, or similar concession. Tenant expressly acknowledges that the Expansion Premises does not include any parking or exterior signage rights. As such, Tenant shall not be required to pay any costs with respect to the parking lot or signage under the Lease (including, without limitation, costs for maintenance or taxes for the parking lot or signage, as applicable, under Sections 17 or 18 of the Lease).
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3. Expansion Premises Term. The term of the Lease with respect to the Expansion Premises shall commence on October 1, 2019 (the Expansion Premises Commencement Date), and shall expire on March 31, 2021 (the Expansion Premises Term). Tenant shall have the option to extend the Expansion Premises Term for a period one (1) year (the Expansion Premises Extension Option), commencing on April 1, 2021 through March 31, 2022 (the Expansion Premises Extension Term). Tenant may exercise its right to extend the Expansion Premises Term by providing written notice to Landlord not earlier than twelve (12) months and no later than six (6) months prior to the end of the current Expansion Premises Term. Notwithstanding the foregoing, with respect to the Expansion Premises only, Landlord shall have the right to terminate the Lease at any time during the Expansion Premises Extension Term, effective on the date specified in Landlords written notice to Tenant, which date shall be at least six (6) months after the date of such notice and shall be no earlier than October 1, 2021. In the event of such termination, the parties shall have no further obligations to each other, except for those which expressly survive termination. Tenant shall have the right to occupy the Expansion Premises commencing one (1) business day after the full execution of this Amendment for the sole purpose of painting, carpeting, constructing improvements, and installing its equipment, data, telecommunications systems and trade fixtures. Such occupancy prior to the Expansion Premises Commencement Date shall be subject to all of the terms of the Lease (including, without limitation, Tenants obligation to provide insurance certificates to Landlord) except the obligation to pay rent.
4. Base Rent. Commencing on the Expansion Premises Commencement Date, the Base Rent payable under the Lease shall be as follows:
Total Base Rent Due
Month |
Existing Premises | Expansion Premises | Total | |||||||||
Expansion Premises Commencement Date |
$ | 47,402.50 | $ | 22,324.40 | $ | 69,726.90 | ||||||
11/1/2019 |
$ | 47,402.50 | $ | 22,324.40 | $ | 69,726.90 | ||||||
12/1/2019 |
$ | 47,402.50 | $ | 22,324.40 | $ | 69,726.90 | ||||||
1/1/2020 |
$ | 47,402.50 | $ | 22,324.40 | $ | 69,726.90 | ||||||
2/1/2020 |
$ | 48,824.57 | $ | 22,324.40 | $ | 71,148.97 | ||||||
3/1/2020 |
$ | 48,824.57 | $ | 22,324.40 | $ | 71,148.97 | ||||||
4/1/2020 |
$ | 48,824.57 | $ | 22,324.40 | $ | 71,148.97 | ||||||
5/1/2020 |
$ | 48,824.57 | $ | 22,324.40 | $ | 71,148.97 | ||||||
6/1/2020 |
$ | 48,824.57 | $ | 22,324.40 | $ | 71,148.97 | ||||||
7/1/2020 |
$ | 48,824.57 | $ | 22,324.40 | $ | 71,148.97 | ||||||
8/1/2020 |
$ | 48,824.57 | $ | 22,324.40 | $ | 71,148.97 | ||||||
9/1/2020 |
$ | 48,824.57 | $ | 22,324.40 | $ | 71,148.97 | ||||||
10/1/2020 |
$ | 48,824.57 | $ | 22,994.13 | $ | 71,818.70 | ||||||
11/1/2020 |
$ | 48,824.57 | $ | 22,994.13 | $ | 71,818.70 | ||||||
12/1/2020 |
$ | 48,824.57 | $ | 22,994.13 | $ | 71,818.70 | ||||||
1/1/2021 |
$ | 48,824.57 | $ | 22,994.13 | $ | 71,818.70 | ||||||
2/1/2021 |
$ | 50,289.31 | $ | 22,994.13 | $ | 73,283.44 | ||||||
3/1/2021 |
$ | 50,289.31 | $ | 22,994.13 | $ | 73,283.44 | ||||||
*4/1/2021 |
$ | 50,289.31 | $ | 22,994.13 | $ | 73,283.44 |
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*5/1/2021 |
$ | 50,289.31 | $ | 22,994.13 | $ | 73,283.44 | ||||||
*6/1/2021 |
$ | 50,289.31 | $ | 22,994.13 | $ | 73,283.44 | ||||||
*7/1/2021 |
$ | 50,289.31 | $ | 22,994.13 | $ | 73,283.44 | ||||||
*8/1/2021 |
$ | 50,289.31 | $ | 22,994.13 | $ | 73,283.44 | ||||||
*9/1/2021 |
$ | 50,289.31 | $ | 22,994.13 | $ | 73,283.44 | ||||||
*10/1/2021 |
$ | 50,289.31 | $ | 23,683.96 | $ | 73,973.27 | ||||||
*11/1/2021 |
$ | 50,289.31 | $ | 23,683.96 | $ | 73,973.27 | ||||||
*12/1/2021 |
$ | 50,289.31 | $ | 23,683.96 | $ | 73,973.27 | ||||||
*1/1/2022 |
$ | 50,289.31 | $ | 23,683.96 | $ | 73,973.27 | ||||||
*2/1/2022 |
$ | 51,797.99 | $ | 23,683.96 | $ | 75,481.95 | ||||||
*3/1/2022 |
$ | 51,797.99 | $ | 23,683.96 | $ | 75,481.95 |
* | if the Expansion Premises Extension Option is exercised and the Lease with respect to the Expansion Premises is not terminated by Landlord pursuant to Section 3 of this Amendment. |
Tenant shall pay the base rent, as set forth above, in accordance with the terms and conditions of the Lease (as amended hereby).
Monetary payments (including base rent) shall be payable by wire transfer to Landlord at the following account:
Account Name: Facebook, Inc., Cushman & Wakefield U.S., Inc. AAF
Account #: *
For Wire Transfers:
Bank Routing and Transit Number: *
SWIFT Code: *
City and State: New York, New York
5. Security Deposit. The parties acknowledge that Landlord is the successor beneficiary of a letter of credit under the Lease in the amount of One Hundred Fifty Thousand Dollars ($150,000.00) (the Original L/C). As partial consideration for Landlords agreement to lease the Expansion Premises to Tenant, Tenant agrees to deliver to Landlord the additional sum of One Hundred Eleven Thousand Six Hundred Twenty Dollars ($111,620.00) (the Additional Security Deposit). The Additional Security Deposit shall be paid in cash, wire transfer or other same day funds upon mutual execution hereof. Tenants failure to deliver the Additional Security Deposit shall constitute a default under the Lease. The Security Deposit (which consists of the Original L/C and the Additional Security Deposit) shall be held by Landlord pursuant to the terms and conditions of Section 19.9 of the Lease, except that with respect to the return of the Additional Security Deposit to Tenant, references in Section 19.9 of the Lease to the expiration of the demised term shall be deemed a reference to the expiration of the Expansion Premises Term.
6. Capital Repairs and Improvements. When calculating costs to be reimbursed by Tenant in Sections 11.5(a) and (b) of the Lease with respect to the Expansion Premises, references therein to initial demised term of this Lease shall mean the Expansion Premises Term (as extended, if extended).
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7. Notice Address. The addresses for notices to Landlord set forth in the Lease are hereby deleted and the following are hereby added in lieu thereof:
Address for notices to Landlord: | ||
1 Hacker Way | ||
Menlo Park, CA 94025 | ||
Attention: Facilities | ||
With a copy to: | ||
1 Hacker Way | ||
Menlo Park, CA 94025 | ||
Attention: Real Estate Counsel |
8. California Civil Code Section 1938. Tenant hereby acknowledges and agrees that, prior to the mutual execution and delivery of this Amendment, Landlord has disclosed to Tenant the following disclosures required by Section 1938 of the California Civil Code: (i) as of the Expansion Premises Commencement Date, Landlord has not had the property being leased hereunder inspected by a Certified Access Specialist (CASp) (as that term is defined in California Civil Code Section 55.52); and (ii) a CASp can inspect the subject premises and determine whether the subject premises comply with all of the applicable construction-related accessibility standards under state law. Although state law does not require a CASp inspection of the subject premises, the commercial property owner or lessor may not prohibit the lessee or tenant from obtaining a CASp inspection of the subject premises for the occupancy or potential occupancy of the lessee or tenant, if requested by the lessee or tenant. The parties shall mutually agree on the arrangements for the time and manner of the CASp inspection, the payment of the fee for the CASp inspection, and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within the premises. Tenant (for itself and all others claiming through Tenant) hereby irrevocably waives and releases all rights and claims it may have under or in connection with Section 1938 of the California Civil Code, as such code section may be amended from time to time, and any successor statutes and similar applicable laws, now or hereafter in effect.
9. Tenant Certifications. Tenant represents and warrants to Landlord that (a) the Lease is in full force and effect; (b) to Tenants knowledge, there exists no breach or default under the Lease on the part of Landlord, nor any state of facts which, with notice, the passage of time, or both, would constitute a breach or default under the Lease on the part of Landlord; (c) Tenant has no option or preferential right to purchase all or any part of the Premises (or the real property of which the Premises are a part); (d) Tenant has no option, right of first offer or right of first refusal to lease or occupy any other space within the property of which the Premises are a part; (e) there has not been filed by Tenant or against Tenant, a petition in bankruptcy, voluntary or otherwise, any assignment for the benefit of creditors, any petition seeking reorganization or arrangement under the bankruptcy laws of the United States, or any state thereof, or any other action brought under said bankruptcy laws with respect to Tenant; (f) all insurance as may be required under the terms of the Lease to be maintained by Tenant is being maintained by Tenant; and (g) to Tenants knowledge, there is no defense, offset, claim or counterclaim by or in favor of Tenant against Landlord under the Lease or against the obligations of the Tenant under the Lease.
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10. Effect of Amendment; Conflicts. Except as expressly provided herein, the Lease shall continue unmodified and in full force and effect and is hereby ratified and reaffirmed by the parties hereto. Tenant represents and warrants that to Tenants knowledge, Landlord is not in default in any respect in the performance of the terms and provisions of the Lease nor is there now any fact or condition which, with notice or lapse of time or both, would constitute such a default. Should any provision of this Amendment conflict with any provisions of the Lease, the provisions containing such inconsistencies shall first be reconciled with one another to the maximum extent possible, and then to the extent of any remaining inconsistency, the provisions of this Amendment shall control.
11. Successors and Assigns. The provisions of this Amendment shall bind and inure to the benefit of the heirs, representatives, successors and assigns of the parties, subject to the applicable provisions of the Lease.
12. No Broker. Each party represents and warrants to the other that no broker or finder has been involved in this transaction, and that there are no claims for brokerage commissions or finders fees in connection with this transaction. If any claims for brokerage commissions or fees are ever made in connection with this transaction, the party whose representation and warrant was inaccurate shall indemnify, defend and hold harmless the other from all claims, suits, judgments, damages, liabilities and expenses arising from any such claim by any broker or finder including, without limitation, the cost of counsel fees.
13. Entire Agreement. This Amendment sets forth the entire understanding of the parties in connection with the subject matter of this Amendment. There are no agreements between Landlord and Tenant relating to the Lease or the Premises other than the Lease and this Amendment. Neither party has relied upon any understanding, representation or warranty not set forth in this Amendment, either oral or written, as an inducement to enter into this Amendment. All Exhibits attached to this Amendment are incorporated herein by this reference as though set forth in full.
14. Counterparts. This Amendment may be executed in two or more faxed, DocuSign or .pdf counterparts, each of which shall be an original, but all of which shall constitute one and the same agreement.
[Remainder of page intentionally left blank;
Signature page to follow.]
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SIGNATURE PAGE TO
FIRST AMENDMENT TO
BUSINESS PARK LEASE
BY AND BETWEEN
FACEBOOK, INC.
&
ADICET BIO, INC.
IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the day and year first above written.
LANDLORD: | ||
FACEBOOK, INC., | ||
a Delaware corporation | ||
By: | /s/ Christopher Hom | |
Name: | Christopher Hom | |
Title: | Director: Real Estate & Facilities | |
TENANT: | ||
ADICET BIO, INC., | ||
a Delaware corporation | ||
By: | /s/ Brian Hogan | |
Name: | Brian Hogan | |
Title: | CFO | |
By: | /s/ Anil Singhal | |
Name: | Anil Singhal | |
Title: | President and CEO |
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Exhibit 10.26
ADICET BIO, INC.
LOAN AND SECURITY AGREEMENT
This LOAN AND SECURITY AGREEMENT (the Agreement) is entered into as of April 28, 2020, by and between PACIFIC WESTERN BANK, a California state chartered bank (Bank) and ADICET BIO, INC., a Delaware corporation (Borrower).
RECITALS
Borrower wishes to obtain credit from time to time from Bank, and Bank desires to extend credit to Borrower. This Agreement sets forth the terms on which Bank will advance credit to Borrower, and Borrower will repay the amounts owing to Bank.
AGREEMENT
The parties agree as follows:
1. DEFINITIONS AND CONSTRUCTION.
1.1 Definitions. As used in this Agreement, all capitalized terms shall have the definitions set forth on Exhibit A. Any term used in the Code and not defined herein shall have the meaning given to the term in the Code.
1.2 Accounting Terms. Any accounting term not specifically defined on Exhibit A shall be construed in accordance with GAAP and all calculations shall be made in accordance with GAAP (except for non-compliance with FAS 123R in monthly reporting). The term financial statements shall include the accompanying notes and schedules.
2. LOAN AND TERMS OF PAYMENT.
2.1 Credit Extensions.
(a) Promise to Pay. Borrower promises to pay to Bank, in lawful money of the United States of America, the aggregate unpaid principal amount of all Credit Extensions made by Bank to Borrower, together with interest on the unpaid principal amount of such Credit Extensions at rates in accordance with the terms hereof.
(b) Term Loan.
(i) Subject to and upon the terms and conditions of this Agreement, Bank agrees to make one (1) or more term loans to Borrower in an aggregate principal amount not to exceed Twelve Million Dollars ($12,000,000) (each a Term Loan and collectively the Term Loans). Borrower may request Term Loans at any time from the date hereof through the Availability End Date. The proceeds of the Term Loans shall be used for general working capital purposes and for capital expenditures.
(ii) Interest shall accrue from the date of each Term Loan at the rate specified in Section 2.2(a), and prior to the Interest Only End Date for the applicable Term Loan shall be payable monthly beginning on the first (1st) day of the month next following such Term Loan, and continuing on the same day of each month thereafter. Any Term Loans that are
1
outstanding on the Interest Only End Date shall be payable in, (i) if Borrower achieves the IND Milestone, twenty-four (24) or (ii) if Borrower does not achieve the IND Milestone, thirty (30), equal monthly installments of principal, plus all accrued interest, beginning on the Amortization Start Date, and continuing on the same day of each month thereafter through the Maturity Date, at which time all amounts due in connection with the Term Loans and any other amounts due under this Agreement shall be immediately due and payable. Term Loans, once repaid, may not be reborrowed. Borrower may prepay any Term Loan without penalty or premium.
(iii) When Borrower desires to obtain a Term Loan, Borrower shall notify Bank (which notice shall be irrevocable) by email to be received no later than 12:30 Pacific time (3:30 p.m. Eastern time) on the day on which the Term Loan is to be made. Such notice shall be given by a Loan Advance/Paydown Request Form in substantially the form of Exhibit C. The notice shall be signed by an Authorized Officer. Bank shall be entitled to rely on any notice given by a person whom Bank reasonably believes to be an Authorized Officer, and Borrower shall indemnify and hold Bank harmless for any damages, loss, costs and expenses suffered by Bank as a result of such reliance.
2.2 Interest Rates, Payments, and Calculations.
(a) Interest Rate. Except as set forth in Section 2.2(b), the Term Loans shall bear interest, on the outstanding daily balance thereof, at a variable annual rate equal to the greater of: (A) 0.25% above the Prime Rate then in effect; or (B) 5.00%;
(b) Late Fee; Default Rate. If any payment is not made within 15 days after the date such payment is due, Borrower shall pay Bank a late fee equal to the lesser of (i) 5% of the amount of such unpaid amount or (ii) the maximum amount permitted to be charged under applicable law. After the occurrence and during the continuance of an Event of Default, all Obligations shall bear interest, upon notice of such increase given by Bank, at a rate equal to five (5) percentage points above the interest rate applicable immediately prior to the occurrence of the Event of Default (such rate, the Default Rate); provided, that, from and after the occurrence of any Event of Default described in Section 8.5, such increase shall be automatic and without the requirement of any notice from Bank. In all such events, and notwithstanding the date on which application of the Default Rate is communicated to Borrower, the Default Rate may be accrued (at the election of Bank) from the initial date of any Event of Default until all existing Events of Default are waived in writing in accordance with the terms of this Agreement;
(c) Payments. Interest on the Term Loans shall be due and payable on the first (1st) calendar day of each month during the term hereof. Borrower authorizes Bank, at Banks option, to charge such interest, all Bank Expenses, all Periodic Payments, and any other amounts due and owing in accordance with the terms of this Agreement against any of Borrowers deposit accounts. Any interest not paid when due shall be compounded by becoming a part of the Obligations, and such interest shall thereafter accrue interest at the rate then applicable hereunder; and
(d) Computation. In the event the Prime Rate is changed from time to time hereafter, the applicable rate of interest hereunder shall be increased or decreased, effective as of the day the Prime Rate is changed, by an amount equal to such change in the Prime Rate. All interest chargeable under the Loan Documents shall be computed on the basis of a 360 day year for the actual number of days elapsed.
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2.3 Crediting Payments. Prior to the occurrence of an Event of Default, Bank shall credit a wire transfer of funds, check or other item of payment to such deposit account or Obligation as Borrower specifies. After the occurrence and during the continuance of an Event of Default, Bank shall have the right, in its sole discretion to immediately apply any wire transfer of funds, check, or other item of payment Bank may receive to conditionally reduce Obligations, but such applications of funds shall not be considered a payment on account unless such payment is of immediately available federal funds or unless and until such check or other item of payment is honored when presented for payment. Notwithstanding anything to the contrary contained herein, any wire transfer or payment received by Bank after 12:30 p.m. Pacific time (3:30 p.m. Eastern time) shall be deemed to have been received by Bank as of the opening of business on the immediately following Business Day. Whenever any payment to Bank under the Loan Documents would otherwise be due (except by reason of acceleration) on a date that is not a Business Day, such payment shall instead be due on the next Business Day, and additional fees or interest, as the case may be, shall accrue and be payable for the period of such extension.
2.4 Fees. Borrower shall pay to Bank the following:
(a) Facility Fee. On or before the Closing Date, a fee equal to Three Thousand Dollars ($3,000), which shall be nonrefundable; and
(b) Bank Expenses. (i) On the Closing Date, all Bank Expenses incurred through the Closing Date in an amount not to exceed the sum of (A) $25,000 plus (B) fifty percent (50%) of Bank Expenses incurred in excess of $25,000, provided that the amount payable under this Section 2.4(b)(i) shall not exceed $35,000 in the aggregate, and, (ii) after the Closing Date, all Bank Expenses, as and when they become due.
2.5 Term. This Agreement shall become effective on the Closing Date and, subject to Section 12.7, shall continue in full force and effect for so long as any Obligations (other than contingent indemnity obligations) remain outstanding or Bank has any obligation to make Credit Extensions under this Agreement. Notwithstanding the foregoing, Bank shall have the right to terminate its obligation to make Credit Extensions under this Agreement immediately and without notice upon the occurrence and during the continuance of an Event of Default in accordance with Article 9.
3. CONDITIONS OF LOANS.
3.1 Conditions Precedent to Closing. The agreement of Bank to enter into this Agreement on the Closing Date is subject to the condition precedent that Bank shall have received, in form and substance satisfactory to Bank, each of the following items and completed each of the following requirements:
(a) this Agreement;
(b) a Corporate Resolution of Borrower with respect to incumbency and resolutions authorizing the execution and delivery of this Agreement;
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(c) a financing statement (Form UCC-1);
(d) current SOS Reports indicating that except for Permitted Liens, there are no other security interests or Liens of record in the Collateral;
(e) current financial statements, including company-prepared statements for Borrowers most recently ended fiscal year; company prepared consolidated balance sheets, income statements, and statements of cash flows for the preceding twelve months and such other updated financial information as Bank may reasonably request;
(f) a current Compliance Certificate in accordance with Section 6.2;
(g) an executed copy of the Regeneron Agreement;
(h) the Warrant;
(i) a copy of the Amended and Restated Investors Rights Agreement among Borrower and certain other parties thereto dated July 25, 2019;
(j) a Borrower Information Certificate;
(k) Borrower shall have opened and funded not less than Fifty Thousand Dollars ($50,000) in deposit accounts held with Bank; and
(l) such other documents or certificates, and completion of such other matters, as Bank may reasonably request.
3.2 Conditions Precedent to all Credit Extensions. The obligation of Bank to make each Credit Extension, and including the initial Credit Extension, is contingent upon the Borrowers compliance with Section 3.1 above, and is further subject to the following conditions:
(a) timely receipt by Bank of the Loan Advance/Paydown Request Form as provided in Section 2.1;
(b) Borrower shall be in compliance with Section 6.6 (provided that, for the avoidance of doubt, nothing herein shall require the Borrower to comply with such obligation prior to the applicable deadline as a condition to the Bank making any Credit Extension);
(c) in Banks sole discretion, there has not been a Material Adverse Effect; and
(d) the representations and warranties contained in Section 5 shall be true and correct in all material respects on and as of the date of such Loan Advance/Paydown Request Form and on the effective date of each Credit Extension as though made at and as of each such date, and no Event of Default shall have occurred and be continuing, or would exist after giving effect to such Credit Extension (provided, however, that those representations and warranties expressly referring to another date shall be true and correct in all material respects as of such date, and provided further that any representation or warranty that contains a materiality
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qualification therein shall be true and correct in all respects). The making of each Credit Extension shall be deemed to be a representation and warranty by Borrower on the date of such Credit Extension as to the accuracy of the facts referred to in this Section 3.2.
3.3 Post-Closing Covenant. Within 30 days from the Closing Date, Borrower shall deliver to Bank in form and substance satisfactory to Bank (a) a landlord waiver in favor of Bank for (i) 200 Constitution Drive, Menlo Park, CA 94025, and (ii) 175 Jefferson Drive, Menlo Park, CA 94025, (b) evidence that the insurance policies required by Section 6.5 hereof are in full force and effect, together with appropriate evidence showing loss payable and additional insured clauses or endorsements in favor of Bank, and (c) a bailee waiver in favor of Bank for 2910 Fortune Circle West Indianapolis, IN 46241 from Brook Life Sciences, Inc.; provided that a landlord waiver in favor of Bank for 1000 Bridge Parkway, Redwood City, CA 94065 shall be delivered within 45 days from the Closing Date.
4. CREATION OF SECURITY INTEREST.
4.1 Grant of Security Interest. Borrower grants and pledges to Bank a continuing security interest in the Collateral to secure prompt repayment of any and all Obligations and to secure prompt performance by Borrower of each of its covenants and duties under the Loan Documents. Except for Permitted Liens or as disclosed in the Schedule, such security interest constitutes a valid, first priority security interest in the presently existing Collateral, and will constitute a valid, first priority security interest in later-acquired Collateral. Borrower also hereby agrees not to sell, transfer, assign, mortgage, pledge, lease, grant a security interest in, or encumber any of its intellectual property. Notwithstanding any termination of this Agreement or of any filings undertaken related to Banks rights under the Code, Banks Lien on the Collateral shall remain in effect for so long as any Obligations are outstanding.
4.2 Perfection of Security Interest. Borrower authorizes Bank to file at any time financing statements, continuation statements, and amendments thereto that (i) either specifically describe the Collateral or describe the Collateral as all assets of Borrower of the kind pledged hereunder, and (ii) contain any other information required by the Code for the sufficiency of filing office acceptance of any financing statement, continuation statement, or amendment, including whether Borrower is an organization, the type of organization and any organizational identification number issued to Borrower, if applicable. Borrower shall have possession of the Collateral, except where expressly otherwise provided in this Agreement or where Bank chooses to perfect its security interest by possession in addition to the filing of a financing statement. Where Collateral is in possession of a third party bailee, Borrower shall take such steps as Bank reasonably requests for Bank to (i) subject to Section 3.3 and Section 7.11, obtain an acknowledgment, in form and substance reasonably satisfactory to Bank, of the bailee that the bailee holds such Collateral for the benefit of Bank, and (ii) obtain control of any Collateral consisting of investment property, deposit accounts, letter-of-credit rights or electronic chattel paper (as such items and the term control are defined in Revised Article 9 of the Code) by causing the securities intermediary or depositary institution or issuing bank to execute a control agreement in form and substance reasonably satisfactory to Bank. Borrower will not create any chattel paper without placing a legend on the chattel paper reasonably acceptable to Bank indicating that Bank has a security interest in the chattel paper. Borrower from time to time may deposit with Bank specific cash collateral to secure specific Obligations; Borrower authorizes
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Bank to hold such specific balances in pledge and to decline to honor any drafts thereon or any request by Borrower or any other Person to pay or otherwise transfer any part of such balances for so long as the specific Obligations are outstanding. Borrower shall take such other actions as Bank reasonably requests to perfect its security interests granted under this Agreement.
4.3 Pledge of Collateral. Borrower hereby pledges, assigns and grants to Bank a security interest in all the Shares, together with all proceeds and substitutions thereof, all cash, stock and other moneys and property paid thereon, all rights to subscribe for securities declared or granted in connection therewith, and all other cash and noncash proceeds of the foregoing, as security for the performance of the Obligations. Borrower will deliver to Bank (i) on the Closing Date, the certificate or certificates for any then-certificated Shares of any Subsidiary (other than Adicet Israel), and (ii) with respect to any Shares uncertificated as of the Closing Date, immediately upon certification, the certificate or certificate for the Shares of any Subsidiary (other than Adicet Israel), in each case accompanied by an instrument of assignment duly executed in blank governing the Shares. Borrower shall cause the books of each entity whose Shares are part of the Collateral and any transfer agent to reflect the pledge of the Shares. Upon the occurrence of an Event of Default hereunder, Bank may effect the transfer of any securities included in the Collateral (including but not limited to the Shares) into the name of Bank and cause new certificates (if any) representing any such securities to be issued in the name of Bank or its transferee. Unless an Event of Default shall have occurred and be continuing, Borrower shall be entitled to exercise any voting rights with respect to the Shares and to give consents, waivers and ratifications in respect thereof, provided that no vote shall be cast or consent, waiver or ratification given or action taken which would be inconsistent with any of the terms of this Agreement or which would constitute or create any violation of any of such terms. All such rights to vote and give consents, waivers and ratifications shall terminate upon the occurrence and continuance of an Event of Default.
5. REPRESENTATIONS AND WARRANTIES.
Borrower represents and warrants as follows:
5.1 Due Organization and Qualification. Borrower and each Subsidiary is an entity duly existing under the laws of the jurisdiction in which it is organized and qualified and licensed to do business in any state in which the conduct of its business or its ownership of property requires that it be so qualified, except in each case where the failure to do so would not reasonably be expected to cause a Material Adverse Effect.
5.2 Due Authorization; No Conflict. The execution, delivery, and performance of the Loan Documents are within Borrowers powers, have been duly authorized, and are not in conflict with nor constitute a breach of any provision contained in Borrowers Certificate of Incorporation or Bylaws, nor will they constitute an event of default under any material agreement by which Borrower is bound. Borrower is not in default under any agreement by which it is bound, except to the extent such default would not reasonably be expected to cause a Material Adverse Effect.
5.3 Collateral. Borrower has rights in or the power to transfer the Collateral, and its title to the Collateral is free and clear of Liens, adverse claims, and restrictions on transfer
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or pledge except for Permitted Liens. All Collateral is located solely in the United States, other than (i) certain patents and know-how held in Israel that have no material value, and (ii) certain immaterial value-added tax receivables. All Inventory is in all material respects of good and merchantable quality, free from all material defects, except for Inventory for which adequate reserves have been made. Except as set forth in the Schedule or as permitted in Section 6.6, none of Borrowers Cash is maintained or invested with a Person other than Bank or Banks Affiliates.
5.4 Intellectual Property. Borrower is the sole owner of the intellectual property created or, to its knowledge, purchased by Borrower, except for (i) non-exclusive licenses granted by Borrower to its customers, suppliers and other business partners, (ii) licenses granted by Borrower to Regeneron or other interests or encumbrances imposed upon such intellectual property pursuant to the Regeneron Agreement and (iii) intellectual property that Borrower jointly owns with Regeneron. The intellectual property created, purchased or licensed by Borrower constitutes all material intellectual property necessary for the conduct of Borrowers business as now conducted and as presently proposed to be conducted. To Borrowers knowledge, (a) each of the copyrights, trademarks and patents created or purchased by Borrower is valid and enforceable, and (b) no part of the intellectual property created or purchased by Borrower has been judged invalid or unenforceable, in whole or in part, and no claim has been made to Borrower that any part of the intellectual property created or purchased by Borrower violates the rights of any third party except to the extent such claim would not reasonably be expected to cause a Material Adverse Effect.
5.5 Name; Location of Chief Executive Office. Except as disclosed in the Schedule, Borrower has not done business under any name other than that specified on the signature page hereof, and its exact legal name is as set forth in the first paragraph of this Agreement. The chief executive office of Borrower is located at the address indicated in Section 10 hereof.
5.6 Litigation. Except as set forth in the Schedule, there are no actions or proceedings pending by or against Borrower or any Subsidiary before any court, or administrative agency, in which a likely adverse decision would reasonably be expected to have a Material Adverse Effect.
5.7 No Material Adverse Change in Financial Statements. The financial statements related to Borrower and any Subsidiary that are delivered by Borrower to Bank fairly present in all material respects Borrowers consolidated (and consolidating, if consolidated and consolidating financial statements are required to be delivered by Borrower to Bank pursuant to Section 6.2) financial condition as of the date thereof and Borrowers consolidated (and consolidating, if applicable) results of operations for the period then ended. There has not been a material adverse change in the consolidated (and consolidating, if applicable) financial condition of Borrower since the date of the most recent of such financial statements submitted to Bank.
5.8 Solvency, Payment of Debts. Borrower and its Subsidiaries are able to pay their debts (including trade debts) as they mature; the fair saleable value of their assets (including goodwill minus disposition costs) exceeds the fair value of their liabilities; and Borrower and its Subsidiaries, on a consolidated basis, are not left with unreasonably small capital after the transactions contemplated by this Agreement.
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5.9 Compliance with Laws and Regulations. Borrower and each Subsidiary have met the minimum funding requirements of ERISA with respect to any employee benefit plans subject to ERISA. No event has occurred resulting from Borrowers failure to comply with ERISA that is reasonably likely to result in Borrowers incurring any liability that could reasonably be expected to have a Material Adverse Effect. Borrower is not an investment company, or a company controlled by an investment company within the meaning of the Investment Company Act of 1940. Borrower is not engaged principally, or as one of its important activities, in the business of extending credit for the purpose of purchasing or carrying margin stock (within the meaning of Regulations T and of the Board of Governors of the Federal Reserve System). Borrower has not violated any statutes, laws, ordinances or rules applicable to it, the violation of which could reasonably be expected to have a Material Adverse Effect. Borrower and each Subsidiary have filed or caused to be filed all income and other material tax returns required to be filed, and have paid, or have made adequate provision for the payment of, all taxes reflected therein except those being contested in good faith with adequate reserves under GAAP or where the failure to file such returns or pay such taxes could not reasonably be expected to have a Material Adverse Effect.
5.10 Subsidiaries. Borrower does not own any stock, partnership interest or other equity securities of any Person, except for its Subsidiaries disclosed to Bank in writing or Permitted Investments.
5.11 Government Consents. Borrower and each Subsidiary have obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all governmental authorities that are necessary for the continued operation of Borrowers business as currently conducted, except where the failure to do so would not reasonably be expected to cause a Material Adverse Effect.
5.12 Inbound Licenses. Except as disclosed on the Schedule or as disclosed in writing to Bank pursuant to Section 6.7, Borrower is not a party to, nor is bound by, any material license or other agreement important for the conduct of Borrowers business that prohibits or otherwise restricts Borrower from granting a security interest in Borrowers interest in such license or agreement or any other property important for the conduct of Borrowers business, other than this Agreement or the other Loan Documents.
5.13 Shares. Borrower has full power and authority to create a first lien on the Shares and no disability or contractual obligations exists that would prohibit Borrower from pledging the Shares pursuant to this Agreement. To Borrowers knowledge, there are no subscriptions, warrants, rights of first refusal or other restrictions on transfer relative to, or options exercisable with respect to the Shares. The Shares have been and remain duly authorized and validly issued, and are fully paid and non-assessable. To Borrowers knowledge, the Shares are not the subject of any present, or threatened in writing, suit, action, arbitration, administrative or other proceeding, and Borrower knows of no reasonable grounds for the institution of any such proceedings.
5.14 Full Disclosure. No representation, warranty or other statement made by Borrower in any certificate or written statement furnished to Bank taken together with all such certificates and written statements furnished to Bank contains any untrue statement of a material
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fact or omits to state a material fact necessary in order to make the statements contained in such certificates or statements not misleading in light of the circumstances in which such statements were made, it being recognized by Bank that the projections and forecasts provided by Borrower in good faith and based upon reasonable assumptions are not to be viewed as facts and that actual results during the period or periods covered by any such projections and forecasts may differ from the projected or forecasted results.
6. AFFIRMATIVE COVENANTS.
Borrower covenants that, until payment in full of all outstanding Obligations, and for so long as Bank may have any commitment to make a Credit Extension hereunder, Borrower shall do all of the following:
6.1 Good Standing and Government Compliance. (a) Borrower shall maintain its and each of its Subsidiaries organizational existence and good standing in its respective state of formation, shall maintain qualification and good standing in each other jurisdiction in which the failure to so qualify would reasonably be expected to have a Material Adverse Effect, and shall furnish to Bank the organizational identification number issued to Borrower by the authorities of the state in which Borrower is organized, if applicable; (b) Borrower shall meet, and shall cause each Subsidiary to meet, the minimum funding requirements of ERISA with respect to any employee benefit plans subject to ERISA; and (c) Borrower shall comply, and shall cause each Subsidiary to comply, with all material statutes, laws, ordinances and government rules and regulations to which it is subject, and shall maintain, and shall cause each of its Subsidiaries to maintain, in force all licenses, approvals and agreements, the failure to comply with which, or the loss of which, would reasonably be expected to have a Material Adverse Effect.
6.2 Financial Statements, Reports, Certificates, Collateral Audits. Borrower shall deliver to Bank:
(a) Each of the following:
(i) promptly upon becoming available, but in any event within thirty (30) days after the end of each calendar month, a company prepared consolidated balance sheet, income statement, and statement of cash flows covering Borrowers operations during such period, in a form reasonably acceptable to Bank and certified by a Responsible Officer, provided that such statement in consolidated and consolidating form shall be provided upon Banks request;
(ii) promptly upon becoming available, but in any event within Two Hundred Seventy (270) days after the end of Borrowers fiscal year, audited consolidated financial statements of Borrower prepared in accordance with GAAP, consistently applied, together with an unqualified opinion (or an opinion qualified only for going concern due to Borrowers projected need for additional funding to continue operations so long as Borrowers investors provide additional equity as needed, or as otherwise consented to by Bank in writing) on such financial statements from an independent certified public accounting firm of nationally recognized standing or otherwise reasonably acceptable to Bank (the Audited Financial Statements); provided that, if Borrowers board of directors (the Board) requires a different level of annual financial statements (e.g., company-prepared) for any applicable fiscal year, Borrower shall deliver to Bank such annual financial statements required by the Board for such fiscal year;
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(iii) an annual budget approved by the Board promptly upon becoming available but no later than February 28 of each year during the term hereof;
(iv) if applicable, copies of all statements, reports and notices sent or made available generally by Borrower to its security holders or to any holders of Subordinated Debt and all reports on Forms 10-K and 10-Q filed with the Securities and Exchange Commission;
(v) promptly upon, but in any event within five (5) Business Days following, receipt by Borrower of notice thereof, a report of any legal actions pending or threatened against Borrower or any Subsidiary that would reasonably be expected to result in damages or costs to Borrower or any Subsidiary of $250,000 or more;
(vi) promptly upon, but in any event within five (5) Business Days following, receipt by Borrower, each management letter prepared by Borrowers independent certified public accounting firm regarding Borrowers management control systems;
(vii) such budgets, sales projections, operating plans, financial exhibits, material FDA correspondence or other financial information as Bank may reasonably request from time to time;
(viii) promptly upon becoming available, but in any event within forty five (45) days of the last day of each fiscal quarter, a report signed by Borrower, in form reasonably acceptable to Bank, describing in reasonable detail any clinical updates that have occurred during such quarter; and
(ix) promptly upon receipt of notice thereof, notice of all returns and recoveries and of all disputes and claims involving inventory having a book value of more than Two Hundred Fifty Thousand Dollars ($250,000).
(b) Within thirty (30) days after the last day of each month, Borrower shall deliver to Bank with the monthly financial statements a Compliance Certificate certified as of the last day of the applicable month and signed by a Responsible Officer in substantially the form of Exhibit D hereto;
(c) promptly upon becoming available, but in any event within thirty (30) days after the end of each calendar month, Borrower shall deliver to Bank copies of all bank account statements for accounts maintained at financial institutions other than Bank;
(d) as soon as possible, but in any event within three (3) Business Days after a Responsible Officer of Borrower becoming aware of the occurrence or existence of an Event of Default hereunder, Borrower shall deliver to Bank a written statement of a Responsible Officer setting forth details of the Event of Default, and the action which Borrower has taken or proposes to take with respect thereto; and
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(e) Bank (through any of its officers, employees, or agents) shall have the right, upon reasonable prior notice, from time to time during Borrowers usual business hours but no more than twice a year (unless an Event of Default has occurred and is continuing), to inspect Borrowers Books and to make copies thereof and to check, test, inspect, audit and appraise the Collateral at Borrowers expense in order to verify Borrowers financial condition or the amount, condition of, or any other matter relating to, the Collateral.
Borrower may deliver to Bank on an electronic basis any certificates, reports or information required pursuant to this Section 6.2, and Bank shall be entitled to rely on the information contained in the electronic files, provided that Bank in good faith believes that the files were delivered by a Responsible Officer. Borrower shall include a submission date on any certificates and reports to be delivered electronically.
6.3 Inventory and Equipment; Returns. Borrower shall keep all Inventory and Equipment in good and merchantable condition, free from all material defects except for Inventory and Equipment (i) sold in the ordinary course of business, and (ii) for which adequate reserves have been made, in all cases in the United States. Returns and allowances, if any, as between Borrower and its account debtors shall be on the same basis and in accordance with the usual customary practices of Borrower, as they exist on the Closing Date.
6.4 Taxes. Borrower shall make, and cause each Subsidiary to make, due and timely payment or deposit of all material federal, state, and local taxes, assessments, or contributions required of it by law, including, but not limited to, those laws concerning income taxes, F.I.C.A., F.U.T.A. and state disability, and will execute and deliver to Bank, on demand and to the extent readily obtainable by Borrower from the applicable taxing authority, proof reasonably satisfactory to Bank indicating that Borrower or a Subsidiary has made such payments or deposits and any appropriate certificates attesting to the payment or deposit thereof; provided that (i) Borrower shall exercise and cause each Subsidiary to exercise best efforts to obtain the foregoing proof and (ii) Borrower or a Subsidiary need not make any payment if the amount or validity of such payment is contested in good faith by appropriate proceedings and is reserved against (to the extent required by GAAP) by Borrower or such Subsidiary.
6.5 Insurance. Borrower, at its expense, shall (i) keep the Collateral insured against loss or damage, and (ii) maintain liability and other insurance, in each case as ordinarily insured against by other owners in businesses similar to Borrowers. All such policies of insurance shall be in such form, with such companies, and in such amounts reasonably satisfactory to Bank. All policies of property insurance shall contain a lenders loss payable endorsement, in a form satisfactory to Bank, showing Bank as lenders loss payee. All liability insurance policies shall show, or have endorsements showing, Bank as an additional insured. Any such insurance policies shall specify that the insurer must give at least twenty (20) days notice to Bank before canceling its policy for any reason. Within thirty (30) days of the Closing Date, Borrower shall cause to be furnished to Bank a copy of its policies including any endorsements covering Bank or showing Bank as an additional insured. Upon Banks request, Borrower shall deliver to Bank certified copies of the policies of insurance and evidence reasonably satisfactory to Bank of all premium
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payments. Proceeds payable under any casualty policy will, at Borrowers option, be payable to Borrower to replace the property subject to the claim, provided that any such replacement property shall be deemed Collateral in which Bank has been granted a first priority security interest, provided that if an Event of Default has occurred and is continuing, all proceeds payable under any such policy shall, at Banks option, be payable to Bank to be applied on account of the Obligations.
6.6 Primary Depository. Subject to the provisions of Section 3.1(k), within sixty (60) days of the Closing Date, Borrower shall maintain, and shall cause each of its Subsidiaries to maintain, all of its Cash in depository and operating accounts with Bank and all of its investment accounts to be managed by Bank or Banks Affiliates (but which investment accounts may, for the avoidance of doubt, be held by a third-party custodian, including, without limitation, U.S. Bank) (an Investment Account); provided that (i) prior to Borrower maintaining any Investment Accounts with Banks Affiliates, Borrower, Bank, and any such affiliate shall have entered into a securities account control agreement with respect to any such Investments Accounts, in form and substance reasonably satisfactory to Bank and (ii) upon the maturity of any investments maintained in any Investment Account, such investments shall be liquidated and all cash proceeds resulting therefrom shall be transferred to one of Borrowers deposit accounts at Bank within fourteen (14) Business Days after such maturity. For the avoidance of doubt, Borrower shall not be permitted to reinvest such cash proceeds into new investment assets. Notwithstanding the foregoing, (a) Borrower shall be permitted to maintain an aggregate amount not to exceed Twenty Thousand Dollars ($20,000) in one or more accounts outside of Bank, and (b) Adicet Israel shall be permitted to maintain an aggregate amount not to exceed Two Hundred Fifty Thousand Dollars ($250,000) in one or more foreign accounts outside of Bank.
6.7 Consent of Inbound Licensors. Promptly following entering into or becoming bound by any material inbound license or agreement, Borrower shall: (i) provide written notice to Bank of the material terms of such license or agreement with a description of its likely impact on Borrowers business or financial condition, subject to any confidentiality obligations to which Borrower is contractually bound; and (ii) in good faith use commercially reasonable efforts to obtain the consent of, or waiver by, any person whose consent or waiver is necessary for Borrowers interest in such licenses or contract rights to be deemed Collateral and for Bank to have a security interest in it that might otherwise be restricted by the terms of the applicable license or agreement, whether now existing or entered into in the future, provided, however, that the failure to obtain any such consent or waiver shall not constitute a default under this Agreement.
6.8 Creation/Acquisition of Subsidiaries. In the event Borrower or any Subsidiary of Borrower creates or acquires any Subsidiary, Borrower or such Subsidiary shall within ten (10) days thereafter notify Bank of such creation or acquisition, and Borrower or such Subsidiary shall take all actions reasonably requested by Bank to achieve any of the following with respect to such New Subsidiary (defined as a Subsidiary formed after the date hereof during the term of this Agreement): (i) to cause such New Subsidiary to become either (A) a co-borrower hereunder, if such New Subsidiary is organized under the laws of the United States, or (B) a secured guarantor with respect to the Obligations, if such New Subsidiary is not organized under the laws of the United States; and (ii) to grant and pledge to Bank a perfected security interest in 100% of the stock, units or other evidence of ownership held by Borrower or its Subsidiaries of any such New Subsidiary.
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6.9 Existing Letters of Credit. Borrower shall be permitted to maintain Borrowers existing cash collateral accounts at Silicon Valley Bank (the SVB Collateral Accounts) securing that certain letter of credit for $4,131,720 in favor of Westport Office Park LLC (the Westport Letter of Credit) and that certain letter of credit for $150,000 in favor of Facebook (the Facebook Letter of Credit, together with the Westport Letter of Credit, the SVB Letters of Credit), provided further that (x) the aggregate balance of the SVB Collateral Accounts shall not exceed $4,281,720 at any time and (y) with respect to each SVB Letter of Credit, upon the earlier of (x) the maturity date of such SVB Letter of Credit as of the Closing Date which is November 8, 2020 with respect to the Westport Letter of Credit and November 2, 2020 with respect to the Facebook Letter of Credit) and (z) such earlier maturity or termination of such SVB Letter of Credit, the entire balance held in the applicable SVB Collateral Account shall immediately be transferred to one of Borrowers accounts at Bank. For the avoidance of doubt, the Westport Letter of Credit and Facebook Letter of Credit shall not be renewed or extended so long as Bank shall have provided similar replacement letters of credit in favor of the applicable beneficiaries in such amounts and on terms substantially similar to the terms of the Westport Letter of Credit and Facebook Letter of Credit, as applicable, resulting in replacement letters of credit that are reasonably acceptable to the applicable beneficiaries.
6.10 Further Assurances. At any time and from time to time Borrower shall execute and deliver such further instruments and take such further action as may reasonably be requested by Bank to effect the purposes of this Agreement.
7. NEGATIVE COVENANTS.
Borrower covenants and agrees that, so long as any credit hereunder shall be available and until the outstanding Obligations are paid in full or for so long as Bank may have any commitment to make any Credit Extensions, Borrower will not do any of the following without Banks prior written consent, which shall not be unreasonably withheld:
7.1 Dispositions. Convey, sell, lease, license, transfer, or otherwise dispose of (collectively, to Transfer), or permit any of its Subsidiaries to Transfer, all or any part of its business or property, or move cash balances on deposit with Bank to accounts opened at another financial institution, other than Permitted Transfers.
7.2 Change in Name, Location, Executive Office, or Executive Management; Change in Business; Change in Fiscal Year; Change in Control; Divide. Change its name or the state of Borrowers formation or relocate its chief executive office without ten (10) days prior written notification to Bank; replace or suffer the departure of its chief executive officer or, following the appointment of a permanent chief financial officer, its chief financial officer, without delivering written notification to Bank within ten (10) days thereof; fail to appoint an interim replacement or fill a vacancy in the position of chief executive officer or chief financial officer for more than thirty (30) consecutive days; suffer a change on its board of directors which results in the failure of at least one partner or managing director of Orbimed or its Affiliates to serve as a voting member, in such case without written notice to Bank prior to or within three (3) Business Days after such occurrence; take action to liquidate, wind up, or otherwise cease to conduct business in the ordinary course; engage in any business, or permit any of its Subsidiaries to engage in any business, other than or reasonably related or incidental to the businesses currently engaged in by Borrower and its Subsidiaries, taken as a whole; change its fiscal year end; convert to another form of incorporated or unincorporated business or entity; have a Change in Control; Divide.
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7.3 Mergers or Acquisitions. Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with or into any other business organization (other than mergers or consolidations of a Subsidiary into another Subsidiary or into Borrower), or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person, or a division, line of business, or business unit of another Person, in each case except where (a) each of the following conditions is applicable: (i) the consideration paid in connection with such transactions (including assumption of liabilities) does not in the aggregate exceed Five Hundred Thousand Dollars ($500,000) during any fiscal year, (ii) no Event of Default has occurred, is continuing or would exist after giving effect to such transactions, (iii) such transactions do not result in a Change in Control, (iv) Borrower shall have provided 5 Business Days notice to Bank prior to consummation of any such transactions having consideration in excess of Two Hundred Fifty Thousand Dollars ($250,000), and (v) Borrower is the surviving entity; or (b) the Obligations are repaid in full and this Agreement is terminated concurrently with the closing of any merger or consolidation of Borrower in which Borrower is not the surviving entity. Borrower shall not, without Banks prior written consent, enter into any binding contractual arrangement with any investment banker, business broker, or similar Person to attempt to facilitate a merger or acquisition of Borrower or Borrowers assets (any such agreement, an Investment Banker Agreement); unless (i) no Event of Default exists when such Investment Banker Agreement is entered into by Borrower, and (ii) such Investment Banker Agreement does not give the counterparty the right, in connection with a sale of Borrowers stock or assets pursuant to or resulting from an assignment for the benefit of creditors, an asset turnover to Borrowers creditors (including, without limitation, Bank), foreclosure, bankruptcy or similar liquidation, to claim any fee, payment or damages from any parties, other than from Borrower or Borrowers investors. Notwithstanding the foregoing, this Section 7.3 shall not apply to Permitted Transactions.
7.4 Indebtedness. (a) Create, incur, assume, guarantee or be or remain liable with respect to any Indebtedness, or permit any Subsidiary so to do, other than Permitted Indebtedness, (b) prepay any Indebtedness or take any actions which impose on Borrower an obligation to prepay any Indebtedness, except Indebtedness to Bank.
7.5 Encumbrances. Create, incur, assume or allow any Lien with respect to its property, or assign or otherwise convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries so to do, except for Permitted Liens, or covenant to any other Person (other than (i) the licensors of in-licensed property with respect to such property or (ii) the lessors of specific equipment or lenders financing specific equipment with respect to such leased or financed equipment) that Borrower in the future will refrain from creating, incurring, assuming or allowing any Lien with respect to any of Borrowers property.
7.6 Distributions. Pay any dividends or make any other distribution or payment on account of or in redemption, retirement or purchase of any capital stock, except that Borrower may (i) repurchase the stock of former employees, directors or consultants pursuant to stock repurchase agreements in an aggregate amount not to exceed Two Hundred Fifty Thousand Dollars ($250,000) in any fiscal year, as long as an Event of Default does not exist prior to such
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repurchase or would not exist after giving effect to such repurchase; (ii) repurchase the stock of former employees, directors or consultants pursuant to stock repurchase agreements where the consideration for repurchase is the cancellation of indebtedness owed by such former employees, directors or consultants to Borrower regardless of whether an Event of Default exists; (iii) cause or permit its Subsidiaries to make dividends and distributions to Borrower (including, without limitation, distributions to Borrower in connection with any liquidation, wind up, or equivalent procedure within the respective Subsidiarys relevant jurisdiction, initiated in respect of any Subsidiary); (iv) convert Subordinated Debt into equity securities of Borrower to the extent permitted under the terms of the applicable subordination or intercreditor agreement with Bank; and (v) distribute capital stock to current or former employees, officers or consultants or directors upon the exercise of warrants, options or other similar instruments so long as such distribution does not result in a Change of Control.
7.7 Investments. Directly or indirectly acquire or own an Investment in, or make any Investment in or to any Person, or permit any of its Subsidiaries so to do, other than Permitted Investments, or maintain or invest any of its investment property with a Person other than Bank or permit any Subsidiary to do so unless such Person has entered into a control agreement with Bank, in form and substance reasonably satisfactory to Bank, or suffer or permit any Subsidiary to be a party to, or be bound by, an agreement that restricts such Subsidiary from paying dividends or otherwise distributing property to Borrower; provided however, for the avoidance of doubt, that payments to third party service providers in the ordinary course of business shall not constitute Investments hereunder.
7.8 Capitalized Expenditures. Make Capitalized Expenditures in excess of Twenty Five Million Dollars ($25,000,000) in the aggregate for fiscal years 2020 and 2021, or in excess of One Million Five Hundred Thousand Dollars ($1,500,000) in the aggregate in any fiscal year thereafter.
7.9 Transactions with Affiliates. Directly or indirectly enter into or permit to exist any material transaction by Borrower with any Affiliate of Borrower except for (i) transactions that are in the ordinary course of Borrowers business, upon fair and reasonable terms that are not materially less favorable to Borrower than would be obtained in an arms length transaction with a non-affiliated Person; (ii) compensation arrangements (including bonus or incentive arrangements), equity awards and benefit plans for officers, directors, consultants and other employees of the Borrower and its Subsidiaries (or similar managing or governing persons) approved by Borrowers board of directors or a committee thereof; (iii) the sale or issuance of Borrowers equity securities in bona fide transactions with Borrowers existing investors that do not result in a Change in Control, or any agreements now existing or subsequently entered into in connection with the foregoing, and any amendments, modifications or restatements thereof; (iv) Permitted Transactions; or (v) transactions with Affiliates otherwise permitted under this Agreement.
7.10 Subordinated Debt. (a) Make any payment in respect of any Subordinated Debt, or permit any of its Subsidiaries to make any such payment, except in compliance with the terms of such Subordinated Debt, or (b) amend any provision affecting Banks rights contained in any documentation relating to the Subordinated Debt without Banks prior written consent.
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7.11 Inventory and Equipment. Subject to Section 3.3 above, (a) store Inventory or Equipment of a book value in excess of Five Hundred Thousand Dollars ($500,000) with a bailee, warehouseman, collocation facility or similar third party unless such third party has been notified of Banks security interest and Bank has received a bailee waiver in favor of Bank, in form and substance reasonably satisfactory to Bank, duly executed by Borrower and such third party; or (b) with respect to any leased or licensed real property, store Collateral of a book value in excess of Five Hundred Thousand Dollars ($500,000) unless the landlord has been notified of Banks security interest and Bank has received a landlord waiver, in form and substance reasonably satisfactory to Bank, duly executed by Borrower and such landlord.
7.12 No Investment Company; Margin Regulation. Become or be controlled by an investment company, within the meaning of the Investment Company Act of 1940, or become principally engaged in, or undertake as one of its important activities, the business of extending credit for the purpose of purchasing or carrying margin stock, or use the proceeds of any Credit Extension for such purpose.
7.13 Subsidiary Assets. Permit Subsidiaries, individually or collectively, to own, hold, acquire or receive any property or assets, measured in accordance with GAAP, with an aggregate book value of greater than Two Hundred Fifty Thousand Dollars ($250,000), provided that Adicet Israel may maintain an additional Five Hundred Thousand Dollars ($500,000) solely to satisfy tax liabilities in connection with its dissolution so long as prior notice of such dissolution shall be delivered to Bank.
8. EVENTS OF DEFAULT.
Any one or more of the following events shall constitute an Event of Default by Borrower under this Agreement:
8.1 Payment Default. If Borrower fails to pay any of the Obligations when due;
8.2 Covenant Default.
(a) If Borrower (i) fails to perform any obligation under Sections 6.2 (financial reporting), 6.4 (taxes), 6.5 (insurance), or 6.6 (primary accounts) or (ii) violates any of the covenants contained in Article 7 of this Agreement; or
(b) If Borrower fails or neglects to perform or observe any other material term, provision, condition, covenant contained in this Agreement, in any of the Loan Documents, or in any other present or future agreement between Borrower and Bank and as to any default under such other term, provision, condition or covenant that can be cured, has failed to cure such default within ten (10) days after Borrower receives notice thereof or any officer of Borrower becomes aware thereof; provided, however, that if the default cannot by its nature be cured within the ten (10) day period or cannot after diligent attempts by Borrower be cured within such ten (10) day period, and such default is likely to be cured within a reasonable time, then Borrower shall have an additional reasonable period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable time period the failure to have cured such default shall not be deemed an Event of Default but no Credit Extensions will be made;
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8.3 Material Adverse Change. If there occurs any circumstance or any circumstances which would reasonably be expected to have a Material Adverse Effect;
8.4 Attachment. If any material portion of Borrowers assets is attached, seized, subjected to a writ or distress warrant, or is levied upon, or comes into the possession of any trustee, receiver or person acting in a similar capacity and such attachment, seizure, writ or distress warrant or levy has not been removed, discharged or rescinded within 10 days, or if Borrower is enjoined, restrained, or in any way prevented by court order from continuing to conduct all or any material part of its business affairs, or if a judgment or other claim becomes a lien or encumbrance upon any material portion of Borrowers assets, or if a notice of lien, levy, or assessment is filed of record with respect to any material portion of Borrowers assets by the United States Government, or any department, agency, or instrumentality thereof, or by any state, county, municipal, or governmental agency, and the same is not paid within ten days after Borrower receives notice thereof, provided that none of the foregoing shall constitute an Event of Default where such action or event is stayed or an adequate bond has been posted pending a good faith contest by Borrower (provided that no Credit Extensions will be made during such cure period);
8.5 Insolvency. If Borrower becomes insolvent, or if an Insolvency Proceeding is commenced by Borrower, or if an Insolvency Proceeding is commenced against Borrower and is not dismissed or stayed within forty-five (45) days (provided that no Credit Extensions will be made prior to the dismissal of such Insolvency Proceeding);
8.6 Other Agreements. If (a) there is a default or other failure to perform in any agreement to which Borrower is a party with a third party or parties (i) resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount in excess of Two Hundred Fifty Thousand Dollars ($250,000), (ii) in connection with any lease of real property, or (iii) that would reasonably be expected to have a Material Adverse Effect, or (b) any default or event of default (however designated) shall occur with respect to any Subordinated Debt which is not cured within any applicable cure period;
8.7 Judgments. If a final, uninsured judgment or judgments for the payment of money in an amount, individually or in the aggregate, of at least Two Hundred Fifty Thousand Dollars ($250,000) shall be rendered against Borrower and shall remain unsatisfied and unstayed for a period of 10 days (provided that no Credit Extensions will be made prior to the satisfaction or stay of the judgment); or
8.8 Misrepresentations. If any material misrepresentation or material misstatement exists now or hereafter in any warranty or representation set forth herein or in any certificate delivered to Bank by any Responsible Officer pursuant to this Agreement or to induce Bank to enter into this Agreement or any other Loan Document.
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9. BANKS RIGHTS AND REMEDIES.
9.1 Rights and Remedies. Upon the occurrence and during the continuance of an Event of Default, Bank may, at its election, without notice of its election and without demand, do any one or more of the following, all of which are authorized by Borrower:
(a) Declare all Obligations, whether evidenced by this Agreement, by any of the other Loan Documents, or otherwise, immediately due and payable (provided that upon the occurrence of an Event of Default described in Section 8.5 (insolvency), all Obligations shall become immediately due and payable without any action by Bank);
(b) Demand that Borrower (i) deposit cash with Bank in an amount equal to the amount of any Letters of Credit remaining undrawn, as collateral security for the repayment of any future drawings under such Letters of Credit, and (ii) pay in advance all Letter of Credit fees scheduled to be paid or payable over the remaining term of the Letters of Credit, and Borrower shall promptly deposit and pay such amounts;
(c) Cease advancing money or extending credit to or for the benefit of Borrower under this Agreement or under any other agreement between Borrower and Bank;
(d) Settle or adjust disputes and claims directly with account debtors for amounts, upon terms and in whatever order that Bank reasonably considers advisable;
(e) Make such payments and do such acts as Bank considers necessary or reasonable to protect its security interest in the Collateral. Borrower agrees to assemble the Collateral if Bank so requires, and to make the Collateral available to Bank as Bank may designate. Borrower authorizes Bank to enter the premises where the Collateral is located, to take and maintain possession of the Collateral, or any part of it, and to pay, purchase, contest, or compromise any encumbrance, charge, or lien which in Banks determination appears to be prior or superior to its security interest and to pay all expenses incurred in connection therewith. With respect to any of Borrowers owned premises, Borrower hereby grants Bank a license to enter into possession of such premises and to occupy the same, without charge, in order to exercise any of Banks rights or remedies provided herein, at law, in equity, or otherwise;
(f) place a hold on any account maintained with Bank, decline to honor presentments (including but not limited to checks, wires, and ACH drafts) against any account at Bank, and/or deliver a notice of exclusive control, any entitlement order, or other directions or instructions pursuant to any control agreement or similar agreements providing control of any Collateral;
(g) Set off and apply to the Obligations any and all (i) balances and deposits of Borrower held by Bank, and (ii) indebtedness at any time owing to or for the credit or the account of Borrower held by Bank;
(h) Ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell (in the manner provided for herein) the Collateral. Bank is hereby granted a license or other right, solely pursuant to the provisions of this Section 9.1, to use, without charge, Borrowers labels, patents, copyrights, rights of use of any name, trade secrets, trade names, trademarks, service marks, and advertising matter, or any property of a similar nature, as it pertains to the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with Banks exercise of its rights under this Section 9.1, Borrowers rights under all licenses and all franchise agreements shall inure to Banks benefit;
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(i) Sell the Collateral at either a public or private sale, or both, by way of one or more contracts or transactions, for cash or on terms, in such manner and at such places (including Borrowers premises) as Bank determines is commercially reasonable, and apply any proceeds to the Obligations in whatever manner or order Bank deems appropriate. Bank may sell the Collateral without giving any warranties as to the Collateral. Bank may specifically disclaim any warranties of title or the like, which procedure will not be considered as adversely affecting the commercial reasonableness of any sale of the Collateral. If Bank sells any of the Collateral upon credit, Borrower will be credited only with payments actually made by the purchaser, received by Bank, and applied to the indebtedness of the purchaser. If the purchaser fails to pay for the Collateral, Bank may resell the Collateral and Borrower shall be credited with the proceeds of the sale;
(j) Bank may credit bid and purchase at any public sale;
(k) Apply for the appointment of a receiver, trustee, liquidator or conservator of the Collateral, without notice and without regard to the adequacy of the security for the Obligations and without regard to the solvency of Borrower, any guarantor or any other Person liable for any of the Obligations; and
(l) Any deficiency that exists after disposition of the Collateral as provided above will be paid immediately by Borrower.
Bank may comply with any applicable state or federal law requirements in connection with a disposition of the Collateral and compliance will not be considered as adversely affecting the commercial reasonableness of any sale of the Collateral.
9.2 Power of Attorney. Effective only upon the occurrence and during the continuance of an Event of Default, Borrower hereby irrevocably appoints Bank (and any of Banks designated officers, or employees) as Borrowers true and lawful attorney to: (a) send requests for verification of Accounts or notify account debtors of Banks security interest in the Accounts; (b) endorse Borrowers name on any checks or other forms of payment or security that may come into Banks possession; (c) sign Borrowers name on any invoice or bill of lading relating to any Account, drafts against account debtors, schedules and assignments of Accounts, verifications of Accounts, and notices to account debtors; (d) dispose of any Collateral; (e) make, settle, and adjust all claims under and decisions with respect to Borrowers policies of insurance; (f) settle and adjust disputes and claims respecting the accounts directly with account debtors, for amounts and upon terms which Bank determines to be reasonable; and (g) file, in its sole discretion, one or more financing or continuation statements and amendments thereto, relative to any of the Collateral; provided Bank may exercise such power of attorney to sign the name of Borrower on any of the documents described in clause (g) above, regardless of whether an Event of Default has occurred. The appointment of Bank as Borrowers attorney in fact, and each and every one of Banks rights and powers, being coupled with an interest, is irrevocable until all of the Obligations have been fully repaid and performed and Banks obligation to provide advances hereunder is terminated.
9.3 Accounts Collection. At any time after the occurrence and during the continuation of an Event of Default, Bank may notify any Person owing funds to Borrower of
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Banks security interest in such funds and verify the amount of such Account. Borrower shall collect all amounts owing to Borrower for Bank, receive in trust all payments as Banks trustee, and immediately deliver such payments to Bank in their original form as received from the account debtor, with proper endorsements for deposit.
9.4 Bank Expenses. If Borrower fails to pay any amounts or furnish any required proof of payment due to third persons or entities, as required under the terms of this Agreement, then Bank may do any or all of the following after reasonable notice to Borrower: (a) make payment of the same or any part thereof; and/or (b) obtain and maintain insurance policies of the type discussed in Section 6.5 of this Agreement, and take any action with respect to such policies as Bank deems prudent. Any amounts so paid or deposited by Bank shall constitute Bank Expenses, shall be immediately due and payable, and shall bear interest at the then applicable rate hereinabove provided, and shall be secured by the Collateral. Any payments made by Bank shall not constitute an agreement by Bank to make similar payments in the future or a waiver by Bank of any Event of Default under this Agreement.
9.5 Banks Liability for Collateral. Bank has no obligation to clean up or otherwise prepare the Collateral for sale. All risk of loss, damage or destruction of the Collateral shall be borne by Borrower.
9.6 No Obligation to Pursue Others. Bank has no obligation to attempt to satisfy the Obligations by collecting them from any other person liable for them and Bank may release, modify or waive any collateral provided by any other Person to secure any of the Obligations, all without affecting Banks rights against Borrower. Borrower waives any right it may have to require Bank to pursue any other Person for any of the Obligations.
9.7 Remedies Cumulative. Banks rights and remedies under this Agreement, the Loan Documents, and all other agreements shall be cumulative. Bank shall have all other rights and remedies not inconsistent herewith as provided under the Code, by law, or in equity. No exercise by Bank of one right or remedy shall be deemed an election, and no waiver by Bank of any Event of Default on Borrowers part shall be deemed a continuing waiver. No delay by Bank shall constitute a waiver, election, or acquiescence by it. No waiver by Bank shall be effective unless made in a written document signed on behalf of Bank and then shall be effective only in the specific instance and for the specific purpose for which it was given. Borrower expressly agrees that this Section 9.7 may not be waived or modified by Bank by course of performance, conduct, estoppel or otherwise.
9.8 Demand; Protest. Except as otherwise provided in this Agreement, Borrower waives demand, protest, notice of protest, notice of default or dishonor, notice of payment and nonpayment and any other notices relating to the Obligations.
10. NOTICES.
Unless otherwise provided in this Agreement, all notices or demands by any party relating to this Agreement or any other agreement entered into in connection herewith shall be in writing and (except for financial statements and other reporting required pursuant to Section 6.2 of this Agreement, which shall be sent as directed in the monthly reporting forms provided by Bank) shall
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be personally delivered or sent by a recognized overnight delivery service, certified mail, postage prepaid, return receipt requested, or by electronic mail to Borrower or to Bank, as the case may be, at its addresses set forth below:
If to Borrower: | Adicet Bio, Inc. | |||
200 Constitution Drive | ||||
Menlo Park, CA 94025 | ||||
Attn: Anil Singhal, Ph.D., President and CEO | ||||
E-Mail: asinghal@adicetbio.com | ||||
with a copy to: | Morrison & Foerster LLP | |||
425 Market Street | ||||
San Francisco, CA 94105 | ||||
Attn: Darío Avram | ||||
E-mail: davram@mofo.com | ||||
If to Bank: | Pacific Western Bank | |||
406 Blackwell Street, Suite 240 | ||||
Durham, North Carolina 27701 | ||||
Attn: Loan Operations Manager | ||||
E-Mail: loannotices@pacwest.com | ||||
with a copy to: | Pacific Western Bank | |||
501 2nd Street, Suite 212 | ||||
San Francisco, CA 94107 | ||||
Attn: Benjermin Colombo | ||||
E-mail: bcolombo@pacwest.com |
The parties hereto may change the address at which they are to receive notices hereunder, by notice in writing in the foregoing manner given to the other.
11. CHOICE OF LAW AND VENUE; JURY TRIAL WAIVER.
This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of North Carolina, without regard to principles of conflicts of law. Jurisdiction shall lie in the State of North Carolina. All disputes, controversies, claims, actions and similar proceedings arising with respect to Borrowers account or any related agreement or transaction shall be brought in the General Court of Justice of North Carolina sitting in Durham County, North Carolina, or the United States District Court for the Middle District of North Carolina, except as provided below with respect to arbitration of such matters. BANK AND BORROWER EACH ACKNOWLEDGE THAT THE RIGHT TO TRIAL BY JURY IS A CONSTITUTIONAL ONE, BUT THAT IT MAY BE WAIVED. EACH OF THEM, AFTER CONSULTING OR HAVING HAD THE OPPORTUNITY TO CONSULT, WITH COUNSEL OF THEIR CHOICE, KNOWINGLY,
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VOLUNTARILY AND INTENTIONALLY WAIVES ANY RIGHT ANY OF THEM MAY HAVE TO A TRIAL BY JURY IN ANY LITIGATION BASED UPON OR ARISING OUT OF THIS AGREEMENT OR ANY RELATED INSTRUMENT OR LOAN DOCUMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT OR ANY COURSE OF CONDUCT, DEALING, STATEMENTS (WHETHER ORAL OR WRITTEN), OR ACTION OF ANY OF THEM. THESE PROVISIONS SHALL NOT BE DEEMED TO HAVE BEEN MODIFIED IN ANY RESPECT OR RELINQUISHED BY BANK OR BORROWER, EXCEPT BY A WRITTEN INSTRUMENT EXECUTED BY EACH OF THEM. If the jury waiver set forth in this Section 11 is not enforceable, then any dispute, controversy, claim, action or similar proceeding arising out of or relating to this Agreement, the Loan Documents or any of the transactions contemplated therein shall be settled by final and binding arbitration held in Durham County, North Carolina in accordance with the then current Commercial Arbitration Rules of the American Arbitration Association by one arbitrator appointed in accordance with those rules. The arbitrator shall apply North Carolina law to the resolution of any dispute, without reference to rules of conflicts of law or rules of statutory arbitration. Judgment upon any award resulting from arbitration may be entered into and enforced by any state or federal court having jurisdiction thereof. Notwithstanding the foregoing, the parties may apply to any court of competent jurisdiction for preliminary or interim equitable relief, or to compel arbitration in accordance with this Section. The costs and expenses of the arbitration, including without limitation, the arbitrators fees and reasonable and documented expert witness fees, and reasonable and documented attorneys fees, incurred by the parties to the arbitration may be awarded to the prevailing party, in the discretion of the arbitrator, or may be apportioned between the parties in any manner deemed appropriate by the arbitrator. Unless and until the arbitrator decides that one party is to pay for all (or a share) of such costs and expenses, both parties shall share equally in the payment of the arbitrators fees as and when billed by the arbitrator.
12. GENERAL PROVISIONS.
12.1 Successors and Assigns. This Agreement shall bind and inure to the benefit of the respective successors and permitted assigns of each of the parties and shall bind all persons who become bound as a debtor to this Agreement; provided, however, that neither this Agreement nor any rights hereunder may be assigned by Borrower without Banks prior written consent, which consent may be granted or withheld in Banks sole discretion. Bank shall have the right without the consent of or notice to Borrower to sell, assign, transfer, negotiate, or grant participation in all or any part of, or any interest in, Banks obligations, rights and benefits hereunder. Notwithstanding the foregoing, so long as no Event of Default has occurred and is continuing, Bank shall not assign its interest herein or the Loan Documents to any Person who is (i) a direct competitor of Borrower, whether as an operating company or direct or indirect parent with voting control over such operating company, or (ii) any vulture fund or similar hedge fund, private equity fund or other investor that invests in distressed debt as a material part of its investment strategy.
12.2 Indemnification. Borrower shall defend, indemnify and hold harmless Bank and its officers, directors, employees, affiliates, advisors and agents against: (a) all obligations, demands, claims, and liabilities claimed or asserted by any other party in connection with the transactions contemplated by this Agreement; and (b) all losses or Bank Expenses in any way suffered, incurred, or paid by Bank, its officers, employees and agents as a result of or in any
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way arising out of, following, or consequential to transactions between Bank and Borrower whether under this Agreement, or otherwise (including without limitation reasonable and documented attorneys fees and expenses), except for losses caused by Banks gross negligence or willful misconduct as determined by a court of competent jurisdiction by final and non-appealable order.
12.3 Time of Essence. Time is of the essence for the performance of all obligations set forth in this Agreement.
12.4 Severability of Provisions. Each provision of this Agreement shall be severable from every other provision of this Agreement for the purpose of determining the legal enforceability of any specific provision.
12.5 Amendments in Writing, Integration. All amendments to or terminations of this Agreement or the other Loan Documents must be in writing. All prior agreements, understandings, representations, warranties, and negotiations between the parties hereto with respect to the subject matter of this Agreement and the other Loan Documents, if any, are merged into this Agreement and the Loan Documents.
12.6 Counterparts. This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, shall be deemed to be an original, and all of which, when taken together, shall constitute but one and the same Agreement. Executed copies of the signature pages of this Agreement sent by facsimile or transmitted electronically in Portable Document Format (PDF), or any similar format, shall be treated as originals, fully binding and with full legal force and effect, and the parties waive any rights they may have to object to such treatment.
12.7 Survival. All covenants, representations and warranties made in this Agreement shall continue in full force and effect so long as any Obligations remain outstanding or Bank has any obligation to make any Credit Extension to Borrower. The obligations of Borrower to indemnify Bank with respect to the expenses, damages, losses, costs and liabilities described in Section 12.2 shall survive until all applicable statute of limitations periods with respect to actions that may be brought against Bank have run.
12.8 Confidentiality and Publicity.
(a) Other than (i) to the extent required by it by law, (ii) as may be required in connection with the examination, audit, or similar investigation of Borrower, (iii) in response to any subpoena or other legal process or informal investigative demand, or (iv) in connection with the actual or potential exercise or enforcement of any right or remedy under any Loan Document, Borrower shall not, and shall not permit any of its Affiliates to: (A) publish or publicly disclose any materials containing Banks name, including in any press release or otherwise in connection with any advertising or marketing, without first obtaining Banks prior written consent, or (B) use Banks name (or the name of any of its Affiliates) in connection with its operations or business; and
(b) In handling any confidential information, Bank shall exercise commercially reasonable efforts to maintain in confidence, in accordance with its customary procedures for handling
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confidential information, all non-public information furnished to Bank in connection with the Loan Documents or derived by or on behalf of Bank through inspection, analysis or observation of the foregoing (Confidential Information) other than any such Confidential Information that becomes generally available to the public or becomes available to Bank from a source other than Borrower and that is not known to Bank to be subject to confidentiality obligations, and shall not disclose any such Confidential Information to any other party; provided, that Bank and its Affiliates shall have the right to disclose Confidential Information to (provided, that in the case of (i)-(vi) below, such Person is bound by similar restrictions regarding disclosure and use of such information): (i) such Persons Affiliates; (ii) such Person or such Persons Affiliates lenders, funding sources, or financing sources; (iii) such Persons or such Persons Affiliates directors, officers, trustees, partners, members, managers, employees, agents, advisors, representatives, attorneys, equity owners, professional consultants, portfolio management services and rating agencies; (iv) any successor or assign of Bank; (v) any Person to whom Bank offers to sell, assign or transfer any Credit Extension or any part thereof or any interest or participation therein in accordance with the terms of this Agreement; (vi) any Person that provides statistical analysis and/or information services to Bank or its Affiliates; and (vii) any Person (A) to the extent required by it by law, rule, regulation or stock exchange requirements, (B) as may be required in connection with the examination, audit, or similar investigation of Bank, (C) in response to any subpoena or other legal process or informal investigative demand, (D) in connection with any litigation, or (E) in connection with the actual or potential exercise or enforcement of any right or remedy under any Loan Document. The obligations of Bank and its Affiliates under this Section 12.8 shall supersede and replace any other confidentiality obligations agreed to by Bank or its Affiliates.
[Balance of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first above written.
ADICET BIO, INC. | ||
By: | /s/ Anil Singhal | |
Name: | Anil Singhal | |
Title: | CEO | |
PACIFIC WESTERN BANK | ||
By: | /s/ Benjermin Colombo | |
Name: | /s/ Benjermin Colombo | |
Title: | Managing Director |
[Signature Page to Loan and Security Agreement]
EXHIBIT A
DEFINITIONS
Accounts means all presently existing and hereafter arising accounts, contract rights, payment intangibles and all other forms of obligations owing to Borrower arising out of the sale or lease of goods (including, without limitation, the licensing of software and other technology) or the rendering of services by Borrower and any and all credit insurance, guaranties, and other security therefor, as well as all merchandise returned to or reclaimed by Borrower and Borrowers Books relating to any of the foregoing.
Adicet Israel means Adicet Bio Israel Ltd. (f/k/a Applied Immune Technologies Ltd.), Borrowers wholly-owned Subsidiary formed under the laws of Israel.
Affiliate means, with respect to any Person, any Person that owns or controls directly or indirectly such Person, any Person that controls or is controlled by or is under common control with such Person, and each of such Persons senior executive officers, directors, and general partners.
Amortization Start Date means the first (1st) day of the month immediately following the Interest Only End Date.
Authorized Officer means someone designated as such in the corporate resolution provided by Borrower to Bank in which this Agreement and the transactions contemplated hereunder are authorized by Borrowers board of directors. If Borrower provides subsequent corporate resolutions to Bank after the Closing Date, the individual(s) designated as Authorized Officer(s) in the most recently provided resolution shall be the only Authorized Officers for purposes of this Agreement.
Availability End Date means the date eighteen (18) months after the Closing Date.
Bank Expenses means all reasonable costs or expenses (including reasonable attorneys fees and expenses, whether generated by in-house or by outside counsel) incurred in connection with the preparation, negotiation, administration, and enforcement of the Loan Documents; reasonable Collateral audit fees; and Banks reasonable attorneys fees and expenses (whether generated in-house or by outside counsel) incurred in amending, enforcing or defending the Loan Documents (including fees and expenses of appeal), incurred before, during and after an Insolvency Proceeding, whether or not suit is brought.
Borrowers Books means all of Borrowers books and records including: ledgers; records concerning Borrowers assets or liabilities, the Collateral, business operations or financial condition; and all computer programs, or tape files, and the equipment, containing such information.
Business Day means any day that is not a Saturday, Sunday, or other day on which banks in the State of North Carolina are authorized or required to close.
Capitalized Expenditures means current period unfinanced cash expenditures that are capitalized and amortized over a period of time in accordance with GAAP, including but not limited to capitalized cash expenditures for capital equipment, capitalized manufacturing and labor costs as they relate to inventory, and capitalized cash expenditures for software development.
Cash means unrestricted cash and cash equivalents.
Change in Control shall mean a transaction other than a bona fide equity financing or series of financings on terms and from investors reasonably acceptable to Bank in which any person or group (within the meaning of Section 13(d) and 14(d)(2) of the Securities Exchange Act of 1934) becomes the beneficial owner (as defined in Rule 13d-3 under the Securities Exchange Act of 1934), directly or indirectly, of a sufficient number of shares of all classes of stock then outstanding of Borrower ordinarily entitled to vote in the election of directors, empowering such person or group to elect a majority of the Board of Directors of Borrower, who did not have such power before such transaction, provided that the Permitted Transactions shall not constitute a Change in Control.
Closing Date means the date of this Agreement.
Code means the North Carolina Uniform Commercial Code as amended or supplemented from time to time.
Collateral means the property described on Exhibit B attached hereto and all Negotiable Collateral to the extent not described on Exhibit B, except to the extent any such property (i) is non-assignable by its terms without the consent of the licensor thereof or another party (but only to the extent such prohibition on transfer is enforceable under applicable law, including, without limitation, §25-9-406 and §25-9-408 of the Code), (ii) is property for which the granting of a security interest therein is contrary to applicable law, provided that upon the cessation of any such restriction or prohibition, such property shall automatically become part of the Collateral, (iii) constitutes the capital stock of a controlled foreign corporation (as defined in the IRC), in excess of 65% of the voting power of all classes of capital stock of such controlled foreign corporations entitled to vote, if the grant of a security interest in such capital stock pursuant to this Agreement would result in material adverse deemed dividend tax consequences to Borrower due to the application of IRC §956, or (iv) is property (including any attachments, accessions or replacements) that is subject to a Lien that is permitted pursuant to clause (c) of the definition of Permitted Liens, if the grant of a security interest with respect to such property pursuant to this Agreement would be prohibited by the agreement creating such Permitted Lien or would otherwise constitute a default thereunder, provided, that such property will be deemed Collateral hereunder upon the termination and release of such Permitted Lien.
Compliance Certificate means a compliance certificate, in substantially the form of Exhibit D attached hereto, executed by a Responsible Officer of the Borrower.
Contingent Obligation means, as applied to any Person, any direct or indirect liability, contingent or otherwise, of that Person with respect to (i) any indebtedness, lease, dividend, letter of credit or other obligation of another, including, without limitation, any such obligation directly or indirectly guaranteed, endorsed, co-made or discounted or sold with recourse by that Person, or in respect of which that Person is otherwise directly or indirectly liable; (ii) any obligations with respect to undrawn letters of credit, corporate credit cards or merchant services issued for the
account of that Person; and (iii) all obligations arising under any interest rate, currency or commodity swap agreement, interest rate cap agreement, interest rate collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; provided, however, that the term Contingent Obligation shall not include endorsements for collection or deposit in the ordinary course of business. The amount of any Contingent Obligation shall be deemed to be an amount equal to the stated or determined amount of the primary obligation in respect of which such Contingent Obligation is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by such Person in good faith; provided, however, that such amount shall not in any event exceed the maximum amount of the obligations under the guarantee or other support arrangement.
Copyrights means any and all copyright rights, copyright applications, copyright registrations and like protections in each work or authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret, now or hereafter existing, created, acquired or held.
Credit Extension means each Term Loan or any other extension of credit by Bank to or for the benefit of Borrower hereunder.
Divide means, with respect to any Person that is an entity, the dividing of such Person into two or more separate Persons, with the dividing Person either continuing or terminating its existence as part of such division, including as contemplated under Section 18-217 of the Delaware Limited Liability Company Act for limited liability companies formed under Delaware law, or any analogous action taken pursuant to any other statute with respect to any corporation, limited liability company, partnership, or other entity.
Equipment means all present and future machinery, equipment, tenant improvements, furniture, fixtures, vehicles, tools, parts and attachments in which Borrower has any interest.
ERISA means the Employee Retirement Income Security Act of 1974, as amended, and the regulations thereunder.
Event of Default has the meaning assigned in Article 8.
FDA means the United States Food and Drug Administration.
GAAP means generally accepted accounting principles, consistently applied, as in effect from time to time in the United States.
IND Milestone means Banks receipt of evidence reasonably satisfactory to Bank of receipt by Borrower of net payments, in one or more installments, from Regeneron equal to Twenty Million Dollars ($20,000,000) occurring within eighteen (18) months after the Closing Date in respect of Borrowers achievement of (i) Borrowers filing of an investigational new drug application with the FDA for ADI-001 and (ii) selection of a second clinical product candidate, ADI-002.
Indebtedness means (a) all indebtedness for borrowed money or the deferred purchase price of property or services, including without limitation reimbursement and other obligations with
respect to surety bonds and letters of credit, (b) all obligations evidenced by notes, bonds, debentures or similar instruments, (c) all capital lease obligations, and (d) all Contingent Obligations, including but not limited to any sublimit contained herein.
Insolvency Proceeding means any proceeding commenced by or against any Person or entity under any provision of the United States Bankruptcy Code, as amended, or under any other bankruptcy or insolvency law, including assignments for the benefit of creditors, formal or informal moratoria, compositions, extension generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.
Interest Only End Date means (i) if Borrower does not achieve the IND Milestone, the date eighteen (18) months after the Closing Date, and (ii) if Borrower achieves the IND Milestone, the date twenty-four (24) months after the Closing Date.
Inventory means all present and future inventory in which Borrower has any interest.
Investment means any beneficial ownership of (including stock, partnership or limited liability company interest or other securities) any Person, or any loan, advance or capital contribution to any Person.
IRC means the Internal Revenue Code of 1986, as amended, and the regulations thereunder.
Letter of Credit means a commercial or standby letter of credit or similar undertaking issued by Bank (or any of its correspondent banks) at Borrowers request.
Lien means any mortgage, lien, deed of trust, charge, pledge, security interest or other encumbrance.
Loan Documents means, collectively, this Agreement, any note or notes executed by Borrower, and any other document, instrument or agreement entered into in connection with this Agreement, all as amended or extended from time to time.
Material Adverse Effect means a material adverse effect on (i) the operations, business or financial condition of Borrower and its Subsidiaries taken as a whole, (ii) the ability of Borrower to repay the Obligations or otherwise perform its obligations under the Loan Documents, or (iii) Borrowers interest in, or the value, perfection or priority of Banks security interest in the Collateral.
Maturity Date means April , 2024.
Negotiable Collateral means all of Borrowers present and future letters of credit of which it is a beneficiary, drafts, instruments (including promissory notes), securities, documents of title, and chattel paper, and Borrowers Books relating to any of the foregoing.
New Subsidiary has the meaning set forth in Section 6.8 hereof.
Obligations means all debt, principal, interest, Bank Expenses and other amounts owed to Bank by Borrower pursuant to this Agreement or any other agreement, whether absolute or contingent,
due or to become due, now existing or hereafter arising, including any interest that accrues after the commencement of an Insolvency Proceeding and including any debt, liability, or obligation owing from Borrower to others that Bank may have obtained by assignment or otherwise.
Periodic Payments means all installments or similar recurring payments that Borrower may now or hereafter become obligated to pay to Bank pursuant to the terms and provisions of any instrument, or agreement now or hereafter in existence between Borrower and Bank.
Permitted Indebtedness means:
(a) Indebtedness of Borrower in favor of Bank arising under this Agreement or any other Loan Document;
(b) Indebtedness existing on the Closing Date and disclosed in the Schedule;
(c) Indebtedness (including capital lease obligations and purchase money indebtedness) not to exceed Two Hundred Fifty Thousand Dollars ($250,000) in the aggregate at any time secured by a Lien described in clause 12.8(c) of the defined term Permitted Liens, provided such Indebtedness does not exceed at the time it is incurred the lesser of the cost or fair market value of the property financed with such Indebtedness;
(d) Subordinated Debt;
(e) Indebtedness to trade creditors incurred in the ordinary course of business;
(f) Indebtedness incurred as a result of endorsing negotiable instruments received in the ordinary course of business;
(g) Indebtedness associated with the SVB Letters of Credit, subject to the terms of Section 6.9;
(h) Other, unsecured Indebtedness of Borrower and any Subsidiary in an aggregate principal amount not to exceed Two Hundred Fifty Thousand Dollars ($250,000); and
(i) Extensions, refinancings and renewals of any items of Permitted Indebtedness, provided that the principal amount is not increased or the terms modified to impose more burdensome terms upon Borrower or its Subsidiary, as the case may be.
Permitted Investment means:
(a) Investments existing on the Closing Date disclosed in the Schedule;
(b) (i) Marketable direct obligations issued or unconditionally guaranteed by the United States of America or any agency or any State thereof maturing within two (2) years from the date of acquisition thereof, (ii) commercial paper maturing no more than two (2) years from the date of creation thereof and currently having rating of at least A-1 or P-1 from either Standard & Poors Corporation or Moodys Investors Service, (iii) Banks certificates of deposit maturing no more than two (2) years from the date of investment therein, (iv) Banks money market
accounts; (v) Investments in regular deposit or checking accounts held with Bank or as otherwise permitted by, and subject to the terms and conditions of, Section 6.6 of this Agreement; and (vi) Investments consistent with any investment policy adopted by Borrowers board of directors;
(c) Investments accepted in connection with Permitted Transfers;
(d) (i) Investments of Subsidiaries in or to other Subsidiaries or Borrower and Investments by Borrower in Subsidiaries not to exceed Two Hundred Fifty Thousand Dollars ($250,000) in the aggregate in any fiscal year, and (ii) additional Investments by Borrower in Adicet Israel solely to satisfy tax liabilities in connection with Adicet Israels dissolution not to exceed Five Hundred Thousand Dollars ($500,000), provided that prior notice of such dissolution shall be delivered to Bank;
(e) Investments not to exceed Two Hundred Fifty Thousand Dollars ($250,000) outstanding in the aggregate at any time consisting of (i) travel advances and employee relocation loans and other employee loans and advances in the ordinary course of business, and (ii) loans to employees, officers or directors relating to the purchase of equity securities of Borrower or its Subsidiaries pursuant to employee stock purchase plan agreements approved by Borrowers Board of Directors;
(f) Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of Borrowers business;
(g) Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business, provided that this subparagraph (g) shall not apply to Investments of Borrower in any Subsidiary;
(h) Joint ventures or strategic alliances in the ordinary course of Borrowers business consisting of the non-exclusive licensing of technology, the development of technology or the providing of technical support, provided that any cash Investments by Borrower do not exceed Two Hundred Fifty Thousand Dollars ($250,000) in the aggregate in any fiscal year; and
(i) Investments permitted under Section 7.3.
Permitted Liens means the following:
(a) Any Liens existing on the Closing Date and disclosed in the Schedule (excluding Liens to be satisfied with the proceeds of the Credit Extensions) or arising under this Agreement, the other Loan Documents, or any other agreement in favor of Bank;
(b) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings and for which Borrower maintains adequate reserves;
(c) Liens not to exceed Two Hundred Fifty Thousand Dollars ($250,000) in the aggregate at any time (i) upon or in any Equipment (other than Equipment financed by a Credit
Extension) acquired or held by Borrower or any of its Subsidiaries to secure the purchase price of such Equipment or indebtedness incurred solely for the purpose of financing the acquisition or lease of such Equipment, or (ii) existing on such Equipment at the time of its acquisition, in each case provided that the Lien is confined solely to the property so acquired and improvements thereon, and the proceeds of such Equipment;
(d) Liens incurred in connection with the extension, renewal or refinancing of the indebtedness secured by Liens of the type described in clauses (a) through (c) above, provided that any extension, renewal or replacement Lien shall be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness being extended, renewed or refinanced does not increase;
(e) Liens arising from judgments, decrees or attachments in circumstances not constituting an Event of Default under Sections 8.4 (attachment) or 8.7 (judgments);
(f) Liens held by Borrower in the assets of any of its Subsidiaries securing intercompany debt permitted under this Agreement;
(g) Liens of carriers, warehousemen, suppliers, or other Persons that are possessory in nature arising in the ordinary course of business so long as such Liens attach only to Inventory, securing liabilities in the aggregate amount not to exceed Two Hundred Fifty Thousand Dollars ($250,000) and which are not delinquent or remain payable without penalty or which are being contested in good faith and by appropriate proceedings, which proceedings have the effect of preventing the forfeiture or sale of the property subject thereto and for which Borrower maintains adequate reserves;
(h) pledges or deposits on assets worth an aggregate amount not to exceed Two Hundred Fifty Thousand Dollars ($250,000) to secure the performance of bids, trade contracts (other than for borrowed money), leases, licenses, statutory obligations, surety and appeal bonds, performance bonds and other obligations of a like nature incurred in the ordinary course of business;
(i) Liens securing Subordinated Debt, provided that such Liens do not encumber assets beyond those assets comprising the Collateral.
(j) Liens in favor of other financial institutions arising in connection with Borrowers deposit accounts held at such institutions to secure standard fees for deposit services charged by, but not financing made available by, such institutions, provided that Bank has a perfected security interest in the amounts held in such deposit accounts.
Permitted Transactions means (i) a proposed reverse triangular merger among Borrower, a publicly traded company previously disclosed to Bank (Parent), and a wholly owned subsidiary of Parent (Merger Sub), pursuant to which Merger Sub will merge with and into Borrower with Borrower surviving as a wholly owned subsidiary of Parent in accordance with the terms of that certain merger agreement by and between Borrower, Parent and Merger Sub (the Merger Agreement), as summarized in that certain Summary of Terms of Funding and Merger and provided to Bank (as may be modified by the terms of the Merger Agreement, the Summary of Terms and such transaction the Merger), (ii) the entry by such parties into agreements,
documents and instruments and the making of filings (including, without limitation, public filings disclosing this Agreement, the other Loan Documents and their terms) for and related to the Merger, and (iii) the transactions contemplated by or entered into in connection with any of the foregoing transactions or agreements; provided, that, (a) the Merger is consummated substantially in accordance with the Summary of Terms unless otherwise approved by Bank in writing, (b) Borrower has delivered to Bank (1) the Merger Agreement, all exhibits thereto, and all material documents, instruments, certificates and/or agreements to be executed by Borrower in connection with the Merger (the Merger Documents) and (2) all diligence materials reasonably requested by Bank (the Merger Diligence), (c) Bank has confirmed in writing its approval of the Merger Documents and the Merger Diligence prior to the consummation of the Merger (and Borrower has delivered to Bank the executed copies of all Merger Documents) and (iv) simultaneously with or promptly following the consummation of the Merger, Borrower takes all actions reasonably required by Bank in its sole discretion to cause Parent to guarantee Borrowers obligations under this Agreement, together with such other documents, and completion of such other matters, including, without limitation, a new warrant as provided for in Section 2.2 of the Warrant, and Parent shall grant and pledge to Bank a perfected security interest in substantially all of its assets other than Intellectual Property, including, without limitation, the stock, units or other evidence of ownership of Borrower.
Permitted Transfer means the conveyance, sale, lease, transfer or disposition by Borrower or any Subsidiary of:
(a) Inventory in the ordinary course of business;
(b) non-exclusive licenses of Intellectual Property granted to third parties in the ordinary course of business, and licenses of Intellectual Property that could not result in a legal transfer of title of the licensed property that may be exclusive in respects other than territory and that may be exclusive as to territory only as to discrete geographical areas outside of the United States;
(c) worn-out, surplus or obsolete Equipment not financed with the proceeds of Credit Extensions;
(d) grants of security interests and other Liens that constitute Permitted Liens;
(e) any asset of any Subsidiary to Borrower;
(f) cash and cash equivalents (i) in the ordinary course of business and in a manner not otherwise prohibited by this Agreement, or (ii) permitted by clause (d) of the definition of Permitted Investments; and
(g) other assets of Borrower or its Subsidiaries that do not in the aggregate exceed Two Hundred Fifty Thousand Dollars ($250,000) during any fiscal year.
Person means any individual, sole proprietorship, partnership, limited liability company, joint venture, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or governmental agency.
Prime Rate means the variable rate of interest, per annum, most recently announced by Bank, as its prime rate, whether or not such announced rate is the lowest rate available from Bank.
Regeneron means Regeneron Pharmaceuticals, Inc., a New York corporation.
Regeneron Agreement means that certain License and Collaboration Agreement by and between Borrower and Regeneron, dated as of July 29, 2016, as amended by that certain Amendment No. 1 to License and Collaboration Agreement dated as of April 4, 2019.
Responsible Officer means each of the Chief Executive Officer, the Chief Operating Officer, the Chief Financial Officer, Vice President of Finance and the Controller of Borrower, as well as any other officer or employee identified as an Authorized Officer in the corporate resolution delivered by Borrower to Bank in connection with this Agreement.
Schedule means the schedule of exceptions attached hereto, as the same may be updated from time to time to the extent approved by Bank.
Shares means one hundred percent (100%) of the issued and outstanding capital stock, membership units or other securities owned or held of record by Borrower in any Subsidiary of Borrower.
SOS Reports means the official reports from the Secretaries of State of the state where Borrowers chief executive office is located, the state of Borrowers formation and other applicable federal, state or local government offices identifying all current security interests filed in the Collateral and Liens of record as of the date of such report.
Subordinated Debt means any debt incurred by Borrower that is subordinated in writing to the debt owing by Borrower to Bank on terms reasonably acceptable to Bank (and identified as being such by Borrower and Bank).
Subsidiary means any corporation, partnership or limited liability company or joint venture in which (i) any general partnership interest or (ii) more than 50% of the stock, limited liability company interest or joint venture of which by the terms thereof ordinary voting power to elect the Board of Directors, managers or trustees of the entity, at the time as of which any determination is being made, is owned by Borrower, either directly or through an Affiliate.
Trademarks means any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like protections, and the entire goodwill of the business of Borrower connected with and symbolized by such trademarks.
Warrant means that certain Warrant to Purchase Stock issued by Borrower to Bank dated as of the Closing Date.
Exhibit 10.27
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH [***]. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
AMENDED AND RESTATED LICENSE AGREEMENT
This Amended and Restated License Agreement (collectively with exhibits and appendices hereto, the Agreement) is entered into on May _, 2014 (the Execution Date), by and between the Technion Research and Development Foundation Ltd. having a place of business at Senate house, Technion City, Haifa Israel, (Licensor), acting on behalf of itself and the Technion-Israel Institute of Technology, and Applied Immune Technology Ltd, a company organized under the laws of the State of Israel and having a place of business at Gutwirth Industrial Park, Technion City, Haifa 32000 Israel (Company).
WHEREAS, Licensor is the wholly-owned subsidiary of Technion - Israel Institute of Technology (the Technion) and serves as its technology licensing arm; and
WHEREAS, the parties hereto signed a License Agreement dated as of March 7, 2010 (collectively with the Letter of License attached as Exhibit B thereto, the Prior Agreement) and desire to amend and restate the Prior Agreement as set forth herein; and
WHEREAS, Licensor has rights in certain Inventions (defined below), including but not limited to those disclosed in the patent(s)/patent application(s) listed in Exhibit A attached hereto.
WHEREAS, Licensor consents to the part-time employment of [***] by the Company in which capacity [***] may engage in research, development and other activities relating to TCRL (defined below) or other matters.
NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby agree as follows:
1. Effectiveness; Termination of Prior Agreement. This Agreement replaces the Prior Agreement in its entirety, effective as of March 1, 2005. The Prior Agreement is hereby terminated and shall be of no further force or effect.
2. Definitions.
Whenever used in this Agreement with an initial capital letter, the terms defined in this Section 2, whether used in the singular or the plural, shall have the meanings specified below.
Additional Ingredient means any compound or substance which (i) is contained in a Combination Product and (ii) when administered to a patient has a therapeutic or prophylactic clinical effect independent of a Licensed Product, either directly or by acting synergistically with or otherwise enhancing the effect of other compounds or substances contained in such product.
Affiliate means, with respect to a party, any person, organization or entity controlling, controlled by or under common control with, such party. For purposes of this definition only, control of another person, organization or entity means the possession, directly or indirectly, of the power to direct or cause the direction of the activities, management
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or policies of such person, organization or entity, whether through the ownership of voting securities, by contract or otherwise. Without limiting the foregoing, control shall be presumed to exist when a person, organization or entity (i) owns or directly controls fifty percent (50%) or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (ii) possesses, directly or indirectly, the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization or other entity.
Antibody or Antibodies shall mean a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.
Calendar Quarter means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect.
Combination Product means a product, substance or device which comprises a Licensed Product and at least one Additional Ingredient.
Company Inventions means inventions, developments or improvements owned by Company pursuant to Section 4.2 hereof.
Commercially Reasonable Efforts, with respect to any entity, means those efforts and resources that are commercially reasonable for a company of the same size as such entity with respect to activities in the field of similar therapeutic biologics development.
Consulting Agreement means the Consulting Agreement between [***] and Company of even date herewith, as such agreement may be extended or renewed.
First Commercial Sale means the first sale of a Licensed Product by Company, a Subsidiary of Company or a Sublicensee to an unaffiliated third party, after Regulatory Approval has been achieved in the country in which such Licensed Product is sold. Sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.
FDA means the United States Food and Drug Administration.
IND means an Investigational New Drug application, as described in 21 C.F.R. Section 312.23, filed for purposes of obtaining FDA approval to conduct Phase I Clinical Trials in accordance with the requirements of the United States Food, Drug and Cosmetic Act of 1938, as amended, and the rules and regulations promulgated thereunder, including all supplements and amendments thereto applicable to the use of the Licensed Product, or approval of the EMA with respect to comparable activities.
Inventions means all, whether or not patentable, inventions, improvements, discoveries, developments, data, information or results, including laboratory notebooks created by or under the supervision of the Researcher or in his laboratory at the Technion (including, without limitation, by other research staff or students under Researchers supervision or in his laboratory) relating to TCRL, which existed as of March 1, 2005, excluding matter generally known or in the public domain.
Joint Researcher Improvement has the meaning set forth in Section 4.1(b).
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Joint Researcher Improvement Patent Rights means any patent or patent application claiming a Joint Researcher Improvement.
Licensed Know-how means all inventions (whether or not patentable), improvements, discoveries, developments, data, information, results or know-how (including without limitation methods, instructions, techniques, practices, procedures, processes, formulas and other information) owned or controlled by Licensor, which relate to Inventions or Researcher Improvements. Licensed Know-how does not include Company Inventions (subject to the final three sentences of Section 4.2 below) Licensors interest in Joint Researcher Improvements or matter commonly known or in the public domain.
Licensed Patent Rights shall mean, in each case to the extent owned or controlled by Licensor: (a) the patents and patent applications listed in Exhibit A attached hereto, patents or patent applications relating to Inventions or Researcher Improvements; (b) any patent or patent application that claims priority to and is a divisional, continuation, reissue, renewal, reexamination, substitution or extension of any patent application identified in (a); (c) any patents issuing on any patent application identified in (a) or (b), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (d) any claim of a continuation-in-part application or patent that is entitled to the priority date of, and is directed specifically to subject matter specifically described in, at least one of the patents or patent applications identified in (a), (b) or (c); (e) any foreign counterpart (including PCTs) of any patent or patent application identified in (a), (b) or (c) or of the claims identified in (d); and (f) any supplementary protection certificates, pediatric exclusivity periods, any other patent term extensions and exclusivity periods and the like of any patents and patent applications identified in (a) through (f). The Licensed Patent Rights existing as of the Execution Date are set forth in Exhibit A, which shall automatically be deemed updated from time to time to include new Licensed Patent Rights unless Company has opted out of receiving a license to such Licensed Patent Rights under the process set forth in Section 4.l(a). Licensed Patent Rights does not include Joint Researcher Improvement Patent Rights.
Licensed Product means a TCRL based therapeutic, diagnostic or theranostic product that (i) comprises or incorporates Licensed Technology or Joint Researcher Improvements or (ii) which has been developed using Licensed Technology or Joint Researcher Improvements, or (iii) the making, using or selling of which falls within the scope of the Licensed Technology or Joint Researcher Improvements.
Licensed Technology means collectively the Licensed Patent Rights and/or the Licensed Know-how.
M&A Transaction means a transaction or series of transactions involving (i) a sale or transfer of all or substantially all of the assets of the Company or an Affiliate relevant to this Agreement (ii) a sale or transfer of all or substantially all of share capital, (iii) a merger or consolidation, (iv) dissolution or liquidation, or (v) the consummation of any transaction or series of related transactions having similar effect as any of the foregoing.
Net Sales means the gross amount actually received by Company and/or its Subsidiaries (the Invoicing Entity) on sales of Licensed Products following First Commercial Sale, less the following: (a) credits, refunds, rebates or trade, quantity, or cash discounts to the extent actually allowed and taken; (b) amounts actually repaid or credited by reason of rejection, return or recall; (c) to the extent separately stated on purchase orders, invoices, or other documents of sale, any taxes or other governmental charges levied on the
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production, sale, transportation, import, export, delivery, or use of a Licensed Product which is paid by or on behalf of the Invoicing Entity; and.(d) invoiced outbound transportation, packing and delivery charges, as well as prepaid freight (including shipping insurance) actually incurred by the Invoicing Entity, provided that:
(i) In any transfers of Licensed Products between the Invoicing Entity and a Subsidiary of the Invoicing Entity not for the purpose of resale by such Affiliate, Net Sales shall be equal to the fair market value of the Licensed Products so transferred, assuming an arms length transaction made in the ordinary course of business;
(ii) In the event that the Invoicing Entity, or the Subsidiary of the Invoicing Entity, receives consideration in the form of goods for any Licensed Products or in the case of transactions for cash not at arms length with a Subsidiary of the Invoicing Entity, Net Sales shall be calculated based on the fair market value of such consideration or transaction, assuming an arms length transaction made in the ordinary course of business;
(iii) Sales of Licensed Products by an Invoicing Party to a Subsidiary of such Invoicing Entity, for resale by such Affiliate, shall not be deemed Net Sales and Net Sales shall be determined based on the total amount invoiced or billed by such Subsidiary on resale to an independent third party purchaser (subject to the deductions as set forth herein); and
(iv) in the event the Invoicing Entity or a Subsidiary of the Invoicing Entity receives Net Sales in the form of equity, either such portion of such equity due to Licensor as royalties shall be issued to Licensor to the extent permitted under applicable law (and where such shares are not publicly traded - where approved by the issuer), or alternatively Company shall hold such shares in trust on Licensors behalf in accordance with a trust agreement to be entered into in good faith by the Company and Licensor which shall ensure the full ownership and rights of Licensor as a beneficial owner of such shares.
For clarity, amounts received as funding for the performance of research or development services, and license rights, cash or equity received under cross-licenses shall not be considered Net Sales.
Patent Rights means any and all (a) patents, (b) pending patent applications, including, without limitation, all provisional applications, continuations, continuations-in-part, divisions, reissues, renewals, and all patents granted thereon, and (c) all patents-of-addition, reissue patents, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation, supplementary protection certificates or the equivalent thereof.
Regulatory Agency means the FDA or equivalent agency or government body of another country.
Regulatory Approval means (i) approval by the FDA permitting commercial sale of a Licensed Product or (ii) any comparable approval permitting commercial sale of a Licensed Product granted by the applicable Regulatory Agency in any other country or jurisdiction, including, where applicable with respect to (i) and (ii) above, the receipt of pricing reimbursement approval.
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Researcher means [***], or in the event that [***] is no longer leading his laboratory at the Technion such other personnel of the Technion conducting research with respect to the Licensed Technology.
[***] Collaboration Period means the period set forth in Section 3(a), as such period may be extended by the parties mutual written agreement.
Researcher Improvements means, whether or not patentable, all novel inventions, improvements, discoveries, developments, data, information or results, including laboratory notebooks, created by or under the supervision of the Researcher at the Technion or in his laboratory at the Technion (including, without limitation, by other research staff or students in his laboratory or supervised by Researcher) that did or will arise or were or will be created, conceived or reduced to practice (i) subsequent to March I, 2005 that relate to TCRL or Licensed Technology (to the extent relating to Licensed Technology or TCRL), (including without limitation Antibodies, other binding scaffolds, animal models, cells, peptides, assays, protocols, anti-CD3, bi-specific, toxin combined with TCRL, effector functions or similar inventions), provided that with respect to matter created subsequent to the Execution Date, only matter created, conceived, or reduced to practice prior to the Royalty Cessation Date shall be considered Researcher Improvements, or (ii) in the course of providing services to the Company pursuant to research arrangements between Company and Technion. For clarity, Researcher Improvements does not include Company Inventions (subject to the final three sentences of Section 4.2 below), Licensors interest in Joint Researcher Improvements, or matter that is commonly known or in the public domain.
Royalty Cessation Date means the earlier to occur of (i) February 13, 2023 or (ii) the five (5) year anniversary of an M&A Transaction having an aggregate value of more than [***] (for clarity, contingent payments or other consideration due post-closing in connection with an M&A Transaction are included in the calculation of the value of the transaction effective as of the closing of the transaction).
Royalty Term shall have the meaning set forth in Section 7.l(b).
Sublicense means (a) a sublicense of rights in Licensed Technology under the License to a third party, other than distributors or third parties performing research, development or other services on behalf of Company or its Affiliates; or (b) any option or other right granted by the Company or its Subsidiaries to any third party to negotiate for or receive any of the rights described under clause (a).
Sublicense Receipts means any payments or other consideration that Company or a Subsidiary actually received in connection with a Sublicense, or the grant of an option to obtain a Sublicense in cash or as equity, including without limitation royalties, license fees, milestone payments, license maintenance fees, lumps sums, and equity; provided that in the event that Company or a Subsidiary of Company receives goods in connection with a Sublicense, Sublicense Receipts shall be calculated based on the fair market value of such consideration, and provided further that where the Company sublicenses Licensed Technology together with other technology, the Sublicense Receipts will include only the value attributed to the Licensed Technology as a percentage of the value of the totality of intellectual property rights licensed to such Sublicensee For clarity, Sublicense Receipts excludes amounts received from Sublicensees as funding for the performance of research or development services, consideration from an M&A Transaction, or license rights, cash or equity received under cross-licenses and grants. For clarity, if Sublicense Receipts are received in the form of equity, such
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portion of such equity due to Licensor as Sublicense payments shall be issued to Licensor to the extent permitted under applicable law (and where such shares are not publicly traded - where approved by the issuer), or alternatively Company shall hold such shares in trust on Licensors behalf in accordance with a trust agreement to be entered into in good faith by the Company and Licensor which shall ensure the full ownership and rights of Licensor as a beneficial owner of such shares.
Sublicensee means a person or entity granted a Sublicense in accordance with Section 5.2, including any sublicensees of other Sublicensees.
Subsidiary of Company means any other entity (a) more than [***] of whose outstanding shares or other equity or voting interests or securities representing the right to vote for the election of directors or other managing authority of such other entity are owned or controlled, directly or indirectly, by such party, or (b) which does not have outstanding shares or securities with such right to vote, as may be the case in a partnership, joint venture or unincorporated association, but more than [***] of whose ownership interest representing the right to make the decisions for such other entity is, now or hereafter, owned or controlled, directly or indirectly, by the Company. Such other entity shall be deemed to be a Subsidiary only so long as such ownership or control exists.
TCRL means any biological or non-biological binding moiety ([***]) that recognizes and binds to those peptide-MHC [***] complexes [***].
TCRL Compound means a specific compound comprising a biological or non-biological binding moiety (including without limitation any Antibody, or other binding scaffold) that recognizes and binds to those peptide-MHC [***] complexes [***].
Valid Claim means: an issued and unexpired claim under the Licensed Patent Rights, that claims either (i) a composition of matter; or (ii) a method of treatment or medical use (hereby defined as Use) in Inventions or Researcher Improvements, in each case only where such Inventions or Researcher Improvements have applicability to a broad class of TCRL Compounds that are directed to more than a single cellular target class or their Use (including, without limitation, an adjuvant, new scaffold for bi-specific or method of treatment by combination therapy), and in each case only for so long as such claim shall not have been held invalid in a final, non-appealable court judgment (or unappealed within the time allowed for appeal) or patent office decision, in the relevant jurisdiction and which claim is not admitted to be invalid or unenforceable through reissue, disclaimer or otherwise and which claim has not been withdrawn, cancelled, or disclaimed and has not been abandoned or lost. For avoidance of doubt, any peptides deriving from a cellular target, such as tyrosinase, are considered a single cellular target class. As used herein, Valid Claim specifically excludes claims to processes of manufacture, screening or research tools, protocols, and other claims not expressly set forth under subclauses (i) or (ii) above. For clarity, claims under Patent Rights referred to in Exhibit B and Joint Researcher Improvement Patent Rights referred to in Exhibit C are not Valid Claims.
3. Scope of Cooperation
(a) Licensor, Technion and [***] agree that, in addition to any services which [***] provides to Company as a Licensor employee pursuant to research agreements between Licensor and Company, during the period between the Execution Date and the five (5) year anniversary of the Execution Date (the [***] Collaboration Period), [***] will devote at
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least one day per week (on an annualized basis) to consult and supervise with respect to research activities made by or on behalf of Company, and Licensor and Technion have irrevocably consented to such engagement. The terms of such engagement are set forth in the Consulting Agreement. The parties will discuss extensions to the [***] Collaboration Period in good faith. During the first eighteen (18) months of the [***] Collaboration Period, the Licensor and Technion will not approve the performance of services by [***] for third parties in the biotech or pharmaceutical industry without the consent of the Company, (provided however that [***] shall be permitted to engage in academic and non-commercial research outside the TCRL field and perform non-commercial services for academic or research institutions outside of the TCRL field during this period) and following such eighteen (18) months period and until the expiration of the [***] Collaboration Period, the Licensor and Technion will notify the Company regarding requests for approvals for performance of services by [***].
(b) During the latter of the term of this Agreement or the period during which sublicense payments are made hereunder, with respect to research and development activities in the field of TCRL (other than Academic Research expressly permitted under Section 5.l(b)) and discovery, development and commercialization of products based on TCRL, (i) in his capacity as a Technion employee, [***] will work exclusively with Company and will not provide services to or collaborate with any other person or entity; and (ii) with respect to matters relating to technology developed by [***] or developed in [***]s laboratory at the Technion during his tenure at his laboratory (and without prejudice to Companys exclusive rights under this Agreement), in the event that [***] is no longer leading his laboratory at the Technion, such other personnel of the Technion conducting research with respect to the Licensed Technology will work exclusively with Company and will not provide services to or collaborate with any other person or entity. Licensor shall not commercialize Researcher Improvements other than as contemplated herein.
4. Title.
4.1 Licensor Inventions.
(a) Researcher Improvements. The entire right, title and interest in Researcher Improvements are owned solely and exclusively by Licensor, and such Researcher Improvements shall be automatically licensed to Company on the terms hereof applicable to Licensed Technology. Patent Rights and know-how in such Researcher Improvements are included within the definitions of Licensed Patent Rights and Licensed Know-How respectively. Company shall have the right [***] of receipt of all information and materials required to be provided by Licensor under subclause (d) below with respect to a Researcher Improvement to provide Licensor with written notice that Company does not wish to receive a license to such Researcher Improvement, and in such event such Researcher Improvement shall cease to be licensed to Company as of the date of such notice and the terms of this Agreement shall be construed to reflect such exclusion.
(b) Compound- Specific Inventions (Joint Researcher Improvements). Subject to Licensors interest in Licensed Technology (other than pursuant to Section 4.l(a)) and Companys rights in Company Inventions, all right, title and interest in matter that would otherwise qualify as Researcher Improvements and that are specific TCRL Compounds (including, without limitation, all TCRL compounds directed to a peptide that is deriving from the same cellular target class (for example, tyrosinase but excluding Company Inventions solely owned by Company pursuant to Exhibit B)), developed and/or conceived or reduced to practice at the Researchers lab in the Technion either (i) during the [***]
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Collaboration Period provided that during such period Company funds research in Researchers laboratory at the Technion in an amount of at least [***] (or a prorated amount where services are performed for less than a full annual period), or (ii) in the course of providing services to the Company pursuant to research arrangements between Technion and Company (collectively, Joint Researcher Improvements), shall be owned jointly by Licensor and Company, and a [***] interest in the totality of each such invention, improvement or other matter is hereby assigned to Company without additional consideration as and when created. A list of Joint Researcher Inventions which have been created as of the Execution Date is attached as Exhibit C hereto. For clarity, as used in the prior sentence directed to a peptide means binding to complex [***] with a cellular peptide. For clarity, Joint Researcher Improvements will be jointly owned even where Company personnel did not contribute to the creation of such Joint Researcher Improvements. Such joint ownership shall not create any obligation between the parties with respect to such Joint Researcher Improvement except to the extent specifically set forth herein. For clarity, matter that is commonly known or in the public domain is not a Joint Researcher Improvement. Company may assign its interest in Joint Researcher Improvements to third parties. Licensor and Technion and their employees and agents (including, without limitation, Researcher) will at the request and expense of the Company reasonably assist Company to transfer to Company its interest in each Joint Researcher Improvement and to obtain and enforce Patent Rights or other proprietary rights relating to any Joint Researcher Improvements in any and all countries, and to that end will execute, verify and deliver such documents and perform such other act as Company may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such Joint Researcher Improvement Patent Rights or other proprietary rights and the assignment thereof. In the event that Company is unable for any reason, after reasonable effort, to secure signatures on any document needed in connection with the actions specified in the preceding sentence, Licensor and Technion and their employees and agents (including, without limitation, Researcher) hereby irrevocably designate and appoint Company and its duly authorized officers and agents as their agent and attorney in fact, which appointment is coupled with an interest, to act for and on their behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by them. Licensor will not transfer, assign, encumber, grant, sell, lease or otherwise dispose of its interest in Joint Researcher Improvements other than assignment of joint interest therein to Company and license of Licensors rights therein to Company as set forth herein, except for licenses expressly permitted under Section 14.4.(b).
(c) Other Inventions. This Agreement does not grant Company any right, title and interest in any of Licensors inventions or results that are not included within Licensed Technology or Joint Researcher Improvement provided that Licensor will not enforce any patents or other rights in respect of such inventions or results against Company, its Affiliates, Sublicensees or their direct or indirect collaborators, licensees or the successors or assigns of any of the foregoing and will include a comparable restrictions in all third party agreements pursuant to which TCRL-related technology may be licensed or sold. Except for the rights granted to Company in respect of Licensed Technology and Joint Researcher Improvement, nothing in this Agreement shall be construed to confer any ownership interest or license rights upon the Company by implication, estoppel or otherwise as to any technology, intellectual property rights, products or materials of Licensor or the Technion.
(d) Disclosure; Transfer of Materials. Licensor and Researcher shall ensure that Researcher shall provide Company with reasonably prompt and full written disclosure of Researcher Improvements and Joint Researcher Improvements as soon as is reasonably practical following discovery or creation thereof together with all reasonably related materials.
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4.2 Company Inventions. All rights, title and interest in and to any and all improvements, developments or inventions that were or are made, arrived at or discovered by or on behalf of Company, its Affiliates or Sublicensees, including, without limitation, improvements to Licensed Technology or to Joint Researcher Improvements, (other than matter created by or under the supervision of Researcher at the Technion or in his laboratory at Technion and included within the definitions of Researcher Improvements licensed to the Company), are and shall be owned solely and exclusively by Company, including without limitation those relating to TCRL, Licensed Technology, Joint Researcher Improvements or arising from the license of the Licensed Technology hereunder. Without limitation of the foregoing, Licensor acknowledges and agrees that any inventions, results or other matter created by Researcher in the course of providing services to Company prior to or following the Execution Date (other than matter created by or under the supervision of Researcher at the Technion or in his laboratory at Technion and included within the definitions of Researcher Improvements or Joint Researcher Improvements) shall be the sole property of Company; without derogating from the other terms of this Agreement, with respect to inventions, results or other matter that is owned by the Company pursuant to this Agreement, Licensor, on behalf of itself, Technion and their Affiliates irrevocably waives any claims that inventions, results or other matter created by [***] in the context of performing services under the Consulting Agreement are owned by Licensor, Technion or its Affiliates. Researcher shall not utilize Technion facilities or personnel in connection with activities on behalf of Company unless a research arrangement between Technion and Company is in place. Researcher shall not utilize third party intellectual property or materials in connection with activities contemplated hereunder without Companys prior written consent. The parties acknowledge that notwithstanding anything to the contrary herein, the inventions set forth on Exhibit B (which represents a non-exhaustive list of certain inventions owned by the Company) are owned solely by Company and Licensor has no interest therein. Inventions owned by Company may be exploited, commercialized and transferred without any obligation to Licensor except as expressly set forth in this Agreement with respect to Joint Researcher Improvements. For clarity, where products which incorporate Company Inventions fall within the definition of Licensed Products, the provisions herein applicable to Licensed Products shall apply. For clarity, but without derogating from the previous sentence, it is acknowledged that Company will develop and commercialize products (including, without limitation, products that incorporate Company Inventions) which products not fall within the definition of Licensed Products. Notwithstanding anything to the contrary herein, Company shall have no payment or other obligations to Licensor or Technion with respect to products that are not Licensed Products.
5. License Grant.
5.1. License.
(a) Subject to the terms and conditions set forth in this Agreement, Licensor hereby grants to Company and its Subsidiaries:
(i) | an exclusive, perpetual (subject to termination only in accordance with the terms and conditions in Section 14, below) worldwide, royalty-bearing license, assignable (subject to Section 15.9), with the right to sub-license (in accordance with Section 5.2 below) under Licensors rights in the Licensed Technology to |
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make any and all uses of the Licensed Technology, including, without limitation, the right to use the Licensed Technology for research and development, to commercialize the Licensed Technology in any manner, to research, have researched, develop, have developed, manufacture, have manufactured, use, market, distribute, offer for sale, sell, have sold, export and import Licensed Products and/or provide services relating thereto, (the License). Notwithstanding the foregoing, solely with respect to the patents and patent applications set forth below (Licensor Reference 567 Patents), the License shall be exclusive only with respect to use in connection with TCRL and Licensor reserves the right to license the Licensor Reference 567 Patents to third parties with respect to all other uses: |
SINGLE CHAIN CLASS I MAJOR HISTOCOMPATIBILITY COMPLEXES | ||||||||||||||||
Our Ref Client Ref |
Country | Earliest Priority |
Entry Date |
Filing Date Application No. |
Issue Date Patent No. |
Next Action | Status | Assignee Inventor | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
For purposes of this subsection, the term exclusive means that Licensor shall not itself nor shall it grant licenses or rights to any third party to engage in any of the foregoing except under Licensors reserved academic research rights under paragraph (b) below. Licensor will not transfer, assign, encumber, grant, sell, lease or otherwise dispose of Licensed Technology other than as may be expressly permitted herein.
(ii) an exclusive, perpetual (subject to termination only in accordance with the terms and conditions in Section 14.4(b), below) worldwide, royalty-bearing, assignable, freely sublicensable license under Licensors interest in Joint Researcher Improvements to make any and all uses of the Joint Researcher Improvements, including, without limitation, the right to use the Joint Researcher Improvements for research and development, to commercialize the Joint Researcher Improvements in any manner, to research, have researched, develop, have developed, manufacture, have manufactured, use, market, distribute, offer for sale, sell, have sold, export and import Licensed Products and/or provide services relating thereto. For purposes of this subsection, the term exclusive means that Licensor shall not itself nor shall it grant licenses or rights to any third party to engage in any of the foregoing except under Licensors reserved academic research rights under paragraph (b) below. Licensor will not transfer, assign, encumber, grant, sell, lease or otherwise dispose of its interest in the Joint Researcher Improvements.
(b) Notwithstanding subsection (a) above, Technion shall have the right to make non-commercial, academic use of the Licensed Technology and Joint Researcher Improvements alone or with other academic institutions solely for educational and non-commercial research purposes, including to obtain funding from non-commercial third
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parties (Academic Research); For the removal of doubt, Licensor shall not, and shall ensure that Technion shall not, obtain funding for Academic Research from any party or participate in Academic Research with other academic institutions on terms that (i) give such party any rights to the Licensed Technology or Joint Researcher Improvements that are inconsistent with the rights granted to Company hereunder, or (ii) limit in any manner the scope or terms of the license and rights granted to Company hereunder. This subsection (b) shall not be construed as Companys consent to academic collaborations between [***] and academic institutions other than Technion where [***] has undertaken under the Consulting Agreement not to engage in such inter-academic collaborations without Companys consent.
5.2. Sublicenses.
(a) Sublicense Grant. Company shall be entitled to grant Sublicenses or other rights to Affiliates or third parties under the License subject to the terms of this Section 5.2. During the Royalty Term for the applicable Licensed Technology, such Sublicenses shall be made only for consideration and in bona fide arms length-equivalent transactions.
(b) Sublicense Agreements. Sublicenses shall only be granted pursuant to written agreements, which shall be in compliance and not inconsistent with and subject and subordinate to the terms and conditions of this Agreement. Each such sublicense agreement shall contain, among other things, provisions to the following effect: All provisions necessary to ensure Companys ability to perform its obligations under this Agreement, including its obligations under Sections 7 and 8 hereof. In the event of termination of the License (in whole or in part - e.g. termination in a particular country), any existing agreements that contain a Sublicense of, or other grant of right with respect to, Licensed Technology shall terminate to the extent of such Sublicense or other grant of right; provided, however, that, for each Sublicensee, upon termination of the Sublicense agreement with such Sublicensee, if the Sublicensee is not then in breach of such Sublicense agreement with Company or this Agreement such that Company would have the right to terminate such Sublicense or Licensor would have the right to terminate this Agreement under Section 14.3(b)(i) (Material Breach), Licensor shall be obligated, at the request of such Sublicensee, to enter into a new agreement with such Sublicensee on substantially the same terms as those contained in such Sublicense agreement, and provided further that such terms shall be amended, if necessary, to the extent required to ensure that such Sublicense agreement does not impose any obligations or liabilities on Licensor which are not included in this Agreement. The Sublicensee shall be entitled to further Sublicense its rights under such Sublicense agreement provided that any such Sublicense granted by a Sublicensee shall comply with the terms of this Section 5.2.
(c) Delivery of Sublicense Agreement. Company shall furnish Licensor with a fully executed copy of any such Sublicense agreement, promptly after (and in no event more than [***] following) its execution and shall ensure that any Sublicensee who further Sublicenses its rights (to the extent permitted hereunder) furnishes Company (and Company will provide Licensor) with a fully executed copy of any such Sublicense agreement, promptly after its execution; provided, however, that the Sublicense agreement may be redacted to the extent that it contains terms unrelated to the Licensed Technology or Companys payment obligations to Licensor hereunder. In addition, Company shall provide Licensor with copies of any amendments, as well as side letters that are pertinent to an accounting of Companys obligations under this Agreement and shall provide Licensor with written notice of any consideration received by Company for such Sublicense, including without limitation cash, stock or other form of payment and transfer to Licensor the required consideration in accordance with the terms hereof.
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(d) Breach by Sublicensee. Company undertakes to take all actions reasonably necessary to enforce its material rights under its agreements with Sublicensees and shall use commercially reasonable efforts to ensure that Sublicensees which grant further Sublicenses take all actions reasonably necessary to enforce their rights under such further Sublicense agreements. Any act or omission by a Sublicensee, which would have constituted a breach of this Agreement had it been an act or omission by Company, shall constitute a breach of this Agreement by the Company; provided, however, that to the extent applicable, any such breach shall be subject to a cure period consistent with the terms of this Agreement.
6. Diligence. Company shall use Commercially Reasonable Efforts, and shall cause its Sublicensees to use their Commercially Reasonable Efforts to develop at least one Licensed Product. Subject to Section 15.10 (Force Majeure), if prior to development of the first Licensed Product the Company for a consecutive eighteen (18) month period fails to use Commercially Reasonable Efforts to discover or develop at least one Licensed Product, Licensor shall have the right at its sole discretion, to convert the License to a non-exclusive license, subject to existing third party rights granted by Company to third parties.
7. Consideration for Grant of License
In consideration for the rights and licenses granted to Company under this Agreement, Company shall pay to Licensor the following amounts:
7.1 Royalty Arrangements.
(a) Royalty Rate.
(i) During the Royalty Period (as defined below), in the event that Company itself or an Affiliate of Company will sell Licensed Products under the license, Company shall pay Licensor [***] of Companys or its Subsidiaries Net Sales.
(ii) Notwithstanding subsection (i), where a Licensed Product is claimed by a Valid Claim and only until the expiration of the last Valid Claim claiming such Licensed Product, the royalty rate applicable to such Licensed Product during such period shall [***] of Companys or its Subsidiaries Net Sales, and during such period such royalty shall not be reduced in the manner set forth under subclause (v) below (Time Based Reduction of Royalty Rate). Following issuance of a Valid Claim under a patent application, Company shall pay the difference between royalties paid under subclause (i) and this subclause (ii) for the period between filing of such claim and the date of issuance of the patent which includes such claim. For clarity, where a Licensed Product falling under subsection (i) is bundled with a Licensed Product falling under subsection (ii), the royalty under subsection (ii) shall be applied only to that portion of the Net Sales attributed to the Licensed Product falling under subsection (ii), calculated by reference to the average sale prices of such Licensed Products on a stand-alone basis in such country.
(iii) For clarity, at any point in time the royalty rate applicable to a Licensed Product shall be either as set forth in subsection (i) or subsection (ii) above, and in no event shall the applicable royalty rate exceed [***] of Company or its Subsidiaries Net Sales.
(iv) Reduction of Royalty Rate Following M&A. Upon the consummation of an M&A Transaction (in a single or series of transactions,) having an
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aggregate value of more than [***], the applicable royalty rates for purposes of subclauseses (i) and (ii) above shall be adjusted as follows:
(x) with respect to Licensed Products conceived and reduced to practice (as determined in accordance with United States patent laws) prior to the closing of the M&A Transaction referenced above, the royalty rates then in effect for purposes of subclauses (i) and (ii) above shall be [***].
(y) with respect to Licensed Products conceived and reduced to practice (as determined in accordance with United States patent laws) following the closing of the M&A Transaction referenced above, the royalty rates then in effect for purposes of subclauses (i) and (ii) above shall be [***].
For clarity, contingent payments or other consideration due post-closing in connection with an M&A Transaction are included in the calculation of the value of the transaction effective as of the closing of the transaction.
(v) Time Based Reduction of Royalty Rate. Commencing as of the later of (i) [***] of First Commercial Sale of the first Licensed Product or (ii) January 1, 2030 the royalty rate then in effect shall [***].
(vi) (vi) With the exception of reductions pursuant to Sections 7.1(d) (Generics), 7.3(a) (Third Party Payments) and 7.3(b) (Royalty Cessation), and adjustments for Combination Products, the royalty rate following reductions under subclauses (iv) or (v) above shall [***] of Companys or its Subsidiaries Net Sales.
(b) Royalty Period. The royalty set forth in this Section 7 shall be payable, on a Licensed Product-by-Licensed Product and country-by-country basis, ten (10) years from the date of the First Commercial Sale of such Licensed Product in such country, provided that only where a Licensed Product is covered by a Valid Claim in the country in which it is sold, the royalty term applicable to sales of such Licensed Product in such country shall be the longer of (i) ten (10) years from the date of the First Commercial Sale of such Licensed Product in such country and (ii) expiration of the last to expire Valid Claim claiming such Licensed Product in such country. The applicable period set forth above shall be the Royalty Term.
(c) Adjustment of Net Sales for Combination Products. For purposes of determining royalty payments on sales of Combination Products, Net Sales shall be adjusted by multiplying the actual Net Sales of such Combination Product during the applicable royalty reporting period, by the fraction A/(A+B) where: A is the average sale price of the Licensed Product contained in the Combination Product when sold separately by Company or its Subsidiary in such country; and B is the average sale price of the other Additional Ingredients included in the Combination Product when sold separately by its supplier in such country, in each case during the applicable royalty reporting period or if sales of both the Licensed Product and/or other Additional Ingredients did not occur in such country during such period, then in the most recent royalty reporting period in which sales of both occurred. In the event that such average sale price cannot be determined for both the Licensed Product and all other Additional Ingredients included in the Combination Product, Net Sales for the purpose of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Products by the fraction of C/(C+D) where C is the fair market value of the Licensed Product and D is the fair market value of all other Additional Ingredients included in the Combination Product. In such event, the parties shall negotiate in good faith to arrive at a determination of the
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respective fair market values of the Licensed Product and all other Additional Ingredients included in the Combination Product. Notwithstanding the foregoing, no adjustment of Net Sales shall be made pursuant to this subsection where the Company obtained a license to such Additional Ingredient under a cross-license and where the sole consideration paid by Company for the license to use the Additional Ingredient was a sublicense of rights in Licensed Technology.
(d) Generics adjustment. Notwithstanding the foregoing, if at any time a Generic Product is commercialized and distributed in any particular country by a third party unaffiliated with the Company, its Subsidiaries or a Sublicensee holding license rights in such country, then no royalties shall be due hereunder with respect to Net Sales for such country. Generic Product shall mean on a country-by-country basis, a product (i) having the same composition of matter as the Licensed Product or (ii) which has a marketing approval as a generic product by the Regulatory Agency in such country and, with respect to both (i) and (ii), which could not have been sold or with respect to which a license would have been required to be obtained from Company, if patent or other exclusivity rights covering the Licensed Product would have been in full force and effect.
7.2. Sublicense Receipts. Company shall pay Licensor a share of Sublicense Receipts as follows:
(i) For sublicenses granted prior to IND filing for such Licensed Product: [***] of Sublicense Receipts; or
(ii) For sublicenses granted after IND filing for such Licensed Product [***] of Sublicense Receipts; or
(iv) For sublicenses granted after Regulatory Approval of the first Licensed [***] of Sublicense Receipts;
provided, however, that other than pursuant to subsection 7.3(a)(Third Party Payments) and (b)(Royalty Cessation), Sublicensing Receipts paid to Licensor for any period during the royalty term under sublicenses shall [***] of the applicable Sublicensees net sales (as defined in the Sublicense agreement) for such period.
7.3 Adjustments. Sections 7.1 and 7.2 are subject to the following adjustments:
(a) Third-Party Payments. Amounts due to Licensor under this Agreement (including without limitation Section 7.1 (Royalty Arrangements) and 7.2 (Sublicense Receipts)) shall be reduced as follows:
(i) In the event that:
(1) Company or its Affiliates is required (pursuant to court or arbitration order, settlement or under the advice of patent counsel) to make payments to one or more third parties to obtain a license from such third party(ies) in order to legally practice the Licensed Technology or Joint Researcher Improvements in a particular country as a result of a claim that the Licensed Patent Rights or Joint Researcher Improvement Patent Rights infringe third parties intellectual property rights, or
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(2) Company is required (pursuant to court or arbitration order, settlement or under the advice of patent counsel) to make payments to one or more third parties arising from or relating to a failure of a representation or warranty of Licensor under Section 12.1 hereunder at any time to be true and correct, or
(3) Company makes makes payments to the [***] mice in connection with Licensed Technology, Company Inventions or activities undertaken by or on behalf of Company pursuant to this Agreement.
Company may offset 100% of such third-party payments against payments that are due to Licensor under this Agreement. In the event a third party claims an ownership interest in Licensed Technology or Joint Researcher Improvements, or a third party makes an allegation which, if correct, would result in the failure of any representation or warranty under Section 12.1 hereunder at any time to be true and correct, and in the opinion of counsel Company may be required to make payments to such third party, then upon such allegation or claim and until such time as such claim or allegation is finally resolved Company shall have the right to deposit amounts due to Licensor hereunder into an escrow account pending resolution of such claim or allegation, such amounts to be used in the event payment is required to be made to such third party (provided that such right shall not apply to amounts which, in the opinion of counsel, exceed the potential liability to third parties).
(ii) In the event that other than pursuant to subsection (i) above Company or its Affiliates makes payments (including, without limitation, milestone payments, royalties or other license fees) to third parties in respect of intellectual property incorporated or used in connection with Licensed Products, Company shall have the right to deduct from amounts due to Licensor under this Agreement the following amounts:
(x) for licenses relating to a Licensed Product or its use (including, without limitation, [***] paid by Company to such third party, provided however that in no event shall the amounts due to Licensor during any Calendar Quarter be reduced under this subsection to [***] of Companys Net Sales for such Calendar Quarter.
(y) for all other licenses (including, without limitation, screening technologies or research tools), [***] of the amounts actually paid by Company to such third party; provided, however, that in no event shall the amounts due to Licensor from the Company be reduced under this subsection to less than the greater of (i) [***] of amounts due to Licensor prior to deductions under this subparagraph in any Calendar Quarter.
(iii) Any amount that Licensee is entitled to deduct that exceeds amounts currently due to Technion or is reduced by the limitation on the deduction may be carried forward (subject to the floor referred to under subsection (ii) above) and Company may deduct such amount from subsequent amounts due to Licensor until the full amount that Company was entitled to deduct is deducted.
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(b) Royalty Cessation. On a country-by-country and Licensed Product-by-Licensed Product basis, where:
(i) a Licensed Product was conceived and reduced to practice (as determined in accordance with United States patent law) following the Royalty Cessation Date; and
(ii) as of the date on which payments under Section 7.1 (Royalty Arrangements) and Section 7.2 (Sublicense Receipts) are due pursuant to Section 8.1(b) (Payment) with respect to sales of such Licensed Product, such Licensed Product is not covered by a Valid Claim in the country in which it is sold;
then no payments shall be due to Licensor hereunder with respect to such Licensed Products (including, without limitation, under Section 7.1 (Royalty Arrangements) and Section 7.2 (Sublicense Receipts)) and Company shall have a fully paid-up, worldwide license (with the right to grant sublicenses) under the Licensed Technology and Joint Researcher Improvements to develop, have developed, manufacture, have manufactured, use, market, offer for sale, sell, have sold, import, export, otherwise transfer physical possession of or otherwise transfer title to such Licensed Products. In addition, on a product by product basis, where the first Regulatory Approval for such Licensed Product occurs subsequent to January 1, 2035, no further payments are due in respect of such Licensed Product(including, without limitation, under Section 7.1 (Royalty Arrangements) and Section 7.2 (Sublicense Receipts)) and Company shall have a fully paid-up, worldwide license (with the right to grant sublicenses) under the Licensed Technology and Joint Researcher Improvements to develop, have developed, manufacture, have manufactured, use, market, offer for sale, sell, have sold, import, export, otherwise transfer physical possession of or otherwise transfer title to such Licensed Products.
8. Reports; Payments; Records.
8.1. Reports and Payments.
(a) Quarterly Reports. Within [***] after the conclusion of each Calendar Quarter commencing with the first Calendar Quarter in which Company or an Subsidiary of Company first receives Net Sales or Sublicense Receipts, Company shall deliver to Licensor a report containing the following information (in each instance, with a Licensed Product-by-Licensed Product and country-by-country breakdown):
(i) the number of units of Licensed Products sold by Company and its Subsidiary for the applicable Calendar Quarter, in each country for the applicable Calendar Quarter;
(ii) the gross amount and other consideration received for the Licensed Product sold or leased or otherwise transferred by Company and its Subsidiaries in each country during the applicable Calendar Quarter;
(iii) a calculation of Net Sales for the applicable Calendar Quarter, in each country and for each selling entity including a listing of applicable deductions and a calculation of the amount payable to Licensor thereon;
(iv) the total amount payable to Licensor in U.S. dollars on Net Sales for the applicable Calendar Quarter, together with the exchange rates used for conversion; and
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(v) a calculation of any Sublicense Receipts received during the applicable Calendar Quarter and the amount payable to Licensor with respect thereto.
If no amounts are due to Licensor for any Calendar Quarter, the report shall so state.
(b) Payment. Concurrent with the delivery of each report delivered pursuant to Section 8.1(a), Company shall remit to Licensor all amounts due with respect to Net Sales and Sublicense Receipts for the applicable Calendar Quarter.
8.2. Payments Currency. All payments due under this Agreement shall be payable in United States dollars or in the currency in which they were received, at the election of Company, provided that amounts that were received in euro, Israeli shekels, and pounds sterling shall be paid in the currency in which they were received. Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the United States (as reported in the Wall Street Journal) on the last working day of the applicable Calendar Quarter. Such payments will be without deduction of exchange charges.
8.3. Records. Company shall maintain, and shall cause its relevant Subsidiaries and Sublicensees to maintain, complete and accurate records of Licensed Products and Combination Products that are made, used, leased, marketed, sold or otherwise transferred under this Agreement, any amounts payable to Licensor in relation to such Licensed Products and all Sublicense Receipts received by Company and its Subsidiaries, which records shall include a country-by-country breakdown and contain sufficient information to permit Licensor to confirm the accuracy of any reports or notifications delivered to Licensor under Section 8.1(a). The relevant party shall retain such records relating to a given Calendar Quarter for at least [***] after the conclusion of that Calendar Quarter. During such three [***], Licensor shall have the right, at Licensors expense, to cause an independent, certified public accountant who is bound by a suitable confidentiality arrangement with Company, to inspect Companys and the relevant Subsidiaries records during normal business hours for the sole purpose of verifying any reports and payments delivered under this Agreement. Such accountant shall not disclose to Licensor or any third party any information gained during the course of such inspection, except that such accountant may disclose to Licensor and Company information gained during the course of such inspection relating to the accuracy of reports and payments delivered under this Agreement. The parties shall reconcile any underpayment or overpayment [***] after the accountant delivers the results of the audit. In the event that any audit performed under this subsection reveals an underpayment in excess of [***] in any calendar year, the audited party shall bear the full cost of such audit. Licensor may exercise their rights under this subsection only once every year per audited party and only with reasonable prior notice to the audited party. Company shall cause its relevant Subsidiaries and Sublicensees to fully comply with the terms of this subsection.
8.4. Certified Report. Company shall furnish Licensor, and shall cause its Subsidiaries who make, use, market or sell Licensed Products to furnish Licensor, within [***] after the end of each calendar year, commencing at the end of the calendar year of the First Commercial Sale of a Licensed Product, with that portion of the financial statements of such entity, certified by an independent certified public accountant, which relates directly to Net Revenues or Sublicense Receipts in respect to the previous calendar year.
8.5. Late Payments. Any payments to be paid under this Agreement that are not paid on or before the date such payments are due under this Agreement shall bear interest at an annual interest, compounded monthly, equal to [***] above the London Interbank Offer Rate
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(LIBOR) as determined for each month on the last business day of that month, assessed from the day payment was initially due until the date of payment. Payment of such interest by the Company shall not limit, in any way, Licensors right to exercise any other remedies Licensor may have as a consequence of the lateness of any payment.
8.6. Payment Method. Each payment due to Licensor under this Agreement shall be made by wire transfer of funds to Licensors accounts in accordance with written instructions provided by Licensor and marked so as to refer to this Agreement.
8.7. Withholding and Similar Taxes. All amounts to be paid to Licensor pursuant to this Agreement shall be without deduction of exchange, collection, or other charges, provided that if provision is made in law or regulation for withholding, such tax shall be deducted by Company from the sums otherwise payable by it hereunder for payment to the proper taxing authority on behalf of Licensor and a receipt of payment of the tax secured and promptly delivered to Licensor. Each Party agrees to assist the other Party in claiming exemption from such deductions or withholdings under any double taxation or similar agreement or treaty from time to time in force.
9. Patent Filing, Prosecution and Maintenance.
9.1 Patent Rights. The Company shall, in consultation with Licensor, be responsible for and control the preparation, filing, prosecution, protection and maintenance of all patents and patent applications within the Licensed Technology and Joint Researcher Improvement Patent Rights at its own expense using an independent patent firm or firms as shall be mutually agreed upon by Licensor and the Company. Notwithstanding the foregoing, Licensor shall bear [***] of patent-related costs and expenses (including, without limitation, fees of patent counsel) relating to Licensor Reference [***] Patents. The Company shall (a) instruct such patent counsel to furnish Licensor with copies of all correspondence relating to such patent rights from the United States Patent and Trademark Office (USPTO) and any other patent office, as well as copies of all proposed responses to such correspondence in time for Licensor to review and comment on each such response; (b) give Licensor an opportunity to review the text of each patent application before filing; (c) consult with Licensor with respect thereto; (d) supply Licensor with a copy of the application as filed, together with notice of its filing date and serial number; and (e) keep Licensor advised of the status of actual and prospective patent filings. The Company shall give Licensor the opportunity to provide comments on and make requests of the Company concerning the preparation, filing, prosecution, protection and maintenance of patents and patent applications within the Licensed Technology and Joint Researcher Improvement Patent Rights, and shall consider such comments and requests in good faith.
9.2 Abandonment. Should Company decide that it does not wish to pay for the preparation, filing, prosecution, protection or maintenance of any patent application or patent within the Licensed Technology or Joint Researcher Improvement Patent Rights in any country (each, an Abandoned Patent Right), Company shall provide the Licensor with prompt written notice of such election but in any event at [***] prior to the applicable deadline for the filing of an application or responding to an office action in such country, specifying the country(ies) with respect to which it shall no longer pay for such Abandoned Patent Rights. Upon receipt of such notice by Licensor, Company shall be released from its obligations pursuant to Section 9.1 hereof with respect to such Abandoned Patent Right, provided, however, that the Company shall remain responsible for expenses incurred prior to the receipt by Licensor of such notice.
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9.3 Effect of Abandonment. In the event of Companys abandonment of any patent application or patent as described in subsection 9.2 above, (Abandoned Patent Rights), any license granted to Company hereunder with respect to such Abandoned Patent Rights shall automatically terminate and such Abandoned Patent Rights will no longer be deemed Licensed Technology or Joint Researcher Improvements for purposes of the License. Licensor shall then be free, without further notice or obligation to Company, to grant rights in and to such Abandoned Patent Right to third parties, subject to Companys other rights under this Agreement.
9.4. No Warranty. Nothing contained herein shall be deemed to be a warranty by any of the parties that they can or will be able to obtain patents on patent applications included in the Licensed Patent Rights or Joint Researcher Improvement Patent Rights, or that any of the Licensed Patent Rights or Joint Researcher Improvement Patent Rights will afford adequate or commercially worthwhile protection.
9.5. Company Patents. For clarity, Company shall have full and complete discretion in respect of patenting activities with respect to patenting activities in respect of inventions owned by the Company.
10. Confidential Information
10.1. Confidentiality.
(a) Licensor Confidential Information. Company agrees that, without the prior written consent of Licensor in each case, during and following the term of this Agreement it will keep confidential, and not disclose or use Licensor Confidential Information (as defined below) other than for the purposes of this Agreement. Company shall treat such Licensor Confidential Information with the same degree of confidentiality as it keeps its own confidential information, but in all events no less than a reasonable degree of confidentiality. Company may disclose the Licensor Confidential Information only (a) to employees and consultants of Company or of its Affiliates or Sublicensees who have a need to know such information in order to enable Company to exercise its rights or fulfill its obligations under this Agreement and are legally bound by agreements which impose confidentiality and non-use obligations comparable to those set forth in this Agreement and (b) to actual and potential business partners, collaborators, investors, acquirers, contractors, service providers and consultants, provided, in each case, that such recipient of Confidential Information first enters into a legally binding agreement with Company which imposes confidentiality and non-use obligations with respect to Confidential Information comparable to those set forth in this Agreement. For purposes of this Agreement, Licensor Confidential Information means any scientific, technical, trade or business information relating to the subject matter of this Agreement designated as confidential or which otherwise should reasonably be construed under the circumstances as being confidential disclosed by or on behalf of Licensor, Technion or any of their employees, researchers or students to Company, whether in oral, written, graphic or machine-readable form, except to the extent such information: (i) was known to Company at the time it was disclosed, other than by previous disclosure by or on behalf of Licensor, Technion or any of their employees, researchers to students; (ii) is at the time of disclosure or later becomes publicly known under circumstances involving no breach of this Agreement; (iii) is lawfully and in good faith made available to Company by a third party who is not subject to obligations of confidentiality to Licensor, or Technion with respect to such information; or (iv) is independently developed by Company without the use of or reference to the Licensor Confidential Information.
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(b) Company Confidential Information. Licensor agrees that, without the prior written consent of Company in each case, during and following the term of this Agreement it will keep confidential, and not disclose or use Company Confidential Information (as defined below) other than for the purposes of this Agreement. Licensor shall treat such Company Confidential Information with the same degree of confidentiality as it keeps its own confidential information, but in all events no less than a reasonable degree of confidentiality. Licensor may disclose the Company Confidential Information only to employees and consultants of Licensor or of its Affiliates who have a need to know such information in order to enable Licensor to exercise its rights or fulfill its obligations under this Agreement and are legally bound by agreements which impose confidentiality and non-use obligations comparable to those set forth in this Agreement. For purposes of this Agreement, Company Confidential Information means any scientific, technical, trade or business information relating to the subject matter of this Agreement designated as confidential or which otherwise should reasonably be construed under the circumstances as being confidential disclosed by or on behalf of Company, including without limitation pursuant to Section 8 of this Agreement, whether in oral, written, graphic or machine-readable form, except to the extent such information: (i) was known to Licensor at the time it was disclosed, other than by previous disclosure by or on behalf of Company specifically excluding information disclosed to Licensor by Researcher; (ii) is at the time of disclosure or later becomes publicly known under circumstances involving no breach of this Agreement; (iii) is lawfully and in good faith made available to Licensor by a third party who is not subject to obligations of confidentiality to Company with respect to such information; (iv) is independently developed by Licensor without the use of or reference to the Company Confidential Information; or (v) is required to be disclosed by Licensor pursuant to interrogatories, requests for information or documents, subpoena, civil investigative demand issued by a court or governmental agency of competent jurisdiction or as otherwise required by law (provided that, in such case, Licensor shall notify the Company promptly upon receipt thereof to give the Company the opportunity to seek a protective order or other similar order with respect to such information).
(c) Disclosure of Agreement. Each party may disclose the terms of this Agreement to the extent required, in the reasonable opinion of such partys legal counsel, to comply with applicable laws, as well as to sublicensees and prospective and current investors or acquirers, pursuant to appropriate non-disclosure arrangements. If a party discloses this Agreement or any of the terms hereof in accordance with this subsection, such party agrees, at its own expense, to seek confidential treatment of portions of this Agreement or such terms, as may be reasonably requested by the other party.
(d) Publicity. Except as expressly permitted under subsection (c) above, no party will make any public announcement regarding this Agreement without the prior written approval of the other party.
11. Patent Infringement.
11.1. Enforcement of Patent Rights.
(a) Notice. In the event either party becomes aware of any possible or actual infringement or unauthorized possession, knowledge or use of any Licensed Technology or Joint Researcher Improvements (collectively, an Infringement), such party shall promptly notify the other party and provide it with details regarding such Infringement.
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(b) Suit by Company. Company shall have the right, but not the obligation, to take action in the prosecution, prevention, or termination of any Infringement. Where such litigation involves defending validity and/or enforceability of Licensor Patent Rights, Licensor may elect to appoint its own counsel (at its own expense) to liaise with Companys counsel with respect to such defense, and the Company shall not concede the validity or enforceability of Licensors Patent Rights without the prior written consent of Licensor, which consent shall not be unreasonably withheld or delayed. The expenses of such suit or suits that Company elects to bring, including any expenses of Licensor incurred at Companys request in conjunction with the prosecution of such suits or the settlement thereof, shall be paid for entirely by Company and Company shall hold Licensor free, clear and harmless from and against any and all costs of such litigation, including attorneys fees. In the event Company exercises its right to sue pursuant to this subsection (b), it shall first reimburse itself out of any sums recovered in such suit or in settlement thereof for all costs and expenses of every kind and character, including attorneys fees, involved in the prosecution of any such suit. If, after such reimbursement, any funds shall remain from said recovery, then Licensor shall receive such percentage of such remaining amounts equal to the applicable adjusted Sublicense Receipts payments rate in effect with respect to the relevant Licensed Product at the time of recovery and the remaining percentage of such funds shall be retained by Company.
(c) Suit by Licensor. If Company does not take action in the prosecution, prevention, or termination of any Infringement pursuant to Section (b) above, and has not commenced negotiations with the infringer for the discontinuance of said Infringement, within [***] after receipt of notice to Company by Licensor of the existence of an Infringement, Licensor may elect to do so. The expenses of such suit or suits that Licensor elects to bring, including any expenses of Company incurred at Licensor request in conjunction with the prosecution of such suits or the settlement thereof, shall be paid for entirely by Licensor and Licensor shall hold Company free, clear and harmless from and against any and all costs of such litigation, including attorneys fees. In the event Licensor exercise its right to sue pursuant to this subsection, it shall first reimburse itself out of any sums recovered in such suit or in settlement thereof for all costs and expenses of every kind and character, including reasonable attorneys fees, necessarily involved in the prosecution of any such suit. If, after such reimbursement, any funds shall remain from said recovery, then Company shall receive such percentage of such remaining amounts equal to the applicable Sublicense Receipts payments rate in effect with respect to the relevant Licensed Product at the time of recovery and the remaining percentage of such funds shall be retained by Licensor.
(d) Own Counsel. Each party shall always have the right to be represented by counsel of its own selection and at its own expense in any suit instituted under this section by the other party for Infringement.
(e) Cooperation. Each party agrees to cooperate fully in any action under this section which is controlled by another party, provided that the controlling party reimburses the cooperating party promptly for any costs and expenses incurred by the cooperating party in connection with providing such assistance.
(f) Standing. If a party lacks standing and another party has standing to bring any such suit, action or proceeding, then such other party shall do so at the request of and at the expense of the requesting party. If a party determines that it is necessary or desirable for another party to join any such suit, action or proceeding, the other party shall execute all papers and perform such other acts as may be reasonably required in the circumstances.
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11.2. Legal Action against a Party. Each Party will provide the others with prompt notice of any action, suit or proceeding brought against it, alleging the infringement of the intellectual property rights of a third party by reason of the discovery, development, manufacture, use, sale, importation, or offer for sale of or otherwise due to the use or practice of the Licensed Technology or Joint Researcher Improvements.
12. Warranties; Limitation of Liability.
12.1. Representations and Warranties. Licensor hereby represents and warrants to the Company that (i) it is the registered owner of the Licensed Patent Rights listed in Exhibit A, Licensor has the right to grant the licenses contemplated hereunder free and clear of any rights or claims of any third party, and Licensed Technology and Licensors interest in Joint Researcher Improvements may be exploited in the manner permitted herein without any obligation or liability of the Company or its Affiliates; (ii) neither Licensor nor Technion has granted or will grant any rights in or to Licensed Technology, or Joint Researcher Improvement which are inconsistent with the rights granted to Company under this Agreement; (iii) the provisions of this Agreement, and the execution and delivery of this Agreement and performance by Licensor and Technion hereunder will not violate any provision of applicable law or conflict with, result in or constitute the material breach of any of the terms or conditions of, permit any party to accelerate any right under, renegotiate or terminate, require consent, approval or waiver by any party under any agreement or instrument to which Licensor or Technion are parties or by which they are or will be bound; (iv) no consent of any party or governmental entity is required with respect to the execution and delivery of this Agreement by Licensor or the consummation by Licensor or Technion of the transactions contemplated hereby; (v) with respect to prior agreements granting third parties rights in Licensed Technology (Former License Agreement), there are no surviving obligations under any of the Former License Agreements that would, in any manner, impact or affect rights granted to the Company pursuant to this Agreement, and there are no claims pending or threatened by third parties under any of the Farmer License Agreements that would in any manner impact or affect rights granted the Company hereunder and there is no reason to expect the same; (vi) no technology owned by any party other than Licensor will be provided or licensed to Company under this Agreement; (vii) the Licensor and Technion have not entered and will not enter into any agreement pursuant to which any party has ownership, license or other rights in or to Company Inventions and Licensor or Technion have not used third party materials in a manner that would vest third parties with right in or claims with respect to Company Inventions; and (viii) except as stated in Schedule of 12.1 attached hereto, it has no actual knowledge as of the date hereof of any legal suit or proceeding by a third party against Licensor or Technion contesting the ownership or validity of the Licensed Patent Rights, or claiming that the practice of the Licensed Patent Rights or Company Inventions in the manner contemplated by this Agreement would infringe the rights of such third party and will promptly notify Company of any future such suit, proceeding or claim of which it becomes aware.
12.2. Compliance with Law. Company warrants that it will comply with, and shall ensure that its Subsidiaries and Sublicensees comply with, all local, state, federal, and international laws and regulations relating to the development, manufacture, use, sale and importation of Licensed Products. Without limiting the foregoing, the Company represents and warrants that it will comply with all applicable export control laws and regulations.
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12.3. No Warranty. Licensor makes no warranties whatsoever as to the commercial or scientific value of the Licensed Technology or Joint Researcher Improvements. Except as otherwise expressly set forth in this Agreement (including without limitation Section 12.1), Licensor makes no representation that the manufacture, use or sale of the Licensed Technology, Joint Researcher Improvements or any Licensed Product, or any element thereof, will not infringe the patent or proprietary rights of any third party. Except as otherwise expressly provided in Section 12.1, no party makes any warranty with respect to any technology, patents, goods, services, rights or other subject matter of this Agreement and hereby disclaims warranties of merchantability, fitness for a particular purpose and non-infringement with respect to any and all of the foregoing.
12.4. Limitation of Liability. Notwithstanding anything else in this Agreement or otherwise, neither Licensor nor Company nor any of their Affiliates will be liable to the other with respect to any subject matter of this Agreement under any contract, negligence, strict liability or other legal or equitable theory for (i) any indirect, incidental, consequential or punitive damages or lost profits of such entities (provided that the provisions of Section 7.3.(a)(i) shall apply with respect to any third parties indirect, incidental, consequential or punitive damages or lost profits with respect to which Company is required to make payments) or (ii) cost of procurement of substitute goods, technology or services. Licensors aggregate liability for all damages of any kind arising out of or relating to this Agreement or its subject matter shall not exceed the aggregate amounts paid to Licensor under this Agreement. Notwithstanding the foregoing, Company may set off amounts due from Licensor hereunder (including, without limitation, in connection with Licensors breach of any term hereof or any representation or warranty herein) in excess of such limitation from amounts subsequently due by Company to Licensor, and any amount that Company is entitled to deduct that is reduced by the limitation may be carried forward and Company may deduct such amount from subsequent amounts due to Licensor until the full amount that Company was entitled to deduct is deducted.
13. Indemnification.
13.1 Indemnity. Company shall indemnify, defend, and hold harmless Licensor, Technion, the Researcher and their respective governors, directors, officers, employees, students and agents and their respective successors, heirs and assigns (the Licensor lndemnitees), from and against any liability, damage, loss, or expense (including reasonable attorneys fees and expenses of litigation) incurred by or imposed upon any of the Licensor Indemnitees in connection with any claims, suits, actions, demands or judgments (Claims) to the extent arising out of a third party claim that the development, use, manufacture, promotion, sale or other disposition of Licensed Technology or Licensed Products by the Company its Subsidiaries and Sublicensees, infringes upon such third partys intellectual property rights, except to the extent such Claim relates to or results from a breach of a representation or warranty by Licensor hereunder or from the negligence or willful misconduct of any Indemnified Party. The foregoing indemnification undertaking shall extend, without limitation, to product liability claims and damages, and to claims, demands, liabilities, losses, costs and expenses attributed to death, personal injury or property damage, or to penalties imposed on account of the violation of any law, regulations or governmental requirement, or any other theory of liability.
13.2. Procedures. If any Licensor Indemnitee receives notice of any Claim, such Licensor Indemnitee shall, as promptly as is reasonably possible, give Company notice of such Claim; provided, however, that failure to give such notice promptly shall only relieve Company
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of any indemnification obligation it may have hereunder to the extent such failure diminishes the ability of Company to respond to or to defend the Licensor Indemnitee against such Claim. Licensor and Company shall consult and cooperate with each other regarding the response to and the defense of any such Claim and Company shall, upon its acknowledgment in writing of its obligation to indemnify the Licensor Indemnitee, be entitled to and shall assume the defense or represent the interests of the Licensor Indemnitee in respect of such Claim, that shall include the right to select and direct legal counsel and other consultants to appear in proceedings on behalf of the Licensor Indemnitee and to propose, accept or reject offers of settlement, all at its sole cost. Nothing herein shall prevent the Licensor Indemnitee from retaining its own counsel and participating in its own defense at its own cost and expense.
13.3. Insurance. Commencing upon the first clinical trial in humans, Company shall maintain insurance that is reasonably adequate to fulfill any potential obligation to the Licensor Indemnitees consistent with industry standards. Company shall provide Licensor, upon request, with written evidence of such insurance and include Licensor as a beneficiary under such insurance policy. The Company shall continue to maintain such insurance after the expiration or termination of this Agreement during any period in which the Company continues to make, use, or sell Licensed Products, and thereafter for a [***] and shall be relieved of the obligation to maintain such insurance where a Sublicensee maintains such reasonably adequate insurance.
14. Term and Termination.
14.1. Term. The term of this Agreement shall commence on the Execution Date and, unless earlier terminated as provided in this Section 14, shall continue in full force and effect on a Licensed Product-by-Licensed Product country-by-country basis until the expiration of the Royalty Term with respect to such Licensed Product in such country.
14.2. Effect of Expiration. Following the expiration of this Agreement pursuant to on a Licensed Product-by-Licensed Product and country-by-country basis (and provided the Agreement has not been earlier terminated pursuant to Section 14.3, in which case Section 14.4(a) shall apply), Company shall have a fully paid-up, exclusive worldwide license (with the right to grant sublicenses) under the Licensed Technology and Licensors interest in Joint Researcher Improvements to develop, have developed, manufacture, have manufactured, use, market, offer for sale, sell, have sold, import, export, otherwise transfer physical possession of or otherwise transfer title to such Licensed Products.
14.3. Termination.
(a) Termination without Cause. Company may terminate this Agreement upon [***] prior written notice to Licensor.
(b) Termination for Default.
(i) Material Breach. In the event that Company commits a material breach of its obligations under this Agreement and fails to cure that breach [***] after receiving written notice thereof from Licensor, Licensor may terminate this Agreement immediately upon written notice to Company. In the event that Licensor commits a material breach of its obligations under this Agreement and fails to cure that breach [***] after receiving written notice thereof from Company, Company may terminate this Agreement immediately upon written notice to Licensor. Notwithstanding the foregoing, in the event that any breach is not susceptible of cure within the stated period and the breaching party uses diligent good faith efforts to cure such breach, the stated period will be extended (one time for each breach) by an additional [***].
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(ii) Bankruptcy. Either Company or Licensor may terminate this Agreement upon notice to the other if the other party becomes insolvent, is adjudged bankrupt, applies for judicial or extra-judicial settlement with its creditors, makes an assignment for the benefit of its creditors, voluntarily files for bankruptcy or has a receiver or trustee (or the like) in bankruptcy appointed by reason of its insolvency, or in the event an involuntary bankruptcy action is filed against the other party and not dismissed [***], or if the other party becomes the subject of liquidation or dissolution proceedings or otherwise discontinues business. Notwithstanding the foregoing, in the event a receiver or trustee (or the like) is appointed or Company has entered into a settlement with its creditors and Company is otherwise meeting its obligations pursuant to this Agreement, Licensor shall not be entitled to terminate this Agreement as contemplated hereunder during such period. For purposes of the preceding sentence, Licensed Technology and each Joint Researcher Improvement shall be treated separately and Licensor shall not be entitled to terminate Companys exclusive rights in a Joint Researcher Improvement where Company is otherwise meeting its obligations pursuant to this Agreement with respect to such Joint Researcher Improvement.
14.4. Effect of Termination.
(a) Termination of Rights. Upon termination of this Agreement by Company or by Licensor under Section 14.3, (a) the rights and licenses granted to Company under the License shall terminate; (b) all rights in and to the Licensed Technology shall revert to Licensor and Company shall not be entitled to make any further use whatsoever of the Licensed Technology and (c) any existing agreements that contain a sublicense of the Licensed Technology shall terminate to the extent of such sublicense; provided, however, that, for each Sublicensee, upon termination of the sublicense agreement with such Sublicensee, Licensor shall be obligated, at the request of such Sublicensee (who is not then in breach of the Sublicense agreement such that the Company would have the right to terminate such Sublicense agreement), to enter into a new license agreement directly with such Sublicensee on substantially the same terms as those contained in such Sublicense agreement, provided that such terms shall be amended, if necessary, to the extent required to ensure that such sublicense agreement does not impose any obligations or liabilities on Licensor which are not included in this Agreement.
(b) Notwithstanding anything to the contrary set forth herein, for purposes of Section 14, (i) Companys activities in relation to each Joint Researcher Improvement shall be considered separately from Companys activities in relation to other Joint Researcher Improvements and Licensed Technology, (ii) a breach of Companys obligations with respect to Licensed Technology shall not give Licensor the right to terminate Companys exclusive rights in Joint Researcher Improvements, and (iii) only where Company commits a material breach of its obligations in respect of a Joint Researcher Improvement under this Agreement and fails to cure such breach within [***] after receiving written notice thereof from Licensor, Licensor may terminate the exclusive license granted under Section 5.l(a)(ii) to Company in Licensors interest in such Joint Researcher Improvement. Following such termination Licensor and Company will each have the right to exploit such Joint Researcher Improvement with respect to which Companys exclusive rights have been terminated and related Joint Researcher Patent Rights without any obligation or accounting to the other, provided that where prior to the date of such termination Company has granted a license in such Joint Researcher Improvement (each such a license, a Joint Researcher Improvement Agreement), upon
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termination of Companys exclusive rights in such Joint Researcher Improvement, if the other party to the Joint Researcher Improvement Agreement is not then in breach of such Joint Researcher Improvement Agreement such that Company would have the right to terminate such Joint Researcher Improvement Agreement, Licensor shall be obligated, at the request of such party, to enter into a new agreement with such party on substantially the same terms as those contained in such Joint Researcher Improvement Agreement, and provided farther that such terms shall be amended, if necessary, to the extent required to ensure that such Joint Researcher Improvement Agreement does not impose any obligations or liabilities on Licensor which are not included in this Agreement. Following termination of Companys exclusive rights in any Joint Researcher Improvement, the provisions of Section 9 shall remain in effect with respect to such Joint Researcher Improvement, provided that the parties shall share patenting costs and expenses. Where Licensor does not wish to pay its share of future patenting costs, the provisions of subsections 9.2 shall apply, mutatis mutandis.
(c) Accruing Obligations. Termination or expiration of this Agreement shall not relieve the parties of obligations accruing prior to such termination or expiration, including obligations to pay amounts accruing hereunder up to the date of termination or expiration.
(d) Survival. The parties respective rights, obligations and duties under Sections 1, 2, 4, 7 (as set forth in subsections 7.3(d) and 14(c)), 10, 11, 12, 13, 14, 15, as well as any rights, obligations and duties which by their nature extend beyond the expiration or termination of this Agreement, and outstanding payment obligations shall survive any expiration or termination of this Agreement.
15. Miscellaneous.
15.1. Publications. Researcher agrees, and Licensor shall use its best efforts to ensure, that no publications in writing, in scientific journals or otherwise, or presentations or other public oral disclosures relating to the Licensed Technology or Joint Researcher Improvements are published or presented, as the case may be, by Researcher or by any researcher, employee or student of the Technion, without the prior written consent of Company, which consent shall not be unreasonably withheld or delayed. Licensor shall provide Company with a written copy of the material to be so submitted or presented, and shall allow Company to review such submission to determine whether the publication or presentation contains subject matter for which patent protection should be sought prior to publication or presentation and to identify trade secrets or know-how the disclosure of which could be detrimental to Company or its sublicensees. Company undertakes to reply in writing to any such request for consent by Licensor [***] of application. If no response is made within this period, such consent shall be deemed to be granted. Company may only decline such an application upon reasonable grounds, which shall be detailed in writing. Should Company decide not to allow publication or presentation as provided above, [***] from the date of submission of the request to Company, in order to enable the necessary patent filings to be made. After such [***] period, the researcher, employee or student, as applicable, shall be free to publish or present the postponed publication as edited as aforesaid in any manner he or she sees fit. Where Licensor uses its best efforts as aforesaid, Licensor will bear no liability for Researchers failure to comply with the provisions of this section.
15.2. Notices. Unless otherwise specifically provided, all notices required or permitted by this Agreement shall be in writing and may be delivered personally, or may be sent by facsimile or certified mail, return receipt requested, to the following addresses, unless
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the parties are subsequently notified of any change of address in accordance with this Section 15.2:
If to Company:
Applied Immune Technology Ltd.
Gutwirth Industrial Park, Technion City, Haifa
32000 Israel
Attn: Chief Executive Officer
With a copy (which shall not constitute notice) to:
Yigal Amon & Co., Law Offices
POB 69
Jerusalem, 91000
Israel
Attention: Barry Levenfeld
Fax: +972-2-623-9236
If to Licensor:
Technion Research and Development Foundation Ltd.
Technology Transfer Office
Technion City, Senate Bldg.
Technion City
Haifa 32000
Attention: Manager
With a copy (which shall not constitute notice) to:
Shibolet & Co., Advocates & Notary
4 Berkowitz Street
Museum Tower
Tel Aviv 64238, Israel
Attn.: Adv. Amir S. Iliescu
Telephone: +972-3-777-8333
Facsimile: +972-3-777-8444
Email: A.Iliescu@shibolet.com
Any notice shall be deemed to have been received as follows: (i) by personal delivery, upon receipt; (ii) by facsimile, one business day after transmission or dispatch; (iii) by airmail, three (3) business days after delivery to the postal authorities by the party serving notice. If notice is sent by facsimile, a confirming copy of the same shall be sent by mail to the same address.
15.3. Governing Law and Jurisdiction. This Agreement shall be governed by and construed in accordance with the laws of the State of Israel, without regard to the application of principles of conflicts of law, except for matters of patent law and inventorship of patents, which shall be governed by United States patent laws The parties hereby consent to personal jurisdiction in Israel and agree that any lawsuit they file to enforce their respective rights under this Agreement shall be brought exclusively in the competent court in Tel Aviv, Israel.
15.4. Binding Effect. This Agreement shall be binding upon and inure to the benefit of the parties and their respective legal representatives, successors and permitted assigns.
15.5. Headings. Section and subsection headings are inserted for convenience of reference only and do not form a part of this Agreement.
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15.6. Entire Agreement; Counterparts. This Agreement is the sole agreement with respect to the subject matter hereof among the parties hereto and except as expressly set forth herein, and with respect to obligations between the Company and [***] or an entity connected with [***], without derogating from the provisions of the Consulting Agreement, supersedes all other agreements and understandings between the parties with respect to same. Without limiting the foregoing, any research, consulting or other agreements between the Company and Technion or the Researcher signed prior to the Execution Date are hereby deemed amended to reflect the terms set forth herein. This Agreement may be executed simultaneously in two or more counterparts, each of which shall be deemed an original.
15.7. Amendment; Waiver. This Agreement may be amended, modified, superseded or canceled, and any of the terms may be waived, only by a written instrument executed by each party or, in the case of waiver, by the party waiving compliance. The delay or failure of any party at any time or times to require performance of any provisions hereof shall in no manner affect the rights at a later time to enforce the same. No waiver by either party of any condition or of the breach of any term contained in this Agreement, whether by conduct, or otherwise, in any one or more instances, shall be deemed to be, or considered as, a further or continuing waiver of any such condition or of the breach of such term or any other term of this Agreement.
15.8. No Agency or Partnership. Nothing contained in this Agreement shall give either party the right to bind the other, or be deemed to constitute either party as agent for the other party or for any third party.
15.9. Assignment and Successors. This Agreement may not be assigned by either party without the consent of the other, which consent shall not be unreasonably withheld, except that each party may, without such consent, assign this Agreement and the rights, obligations and interests of such party, in whole or in part, to any of its Affiliates, to any purchaser of all or substantially all of its shares, or all or substantially all of the assets or research to which the subject matter of this Agreement relates, or to any successor corporation resulting from any merger or consolidation of such party with or into such corporation.
15.10. Force Majeure. Neither party will be responsible for delays resulting from causes beyond the reasonable control of such party, including without limitation fire, explosion, flood, regulatory delay, war, strike, riot, government regulation or intervention, provided that the nonperforming party uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed.
15.11. Interpretation. The parties hereto acknowledge and agree that: (i) each party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (ii) the rule of construction to the effect that any ambiguities are resolved against the drafting party shall not be employed in the interpretation of this Agreement; and (iii) the terms and provisions of this Agreement shall be construed fairly as to both parties hereto and not in favor of or against either party, regardless of which party was generally responsible for the preparation of this Agreement.
15.12. Severability. If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competent jurisdiction or is deemed unenforceable, it is the intention of the parties that the remainder of this Agreement shall not be affected.
28
15.13. Use of Name. The Company shall not, and shall ensure that its Subsidiaries shall not, use the name or insignia of Technion or Licensor or the name of any of Technions or Licensors officers, faculty, employees, other researchers or students, or any adaptation of such names, in any advertising, promotional or sales literature, including without limitation any press release, without the prior written approval of Licensor. The Company shall include a similar restriction in its agreements with Sublicensees.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
29
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as of the date first written above.
Technion Research and Development Foundation Ltd. | ||||||||
By: | /s/ Mira Peled-Kamar |
By: | /s/ [Authorized Signatory] | |||||
Name: | Mira Peled-Kamar | Name: | [Authorized Signatory] | |||||
Title: | CEO | Title: | Authorized Signatory |
I, the undersigned, hereby confirm that I have read the Agreement, that its contents are acceptable to me and that I will act in accordance with the obligations applicable to me set forth herein.
/s/ [Authorized Signatory] |
[***] |
30
Exhibit 10.28
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH [***]. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
AMENDMENT NO. 1 TO AMENDED AND RESTATED LICENSE AGREEMENT
This Amendment No. 1 to Amended and Restated License Agreement (collectively with exhibits and appendices hereto, the Amendment) is entered into on June 30th, 2015 (Execution Date) by and between the Technion Research and Development Foundation Ltd. having a place of business at Senate house, Technion City, Haifa Israel (Licensor), acting on behalf of itself and the Technion- Israel Institute of Technology, and Applied Immune Technology Ltd., a company organized under the laws of the State of Israel and having a place of business at Gutwirth Industrial Park, Technion City, Haifa 32000 Israel (Company).
WHEREAS, Licensor is the wholly-owned subsidiary of Technion Israel Institute of Technology (the Technion) and serves as its technology licensing arm; and
WHEREAS, the parties entered into an Amended and Restated License Agreement dated as of May 21, 2014 (the License Agreement); and
WHEREAS, the Parties have agreed to amend the License Agreement to clarify that TCRL compounds directed to a peptide that is presented by [***] within the scope of the technology licensed to Company under the License Agreement; and
WHEREAS, notwithstanding the foregoing, the parties have agreed that the Existing Patents (as defined below) are expressly excluded from the scope of the license and AIT shall have no right or interest therein; and
WHEREAS, Company wishes to fund research in the field of [***] in the laboratory of [***] (Researcher) at the Technion on the terms and subject to the conditions set forth below.
NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby agree as follows:
1. | Amendment to License Agreement. Effective as of March 1, 2005, the definitions of TCRL and TCRL Compound in the License Agreement shall be deleted and replaced by the following: |
TCRL means any biological or non-biological binding moiety [***].
TCRL Compound means a specific compound comprising a biological or non-biological binding moiety [***].
For clarity, except as otherwise set forth in this Amendment, references in the Agreement to MHC shall be deemed to relate to both [***] as appropriate. For clarity, notwithstanding the terms of this Amendment or anything to the contrary set forth in the License Agreement, the patent applications listed in Exhibit A to this Amendment (Existing [***]), which, to TRDFs knowledge, are the sole patent applications filed in the name of the Researcher or Technion as of the date hereof relating to [***] complexes recognized by T-cells, are expressly excluded from the scope of the licenses granted AIT under the License Agreement, are expressly excluded from the definition of Licensed Patent Rights under the License Agreement, and AIT shall have no right or interest therein.
2. | The following clause is hereby added at the end of existing Section 14.4(b) of the License Agreement: |
Notwithstanding anything to the contrary set forth herein, for purposes of Section 14, Companys and/or Licensors activities in relation [***] shall be considered separately from Companys and/or Licensors activities in relation to other Licensed Technology, {ii) a breach of Companys and/or Licensors obligations with respect to [***] shall not give Licensor the right to terminate Companys exclusive rights in other Licensed Technology, (iii) only where Company commits a material breach of its obligations in respect of [***] under this Agreement and fails to cure such breach [***] after receiving written notice thereof from Licensor, Licensor may terminate the exclusive license granted in [***] under Section 5.1(a)(ii) and (iv) Company shall not have any rights to deduct or withhold payments and shall not deduct or withhold payments otherwise due to Licensor with respect to any Licensed Technology (which does not include [***]) due to any potential liability or indebtedness in connection with [***] and Company shall not have any rights to deduct or withhold payments and shall not deduct or withhold payments otherwise due to Licensor with respect to [***] due to any potential liability or indebtedness in connection with any Licensed Technology (which does not Include [***]).
3. | Funded Research; Inclusion of [***] in Licensed Technology. |
(a) | Company agrees to fund research in Researchers laboratory at the Technion relating to [***] complexes recognized by T-Cells in an [***] for a period [***] from the Execution Date of this Amendment (Initial Research Period). Such amount may be increased, subject to agreement on a research plan, by the parties mutual agreement in their discretion. Company may cease providing such research funding in the event of breach under the License Agreement, if [***] ceases to be available to perform the research or if the License Agreement is terminated for any reason. Company may, but shall not be obligated, to continue such funding in its discretion for additional periods, subject to the Parties mutual agreement in writing. |
The Parties further agree that, subject to the provisions of Section 2 above, the diligence requirements under Section 6 of the License Agreement shall apply to [***] mutatis mutandis.
(b) | Without limiting the Parties rights under the License Agreement, during the Initial Research Period and any subsequent period in which Company funds research relating to [***] in the Researchers laboratory at the Technion, all results or inventions relating to [***] created by or under the supervision of the Researcher at the Technion ([***]) (collectively, Research Results) will be automatically deemed Researcher Improvements under the license Agreement, provided that Research Results that are specific TCRL Compounds ([***]) will be Joint Researcher Improvements. |
(c) | The terms of the License Agreement relating to Researcher Improvements and Joint Researcher Improvements (as applicable) apply equally to Research Results, including without limitation the provisions of Section 7 (Consideration for Grant of License). For clarity, provided the funding commitment in paragraph (a) above is met, the terms of this paragraph apply to Research Results even if aggregate research funding provided by Company to Technion for research in Researchers laboratory is [***]. |
(d) | During the Initial Research Period and any subsequent period in which Company funds research relating to [***] in the Researchers laboratory at the Technion, the Researcher undertakes that he will first notify and coordinate with the Company in writing before engaging in collaborations with third parties or using third party intellectual property in connection with [***] research, and if the Company objects in writing during the [***] period following receipt of said notice he will either find an alternative acceptable to the Company or abstain from performing the research using |
funding from the Company. It is hereby agreed by the Parties that the limitations contained in this subclause (d) shall not affect any research by or under the supervision of the Researcher which commenced prior to the Effective Date in the Researchers laboratory at the Technion, provided that in each case (i) no funding from Company is used in connection with such research; and (ii) for collaborations with third parties or use of third party intellectual property in connection with [***] research performed following the Execution Date, Company has received written notice of such. |
(e) | Notwithstanding the terms of paragraphs (b} and (c) above, the side letter between Licensor and the [***] investors named therein [***] will not apply to elements of Licensed Technology that are [***] complexes relating to TCRLs. Solely with respect to the foregoing, the following representations and warranties replace the representations and warranties set forth in Section 12.1 of the License Agreement: |
Licensor hereby represents and warrants to the Company that (i) neither Licensor nor Technion has granted or will grant any rights in or to Licensed Technology, or Joint Researcher Improvement which are inconsistent with the rights granted to Company under this Agreement; and (ii) the Licensor and Technion have not entered and will not enter into any agreement pursuant to which any party has ownership1 license or other rights in or to Company Inventions.
4. | General. Capitalized terms used and not otherwise defined in this Amendment shall have the meanings ascribed to such terms under the License Agreement. The terms of this Amendment shall be deemed an integral part of the License Agreement. Other than as specifically amended herein, the provisions, terms and conditions of the license Agreement shall remain unchanged and in full force and effect. |
[Remainder of page intentionally left blank]
IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their duly authorized representatives as of the date first written above.
Applied Immune Technologies Ltd. | Technion Research and Development Foundation Ltd. | |||||||
By: | /s/ Mira Peled-Kamar |
By: | /s/ [Authorized Signatory] | |||||
Name: | Mira Peled-Kamar | Name: | [Authorized Signatory] | |||||
Title: | CEO | Title: | Authorized Signatory |
I, the undersigned, hereby confirm that I have read this Amendment No. 1 to License Agreement, that its contents are acceptable to me and that I will act in accordance with the obligations applicable to me set forth herein.
/s/ [Authorized Signatory] |
[***] |
Exhibit 10.29
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH [***]. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
AMENDMENT No. 2 TO
AMENDED AND RESTATED LICENSE AGREEMENT
This Amendment No. 2 to Amended and Restated License Agreement (this Amendment) dated as of January 13, 2016 (the Effective Date), is entered into among Technion Research and Development Foundation Ltd. (TRDF), Applied Immune Technology Ltd. (AIT), and Adicet Bio Inc. (Adicet) (TRDF, AIT and Adicet, collectively, the Parties), with respect to the following facts:
TRDF and AIT are parties to the Amended and Restated License Agreement entered into on May 21st, 2014, and its Amendment No. 1 dated June 30th, 2015, as may be further amended or restated from time to time (collectively, the License Agreement). All capitalized terms used, but not defined, herein shall have the respective meanings set forth in the License Agreement.
The Parties desire to amend the License Agreement in certain respects and agree to the other provisions of this Amendment.
Now, therefore, the Parties hereby agree as follows:
1. The License Agreement hereby is amended as follows:
1.1 For purposes of Section 2 (Definitions), Section 7 (Consideration for Grant of License) (as amended hereby) and Section 8 (Reports; Payments; Records) of the License Agreement and the defined terms as used therein, Licensed Product shall mean any product (a) which entirely or partially (1) comprises or incorporates technology developed by or in collaboration with, licensed to, controlled or otherwise acquired by Adicet Bio Inc. (Adicet) or its Subsidiaries or Affiliates controlled by it (without regard to the [***] requirement in the definition of Subsidiary (a Downstream Affiliate) or by AIT or its Subsidiaries or its Downstream Affiliates (including but not limited to the Licensed Technology and Joint Researcher Improvements) (the Adicet Licensed Product and the AIT Licensed Product, respectively), or (2) the making, using or selling of which falls within the scope of the Licensed Technology or Joint Researcher Improvements, and (b) for which an IND is granted on or prior to December 31, 2024.
In addition, the following defined terms under Section 2 of the License Agreement shall be deleted and the corresponding provisions in the License Agreement shall be revised accordingly: Additional Ingredient, Combination Product, Royalty Cessation Date and Valid Claim.
1.2 Section 7.1 of the License Agreement is amended and restated to read in full as follows:
7.1 Royalties. During the Royalty Period (as defined below), in the event that Company itself or any Subsidiary or Downstream Affiliates of Company or Adicet will sell Licensed Products, Company shall pay Licensor a running royalty equal [***] of Net Sales by Company itself or any Subsidiary or Downstream Affiliates of Company or Adicet. Notwithstanding anything to the contrary herein, Company or Adicet shall not owe to Licensor (and Licensor shall not be entitled to receive) any royalties on any sales by Adicet, AIT or their respective Subsidiaries or Downstream Affiliates to each other but shall not derogate from any obligations to pay royalties on sales to third parties.
1
1.3 Section 7.2 of the License Agreement is amended and restated to read in full as follows:
7.2 Sublicense Receipts. During the Royalty Period, in the event that a Sublicensee itself or any Subsidiary or Affiliates of Sublicensee will sell Licensed Products, Company shall pay Licensor the lesser of (a) [***] sales of Licensed Products by Sublicensee itself or any Subsidiary or Affiliates of Sublicensee (as defined in the sublicense agreement), or (b) except if a Sublicensee is an Affiliate of Company or Adicet (in which case only the preceding subsection (a) will apply), [***] of the amounts received by Company or Adicet or its Subsidiary or Downstream Affiliate in the form of royalties on net sales of Licensed Products by Sublicensee itself or any Subsidiary or Affiliates of Sublicensee (as defined in the sublicense agreement). Company shall owe no other sublicense-related payments. Notwithstanding anything to the contrary herein, Company or Adicet shall not owe to Licensor (and Licensor shall not be entitled to receive) royalties based on any amounts received by Adicet, AIT or their respective Subsidiaries or Downstream Affiliates from each other, but shall not derogate from any obligations to pay royalties on sales to third parties.
1.4 Section 7.3 of the License Agreement is amended and restated to read in full as follows:
7.3 Royalty Period and No Adjustments. Royalty Period shall mean, with respect to each Licensed Product, ten (10) years after the First Commercial Sale of such Licensed Product, on a Licensed Product-by-Licensed Product basis. There shall be no adjustments or offsets to the royalty obligations hereunder (including, without limitation, adjustments or offsets for combination products, third party royalty stacking, generic products, M&A or time based adjustments). Other than the payments expressly set forth in Sections 7.1 and 7.2, Adicet, AIT and their respective Affiliates shall not owe to Licensor any payments in connection with the sale of Licensed Products or the sublicense of the Licensed Technology or Joint Researcher Improvements. For the avoidance of any doubt, nothing herein shall derogate from the commitment by the Company to pay for the preparation, filing, prosecution, protection and maintenance of all patents and patent applications within the Licensed Technology and Joint Researcher Improvement Patent Rights in accordance with Section 9 to the License Agreement and to fund the research in Researchers laboratory at the Technion relating to [***] complexes recognized by T-Cells during the Initial Research Period as stated in Amendment No. 1.
1.5 Unless terminated in accordance with the terms of the Agreement, it is hereby clarified that the term of the Agreement as set forth in Section 14.1 of the License Agreement shall not be sooner than the Royalty Period as such term is defined herein.
1.6 In the event of a termination pursuant to Section 14.3(a) (Termination without Cause), the obligations of Company to pay royalties under Section 7 of the License Agreement and Adicet to pay royalties under Section 2 of this Amendment shall survive such termination with respect to those Licensed Products for which an IND was granted prior to the date of such termination ([***]) as well as any obligations which in accordance with the License Agreement are intended to survive termination.
2. Adicet shall be bound by the obligations under Section 7 (Consideration for Grant of License) (as amended hereby) and Section 8 (Reports; Payments; Records) of the License Agreement with respect to sales of any Licensed Product by Adicet, its Subsidiaries or Downstream Affiliates, or Sublicensees, its Subsidiaries or Affiliates. It is hereby clarified that this provision shall not be affected by any termination or assignment of the License Agreement or any disposition of AIT or AITs assets or securities.
2
3. Without derogating or amending the provisions of Section 2 above in any manner and in addition thereto, Adicet shall also be jointly and severally bound by the obligations of AIT under the License Agreement, including without limitation Section 7 (Consideration for Grant of License) (as amended hereby) and Section 8 (Reports; Payments; Records) of the License Agreement, with respect to the Licensed Products only for so long as Adicet directly or indirectly owns or controls AIT; provided, however, without limiting Adicets obligation under Section 2 of this Amendment, upon the sale, transfer or change of control to a third party of control of AIT, such third party thereafter shall be jointly and severally bound by the obligations of AIT under the License Agreement, including without limitation Section 7 (Consideration for Grant of License) (as amended hereby) and Section 8 (Reports; Payments; Records) of the License Agreement. Nothing herein shall relieve Adicet from its obligations under Section 2 of this Amendment regarding Adicet Licensed Products. Adicet additionally shall remain bound by all the terms and conditions of any sublicense agreement with AIT.
4. If a third party acquires Adicet and its Subsidiaries or Downstream Affiliates in an M&A Transaction, then Licensed Products shall exclude all products of the acquiror or its Affiliates (other than Adicet and its Subsidiaries and Downstream Affiliates) provided that such products do not comprise or incorporate technology owned or controlled by Adicet or its Subsidiaries or Downstream Affiliates, or by AIT or its Subsidiaries or Downstream Affiliates (including without limitation the Licensed Technology and Joint Researcher Improvements).
5. If a third party acquires AIT and its Subsidiaries or Downstream Affiliates in an M&A Transaction, then Licensed Products shall exclude all products of the acquiror or its Affiliates (other than AIT and its Subsidiaries and Downstream Affiliates) provided that such products do not comprise or incorporate technology owned or controlled by Adicet or its Subsidiaries or Downstream Affiliates, or by AIT or its Subsidiaries or Downstream Affiliates (including without limitation the Licensed Technology and Joint Researcher Improvements) and further provided that in such M&A Transaction, Adicet shall not be relieved from its obligations under Section 2 of this Amendment regarding Adicet Licensed Products without TRDFs written consent which shall not be unreasonably withheld.
6. Without limiting Adicets obligations under this Amendment, Adicet shall have the option to acquire and assume from AIT all rights and obligations of Company set forth in the License Agreement with respect to all but not part of the licensed intellectual property and technology thereunder.
7. As of the date hereof, the License Agreement is in full force and effect, and TRDF is not aware of any facts or circumstances that may indicate that AIT has not used Commercially Reasonable Efforts to discover or develop at least one Licensed Product.
8. Other than as specifically amended herein, the provisions, terms and conditions of the License Agreement shall remain unchanged and in full force and effect.
9. Nothing herein shall be construed (a) as providing Adicet or AIT or their respective Affiliates with any ownership or license rights to any intellectual property beneficially owned by TRDF other than the intellectual property subject to the License Agreement, or (b) as providing TRDF with any ownership or license rights to any intellectual property beneficially owned by Adicet or AIT or their respective Affiliates.
3
The effectiveness of this Amendment is conditioned upon the closing of that certain Series A Preferred Stock Purchase Agreement dated as of January 13, 2016, regarding, and the closing of, the acquisition by Adicet of AIT. To the extent such closings do not occur by June 30, 2016, this Amendment shall be void and null, ab initio.
Accepted and Agreed: | ||
Adicet Bio Inc. | ||
By: | /s/ Aya Jakobovits | |
Title: | President & CEO | |
Date: | January 13, 2016 | |
Accepted and Agreed: | ||
Applied Immune Technology Ltd. | ||
By: | /s/ Mira Peled-Kamar | |
Title: | CEO | |
Date: | January 13, 2016 | |
Accepted and Agreed: | ||
Technion Research and Development Foundation Ltd. | ||
By: | /s/ [Authorized Signatory] | |
Title: | [Authorized Signatory] | |
Date: | January 13, 2016 | |
Accepted and Agreed: | ||
/s/ Authorized Signatory | ||
[***] | ||
Date: | January 13, 2016 |
4
Exhibit 10.30
FINAL
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH [***]. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
LICENSE AND COLLABORATION AGREEMENT
By and Between
REGENERON PHARMACEUTICALS, INC.
and
ADICET BIO, INC.
Dated as of July 29, 2016
TABLE OF CONTENTS
Page
ARTICLE 1 | DEFINITIONS |
1 | ||
ARTICLE 2 | RESEARCH PROGRAM |
27 | ||
2.1 | Research Program |
27 | ||
2.2 | Term of the Research Program. |
29 | ||
2.3 | Research Plans; Research Plan Activities |
30 | ||
2.4 | Research Plan Performance. |
31 | ||
2.5 | Target List. |
33 | ||
2.6 | Exchange of Information and Materials. |
35 | ||
2.7 | Restrictions on Use of Regeneron Mice |
35 | ||
ARTICLE 3 | RESEARCH PROGRAM GOVERNANCE |
36 | ||
3.1 | The Joint Research Committee. |
36 | ||
3.2 | Alliance Management |
37 | ||
ARTICLE 4 | EXCLUSIVITY |
38 | ||
4.1 | Exclusivity |
38 | ||
4.2 | Exceptions to Adicets Exclusivity Obligations. |
40 | ||
4.3 | Change of Control and Acquired Competing Programs and Products |
40 | ||
ARTICLE 5 | LICENSES |
44 | ||
5.1 | License Grants. |
44 | ||
5.2 | Freedom to Operate. |
48 | ||
5.3 | Licenses Generally; No Implied License |
49 | ||
5.4 | Retained Rights |
49 | ||
5.5 | Sublicensing. |
50 | ||
5.6 | Invention Assignment |
51 | ||
ARTICLE 6 | REGENERON COMMERCIAL LICENSE OPTIONS; AND REGENERON RIGHT OF FIRST NEGOTIATION |
51 | ||
6.1 | Option-Eligible Collaboration-ICPs and Option-Ineligible Collaboration ICPs |
51 | ||
6.2 | Option. |
52 | ||
6.3 | Regeneron Right of First Negotiation for Rights to Option-Ineligible Collaboration ICPs. |
53 | ||
6.4 | Transfer of Responsibilities with Respect to Optioned Collaboration ICPs after Regenerons Exercise of the Option |
54 |
-i-
TABLE OF CONTENTS
(continued)
Page
ARTICLE 7 | ROYALTY PRODUCTS, MICE DERIVED ADICET ICP PRODUCTS AND REGENERON NON-ICP PRODUCTS |
55 | ||
7.1 | Overview |
55 | ||
7.2 | Diligence Obligations |
55 | ||
7.3 | Development of Royalty Products. |
55 | ||
7.4 | Development Records. |
55 | ||
7.5 | Development Reports. |
56 | ||
7.6 | Regulatory. |
56 | ||
7.7 | Licensing. |
57 | ||
7.8 | Regeneron Right of First Negotiation for Adicet to use Regeneron Antibodies in Co-Administration Studies with Adicet Royalty-Bearing Collaboration ICPs. |
57 | ||
ARTICLE 8 | ADICET CO-FUNDING OPTION AND CO-FUNDED PRODUCTS (GENERALLY) |
58 | ||
8.1 | Co-Funding Option. |
58 | ||
8.2 | Development and Commercialization of Co-Funded Products |
59 | ||
ARTICLE 9 | GOVERNANCE OF CO-FUNDED PRODUCTS |
59 | ||
9.1 | Committees/Management. |
59 | ||
9.2 | Joint Steering Committee. |
60 | ||
9.3 | Resolution of Committee Disputes |
61 | ||
ARTICLE 10 | DEVELOPMENT OF CO-FUNDED PRODUCTS |
62 | ||
10.1 | Development of Co-Funded Products |
62 | ||
10.2 | Preparation, Updates and Approval of Development Plans |
62 | ||
10.3 | Development Cost and Payment Reports. |
62 | ||
ARTICLE 11 | COMMERCIALIZATION OF CO-FUNDED PRODUCTS |
63 | ||
11.1 | Commercialization of Co-Funded Products |
63 | ||
11.2 | Preparation, Updates and Approval of Commercial Plans |
63 | ||
11.3 | Adicet Co-Promotion Option in the United States. |
64 | ||
11.4 | Other Responsibilities |
64 | ||
ARTICLE 12 | CLINICAL AND REGULATORY AFFAIRS FOR CO-FUNDED PRODUCTS |
65 | ||
12.1 | Regulatory Responsibilities. |
65 |
-ii-
TABLE OF CONTENTS
(continued)
Page
12.2 | Regulatory Events |
65 | ||
12.3 | Recalls and Other Corrective Actions |
66 | ||
ARTICLE 13 | MANUFACTURING AND SUPPLY |
66 | ||
13.1 | Supply for Research Program |
66 | ||
13.2 | Supply for Initial Phase I Trial for Optioned Collaboration ICPs. |
66 | ||
13.3 | Subsequent Supply of Co-Funded Products and Regeneron Royalty Products. |
67 | ||
13.4 | Manufacturing Process Technology Transfer |
68 | ||
ARTICLE 14 | PAYMENTS |
69 | ||
14.1 | Upfront Payment |
69 | ||
14.2 | Research Program Funding |
69 | ||
14.3 | Royalty Payments for Adicet Royalty Products. |
69 | ||
14.4 | Royalty Payments for Regeneron Royalty Products |
72 | ||
14.5 | Royalty Payments for Regeneron Non-ICP Products |
72 | ||
14.6 | Royalty Payments for Mice Derived Adicet ICP Products |
72 | ||
14.7 | Sharing of Profits and Development Costs from Co-Funded Products. |
73 | ||
14.8 | Payment Method and Currency |
75 | ||
14.9 | Late Payments |
75 | ||
14.10 | Taxes |
75 | ||
14.11 | Resolution of Payment Disputes |
75 | ||
ARTICLE 15 | RIGHTS IN FUTURE EQUITY FINANCINGS |
76 | ||
15.1 | Side Letter Agreement |
76 | ||
ARTICLE 16 | INTELLECTUAL PROPERTY |
76 | ||
16.1 | Ownership of Newly Created Intellectual Property. |
76 | ||
16.2 | Prosecution and Maintenance of Patent Rights. |
77 | ||
16.3 | Administrative Patent Proceedings. |
79 | ||
16.4 | Third Party Infringement Suits. |
80 | ||
16.5 | Patent Marking |
81 | ||
16.6 | Third Party Claims |
81 | ||
16.7 | Third Party Vigilance |
81 | ||
16.8 | Infringement of Third Party Patent Rights in the Territory. |
82 |
-iii-
TABLE OF CONTENTS
(continued)
Page
16.9 | Product Trademarks |
83 | ||
16.10 | Compliance with Third Party Licenses |
83 | ||
ARTICLE 17 | BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS |
84 | ||
17.1 | Books and Records |
84 | ||
17.2 | Audits and Adjustments. |
84 | ||
17.3 | GAAP |
85 | ||
ARTICLE 18 | REPRESENTATIONS, WARRANTIES AND COVENANTS |
85 | ||
18.1 | Joint Representations and Warranties |
85 | ||
18.2 | Knowledge of Pending or Threatened Litigation |
85 | ||
18.3 | Additional Regeneron Representations, Warranties and Covenants of Regeneron. |
85 | ||
18.4 | Additional Adicet Representations, Warranties and Covenants of Adicet. |
86 | ||
18.5 | Mutual Covenants |
87 | ||
18.6 | Compliance with Laws. |
88 | ||
18.7 | Disclaimer of Warranties |
88 | ||
ARTICLE 19 | CONFIDENTIALITY |
89 | ||
19.1 | Confidential Information |
89 | ||
19.2 | Exceptions |
89 | ||
19.3 | Injunctive Relief |
90 | ||
19.4 | Publications. |
90 | ||
19.5 | Disclosures Concerning this Agreement. |
91 | ||
ARTICLE 20 | INDEMNITY |
93 | ||
20.1 | Indemnity. |
93 | ||
20.2 | Indemnity Procedure. |
95 | ||
20.3 | Insurance |
95 | ||
ARTICLE 21 | FORCE MAJEURE |
96 | ||
ARTICLE 22 | TERM AND TERMINATION |
96 | ||
22.1 | Term |
96 | ||
22.2 | Termination for Material Breach |
97 |
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TABLE OF CONTENTS
(continued)
Page
22.3 | Termination of Co-Funded Products by Regeneron for Convenience |
98 | ||||
22.4 | Termination of Co-Funding Term by Adicet for Convenience |
98 | ||||
22.5 | Termination of Regeneron Royalty Products by Regeneron for Convenience |
98 | ||||
22.6 | Termination of Adicet Royalty Products by Adicet for Convenience |
98 | ||||
22.7 | Effects of Termination |
99 | ||||
22.8 | Survival of Obligations |
108 | ||||
22.9 | Return of Confidential Information |
109 | ||||
22.10 | Change of Control of Adicet |
109 | ||||
ARTICLE 23 |
DISPUTE RESOLUTION |
111 | ||||
23.1 | Generally |
111 | ||||
23.2 | Executive Officers Resolution of Disputes |
111 | ||||
23.3 | Failure on Parties to Agree on a Royalty Rate for Co-Funded Product After Termination. |
111 | ||||
23.4 | Obligations of the Parties and their Affiliates |
112 | ||||
ARTICLE 24 |
MISCELLANEOUS |
113 | ||||
24.1 | Governing Law; Submission to Jurisdiction |
113 | ||||
24.2 | Waiver |
113 | ||||
24.3 | Notices |
113 | ||||
24.4 | Entire Agreement |
113 | ||||
24.5 | Amendments |
113 | ||||
24.6 | Interpretation |
113 | ||||
24.7 | Construction |
114 | ||||
24.8 | Severability |
114 | ||||
24.9 | Assignment |
114 | ||||
24.10 | Successors and Assigns |
114 | ||||
24.11 | Performance Standards |
115 | ||||
24.12 | Counterparts |
116 | ||||
24.13 | Third Party Beneficiaries |
116 | ||||
24.14 | Relationship of the Parties |
116 | ||||
24.15 | Limitation of Damages |
116 |
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TABLE OF CONTENTS
(continued)
Page
24.16 | Injunctive or Other Equity Relief |
117 | ||
24.17 | Rights in Bankruptcy |
117 | ||
24.18 | Non-Exclusive Remedies |
117 |
-vi-
LICENSE AND COLLABORATION AGREEMENT
THIS LICENSE AND COLLABORATION AGREEMENT (Agreement), dated as of July 29, 2016 (the Effective Date), is by and between REGENERON PHARMACEUTICALS, INC., a corporation organized under the laws of New York and having a principal place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591 (Regeneron), and ADICET BIO, INC., a corporation organized under the laws of Delaware and having a place of business at 200 Constitution Drive, Menlo Park, California 94025 (Adicet) (with each of Regeneron and Adicet referred to herein individually as a Party and collectively as the Parties).
WHEREAS, Adicet has scientific expertise and technology that are useful for the discovery and development of immune cell therapeutic products;
WHEREAS, Regeneron has scientific expertise and technology that are useful for the discovery and development of such immune cell therapeutic products;
WHEREAS, the Parties wish to enter into and collaborate with respect to a research program in which they will research and develop next-generation immune cell therapeutic technologies and immune cell therapeutic products directed to certain molecular targets selected by the Parties;
WHEREAS, Adicet wishes to grant Regeneron an option to license a certain number of such immune cell products;
WHEREAS, Regeneron wishes to grant Adicet an option to co-fund development, and collaborate with Regeneron on immune cell products for which Regeneron has exercised its option, in exchange for a commensurate share of the financial returns for such co-funded immune cell products; and
WHEREAS, the Parties wish to grant each other licenses to perform their respective obligations in the Research Program and in connection with the development, manufacturing and commercialization of such immune cell products, all as set forth in this Agreement.
NOW, THEREFORE, in consideration of the following mutual promises and obligations, and for other good and valuable consideration the adequacy and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
Capitalized terms used in this Agreement, whether used in the singular or plural, except as expressly set forth herein, shall have the meanings set forth below:
1.1 Adicet Background IP shall mean the Adicet Background Patent Rights and the Adicet Background Know-How.
1.2 Adicet Background Know-How shall mean any and all Know-How that (i) is Controlled by Adicet or its Affiliates as of the Effective Date or thereafter during the Research Program Term and (ii) is used by or behalf of Adicet or its Affiliates or is provided by or on behalf of Adicet or its Affiliates to Regeneron for use, in each case in the performance of this Agreement; provided, however, that Adicet Background Know-How shall exclude Adicet CTM Inventions and Collaboration Inventions.
1.3 Adicet Background Patent Rights shall mean those Patent Rights that (i) are Controlled by Adicet or its Affiliates as of the Effective Date or thereafter during the Research Program Term (or thereafter are prosecuted therefrom), and (ii) claim Know-How that is used by or on behalf of Adicet or its Affiliates or provided by or on behalf of Adicet or its Affiliates to Regeneron for use, in each case in the performance of this Agreement; provided, however, that Adicet Background Patent Rights shall exclude Patent Rights to the extent they claim Adicet CTM Inventions and Collaboration Inventions.
1.4 Adicet CTM shall mean (i) a Targeting Moiety that was first generated solely by or on behalf of Adicet under the Research Program that Binds a Collaboration Target or (ii) a derivative, modification, fragment or improvement of such Collaboration Targeting Moiety that Binds the same Collaboration Target as the molecule described in subclause (i), in each case without use of the Regeneron Transferred Technologies. Adicet CTMs shall exclude any Targeting Moiety that is a Regeneron CTM.
1.5 Adicet CTM Invention shall mean any composition of, or method of using or making an Adicet CTM in each case that is discovered, invented, created or otherwise generated under this Agreement.
1.6 Adicet Designated Activities shall mean Adicets Research Plan Activities and those additional activities which Adicet agrees to perform pursuant to this Agreement.
1.7 Adicet IP shall mean the Adicet Patent Rights and the Adicet Know-How.
1.8 Adicet Know-How shall mean Adicet Background Know-How and any and all other Know-How Controlled by Adicet or its Affiliates, in each case to the extent it either (a) constitutes Adicet CTM Inventions or Collaboration Inventions, or (b) with respect to Adicet Background Know-How (i) is reasonably necessary to make, use, offer for sale, sell or import a Research Program ICP or (ii) is useful to make, use, offer for sale, sell or import a Research Program ICP and was actually provided by Adicet or its Affiliates to Regeneron pursuant to the Research Program or Section 6.4, 10.4 or 13.4.
1.9 Adicet Mice Derived Adicet Targeting Moiety IP shall mean that certain Adicet IP that constitutes, or to the extent it claims, any Mice Derived Adicet Targeting Moiety Invention that is incorporated into, or otherwise constitutes, a composition of, or any method of making or any method of using, any Regeneron Non-ICP Product (or any component thereof).
1.10 Adicet Patent Rights shall mean Adicet Background Patent Rights and those other Patent Rights Controlled by Adicet or its Affiliates, in each case to the extent they either (a) claim any Collaboration Inventions or Adicet CTM Inventions, or (b) with respect to Adicet Background Patent Rights (i) is reasonably necessary to make, use, offer for sale, sell or import a Research Program ICP or (ii) is useful to make, use, offer for sale, sell or import a Research Program ICP and was actually provided by Adicet or its Affiliates to Regeneron pursuant to the Research Program or Section 6.4, 10.4 or 13.4.
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1.11 Adicet Product IP shall mean that certain Adicet IP, in each case that is incorporated into, or otherwise constitutes, a composition of, or any method of making or any method of using, any Collaboration ICP or Royalty Product or Co-Funded Product (or any component thereof).
1.12 Adicet Royalty-Bearing Collaboration ICPs shall mean (a) Declined Collaboration ICPs and (b) Option-Ineligible ICPs.
1.13 Adicet Royalty Product shall mean any therapeutic, prophylactic, diagnostic or theranostic product, therapy, treatment or service that incorporates, includes or consists of an Adicet Royalty-Bearing Collaboration ICP.
1.14 Adicet Trademarks shall mean the Trademarks Controlled by Adicet during the Term and designated in writing by Adicet for use with one or more Collaboration ICPs.
1.15 Affiliate shall mean, with respect to any Person, another Person which controls, is controlled by, or is under common control with such Person. A Person shall be deemed to control another Person if such Person possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such other Person, whether through the ownership of voting securities, by contract, or otherwise. Without limiting the generality of the foregoing, a Person shall be deemed to control another Person if any of the following conditions is met: (a) in the case of corporate entities, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of more than fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entity. For purposes of this Agreement, in no event shall Adicet or any of its Affiliates be deemed an Affiliate of Regeneron, or any of its Affiliates nor shall Regeneron or any of its Affiliates be deemed an Affiliate of Adicet or any of its Affiliates.
1.16 Agreement shall have the meaning set forth in the introductory paragraph, including all Schedules and Exhibits.
1.17 Antibody shall mean any antibody, or any fragment, variant, derivative or construct thereof, or antibody fusion protein produced therefrom.
1.18 Anti-Corruption Laws shall mean all Applicable Laws regarding public or private-sector corruption, bribery, kickbacks, speed or facilitation payments, ethical business conduct, money laundering, embezzlement, political contributions, gifts, gratuities, expenses, entertainment, hospitalities, agency relationships, commissions, lobbying, books and records, and financial controls, including the FCPA, the U.S. Travel Act, and other anti-corruption laws.
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1.19 Anticipated First Commercial Sale shall mean, with respect to a Co-Funded Product in a particular country of the Co-Funding Territory, the date agreed upon by the JSC in advance as the expected date of First Commercial Sale of such Co-Funded Product in such country. The JSC shall attempt to agree upon such date [***] in advance of its expected occurrence. In the event that Development timelines are accelerated such that the JSC is unable to agree on the expected date of First Commercial Sale [***] in advance of its expected occurrence, the JSC shall attempt to agree upon the expected date of First Commercial Sale as soon as practicable after the Development timeline acceleration.
1.20 API shall mean any active pharmaceutical (including biological) ingredient or component (other than an adjuvant or excipient).
1.21 Applicable Law shall mean applicable laws, rules, and regulations, including any rules, regulations, guidelines, or other requirements of any Regulatory Authority, which may be in effect from time to time.
1.22 Approval shall mean, with respect to each Product, any approval (including Marketing Approvals and Pricing Approvals), registration, license or authorization from any Regulatory Authority required for the Development, Manufacture or Commercialization of such Product in a regulatory jurisdiction anywhere in the Territory, and shall include, without limitation, an approval, registration, license or authorization granted in connection with any Registration Filing.
1.23 Binds or binds shall mean, with respect to a particular Targeting Moiety and Target, that such Targeting Moiety (i) binds directly to such Target and was initially identified and selected by screening against such Target, and (ii) contributes to a cytotoxic or cytostatic response against the cell expressing such Target (whether by itself or by delivery of an immune cell on the surface of which it is expressed).
1.24 Business Day shall mean any day other than a Saturday, a Sunday or a day on which commercial banks in New York, New York, are authorized or required by law to remain closed.
1.25 Change of Control shall mean, with respect to a Party, (a) a merger or consolidation of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, or (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Partys business to which the subject matter of this Agreement relates.
1.26 Clinical Supply Costs shall mean, with respect to a Co-Funded Product, the Manufacturing Cost for the Clinical Supply Requirements, at the time the applicable Co-Funded Product is produced.
4
1.27 Clinical Supply Requirements shall mean, with respect to a Co-Funded Product, the quantities of such Co-Funded Product required by Regeneron for Development in the Co-Funding Territory under this Agreement in accordance with the applicable Development Plan.
1.28 Co-Administration Study shall mean, a clinical study for purposes of testing the safety or efficacy of, and generating data to support, a Regulatory Filing for the Marketing Approval of the administration to patients of (i) an Adicet Royalty Product together with (ii) any product that is directed towards a target, but that is not a Product or a component thereof, for the treatment of one or more diseases or conditions in such subjects. For clarity, Co-Administration Studies shall include studies of combination regimens with sequential administration schedules.
1.29 Co-Fund or Co-Funding shall mean, with respect to an Optioned Collaboration ICP, that Adicet has delivered a Co-Funding Notice and is co-funding Regenerons Development of such Optioned Collaboration ICP for the Co-Funding Territory at the Co-Funding Percentage, in accordance with Section 8.1.
1.30 Co-Funded Product shall mean any therapeutic, prophylactic, diagnostic or theranostic product, therapy, treatment or service that incorporates, includes or consists of an Optioned Collaboration ICP that Adicet is Co-Funding, but only with respect to the Development, Commercialization or Manufacture of such Optioned Collaboration ICP for the Co-Funding Territory. For clarity, if Adicet only elects to Co-Fund Development of an Optioned Collaboration ICP for the United States, then such Optioned Collaboration ICP shall only be a Co-Funded Product with respect to the Development, Commercialization and Manufacture of such Optioned Collaboration ICP for the United States, but shall be a Regeneron Royalty Product with respect to the development, commercialization and manufacture of the Product for the Royalty Territory.
1.31 Co-Funded Product Net Sales shall mean, with respect to a Co-Funded Product, (i) the Net Sales of such Co-Funded Product sold by or on behalf of Regeneron or its Affiliates, plus (ii) other proceeds received by Regeneron from Third Parties in respect of the sale, license or other disposition of such Co-Funded Product and rights thereto (including, for example, royalties, milestones, upfront and transfer payments); provided, however, that (a) sales of such Co-Funded Product by or on behalf of licensees or sublicensees shall be omitted from (i), (b) amounts paid to Regeneron as a result of sales of such Co-Funded Product by licenses or sublicensees shall be included in (ii) above, and (c) in the case of sales of Combination Products, the Net Sales included in (i) shall be determined as set forth in Schedule 2.
1.32 Co-Funding Arrangement shall mean the co-funding and profit-sharing arrangement between the Parties for Co-Funded Products as described in Article 8 and elsewhere in this Agreement.
1.33 Co-Funding Percentage shall mean, with respect to a Co-Funded Product, the percentage share of financial investment, profit and loss as between the Parties on a Co-Funding Territory basis as determined in accordance with Section 8.1(a). The Regeneron Co-Funding Percentage and the Adicet Co-Funding Percentage shall together equal one hundred percent (100%).
5
1.34 Co-Funding Term shall mean on a Co-Funded Product-by-Co-Funded Product basis and with respect to all Co-Funded Products that Bind a given Collaboration Target, the time period commencing on the date Regeneron receives Adicets Co-Funding Notice (in accordance with Section 8.1) and concluding on the effective date of (i) Adicets termination of the Co-Funding Term pursuant to Section 22.4, and (ii) Regenerons termination of the Co-Funding Term pursuant to Section 22.3.
1.35 Co-Funding Territory shall mean any one of (i) the United States, (ii) the United States and the European Union, or (iii) the entire Territory, as specified by Adicet in the Co-Funding Notice for such Co-Funded Product.
1.36 Co-Promote or Co-Promotion shall mean the joint Detailing of Co-Funded Product(s) by the Parties (or their respective Affiliates) under the same Trademark in the United States pursuant to the applicable Co-Promotion Agreement.
1.37 Collaboration ICP shall mean any ICP that contains a Collaboration Targeting Moiety.
1.38 Collaboration Invention shall mean all Intellectual Property that (a)(i) is discovered, invented, created or otherwise generated in the performance by or on behalf of either Party (or by the Parties jointly) of any Research Program and (ii) is necessary or useful for the research, development, commercialization or manufacture of any Collaboration ICP, Royalty Product or Co-Funded Product under this Agreement, or (b) otherwise is discovered, invented, created or otherwise generated in the performance by or on behalf of either Party (or by the Parties jointly) of any Technology Research Program; provided, however, that Collaboration Inventions shall exclude all Adicet CTM Inventions, Regeneron CTM Inventions, Regeneron Mice Inventions and Regeneron Transferred Technologies Inventions.
1.39 Collaboration Target shall mean any Target placed on the Target List pursuant to Section 2.5, but excluding those Targets that are Non-Collaboration Targets or that become Terminated Targets.
1.40 Collaboration Targeting Moiety or CTM shall mean (a) Regeneron CTMs, (b) Adicet CTMs and (c)(i)any Targeting Moiety other than a Regeneron CTM or Adicet CTM that Binds to a Collaboration Target [***] or (ii) a derivative, fragment or modification of a molecule described in the foregoing subclause (c)(i) that Binds to the same Collaboration Target as the molecule described in subclause (c)(i).
1.41 Combination Product shall mean any Product in the form of a combination product or combination therapy that includes one or more APIs in addition to the Collaboration ICP or Mice Derived Adicet ICP as applicable (whether such API is combined with the Product in a single formulation or package, as applicable, or formulated or packaged separately but sold together for a single price).
1.42 Commercial Overhead Charge shall mean, on a country-by-country and Co-Funded Product-by-Co-Funded Product basis, beginning [***] prior to the date of the Anticipated First Commercial Sale in the applicable country in the Co-Funding Territory, an amount (proposed by Regeneron and approved by the JSC at least [***] prior to the Anticipated First Commercial Sale in such country) to cover Regenerons internal costs for [***]. The Commercial Overhead Charge will be updated by Regeneron and approved by the JSC as of January 1 of each following Contract Year.
6
1.43 Commercial Plan shall mean, with respect to a Co-Funded Product, the [***] rolling plan developed by Regeneron and approved by the JSC, which (a) shall describe the significant Commercialization activities (including significant pre-launch and launch activities) planned to be undertaken by Regeneron for such Co-Funded Product in the Co-Funding Territory and the associated budget for such Commercialization activities, and (b) shall contain not less the same information and detail as provided to Regeneron management with direct supervisory control over such activities.
1.44 Commercial Supply Costs shall mean, with respect to a Co-Funded Product, the Manufacturing Cost for the Commercial Supply Requirements therefor, at the time the applicable Co-Funded Product is produced.
1.45 Commercial Supply Requirements shall mean, with respect to a Co-Funded Product, the quantities of such Co-Funded Product required by Regeneron for Commercialization in the Co-Funding Territory under this Agreement in accordance with the applicable Commercial Plan, including, as applicable, quantities required for pre-launch stockpiling.
1.46 Commercialize or Commercialization shall mean, with respect to a Co-Funded Product, any and all activities directed to marketing, distributing, market access, Detailing, promoting, and/or importing, such Co-Funded Product in the Co-Funding Territory, including market research, obtaining Pricing Approvals, pre-launch marketing, marketing and educational activities, and surveys, registries and clinical trials not intended to gain additional labeled indications in the Co-Funding Territory, post-Approval pharmacovigilance (excluding pharmacovigilance for clinical trials under the Development Plan).
1.47 Commercially Reasonable Efforts shall mean with respect to the efforts to be expended by a Party or its Affiliate with respect to any objective, activity or decision to be undertaken hereunder, reasonable, good faith efforts to accomplish such objective, activity or decision as a Third Party of similar size and resources in the biopharmaceutical industry, would normally use to accomplish a similar objective, activity or decision under similar circumstances, it being understood and agreed that with respect to the research, development, manufacture, seeking and obtaining Marketing Approval, or commercialization of a Collaboration ICP or a Royalty Product or Co-Funded Product, such efforts and resources shall be consistent with those efforts and resources commonly used by a Third Party of similar size and resources in the biopharmaceutical industry under similar circumstances for similar compounds or products owned by it or to which it has similar rights, which compound or product, as applicable, is at a similar stage in its development or product life and is of similar market potential, taking into account all scientific, commercial, and other factors that such Third Party would take into account under similar circumstances, including issues of safety and efficacy, expected and actual cost and time to develop, expected and actual profitability (including royalties and other payments required hereunder), expected and actual competitiveness of alternative Third Party products in the marketplace, the nature and extent of expected and actual market exclusivity (including patent coverage and regulatory exclusivity), the expected likelihood of Marketing Approval, the expected
7
and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required. Commercially Reasonable Efforts shall be determined on a Target-by-Target, CTM-by-CTM, Collaboration ICP-by-Collaboration ICP, Royalty Product-by-Royalty Product, or Co-Funded Product-by-Co-Funded Product basis, as applicable, in view of conditions prevailing at the time, and evaluated taking into account all relevant factors.
1.48 Competing Product shall mean an ICP [***] that is not a Co-Funded Product or a Royalty Product and that [***].
1.49 Contract Year shall mean the period beginning on the Effective Date and ending on December 31, 2016, and each succeeding twelve (12) month period thereafter during the Term (except that the last Contract Year shall end on the effective date of any termination or expiration of the Term).
1.50 Control shall mean, with respect to any material, Confidential Information, Intellectual Property right, or Trademark that a Party (a) owns such material, Confidential Information, Intellectual Property right, or Trademark, or (b) has a license or right to use to such material, Confidential Information, Intellectual Property right, or Trademark, in each case of (a) or (b), with the ability to grant to the other Party access, a right to use, or a license, or a sublicense (as applicable) to such material, Confidential Information, Intellectual Property right, or Trademark on the terms and conditions set forth herein, without violating the terms of any agreement with or obligation to any Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such access, right to use or (sub)license.
1.51 Cost of Goods Sold shall mean, with respect to a Co-Funded Product for a Quarter, Manufacturing Cost (calculated in accordance with GAAP and Schedule 1) for such Co-Funded Products sold in the Co-Funding Territory during such Quarter.
1.52 Cover, Covering or Covered means, with respect to a product, technology, process or method, that, in the absence of ownership of or a license granted under a Valid Claim, the practice or exploitation of such product, technology, process or method would infringe such Valid Claim (if in a Patent).
1.53 CPI shall mean the Consumer Price Index All Urban Consumers for the applicable country in which the personnel are located published by the United States Department of Labor, Bureau of Statistics (or its successor equivalent index), or an equivalent index in a foreign country applicable to FTEs in such country, accounting if possible for the area in such country where the personnel are located.
1.54 CPI Adjustment shall mean the percentage increase or decrease, if any, in the CPI applicable to such personnel for [***] of the Contract Year prior to the Contract Year for which the adjustment is being made.
1.55 Declined Collaboration ICPs shall mean (a) all Option-Eligible Collaboration ICPs with respect to which (i) Adicet delivers a Final Option Data Package in accordance with Section 2.4(d) and (ii) Regeneron fails to exercise its Option, or expressly declines to exercise its Option, prior to the expiration of the Option Period, and (b) all Collaboration ICPs that become Declined Collaboration ICPs in accordance with Sections 2.4(c), 2.5(g), 4.3(a)(i), 4.3(a)(ii) or 22.10(a).
8
1.56 Detail shall mean, with respect to each Co-Funded Product, a selling presentation for such product by a representative of a Partys sales force, or another employee of such Party who may be deemed to be part of the promotional activities for such Co-Funded Product (e.g., key account manager).
1.57 Develop or Development shall mean, with respect to a Co-Funded Product, the following activities undertaken or performed for such Co-Funded Product (following Regenerons exercise of the Option for such Co-Funded Product): (a) activities relating to research, pre-clinical and clinical development of such Co-Funded Product, including test method development and stability testing, assay development, toxicology, pharmacology, formulation, quality assurance/quality control development, technology transfer, statistical analysis, process development and scale-up, pharmacokinetic studies, data collection and management, clinical studies (including research to design clinical studies), regulatory affairs, project management, drug safety surveillance activities related to clinical studies, the preparation submission and maintenance of Registration Filings, but excluding activities necessary to obtain a Pricing Approval, reimbursement and/or listing on health care providers and payers formularies and (b) any other research and development activities with respect to such Co-Funded Product, including, activities to support the discovery of biomarkers and activities to support new product formulations, delivery technologies and/or new indications, either before or after the First Commercial Sale.
1.58 Development Costs shall mean, with respect to a Co-Funded Product, those costs incurred by Regeneron for the Development of such Co-Funded Product in accordance with this Agreement and the applicable Development Plan (and in accordance with the Co-Funding Materials prior to approval of the Development Plans) including:
(a) Out-of-Pocket Costs (including fees and expenses) for obtaining Marketing Approvals for such Co-Funded Product under this Agreement;
(b) Development FTE Costs;
(c) Clinical Supply Costs;
(d) Out-of-Pocket Costs incurred for (i) Manufacturing process, formulation, cleaning, and shipping development and validation, (ii), Manufacturing scale-up and improvements, (iii) stability testing, (iv) quality assurance/quality control development (including management of Third Party fillers, packagers and labelers), and (v) internal and Third Party costs and expenses incurred in connection with (A) qualification and validation of Third Party contract manufacturers and vendors and (B) subject to the terms of this Agreement, establishing a primary or secondary source supplier, including, the transfer of process and Manufacturing technology and analytical methods, scale-up up to First Commercial Sale, process and equipment validation, cleaning validation and initial Manufacturing licenses, approvals and Regulatory Authority inspections (in each case, to the extent not included in Clinical Supply Costs or Commercial Supply Costs); in each case for such Co-Funded Product under this Agreement;
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(e) any Third Party License Payments under a Third Party License entered into in accordance with Section 16.7 below to the extent attributable to the Development of such Co-Funded Product (to the extent not otherwise included in Development Costs); and
(f) any other costs or expenses for such Co-Funded Product specifically identified and included in the applicable Development Plan or included as Development Costs under this Agreement.
(g) In the event that any of the foregoing costs benefit both Co-Funded Product(s) and other products or activities (for example, if a manufacturing scale-up activity is not exclusively of benefit to Co-Funded Products) or benefits both Co-Funded Product(s) in the Co-Funding Territory and Regeneron Royalty Products in the Royalty Territory, then Regeneron shall apportion such costs in a manner that fairly reflects the benefit to the Co-Funded Products and the other products or activities or the benefit to the Co-Funded Product(s) in the Co-Funding Territory and the Regeneron Royalty Products in the Royalty Territory. Regeneron shall disclose both the total costs incurred and the apportionment in the information reported under Section 10.3. At the request of Adicet, Regeneron shall provide additional reasonable supporting documentation and make its personnel reasonably available to answer questions. In the event of a dispute regarding an apportionment, the Parties shall resolve the dispute in accordance with Article 23. In no event shall the same costs be included more than once in Development Costs under this Agreement, even if such costs are of benefit to multiple Co-Funded Products.
If Adicet only elects to Co-Fund Development of an Optioned Collaboration ICP for a Co-Funding Territory that is less than the entire Territory, then any costs of Development activities conducted by Regeneron shall not be Development Costs to the extent such activities are solely in support of the Marketing Approval or commercialization of such Product in the Royalty Territory and do not also support the Marketing Approval or commercialization of such Product in the Co-Funding Territory.
1.59 Development FTE Cost shall mean the product of (a) the number of FTEs performing activities under a Development Plan and (b) the applicable Development FTE Rate for such FTEs.
1.60 Development FTE Rate shall mean the rate proposed by Regeneron and approved by the JSC in the first Contract Year in which Regeneron first exercises its Option, such amount to be adjusted annually (effective as of [***] of each subsequent Contract Year, but such adjustment determined no later than the preceding [***]) with respect to the FTEs in a particular location, by the applicable CPI Adjustment.
1.61 Development Payment Report shall mean the Quarterly report prepared by Regeneron in accordance with Section 10.3 which sets forth in reasonable detail, for each Co-Funded Product individually, and in the aggregate for all Co-Funded Products, (a) the Development Costs incurred by Regeneron for such Quarter and (b) the Quarterly Development True-Up calculated in accordance with Schedule 2.
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1.62 Development Plan shall mean, with respect to a Co-Funded Product, [***] rolling plan developed by Regeneron and approved by the JSC for the Development of such Co-Funded Product for Commercialization in the Co-Funding Territory, which shall include the following:
(a) the overall strategies and timelines for Developing and obtaining Approvals for such Co-Funded Product in the Co-Funding Territory;
(b) clinical study design, clinical methodology and monitoring requirements for clinical trials of such Co-Funded Product;
(c) a non-binding budget forecast for the next [***] Contract Years, as the same may be amended from time-to-time in accordance with the terms of this Agreement; and
(d) pre-clinical research directed to such Co-Funded Product.
1.63 European Union or EU shall mean the countries of the European Economic Area, as it is constituted on the Effective Date and as it may be modified from time to time after the Effective Date.
1.64 Executive Officers shall mean the Chief Executive Officer of Regeneron and the Chief Executive Officer of Adicet, or their respective designees with equivalent decision-making authority with respect to matters under this Agreement.
1.65 FCPA shall mean the U.S. Foreign Corrupt Practices Act of 1977 (15 U.S.C. §§78dd-1, et seq.) as amended.
1.66 FDA shall mean the United States Food and Drug Administration and any successor agency thereto.
1.67 Field Force Cost shall mean, for a Co-Funded Product in any country or Region in the Co-Funding Territory, the product of (a) the number of Regeneron FTEs conducting Details, performing account management, medical science liaison or medical affairs functions (or the number of Adicet FTEs conducting such activities in connection with Adicets Co-Promotion of such Co-Funded Product under the Co-Promotion Agreement) and (b) the applicable Field Force FTE Rate. For the avoidance of doubt, the activities of Third Party contract personnel, shall be charged as Out-of-Pocket Costs and not included in the Field Force Cost.
1.68 Field Force FTE Rates shall mean, on a country-by-country or Region-by-Region (as proposed by Regeneron and approved by the JSC) basis (determined based on the location of the field force representative), a rate or rates proposed by Regeneron and approved by the JSC at least [***] prior to the Anticipated First Commercial Sale in the country or Region, as applicable, based upon the fully burdened cost (inclusive of bonuses and other incentive compensation) of field force representatives of pharmaceutical companies in the applicable country in comparable roles, and including an allocation of regional and country field force management cost, to be updated as proposed by Regeneron and approved by the JSC [***] to the Anticipated First Commercial Sale, such amount to be adjusted annually (effective as of [***] of each subsequent Contract Year, but such adjustment determined no later than the preceding [***]) by the percentage increase or decrease, if any, in the CPI applicable to such personnel through [***]. The Field Force FTE Rate shall be inclusive of Out-of-Pocket Costs and other expenses for the employee providing the services, including travel costs, information systems and allocated costs, such as, for example, allocated overhead costs.
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1.69 Finished Product means the final, finished, packaged and labeled form, ready for sale, of a Product.
1.70 First Commercial Sale shall mean, with respect to a Product in a country in the Territory, or Co-Funding Territory, as applicable, the first commercial sale of the Product to a Third Party (other than a licensee or sublicensee) for use in such country following receipt of Marketing Approval. Sales for test marketing or clinical trial purposes or compassionate or similar use shall not constitute a First Commercial Sale.
1.71 FTE shall mean a full time equivalent employee (i.e., one fully-committed or multiple partially-committed employees aggregating to one full-time employee) employed by Party (or its Affiliate) who performs work for the Development or Commercialization of Co-Funded Products, with such commitment of time and effort to constitute one employee performing such work on a full-time basis, which for purposes hereof shall be 1800 hours per year.
1.72 GAAP shall mean generally accepted accounting principles as applicable in the United States.
1.73 Good Practices shall mean compliance with the applicable standards contained in then-current Good Laboratory Practices, or GLP, Good Manufacturing Practices or GMP and/or Good Clinical Practices, or GCP as promulgated by the FDA and all analogous guidelines promulgated by the EMA or the ICH, as applicable.
1.74 Governmental Authority shall mean any court, agency, authority, department, regulatory body, or other instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city, or other political subdivision of any such government or any supranational organization of which any such country is a member.
1.75 Immune Cell Products or ICPs shall mean human immune cells that are engineered ex vivo to express a Targeting Moiety on its cell surface.
1.76 IND shall mean, with respect to each Collaboration ICP, an Investigational New Drug Application filed with the FDA pursuant to 21 C.F.R. § 312 before the commencement of clinical trials involving such Collaboration ICP, including all amendments and supplements to such application, or any equivalent filing with any Regulatory Authority outside the United States.
1.77 IND Acceptance shall mean, with respect to a particular Collaboration ICP, that the first IND for such Product was accepted by the relevant Regulatory Authority, as evidenced by no objection by such Regulatory Authority within [***] after the date of the IND submission.
1.78 Initial Development Cost Forecast means the non-binding forecast for the total expected costs of Development for a Co-Funded Product in the Territory during the period that begins on IND Acceptance and ends upon the expected first Marketing Approval for such Co-Funded Product. The initial Total Co-Funding Territory Development Budget shall set forth separate budget forecasts for (i) the United States, (ii) the United States and the European Union, and (iii) the entire Territory.
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1.79 Initial Option Data Package shall mean, with respect to a particular Collaboration ICP, (i) the set of preclinical data and analyses, regulatory communications, CMC information, and results and commercial/financial information that is described in the Research Plan and is generated by Adicet up to the point of Adicets delivery of the Initial Option Data Package, (ii) the disclosures to Regeneron counsel required by Section 16.6 with respect to such Collaboration ICP and (iii) any additional Collaboration ICP-related information as mutually agreed in writing by the Parties.
1.80 Intellectual Property shall mean any Know-How, Patent Rights, copyrights, trade secrets, and any other intellectual property rights, excluding Trademarks.
1.81 Joint Research Committee or JRC shall mean the Joint Research Committee described in Section 3.1.
1.82 Know-How shall mean any and all proprietary technical, scientific or other information, data, test results, knowledge, techniques, discoveries, inventions, specifications, designs, trade secrets, regulatory filings and other technology (whether or not patentable or otherwise protected by trade secret law), in each case that is not in the public domain or otherwise publicly known.
1.83 Launch Preparation Expenses shall mean, with respect to a Co-Funded Product, on a country-by-country basis in the Co-Funding Territory, all Commercialization expenses incurred prior to receipt of Marketing Approval for such Co-Funded Product for such Co-Funded Product.
1.84 Legal Dispute shall mean any dispute related to a Partys alleged failure to comply with this Agreement or the validity, breach, termination or interpretation of this Agreement.
1.85 Licensed Mice shall mean Regenerons proprietary, genetically engineered mice set forth on Schedule 3.
1.86 Major Market Country shall mean each of the United States of America, Japan, France, Germany, Italy, the United Kingdom, Spain, Canada, and [***].
1.87 Manufacture or Manufacturing shall mean activities directed to producing, manufacturing, processing, packaging, labeling, devices and other delivery technologies, assembly, quality assurance testing and release, shipping and/or storage of a Co-Funded Product, Royalty Product or Collaboration ICP (or any components or process steps involving the Co-Funded Product, Royalty Product or Collaboration ICP, including immune cell culturing, activation and expansion), placebo or a comparator agent, as the case may be.
1.88 Manufacturing Cost shall mean the fully burdened cost (without mark-up) of Manufacturing (i) Co-Funded Products or (ii) Optioned Collaboration ICPs pursuant to Section 13.2, each as calculated in accordance with Schedule 1.
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1.89 Marketing Approval shall mean an approval of the applicable Regulatory Authority necessary for the marketing and sale of a Product in a country, but excluding any separate Pricing Approval.
1.90 Mice Derived Adicet ICP shall mean any ICP Controlled by Adicet that contains a Mice Derived Adicet Targeting Moiety.
1.91 Mice Derived Adicet ICP Product shall mean any therapeutic, prophylactic, diagnostic or theranostic product, therapy, treatment or service that incorporates, includes or consists of a Mice Derived Adicet ICP.
1.92 Mice Derived Adicet Targeting Moiety shall mean any Targeting Moiety (a)(i) that Binds to a Non-Collaboration Target, (ii) that is generated by Adicet using Licensed Mice outside the course of the Research Program in accordance with Adicets license to use Licensed Mice in accordance with Section 5.1(d), and (iii) which is incorporated into an ICP that is designated by Adicet as a lead product candidate pursuant to Section 5.1(d)(ii)(B); (b)(i) that Binds to the same Non-Collaboration Target as the Targeting Moiety described in subclause (a), (ii) that is generated by Adicet using Licensed Mice outside the course of the Research Program in accordance with Adicets license to use Licensed Mice in accordance with Section 5.1(d), and (iii) which were so generated and identified as Binding to such Non-Collaboration Target prior to designation by Adicet of the applicable lead product candidate pursuant to Section 5.1(d)(ii)(B); or (c) that is a derivative, fragment or modification of a molecule described in the foregoing subclause (a) or (b) and Binds to the same Non-Collaboration Target as the molecule described in subclause (a) or (b).
1.93 Mice Derived Adicet Targeting Moiety Inventions shall mean the composition of, or method of using or making a Mice Derived Adicet Targeting Moiety.
1.94 Net Sales shall mean, with respect to a Product, the gross amount invoiced for bona fide arms length sales of Products in the Territory by or on behalf of a Party, or its Affiliates, licensees or sublicensees to Third Parties, less the following deductions determined in accordance with GAAP consistently applied:
(a) normal and customary trade, cash, quantity and free-goods allowances granted and taken directly with respect to sales of such Product;
(b) amounts repaid or credited with respect to such Product by reason of defects, rejections, recalls, returns, rebates and allowances;
(c) chargebacks and other amounts paid on sale or dispensing of such Product;
(d) Third Party cash rebates and chargebacks related to sales of such Product, to the extent allowed;
(e) retroactive price reductions for such Products that are actually allowed or granted;
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(f) compulsory refunds, credits and rebates directly related to the sale of such Products, accrued, paid or deducted pursuant to government entities or payor agreements (including managed care agreements) or governmental regulations;
(g) branded co-pay or similar programs specifically for the Product;
(h) freight, postage, shipment and insurance costs (or wholesaler fees in lieu of those costs) and customs duties incurred in delivering such Products that are separately identified on the invoice or other documentation;
(i) sales taxes, excess duties, or other consumption taxes and compulsory payments to Governmental Authorities or other governmental charges imposed on the sale of such Products, which are separately identified on the invoice or other documentation; and
(j) if and to the extent expressly agreed in writing by the Parties, any other specifically identifiable costs or charges included in the gross invoiced sales price of such Product falling within categories substantially equivalent to those listed above and ultimately credited to customers or a Governmental Authority or agency thereof.
Net Sales in currency other than United States Dollars shall be translated into United States Dollars according to the provisions of Section 14.7(e) of this Agreement.
Sales between Adicet, Regeneron, and their licensees or sublicensees and the Affiliates of any of the foregoing, for resale, shall be disregarded for purposes of calculating Net Sales. Any of the items set forth above that would otherwise be deducted from the invoice price in the calculation of Net Sales but which are separately charged to and paid by Third Parties shall not be deducted from the invoice price in the calculation of Net Sales.
In the case of any sale of a Product for consideration other than cash, such as barter or countertrade, then (i) the gross amount invoices for such Product for purposes of calculating Net Sales of such Product shall equal the weighted average invoiced sales price of such Product sold in the same country during the same reporting period, or (ii) if no such invoiced sales occur in such country in such reporting period, then the Net Sales of such Product shall equal the fair market value of the consideration received as reasonably agreed by the Parties.
Solely for purposes of calculating Net Sales, if Adicet, Regeneron or any of their Affiliates, licensees or sublicensees sells any Product in the form of a Combination Product, then (A) if such Product is a Royalty Product or a Mice Derived Adicet ICP Product, then prior to the first commercial sale of such Royalty Product or Mice Derived Adicet ICP Product in the form of a Combination Product, then (1) if the ICP component and the other API component of such Product each are sold separately in the applicable country and the applicable period, then Net Sales of such Product will be calculated by multiplying the Net Sales (as described above) of the Combination Product by the fraction A/(A+B), where A is the weighted average Net Sales price of the ICP component thereof sold separately in such country during such period in the same formulation and dosage, and B is the weighted average Net Sales price of the other API component thereof sold separately in such country during such period in the same formulation and dosage, and (2) otherwise, including with respect to calculating Net Sales of a Regeneron Non-ICP Product sold as Combination Product, the Parties shall reasonably determine, by mutual agreement prior
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to the First Commercial Sale of such Combination Product, the relative value of each component of such Combination Product and the appropriate method for accounting for sales of such Combination Product, and (B) if such Product is a Co-Funded Product, then Net Sales of such Co-Funded Product in the form of a Combination Product shall be determined as set forth in Schedule 2.
1.95 Non-Collaboration Targets shall mean (a) during the Target Selection Term, (i) Targets that are designated Non-Collaboration Targets pursuant to Section 4.1(d), and (ii) Terminated Targets, and (b) as of the date of the final expiration or termination of the Target Selection Term, including any mutually agreed extensions, all targets that are not Collaboration Targets.
1.96 Option-Eligible Collaboration ICPs shall mean (a) all Collaboration ICPs that are subject to the Option as set forth in Section 6.1(b) and (b) all other Collaboration ICPs that Bind the same Collaboration Target as a Collaboration ICP described in subsection (a). Option-Eligible Collaboration ICPs shall exclude Optioned Collaboration ICPs, Declined Collaboration ICPs or Option-Ineligible ICPs.
1.97 Option-Ineligible Collaboration ICPs shall mean (a) all Collaboration ICPs that are excluded from the Option as set forth in Section 6.1(b) and (b) all other Collaboration ICPs that Bind to the same Collaboration Target as a Collaboration ICP described in subsection (a). Option-Ineligible Collaboration ICPs exclude all such Option-Ineligible ICPs to the extent that Regeneron exercises its ROFN pursuant to Section 6.3 and obtains a license or other right thereunder.
1.98 Optioned Collaboration ICPs shall mean (a) the Collaboration ICPs that exist at the time of Adicets delivery of the Option Data Package to Regeneron, with respect to which Regeneron has exercised an Option pursuant to Section 6.2 and (b) all other Collaboration ICPs that contain a Targeting Moiety that [***].
1.99 Other Shared Expenses shall mean those costs and expenses specifically referred to in Sections 12.3, 16.4(c), 16.8(c)(iii), 16.9 and 20.1(c) and other costs mutually agreed in writing by the Parties to be included therein.
1.100 Out-of-Pocket Costs shall mean costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with GAAP) by Regeneron (or its Affiliate) or Adicet (or its Affiliate) directly incurred in the performance of the Collaboration.
1.101 Patent Application shall mean any application for a Patent, including any provisional, non-provisional, continuation, continuation-in-part or divisional applications and any PCT international applications or national phase applications, whether in the U.S. or any foreign country.
1.102 Patent Rights shall mean Patents and Patent Applications and without limiting the foregoing, the right to claim priority of such Patents and Patent Applications.
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1.103 Patents shall mean any patent (including any reissue, extension, substitution, confirmation, re-registrations, re-examination, revival, supplementary protection certificate or patents of addition), whether in the U.S. or any foreign country.
1.104 Person shall mean an individual, partnership, joint venture, limited liability company, corporation, firm, trust, unincorporated organization and government or other department or agency thereof.
1.105 Phase I Trial shall mean a human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(a) (as amended or any replacement thereof), including an equivalent clinical trial conducted in a country other than the United States.
1.106 Phase II Trial shall mean a human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(b) (as amended or any replacement thereof), including an equivalent clinical trial conducted in a country other than the United States.
1.107 Phase III Trial shall mean a human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), including, to the extent satisfying the foregoing requirements (a) a human clinical trial that becomes a registration trial sufficient for filing an application for a Marketing Approval for such product in the United States or (b) an equivalent clinical trial in conducted in a country other than the United States.
1.108 Pricing Approval shall mean such approval, agreement, determination or decision establishing prices for a Product that can be charged to consumers or will be reimbursed by Governmental Authorities in a country where Governmental Authorities or Regulatory Authorities of such country approve or determine pricing for pharmaceutical products for reimbursement or otherwise.
1.109 Product shall mean an Adicet Royalty Product, Regeneron Royalty Product, Co-Funded Product, Mice Derived Adicet ICP Product or Regeneron Non-ICP Product, as context requires.
1.110 Product Specifications means those Manufacturing, performance, quality-control release specifications for a Collaboration ICP, which shall be set forth in the applicable Research Plan.
1.111 Product Trademark shall mean, with respect to each Co-Funded Product in the Territory, the Trademark(s) selected by Regeneron solely for use on such Co-Funded Product throughout the Territory and/or accompanying logos, slogans, trade names, trade dress and/or other indicia of origin, in each case as selected by Regeneron.
1.112 Profit Payment Report shall mean the consolidated Quarterly report prepared by Regeneron (based on information reported under Section 14.7(b)) setting forth in reasonable detail, for each Major Market Country in the Co-Funding Territory and to the extent Regenerons internal systems are segregating such information on a country-by-country basis, for each such country in the Co-Funding Territory, and in the aggregate for the Co-Funding Territory as a whole, (a) Co-Funded Product Net Sales, Cost of Goods Sold, and Shared Commercial Expenses invoiced or incurred by each Party for such Quarter, (b) Other Shared Expenses incurred by each Party for such Quarter, and (c) the Quarterly Profit True-Up, and the component items and calculations in determining such Quarterly Profit True-Up, calculated in accordance with Schedule 2. If an item is included in one Quarterly report, in no event shall the same item be included in a subsequent Quarterly report.
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1.113 Public Official or Entity shall mean (i) any officer, employee, agent, representative, department, agency, de facto official, corporate entity, instrumentality or subdivision of any government, military or international organization, including any state-owned or affiliated company or hospital, or (ii) any candidate for political office, any political party or any official of a political party.
1.114 Quarter or Quarterly shall refer to a calendar quarter, except that the first (1st) Quarter shall commence on the Effective Date and extend to the end of the then-current calendar quarter and the last calendar quarter shall extend from the first day of such calendar quarter until the effective date of the termination or expiration of this Agreement.
1.115 Regeneron Background IP shall mean the Regeneron Background Patent Rights and the Regeneron Background Know-How.
1.116 Regeneron Background Know-How shall mean any and all Know-How that (i) is Controlled by Regeneron or its Affiliates as of the Effective Date or thereafter during the Research Program Term and (ii) is used by or behalf of Regeneron or its Affiliates or is provided by or on behalf of Regeneron or its Affiliates to Regeneron for use, in each case in the performance of this Agreement; provided, however, that Regeneron Background Know-How shall exclude Regeneron CTM Inventions and Collaboration Inventions.
1.117 Regeneron Background Patent Rights shall mean those Patent Rights that (i) are Controlled by Regeneron or its Affiliates as of the Effective Date or thereafter during the Research Program Term (or thereafter are prosecuted therefrom), and (ii) claim Know-How that is used by or behalf of Regeneron or its Affiliates or is provided by or on behalf of Regeneron or its Affiliates to Adicet for use, in each case in the performance of this Agreement; provided, however, that Regeneron Background Patent Rights shall exclude Patent Rights to the extent they claim Regeneron CTM Inventions and Collaboration Inventions.
1.118 Regeneron CTM shall mean (a)(i) a Targeting Moiety that was first generated solely by or on behalf of Regeneron under the Research Program or otherwise Controlled by Regeneron and introduced by Regeneron under the Research Program, in each case, that Binds a Collaboration Target or (ii) a derivative, modification, fragment or improvement of such Targeting Moiety that Binds to the same Collaboration Target as the molecule described in subclause (a)(i) or (b)(i) a Targeting Moiety, that was first generated by or on behalf of Adicet or jointly generated by or on behalf of the Parties using the Regeneron Transferred Technologies that Binds a Collaboration Target or (ii) a derivative, modification, fragment or improvement of such Targeting Moiety that Binds to the same Collaboration Target as the molecule described in subclause (b)(i).
1.119 Regeneron CTM Invention shall mean any composition of, or method of using or making a Regeneron CTM in each case that is discovered, invented, created or otherwise generated under this Agreement.
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1.120 Regeneron Designated Activities shall mean Regenerons Research Plan Activities.
1.121 Regeneron IP shall mean the Regeneron Patent Rights and the Regeneron Know-How.
1.122 Regeneron Know-How shall mean Regeneron Background Know-How and any and all other Know-How Controlled by Regeneron or its Affiliates, in each case to the extent it either (a) constitutes Regeneron CTM Inventions, Regeneron Mice Inventions or Regeneron Transferred Technologies Inventions, or (b) with respect to Regeneron Background Know-How (i) is reasonably necessary to make, use, offer for sale, sell or import a Regeneron CTM or (ii) is useful to make, use, offer for sale, sell or import a Regeneron CTM or Research Program ICP and either is Regeneron Transferred Technology actually provided by Regeneron or its Affiliates to Adicet pursuant to Section 2.1(d)(ii) or was actually provided by Regeneron or its Affiliates to Adicet under the Research Program.
1.123 Regeneron Mice shall mean Regenerons proprietary, genetically engineered mice that are used in the performance of this Agreement, and any progeny (including cross-bred progeny resulting from producing a genetically engineered mouse by breeding or by using any portion of any of Regenerons proprietary genetically engineered mice) or other mice derived therefrom. For clarity, Regeneron Mice shall include the Licensed Mice.
1.124 Regeneron Mice Inventions shall mean the composition of or any method specific to using or making Regeneron Mice, including methods specific to selecting and screening Targeting Moieties derived from the Regeneron Mice, in each case that is discovered, invented, created or otherwise generated by or on behalf of one or both Parties, their Affiliates, employees, agents and consultants pursuant to this Agreement (including under the Research Program).
1.125 Regeneron Mice IP shall mean that certain Regeneron IP that constitutes, or to the extent it claims, Regeneron Mice, Regeneron Mice Inventions, Regeneron Transferred Technologies or Regeneron Transferred Technologies Inventions.
1.126 Regeneron Non-ICP Product shall mean any therapeutic, prophylactic, diagnostic or theranostic product, therapy, treatment or service that incorporates, includes or consists of a Mice Derived Adicet Targeting Moiety but does not incorporate, include or consist of an ICP.
1.127 Regeneron Patent Rights shall mean Regeneron Background Patent Rights and those other Patent Rights Controlled by Regeneron or its Affiliates, in each case to the extent they either (a) claim any Collaboration Inventions, Regeneron CTM Inventions, Regeneron Mice Inventions or Regeneron Transferred Technologies Inventions, or (b) with respect to Regeneron Background Patent Rights (i) is reasonably necessary to make, use, offer for sale, sell or import a Regeneron CTM or (ii) is useful to make, use, offer for sale, sell or import a Regeneron CTM or Research Program ICP and claims either Regeneron Transferred Technology actually provided by Regeneron or its Affiliates to Adicet pursuant to Section 2.1(d)(ii) or Intellectual Property that was actually provided by Regeneron or its Affiliates to Adicet under the Research Program.
1.128 Regeneron Product IP shall mean that certain Regeneron IP, in each case that is incorporated into, or otherwise constitutes, the composition of, or any method of making or any method of using, any Collaboration ICP or Royalty Product or Co-Funded Product (or any component thereof).
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1.129 Regeneron Royalty-Bearing Collaboration ICPs shall mean Optioned Collaboration ICPs for which Adicet has not exercised its Co-Funding Option in accordance with Section 8.1.
1.130 Regeneron Royalty Product shall mean any therapeutic, prophylactic, diagnostic or theranostic product, therapy, treatment or service that incorporates, includes or consists of a Regeneron Royalty-Bearing Collaboration ICP.
1.131 Regeneron Trademarks shall mean the Trademarks Controlled by Regeneron during the Term and designated in writing by Regeneron for use with the Collaboration ICPs.
1.132 Regeneron Transferred Technologies shall mean (i) the Licensed Mice, (ii) any other Regeneron Mice that are used, or intended for use, for testing the efficacy or toxicity of any Collaboration ICP, (iii) any other Regeneron Mice approved by the JRC to be transferred from Regeneron to Adicet pursuant to Section 2.1, (iv) any antibodies or other targeting moieties, or any other technology Controlled by Regeneron that has been approved by the JRC to be transferred from Regeneron to Adicet pursuant to Section 2.1, and (v) any Know-How Controlled by Regeneron or its Affiliates regarding the instructions, protocols and other information provided by Regeneron pursuant to Section 2.1(d)(ii).
1.133 Regeneron Transferred Technologies Inventions shall mean the composition of or any method of using or making specific to the Regeneron Transferred Technologies (other than the Regeneron Mice Inventions), in each case that is discovered, invented, created or otherwise generated by or on behalf of one or both Parties, their Affiliates, employees, agents and consultants pursuant to this Agreement (including under the Research Program).
1.134 Region shall mean a group of countries as approved by the JSC.
1.135 Registration Filing shall mean the submission to the relevant Regulatory Authority of an appropriate application seeking Approval, and shall include, without limitation, any IND or Marketing Approval application.
1.136 Regulatory Authority shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity anywhere in the world with authority over the activities conducted under this Agreement.
1.137 Regulatory Filings means regulatory applications, submissions, dossiers, notifications, registrations, Registration Filings, Approvals, and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture or commercialize a Product in a particular country or regulatory jurisdiction.
1.138 Research Program shall mean the research and development activities to be performed under this Agreement and as set forth in a Research Plan, which shall include (a)(i) discovery research activities directed at Target identification, validation, and selection,
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(ii) CTM (or other Targeting Moieties) discovery, characterization, and optimization, (iii) creation, characterization and optimization of chimeric antigen receptors or T-cell receptors that include CTMs (or other Targeting Moieties), (iv) creation, testing and optimization of Collaboration ICPs (including features that enhance safety or efficacy such as armored chimeric antigen receptors or inhibitory chimeric antigen receptors), (v) development of Manufacturing processes to Manufacture Collaboration ICPs for use in the Research Program and for use in clinical studies, and (vi) preclinical Development as set forth in the applicable Research Plan, or (b) technology development activities mutually agreed by the Parties and set forth in the applicable Technology Research Plan that are separate and distinct from activities to be performed under a Collaboration Research Plan.
1.139 Royalty Product shall mean an Adicet Royalty Product or a Regeneron Royalty Product.
1.140 Royalty Term shall mean:
(a) With respect to each Adicet Royalty Product in each country, the period commencing on the First Commercial Sale of such Adicet Royalty Product in such country and continuing until the later of (i) the expiration of the last Valid Claim Covering [***] such Adicet Royalty Product included in the Patent Rights comprising Adicet Product IP or the Patent Right licensed by Regeneron to Adicet in accordance with Section 5.1, or (ii) twelve (12) years from the First Commercial Sale of such Adicet Royalty Product in such country;
(b) With respect to each Regeneron Royalty Product in each country, the period commencing on the First Commercial Sale of such Regeneron Royalty Product in such country and continuing until the later of (i) the expiration of the last Valid Claim Covering [***] such Regeneron Royalty Product included in the Patent Rights comprising Regeneron Product IP or the Patent Right licensed by Adicet to Regeneron in accordance with Section 5.1, or (ii) twelve (12) years from the First Commercial Sale of such Regeneron Royalty Product in such country;
(c) With respect to each Regeneron Non-ICP Product in each country, the period commencing on the First Commercial Sale of such Regeneron Non-ICP Product in such country and continuing until twelve (12) years from the First Commercial Sale of such Regeneron Non-ICP Product in such country; and
(d) With respect to each Mice Derived Adicet ICP Product (other than one generated or derived from any Licensed Mice set forth under the heading Class 3 Licensed Mice on Schedule 4, and such generation and derivation did not involve the use of any Class 1 Licensed Mice or Class 2 Licensed Mice ) in each country, the period commencing on the First Commercial Sale of such Mice Derived Adicet ICP Product in such country and continuing until twelve (12) years from the First Commercial Sale of such Mice Derived Adicet ICP Product in such country.
1.141 Royalty Territory shall mean, in the event that Adicet in its Co-Funding Notice delivered pursuant to Section 8.1, limits the Co-Funding Territory [***], all countries and territories of the Territory other the Co-Funding Territory. For clarity, in the event Adicet includes the entire Territory in its Co-Funding Notice there shall be no Royalty Territory.
1.142 Securities Act means the Securities Act of 1933, as amended.
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1.143 Shared Commercial Expenses shall mean, for each Co-Funded Product, the costs incurred by Regeneron (or by Adicet pursuant to clause (c) below) directly for the Commercialization of such Co-Funded Product for the Co-Funding Territory, in each case in accordance with this Agreement including:
(a) [***] percent ([***]%) of Net Sales of such Co-Funded Product to cover the cost of distribution, freight, insurance and warehousing, for the sale of such Co-Funded Product in the Co-Funding Territory, less any amount deducted from Net Sales of such Co-Funded Product pursuant to clause (h) of the definition of Net Sales for such Co-Funded Product (and which for clarity shall be a proxy for costs actually incurred);
(b) bad debt attributable to such Product sold in the Co-Funding Territory;
(c) Field Force Costs, including Field Force Costs incurred by Adicet in its performance of its Co-Promotion activities as further set forth in the Co-Promotion Agreement;
(d) Out-of-Pocket Costs for (i) the marketing, advertising and/or promotion of Co-Funded Products in the Co-Funding Territory (including pricing activities, commercial pharmacovigilance, educational expenses, advocate development programs and symposia and promotional materials), (ii) market research for Co-Funded Products in the Co-Funding Territory or (iii) the preparation of training and communication materials for Co-Funded Products in the Co-Funding Territory;
(e) Out-of-Pocket Costs for surveys, registries and clinical trials not intended to gain additional labeled indications for such Co-Funded Product in the Co-Funding Territory, including the Out-of-Pocket Cost of clinical research organizations, investigator and expert fees, lab fees and scientific service fees, the Out-of-Pocket Cost of shipping clinical supplies to centers or disposal of clinical supplies, in each case, to the extent not already included in the Cost of Goods Sold for such Co-Funded Product;
(f) Out-of-Pocket Costs for Pricing Approvals and the maintenance of all Marketing Approvals directly related to the Commercialization of such Co-Funded Product in the Co-Funding Territory;
(g) Commercial Overhead Charge;
(h) Out-of-Pocket Costs for regulatory affairs activities, other than activities to secure Registration Filing of indications or line extension;
(i) Third Party License Payments under a Third Party License entered into in accordance with this Agreement for such Co-Funded Product pursuant to Section 16.7 to the extent attributable to the Commercialization for the Co-Funded Product; and
(j) any other internal costs or expenses or Out-of-Pocket Costs for the Commercialization of such Co-Funded Product and not included in clauses (a) through (i) above.
For clarity, Shared Commercial Expenses shall include Launch Preparation Expenses. In the event that any of the foregoing costs benefit both Co-Funded Product(s) and other products or
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activities (for example, if a Third Party License is not exclusively of benefit to Co-Funded Products) or benefits both Co-Funded Product(s) in the Co-Funding Territory and Regeneron Royalty Products in the Royalty Territory, then Regeneron shall apportion such costs in a manner that fairly reflects the benefit to the Co-Funded Products and the other products or activities or the benefit to the Co-Funded Product(s) in the Co-Funding Territory and the Regeneron Royalty Products in the Royalty Territory. Regeneron shall disclose both the total costs incurred and the apportionment in the information reported under Section 10.3. At the request of Adicet, Regeneron shall provide additional reasonable supporting documentation and make its personnel reasonably available to answer questions. In the event of a dispute regarding an apportionment, the Parties shall resolve the dispute in accordance with Article 23. In no event shall the same costs be included more than once in Shared Commercial Expenses under this Agreement, even if such costs are of benefit to multiple Co-Funded Products.
1.144 Side Letter Agreement means that certain letter agreement dated as of the Effective Date, by and between Regeneron and Adicet.
1.145 Target shall mean (a) any specifically identifiable, separate and distinct molecule or molecular complex (and all isoforms thereof, and genetic and post-translational variants thereof (provided, however, that if the unique portion of such isoform or variant allows generation of a polypeptide that only binds to that unique portion of such isoform or variant, the JRC may choose to nominate such unique portion as a separate Target), in each case that (i) is capable of being bound by polypeptide that includes a complementarity determining region (CDR), and (ii) is reasonably considered in the scientific community (or otherwise by the Parties) to have therapeutic relevance in oncology, and (b) all epitopes within the applicable molecule or molecular complex.
1.146 Target List shall mean the list of Collaboration Targets selected by the Parties pursuant to Section 2.5. For clarity, the Target List shall not include the Non-Collaboration Targets.
1.147 Target Selection Term shall mean the period beginning on the Effective Date and ending on the five (5)-year anniversary thereof unless the Research Program is terminated in accordance with Section 2.2(b), 2.2(c), 2.2(c) or 22.10(a), or this Agreement is earlier terminated in accordance with Article 22, in which event the Target Selection Term shall end on the effective date of such termination.
1.148 Targeting Moiety shall mean (a) any polypeptide that includes a complementarity determining region (CDR), including a single-chain variable fragment (scFv), Antibody or T-cell receptor and was designed and selected to bind, and binds, a specific Target, and (b) any DNA or RNA sequence encoding a polypeptide described in (a). For clarity, a Targeting Moiety does not include spacer, costimulatory or other non-CDR elements contained in a chimeric antigen receptor or chimeric T-cell receptor.
1.149 Technology Collaboration Invention shall mean a Collaboration Invention described in clause (b) of Section 1.38.
1.150 Technology Research Plan shall mean a Research Plan described in clause (ii) of Section 2.3(a).
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1.151 Technology Research Program shall mean a Research Program described in clause (b) of Section 1.138.
1.152 Terminated ICPs shall mean, collectively, Terminated Collaboration ICPs and Terminated Mice Derived Adicet ICPs.
1.153 Terminated Products shall mean, collectively, Terminated ICP Products, Terminated Mice Derived Adicet ICP Products and Terminated Regeneron Non-ICP Products.
1.154 Territory shall mean all the countries and territories of the world.
1.155 Third Party shall mean any Person other than Adicet or Regeneron or any Affiliate of either Party.
1.156 Third Party License shall mean any agreement between a Party and a Third Party pursuant to which such Third Party grants a license to such Party with respect to Intellectual Property Rights of such Third Party that pertain to a Collaboration ICP or Product.
1.157 Third Party License Payment shall mean any payment due to any Third Party under any Third Party License, including royalties, milestone payments and any other payments.
1.158 Trademarks shall mean all registered and unregistered trademarks (including all common law rights thereto), service marks, trade names, brand names, logos, taglines, slogans, certification marks, Internet domain names, trade dress, corporate names, business names and other indicia of origin, together with the goodwill associated with any of the foregoing and all applications, registrations, extensions and renewals thereof throughout the world, and all rights therein provided by international treaties and conventions.
1.159 United States or U.S. means the United States of America and its territories and possessions.
1.160 Updated Development Cost Forecast means the non-binding forecast, which shall be updated annually in accordance with Section 9.2, for the total expected costs of (i) the Development for a Co-Funded Product in the Co-Funding Territory during the period that begins on the date of such annual update and ends upon the expected first Marketing Approval for such Co-Funded Product plus (ii) the actual Development Costs incurred by Regeneron in the Co-Funding Territory prior to the date of such annual update.
1.161 U.S. Export Control Laws shall mean all applicable U.S. laws and regulations relating to the export or re-export of commodities, technologies, or services, including the Export Administration Act of 1979, 24 U.S.C. §§ 2401-2420, the International Emergency Economic Powers Act, 50 U.S.C. §§ 1701-1706, the Trading with the Enemy Act, 50 U.S.C. §§ 1 et. seq., the Arms Export Control Act, 22 U.S.C. §§ 2778 and 2779, and the International Boycott Provisions of Section 999 of the U.S. Internal Revenue Code of 1986.
1.162 Valid Claim shall mean either (a) a claim of an issued and unexpired Patent (including the term of any patent term extension, supplemental protection certificate, renewal or other extension) that has not been held unpatentable, invalid or unenforceable in a final decision
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of a court or other Governmental Authority of competent jurisdiction from which no appeal may be or has been taken, and that has not been admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise, or (b) a pending claim of a Patent Application that was filed in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling; provided however, that Valid Claim will exclude any such pending claim in any such Patent Application that has not been granted within [***] years after the filing date of any of (i) such Patent Application, (ii) a PCT application of which such Patent Application is the national or regional stage; or (iii) a PCT or regular national or regional patent application to which such Patent Application claims a prior filing date.
The remaining capitalized terms used in this Agreement shall have the meanings set forth in the following Sections of this Agreement:
Term |
Section Reference | |
AAA | 23.3 | |
Acquired Party | 4.3 | |
Acquiring Party | 4.3 | |
Adicet Co-Funding Percentage | 8.1 | |
Adicet Funding Wind Down Period | 22.7(d) | |
Acquisition Product | 4.3 | |
Adicet Commitment Level | 11.2 | |
Adicet Indemnitees | 20.1(b) | |
Adicet Quarterly Expenses | Schedule 2 | |
Agreement | introductory paragraph | |
Antibody Target | 7.8(a) | |
Alliance Manager | 3.2 | |
Base Yearly New Collaboration Target Initiation Number | 2.5(c) | |
CDA | 19.1 | |
Change of Control Notice | 22.10 | |
Co-Funding Option Deadline | 8.1(a) | |
Collaboration Research Plans | 2.3 | |
Committees | 9.1(a) | |
Competing Program | 4.3 | |
Confidential Information | 19.1 | |
CREATE Act | 16.2(i) | |
Co-Administration Study Notice | 7.8(a) | |
Co-Administration Target | 7.8(a) | |
Co-Funding Materials | 8.1 | |
Co-Funding Option | 8.1 | |
Co-Funding Reduction Notice | 8.1(c) | |
Co-Promotion Agreement | 11.2(a) | |
Co-Funding Notice | 8.1 | |
CREATE Act | 16.2(i) | |
Damages | 20.1(a) | |
Default Interest Rate | 14.9 |
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Term |
Section Reference | |
Direct Costs | Schedule 1 | |
Disclosing Party | 19.1 | |
Effective Date | introductory paragraph | |
Evaluation Targets | 2.5(d) | |
Exclusive Negotiation Period | 6.3(d) | |
Expression of Interest | 7.8(a) | |
Final Option Data Package | 2.4(d) | |
First IND Candidate | 6.1(a) | |
Force Majeure | Article 21 | |
Existing Regeneron Target List | 2.5(a) | |
Human Materials | 2.4(g) | |
Indemnified Party | 20.2(a) | |
Indemnifying Party | 20.2(a) | |
Indirect Costs | Schedule 1 | |
Infringement Claim | 16.8(c) | |
Initial Collaboration Target List | 2.5(a) | |
Initial Phase I Supply | 13.2 | |
JSC | 9.1(a) | |
Key Adicet Personnel | 2.2(d) | |
Lead Litigation Party | 16.4(b) | |
Manufacturing Cost | Schedule 1 | |
Maximum Adicet Effort | 11.2 | |
Modified Clause | 24.8 | |
Non-Acquiring Party | 4.3 | |
Non-Performing Party | 2.4(h) | |
Option | 6.2(a) | |
Option Cap | 6.1(c) | |
Option Exercise Fee | 6.2(b) | |
Option Exercise Notice | 6.2(b) | |
Option-Ineligible ICP Agreement | 6.3 | |
Option Period | 6.2(b) | |
Party or Parties | introductory paragraph | |
Performing Party | 2.4(h) | |
Product Infringement | 16.4(a) | |
Product Term | 22.1 | |
Profit Split | Schedule 2 | |
Profits | Schedule 2 | |
Providers | 2.4(g) | |
Quarterly Development True-Up | Schedule 2 | |
Quarterly Profit True-Up | Schedule 2 | |
Receiving Party | 19.1 | |
Regeneron | introductory paragraph | |
Regeneron Antibody | 7.8(b) | |
Regeneron Co-Funding Percentage | 8.1 |
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Term |
Section Reference | |
Regeneron Funding Wind Down Period | 22.8(c) | |
Regeneron Indemnitees | 20.1(a) | |
Regeneron Quarterly Expenses | Schedule 2 | |
Research Plans | 2.3 | |
Research Plan Activities | 2.3(d) | |
Research Program Term | 2.2(a) | |
Research Program Term Licenses | 16.7(a) | |
ROFN | 6.3 | |
ROFN Exercise Notice | 6.3(c) | |
ROFN Notice | 6.3 | |
Rules | 23.3 | |
Shared Facility | Schedule 1 | |
Sole Inventions | 16.1 | |
Target Draft Meetings | 2.5(c) | |
Term | 22.1 | |
Terminated Collaboration ICPs | 22.2 | |
Terminated Mice Derived Adicet ICP | 22.2 | |
Terminated Mice Derived Adicet ICP Products | 22.2 | |
Terminated ICP Products | 22.2 | |
Terminated Regeneron Non-ICP Products | 22.2 | |
Terminated Target | 4.1(f) | |
Third Party Acquisition | 4.3 | |
Third Party Agreement | 4.2(b) | |
Third Party Patent Licenses | 14.3(b) | |
Total Development Costs | Schedule 2 | |
Up-Front Payment | 14.1 | |
Working Group | 9.1(a) |
ARTICLE 2
RESEARCH PROGRAM
2.1 Research Program. The objective of the Parties under the Research Program is to collaborate to discover, research, and conduct preclinical development of Collaboration ICPs that are directed to Collaboration Targets selected by the Parties in accordance with Section 2.5. The Research Program shall be conducted in accordance with a Research Plan for each Collaboration Target as set forth in Section 2.3, and subject entirely thereto, the Parties generally anticipate they will conduct the following activities as part of the Research Program:
(a) The Parties will collaborate to identify and validate Targets that would be most suitable for designation as Collaboration Targets and designate Collaboration Targets as set forth in Section 2.5.
(b) The Parties will collaborate to research and develop new technologies and methods to generally improve the safety, efficacy, and production of ICPs.
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(c) The Parties will collaborate to generate and evaluate Collaboration Targeting Moieties against each Collaboration Target, generate Collaboration ICPs for each Collaboration Targeting Moiety and conduct preclinical development of Collaboration ICPs, with each Party having primary responsibilities for the following:
(d) Regeneron will be primarily responsible for and will use Commercially Reasonable Efforts to:
(i) Subject to Section 2.5(b), Section 2.5(c) and Section 2.5(f), generate, validate and optimize and deliver Regeneron CTMs to Adicet for use in Collaboration ICPs under this Agreement and for no other purpose; and
(ii) provide Regeneron Transferred Technologies to Adicet, for Adicet to generate Regeneron CTMs for the creation of Collaboration ICPs and evaluate Regeneron CTMs, Adicet CTMs; and Collaboration ICPs under this Agreement in accordance with the Research Plan; provided that the quantities of any Regeneron Mice within the Regeneron Transferred Technologies and the timelines for providing any Regeneron Mice shall be subject to Regenerons available capacity for generating and supplying such Regeneron Mice. Additionally, Regeneron shall provide to Adicet all instructions, protocols and other information to the extent reasonably necessary to use the Regeneron Transferred Technologies, and shall make its scientists reasonably available to answer questions regarding the use of the Regeneron Transferred Technologies. If for any reason whatsoever, Regeneron is unable to timely provide the quantities of Regeneron Mice within the timelines set forth in the applicable Research Plan, Regeneron shall give Adicets requirements at least equal priority to those of Regeneron and it Affiliates other most favored Third Party transferees and shall allocate its resources accordingly.
(e) Adicet will be primarily responsible for and will use Commercially Reasonable Efforts to:
(i) determine whether to designate Evaluation Targets as Collaboration Targets;
(ii) use CTMs to generate, validate and optimize Collaboration ICPs under this Agreement for the Parties to evaluate as potential candidates for preclinical development;
(iii) as determined by the JRC, use the Regeneron Transferred Technologies to generate and evaluate Regeneron CTMs for the creation of Collaboration ICPs under this Agreement;
(iv) in the event that (A) pursuant to Section 2.1(d)(i), Regeneron is unable to generate a Regeneron CTM against a particular Collaboration Target and pursuant to Section 2.1(e)(iii) to the extent applicable, Adicet is unable to generate a Regeneron CTM against a particular Collaboration Targets using the Regeneron Transferred Technology, in each case in accordance with the requirements set forth in the Research Plan, or (B) as otherwise determined by the JRC, then subject to Section 16.7(a), Adicet may use other Targeting Moiety discovery technologies available to Adicet to generate Adicet CTMs directed to such Collaboration Target for use in creating Collaboration ICPs under this Agreement;
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(v) develop processes for the manufacture and the scale-up of production of Collaboration ICPs for preclinical and clinical studies;
(vi) conduct all preclinical studies to evaluate the safety, efficacy of Collaboration ICPs, and PK/PD of Collaboration ICPs that are reasonably necessary to support an IND submission as set forth in the applicable Research Plan; and
(vii) prepare draft INDs for Collaboration ICPs in close cooperation with Regeneron and considering any reasonable comments made by Regeneron.
(f) Subject to JRC oversight, unless the Parties otherwise expressly agree in writing, Adicet shall conduct all communications with the applicable Regulatory Authorities for Collaboration ICPs prior to IND submission and shall copy Regeneron on all such communications. As between the Parties, Regeneron shall have the sole right to submit the IND for all Optioned Collaboration ICPs and shall bear the filing costs associated therewith, and Adicet shall have the sole right to submit the IND for all Declined Collaboration ICPs and Option-Ineligible Collaboration ICPs and shall bear the filing costs associated therewith.
(g) The Parties shall discuss and, as reasonably determined by the JRC , and subject to the terms of Regenerons agreements with Third Parties regarding an Antibody, evaluate in pre-clinical studies potential combinations of Collaboration ICPs with immuno-modulatory Antibodies Controlled by Regeneron, and provide mutually agreed reporting to the other Party of the data and other results from such studies.
(h) The Parties shall discuss and, as reasonably determined by the JRC, collaborate on research to advance the ICP technology platform, including [***].
2.2 Term of the Research Program.
(a) The Research Program shall commence as of the Effective Date and shall end, on a Collaboration Target-by-Collaboration Target basis, upon the earliest of the date of (i) Regenerons delivery of the Option Exercise Notice within the time period set forth Section 6.2(b) or Regenerons failure to deliver the Option Exercise Notice within the time period set forth in Section 6.2(b), in each case after receipt of the applicable Final Option Data Package pursuant to Section 2.4(d), (ii) the Parties agreement in writing that they are terminating all work (including research and preclinical development) hereunder on all Collaboration ICPs that Bind to such Collaboration Target (or, if later, the effective date of such termination), (iii) earlier termination of this Agreement in accordance with Article 22, in which event the Research Program shall end on the effective date of such termination; (iv) Regenerons termination of the Research Program pursuant to Sections 2.2(b), 2.2(c), 2.2(c), 2.5(g), 4.3(a)(i)(Z) or 22.10(a), (v) Adicets termination of the Research Program pursuant to Section 4.3(a)(ii)(Z), or (vi) either Partys termination of the Research Program in accordance with Section 2.4(h) (Research Program Term). Each Technology Research Program shall commence as set forth in the applicable Technology Research Plan and (unless earlier terminated as set forth in this Agreement or such Technology Research Plan) shall terminate on the fifth (5th) anniversary of the Effective Date.
(b) Regeneron may, by written notice to Adicet given at any time after the [***] anniversary of the Effective Date, terminate the Research Program in its entirety and end all performance of the Research Plan Activities, in each case upon at least [***] advance written notice.
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(c) Following a Change of Control of Adicet, Regeneron may, by written notice to Adicet, terminate the Research Program and end all performance of the Research Plan Activities, in each case as of the date or dates specified in such notice as set forth in Section 22.10(a).
(d) Regeneron considers the performance of the Adicet personnel set forth on Schedule 4 (the Key Adicet Personnel) as critical for the success of the Research Program. In the event that any of the Key Adicet Key Personnel leave or are removed (or are otherwise unwilling or unavailable to direct or oversee the Research Program in accordance with this Agreement) at any time prior to the [***] anniversary of the Effective Date, then Adicet shall, as soon as practicable but in any event within [***] Business Days of such event, provide written notice of such event to Regeneron and Regeneron may terminate the Research Program in its entirety and end all performance of the Research Plan Activities, in each case upon at least [***] advance written notice.
2.3 Research Plans; Research Plan Activities.
(a) The Research Program will be conducted pursuant to written research plans that set forth (i) the overall strategy, plan, goals, and each Partys activities and responsibilities for each Collaboration Target reasonably necessary to support an IND submission to the FDA or such other jurisdiction as determined by the JRC (or in the case of an Option-Ineligible Collaboration ICP, as determined by Adicet) and shall set forth a timeline for each Partys material activities (the Collaboration Research Plans), or (ii) technology development activities that are separate and distinct from those conducted under a Collaboration Research Plan (the Technology Research Plans and together with the Collaboration Research Plans, the Research Plans). Notwithstanding anything to the contrary in this Agreement, each Technology Research Plan shall require the mutual written agreement of both Parties and shall be identified in writing as a Technology Research Plan at the time of such mutual written agreement, and either Party shall have the right to not agree to any proposed Technology Research Plan.
(b) The Parties will work together to create a Research Plan for each of the initial Collaboration Targets selected pursuant to Section 2.5(b) as soon as possible but in no event later than thirty (30) days after the initial Collaboration Targets are added to the Target List. The Parties shall use Commercially Reasonable Efforts to prepare, finalize and approve a Research Plan for each additional Collaboration Target within [***] after such Collaboration Target is added to the Target List. The Parties acknowledge and agree that the Parties may not agree to the Product Specifications for a Collaboration ICP at the time a Research Plan is initially agreed to in accordance with this clause (b) and the Parties shall subsequently amend the Research Plan for a Collaboration ICP to include the Product Specifications as such Product Specifications are agreed to by the Parties, including the Product Specifications for the Initial Phase I Supply for an Optioned Collaboration ICP to be Manufactured by Adicet pursuant to Section 13.2.
(c) In each Research Plan, the Parties shall specify the desired properties for CTMs and which Party(ies) shall be responsible for generating such CTMs. Each Party shall provide the Adicet Background Know-How or Regeneron Background Know-How, as applicable, that is reasonably necessary for the other Party to conduct its activities under the Research Program, for use in the Research Program.
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(d) Each Research Plan will set forth in detail the material activities of each Party with respect to such Collaboration Target, together with any relevant timelines for such activities (Research Plan Activities). In allocating the activities of each Party under the Research Plan, the JRC will endeavor to focus on each Partys areas of competence in order to avoid duplication of effort and to efficiently and expeditiously achieve the objectives of the Research Plan.
2.4 Research Plan Performance.
(a) Each Party shall use Commercially Reasonable Efforts to perform its Research Plan Activities and to complete such Research Plan Activities within the timelines set forth in the Research Plan and to achieve the goals and deliverables set forth in the Research Plan.
(b) Subject to Section 14.2, each Party shall be responsible for any costs it incurs in the conduct of the Research Program.
(c) No more than [***] and no less than [***] months prior to the anticipated date of IND submission to the FDA, as such date is reasonably determined by Adicet in consultation with the JRC with respect to a Collaboration ICP that Binds such Collaboration Target, Adicet shall provide Regeneron with an Initial Option Data Package. Following the receipt of the Initial Option Data Package and continuing up to the point of Adicets delivery of the Final Option Data Package to Regeneron in accordance with Section 2.4(d) the Parties will communicate regularly as necessary to (i) discuss the design, conduct and results of ongoing pre-clinical studies or planned pre-clinical studies designed to support an IND, (ii) discuss design, conduct, and results of production of GMP materials for clinical trials, (iii) discuss IND drafting and data compilation for the IND, (iv) discuss protocols and study design for the Phase I Trial and (v) discuss any reasonable questions Regeneron may have related to the content of the Initial Option Data Package. Within [***] following the receipt by Regeneron of the Initial Option Data Package for a Collaboration ICP that Binds a Collaboration Target, Regeneron shall provide a written non-binding notice thereof to Adicet in good faith as to whether Regeneron has a bona fide intention to obtain a license under Section 5.1(a)(iv) with respect to such Collaboration ICP that Binds such Collaboration Target. If Regeneron provides Adicet with timely written notice that it has a bona fide intention to obtain a license under Section 5.1(a)(iv) with respect to such Collaboration ICP that Binds such Collaboration Target, then Regeneron shall exercise the applicable Option in accordance with Section 6.2(b) unless data, information or circumstances not contained or explicitly accounted for within the Initial Option Data Package, has, or is reasonably expected to have, a material adverse effect on the development or commercialization of such Collaboration ICP, as determined in Regenerons sole and reasonable discretion. If Regeneron fails to provide Adicet with timely written notice that it has a bona fide intention to obtain a license under Section 5.1(a)(iv) or notifies Adicet that it has no intention to obtain a license under Section 5.1(a)(iv) with respect to such Collaboration ICP that Binds such Collaboration Target, then such Collaboration ICP and all other Collaboration ICPs Binding to the same Collaboration Target shall become Declined Collaboration ICPs.
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(d) No more than [***] and no less than [***] prior to the anticipated date of IND submission to the FDA as such date is reasonably determined by Adicet in consultation with the JRC, Adicet shall deliver to Regeneron a report of (a) all other data that it has generated with respect to a Collaboration ICP since Adicets delivery of the Initial Option Data Package, (b) any updates to such disclosures to Regeneron counsel required by Section 16.6 with respect to such Collaboration ICP and (c) and any additional Collaboration ICP-related information as reasonably requested by Regeneron; provided, however, that the foregoing shall not require Adicet to prepare, obtain or otherwise provide any information, data or materials other than those that are then in Control of Adicet (the Final Option Data Package). In the event that Regeneron reasonably determines that the data included in the Final Option Data Package furnished by Adicet under this Section 2.4(d) is inaccurate or incomplete, Regeneron shall provide written notice thereof to Adicet, provided that such request is made within [***] after Adicet has delivered the Final Option Data Package, and Adicet shall use its Commercially Reasonable Efforts to furnish to Regeneron corrected and/or complete copies of such additional information requested by Regeneron (and the Option Period shall be tolled until such additional information is provided); provided, however, that the foregoing shall not require Adicet to prepare, obtain or otherwise provide any information, data or materials other than those that are then in Control of Adicet.
(e) Each Party shall prepare and maintain, or shall cause to be prepared and maintained, complete and accurate written records, accounts, notes, reports and data with respect to its activities conducted pursuant to the Research Plans in conformity with Applicable Law and standard pharmaceutical industry practices; provided that in no case shall written documentation be maintained for less than [***] years following the Contract Year to which such records pertain. Upon reasonable advance notice, each Party agrees to make the information referred to in the previous sentence available for inspection by the other Party during the Term and the period of [***] following the Term for purposes of ascertaining compliance with this Agreement. Upon reasonable advance notice, at the request of the JRC, each Party agrees to make its employees and consultants reasonably available at their respective places of employment to consult with the other Party on issues arising under the Research Plans. In accordance with the reporting format and schedule approved by the JRC, each Party shall promptly disclose to the other Party in writing all data, including preclinical data, formulation data and Manufacturing data, generated by or on behalf of such Party with respect to a Collaboration ICP. The Parties acknowledge the importance of ensuring that the Research Plans are undertaken in accordance with the following good data management practices: (i) data shall be generated using sound scientific techniques and processes; (ii) data shall be accurately and reasonably contemporaneously recorded in accordance with good scientific practices by Persons conducting research hereunder; (iii) data shall be analyzed appropriately without bias in accordance with good scientific practices; and (iv) all data and results shall be stored securely and shall be easily retrievable. The Parties agree that they shall carry out the Research Plans so as to collect and record any data generated therefrom in a manner consistent with the foregoing requirements.
(f) If animals are used in research hereunder, each Party will comply with the Animal Welfare Act and any other Applicable Laws relating to the care and use of laboratory animals. Regeneron encourages Adicet to use the highest standards, such as those set forth in the Guide for the Care and Use of Laboratory Animals (NRC, 1996), for the humane handling, care and treatment of such research animals. Any animals which are used in the course of the Research Plan, or products derived from such animals, such as eggs or milk, will not be used for food purposes, nor will such animals be used for commercial breeding purposes.
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(g) If any human cell lines, tissue, human clinical isolates or similar human-derived materials (Human Materials) have been or are to be collected and/or used in the Research Plan, each Party represents and warrants (i) that it has complied, or shall comply, with all Applicable Laws relating to the collection and/or use of the Human Materials and (ii) that it has obtained, or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and/or use of such Human Materials. Each Party further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities (Providers) who contributed the Human Materials, including any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purpose.
(h) If a Party fails to use Commercially Reasonable Efforts to perform its Research Plan Activities (the Non-Performing Party), the other Party (the Performing Party) may, at its election, issue a notice of a termination of the Research Program with respect to such Collaboration Target. Such notice of termination shall set forth in reasonable detail the facts underlying or constituting the alleged breach, and the termination which is the subject of such notice shall be effective [***] after the date such notice is given unless the breaching Party shall have cured such breach within such [***] period. If termination becomes effective, the Research Program shall terminate with respect to such Collaboration Target and solely with respect to the Performing Party, the Collaboration Target shall be removed from the Target List, and such Target shall by a Terminated Target solely with respect to the Performing Party.
2.5 Target List.
(a) Existing Regeneron Targets. A list of cancer cell Targets that Regeneron is currently researching as of the Effective Date is set forth on Schedule 5 (the Existing Regeneron Target List).
(b) Initial Targets. The Parties shall meet within [***] of the Effective Date and the Parties shall discuss and agree to designate [***] Targets as the initial Collaboration Targets on the Target List, which may include Targets on the Existing Regeneron Target List. Notwithstanding the foregoing, if the Parties mutually desire additional time to designate [***] Targets as the initial Collaboration Targets or to designate a Target as an Evaluation Target, such meeting shall be postponed for such period and/or such meeting shall be held on more than one date, in each case as the Parties mutually agree in writing for purposes of designating [***] Targets as the initial Collaboration Targets or designating one or more Targets as Evaluation Targets. Additionally, if the Parties mutually desire to conduct validation work and evaluation of a nominated Target before determining whether to add such Target as a Collaboration Target or Evaluation Target at such initial meeting, the Parties shall mutually agree in writing on a plan therefor. In such a case, each Party shall conduct its obligations under such plan and share with the other Party the results thereof, and such meeting shall be postponed and/or such meeting shall be held on more than one date, in each case to allow the Parties to determine whether to add any such Target as one of the initial Collaboration Targets or as an Evaluation Target.
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(c) Target Draft Meetings. The Parties shall meet in the [***] of such date, or more often if agreed between the Parties (together with the initial meeting described in Section 2.5(b), the Target Draft Meetings), and the Parties shall discuss additional Targets for inclusion in the Research Program. The Parties shall add [***] mutually agreed Targets per Contract Year (Base Yearly New Collaboration Target Initiation Number), subject to Section 2.5(f) (in which case the Parties will add [***] mutually agreed to Targets to the Target List in such Contract Year) and in each case, in accordance with the selection process set forth in Section 2.5(e) below.
(d) Evaluation Targets. In addition to the Base Yearly New Collaboration Target Initiation Number for each Contract Year during the Target Selection Term, at each Target Draft Meeting other than the Target Draft Meeting held [***] of the Target Selection Term, the Parties may discuss and mutually agree to include up to an [***] Targets for further evaluation as potential Collaboration Targets (Evaluation Targets); provided, however, that the maximum number of Evaluation Targets existing at any one time shall not exceed [***]. At each Target Draft Meeting, other than the first Target Draft Meeting, the Parties shall discuss whether to include any Evaluation Targets selected in the prior Target Draft Meeting as Collaboration Targets; provided, however, in the event of a dispute, Adicet shall have the right to determine whether an Evaluation Target becomes a Collaboration Target. The Parties shall have the right to replace any previously added Evaluation Target at any time by mutual written agreement of the Parties. Any Evaluation Target not selected as Collaboration Targets prior to or at the first Target Draft Meeting that is [***] after the Target Draft Meeting at which such Evaluation Target was first selected (or the end of the Target Selection Term, if earlier) shall cease to be an Evaluation Target. Evaluation Targets shall be considered Collaboration Targets for purposes of Section 4.1(b), Section 4.2 and Section 4.3(a).
(e) Target Selection Process.
(i) Mutual Agreement. Except as otherwise set forth in Section 2.5(d), all Collaboration Targets and Evaluation Targets shall be mutually agreed to by the Parties.
(ii) Rejected Targets. If a Party does not agree to include a Target nominated by the other Party as a Collaboration Target or Evaluation Target, then such rejected Target shall be subject to the exclusivity restrictions set forth in Section 4.1(d) or Section 4.1(e) (as applicable).
(f) Target Addition and Replacement. If both Parties wish to add a Collaboration Target(s) without a Target Draft Meeting, the Parties may add such Collaboration Target(s) by a writing signed by both Parties. Furthermore, if the Research Program Term is terminated for a Target pursuant to clause (ii) of Section 2.2(a), then (i) such Target shall be removed from the Target List and shall be a Terminated Target, and (ii) notwithstanding the [***] New Collaboration Target Initiation Number, the Parties shall mutually agree to add [***] additional Collaboration Target to the Target List, provided, however, that no new Collaboration Targets will be added after the end of the Target Selection Term and that the Parties shall only be obligated to initiate such activities for a maximum of [***] additional Collaboration Target in a given Contract Year.
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(g) Target Removal. Collaboration Targets may be removed from the Target List or replaced by new Collaboration Targets (or previously Non-Collaboration Targets) at any time by the mutual written consent of the Parties, whether at a Target Draft Meeting or otherwise or as explicitly set forth in this Agreement. Additionally, if the Parties successfully generate a CTM in accordance with the Research Plan, and Adicet is using Commercially Reasonable Efforts to perform its Research Plan Activities for a period of least [***] after successful generation of a CTM, but Adicet nevertheless fails to meet the timelines set forth in the Research Plan, then such failure shall not be a considered a breach of this Agreement, but Regeneron may terminate the Research Program with respect to such Collaboration Target upon written notice to Adicet , and in such case (i) the restrictions in Section 4.1(b) shall not apply to either Party with respect to such Collaboration Target and (ii) all Collaboration ICPs that Bind to such Terminated Target shall be Declined Collaboration ICPs.
2.6 Exchange of Information and Materials.
(a) Research Program. Each Party will share information with the JRC in a timely manner concerning the progress of the Research Program. Without limiting the foregoing, at least [***] prior to each regular Quarterly meeting of the JRC, each Party will provide to the JRC a written report (in electronic form) summarizing the material activities undertaken by such Party under the Research Program and the results of such activities since such Partys most recent report. Additionally, in the event either Party generates a Regeneron CTM, the generating Party shall disclose to the other Party, to the extent not previously disclosed, the structure and sequence of such Regeneron CTM and any additional known material characteristics of such Regeneron CTM promptly after such information becomes available. The other Party shall have the right to reasonably request and to receive in a timely manner clarifications and answers to questions with respect to such reports and any other data and any other information it reasonably requests with respect to the conduct of the Research Program. Additionally, upon Regenerons exercise of the Option for an Option-Eligible Collaboration ICP, to the extent not provided in the Initial Option Data Package or Final Option Data Package, Adicet shall disclose and provide to Regeneron (in writing and in an electronic format, or in other tangible form, as applicable), within [***] after such exercise, all Adicet Know-How (including any updates or additions thereto) and related materials for such Optioned Collaboration ICP.
(b) Use of Regeneron CTMs Outside of ICPs. During the Research Program Term with respect to a Collaboration Target, if Regeneron conducts any preclinical or clinical study with Regeneron CTMs as part of an Antibody for products other than ICPs, subject to the terms of Regenerons agreements with Third Parties regarding an Antibody, Regeneron shall provide to Adicet summaries of all material results generated from such studies and shall make its scientists reasonable available to discuss results from such studies.
2.7 Restrictions on Use of Regeneron Mice. Notwithstanding anything in this Agreement to the contrary, Adicet agrees that it will (and will ensure that its Affiliates and subcontractors will, if permitted access to the Regeneron Mice under this Agreement): (a) use Regeneron Mice solely for purpose of performing those Adicet Research Plan Activities, and will do so only as expressly set forth in this Agreement and with respect to the Licensed Mice solely for Adicets exercise of its rights under Section 5.1(d) and only as expressly set forth in this Agreement; (b) not use any Regeneron Mice for any research that is subject to consulting or
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licensing obligations, options, or rights to or of a Third Party, without the prior written consent of Regeneron, which may be withheld in Regenerons sole discretion; (c) ensure that all Regeneron Mice (and any materials obtainable from Regeneron Mice from which such Regeneron Mice can be reproduced) supplied to Adicet remain in Adicets sole possession, and will not transfer to any Third Party any Regeneron Mice (and any materials obtainable from Regeneron Mice from which such Regeneron Mice can be reproduced), without the prior written consent of Regeneron, which may be withheld in Regenerons sole discretion; (d) not breed the Regeneron Mice; (e) use diligent efforts to ensure that the Regeneron Mice do not come into contact with any mice other than Regeneron Mice; (f) not transfer nucleic acids (e.g., DNA, RNA) or cells or nuclei from Regeneron Mice to any other mice or into cells of any other mice other than for preclinical development (that does not include germline manipulation); (g) not make any heritable genetic modifications to the Regeneron Mice; (h) not derive embryonic cells, pluripotent cells, or other cells from Regeneron Mice that could be used to make Regeneron Mice or other mice; (i) not create Regeneron Mice, or use Regeneron Mice to create any mice, or any transgenic animals or create any transgenic cell lines, or maintain any cell lines derived from Regeneron Mice and (j) abide by all Applicable Laws for the use, handling and disposal of genetically modified animals, including the Regeneron Mice. For clarity, Adicets license to the Regeneron Mice in Section 5.1(a)(i) and Adicets license to the Licensed Mice in Section 5.1(d)(i) shall be subject to this Section 2.7.
ARTICLE 3
RESEARCH PROGRAM GOVERNANCE
3.1 The Joint Research Committee.
(a) Formation, Composition and Membership. Promptly after the Effective Date, the Parties will establish the JRC, which shall consist of at least three (3) senior representatives appointed by each of Regeneron and Adicet. Each Party may replace its JRC members upon written notice to the other Party (which may be via email); provided that such replacement is a senior representative of such Party, or is otherwise reasonably acceptable to the other Party. The JRC will have two (2) co-chairpersons, one designated by each of Regeneron and Adicet.
(b) Decision Making. The JRC shall operate by consensus. The representatives of each Party shall have collectively one (1) vote on behalf of such Party; provided that no such vote taken at a meeting shall be valid unless a representative of each Party is present and participating in the vote. Notwithstanding the foregoing, each Party, in its sole discretion, by written notice to the other Party (which may be via email), may choose not to have representatives on the JRC and leave decisions of the JRC to representatives of the other Party. Disputes at the JRC level shall be resolved in accordance with Article 23.
(c) Meetings of the JRC. The JRC shall meet at least once every Quarter through the duration of the Research Program Term, unless the JRC co-chairpersons otherwise agree. All JRC meetings may be conducted by telephone, video-conference or in person as determined by the JRC co-chairpersons; provided, however, that the JRC shall meet in person at least once each calendar year. Unless otherwise agreed by the Parties, all in-person meetings of the JRC shall be held on an alternating basis between Regenerons facilities and Adicets facilities. Further, each co-chairperson shall be entitled to call meetings in addition to the regularly scheduled
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quarterly meetings. The co-chairpersons, with the assistance of the Alliance Managers, shall coordinate activities to prepare and circulate an agenda in advance of each meeting and prepare and issue draft minutes of each meeting within [***] thereafter and final minutes within [***] thereafter. With the consent of other Party (not to be unreasonably withheld or delayed), a reasonable number of other representatives of a Party may attend any JRC meeting as non-voting observers (provided that such additional representatives are under obligations of confidentiality and non-use applicable to the Confidential Information of the other Party that are at least as stringent as those set forth in Article 19 below). Each Party shall be responsible for all of its own personnel and travel costs and expenses relating to participation in JRC meetings.
(d) Duties. The JRC shall:
(i) maintain the lists of Collaboration Targets and Non-Collaboration Targets as provided in this Agreement and conduct the Target Draft Meetings;
(ii) discuss the prioritization of Collaboration Targets and Collaboration ICPs;
(iii) discuss the inclusion of Evaluation Targets as Collaboration Targets;
(iv) approve the Research Plan for each Collaboration Target including setting forth each Partys Research Plan Activities;
(v) exchange and review scientific information and data from activities being conducted under, and the then-current progress of, each Research Plan, and establish processes for the exchange of information relating to the progress of the activities under each Research Plan;
(vi) provide guidance and recommendations on the direction of each Research Plan;
(vii) consider and act upon such other matters as specified in this Agreement or as otherwise agreed to by the Parties;
(viii) make any such decisions as are expressly allocated to the JRC under this Agreement; and
(ix) at the request of either Partys representatives to the JRC, conduct ad hoc meetings in addition to the quarterly meetings of the JRC as reasonably necessary to coordinate and expedite all decisions made by the JRC.
3.2 Alliance Management. Upon initiation of the Research Program, each of Adicet and Regeneron shall appoint a senior representative who possesses a general understanding of research, clinical, regulatory, manufacturing and marketing issues to act as its alliance manager, and each Party may replace such person upon notice (which may be via email) to the other Party (Alliance Manager or Alliance Managers). Each Alliance Manager shall be charged with creating and maintaining a collaborative work environment between the Parties. Each Alliance
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Manager will also be responsible for acting as a single-point of communication for seeking consensus both internally within the respective Partys organization and with the other Partys organization, including facilitating review of external corporate communications. The Alliance Managers shall continue to serve in their role until the Parties are no longer developing or commercializing any Collaboration ICP, Royalty Product or Co-Funded Product under this Agreement.
ARTICLE 4
EXCLUSIVITY
4.1 Exclusivity. The Parties agree to the following exclusivity provisions:
(a) Adicet Target Selection Term Exclusivity. Subject to Section 4.2 during the Target Selection Term, neither Adicet nor any of its Affiliates shall, either directly, or with or through any Third Party, research, develop, manufacture or commercialize any ICP or grant any license to any Know-How or Patent Rights for the purposes of researching, developing, manufacturing or commercializing any ICP, in each case other than Collaboration ICPs under and in compliance with Section 4.2 and other provisions within this Agreement.
(b) Mutual Research Program Exclusivity. Without limiting Adicets obligations in Section 4.1(a) with respect to Adicet, for so long as the Parties or their Affiliates are researching or developing any Collaboration ICP that Binds a given Collaboration Target under the Research Program in accordance with this Agreement, neither Party nor any of their respective Affiliates shall, either directly, or with or through any Third Party, research, develop, manufacture or commercialize any Competing Product or grant any license to any Know-How or Patent Rights for the purposes of researching, developing, manufacturing or commercializing any Competing Product in each case that Binds such Collaboration Target.
(c) Royalty Products and Co-Funded Products. For so long as a Party or its Affiliates, licensees or sublicensees are researching, developing or commercializing any Royalty Product or Co-Funded Product that Binds a given Collaboration Target in accordance with this Agreement, neither Party nor any of its Affiliates shall, either directly, or with or through any Third Party, research, develop, manufacture or commercialize any Competing Product that Binds such Collaboration Target or grant any license to any Know-How or Patent Rights for the purposes of researching, developing, manufacturing or commercializing any such Competing Product.
(d) Restrictions on Regeneron with Respect to Rejected Nominated Targets.
(i) During the Target Selection Term, if (A) Regeneron does not agree to include any Target nominated by Adicet as a Collaboration Target or Evaluation Target and (B) Regeneron is not actively pursuing the research, development or commercialization either alone, or with or through (including by means of license) a Third Party, of a Targeting Moiety, or an ICP that contains a Targeting Moiety, that Binds to such Target at the time of Adicets nomination of such Target, then (1) such rejected Target shall be a Non-Collaboration Target, and (2) for a period of [***] from the date of Regenerons rejection of such Target, unless Regeneron subsequently nominates such Target during the Target Selection Term as a Collaboration Target and Adicet does not agree to include such Target as a Collaboration Target, neither Regeneron nor
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any of its Affiliates shall, either directly, or with or through any Third Party, research, develop, manufacture or commercialize any ICP that contains a Targeting Moiety that Binds to such Non-Collaboration Target or grant any license to any Know-How or Patent Rights for the purposes of researching, developing, manufacturing or commercializing any ICP that contains a Targeting Moiety that Binds to a such Non-Collaboration Target.
(ii) During the Target Selection Term, if (A) Regeneron does not agree to include any Target nominated by Adicet as a Collaboration Target or Evaluation Target and (B) Regeneron is actively pursuing the research, development or commercialization either alone, or with or through (including by means of license) a Third Party, of a Targeting Moiety that Binds to such Target (but is not actively pursuing the research, development or commercialization either alone, or with or through (including by means of license) a Third Party, of an ICP that contains a Targeting Moiety that Binds to such Target) at the time of Adicets nomination of such Target, then such rejected Target shall be a Non-Collaboration Target.
(e) Restrictions on Adicet with Respect to Rejected Nominated Targets. During the Target Selection Term, if Adicet does not agree to include any Target nominated by Regeneron as a Collaboration Target or Evaluation Target and (i) Adicet has not otherwise licensed Patent Rights or Know-How or agreed to license Patent Rights or Know-How in connection with a Third Party Agreement with respect to an ICP that contains a Targeting Moiety that Binds to such Target at the time of Regenerons nomination of such Target, or (ii) except as otherwise set forth in the following sentence, then for a period of [***] from the date of Adicets rejection of such Target, unless Adicet subsequently nominates such Target during the Target Selection Term as a Collaboration Target and Regeneron does not agree to include such Target as a Collaboration Target, neither Adicet nor any of its Affiliates shall enter into a Third Party Agreement with respect to such rejected nominated Target or perform the activities contemplated thereunder. Notwithstanding anything to the contrary in Article 4, prior to the [***] anniversary of the Effective Date, Adicet shall have the right not to agree to include up to [***] Targets for which Adicet or its Affiliate has active programs prior to the Effective Date, and to enter into a Third Party Agreement, and shall not be subject to the restriction set forth in the previous sentence, with respect thereto. As of the Effective Date, Adicet shall deposit with its outside counsel a list of up to [***] Targets for which Adicet or its Affiliate has active programs prior to the Effective Date which list shall be signed by an officer of Adicet and notarized. In the event Adicet does not agree to include any Target nominated by Regeneron as a Collaboration Target or Evaluation Target on account of one of these Targets being on the list set forth on the previous sentence, Regeneron shall have the right to appoint a neutral Third Party lawyer that is reasonably acceptable to Adicet to confirm that such Target is in fact on such list; provided that the neutral Third Party lawyer may only confirm or deny whether the Target in question is on the list.
(f) No Exclusivity with Respect to Terminated Targets. On a Collaboration Target-by-Collaboration Target basis, a Target shall no longer be a considered a Collaboration Target, and shall be a Terminated Target, and neither Party nor its Affiliates shall have any further exclusivity obligations pursuant to Article 4 with respect to such Target if (i) the Research Program is terminated (other than pursuant to Section 2.4(h)) with respect to such Collaboration Target prior to Adicets delivery of Option Data Package of a Collaboration ICP that Binds to such Collaboration Target; (ii) the Product Term has expired with respect to Royalty Products or Co-Funded Products that Bind to such Collaboration Target, (iii) this Agreement has been terminated in its entirety or with respect to Royalty Products or Co-Funded Products that Bind to such Collaboration Target, or (iv) the Research Program is terminated pursuant to Section 2.4(h), provided that in such case such Target shall be a Terminated Target solely with respect to the Performing Party.
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4.2 Exceptions to Adicets Exclusivity Obligations. Notwithstanding the foregoing:
(a) Exceptions for Non-Collaboration Targets and Declined Collaboration ICPs. At any time during the Target Selection Term, Adicet has the right to independently research, develop, manufacture and commercialize, or to grant licenses to any Know-How or Patent Rights for the purposes of researching, developing, manufacturing or commercializing, (a) ICPs that Bind up to [***] Non-Collaboration Targets (but which do not also Bind to any Target that is a Collaboration Target), and (b) Declined Collaboration ICPs and all other Collaboration ICPs Binding to the same Collaboration Target as a Declined Collaboration ICP.
(b) Exceptions with Respect to Adicets use of Patent Rights and Know-How. At any time during the Term, Adicet reserves the right to license its or its Affiliates Patent Rights and Know-How or provide services to Third Parties researching, developing, manufacturing or commercializing ICPs (other than ICPs that Bind to Collaboration Targets), where the engineered immune cell (other than the Targeting Moiety) was not and will not be generated, developed or otherwise manufactured using Intellectual Property Controlled by Adicet or its Affiliates and without the active participation by Adicet or its Affiliates in the development or commercialization of such ICPs, provided that such ICPs do not also Bind to any Target that is a Collaboration Target (a Third Party Agreement).
4.3 Change of Control and Acquired Competing Programs and Products. If, during the Term, (i) there is a Change of Control of a Party (such Party, the Acquired Party) and as of the effective date of such Change of Control, a Third Party described in the definition of Change of Control is engaged, directly or indirectly, in any activities that, if carried out by the Acquired Party, would be a breach of the exclusivity obligations set forth in Section 4.1(a) in the case of Adicet (solely with respect to a Change of Control during the Target Selection Term), Section 4.1(b) or Section 4.1(c) (such activities, a Competing Program), or (ii) as the result of an acquisition of a Third Party or the assets of a Third Party by a Party or one or more of its Affiliates (the Acquiring Party), the Acquiring Party directly or indirectly acquires rights during the Target Selection Term to an ICP in the case of Adicet, or during the Term to a Competing Product with respect to either Party (each such ICP or Competing Product, an Acquisition Product and each transaction described in subsection (i) or (ii), a Third Party Acquisition); then, the Acquired Party or Acquiring Party, as applicable, at its sole discretion, shall do one of the following:
(a) Research Program Term. If the Third Party Acquisition occurs during the Research Program Term and the Competing Program or the Acquisition Product contains a Targeting Moiety that Binds a Collaboration Target being researched or developed under the Research Program:
(i) If Adicet is the Acquired Party or Adicet is the Acquiring Party; Adicet shall give Regeneron express written notice thereof within [***] after the closing of such
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Third Party Acquisition and furthermore Adicet shall in its sole discretion do one of the following within [***] after the closing of such Third Party Acquisition: (W) present a proposal to the JRC to include the Competing Program or Acquired Competing Product in the Research Program or other arrangement under this Agreement between the Parties in each case in accordance with Section 4.3(e), (X) as soon as reasonably practicable terminate all research, development, manufacture and commercialization with respect to such Competing Program or Acquisition Product and deliver to Regeneron a notice of such termination, which notice shall include a covenant that no further research, development, manufacture or commercialization shall be performed by any Person on such Competing Program or Acquisition Product; (Y) divest its rights in the Competing Program or Acquisition Product to a Third Party pursuant to Section 4.3(f); or (Z) solely if Adicet is the Acquired Party, retain its rights to continue the Competing Program as a separately segregated program and personnel working on the Competing Program shall not have access to any Confidential Information of the relevant Research Program and Adicet shall implement procedures to prevent the foregoing, which shall not constitute a breach of this Agreement; provided, however, solely in the case of this clause (Z), Regeneron shall have the right, by giving Adicet written notice within [***] after the receipt of such notice from Adicet, to terminate the Research Program with respect to the Collaboration Target that is the subject of such Competing Program in which case all Collaboration ICPs that Bind to such Collaboration Target shall be Declined Collaboration ICPs.
(ii) If Regeneron is the Acquired Party or the Acquiring Party; Regeneron shall give Adicet express written notice thereof within [***] after the closing of such Third Party Acquisition and furthermore Regeneron shall in its sole discretion do one of the following within [***] after the closing of such Third Party Acquisition: (W) present a proposal to the JRC to include the Competing Program or Acquisition Product in the Research Program or other arrangement under this Agreement between the Parties in each case in accordance with Section 4.3(e), (X) as soon as reasonably practicable terminate all research, development, manufacture and commercialization with respect to such Competing Program or Acquisition Product and deliver to Adicet a notice of such termination, which notice shall include a covenant that no further research, development, manufacture or commercialization shall be performed by any Person on such Competing Program or Acquisition Product; or (Y) divest its rights in the Competing Program or Acquisition Product to a Third Party pursuant to Section 4.3(f); or (Z) solely if Regeneron is the Acquired Party, retain its rights to continue the Competing Program as a separately segregated program and in each such case personnel working on the Competing Program shall not have access to any Confidential Information of the relevant Research Program and Regeneron shall implement procedures to prevent the foregoing, which shall not constitute a breach of this Agreement; provided, however, solely in the case of this clause (Z), Adicet shall have the right, by giving Regeneron written notice within [***] after the receipt of such notice from Regeneron, to terminate the Research Program with respect to the Collaboration Target that is the subject of such Competing Program in which case all Collaboration ICPs that Bind to such Collaboration Target shall be Declined Collaboration ICPs.
(b) Co-Funded Products. If either Party is the Acquired Party or the Acquiring Party of a Competing Program or Acquisition Product and there is a Targeting Moiety in such Competing Program or Acquisition Product that Binds the same Collaboration Target as a Collaboration Targeting Moiety in a Co-Funded Product, such Party shall give the other Party express written notice thereof within [***] after the closing of such Third Party Acquisition and
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furthermore the Party that is a party to the Third Party Acquisition shall in its sole discretion do one of the following within [***] after the closing of such Third Party Acquisition: (W) present a proposal to the JSC to include the Competing Program or Acquisition Product in the Co-Funding Arrangement in accordance with Section 4.3(e); (X) as soon as reasonably practicable terminate all research, development, manufacture and commercialization with respect to such Competing Program or Acquisition Product and deliver to the other Party a notice of such termination, which notice shall include a covenant that no further research, development, manufacture or commercialization shall be performed by any Person on such Acquisition Product or (Y) divest its rights in the Competing Program or Acquisition Product to a Third Party pursuant to Section 4.3(f); or (Z) solely if Adicet is the Acquired Party, retain its rights to continue the Competing Program as a separately segregated program and in such case personnel working on the Competing Program shall not have access to any Confidential Information of the relevant Co-Funded Product and Adicet shall implement procedures to prevent the foregoing, which shall not constitute a breach of this Agreement; provided, however, solely in the case of this clause (Z), Regeneron shall have the right, by giving Adicet written notice within [***] after the receipt of such notice from Adicet, to terminate the Co-Funding Term for the applicable Co-Funded Product with the same effect as if such Co-Funding Term were terminated by Adicet pursuant to Section 22.4.
(c) Regeneron Royalty Products. If Regeneron is the Acquired Party or the Acquiring Party of a Competing Program or Acquisition Product and there is a Targeting Moiety in such Competing Program or Acquisition Product that Binds the same Collaboration Target as a Collaboration Targeting Moiety in a Regeneron Royalty Product, Regeneron shall at its sole discretion, do one of the following: (X) present a proposal to Adicet to include the Competing Program or Acquisition Product as a Regeneron Royalty Product in accordance with Section 4.3(e); (Y) terminate all research, development, manufacture and commercialization with respect to such Competing Program or Acquisition Product and deliver to Adicet a notice of such termination, which notice shall include a covenant that no further research, development, manufacture or commercialization shall be performed by any Person on such Acquisition Product or (Z) divest its rights in the Competing Program or Acquisition Product to a Third Party pursuant to Section 4.3(f). If Adicet is the Acquired Party, Adicet and its Affiliates shall have the right to retain its rights to continue the Competing Program, which shall not constitute a breach of this Agreement; provided, that within [***] after the closing of such Third Party Acquisition, Adicet gives Regeneron express written notice thereof.
(d) Adicet Royalty Products. If Adicet is the Acquired Party or the Acquiring Party of a Competing Program or Acquisition Product and there is a Targeting Moiety in such Competing Program or Acquisition Product that Binds the same Collaboration Target as a Collaboration Targeting Moiety in an Adicet Royalty Product, Adicet shall at its sole discretion do one of the following: (X) present a proposal to Regeneron to include the Competing Program or Acquisition Product as an Adicet Royalty Produce in accordance with Section 4.3(e); (Y) terminate all research, development, manufacture and commercialization with respect to such Competing Program or Acquisition Product and deliver to Adicet a notice of such termination, which notice shall include a covenant that no further research, development, manufacture or commercialization shall be performed by any Person on such Acquisition Product or (Z) divest its rights in the Competing Program or Acquisition Product to a Third Party pursuant to Section 4.3(f). If Regeneron is the Acquired Party, Regeneron and its Affiliates shall have the right to retain its rights to continue the Competing Program, which shall not constitute a breach of this Agreement; provided that within [***] after the closing of such Third Party Acquisition, Regeneron gives Adicet express written notice thereof.
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(e) Proposal for Inclusion. If the Acquired Party or Acquiring Party, as applicable, chooses this alternative, within [***] after the closing of such Third Party Acquisition, the Acquired Party or Acquiring Party, as applicable, shall present a proposal to the other Party (the Non-Acquiring Party) to include the Competing Program or Acquisition Product in the Research Program based on the terms of this Agreement, a Co-Funding Arrangement based on the terms of this Agreement or an alternative arrangement, each as contemplated in Section 4.3(a)-(d). As part of such presentation, the Acquired Party or Acquiring Party, as applicable, shall provide the Non-Acquiring Party with all information with respect to such Competing Program or Acquisition Product reasonably available to the Acquired Party or Acquiring Party, as applicable, and material to a decision by the Non-Acquiring Partys representatives on the JSC as to whether to approve the inclusion of the Competing Program or Acquisition Product in the Research Program, Co-Funding Arrangement or other alternative arrangement as applicable. The Non-Acquiring Party shall, on or before the date which is [***] after the closing of such Third Party Acquisition, decide whether to approve the inclusion of the Competing Program or Acquisition Product in the Research Program or Co-Funding Arrangement, under the terms of this Agreement or other alternative arrangement as applicable. If the Non-Acquiring Party timely approves the inclusion of the Competing Program or Acquisition Product in the Research Program or Co-Funding Arrangement, upon the closing of such Third Party Acquisition the Competing Program or the Acquisition Product shall automatically be included in the Research Program or the relevant Co-Funding Arrangement as a Co-Funded Product. If the Non-Acquiring Party does not approve the inclusion of the Competing Program or Acquisition Product in the Research Program or Co-Funding Arrangement under the terms of this Agreement or other alternative arrangement as applicable, the Acquired Party or Acquiring Party, as applicable, shall pursue one of the other options available to it pursuant to Section 4.3(a)-(d), including a divestiture pursuant to Section 4.3(f).
(f) Transfer of Rights. If the Acquired Party or Acquiring Party, as applicable, chooses this alternative, the Acquired Party or Acquiring Party, as applicable, shall commit in writing to the Non-Acquiring Party, within [***] after the closing of such Third Party Acquisition, to divest such Competing Program or Acquisition Product, as applicable, to a Third Party (without any consideration or payment to the Non-Acquiring Party) within six (6) months after the closing of the Third Party Acquisition, and shall do so within such six (6) month period. Any divestiture of rights under this Section 4.3(f) shall not permit the Acquired Party or Acquiring Party, as applicable, or its Affiliates to retain any rights in (other than the right to receive payments) or involvement with the Competing Program or Acquisition Product, including without limitation rights to direct or influence the course of research, development or commercialization thereof, or to contribute or receive nonpublic know-how or information of any sort with respect thereto (other than reports showing the basis for calculating payments made to the Acquired Party or Acquiring Party and the right to audit the accuracy of such reports).
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ARTICLE 5
LICENSES
5.1 License Grants.
(a) Designated Activities Licenses and Royalty Products Licenses.
(i) Regeneron shall grant and hereby grants to Adicet a non-exclusive, non-transferable (except as permitted by Section 24.9), non-sublicensable (except as permitted under Section 5.5(d)), worldwide license under the Regeneron IP solely to perform the applicable Adicet Designated Activities during the Research Program Term.
(ii) Regeneron shall grant and hereby grants to Adicet (a) an exclusive (even as to Regeneron and its Affiliates), non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers (in accordance with Section 5.5), worldwide license under the Regeneron Product IP (other than the Regeneron Mice IP) (A) to develop, make, have made, use and import Adicet Royalty Products, (B) to offer for sale and sell Adicet Royalty Products in Finished Product Form, and (C) to sell or transfer Adicet Royalty Products (other than in Finished Product Form) solely to its Affiliates or sublicensees for such Affiliates or sublicensees developing, making, having made, using and importing Adicet Royalty Products, and offering for sale or selling Adicet Royalty Products in Finished Product Form, in each case during the Term in accordance with the terms of this Agreement and (b) a non-exclusive non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers (in accordance with Section 5.5), worldwide license under the Regeneron Mice IP (X) to develop, make, have made, use and import Adicet Royalty Products, (Y) to offer for sale and sell Adicet Royalty Products in Finished Product Form, and (Z) to sell or transfer Adicet Royalty Products (other than in Finished Product Form) solely to its Affiliates or sublicensees for such Affiliates or sublicensees developing, making, having made, using and importing Adicet Royalty Products, and offering for sale or selling Adicet Royalty Products in Finished Product Form, in each case during the Term in accordance with the terms of this Agreement. In the event Adicet exercises its Co-Promotion option in accordance with Section 11.3(a) with respect to a Co-Funded Product in the United States, then Regeneron shall grant to Adicet the licenses to be set forth in the in Co-Promotion Agreement to enable Adicet to perform Co-Promotion of such Co-Funded Product under the Co-Promotion Agreement.
(iii) Adicet shall grant and hereby grants to Regeneron a non-exclusive, non-transferable (except as permitted by Section 24.9), non-sublicensable (except as permitted under Section 5.5(d)), worldwide license under the Adicet IP solely to perform the Regeneron Designated Activities during the applicable Research Program Term.
(iv) Adicet shall grant and hereby grants to Regeneron an exclusive (even as to Adicet and its Affiliates but subject to Adicets Co-Promotion option in Section 11.3(a)), non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers (in accordance with Section 5.5), license under the Adicet Product IP (A) to develop, make, have made, use and import Regeneron Royalty Products and Co-Funded Products, (B) to offer for sale and sell Regeneron Royalty Products and Co-Funded Products, in each case in Finished Product Form, and (C) to sell or transfer Regeneron Royalty Products and Co-Funded Products (in each case other than in Finished Product Form) solely to its Affiliates or sublicensees for such
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Affiliates or sublicensees developing, making, having made, using and importing Regeneron Royalty Products and Co-Funded Products, and offering for sale or selling Regeneron Royalty Products and Co-Funded Products in each case in Finished Product Form, in each case during the Term in the Territory (with respect to Regeneron Royalty Products), or in the Co-Funding Territory (with respect to Co-Funded Products), during the Term in accordance with the terms of this Agreement. For clarity, the exclusivity of the license in this Section 5.1(a)(iv) shall be subject to Adicets right to Co-Promote a Co-Funded Product in the United States pursuant to Section 11.3.
(v) Notwithstanding anything to the contrary in this Agreement, except as otherwise expressly mutually agreed by the Parties pursuant to Section 10.4 or as otherwise set forth in Sections 6.4 and 13.4, (A) Adicet shall have no obligation, directly or indirectly, to transfer to Regeneron any Adicet Background IP (other than to the extent constituting Adicet Product IP), and (B) the license grants by Adicet to Regeneron under this Agreement shall exclude any license under Adicet Background IP to generate, derive, modify or otherwise develop (1) an ICP to a Collaboration Target of a different cell type than the Research Program ICP to such Collaboration Target, or (2) an ICP other than an ICP that is an improvement, modification or derivative of a Research Program ICP.
(vi) Notwithstanding anything to the contrary in this Agreement, except for Regeneron Transferred Technologies provided by Regeneron pursuant to Section 2.1, (A) Regeneron shall have no obligation, directly or indirectly, to transfer to Adicet any Regeneron Background IP (other than to the extent constituting Regeneron Product IP), and (B) the license grants by Regeneron to Adicet under this Agreement shall exclude any license under Regeneron Background IP to generate, derive, modify or otherwise develop (1) an ICP to a Collaboration Target of a different cell type than the Research Program ICP to such Collaboration Target, or (2) an ICP other than an ICP that is an improvement, modification or derivative of a Research Program ICP.
(b) Collaboration Inventions License.
(i) Adicet shall grant and hereby grants to Regeneron and its Affiliates a non-exclusive, non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers (in accordance with Section 5.5), perpetual, worldwide, irrevocable, fully paid-up royalty-free license under any Patent claiming Collaboration Inventions other than Technology Collaboration Inventions with respect to which a Regeneron employee is (or in the case of a foreign Patent properly would be) a named inventor (either solely or jointly with an Adicet employee) under United States patent law (other than Patents solely claiming Collaboration Inventions that recite the composition, generation, selection, optimization, formulation, development, isolation, activation, expansion, making or using of allogeneic immune cells, and other than Technology Collaboration Inventions), in each case to research, develop, make, have made, use offer for sale, sell and import products, other than (i) products using or comprising allogeneic immune cells that are not Products and/or (ii) Competing Products.
(ii) Adicet shall grant and hereby grants to Regeneron and its Affiliates a non-exclusive, non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers (in accordance with Section 5.5), perpetual, worldwide, irrevocable, fully paid-up royalty-free license under any Patent claiming a Technology Collaboration Invention with respect to which a Regeneron employee is (or in the case of a foreign Patent properly would be) a named inventor (either solely or jointly with an Adicet employee) under United States patent law, in each case to research, develop, make, have made, use offer for sale, sell and import products other than Competing Products.
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(c) Trademark Licenses.
(i) To the extent applicable, Regeneron shall grant and hereby grants to Adicet a non-exclusive license (A) to use the Regeneron Trademarks in connection with the performance of the Adicet Designated Activities during the Term, and Adicets Co-Promotion of a Co-Funded Product in accordance with the Co-Promotion Agreement, and (B) to use the Product Trademarks in connection with Adicets Co-Promotion of a Co-Funded Product in accordance with the Co-Promotion Agreement. Any and all goodwill derived from the use of the Regeneron Trademarks or the Product Trademarks shall inure solely to the benefit of Regeneron.
(ii) To the extent applicable, Adicet shall grant and hereby grants to Regeneron a non-exclusive license to use the Adicet Trademarks in connection with the Regeneron Designated Activities during the Research Program Term and Regenerons Co-Promotion of the Co-Funded Product in accordance with the Co-Promotion Agreement. Any and all goodwill derived from the use of the Adicet Trademarks shall inure solely to the benefit of Adicet.
(iii) Each Party agrees that the use of the other Partys Trademarks shall be subject to the approval of by the other Party and shall comply with all Applicable Law and such other Partys Trademark policies. Each party will refrain from any use of the others Trademarks in a manner that threatens to damage the goodwill associated with the respective Trademarks or which threatens to tarnish the reputation or otherwise reflect unfavorably upon the owner of the Trademarks. Neither Party shall, during the Term, anywhere in the world, take any action that in the other Partys sole and absolute discretion impairs or contests or is likely to impair or contest the validity of the other Partys right, title and interest in and to its Trademarks, including, using, or filing an application to register, any word, mark, symbol or device, or any combination thereof, that is confusingly similar to or dilutes the distinctiveness of any of the other Partys Trademarks.
(d) Mice Derived Adicet ICPs.
(i) Adicet License to Licensed Mice to Generate Mice Derived Adicet Targeting Moieties. During the Target Selection Term and thereafter until the [***] anniversary of the Effective Date, Regeneron hereby grants to Adicet: (A) a worldwide non-exclusive license, without the right sub-license, to use the Class 1 Licensed Mice or Class 2 Licensed Mice set forth on Schedule 3 to generate and the Class 3 Licensed Mice to test (but not generate) (i) during the Target Selection Term, Mice Derived Adicet Targeting Moieties against up to [***] Non-Collaboration Targets, except that without limiting Adicets exclusivity obligations in Article 4, the foregoing limitation shall not apply to Class 3 Licensed Mice and (ii) thereafter until the [***] anniversary of the Effective Date, Mice Derived Adicet Targeting Moieties against Non-Collaboration Targets; and (B) a worldwide non-exclusive license with the right to sublicense to make, use and import the Mice Derived Adicet Targeting Moieties generated or tested pursuant to clause (i) of this Section 5.1(d)(i)(A) (i) to develop, make, have made, use and import Mice Derived Adicet ICP Products, (ii) to offer for sale and sell Mice Derived Adicet ICP Products in
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Finished Product Form, and (iii) to sell or transfer Mice Derived Adicet ICP Products (other than in Finished Product Form) solely to its Affiliates or sublicensees for such Affiliates or sublicensees developing, making, having made, using and importing Mice Derived Adicet ICP Products, and offering for sale or selling Mice Derived Adicet ICP Products in Finished Product Form, in each case during the Term, in accordance with the terms of this Agreement, anywhere in the world and for no other purpose. Following a Change of Control of Adicet, Regeneron may, by written notice to Adicet, terminate the license granted pursuant to Section 5.1(d)(i)(A) for programs that were not initiated prior to the date Adicet receives such notice. For clarity, Adicet or its sublicensees shall not use or incorporate the Mice Derived Adicet Targeting Moieties in any products other than ICPs. To the extent not previously provided, Regeneron shall use Commercially Reasonable Efforts to provide Adicet with Licensed Mice in the quantities and on the timelines reasonably requested by Adicet and subject to Regenerons available capacity to supply such Licensed Mice to exercise such license rights under Section 5.1(d)(i)(A); provided that Adicet shall only use such Licensed Mice for the purpose set forth in Section 5.1(d)(i)(A) and no other purpose. If for any reason whatsoever, Regeneron is unable to timely provide the quantities of Licensed Mice within the timelines reasonably requested by Adicet hereunder, Regeneron shall give Adicets requirements at least equal priority to those of Regeneron and its Affiliates other most favored Third Party transferees and shall allocate its resources accordingly.
(ii) Adicet Notice of Mice Derived Adicet Targeting Moieties.
A. On a Non-Collaboration Target-by-Non-Collaboration Target basis, in the event Adicet initiates immunization activities to generate a Mice Derived Adicet Targeting Moiety against a Non-Collaboration Target that was previously nominated as a Collaboration Target by Regeneron but Adicet did not agree include such Target as a Collaboration Target (and for clarity, therefore Adicet is only permitted to initiate such activities after final expiration or termination of the Target Selection Term), Adicet shall provide written notice to Regeneron identifying such Non-Collaboration Target within [***] after initiating such immunization activities.
B. In addition to Adicets obligations set forth in clause A immediately above, on a Non-Collaboration Target-by-Non-Collaboration Target basis, within [***] after Adicet identifies and designates a specific Mice Derived Adicet ICP Product containing a Mice Derived Adicet Targeting Moiety for a given Non-Collaboration Target as a lead pre-clinical product candidate (i.e. completion of non-GLP in-vivo preclinical efficacy and toxicity studies) under the license granted pursuant to Section 5.1(d)(i)(B), Adicet shall provide written notice to Regeneron identifying such Non-Collaboration Target, and (without the obligation to conduct any additional work at such time) any then-known properties, structures and sequences of such Mice Derived Adicet Targeting Moiety that Bind such Non-Collaboration Target.
C. In addition, if Adicet initiates immunization activities to generate a Mice Derived Adicet Targeting Moiety against a Non-Collaboration Target but does not designate any such Mice Derived Adicet Targeting Moiety as a pre-clinical lead product candidate, then Adicet shall so inform Regeneron in writing (without any obligation to disclose the target therefor or any confidential information), together with such other information regarding such decision as Adicet determines in its sole discretion.
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(iii) Regeneron License to Mice Derived Adicet Targeting Moieties. Adicet hereby grants to Regeneron a worldwide, exclusive (even as to Adicet and its Affiliates), non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers (in accordance with Section 5.5), license under the Adicet Mice Derived Adicet Targeting Moiety IP solely to develop, make, have made, use, sell, have sold, and import Regeneron Non-ICP Products in accordance with the terms of this Agreement.
5.2 Freedom to Operate.
(a) In the event and to the extent that the making, having made, use, offer for sale, sale, import and/or other exploitation by Regeneron or its Affiliates or sublicensees of a Regeneron Royalty Product or Co-Funded Product in each case containing an ICP generated during the Research Program Term as such ICP exists at the end of the Research Program Term (Research Program ICP), or any biomarker or assay to be used in connection with such Regeneron Royalty Product or Co-Funded Product (including in connection with any diagnostics for an indication for which such Regeneron Royalty Product or Co-Funded Product may be used), would infringe a claim of a Patent Right which Adicet (or any of its Affiliates) Controls (other than Patent Rights licensed from Third Parties which require payment to such Third Parties for the use of such license) and which are not covered by the grant in Section 5.1(a)(iv) or Section 5.1(b), Adicet (and its Affiliates) hereby grants to Regeneron, a non-exclusive, sublicensable, royalty-free license in the Territory under such Patent Right for Regeneron, its Affiliates and sublicensees to develop, make, have made, use and import, and to offer for sale and sell, Regeneron Royalty Products containing such Research Program ICP (or any improvements, modifications or derivatives to or of such Research Program ICP) in the Territory and Co-Funded Products containing such Research Program ICP (or any improvements, modifications or derivatives to or of such Research Program ICP) in the Co-Funding Territory, or biomarker(s) or assay(s) to be used in connection with such Regeneron Royalty Products in the Territory or Co-Funded Products in the Co-Funding Territory, in each case in accordance with the terms of this Agreement. In addition to, and without limiting the foregoing, in the case of Patent Rights in-licensed by Adicet or its Affiliates, but not Controlled by Adicet or its Affiliates, then to the extent Adicet or its Affiliate has the right to enforce such in-licensed Patent Right, then Adicet and its Affiliates shall not enforce, either directly or through an agent, such Patent Rights against Regeneron or its Affiliates or sublicensees for the licensed activities set forth in this Section 5.2(a). Notwithstanding anything to the contrary herein, the foregoing license and covenant shall exclude any Patent Right to the extent it would not be infringed by the making, having made, use, offer for sale, sale, import and/or other exploitation by Regeneron or its Affiliates or sublicensees of such Research Program ICP, biomarker or assay.
(b) In the event and to the extent that the making, having made, use, offer for sale, sale, import and/or other exploitation by Adicet or its Affiliates or sublicensees of an Adicet Royalty Product containing a Research Program ICP, or any biomarker or assay to be used in connection with such Adicet Royalty Product (including in connection with any diagnostics for an indication for which an Adicet Royalty Product may be used), would infringe a claim of a Patent Right which Regeneron (or any of its Affiliates) Controls (other than Patent Rights licensed from Third Parties which require payment to such Third Parties for the use of such license) and which are not covered by the grant in Section 5.1(a)(ii), Regeneron (and its Affiliates) hereby grants to Adicet a non-exclusive, sublicensable, royalty-free license in the Territory under such Patent Right
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for Adicet, its Affiliates and sublicensees to develop, make, have made, use and import, and to offer for sale and sell, Adicet Royalty Products containing such Research Program ICP (or any improvements, modifications or derivatives to or of such Research Program ICP) in the Territory, or biomarker(s) or assay(s) to be used in connection with such Adicet Royalty Products in the Territory, in each case in accordance with the terms of this Agreement. In addition to, and without limiting the foregoing, in the case of Patent Rights in-licensed by Regeneron or its Affiliates, but not Controlled by Regeneron or its Affiliates, then to the extent Regeneron or its Affiliate has the right to enforce such in-licensed Patent Right, then Regeneron and its Affiliates shall not enforce, either directly or through an agent, such Patent Rights against Adicet or its Affiliates or sublicensees for the licensed activities set forth in this Section 5.2(b). Notwithstanding anything to the contrary herein, the foregoing license and covenant shall exclude any Patent Right to the extent it would not be infringed by the making, having made, use, offer for sale, sale, import and/or other exploitation by Adicet or its Affiliates or sublicensees of such Research Program ICP, biomarker or assay.
(c) Notwithstanding the foregoing, the rights granted by this Section 5.2 specifically exclude any licenses related to Targeting Moieties other than CTMs.
5.3 Licenses Generally; No Implied License. Except as expressly provided for herein, nothing in this Agreement grants either Party any right, title or interest in and to the intellectual property rights, materials or Confidential Information of the other Party (either expressly or by implication or estoppel). Except as expressly provided for in this Article 5 or elsewhere in this Agreement, neither Party will be deemed by this Agreement to have been granted any license or other rights to the other Partys Patent Rights or Know-How, either expressly or by implication, estoppel or otherwise. Subject to Section 5.1(d)(i), no license or right granted in Section 5.1 or elsewhere in this Agreement includes any right for Adicet to use any Regeneron Mice for the research, development, manufacture or commercialization of any ICP that is not a Collaboration ICP. No license or right granted in Section 5.1 or elsewhere in this Agreement includes any right for Regeneron to use any Mice Derived Adicet Targeting Moiety Inventions for the research, development, manufacture or commercialization of any ICP. No license or right granted in Section 5.1 or elsewhere in this Agreement includes any right for either Party to use, and neither Party shall use or grant any Third Party the right to use, any CTM for the research, development, manufacture or commercialization of any ICP, other than a Collaboration ICP in accordance with this Agreement.
5.4 Retained Rights. Notwithstanding anything to the contrary in Article 4 or Article 5, and for the avoidance of doubt, each Party expressly reserves for itself and its Affiliates and Third Party licensees under the Regeneron IP and Adicet IP, as applicable, (i) the right to research, develop and commercialize Targeting Moieties outside the Research Program, (a) with respect to Adicet not for use in ICPs during the Target Selection Term (except as expressly permitted pursuant to Section 4.2) and (b) with respect to either Party, not for use in ICPs that bind to Collaboration Targets during the Term, except in accordance with this Agreement, or (ii) otherwise undertake activities in compliance with, or not prohibited by, Article 4. Additionally, with respect to the licenses granted under this Article 5, and for the avoidance of doubt, Adicet expressly reserves for itself and its Affiliates and Third Party licensees under the Mice Derived Adicet Targeting Moiety Inventions, the right to research, develop and commercialize any ICP containing a Mice Derived Adicet Targeting Moiety; provided that such ICP doesnt contain any CTM
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contained in a Regeneron Royalty Product or Co-Funded Product. Without limiting the exclusivity restrictions set forth in Section 4.1, each Party reserves the right to grant licenses to Third Parties to use Intellectual Property Controlled by it or its Affiliates (other than with respect to Intellectual Property Controlled by a Party as a licensee of the other Party pursuant to this Agreement) for general antibody discovery purposes (i.e., that is not specific to any particular Collaboration Target for use in ICPs), which may involve the research and testing of Targeting Moieties, and such grant and any associated disclosure or provision of such Intellectual Property in connection therewith shall not constitute a breach of this Agreement (including Section 4.1), provided that, such Party and its Affiliates will not otherwise actively assist any such Third Party in generating, validating, researching or developing any Targeting Moiety if doing so would not comply with Section 4.1. Notwithstanding anything to the contrary in Article 4 or Article 5, and for the avoidance of doubt, each Party further reserves the right to grant licenses to academic Third Parties to use the Intellectual Property Controlled by such Party or its Affiliates (other than with respect to Intellectual Property Controlled by a Party as a licensee of the other Party pursuant to this Agreement) for academic research purposes, which may involve the research and testing of Targeting Moieties or the research (in each case, but not human clinical testing) of ICPs, with respect to Adicet that is not specific to any particular ICPs that Bind the same Collaboration Target as a Co-Funded Product or a Regeneron Royalty Product, and with respect to Regeneron that is not specific to any particular ICPs that Bind the same Collaboration Target as an Adicet Royalty Product, and such grant and any associated disclosure or provision of Intellectual Property in connection therewith shall not constitute a breach of this Agreement (including Section 4.1), provided that, such Party and its Affiliates will not otherwise actively assist any such Third Party in such research and testing if such active assistance would not comply with Section 4.1.
5.5 Sublicensing.
(a) Regeneron has the right to sublicense any of its rights under the license granted in Sections 5.1(a)(iv) and the rights granted in Section 5.2 (subject to Adicets Co-Funding Option and Co-Promotion option herein) to any licensee of the Co-Funded Products or the Regeneron Royalty Products without the prior written consent of Adicet. Regeneron has the right to sublicense any of its rights under the license granted in Section 5.1(d)(iii) to any licensee of the Regeneron Non-ICP Products without the prior written consent of Adicet. Additionally, Regeneron has the right to sublicense any of its rights under the license granted in Section 5.1(b) without the prior written consent of Adicet.
(b) Adicet has the right to sublicense any of its rights under the exclusive license granted in Section 5.1(a)(ii)and the rights granted in Section 5.2 to any licensee of any Adicet Royalty Products without prior written consent of Regeneron, but only in the event that Adicet has fully satisfied all of its obligations pursuant to Sections 6.1, 6.2 and 6.3 with respect to the applicable Adicet Royalty Product. Adicet has the right to sublicense any of its rights under the non-exclusive license granted in Section 5.1(d)(i)(B) to any licensee of any Mice Derived Adicet ICP Products without the prior written consent of Regeneron.
(c) A Party has the right to sublicense any of its other rights under the licenses granted in Section 5.1 or the rights granted in Section 5.2, except for those license rights described in Section 5.5(a) and 5.5(b), only with the prior written consent of the other Party.
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(d) Notwithstanding the foregoing provisions of this Section 5.5, either Party may sublicense any of its rights hereunder without such other Partys consent, (i) to an Affiliate or (ii) to any permitted subcontractor performing Regeneron Designated Activities or Adicet Designated Activities, as applicable, provided in the case of clause (ii) that the subcontracting Party granting such sublicense has fully satisfied all of its obligations pursuant to Sections 5.6 and 24.11, including any applicable subcontract consent requirements.
5.6 Invention Assignment. All of the employees, officers and consultants of each Party that are engaged in the performance of its obligations or exercise of its rights under this Agreement shall have executed agreements assigning to such Party of all inventions and intellectual property made during the course of and as the result of their association with such Party, obligating the individual upon request to sign any documents to confirm or perfect such assignment and to cooperate in the preparation and prosecution of any Patent Applications disclosing or claiming such inventions and obligating the individual to obligations of confidentiality and non-use regarding Confidential Information, that are at least as stringent as those undertaken by the Parties pursuant to Article 19 hereof.
ARTICLE 6
REGENERON COMMERCIAL LICENSE OPTIONS; AND REGENERON RIGHT OF FIRST NEGOTIATION
6.1 Option-Eligible Collaboration-ICPs and Option-Ineligible Collaboration ICPs. Regeneron has the right to exercise its Option with respect to Option-Eligible Collaboration ICPs pursuant to Section 6.2. Whether a Collaboration ICP is an Option-Eligible Collaboration ICP or an Option-Ineligible Collaboration ICP shall be determined in accordance with this Section 6.1.
(a) Adicet shall have the right to develop and commercialize the first Collaboration ICP (and all other Collaboration ICPs that Bind the same Collaboration Target) for which Adicet delivers a Final Option Data Package (First IND Candidate), and such First IND Candidate (and all other Collaboration ICPs that Bind the same Collaboration Target) shall be an Option-Ineligible Collaboration ICP.
(b) Subject to Section 6.1(a) with respect to the First IND Candidate and the Option Cap in Section 6.1(c), a Collaboration ICP for which Adicet delivers a Final Option Data Package (and all other Collaboration ICPs that Bind the same Collaboration Target) shall be an Option-Eligible Collaboration ICP unless Regeneron exercised its Option with respect to the preceding Collaboration ICP (that binds a different Collaboration Target) for which Adicet delivered a Final Option Data Package. For clarity, in the event Regeneron did exercise its Option for the preceding Collaboration ICP, then the Collaboration ICP (that binds a different Collaboration Target) for which Adicet delivers the next Final Option Data Package (and all other Collaboration ICPs that Bind the same Collaboration Target) shall become an Option-Ineligible Collaboration ICP at the time of such Final Option Data Package delivery. For further clarity, after a particular Collaboration ICP (and all other Collaboration ICPs that Bind the same Collaboration Target) becomes an Option-Ineligible Collaboration ICP, each future Collaboration ICP that Binds a different Collaboration Target shall be considered an Option-Eligible Collaboration ICP when Adicet delivers to Regeneron a Final Option Data Package for such Collaboration ICP until such time as Regeneron exercises its Option for an Option-Eligible
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Collaboration ICP, in which case the next Collaboration ICP for which Regeneron delivers a Final Option Data Package (and all other Collaboration ICPs that Bind the same Collaboration Target) shall be an Option-Ineligible ICP.
(c) The maximum number times that Regeneron may exercise its Option for Option-Eligible Collaboration ICPs is [***] (the Option Cap); provided, however, that if Regeneron does not exercise its Option for [***] consecutive Option-Eligible Collaboration ICPs for which it receives the Final Option Data Package, then the Option Cap shall be reduced by [***]. Once the Option Cap has been reached, all Collaboration ICPs shall be Option-Ineligible ICPs.
6.2 Option.
(a) Option Grant. Adicet hereby grants to Regeneron an exclusive option, on each Option-Eligible Collaboration ICP (and all other Collaboration ICPs containing a Collaboration Targeting Moiety that Binds the same Collaboration Target) on an Option-Eligible Collaboration ICP by Option-Eligible Collaboration ICP basis, to obtain an exclusive license under Section 5.1(a)(iv) (each such option, an Option).
(b) Option Exercise. If Regeneron wishes to exercise the Option for a particular Option-Eligible Collaboration ICP, then within thirty (30) days following the receipt by Regeneron of the Final Option Data Package for such Option-Eligible Collaboration ICP (the Option Period), it shall provide written notice thereof (the Option Exercise Notice) to Adicet and shall pay [***] to Adicet (Option Exercise Fee) on an Optioned Collaboration ICP-by-Optioned Collaboration ICP basis. Upon Regenerons timely exercise of its Option and payment of the Option Exercise Fee with respect to a particular Collaboration ICP, such Option-Eligible Collaboration ICP and all other Collaboration ICPs Binding to the same Collaboration Target shall become Optioned Collaboration ICPs. If Regeneron fails to timely exercise the Option with respect to a particular Option-Eligible Collaboration ICP, such Collaboration ICP and all other Collaboration ICPs Binding to the same Collaboration Target shall become Declined Collaboration ICPs.
(c) Overlapping Option Periods. In the event that the Option Period has not expired with respect to an Option-Eligible Collaboration ICP and Adicet delivers to Regeneron a Final Option Data Package for a Collaboration ICP that Binds a Collaboration Target distinct from the Option-Eligible Collaboration ICP, then both Collaboration ICPs shall be deemed to be Option-Eligible Collaboration ICPs, but Regeneron shall only have the right to exercise its Option with respect one Collaboration ICP, and upon such Option exercise, the other Collaboration ICP shall be deemed to be an Option-Ineligible Collaboration ICP.
(d) Exclusivity for Collaboration ICPs. Prior to Adicets delivery of a Final Option Data Package with respect to Option-Ineligible Collaboration ICPs and prior to the expiration of the Option Period with respect to Option Eligible Collaboration ICPs, Adicet shall not enter into any license, sale or other similar agreement with a Third Party in which such Third Party would receive any rights, or an option to obtain any rights, to develop or commercialize such Collaboration ICP, except in connection with a subcontract as permitted pursuant to Section 24.11(b), provided, however, that (x) any sale of capital stock in Adicet (whether a
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controlling interest or otherwise) or (y) any merger, consolidation or other business combination transaction involving Adicet shall not be restricted by this Section 6.2(d).
6.3 Regeneron Right of First Negotiation for Rights to Option-Ineligible Collaboration ICPs.
(a) Except in compliance with this Section 6.3, Adicet shall not enter into any Option-Ineligible ICP Negotiations or execute an Option-Ineligible ICP Agreement other than in connection with a subcontract as permitted pursuant to Section 24.11(b).
(b) Adicet hereby grants to Regeneron a right of first negotiation (each, a ROFN) on an Option-Ineligible Collaboration ICP-by-Option-Ineligible Collaboration ICP basis, as set forth in this Section 6.3. In the event Adicet wishes to enter an agreement to license, sell or option to any Third Party rights to further develop and/or commercialize any Option-Ineligible Collaboration ICP (Option-Ineligible ICP Agreement), then Adicet must deliver a notice to Regeneron thereof (the ROFN Notice) prior to Adicet engaging in any negotiations with, accepting any offer from, or entering into any agreement, with any Third Party to license, sell or option rights to further develop and/or commercialize such Option-Ineligible ICP (collectively, Option-Ineligible ICP Negotiations).
(c) If the event Regeneron wishes to enter into exclusive negotiations with Adicet to obtain the rights that Adicet wishes to grant with respect to such Option-Ineligible Collaboration ICP, Regeneron shall provide Adicet with notice thereof (ROFN Exercise Notice) within [***] after receipt of the ROFN Notice. If Regeneron fails to deliver the ROFN Exercise Notice within such [***] period, Adicet shall thereafter be free to engage in Option-Ineligible ICP Negotiations with Third Parties for, and enter into Option-Ineligible ICP Agreements with Third Parties with respect to, such Option-Ineligible ICP without further obligations under this Section 6.3.
(d) In the event Regeneron timely delivers the ROFN Exercise Notice, the Parties will engage in good faith negotiations, and Adicet will permit Regeneron to conduct, and will permit Regenerons conduct of, technical and legal due diligence, for a period of [***] after delivery of the ROFN Notice (Exclusive Negotiation Period) in an attempt to agree upon the terms and conditions pursuant to which Regeneron would receive a license or other rights to further develop and/or commercialize such Option-Ineligible ICP. If the parties are able to reach mutual agreement on such terms and conditions during the Exclusive Negotiation Period, the Parties shall promptly thereafter enter into a definitive agreement reflecting such terms. If the Parties fail to reach mutual agreement during the Exclusive Negotiation Period on terms and conditions of a license or other rights to further develop and/or commercialize such Option-Ineligible ICP, Adicet shall thereafter be free to engage in Option-Ineligible ICP Negotiations with Third Parties for, and enter into Option-Ineligible ICP Agreements with Third Parties with respect to, such Option-Ineligible ICP without further obligations under this Section 6.3.
(e) Regenerons ROFN shall expire in the event that (i) Regeneron terminates the Research Program pursuant to Section 2.2(b) or in accordance with Section 2.2(c), 2.2(c) or 22.10(a), or (ii) if Regeneron exercises its ROFN pursuant to this Section 6.3 and obtains licenses or other rights to Option-Ineligible ICPs that Bind to two (2) Collaboration Targets.
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(f) To the extent that Regeneron exercises its ROFN pursuant to this Section 6.3 and obtains a license or other right under a given Collaboration ICP, such ICP shall no longer be considered a Collaboration ICP or an Option-Ineligible Collaboration ICP to such extent only, and the rights and obligations of the Parties with respect to such ICP shall instead be as set forth in the definitive agreement pursuant to which Regeneron gained a license or other right. For clarity, if Regeneron obtains less than a complete assignment or exclusive license under an Option-Ineligible Collaboration ICP pursuant to its ROFN (for example, Regeneron obtains assignment of U.S.-only rights or a field-limited license under an Option-Ineligible Collaboration ICP) then such Option-Ineligible Collaboration ICP shall remain an Option-Ineligible Collaboration ICP under this Agreement solely to the extent of the rights and licenses that are not transferred or licensed to Regeneron pursuant to the ROFN.
6.4 Transfer of Responsibilities with Respect to Optioned Collaboration ICPs after Regenerons Exercise of the Option. In the event of the timely exercise of its Option and payment of the Option Exercise Fee with respect to an Optioned Collaboration ICP, on an Optioned Collaboration ICP-by-Optioned Collaboration ICP basis:
(a) Subject to and except as otherwise set forth in Section 13.4 regarding Manufacturing process technology transfer, promptly (but in any event within [***] after Regenerons exercise of an Option, on an Optioned Collaboration ICP-by-Optioned Collaboration ICP basis, Adicet shall transfer all tangible embodiments of the Optioned Collaboration ICP, included related documentation and materials to Regeneron.
(b) After timely exercise of its Option and payment of the Option Exercise Fee with respect to an Optioned Collaboration ICP, until the later of [***] after timely exercise of its Option and payment of the Option Exercise Fee, [***] after the first response from the applicable Regulatory Authority following IND submission (or such longer period of time as mutually agreed by the Parties, not to be unreasonably withheld or delayed), for such Optioned Collaboration ICP, Adicet will, at the request of Regeneron, make suitably experienced and qualified members of its staff available to Regeneron by telephone or in person (provided that Regeneron personnel travel to Adicet) to reasonably explain such documentation and materials, not to exceed [***] in the aggregate (or such longer period of time as mutually agreed by the Parties, not to be unreasonably withheld or delayed) for any one Collaboration Target. To the extent such request results in more than) [***] of time in the aggregate for any one Collaboration Target, Adicet shall have the right to invoice Regeneron for the fully-burdened cost therefor, and Regeneron shall pay such invoiced amounts within [***] after the date of such invoice.
(c) On an Optioned Collaboration ICP-by-Optioned Collaboration ICP basis, Adicet shall promptly, and shall use Commercially Reasonable Efforts to do so within [***] after Regenerons exercise of the applicable Option, (i) deliver to Regeneron electronic copies (unless otherwise required by Applicable Law) of all Regulatory Filings Controlled by Adicet relating to the Optioned Collaboration ICPs, and (ii) to the extent permitted by Applicable Law, take all steps reasonably necessary to assign all Regulatory Filings to Regeneron, including submitting to any applicable Regulatory Authority a letter or other necessary documentation (with copy to Regeneron) notifying the Regulatory Authority of such assignment.
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(d) For a period of [***] after timely exercise of its Option and payment of the Option Exercise Fee with respect to an Optioned Collaboration ICP, Adicet will, at the request of Regeneron, conduct continuations or extensions of the preclinical studies set forth in the applicable Research Plan as are reasonably necessary to support an IND Acceptance in the United States, and provide Regeneron the data resulting therefrom. Adicet shall have the right to invoice Regeneron for the fully-burdened cost therefor, and Regeneron shall pay such invoiced amounts within [***] after the date of such invoice.
ARTICLE 7
ROYALTY PRODUCTS, MICE DERIVED ADICET ICP PRODUCTS AND REGENERON NON-ICP PRODUCTS
7.1 Overview. Adicet shall be solely responsible, at its sole cost, for all development, manufacturing and commercialization of Adicet Royalty Products and Mice Derived Adicet ICP Products. Regeneron shall be solely responsible, at its sole cost, for all development, manufacturing and commercialization of Regeneron Royalty Products and Regeneron Non-ICP Products.
7.2 Diligence Obligations. Adicet shall use Commercially Reasonable Efforts to develop and commercialize [***] Adicet Royalty Product for each Collaboration Target. Regeneron shall use Commercially Reasonable Efforts to develop and commercialize [***] Regeneron Royalty Product for each Collaboration Target.
7.3 Development of Royalty Products.
(a) Adicet shall conduct all development and commercialization activities with respect to Adicet Royalty Products and Mice Derived Adicet ICP Products in compliance with Applicable Laws, including Good Practices.
(b) Regeneron shall conduct all development and commercialization activities with respect to Regeneron Royalty Products and Regeneron Non-ICP Products in compliance with Applicable Laws, including Good Practices.
7.4 Development Records.
(a) Adicet shall maintain complete, current and accurate records of all development activities conducted by or on its behalf with respect to Adicet Royalty Products and Mice Derived Adicet ICP Products, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the development activities in good scientific manner appropriate for regulatory and patent purposes. Adicet shall document all non-clinical studies and clinical trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, GCP, GLP, and GMP).
(b) Regeneron shall maintain complete, current and accurate records of all development activities conducted by or on its behalf with respect to Regeneron Royalty Products and Regeneron Non-ICP Products, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the development activities in good scientific manner appropriate for regulatory and patent purposes. Regeneron shall document all non-clinical studies and clinical trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, GCP, GLP, and GMP).
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7.5 Development Reports.
(a) Adicet shall provide Regeneron with bi-annual written reports detailing the status of all development, regulatory and material manufacturing activities for Adicet Royalty Products and Mice Derived Adicet ICP Products.
(b) Regeneron shall provide Adicet with bi-annual written reports detailing the status of all development, regulatory and material manufacturing activities for Regeneron Royalty Products and Regeneron Non-ICP Products.
7.6 Regulatory.
(a) Adicet shall be responsible, at its expense, for all regulatory activities necessary to obtain and maintain marketing approval of the Adicet Royalty Products and Mice Derived Adicet ICP Products, including the preparation and submission of any and all regulatory materials for Adicet Royalty Products and Mice Derived Adicet ICP Products throughout the world. Adicet shall own all such regulatory materials, including all INDs and Approvals with respect to Adicet Royalty Products and Mice Derived Adicet ICP Products. Decisions with respect to any recall, market withdrawal or other corrective action related to any Adicet Royalty Product and Mice Derived Adicet ICP Product in the Territory shall be made by Adicet, and expenses associated with such recalls will be borne by Adicet.
(b) Regeneron shall be responsible, at its expense, for all regulatory activities necessary to obtain and maintain marketing approval of the Regeneron Royalty Products and Regeneron Non-ICP Products, including the preparation and submission of any and all regulatory materials for Regeneron Royalty Products throughout the world or the Royalty Territory as applicable and for Regeneron Non-ICP Products throughout the world; provided, however, (i) Regeneron shall consult with Adicet regarding the regulatory strategy and approach for Regeneron Royalty Products and shall consider in good faith reasonable comments of Adicet to the extent relating to consistency in strategy and approach as compared to the regulatory strategy and approach for Adicet Royalty Products, provided, however, that Regeneron shall have final discretion with respect thereto, and (ii) Regeneron shall permit a representative of Adicet to attend as an observer in all material meetings and other communications with the applicable Regulatory Authorities regarding Regeneron Royalty Products. Regeneron shall own all such regulatory materials, including all INDs and Approvals with respect to Regeneron Royalty Products and Regeneron Non-ICP Products. Decisions with respect to any recall, market withdrawal or other corrective action related to any Regeneron Royalty Product in the Territory or the Royalty Territory as applicable and for Regeneron Non-ICP Products throughout the world shall be made by Regeneron, and expenses associated with such recalls will be borne by Regeneron.
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7.7 Licensing.
(a) Adicet may grant, to one or more Third Parties, a license to develop, manufacture or sell Adicet Royalty Products or Mice Derived Adicet ICP Products; provided, that (i) Adicet has fully complied with Section 6.3 with respect to Adicet Royalty Products, and (ii) Adicet pays royalties to Regeneron in accordance with Section 14.3 on the sales of Adicet Royalty Products and in accordance with Section 14.6 on the sales of Mice Derived Adicet ICP Products by or on behalf of such licensees or their further sublicensees as if such sales had been made by or on behalf of Adicet.
(b) Regeneron may grant, to one or more Third Parties, a license to develop, manufacture or sell Regeneron Royalty Products and Regeneron Non-ICP Products; provided, that Regeneron pays royalties to Adicet in accordance with Section 14.4 on the sales of Regeneron Royalty Products and in accordance with Section 14.5 on the sales on Regeneron Non-ICP Products by or on behalf of such licensees or their further sublicensees as if such sales had been made by or on behalf of Adicet.
7.8 Regeneron Right of First Negotiation for Adicet to use Regeneron Antibodies in Co-Administration Studies with Adicet Royalty-Bearing Collaboration ICPs.
(a) In the event that Adicet or any of its Affiliates wishes to, either directly, or with or through any Third Party, to conduct one or more Co-Administration Studies, Adicet shall inform Regeneron in writing of such proposed Co-Administration Study(ies), which notice shall include the Target that the product in clause (ii) of the definition of Co-Administration Study is directed toward (the Co-Administration Target) and a summary of the study plan for such proposed Co-Administration Stud(ies) (the Co-Administration Study Notice).
(b) If Regeneron wishes to enter into negotiations with Adicet for the Co-Administration Study for Adicet to use an Antibody Controlled by Regeneron that is either in clinical development or commercially available that is directed towards the Co-Administration Target (Regeneron Antibody) in lieu of the product in clause (ii) of Section 1.28, Regeneron shall provide Adicet with notice thereof, and such notice shall also include the identity of the Regeneron Antibody (Expression of Interest) within [***] after receipt of the Co-Administration Study Notice. If Regeneron does not deliver the Expression of Interest within such [***] period, Adicet shall thereafter be free to use in the Co-Administration Study, Antibodies Controlled by Third Parties that are directed against the Co-Administration Target without further obligations under this Section 7.8.
(c) In the event Regeneron timely delivers the Expression of Interest, the Parties will engage in good faith negotiations for a for a period of [***] after receipt of the Co-Administration Study Notice, in an attempt to agree upon the terms and conditions pursuant to which a Co-Administration Study involving an Adicet Royalty-Bearing Collaboration ICP and a Regeneron Antibody would be conducted. If the Parties are unable to reach agreement during such [***] period on such terms and conditions for such Co-Administration Study, Adicet shall thereafter be free to use in the Co-Administration Study, products controlled by Third Parties without further obligations under this Section 7.8.
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ARTICLE 8
ADICET CO-FUNDING OPTION AND CO-FUNDED PRODUCTS (GENERALLY)
8.1 Co-Funding Option.
(a) Adicet shall have the exclusive option, at its discretion, on or prior to the Co-Funding Option Deadline, to elect to co-fund an Optioned Collaboration ICP at the Adicet Co-Funding Percentage in the Co-Funding Territory (the Co-Funding Option). The Adicet Co-Funding Percentage and the Co-Funding Territory shall be specified in the Co-Funding Notice delivered by Adicet as described in this Section 8.1. Upon Adicets written request delivered not later than [***] after Regenerons exercise of the Option for an Optioned Collaboration ICP (but no earlier than the date of Regenerons exercise of the Option for such Optioned Collaboration ICP), Regeneron shall share with Adicet, Regenerons plan for the material activities, clinical Development timelines, the Initial Development Cost Forecast, and Manufacture and Commercialization in more general terms, of the Optioned Collaboration ICP (the Co-Funding Materials), provided, however, that the foregoing shall not require Regeneron to prepare, obtain or otherwise provide any Co-Funding Materials other than those that have been prepared by Regeneron for its internal purposes. Regeneron shall deliver the Co-Funding Materials to Adicet within [***] days of Adicets written request. After delivery of the Co-Funding Materials, but prior to the Co-Funding Option Deadline, upon Adicets request, Regeneron shall make itself reasonably available to Adicet to discuss the Co-Funding Materials. Adicet may exercise such Co-Funding Option for the Adicet Co-Funding Percentage as specified by Adicet in the Co-Funding Territory as specified by Adicet by delivering written notice thereof to Regeneron (the Co-Funding Notice) no later than [***] days after receipt of the Co-Funding Materials from Regeneron (the Co-Funding Option Deadline), with such exercise being deemed effective upon Regenerons receipt of such Co-Funding Notice. In no event shall the Co-Funding Percentage borne by Adicet (the Adicet Co-Funding Percentage) be less than [***] or more than [***] of the total financial investment, profit and loss related to the Co-Funded Product in the Co-Funding Territory. The Co-Funding Percentage borne by Regeneron for the Co-Funded Product in the Co-Funding Territory shall be [***] of the financial investment, profit and loss minus the Co-Funding Percentage borne by Adicet (the Regeneron Co-Funding Percentage). Upon Adicets exercise of the Co-Funding Option, such Optioned Collaboration ICP shall be considered a Co-Funded Product in the Co-Funding Territory.
(b) If Adicet fails to request the Co-Funding Materials in accordance with the time period set forth in this Section 8.1 or Adicet fails to deliver a Co-Funding Notice after receiving the Co-Funding Materials by the Co-Funding Option Deadline, Adicets Co-Funding Option with respect to such Optioned Collaboration ICP shall immediately and permanently expire.
(c) If, after Adicet exercises its Co-Funding Option in accordance with Section 8.1(a), the JSC approves an Updated Development Cost Forecast that is [***], Adicet shall have the right to exercise by delivering written notice to Regeneron to reduce the Adicet Co-Funding Percentage to [***] (the Co-Funding Reduction Notice), provided that Adicet may not deliver a Co-Funding Reduction Notice more than once for a given Co-Funded Product. If Adicet delivers a Co-Funding Reduction Notice pursuant to this Section 8.1(c), the Adicet Co-Funding Percentage shall be reduced by [***] and the Regeneron Co-Funding Percentage shall be adjusted
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accordingly for such Co-Funded Product as of [***] of Adicets delivery of the Co-Funding Reduction Notice; provided, however, that Regeneron shall pay to Adicet an additional royalty equal to [***] of Net Sales of such Co-Funded Product (on the same terms and conditions as if it were a Regeneron Royalty Bearing Product hereunder, but without offsets or deductions) until [***]. If Adicet fails to deliver a Co-Funding Reduction Notice pursuant to this Section 8.1(c) with respect to a Co-Funded Product, Adicets rights to reduce it Co-Funding Percentage pursuant to this Section 8.1(c) shall permanently expire with respect to such Co-Funded Product.
8.2 Development and Commercialization of Co-Funded Products. Upon and subject to the terms and conditions of this Agreement, including Adicets option to Co-Promote a Co-Funded Product pursuant to Section 11.2, Regeneron shall be solely responsible for and will use Commercially Reasonable Efforts to Develop and Commercialize Co-Funded Products in the Co-Funding Territory and not to materially exceed the Initial Development Cost Forecast (or the most recent Updated Development Cost Forecast) therefor. Notwithstanding anything to the contrary in this Agreement, the Development or Commercialization of a Co-Funded Product in the Co-Funding Territory shall not materially deviate from the applicable Co-Funding Materials without Regeneron first discussing such material deviation at the JSC, but the Parties acknowledge and agree that Regeneron shall be solely responsible and shall have final discretion and decision making authority over the Development and Commercialization of Co-Funded Products. The Parties shall establish the JSC to oversee and/or coordinate the Development, Manufacture and Commercialization of Co-Funded Products in the Co-Funding Territory as set forth in Article 9. Each Party shall, subject to the terms and conditions set forth in Article 19, provide (or cause its Affiliates to provide) to any relevant Committee any necessary Confidential Information and such other information and materials as may be reasonably required for the Parties to operate effectively and efficiently with respect to Co-Funded Products under and in accordance with the terms and conditions of this Agreement, in each case to the extent Controlled by such Party.
ARTICLE 9
GOVERNANCE OF CO-FUNDED PRODUCTS
9.1 Committees/Management.
(a) Committees. In addition to the JRC, in the event Regeneron exercises an Option and Adicet exercises a Co-Funding Option for a Co-Funded Product, the Parties agree to establish, for the purposes specified herein, a Joint Steering Committee (the JSC). It is understood that the Parties may wish to establish multiple Committees reporting to the JSC with responsibility for different functions or different Co-Funded Products. The JSC shall be established within [***] after Adicet first exercises a Co-Funding Option. The roles and responsibilities of the JSC are set forth in this Agreement. The JSC, and any other committees the JSC establishes pursuant to this Article 9, are the Committees. From time to time, each Committee may establish working groups (each, a Working Group) to oversee particular projects or activities, and each such Working Group shall be constituted and shall operate as the Committee which establishes the Working Group determines.
(b) Decision-making. The Committees shall operate by consensus. The representatives of each Party shall have collectively one (1) vote on behalf of such Party; provided that no such vote taken at a meeting shall be valid unless a representative of each Party is present and participating in the vote. Notwithstanding the foregoing, each Party, in its sole discretion, by written notice to the other Party, may choose not to have representatives on a Committee and leave decisions of such Committee(s) to representatives of the other Party.
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(c) Membership. Each of the Committees shall be composed of an equal number of representatives appointed by each of Regeneron and Adicet. Each Party may replace its Committee members upon written notice (which may be via email) to the other Party. Each Committee will have two (2) co-chairpersons, one designated by each of Regeneron and Adicet. Each co-chairperson shall be entitled to call meetings. The co-chairpersons shall coordinate activities to prepare and circulate an agenda in advance of the meeting and prepare and issue final minutes within [***] thereafter.
(d) Meetings. Each Committee shall hold meetings at such times as the Parties shall determine, but in no event less frequently than once every Quarter during the Term as long as there is at least one Co-Funding Term then in effect, commencing from and after the time such Committee is established as provided herein. If possible, the meetings shall be held in person (to the extent practicable, alternating the site for such meetings between the Parties or their Affiliates) or when agreed by the Parties, by video or telephone conference. Other representatives of each Party or of Third Parties involved in the Development, Manufacture or Commercialization of any Co-Funded Product (under obligations of confidentiality) may be invited by the Committee co-chairs to attend meetings of the Committees as nonvoting participants. Each Party shall be responsible for all of its own expenses of participating in the Committees. Either Partys representatives on a Committee may call a special meeting of the applicable Committee upon at [***] Business Days prior written notice (which may be via email), except that emergency meetings may be called with at [***] Business Days prior written notice (which may be via email).
(e) Limited Powers. None of the Committees or the Executive Officers shall have the power to amend any of the terms or conditions of this Agreement or to waive compliance with this Agreement, other than by mutual agreement of the Parties as set forth in Section 24.5.
9.2 Joint Steering Committee.
(a) Composition and Purpose. The JSC shall have overall responsibility for the oversight of the Development and Commercialization of Co-Funded Products. The JSC shall be composed of at least three (3) senior management employees of each Party; provided that the total number of representatives may be changed upon mutual agreement of the Parties (so long as each Party has an equal number of representatives). In addition to its overall responsibility for overseeing the Development and Commercialization of Co-Funded Products, the JSC shall in particular:
(i) review the overall Development strategy and Commercialization strategy in the Co-Funding Territory for each Co-Funded Product as formulated by Regeneron;
(ii) annually review and approve an Updated Development Cost Forecast;
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(iii) annually review, discuss and approve the Development Plan(s) and Commercial Plan(s), including overseeing compliance with the Development Plan and Commercial Plan, which plans shall be initially prepared by Regeneron and presented to the JSC;
(iv) coordinate the promotional efforts of the Parties for each Co-Funded Product that is subject to a Co-Promotion Agreement pursuant to such Co-Promotion Agreement;
(v) discuss the regulatory strategy for the Co-Funded Products;
(vi) oversee Manufacturing activities for Co-Funded Products, including process and technology selection and process improvements;
(vii) review any proposal to license Development, Commercialization or Manufacturing rights for any Co-Funded Product to any Third Party;
(viii) facilitate an exchange between the Parties of data, information, material and results relating to the Development and Commercialization of Co-Funded Products;
(ix) provide a single-point of communication and attempt in good faith to resolve any disputes referred to it by any of the other Committees;
(x) be responsible for accounting, financial and funds flow matters related to the Collaboration Arrangement, including such specific responsibilities set forth in Sections 10.3, 14.7, and 14.11;
(xi) establish sub-committees of the JSC, as the JSC deems appropriate; and
(xii) oversee the other Committees and resolve matters referred by the other Committees to the JSC for decision-making and approval as set forth in this Agreement or otherwise, and to resolve matters on which such Committees are unable to reach consensus pursuant to the provisions of Section 9.3 and Article 23 below, as applicable; and
(xiii) consider and act upon such other matters as are specifically assigned to the JSC under this Agreement or otherwise agreed by the Parties.
9.3 Resolution of Committee Disputes. In the event there is a dispute at the level of a Committee other than the JSC which the relevant Committee has decision making authority over, the Parties, through such Committee, will seek to resolve the dispute as promptly as possible, but no later than [***] after a Party has delivered to the other Party a written request to resolve the matter, and in the event that no resolution is reached by such Committee, such matter shall be promptly referred to the JSC. In the event there is a dispute at the JSC (including in cases where such dispute is referred to the JSC pursuant to this Section 9.3), the Parties, through the JSC, will seek to resolve the dispute as promptly as possible, but no later than [***] after a Party has delivered to the other Party a written request to resolve the matter (or in cases where such dispute is referred to the JSC pursuant to this Section 9.3, within [***] after such dispute is referred to the JSC), and in the event that no resolution is reached at the JSC, such matter and resolved in accordance with Article 23.
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ARTICLE 10
DEVELOPMENT OF CO-FUNDED PRODUCTS
10.1 Development of Co-Funded Products. Subject to the terms of this Agreement, Regeneron shall undertake Development activities with respect to Co-Funded Products pursuant to the Development Plans under the oversight of the JSC. Regeneron shall use Commercially Reasonable Efforts to Develop Co-Funded Products and carry out the Development activities set forth in the Development Plans in a timely manner, and shall conduct all such activities in compliance with Applicable Laws, including Good Practices. To the extent Adicet or its Affiliates performs any Development activities with respect to Co-Funded Products at the request of Regeneron, Section 10.3(a) shall apply, except that all references to Adicet shall be deemed to refer to Regeneron and all references to Regeneron shall be deemed to refer to Adicet. Adicets activities (if any) regarding process development for the Manufacture of a Co-Funded Product after the Research Program Term shall be set forth in and governed by a development services addendum or agreement entered into in connection with the applicable Supply Agreement. Regeneron (and the extent applicable, Adicet) shall maintain complete, current and accurate records of all development activities conducted by or on its behalf with respect to Co-Funded Products, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the development activities in good scientific manner appropriate for regulatory and patent purposes. Regeneron (and to the extent applicable, Adicet) shall document all non-clinical studies and clinical trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, GCP, GLP, and GMP).
10.2 Preparation, Updates and Approval of Development Plans. With respect to each Co-Funded Product, Regeneron shall prepare and present a Development Plan for review by the JSC within [***] after exercise by Adicet of its Co-Funding Option, and the JSC shall review and approve an initial Development Plan (which shall be consistent in all material respects with the applicable Co-Funding Materials) for such Co-Funded Product within [***] after Regeneron presents such Development Plan to the JSC. Regeneron shall consider in good faith comments by Adicet regarding the Development Plan for each Co-Funded Product, specifically regarding clinical Development, process development for Manufacturing, and regulatory activities, provided that Regeneron shall have final discretion and decision making authority over the Development Plan. An updated Development Plan for such Co-Funded Product will be presented by Regeneron for review to the JSC and approved by the JSC, [***] prior to the end of each calendar year.
10.3 Development Cost and Payment Reports.
(a) Within [***] after the end of each Quarter, commencing with the Quarter in which the Co-Funding Notice for the first Co-Funded Product is received by Regeneron, Regeneron shall provide to Adicet a written report (in electronic form) summarizing the material activities undertaken by Regeneron during such Quarter in connection with each Development Plan (or, if the Development Plan is not yet in effect, pursuant to Regenerons development activities it conducts subsequent to Adicets exercise of its Co-Funding Option), together with a statement of Development Costs incurred by Regeneron during such Quarter, which statement shall detail those amounts to be included in the Development Payment Report for such Quarter and shall be in such form, format and of such level of detail as approved by the JSC.
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(b) Within [***] after the end of each Quarter, Regeneron shall deliver electronically to Adicet a Development Payment Report in respect of such Quarter, combining the information reported by Regeneron pursuant to this Section 10.3 (and to the extent applicable pursuant to Section 10.1, Adicet) and showing its calculations in accordance with Schedule 2 of the amount of any payments to be made by the Parties hereunder for such Quarter as contemplated by this Section 10.3 (including, as applicable, showing the sharing of Development Costs) and, if applicable, providing for the netting of such payments. All reports referred to in this Section 10.3 shall be in such form, format and level of detail approved by the JSC. Unless otherwise agreed by the JSC, the financial data in the reports will include calculations in local currency and United States Dollars.
10.4 Development Utilizing Adicet Background Technology. If the Parties mutually agree in writing to utilize any Adicet Background IP in the Development of a Co-Funded Product (other than to the extent constituting applicable Adicet Product IP), then Adicet either (A) shall perform such specific Development activities utilizing such Adicet Background IP for such Co-Funded Product, or (B) shall grant to Regeneron a limited license under (and transfer to Regeneron) such Adicet Background IP solely to perform such specific Development activities utilizing such Adicet Background IP for such Co-Funded Product and for no other purpose.
ARTICLE 11
COMMERCIALIZATION OF CO-FUNDED PRODUCTS
11.1 Commercialization of Co-Funded Products. Subject to the terms of this Agreement and Adicets rights to Co-Promote a Co-Funded Product in the United States after Adicets exercise of its option under Section 11.2(a), Regeneron will perform all Commercialization activities for Co-Funded Products under the oversight of the JSC. Regeneron shall use Commercially Reasonable Efforts to Commercialize Co-Funded Products, and shall conduct all such activities in compliance with Applicable Laws. Regeneron shall be responsible for handling collection and receivables and recording and booking sales in each country in the Co-Funding Territory. If Adicet exercises its rights to Co-Promote a Co-Funded Product in the United States pursuant to Section 11.3(a), Adicet shall use Commercially Reasonable Efforts to Co-Promote the relevant Co-Funded Product and carry out the Co-Promotion activities set forth in the Co-Promotion Agreement in a timely manner, and shall conduct all such activities in compliance with Applicable Laws.
11.2 Preparation, Updates and Approval of Commercial Plans. With respect to each Co-Funded Product, Regeneron shall prepare and present a Commercial Plan for review by the JSC within [***] after exercise by Adicet of its Co-Funding Option, and the JSC shall review and approve a Commercial Plan for such Co-Funded Product within [***] after Regeneron presents such Commercial Plan to the JSC. Regeneron and the JSC shall consider in good faith comments by Adicet regarding the Commercial Plan for each Co-Funded Product, provided that Regeneron shall have final discretion and decision making authority over the approval of the Commercial Plan (and provided that nothing herein shall prevent Regeneron from operating under the Co-Funding Materials prior to JSC approval of the Commercial Plans). An updated Commercial Plan for such Co-Funded Product will be presented by Regeneron for review to the JSC and approved by the JSC, [***] prior to the end of each calendar year. The Parties acknowledge and agree that the initial Commercial Plans may contain less detail than the Commercial Plans that are prepared as the Co-Funded Product advances towards Marketing Approval or Commercial Plans prepared after Marketing Approval, provided, however, that the foregoing shall not require Regeneron to prepare, obtain or otherwise provide detail in a Commercialization Plan other than those that have been prepared by Regeneron for its internal purposes.
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11.3 Adicet Co-Promotion Option in the United States.
(a) Exercise of Co-Promote Option. In the event that Adicet desires to Co-Promote a Co-Funded Product in the United States, it shall notify Regeneron of its decision regarding whether to Co-Promote such Co-Funded Product in the United States [***] after the Anticipated First Commercial Sale of such Co-Funded Product in the United States is determined by the JSC. If Adicet does not timely notify Regeneron by the deadline set forth above, as applicable, Adicets right to Co-Promote such Co-Funded Product in the United States shall immediately and permanently expire.
(b) Co-Promotion FTE Efforts. Simultaneously with Adicets exercise of its option pursuant to Section 11.2(a) to Co-Promote a Co-Funded Product in the United States, Adicet will provide to Regeneron a binding notice of the FTE effort which shall be a percentage of the anticipated total FTE effort that Adicet will commit to Co-Promote such Co-Funded Product in the United States for each Contract Year (the Adicet Commitment Level). In no event shall the Adicet Commitment Level in Co-Promoting such Co-Funded Product in the United States exceed [***] of the anticipated total FTE effort by both Parties in Co-Promoting such Co-Funded Product in the United States or such other maximum percentage agreed by the Parties (the Maximum Adicet Effort). If Adicet elects to Co-Promote a Co-Funded Product in the United States, the Adicet Commitment Level shall be the same as Adicets Co-Funding Percentage for such Co-Funded Product, unless otherwise expressly agreed in writing by the Parties. Such FTE effort shall be based upon the forecasted number and position of Details required to meet the market and sales forecasts in the United States, and their conversion (with such conversion approved by the JSC) into the equivalent number of Detailing FTEs in the United States. Adicet shall use Commercially Reasonable Efforts to perform the anticipated total FTE effort above for the Adicet Commitment Level, and Regeneron shall use Commercially Reasonable Efforts to perform the anticipated total FTE effort above the Adicet Commitment Level.
(c) Co-Promotion Agreement. Promptly, and in no event later than [***] days following Adicets exercise of any option under Section 11.2(a), the Parties shall negotiate in good faith the terms of and enter into a co-promotion agreement (Co-Promotion Agreement), or amendment of any co-promotion agreement previously entered into pursuant to this Section 11.3(c), consistent with this Article 11 and containing other commercially reasonable terms as the Parties may agree; provided that, in the case of any conflict between any such Co-Promotion Agreement and this Agreement, this Agreement shall control.
11.4 Other Responsibilities. Regeneron shall, and with respect to the United States, in the event the Parties are Co-Promoting the Co-Funded Product, each Party shall, maintain records relating to its sales force, account management, medical science liaison and medical affairs functions FTEs for the Co-Funded Products in each country in a manner sufficient to permit the determination of Field Force Cost.
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ARTICLE 12
CLINICAL AND REGULATORY AFFAIRS FOR CO-FUNDED PRODUCTS
12.1 Regulatory Responsibilities.
(a) Subject to the terms of this Agreement, Regeneron shall determine and execute the appropriate regulatory strategy with respect to Co-Funded Products under the oversight of the JSC. The regulatory strategy shall be consistent with the overall objective of facilitating Marketing Approval in the Co-Funding Territory in connection with the Development Plan.
(b) Regeneron shall prepare all Regulatory Filings for Co-Funded Products. Regeneron shall be responsible for submitting and maintaining all such Regulatory Filings and shall act as the primary point of contact for regulatory communications with each applicable Regulatory Authority with respect to each Co-Funded Product. Without limiting the foregoing, Regeneron will be responsible for, and will use Commercially Reasonable Efforts in applying for, obtaining and maintaining the applicable Approval or other Registration Filing for each Co-Funded Product.
(c) Unless otherwise agreed to by the Parties, Regeneron shall own (i) all Approvals with respect to each Co-Funded Product and (ii) all Regulatory Filings for Co-Funded Products.
(d) To the extent Adicet is performing Manufacturing for the Co-Funded Product as set forth in Article 13, Adicet shall provide any assistance requested by Regeneron for Regeneron to prepare any CMC (or equivalent) Section of any Regulatory Filings related to the Manufacture of the Co-Funded Product.
(e) To the extent Adicet is Co-Promoting the Co-Funded Product in the United States, the Parties shall establish procedures, through the JSC, to ensure that the Parties exchange on a timely basis all necessary information to enable each Party and its licensees, as applicable, to comply with its regulatory obligations in connection with the Commercialization of Co-Funded Products, including filing updates or supplements with Regulatory Authorities or pharmacovigilance filings, and to comply with Applicable Laws in the Territory.
(f) Notwithstanding anything to the contrary in this Agreement, (i) Regeneron shall consult with Adicet regarding the regulatory strategy and approach for Co-Funded Products and shall consider in good faith reasonable comments of Adicet to the extent relating to consistency in strategy and approach as compared to the regulatory strategy and approach for Adicet Royalty Products, provided, however, that Regeneron shall have final discretion with respect thereto, and (ii) Regeneron shall permit a representative of Adicet to attend as an observer (and participate as reasonably necessary) in all material meetings and other communications with the applicable Regulatory Authorities regarding Co-Funded Products.
12.2 Regulatory Events. Each Party shall keep the other Party informed, as soon as possible but no later than [***] after notification (or other time period specified below), of any action by, or notification or other information which it receives (directly or indirectly) from, any Regulatory Authority, Third Party or other Governmental Authority, which:
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(a) raises any material concerns regarding the safety or efficacy of any Co-Funded Product;
(b) indicates or suggests a potential investigation or formal inquiry by any Regulatory Authority in connection with the Development, Manufacture or Commercialization of a Co-Funded Product; provided, however, that each Party shall inform the other Party of the foregoing as soon as possible but in no event later than [***] after receipt of a notification referred to in this clause (b); or
(c) is reasonably likely to lead to a recall or market withdrawal of any Co-Funded Product anywhere in the Territory.
12.3 Recalls and Other Corrective Actions. Decisions with respect to any recall, market withdrawal or other corrective action related to any Co-Funded Product in the Co-Funding Territory shall be made by Regeneron, provided that to the extent practicable, Regeneron shall discuss such decision with Adicet in advance. Regeneron shall, as soon as reasonably possible, but in no event later than twenty-four (24) hours of such final determination, notify Adicet. The Parties shall cooperate with respect to any actions taken or public statements made in connection with any such recall or market withdrawal; provided that Regeneron shall have final decision making with respect thereto. Expenses associated with such recalls will be treated as Other Shared Expenses.
ARTICLE 13
MANUFACTURING AND SUPPLY
13.1 Supply for Research Program. Adicet shall use Commercially Reasonable Efforts to Manufacture (or have Manufactured) required quantities of Collaboration ICPs to perform the activities under the Research Program (including any required quantities of GLP-compliant Collaboration ICP) in accordance with Applicable Laws and the Product Specifications. All Manufacturing (included process development) related costs and expenses incurred by Adicet in connection with the Manufacture of Product for use under the Research Plan shall be borne by Adicet. The Parties acknowledge that Adicet may use a Third Party contract manufacturer to Manufacture Collaboration ICPs pursuant to this Section 13.1, and that the selection of such Third Party contract manufacturer shall be subject to Regenerons prior written consent, which shall not be unreasonably withheld or delayed. Regeneron shall have the right to review and comment on the draft agreement with each such Third Party contract manufacturer, and Adicet shall consider in good faith the reasonable comments of Regeneron thereon.
13.2 Supply for Initial Phase I Trial for Optioned Collaboration ICPs.
(a) For each Optioned Collaboration ICP, Adicet shall use Commercially Reasonable Efforts (i) to scale up the Manufacturing process developed pursuant to Section 13.1 to a level sufficient to Manufacture, such quantities as set forth in the applicable Research Plan of such Optioned Collaboration ICP in accordance with Applicable Laws (and GMP), the applicable Product Specifications and the applicable Research Plan for the conduct by Regeneron of an initial Phase I Trial for such Optioned Collaboration ICP (collectively, the Initial Phase I Supply), and (ii) to Manufacture (or have Manufactured) such Initial Phase I Supply of such Optioned
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Collaboration ICP. The Parties acknowledge that Adicet may use a Third Party contract manufacturer to scale up such process and Manufacture the Initial Phase I Supply, and that the selection of such Third Party contract manufacturer shall be subject to Regenerons prior written consent, which shall not be unreasonably withheld or delayed. Regeneron shall have the right to review and comment on the draft agreement with each such Third Party contract manufacturer, and Adicet shall consider in good faith the reasonable comments of Regeneron thereon.
(b) Within [***] after Regenerons timely exercise of its Option and payment of the Option Exercise Fee with respect to an Optioned Collaboration ICP, Adicet shall sell and supply to Regeneron the Initial Phase I Supply of such Optioned Collaboration ICP, and Regeneron shall pay Adicet a price equal to [***] of Adicets Manufacturing Cost for such Optioned Collaboration ICP that is a Regeneron Royalty Product within [***] after receipt of such Initial Phase I Supply and the applicable invoice therefor, or for a Co-Funded Product, [***] of Adicets Manufacturing Cost for such Co-Funded Product multiplied by the Regeneron Co-Funding Percentage and reimbursed in accordance with Section 14.7. If such Initial Phase I Supply of such Optioned Collaboration ICP is manufactured by a Third Party contract manufacturer, Adicet shall pass through to Regeneron such representations and warranties as Adicet receives from such Third Party contract manufacturer with respect thereto. Adicet shall use good faith efforts to include in the agreement with the Third Party manufacturer a provision that Regeneron is a third party beneficiary of Adicets rights under such agreement with such Third Party manufacturer. If such Initial Phase I Supply of such Optioned Collaboration ICP is manufactured by Adicet or its Affiliate, Adicet shall represent and warrant to Regeneron and hereby represents and warrants to Regeneron that such Initial Phase I Supply shall be manufactured in accordance with Applicable Laws (and GMP), shall meet the applicable Product Specifications, (and GMP), shall be free from contaminants, shall not be adulterated or misbranded, and shall be supplied free and clear of Third Party liens and encumbrances.
13.3 Subsequent Supply of Co-Funded Products and Regeneron Royalty Products.
(a) Within [***] after Regenerons timely exercise of its Option, payment of the Option Exercise Fee and delivery of its good faith forecasted requirements for Phase II clinical trial materials with respect to an Optioned Collaboration ICP, Adicet may give written notice to Regeneron if Adicet desires to Manufacture (or have Manufactured) and supply subsequent quantities of such Optioned Collaboration ICP and Regeneron Royalty Products or Co-Funded Products (as applicable) that incorporate, include or consist of such Optioned Collaboration ICP. [***] after Regenerons timely exercise of its Option, payment of the Option Exercise Fee and delivery of its good faith forecasted requirements for Phase II clinical trial materials with respect to an Optioned Collaboration ICP, Regeneron may give written notice to Adicet if Regeneron desires Adicet to Manufacture (or have Manufactured) and supply subsequent quantities of such Optioned Collaboration ICP and Regeneron Royalty Products or Co-Funded Products (as applicable) that incorporate, include or consist of such Optioned Collaboration ICP.
(b) If either Party gives the other Party timely written notice with respect to an Optioned Collaboration ICP pursuant to Section 13.3(a) and the Party receiving such notice does not object, the Parties promptly shall meet, negotiate in good faith and attempt to reach mutual written agreement on commercially reasonable and customary terms and conditions of a supply agreement and quality agreement for such Manufacture by or on behalf of Adicet and supply of such Optioned Collaboration ICP and Regeneron Royalty Products or Co-Funded Products (as applicable) that incorporate, include or consist of such Optioned Collaboration ICP. Any such supply agreement shall include commercially reasonable and customary provisions for a second source of supply by a Third Party.
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(c) If the Parties reach mutual written agreement on commercially reasonable and customary terms and conditions of a supply agreement and a quality agreement for the Manufacture and supply by or on behalf of Adicet of such Optioned Collaboration ICP, Regeneron Royalty Products or Co-Funded Products (as applicable), then Adicet shall Manufacture (or have Manufactured) and supply subsequent quantities of such Optioned Collaboration ICP and Regeneron Royalty Products or Co-Funded Products (as applicable) that incorporate, include or consist of such Optioned Collaboration ICP solely on the terms and conditions of such supply agreement and quality agreement.
(d) If either Party fails to timely give the other Party such written notice pursuant to Section 13.2(a), the Party receiving such notice reasonably objects, or the Parties fail to reach mutual written agreement on commercially reasonable and customary terms and conditions of a supply agreement and quality agreement for such Manufacture by or on behalf of Adicet and supply of such Optioned Collaboration ICP and Regeneron Royalty Products or Co-Funded Products (as applicable) that incorporate, include or consist of such Optioned Collaboration ICP within ninety (90) days after notice was delivered pursuant to Section 13.2(a), then Regeneron shall be solely responsible for the subsequent Manufacture thereof.
13.4 Manufacturing Process Technology Transfer. Following Regenerons timely exercise of its Option and payment of the Option Exercise Fee with respect to an Optioned Collaboration ICP, upon written request by Regeneron:
(a) Adicet (i) shall transfer to Regeneron (or its single designee, which may be increased to two (2) designees in the event a second designee is necessary to continue supply of such Optioned Collaboration ICP due to a failure to supply by the first designee for reasons outside the reasonable control of Regeneron) a copy of such Adicet Know-How regarding the Manufacturing process developed by or on behalf of Adicet therefor as of such date that is reasonably necessary for the Manufacture of such Optioned Collaboration ICP, Regeneron Royalty Products or Co-Funded Products (as applicable), (ii) shall provide reasonable technical assistance (including answering reasonable questions) regarding the transferred Manufacturing process, and (iii) shall allow a mutually agreed number of representatives of Regeneron to observe manufacturing processes in otherwise scheduled manufacturing runs (but without any obligation to conduct a manufacturing run for purposes of such observation, and subject to customary restrictions and obligations applicable to visitors), all in accordance with a mutually agreed and commercially reasonable technology transfer plan and schedule.
(b) Adicet shall use Commercially Reasonable Efforts to facilitate the transfer from Adicets Third Party contract manufacturer (if applicable) to Regeneron (or its single designee, which may be increased to two (2) designees in the event a second designee is necessary to continue supply of such Optioned Collaboration ICP due to a failure to supply by the first designee for reasons outside the reasonable control of Regeneron) a copy of such Know-How regarding the Manufacturing process developed by or on behalf of Adicet therefor as of such date
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that is Controlled by such Third Party that Adicet is entitled to receive and is reasonably necessary for the Manufacture of such Optioned Collaboration ICP, Regeneron Royalty Products or Co-Funded Products (as applicable). Additionally, Adicet shall pass through to Regeneron any of Adicets rights to receive Manufacturing transfer assistance (including, to the extent contemplated, pursuant to a technology transfer plan and schedule) from Adicets Third Party contract manufacturer to the extent provided under (and in accordance with) Adicets agreement with its Third Party manufacturer.
(c) Upon Regenerons written request, Adicet shall use Commercially Reasonable Efforts to facilitate an introduction to Adicets Third Party contract manufacturer (if applicable) regarding supply of such Optioned Collaboration ICP from such Third Party contract manufacturer.
(d) Regeneron shall reimburse Adicet within [***] after receipt of the applicable invoice, for the fully-burdened cost to Adicet for such Manufacturing process technology transfer incurred pursuant this Section 13.4 for a Regeneron Royalty Product. For a Co-Funded Product, the fully-burdened cost of both Parties for such Manufacturing process technology transfer incurred pursuant this Section 13.4 shall be calculated and reimbursed in accordance with Section 14.7.
ARTICLE 14
PAYMENTS
14.1 Upfront Payment. Within [***] after the Effective Date, Regeneron shall pay Adicet a non-refundable, non-creditable amount of Twenty Five Million Dollars (US$25,000,000) (the Up-Front Payment). Adicet shall use the Up-Front Payment to fund activities related to the Research Program.
14.2 Research Program Funding. Unless the Research Program is terminated pursuant to Section 2.2, (i) Regeneron shall pay Adicet an annual research funding fee of five million Dollars ($5,000,000) on each of the first and second anniversaries of the Effective Date and (ii) Regeneron shall pay Adicet an annual research funding fee of [***] on each of the [***]. Adicet shall submit to Regeneron an invoice for each payment and Regeneron shall remit payment by the later of the date specified in the preceding sentence or [***] after receipt of such invoice. Adicet shall use the research funding fees it receives from Regeneron pursuant to this Section 14.2 to fund activities related to the Research Program.
14.3 Royalty Payments for Adicet Royalty Products.
(a) For each Quarter during the applicable Royalty Term, Adicet shall pay non-refundable, non-creditable royalties to Regeneron on Net Sales of Adicet Royalty Products during such Quarter, on a Collaboration Target-by-Collaboration Target basis, equal to the following percentage of Net Sales:
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Aggregate Worldwide Annual Net Sales of all Adicet Royalty |
Royalty Rate on all Net Sales in such Calendar Year | |
If Net Sales of all Adicet Royalty Products directed to a given Collaboration Target are up to, but are not in excess of, [***] in a calendar year | [***] | |
If Net Sales of all Adicet Royalty Products directed to a given Collaboration Target are in excess of [***] and up to, but not in excess of, [***] in a calendar year | [***] | |
If Net Sales of all Adicet Royalty Products directed to a given Collaboration Target are in excess of [***] and up to, but not in excess of, [***] in a calendar year | [***] | |
If Net Sales of all Adicet Royalty Products directed to a given Collaboration Target are in excess of [***] in a calendar year | [***] |
For clarity, in the event worldwide Net Sales of all Adicet Royalty Products directed to a given Collaboration Target in the second, third or fourth Quarter in a given calendar year achieves a higher royalty rate than the royalty rate payable in the previous Quarter(s) of such calendar year, the higher royalty rate shall apply to all Net Sales of Adicet Royalty Products in the previous Quarter(s) in such calendar year and Adicet shall make any true-up payments to Regeneron for previous Quarters together with royalty payment due for the Quarter in which the higher royalty rate was achieved.
(b) Royalty Stacking. On an Adicet Royalty Product-by-Adicet Royalty Product basis:
(i) in accordance with Section 16.7(a), in the event (and to the extent) that a Research Program Term License is required to make, use, offer for sale, sell or import in a specific country, a specific Adicet Royalty Product as a result of an allegation or potential allegation of infringement of such Third Parties patents as a result thereof;
(ii) in accordance with Section 16.7(a), the entry into a potential Research Program Term License was mutually agreed to but such Research Program Term License was not finalized prior to the expiration of the Research Program Term and in the event (and to the extent) that such Research Program Term License is required to make, use, offer for sale, sell or import in a specific country, a specific Adicet Royalty Product as a result of an allegation or potential allegation of infringement of such Third Parties patents as a result thereof;
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(iii) in accordance with Section 16.7(a), the entry into potential Research Program Term License regarding Intellectual Property rights of any Third Party was discussed by the Parties and was not consented to by Regeneron, and subsequently, after the Research Program Term, both Parties independently or both Parties jointly enter into a Third Party License regarding such Intellectual Property rights of such Third Party(s), and in the event (and to the extent) that such Third Party License is required to make, use, offer for sale, sell or import in a specific country, a specific Adicet Royalty Product as a result of an allegation or potential allegation of infringement of such Third Parties patents as a result thereof; or
(iv) in the event (and to the extent) that Adicet obtains a license after the end of the Research Program Term from one or more Third Parties where such license is required to make, use, offer for sale, sell or import in a specific country, a specific Adicet Royalty Product as a result of an allegation or potential allegation of infringement of such Third Parties patents (1) where such infringement is a result of Adicets practice of any Regeneron CTM or any Regeneron Product IP in compliance with the terms of this Agreement or (2) where such Third Partys Patents were filed prior to November 29, 2000 and were first published after the end of the Research Program Term and in the event (and to the extent) that a license is required to make, use, offer for sale, sell or import in a specific country, a specific Adicet Royalty Product as a result of an allegation or potential allegation of infringement of such Third Parties patents as a result thereof (clauses (i), (ii), (iii) and (iv), collectively, hereinafter Third Party Patent Licenses),
then in each such case, Adicet shall have the right to credit [***] of the royalties and milestones actually paid by Adicet or its Affiliates under such Third Party Patent Licenses, in each case with respect to sales of such Adicet Royalty Product in such country during a particular Quarter against the royalty payments due to Regeneron with respect to the sale of such Adicet Royalty Product in such country during such Quarter; provided, however, that in no event shall the royalties paid by Adicet to Regeneron with respect to the sale of such Adicet Royalty Product in such country during such Quarter be reduced to less than [***] of the amounts that would be owed pursuant to Section 14.3(a) in the absence of such credit. In addition to the provisions of Section 14.3(b)(iv), if the Patent Rights covering the subject intellectual property in the Third Party License were filed with the relevant authority prior to the expiration of the Research Program Term but were published after the expiration of the Research Program Term, to the extent the Parties mutually agree to enter into such Third Party License, Section 14.3(b)(i) shall apply, and to the extent the Parties do not mutually agree to enter into such Third Party License, Section 14.3(b)(iii) shall apply.
(c) Notwithstanding Section 14.3(a), in the event that the Royalty Term continues solely due to clause (a)(ii) in the definition of Royalty Term (i.e. in a specific country the Product is not Covered by a Valid Claim of a Patent Right Controlled by Adicet or a Patent Right licensed by Regeneron to Adicet in accordance with Section 5.1), then the royalty rates in such country for such Product for such Quarter will be reduced to [***] of the applicable rate in Section 14.3(a), provided, however, in no event shall the aggregate deductions under this Section 14.3(c) combined with deductions taken under Section 14.3(b) reduce any royalty payment made by Adicet in respect of Net Sales of such Licensed Product pursuant to Section 14.3(a) by more than [***]; provided, further, that Adicet may credit unused royalty reductions in excess of such cap in future Quarters.
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(d) The royalties payable under this Section 14.3 shall each be paid during the applicable Royalty Term, as determined on an Adicet Royalty Product-by-Adicet Royalty Product and country-by-country basis
(e) During the applicable Royalty Term, within [***] after the end of each Quarter, Adicet shall deliver to Regeneron a report detailing in reasonable detail the information necessary to calculate the royalty payments due under this Agreement for such Quarter, including the following information, specified on a Adicet Royalty Product-by-Adicet Royalty Product and country-by-country basis: (i) total gross invoiced amount from sales of each Adicet Royalty Product; (ii) all relevant deductions from gross invoiced amounts to calculate Net Sales of each Adicet Royalty Product; (iii) Net Sales of each Adicet Royalty Product in local currency and in United States Dollars; (iv) calculation of all reductions pursuant to Section 14.3(b) or 14.3(c), and (v) royalties payable. Adicet shall pay to Regeneron the royalty amount due for Net Sales during a given Quarter [***] after the end of such Quarter.
14.4 Royalty Payments for Regeneron Royalty Products. For each Quarter during the applicable Royalty Term, Regeneron shall pay non-refundable, non-creditable royalties to Adicet equal [***] of Net Sales of Regeneron Royalty Products during such Quarter. Sections 14.3(b), 14.3(c), 14.3(d) and 14.3(e) shall apply to Regeneron with respect to Net Sales of Regeneron Royalty Products mutatis mutandis, and all references to Adicet shall be deemed to refer to Regeneron and all references to Regeneron shall be deemed to refer to Adicet.
14.5 Royalty Payments for Regeneron Non-ICP Products. For each Quarter during the applicable Royalty Term, Regeneron shall pay non-refundable, non-creditable royalties to Adicet equal to [***] of Net Sales of Regeneron Non-ICP Products during such Quarter. Sections 14.3(d) and 14.3(e) shall apply to Regeneron with respect to Net Sales of Regeneron Non-ICP Products mutatis mutandis, and all references to Adicet shall be deemed to refer to Regeneron and all references to Regeneron shall be deemed to refer to Adicet. Sections 14.3(b) and 14.3(c) shall not apply with respect to Net Sales of Regeneron Non-ICP.
14.6 Royalty Payments for Mice Derived Adicet ICP Products. With respect to each Mice Derived Adicet ICP Product incorporating a Mice Derived Adicet Targeting Moiety ([***]), for each Quarter during the applicable Royalty Term, Adicet shall pay non-refundable, non-creditable royalties to Regeneron on Net Sales of Mice Derived Adicet ICP Products during such Quarter equal to the following percentage of Net Sales of such Mice Derived Adicet ICP Product:
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Product |
Royalty Rate | |
If the Mice Derived Adicet Targeting Moiety incorporated into such Mice Derived Adicet ICP Product was generated using the Licensed Mice set forth under the heading [***]and not [***] | [***] | |
If the Mice Derived Adicet Targeting Moiety incorporated into such Mice Derived Adicet ICP Product was generated using the Licensed Mice set forth under the heading [***] | [***] |
Sections 14.3(d) and 14.3(e) shall apply to Adicet with respect to Net Sales of Mice Derived Adicet ICP Products mutatis mutandis, and all references to Adicet Royalty Products shall be deemed to refer to Mice Derived Adicet ICP Products. Sections 14.3(b) and 14.3(c) shall not apply with respect to Net Sales of Mice Derived Adicet ICP Products. Adicet shall have a fully paid up and royalty-free license to use the Licensed Mice set forth under the heading Class 3 Licensed Mice on Schedule 3 for testing purposes in accordance with Section 5.1(d)(i).
14.7 Sharing of Profits and Development Costs from Co-Funded Products.
(a) Sharing. In the event Adicet exercises it Co-Funding Option and delivers a Co-Funding Notice pursuant to Section 8.1, commencing on the date Regeneron exercises its Option and continuing during the Product Term for such Co-Funded Product, the Parties shall share Profits and Development Costs and other costs in accordance with their Co-Funding Percentages as described in Schedule 2.
(b) Periodic Reports. Adicet and Regeneron shall each prepare and deliver to the other Party the periodic reports specified below:
(i) Regeneron shall deliver electronically the Development Cost and Payment reports required to be delivered by it pursuant to Section 10.3;
(ii) Within [***] following the end of each month, Regeneron shall deliver electronically to Adicet a monthly detailed Regeneron Collaboration Net Sales report, in each case with monthly and year-to-date sales in local currency and in United States Dollars of each Co-Funded Product in each country in the Co-Funding Territory in which such Co-Funded Product is sold, such reporting obligation to commence with the month in which the First Commercial Sale of any Co-Funded Product occurs in any country;
(iii) Within [***] following the end of each Quarter, commencing with the Quarter in which the First Commercial Sale of any Co-Funded Product occurs in any country in the Co-Funding Territory, Regeneron shall deliver electronically to Adicet a written report setting forth, on a country-by-country basis for such Quarter, for each country in the Co-Funding Territory, (A) the Regeneron Collaboration Net Sales of each Co-Funded Product in local currency and in United States Dollars, (B) Co-Funded Product quantities sold and (C) gross Co-Funded Product sales and an accounting of the deductions from gross sales permitted by the definition of Regeneron Collaboration Net Sales.
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(iv) Within [***] following the end of each Quarter, each Party that has incurred any Other Shared Expenses, Shared Commercial Expenses or Cost of Goods Sold in that Quarter shall deliver electronically to the other Party a written report setting forth in reasonable detail the Other Shared Expenses, Shared Commercial Expenses and/or Cost of Goods Sold incurred by such Party in such Quarter on a Major Market Country-by-Major Market Country basis in the Co-Funding Territory and to the extent Regenerons internal systems are segregating such information on a country-by-country basis, for each such country in the Co-Funding Territory, and on a Co-Funded Product-by-Co-Funded Product basis, in local currency and in United States Dollars, including whether any such expenses are also included in the reports delivered pursuant to clause (v) below;
(v) Within [***] following the end of each Quarter, Regeneron shall deliver electronically to Adicet a Profit Payment Report in respect of such Quarter, combining the information reported by each Party pursuant to this Section 14.7(b)(i)-(iv) and showing its calculations in accordance with Schedule 2 of the amount of any payments to be made by the Parties hereunder for such Quarter as contemplated by this Section 14.7(b) (including, as applicable, showing the calculation of the Profit Split or sharing of costs) and, if applicable, providing for the netting of such payments.
All reports referred to in this Section 14.7(b) shall be in such form, format and level of detail approved by the JSC. Unless otherwise agreed by the JSC, the financial data in the reports will include calculations in local currency and United States Dollars.
(c) Adjustments to FTE Rates. Notwithstanding anything herein to the contrary, upon the request of either Party, the Parties shall meet to review the accuracy of an applicable FTE rate in any country (e.g., Field Force FTE Rate, Development FTE Rate, etc.). The Parties agree to share reasonable supporting documents and materials in connection with an assessment of the applicable FTE rate and to determine in good faith whether to adjust the rate(s) in any country.
(d) Funds Flow. The Parties shall make Quarterly Development True-Up and Quarterly Profit True-Up payments as set forth in Schedule 2. If Regeneron is the Party owing Quarterly Development True-Up or Quarterly Profit True-Up payment(s) based on the calculations in the applicable Development Payment Report or Profit Payment Report, it shall, subject to Section 14.11, make such payment to Adicet [***] after its delivery to Adicet of such Development Payment Report or Profit Payment Report, as applicable. If Adicet is the Party owing the Quarterly Development True-Up or Quarterly Profit True-Up payment(s) based on the calculations in the applicable Development Payment Report or Profit Payment Report, it shall, subject to Section 14.11, make such payment to Regeneron within [***] after its receipt of such Development Payment Report or Profit Payment Report, as applicable, from Regeneron. If agreed between the Parties, the Parties may also net the collective payment(s) due under the Development Payment Report and Profit Payment Report. In the event that the Third Party Licenses entered in compliance with this Agreement reasonably require the payment of royalties or other amounts payable thereunder (to the extent attributable to the Manufacture, Development and/or
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Commercialization of Co-Funded Products for the Territory) on a Schedule other than the Schedule set forth in this Agreement for Quarterly Development True-Up or Quarterly Profit True-Up payment(s), the Parties shall discuss in good faith an appropriate Schedule upon which the Party that is not party to such Third Party License shall make such payment to the other Party or its designee, and the Parties shall adjust the amounts payable for the next Quarterly Development True-Up or Quarterly Profit True-Up payment(s) accordingly to credit such paying Party for its pre-payment of any amounts under the Third Party Licenses.
(e) Invoices and Documentation. The JSC shall approve the form of any necessary documentation relating to any Development Cost or Profit Split payments hereunder so as to afford the Parties appropriate accounting treatment in relation to any of the transactions or payments contemplated hereunder.
14.8 Payment Method and Currency. All payments under this Agreement shall be made by bank wire transfer in immediately available funds to an account designated by the Party to which such payments are due. All sums due under this Agreement shall be payable in United States Dollars. In those cases where the amount due in United States Dollars is calculated based upon one or more currencies other than United States Dollars, such amounts shall be converted to United States Dollars at the average rate of exchange for the Quarter to which such payment relates using the arithmetic mean of the daily rate of exchange (Mid Price Close), as reported in Thomson Reuters Eikon or any other source as agreed to by the Parties.
14.9 Late Payments. All late payments made under this Agreement (including payments made pursuant to Section 14.3, Section 14.4, Section 14.5, Section 14.6 and Section 14.7 above), shall earn interest, to the extent permitted by Applicable Law, from the date due until paid at a rate equal to the one month London Inter-Bank Offering Rate (LIBOR) U.S. Dollars, as quoted on Thomson Reuters Eikon (or any other source agreed to by the Parties) effective for the date on which the payment was due, plus [***] (such sum being referred to as the Default Interest Rate) unless such payments are disputed in good faith pursuant to Section 14.11.
14.10 Taxes. Any withholding or other taxes that a Party is required by Applicable Law to withhold or pay on behalf of the other Party, with respect to any payments to such other Party hereunder, shall be deducted from such payments and paid to the appropriate tax authority contemporaneously with the remittance to such other Party; provided, however, that the remitting Party shall furnish the other Party with proper evidence, including any self-reporting documentation, of the taxes so paid. Each Party shall cooperate with the other to minimize the effect of any such withholding taxes, and shall furnish the other Party with appropriate documents to secure application of the most favorable rate of withholding tax under Applicable Law (or exemption from such withholding tax payments, as applicable).
14.11 Resolution of Payment Disputes. In the event there is a dispute relating to any of the Profit Split payment obligations or reports under this Article 14, the Party with the dispute shall have its representative on the JSC provide the other Partys representative on the JSC with written notice setting forth in reasonable detail the nature and factual basis for such good faith dispute and the Parties, through the JSC, will seek to resolve the dispute as promptly as possible, but no later than [***] after such written notice is received. In the event that no resolution is reached by the JSC, and resolved in accordance with Article 23. The Parties agree that if there is a dispute regarding any payment amount, only the disputed amount shall be withheld from the payment; the undisputed amount shall be paid within the timeframes set forth in this Article 14.
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ARTICLE 15
RIGHTS IN FUTURE EQUITY FINANCINGS
15.1 Side Letter Agreement. As a condition precedent to the effectiveness of this Agreement, the Parties concurrently shall duly authorize, execute and deliver the Side Letter Agreement and perform their respective obligations that are required to be performed on or before the Effective Date.
ARTICLE 16
INTELLECTUAL PROPERTY
16.1 Ownership of Newly Created Intellectual Property.
(a) Regeneron shall solely own all Regeneron CTM Inventions, Regeneron Mice Inventions and Regeneron Transferred Technologies Inventions together with all Intellectual Property thereto.
(b) Adicet shall solely own all Adicet CTM Inventions, Collaboration Inventions and Mice Derived Adicet Targeting Moiety Inventions, together with all Intellectual Property thereto.
(c) Except as otherwise set forth in this Section 16.1, any invention, discovery or other result generated solely by employees, agents, or independent contractors of a Party or its Affiliates in the course of performing activities under this Agreement, together with all Intellectual Property therein (Sole Inventions), shall be owned by such Party. Except as otherwise set forth in this Section 16.1, any invention, discovery or other result generated jointly by at least one (1) employee, agent or contractor of each Party or such Partys Affiliate, together with all Intellectual Property therein, shall be owned jointly by the Parties. Subject to the provisions of this Agreement, each Party shall have the right to freely sell, assign, license, encumber and otherwise exploit its rights in jointly-owned inventions, discoveries and other results, together with all Intellectual Property therein.
(d) To the extent that any right, title or interest in or to any Intellectual Property discovered, invented, created or otherwise generated under this Agreement vests in a Party or its Affiliate, by operation of law or otherwise, in a manner contrary to the agreed upon ownership as set forth in this Agreement, such Party (or its Affiliate) shall, and hereby does, irrevocably assign to the other Party any and all such right, title and interest in and to such intellectual property to the other Party without the need for any further action by any Party.
(e) The Parties agree that nothing in this Agreement, and no use by a Party of the other Partys Intellectual Property pursuant to this Agreement, shall vest in a Party any right, title or interest in or to the other Partys Intellectual Property, other than the license rights expressly granted hereunder and the assignments expressly made hereunder.
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(f) Each Party shall promptly disclose to the other Party all Intellectual Property that (i) is discovered, invented, created or otherwise generated by such Party, its employees, agents and consultants pursuant to this Agreement (including under the Research Program) and (ii) that is (1) a Collaboration Invention, (2) a Regeneron CTM Invention, (3) an Adicet CTM Invention, (4) a Regeneron Mice Invention or (5) a Regeneron Transferred Technologies Invention discovered or made on the part of Adicet.
16.2 Prosecution and Maintenance of Patent Rights.
(a) Subject to Section 16.2(b), Regeneron shall use Commercially Reasonable Efforts to prepare, file, prosecute and maintain Patents and Patent Applications claiming the Regeneron CTM Inventions in at least the countries mutually agreed upon by the Parties. Regeneron shall confer with and keep Adicet reasonably informed regarding the status of such activities with respect to all Regeneron CTM Inventions. Regeneron shall have the following obligations with respect to the filing, prosecution and maintenance thereof: (i) Regeneron shall provide to Adicet for review and comment a copy of a substantially completed draft of any priority Patent Application in the Territory [***] days prior to the filing of any such priority Patent Application by Regeneron, and Regeneron shall reasonably consider any comments from Adicet; (ii) Regeneron shall provide Adicet promptly with copies of all material communications received from or filed in patent offices with respect to such filings; (iii) Regeneron shall consult with Adicet promptly following the filing of the priority Patent Applications in the Territory to mutually determine in which countries in the Territory it shall file convention Patent Applications and (iv) Regeneron shall consult with Adicet a reasonable time prior to taking or failing to take any substantive action with respect to such Patent Applications or Patents, including any action that would materially affect the scope or validity of rights under any Patent Applications or Patents (such as substantially narrowing or canceling any claim or allowing claims to issue in a patent without reserving the right to file a continuing or divisional Patent Application, abandoning any Patent or not filing or perfecting the filing of any Patent Application in any country) and Regeneron shall reasonably consider all comments thereto from Adicet, including not taking or not failing to take such action, except as permitted by Section 16.2(b).
(b) In the event that Regeneron desires not to file or to abandon any Patent or Patent Application included in the Regeneron Product IP in the Territory, wherein such decision not to file or abandonment results in substantive loss of Patent Rights, Regeneron shall provide reasonable prior written notice to Adicet of such intention to abandon (which notice shall, in any event, be given [***] prior to the next deadline for any action that may be taken with respect to a Patent or Patent Application within such Regeneron Product IP with the applicable patent office) and Adicet shall have the right, but not the obligation, to assume responsibility for the prosecution and maintenance thereof, in Regenerons name, unless, with respect to any such Patent Applications included in the Regeneron Product IP that are unpublished, Regeneron notifies Adicet that Regeneron would prefer to maintain the subject matter of such Patent Application as a trade secret.
(c) Subject to Section 16.2(e), Adicet shall use Commercially Reasonable Efforts to prepare, file, prosecute and maintain Patents and Patent Applications claiming the Mice Derived Adicet Targeting Moiety Inventions.
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(d) Subject to Section 16.2(e), Adicet, by counsel it selects to whom Regeneron has no reasonable objection, shall use Commercially Reasonable Efforts to prepare, file, prosecute and maintain Patents and Patent Applications claiming the Adicet CTM Inventions and Collaboration Inventions in the countries mutually agreed upon by the Parties. Adicet shall confer with and keep Regeneron reasonably informed regarding the status of such activities with respect to all Adicet CTM Inventions and Collaboration Inventions. Adicet shall have the following obligations with respect to the filing, prosecution and maintenance thereof: (i) Adicet shall provide to Regeneron for review and comment a copy of a substantially completed draft of any priority Patent Application in the Territory at [***] prior to the filing of any such priority Patent Application by Adicet, and Adicet shall reasonably consider any comments from Regeneron; (ii) Adicet shall provide Regeneron promptly with copies of all material communications received from or filed in patent offices with respect to such filings; (iii) Adicet shall consult with Regeneron promptly following the filing of the priority Patent Applications in the Territory to mutually determine in which countries in the Territory it shall file convention Patent Applications; and (iv) Adicet shall consult with Regeneron a reasonable time prior to taking or failing to take any substantive action with respect to such Patent Applications or Patents, including any action that would materially affect the scope or validity of rights under any Patent Applications or Patents (such as substantially narrowing or canceling any claim or allowing claims to issue in a patent without reserving the right to file a continuing or divisional Patent Application, abandoning any Patent or not filing or perfecting the filing of any Patent Application in any country) and Adicet shall reasonably consider all comments thereto from Regeneron, including not taking or not failing to take such action, except as permitted by Section 16.2(e).
(e) In the event that Adicet desires not to file or to abandon any Patent or Patent Application included in the Adicet Product IP or any Patent or Patent Application claiming Collaboration Inventions, in each case in any country in the Territory wherein such decision not to file or abandonment results in substantive loss of Patent Rights, Adicet shall provide reasonable prior written notice to Regeneron of such intention to not to file or to abandon (which notice shall, in any event, be given no later [***] prior to the next deadline for any action that may be taken with respect to such Patent or Patent Application with the applicable patent office) and Regeneron shall have the right, but not the obligation, to assume responsibility for the filing, prosecution and maintenance thereof in Adicets name, unless, with respect to any such Patent Applications that are unpublished, Adicet notifies Regeneron that Adicet would prefer to maintain the subject matter of such Patent Application as a trade secret.
(f) If either Party desires to file either (i) a Patent Application that discloses (but does not claim) the sequence of a Targeting Moiety that was first Generated by or on behalf of the other Party and used in the performance of this Agreement or (ii) a Patent Application that discloses a derivative, modification, fragment or improvement of such Targeting Moiety, then such Party shall provide such other Party, at least [***] prior to the anticipated filing date, a copy of such Patent Application and, upon the request of the other Party, shall provide sufficient time to file a Patent Application Covering such Targeting Moiety, if such a Patent Application has not yet been filed.
(g) Each Party agrees to cooperate with the other with respect to the preparation, filing, prosecution and maintenance of Patents and Patent Applications pursuant to this Section 16.2, including the execution of all such documents and instruments and the
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performance of such acts (and causing its relevant employees and consultants to execute such documents and instruments and to perform such acts) as may be reasonably necessary for any such preparation, filing, prosecution or maintenance; provided, however, that where a Party has the right as set forth in this Agreement to take an action or make a determination without agreement from the other Party, the foregoing clause shall not limit such right. With respect to any Co-Funded Product, Regeneron, with the review by the JSC will determine, and with respect to a Regeneron Royalty Product, Regeneron will determine, which of the Patents or Patent Applications within the Adicet Product IP and Regeneron Product IP for which to seek an extension of term and the applicable Party will file for said patent term extension.
(h) Costs. All Out-of-Pocket Costs incurred in the filing, prosecution and maintenance of any Patents and Patent Applications pursuant to this Section 16.2 shall be borne [***].
(i) Neither Party shall have the right, without the prior written consent of the other Party, to invoke the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. 103(c)(2)-(c)(3) (the CREATE Act) with respect to any invention that is developed pursuant to this Agreement.
16.3 Administrative Patent Proceedings.
(a) Each Party will notify the other within [***] of receipt by such Party of information concerning the request for, or filing or declaration of, any reissue, post-grant review, inter partes review, derivation proceeding, supplemental examination, interference, opposition, reexamination or other administrative proceeding relating to Patents or Patent Applications within the Regeneron Product IP or Adicet Product IP or any other Patent or Patent Application claiming Collaboration Inventions in the Territory. The Parties will thereafter consult and reasonably cooperate to determine a course of action with respect to any such proceeding and will reasonably consult with one another in an effort to agree with respect to decisions on whether to initiate or how to respond to such a proceeding, as applicable, and the course of action in such proceeding, including settlement negotiations and terms; provided, however, that, except as otherwise agreed by the Parties and except as set forth below in Section 16.3(b), (i) Regeneron shall control and have final decision making authority with respect to any such proceeding relating to the Patents or Patent Applications within the Regeneron Product IP and (ii) Adicet shall control and have final decision making authority with respect to any such proceeding relating to the Patents or Patent Applications within the Adicet Product IP or other Collaboration Inventions.
(b) If any proceeding under Section 16.3(a) involves Patents involved in a Product Infringement under Section 16.4, any decisions on whether to initiate or how to respond to such a proceeding, as applicable, and the course of action in such proceeding shall be made by the Party controlling such third party infringement action in consultation with the other Party.
(c) All Out-of-Pocket Costs incurred in connection with any proceeding under Section 16.3(a) relating to the Patents and Patent Applications within the Regeneron Product IP, Adicet Product IP or Patent Rights claiming Collaboration Inventions shall be borne [***].
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16.4 Third Party Infringement Suits.
(a) In the event that either Party or any of its Affiliates becomes aware of an actual or suspected infringement of [***] , Product Infringement), the Party that became aware of the Product Infringement shall promptly notify the other Party in writing of this actual or suspected infringement and shall provide such other Party with all available evidence supporting such actual or suspected infringement.
(b) The Parties will consult and reasonably cooperate in an effort to determine a mutually agreeable course of action, provided that, (i) if the Product Infringement relates to an ICP directed to a Collaboration Target to which a Regeneron Royalty Product or Co-Funded Product is directed, then [***] shall be the Party that controls and has final decision making authority regarding the course of action, including any potential litigation, other proceeding or settlement, to abate such Product Infringement (the Lead Litigation Party), (ii) if the Product Infringement relates to an ICP directed to a Collaboration Target to which an Adicet Royalty Product or Mice Derived Adicet Targeting Moiety is directed, then [***] shall be the Lead Litigation Party, (iii) if the Product Infringement relates to an ICP product directed to a Non- Collaboration Target to which a Mice Derived Adicet Targeting Moiety is directed, then [***] shall be the Lead Litigation Party, (iv) if the Product Infringement relates to a non-ICP product directed to a Non- Collaboration Target to which a Mice Derived Adicet Targeting Moiety is directed (and such Product Infringement doesnt also relate to an ICP Product directed to a Non-Collaboration Target being developed or commercialized by or behalf of Adicet, in which case clause (iii) shall apply), then [***] shall be the Lead Litigation Party and (v) in all other cases, the Party that Controls the infringed Patent Rights shall be the Lead Litigation Party. The Lead Litigation Party cannot require the non-Lead Litigation Party to join in the suit, provided, however that, [***].
(c) Except as set forth in the last sentence of Section 16.4(b), (i) all Out-of-Pocket Costs incurred in the connection with the enforcement of a Product Infringement in connection with a Co-Funded Product shall be [***].
(d) The amount of any recovery from any such Product Infringement suit shall first be used to pay reasonable costs, including attorneys fees, relating to such legal proceedings and then [***].
(e) In the event either Party initiates a proceeding pursuant to this Section 16.4(b), without prejudice to the terms of Section 16.4(b), the other Party shall provide such assistance as reasonably requested by the Lead Litigation Party, [***].
(f) The Parties agree not to grant any licenses, covenants not to sue or otherwise transfer any rights, title or interest in any Patents or Patent Applications to any Third Parties against which any enforcement actions with respect to Product Infringement have been initiated pursuant to this Section 16.4(b) (except for those Product Infringements described in Section 16.4(h)), nor make any admission concerning claim invalidity or enforceability concerning such Patents or Patent Applications, without the prior written consent of the other Party, such consent not to be unreasonably withheld or delayed, until such action is finally resolved, terminated or settled.
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(g) Subject to Section 16.4(h), if either Party declines to initiate or fails to initiate litigation with respect to a particular Product Infringement within [***] following written notice of the Product Infringement from the other Party, then the other Party may thereafter commence an infringement action and be the Lead Litigation Party with respect to such Product Infringement after delivering written notice to the non-initiating Party.
(h) In the event there is a Product Infringement where (i) at the time of notice of such Product Infringement, a Party or its Affiliate or licensee is developing or selling a product that is not a Product and which is covered by one or more of the potentially infringed Patents involved in the Product Infringement, and (ii) such Party reasonably believes the pursuit of such litigation with respect to such Product Infringement is reasonably likely to have a material adverse effect on such other product, then (A) such Party, upon notice to the other Party, shall have the right not to pursue litigation with respect to such Product Infringement, and (B) the other Party shall not have any rights to assume the Lead Litigation Party status with respect to such Product Infringement or to otherwise pursue such Product Infringement, and thereafter the potentially infringed Patents involved in the Product Infringement shall no longer be considered for purposes of calculating the Royalty Term for any Product.
16.5 Patent Marking. Each Party shall comply with the patent marking statutes in each country in which a Product is made, offered for sale, sold or imported by such Party, its Affiliates and/or licensees or sublicensees.
16.6 Third Party Claims. [***]. If either Party or its Affiliates shall learn of a Third Party claim, assertion or certification that the activities under the Research Program infringe or otherwise violate the intellectual property rights of any Third Party in the Territory, then such Party shall promptly notify the other Party in writing of this claim, assertion or certification. As soon as reasonably practical after the receipt of such notice, the Parties shall [***].
16.7 Third Party Vigilance. During the Term, if either Party wishes to enter into any Third Party License in connection with the research, development, manufacture or commercialization of Collaboration ICPs (or that otherwise could result in any financial burden with respect to the research, development, manufacture or commercialization of any Collaboration ICPs or any Product), the following provisions shall apply:
(a) Research Program Term Licenses. In the case of any Third Party License for [***] (Research Program Term Licenses), neither Party shall have the right to enter into a such Research Program Term Licenses without the prior consent of the other Party which shall not be unreasonably withheld or delayed. In the event that the Parties do agree to enter into any such Research Program Term Licenses, the Parties will discuss and agree on which Party will take the lead on entering into such Research Program Term License, ensuring that the lead Party obtains the right to sublicense to the other Party the necessary rights to develop and commercialize such Collaboration ICPs.
(i) In the event Third Party License Payments are payable as a result of a Research Program Term License entered into by Regeneron and such payments are due [***].
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(ii) In the event Third Party License Payments are payable as a result of a Research Program Term License entered into by Adicet and such payments are due [***].
(iii) In the event Third Party License Payments are payable as a result of a Research Program Term License entered into by either Party in accordance with Section 16.7(a) and such payments are due [***].
(b) Product Licenses.
(i) In the case of any Third Party License for any Co-Funded Product, [***].
(ii) In the case of Adicet Royalty-Bearing Collaboration ICPs, [***].
(iii) In the case of Regeneron Royalty-Bearing Collaboration ICPs, [***].
16.8 Infringement of Third Party Patent Rights in the Territory.
(a) Notice. If any Product used or sold by either Party, its Affiliates, or sublicensees becomes the subject of a Third Partys claim or assertion of infringement of a Patent granted by a jurisdiction within the Territory, the Party first having notice of the claim or assertion shall promptly notify the other Party.
(b) Regeneron Royalty Products, Adicet Royalty Products, Mice Derived Adicet Products or Regeneron Non-ICP Products. Regeneron shall have the sole right, but not the obligation, to defend any such Third Party claim or assertion of infringement of a Regeneron Royalty Product or Regeneron Non-ICP Product. Regeneron shall bear its own costs in connection with a defense against a Third Party claim or assertion pursuant to this Section 16.8(b) with respect to a Regeneron Royalty Product or Regeneron Non-ICP Product. Adicet shall have the sole right, but not the obligation, to defend any such Third Party claim or assertion of infringement of an Adicet Royalty Product or a Mice Derived Adicet Product. Adicet shall bear its own costs in connection with a defense against a Third Party claim or assertion pursuant to this Section 16.8(b) with respect to an Adicet Royalty Product or Mice Derived Adicet Product. In exercising their rights under Section 16.8(b) neither Party shall enter into any settlement of any claim described in this Section 16.8(b) that materially affects the rights or interests of the other Party without the other Partys written consent, such consent not to be unreasonably withheld or delayed.
(c) Co-Funded Products.
(i) Infringement Claims. If any Co-Funded Product is the subject of a Third Partys claim or assertion of infringement of a Patent granted by a jurisdiction within the Co-Funding Territory then defense of such claim (an Infringement Claim) shall be managed in accordance with Section 16.8(c)(ii), with coordination and cooperation between the defending Party and the other Party. In the event that the defending Party determines that it is reasonably advisable to obtain a license to such Third Partys Patents, the decision to obtain such a license shall be subject to Section 16.7(b).
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(ii) Defense. Unless the Parties otherwise agree by mutual written consent, [***]shall have the first right, but not the obligation, to control such defense with respect to the Co-Funded Product or related activity accused of infringement, [***]. If [***] chooses not to control the litigation, [***] shall have the right, but not the obligation, to defend against such claim. The Party that does not control defense of a claim hereunder shall have the right to be represented by counsel of its own choice at its sole expense, which expense shall not be included in Other Shared Expenses. Without limiting the foregoing, the defending Party shall keep the non-defending Party advised of all material communications, actual and prospective filings or submissions regarding such action, and shall provide the non-defending Party copies of and an opportunity to review and comment on any such communications, filings and submissions. Subject to the strategy agreed above and continuing consultation with the non-defending Party, the defending Party shall control the defense and settlement of Infringement Claims or opposition proceedings, with the costs thereof (including the non-defending Partys reasonable outside counsel attorneys fees and expenses and the out-of-pocket costs of cooperating with the defending Party as provided above, but excluding the costs and expenses of any separate outside counsel chosen by the non-defending Party to represent it in the applicable action) being included in Other Shared Expenses. The defending Party shall not settle such Infringement Claims, including any counterclaims, without the prior written consent of the non-defending Party, such consent not to be unreasonably withheld or delayed.
(iii) Costs. Except as set forth in Section 16.8(c)(ii) and without limiting Section 20.1(c), all Out-of-Pocket Costs incurred in the connection with the defense of an Infringement Claim (including any nullification, declaratory judgment, revocation, or opposition proceeding against any such Patents or other rights in response to prospective or actual Infringement Claim) shall be [***].
16.9 Product Trademarks. Regeneron shall exclusively own and be responsible for, filing, prosecuting, protecting and maintaining the Product Trademarks, including all enforcement and defense thereof. Without limiting Section 20.1(c), all Out-of-Pocket Costs incurred in the filing, prosecution and maintenance, enforcement and defense of Product Trademarks pursuant to this Section 16.9 shall be [***]. Adicet shall provide all assistance reasonably requested by the Regeneron in connection with the maintenance, enforcement and defense of the Product Trademarks.
16.10 Compliance with Third Party Licenses. Each Party agrees to comply with the obligations set forth in (i) any Third Party Licenses to which it is a party and to notify the other Party of any terms or conditions in any such Third Party License with which such other Party is required to comply as a licensee, co-licensee or sublicensee, as the case may be, and (ii) any other material agreement, including any sublicense under a Third Party License referenced in subsection (i) above, to which it is a party and that is related to the Collaboration Arrangement, including any obligations to pay royalties, fees or other amounts due thereunder. Neither Party may terminate or amend any Third Party License or any other material agreement entered into pursuant to a JSC approval without the prior written consent of the other Party, such consent not to be unreasonably withheld or delayed, if the amendment or termination imposes any material liability or restriction on either Party with respect to the Development, Manufacture or Commercialization of Co-Funded Products in the Territory.
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16.11 Background Patent Rights. Notwithstanding anything to the contrary in this Agreement:
(a) Adicet shall have the sole right (and Regeneron shall have no right) to control the preparation, prosecution, maintenance, enforcement or defense of the Adicet Background Patent Rights; [***].
(b) Regeneron shall have the sole right (and Adicet shall have no right) to control the preparation, prosecution, maintenance, enforcement or defense of the Regeneron Background Patent Rights; [***].
ARTICLE 17
BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS
17.1 Books and Records. Each Party shall keep proper books of record and account in which full, true and correct entries (in conformity with GAAP) shall be made for the purpose of determining the amounts payable or owed pursuant to this Agreement. Each Party shall, and shall cause each of its respective Affiliates to, permit auditors to visit, inspect and examine, during regular business hours and under the guidance of officers of the Party being inspected, the books of record and account of such Party or such Affiliate as provided in Section 17.2.
17.2 Audits and Adjustments.
(a) Each Party shall have the right, upon no less than [***] advance written notice and at such reasonable times and intervals and to such reasonable extent as the Party shall request, not more than once during any Contract Year, to have the books and records of the other Party to the extent relating to this Agreement for the preceding [***] years audited by an independent Big Four (or equivalent) accounting firm of its choosing under reasonable, appropriate confidentiality provisions, for the sole purpose of verifying the accuracy of all financial, accounting and numerical information and calculations provided, and payments made, under this Agreement; provided, that no period may be subjected to audit more than one (1) time unless a material discrepancy is found in any such audit of such period, in which case additional audits of such period may be conducted until no material discrepancies are found.
(b) Such accountants shall disclose to each Party only whether the financial, accounting and numerical information and calculations are accurate, and the amount of any discrepancies. The results of any such audit shall be delivered in writing to each Party and shall be final and binding upon the Parties, unless disputed by a Party within [***] of delivery. If a Party over billed or underpaid an amount due under this Agreement resulting in a cumulative discrepancy during any year of more than [***], it shall also reimburse the other Party for the reasonable out-of-pocket costs of such audit (with the cost of the audit to be paid by the Party initiating the audit in all other cases). Such accountants shall not reveal to the Party requesting the audit the details of its review, except for the findings of such review and such information as is required to be disclosed under this Agreement, and shall be subject to the confidentiality provisions contained in Article 19.
(c) If any examination or audit of the records described above discloses an over billing or underpayment of amounts due hereunder, then unless the result of the audit is contested
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pursuant to Section 17.2(b) above, the Party that overbilled or underpaid shall pay the same (plus interest thereon at the Default Interest Rate from the date of such overbilling or underpayment through the date of payment of the amount required to be paid pursuant to this Section 17.2(c)) to the Party entitled thereto within [***] after receipt of the written results of such audit pursuant to this Section 17.2.
(d) Disputes. Any disputes with respect to the results of any audit conducted under Section 17.2 above shall be elevated to the JSC and resolved in accordance with Article 23.
17.3 GAAP. Except as otherwise provided herein, all costs and expenses and other financial determinations with respect to this Agreement shall be determined in accordance with GAAP, as generally and consistently applied.
ARTICLE 18
REPRESENTATIONS, WARRANTIES AND COVENANTS
18.1 Joint Representations and Warranties. Each Party hereto represents and warrants to the other Party, as of the Effective Date, as follows: (a) it is duly organized and validly existing under the laws of its jurisdiction of incorporation; (b) it has full corporate power and authority and has taken all corporate action necessary to enter into and perform this Agreement; (c) the execution and performance by it of its obligations hereunder will not constitute a breach of, or conflict with, its organizational documents nor any other material agreement or arrangement, whether written or oral, by which it is bound or requirement of Applicable Laws; (d) this Agreement is its legal, valid and binding obligation, enforceable in accordance with the terms and conditions hereof (subject to Applicable Laws of bankruptcy and moratorium); (e) such Party is not prohibited by the terms of any agreement to which it is a party from performing the Research Program or granting the rights and/or licenses hereunder; and (f) no broker, finder or investment banker is entitled to any brokerage, finders or other fee in connection with this Agreement or the transactions contemplated hereby based on arrangements made by it or on its behalf.
18.2 Knowledge of Pending or Threatened Litigation. Each Party represents and warrants to the other Party that, as of the Effective Date, there is no announced investigation, suit, action or proceeding pending or, to such Partys knowledge, threatened, against such Party before or by any court, arbitrator, or Governmental Authority that, individually or in the aggregate, is reasonably expected to (a) materially impair the ability of such Party to perform its obligations under this Agreement or (b) prevent or materially delay or alter the consummation of any or all of the transactions contemplated hereby. During the Term each Party shall promptly notify the other Party in writing upon learning of any of the foregoing.
18.3 Additional Regeneron Representations, Warranties and Covenants of Regeneron.
(a) Regeneron additionally represents and warrants to Adicet that, as of the Effective Date:
(i) to Regenerons knowledge after due inquiry, Regeneron owns or has a valid license to with a right to sublicense all Regeneron Background Patent Rights;
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(ii) Regeneron has the right and authority to grant the rights granted pursuant to the terms and conditions of this Agreement and Regeneron has not granted any rights that would be inconsistent with or in conflict with or in derogation of the rights granted herein;
(iii) except as set forth on Schedule 18.3(a), there is no pending litigation of which Regeneron has received notice, or to Regenerons knowledge after due inquiry is otherwise aware, in each case that alleges that any of Regenerons activities relating to the (i) Regeneron Background Patent Rights or (ii) the Know-How of Regeneron that Regeneron knows as of the Effective Date is necessary to perform under this Agreement, in each case, have violated, or would violate, the intellectual property rights of any Third Party; and
(iv) all current and former officers, employees, agents, advisors, consultants, contractors or other representatives of Regeneron or any of its Affiliates who are inventors of or have otherwise contributed in a material manner to the creation or development of any Regeneron Background IP have executed and delivered to Regeneron or any such Affiliate an assignment or other agreement regarding the protection of proprietary Information and the assignment to Regeneron or any such Affiliate of any Regeneron Background IP. To Regenerons knowledge after due inquiry, no current officer, employee, agent, advisor, consultant, contractor or other representative of Regeneron or any of its Affiliates is in violation of any term of any assignment or other agreement regarding the protection of Regeneron Patent Rights or other Regeneron IP or of any employment contract or any other contractual obligation relating to the relationship of any such Person with Regeneron or any such Affiliate.
(b) Regeneron additionally covenants to Adicet that, during the Term, neither Regeneron nor any of its Affiliates shall transfer ownership, assign ownership, grant a security interest in or otherwise encumber any of its rights in, to or under any Regeneron IP in a way that will impair Adicets rights or Regeneron ability to perform its obligations under this Agreement.
18.4 Additional Adicet Representations, Warranties and Covenants of Adicet.
(a) Adicet additionally represents and warrants to Regeneron that, as of the Effective Date:
(i) to Adicets knowledge after due inquiry, Adicet owns or has a valid license to with a right to sublicense all Adicet Background Patent Rights;
(ii) Adicet has the right and authority to grant the rights granted pursuant to the terms and conditions of this Agreement and Adicet has not granted any rights that would be inconsistent with or in conflict with or in derogation of the rights granted herein;
(iii) there is no pending litigation of which Adicet has received notice, or to Adicets knowledge after due inquiry is otherwise aware, in each case that alleges that any of Adicets activities relating to the (i) Adicet Background Patent Rights or (ii) the Know-How of Adicet that Adicet knows as of the Effective Date is necessary to perform under this Agreement, in each case, have violated, or would violate, the intellectual property rights of any Third Party; and
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(iv) all current and former officers, employees, agents, advisors, consultants, contractors or other representatives of Adicet or any of its Affiliates who are inventors of or have otherwise contributed in a material manner to the creation or development of any Adicet Background IP have executed and delivered to Adicet or any such Affiliate an assignment or other agreement regarding the protection of proprietary Information and the assignment to Adicet or any such Affiliate of any Adicet Background IP. To Adicets knowledge after due inquiry, no current officer, employee, agent, advisor, consultant, contractor or other representative of Adicet or any of its Affiliates is in violation of any term of any assignment or other agreement regarding the protection of Adicet Patent Rights or other Adicet IP or of any employment contract or any other contractual obligation relating to the relationship of any such Person with Adicet or any such Affiliate.
(v) Adicet does not believe it is or will be necessary to utilize any inventions of any of its employees made prior to the Effective Date and prior to or outside the scope of their employment by Adicet that have not otherwise been assigned to Adicet. To Adicets knowledge, no officer, director, employee, or consultant of Adicet is obligated under or bound by any agreement or instrument, or any judgment, decree, or order of any court or administrative agency, that conflicts or may conflict with his or her agreements and obligations to promote the interests of Adicet.
(vi) Adicet is not aware that any of its officers or employees is obligated under any contract (including licenses, covenants or commitments of any nature) or other agreement, or subject to any judgment, decree or order of any court or administrative agency, that would interfere with the use of his, her or its best efforts to promote the interests of Adicet or that would conflict with Adicets business as proposed to be conducted. Neither the execution nor delivery of this Agreement, nor the carrying on of Adicets business by the employees of Adicet, will, to Adicets knowledge, conflict with or result in a breach of the terms, conditions or provisions of, or constitute a default under, any contract, covenant or instrument under which any of such employees is now obligated.
(b) Adicet additionally covenants to Regeneron that, during the Term, neither Adicet nor any of its Affiliates shall transfer ownership, assign ownership, grant a security interest in or otherwise encumber any of its rights in, to or under any Adicet IP in a way that will impair Regenerons rights, or Adicets ability to perform its obligations, under this Agreement.
18.5 Mutual Covenants. Each Party hereby covenants to the other Party as follows: (a) it will not during the Term grant any right or license to any Third Party which would be inconsistent with or in conflict with or in derogation of the rights granted to the other Party under this Agreement, and will not take any action that would materially conflict with its obligations to the other Party under this Agreement; (b) neither Party will use the Patent Rights, Know-How, materials, or Confidential Information of the other Party outside the scope of the licenses and rights granted to it under this Agreement; (c) in the course of the Development or Commercialization of a Product under this Agreement, it will not use an employee or consultant who is or has been debarred by a Regulatory Authority or, to such Partys knowledge, is or has been the subject of debarment proceedings by a Regulatory Authority; and (d) such Party will not use in or contribute to the Research Program or the Parties other activities under this Agreement any material, Confidential Information, Intellectual Property right, or Trademark that such contributing Party knows that it does not Control, unless the other Party has provided its prior written consent thereto which specifically refers to such lack of Control.
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18.6 Compliance with Laws.
(a) Each Party agrees, in its performance of this Agreement, to comply, and to cause its Affiliates to comply, with all Applicable Laws in all material respects, including the FCPA, U.S. Export Control Laws and Anti-Corruption Laws. Each Party shall not knowingly take any action that would cause the other Party to be in violation of the FCPA, U.S. Export Control Laws or any other applicable Anti-Corruption Laws. Further, each Party shall immediately notify the other Party if such Party has any information or suspicion that there may be a violation of the FCPA or any other Anti-Corruption Law in connection with the performance of this Agreement.
(b) In connection with this Agreement, each Party shall not knowingly sell any Products or engage in any other transaction in, to, or with (i) any country that becomes subject to sanctions imposed by the U.S. Government, or (ii) any individual or entity that is listed in the following: (A) List of Specially Designated Nationals & Blocked Persons, Office of Foreign Assets Control, U.S. Treasury Department; (B) List of Debarred Parties, Directorate of Defense Trade Controls, U.S. State Department; (C) Denied Persons List, Bureau of Industry and Security, U.S. Department of Commerce; (D) Entity List, Bureau of Industry and Security, U.S. Department of Commerce; (e) Unverified List, Bureau of Industry and Security, U.S. Department of Commerce; or (F) the Palestinian Legislative Counsel (PLC) List, Office of Foreign Assets Control, U.S. Treasury Department.
(c) Each Party and its employees and agents have not, and shall not, directly or indirectly through Third Parties, knowingly pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value, to a Public Official or Entity or other person for purposes of corruptly obtaining or retaining business for or with, or directing business to, any Person, including either Party, by (i) influencing any official act, decision or omission of such Public Official or Entity; (ii) inducing such Public Official or Entity to do or omit to do any act in violation of the lawful duty of such Public Official or Entity; (iii) securing any improper advantage; or (iv) inducing such Public Official or Entity to affect or influence any act or decision of another Public Official or Entity.
(d) Each Party and its employees and agents have not and shall not knowingly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, excessive gift or hospitality or other illegal or unethical benefit to a customer or a Third Party customer or to a Public Official or Entity. In addition, each Party and its employees and agents shall ensure that no part of any payment, commission, reimbursement or fee paid by either Party pursuant to this Agreement or otherwise will be used knowingly as a corrupt payment, gratuity, emolument, bribe, kickback, excessive gift or hospitality or other illegal or unethical benefit to a customer or to Third Party customer or to a Public Official or Entity.
18.7 Disclaimer of Warranties. EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, CONCERNING THE SUCCESS OR POTENTIAL SUCCESS OF THE RESEARCH PROGRAM, THE
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DEVELOPMENT, COMMERCIALIZATION, MARKETING OR SALE OF ANY PRODUCT OR ANY INTELLECTUAL PROPERTY RIGHTS. EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 19
CONFIDENTIALITY
19.1 Confidential Information. During the Term and for a period of five (5) years thereafter, each Party and its Affiliates (in such capacity, collectively, the Receiving Party) shall keep confidential, and other than as provided herein, shall not disclose, directly or indirectly, any proprietary information, including any proprietary data, inventions, documents, ideas, information, discoveries, or materials, Controlled by the other Party or its Affiliates (in such capacity, collectively, the Disclosing Party), whether in tangible or intangible form, including but not limited to Regeneron Know-How and Adicet Know-How, that is disclosed pursuant to this Agreement (the Confidential Information). Each Party and its Affiliates shall use the Confidential Information of the other Party and its Affiliates solely for the purpose of exercising its rights and performing its obligations hereunder. For purposes of this Agreement, all confidential information disclosed by a Party under the terms of the Confidentiality Agreement between the Parties dated May 18, 2015, (CDA) is hereby deemed Confidential Information of such Party and treated as if disclosed hereunder and shall be subject to the terms of this Agreement. Each Party covenants that neither it nor any of its respective Affiliates shall disclose any Confidential Information of the other Party to any Third Party except (i) to its employees, agents, consultants or any other Person under its authorization; provided such employees, agents, consultants or other Persons are subject in writing (or by explicit professional obligations such as the attorney-client relationship) to confidentiality obligations applicable to such Confidential Information no less strict than those set forth herein, (ii) as approved by both Parties hereunder or (iii) as set forth elsewhere in this Agreement, including to subcontractors and sublicensees in accordance with Section 24.11. Regeneron Mice Inventions, Regeneron CTM Inventions and Regeneron Transferred Technologies Inventions shall be Confidential Information of Regeneron, and Adicet CTM Inventions and Mice Derived Adicet Targeting Moiety Inventions shall be Confidential Information of Adicet. Collaboration Inventions shall be Confidential Information of both Parties; provided that the Collaboration Inventions may be used by both Parties as provided herein but not disclosed to Third Parties, except as expressly permitted herein, without the prior written consent of the other Party. The results from the Research Program shall be the Confidential Information of both Parties; provided that such results may be used by both Parties as provided herein but not disclosed to Third Parties without the prior written consent of the other Party. The results from the development and commercialization of Regeneron Royalty Products, Co-Funded Products or Regeneron Non-ICP Products shall be the Confidential Information of Regeneron. The results from the development and commercialization of Adicet Royalty Products or Mice Derived Adicet ICP Products shall be the Confidential Information of Adicet.
19.2 Exceptions. Notwithstanding Section 19.1 or anything to the contrary in this Agreement:
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(a) Confidential Information shall not include information and materials (and such information and materials shall not be Confidential Information under this Agreement) to the extent that it can be established by written documentation by the Receiving Party that such information or material: (i) already is in the public domain prior to disclosure by the Disclosing Party or becomes publicly known through no act, omission or fault of the Receiving Party or any Person to whom the Receiving Party provided such information; (ii) is or was already lawfully, and not under an obligation of confidentiality owed to the Disclosing Party, in the possession of the Receiving Party at the time of disclosure by the Disclosing Party; provided that the Receiving Party did not initially generate such information and assign its rights to such information to the Disclosing Party in accordance with the terms of this Agreement; (iii) is disclosed to the Receiving Party on an unrestricted basis from a Third Party not under an obligation of confidentiality to the Disclosing Party with respect to such information; or (iv) has been independently created by the Receiving Party, as evidenced by written or electronic documentation, without any aid, application or use of the Disclosing Partys Confidential Information; provided that, unless (i)-(iv) applies to such information, it shall still be treated as Confidential Information for all purposes other than satisfaction of such disclosure requirement. Specific aspects or details of Confidential Information will not be deemed to be within the public knowledge or in the prior possession of a Person merely because such aspects or details of the Confidential Information are embraced by general disclosures in the public domain.
(b) The Receiving Party shall have the right to disclose information or materials to the extent required by Applicable Law (or the rules and regulations of any stock exchange or trading market on which a Partys (or its parent entitys) securities are traded), provided that the Receiving Party uses reasonable efforts to give the Disclosing Party advance notice of such required disclosure in sufficient time to enable the Disclosing Party to seek confidential treatment for such information, and provided further that the Receiving Party provides reasonable cooperation to assist the Disclosing Party to protect such information and limits the disclosure to that information which is required to be disclosed.
19.3 Injunctive Relief. The Parties hereby acknowledge and agree that the rights of the Parties under this Article 19 are special, unique and of extraordinary character, and that if any Party refuses or otherwise fails to act, or to cause its Affiliates to act, in accordance with the provisions of this Article 19, such refusal or failure would result in irreparable injury to the other Party, the exact amount of which would be difficult to ascertain or estimate and the remedies at law for which would not be reasonable or adequate compensation. Accordingly, if any Party refuses or otherwise fails to act, or to cause its Affiliates to act, in accordance with the provisions of this Article 19, then, in addition to any other remedy which may be available to any damaged Party at law or in equity, such damaged Party will be entitled to seek specific performance and injunctive relief, without posting bond or other security, and without the necessity of proving actual or threatened damages, which remedy such damaged Party will be entitled to seek in any court of competent jurisdiction.
19.4 Publications.
(a) Subject to the requirements of Section 19.4(d), each Party shall have the right to issue publications in scientific journals and make scientific presentations related to any of its results from the Research Program with the order and inclusion of Adicet and Regeneron
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authors to be agreed upon in accordance with ICJME Standards or other mutually agreed upon applicable standards and in compliance with any applicable rules or policies of the publisher of such publication; provided, however, that for so long as the confidentiality exceptions in Section 19.2 do not apply with respect to a given Collaboration Target, any such publication shall not directly or indirectly disclose the identity of any Collaboration Target without the prior written consent of the other Party.
(b) Subject to the requirements of Section 19.4(d), Regeneron shall have the sole right to issue and control all publications in scientific journals and make scientific presentations related to Regeneron Royalty Products, Regeneron Non-ICP Products and Co-Funded Products; provided, however, that so long as the confidentiality exceptions in Section 19.2 do not apply with respect to a given Non-Collaboration Target and Phase I Trials have not been initiated with respect to such Regeneron Non-ICP Product, any such publication relating to a Regeneron Non-ICP Product shall not directly or indirectly disclose the identity of the applicable Target to which it binds without the prior written consent of Adicet.
(c) Subject to the requirements of Section 19.4(d), Adicet shall have the sole right to issue and control all publications in scientific journals and make scientific presentations related to Adicet Royalty Products and Mice Derived Adicet ICP Products.
(d) In case of any publication or disclosure pursuant to Section 19.4(a), 19.4(b) or 19.4(c) with respect to results from the Research Program (including Collaboration Inventions), Royalty Products or Co-Funded Products, the publishing Party shall provide the non-publishing Party with an advance copy of the proposed publication, and each Party shall then have [***] days prior to submission for any publication in which to recommend any changes it reasonably believes are necessary to preserve any Patent Rights or Know-How belonging in whole or in part to the non-publishing Party or which is the Confidential Information of the non-publishing Party. If the non-publishing Party informs the publishing Party that such publication, in the non-publishing Partys reasonable judgment, could be expected to have a material adverse effect on any patentable invention owned by or licensed, in whole or in part, to the non-publishing Party, or on any Know-How which is Confidential Information of the non-publishing Party, the publishing Party shall delay or prevent such publication as follows: (A) with respect to a patentable invention, such publication shall be delayed sufficiently long (not to exceed [***] days) to permit the timely preparation and filing of a Patent Application; and (B) with respect to Know-How which is Confidential Information of such non-publishing Party, such Know-How shall be deleted from the publication.
19.5 Disclosures Concerning this Agreement.
(a) Prior to the Effective Date, the Parties have mutually agreed upon the contents of a joint press release or separate press releases, in each case with respect to the execution of this Agreement which the Parties shall have the right to issue and disclose. Adicet and Regeneron agree not to (and to ensure that their respective Affiliates do not) issue any other press releases or public announcements concerning this Agreement or any other activities contemplated hereunder without the prior written consent of the other Party (which shall not be unreasonably withheld or delayed), except to the extent required by a Governmental Authority or Applicable Law (or the rules and regulations of any stock exchange or trading market on which a Partys (or
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its parent entitys) securities are traded); provided, that the Party intending to disclose such information shall use reasonable efforts to provide the other Party advance notice of such required disclosure, an opportunity to review and comment on such proposed disclosure (which comments shall be considered in good faith by the disclosing Party) and reasonable cooperation to assist the other Party to protect such information and shall limit the disclosure to that information which is required to be disclosed. Notwithstanding the foregoing, without prior submission to or approval of the other Party, either Party may issue press releases or public announcements which incorporate information concerning this Agreement or any activities contemplated hereunder which information was included in a press release or public disclosure which was previously disclosed under the terms of this Agreement or which contains only non-material factual information regarding the existence of this Agreement.
(b) Except as required by a Governmental Authority or Applicable Law (or the rules and regulations of any stock exchange or trading market on which a Partys (or its parent entitys) securities are traded), or in connection with the enforcement of this Agreement, neither Party (or their respective Affiliates) shall disclose to any Third Party, under any circumstances, any terms of this Agreement that have not been previously disclosed publicly pursuant to this Article 19 without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; except for disclosures to Third Parties that are bound by obligations of confidentiality and nonuse substantially equivalent in scope to those included herein with a term of at least [***].
(c) The Parties, through the Committees, shall establish mechanisms and procedures to ensure that there are coordinated timely corporate communications relating to the Products.
(d) Adicet acknowledges that Regeneron, as a publicly traded company, is legally obligated to make timely disclosures of all material events relating to its business. Regeneron acknowledges that in the future, Adicet may become a publicly traded company, and upon such occurrence, shall be legally obligated to make timely disclosures of all material events relating to its business. Therefore, the Parties acknowledge that either or both Parties may be obligated to file a copy of this Agreement with the United States Securities and Exchange Commission or its equivalent in the Territory. Each Party will be entitled to make such filing but shall cooperate with one another and use reasonable efforts to obtain confidential treatment of confidential, including trade secret, information in accordance with Applicable Law. The filing Party will, no later than [***] days prior to the anticipated filing, provide the non-filing Party with an advance copy of the Agreement marked to show provisions for which the filing Party intends to seek confidential treatment, allowing a reasonable time for the non-filing Party to review and comment as permitted by Applicable Law, and will reasonably consider the non-filing Partys timely comments thereon. In addition, the filing Party will provide the non-filing Party with an advance copy of the securities filings with which the Agreement is furnished or filed or otherwise discussed or disclosed in each case only to the extent describing this Agreement, allowing a reasonable time for the non-filing Party to review and comment as permitted by Applicable Law, and will reasonably consider the non-filing Partys timely comments thereon; provided, that the filing Party need not provide for review and comment such securities filings that repeat such previous disclosures already reviewed and commented upon by the other non-filing Party under the terms of this Section 19.5 or which contains only non-material factual information regarding this Agreement.
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ARTICLE 20
INDEMNITY
20.1 Indemnity.
(a) Adicet will defend, indemnify and hold harmless Regeneron, its Affiliates and their respective officers, directors, employees, sublicensees and agents (Regeneron Indemnitees) from and against all losses, liabilities, damages, penalties, fines and expenses, including reasonable attorneys fees and costs (collectively, Damages), arising from or occurring as a result of a Third Partys claim, action, suit, proceeding, judgment or settlement against a Regeneron Indemnitee to the extent it is due to or based upon:
(i) the negligence, recklessness, bad faith, willful misconduct, intentional wrongful acts or omissions of Adicet, its Affiliates or their respective directors, officers, employees or agents in connection with the Research Program, except to the extent that Damages arise out of the negligence, recklessness, bad faith, willful misconduct, or intentional wrongful acts, or omissions committed by Regeneron or its Affiliates;
(ii) the negligence, recklessness, bad faith, willful misconduct, intentional wrongful acts or omissions or violations of Applicable Law by or of Adicet, its Affiliates or their respective directors, officers, employees, agents or sublicensees, including in connection with the development, manufacture or commercialization of any Co-Funded Product (to the extent performed by or on behalf of Adicet), Adicet Royalty Product or Mice Derived Adicet -ICP Product, except to the extent that Damages arise out of, and are allocable to, the negligence, recklessness, bad faith, willful misconduct, intentional wrongful acts or omissions or violations of Law committed by Regeneron or any other Regeneron Indemnitee;
(iii) product liability, personal injury, property damage, or other damage or liability of any kind resulting from the research, development, manufacture, use, offer for sale, sale or importation of any Adicet Royalty Products or Mice Derived Adicet ICP Products by or on behalf of Adicet, its Affiliates or any of its or their licensees or contract manufacturers;
(iv) infringement or misappropriation of any Patent or other Intellectual Property or Trademark rights of any Third Party to the extent resulting from the manufacture, use, offer for sale, sale or importation of Adicet Royalty Products or Mice Derived Adicet ICP Products by or on behalf of Adicet, its Affiliates or any of its or their licensees or contract manufacturers; or
(v) breach by Adicet of this Agreement, or the inaccuracy of any representation or warranty made by Adicet in this Agreement.
(b) Regeneron will defend, indemnify and hold harmless Adicet, its Affiliates and their respective officers, directors, employees, sublicensees and agents (Adicet Indemnitees) from and against all Damages arising from or occurring as a result of a Third Partys claim, action, suit, proceeding, judgment or settlement against a Adicet Indemnitee to the extent it is due to or based upon:
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(i) the negligence, recklessness, bad faith, willful misconduct, intentional wrongful acts or omissions of Regeneron, its Affiliates or their respective directors, officers, employees or agents, in connection with the Research Program, except to the extent that Damages arise out of the negligence, recklessness, bad faith, willful misconduct, or intentional wrongful acts, or omissions committed by Adicet or its Affiliates;
(ii) the negligence, recklessness, bad faith, willful misconduct, intentional wrongful acts or omissions or violations of Applicable Law by or of Regeneron, its Affiliates or their respective directors, officers, employees, licensees or agents including in connection with the development, manufacture or commercialization of any Co-Funded Product (except to the extent performed by or on behalf of Adicet), Regeneron Royalty Product or Regeneron Non-ICP Product, except to the extent that Damages arise out of, and are allocable to, the negligence, recklessness, bad faith, willful misconduct, intentional wrongful acts, or omissions or violations of Law committed by Adicet or any other Adicet Indemnitee;
(iii) product liability, personal injury, property damage, or other damage or liability of any kind resulting from the research, development, manufacture, use, offer for sale, sale or importation of any Regeneron Royalty Products or Regeneron Non-ICP Products by or on behalf of Regeneron, its Affiliates or any of its or their licensees or contract manufacturers;
(iv) infringement or misappropriation of any Patent or other Intellectual Property or Trademark rights of any Third Party to the extent resulting from the manufacture, use, offer for sale, sale or importation of Regeneron Royalty Products or Regeneron Non-ICP Products by or on behalf of Regeneron, its Affiliates or any of its or their licensees or contract manufacturers (except to the extent resulting from the manufacture of the Regeneron Royalty Product by Adicet pursuant to the Supply Agreements which indemnification obligations shall be set forth in the Supply Agreements); or
(v) breach by Regeneron of this Agreement, or the inaccuracy of any representation or warranty made by Regeneron in this Agreement.
(c) In the event of any Third Party (i) product liability, personal injury, or property damage claim alleging that the development or commercialization of any Co-Funded Product causes Damages or (ii) claim for infringement or misappropriation of any Patent or other Intellectual Property or Trademark rights of any Third Party resulting from the research, development manufacture, use, offer for sale, sale or importation of Co-Funded Products, in each case, except to the extent such claims are due to or based upon the events set forth in Section 20.1(a)(i), 20.1(a)(ii), 20.1(a)(a)(v), 20.1(b)(i), 20.1(b)(ii), 20.1(b)(v), then each Party shall indemnify the other in accordance with the other Partys respective Co-Funding Percentage of all Damages therefrom, and during the Term such Damages shall be treated as Other Shared Expenses.
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20.2 Indemnity Procedure.
(a) The Party entitled to indemnification under this Article 20 (an Indemnified Party) shall notify the Party potentially responsible for such indemnification (the Indemnifying Party) within five (5) Business Days of becoming aware of any claim or claims asserted or threatened in writing against the Indemnified Party which could give rise to a right of indemnification under this Agreement; provided, however, that the failure to give such notice shall not relieve the Indemnifying Party of its indemnity obligation hereunder except to the extent that such failure materially prejudices its rights hereunder.
(b) If the Indemnifying Party has acknowledged in writing to the Indemnified Party the Indemnifying Partys responsibility for defending such claim, and except as otherwise set forth in Section 16.8(b) and 16.8(c) the Indemnifying Party shall have the right to defend, at its sole cost and expense, such claim by all appropriate proceedings, which proceedings shall be prosecuted diligently by the Indemnifying Party to a final conclusion or settled at the discretion of the Indemnifying Party; provided, however, that the Indemnifying Party may not enter into any compromise or settlement unless (i) such compromise or settlement includes as an unconditional term thereof, the giving by each claimant or plaintiff to the Indemnified Party of a release from all liability in respect of such claim; and (ii) the Indemnified Party consents to such compromise or settlement, which consent shall not be withheld or delayed unless such compromise or settlement involves (A) any admission of legal wrongdoing by the Indemnified Party, (B) any payment by the Indemnified Party that is not indemnified hereunder or (C) the imposition of any equitable relief against the Indemnified Party. If the Indemnifying Party does not elect to assume control of the defense of a claim or if a good faith and diligent defense is not being or ceases to be materially conducted by the Indemnifying Party, the Indemnified Party shall have the right, at the expense of the Indemnifying Party, upon at least ten (10) Business Days prior written notice to the Indemnifying Party of its intent to do so, to undertake the defense of such claim for the account of the Indemnifying Party (with counsel reasonably selected by the Indemnified Party and approved by the Indemnifying Party, such approval not unreasonably withheld or delayed), provided, that the Indemnified Party shall keep the Indemnifying Party apprised of all material developments with respect to such claim and promptly provide the Indemnifying Party with copies of all correspondence and documents exchanged by the Indemnified Party and the opposing party(ies) to such litigation. The Indemnified Party may not compromise or settle such litigation without the prior written consent of the Indemnifying Party, such consent not to be unreasonably withheld or delayed.
(c) The Indemnified Party may participate in, but not control, any defense or settlement of any claim controlled by the Indemnifying Party pursuant to this Section 20.2 and shall bear its own costs and expenses with respect to such participation; provided, however, that the Indemnifying Party shall bear such costs and expenses if counsel for the Indemnifying Party shall have reasonably determined that such counsel may not properly represent both the Indemnifying and the Indemnified Party.
20.3 Insurance. During the Term and for a minimum period of [***] years thereafter and for an otherwise longer period as may be required by Applicable Law, each of Regeneron and Adicet will (i) use Commercially Reasonable Efforts to procure and maintain appropriate commercial general liability and product liability insurance in an industry-appropriate amounts per
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occurrence and in the annual aggregate and consistent with normal business practices of companies in the life sciences industry developing drugs or (ii) with respect to Regeneron only, procure and maintain adequate insurance by means of self-insurance in such amounts and on such terms as are consistent with normal business practices of large pharmaceutical companies in the life sciences industry. Such insurance shall insure against liability arising from this Agreement on the part of Regeneron or Adicet, respectively, or any of their respective Affiliates, due to injury, disability or death of any person or persons, or property damage arising from activities performed in connection with this Agreement. Any insurance proceeds received by a Party in connection with any losses shall be retained by such Party and shall not reduce any obligation of the other Party.
ARTICLE 21
FORCE MAJEURE
Neither Party will be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any obligation (other than a payment obligation) under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including embargoes, acts of terrorism, acts of war (whether war be declared or not), insurrections, strikes, riots, civil commotions or acts of God (Force Majeure). Such excuse from liability and responsibility shall be effective only to the extent and duration of the event(s) causing the failure or delay in performance and provided that the affected Party has not caused such event(s) to occur. The affected Party will notify the other Party of such Force Majeure circumstances as soon as reasonably practical and will make every reasonable effort to mitigate the effects of such Force Majeure circumstances.
ARTICLE 22
TERM AND TERMINATION
22.1 Term. The Term of this Agreement shall begin on the Effective Date and will expire on the expiration of the final Product Term, unless this Agreement is earlier terminated in its entirety in accordance with this Article 22, in which event the Term shall end on the effective date of such termination.
(a) For purposes of this Article 22, the Product Term shall mean, with respect to all Regeneron Royalty Products that Bind a Collaboration Target, all Adicet Royalty Products that Bind a Collaboration Target, all Mice Derived Adicet ICP Products that Bind a Non-Collaboration Target and all Regeneron Non-ICP Products that Bind a Non-Collaboration Target, the period of time beginning when any of the foregoing becomes a Regeneron Royalty Product, Adicet Royalty Product, Mice Derived Adicet ICP Product and Regeneron Non-ICP Product until the expiration of the Royalty Term with respect to such Adicet Royalty Products, Mice Derived Adicet ICP Products, Regeneron Royalty Products or Regeneron Non-ICP Products as applicable.
(b) For purposes of this Article 22, the Product Term shall mean, with respect to all Co-Funded Products that Bind a Collaboration Target, the period of time beginning when Adicet exercises its Co-Funding Option for such Co-Funded Product in accordance with Section 8.1(a) until this Agreement is terminated or the Co-Funding Term is terminated in accordance Section 22.3 or Section 22.4 with respect to all Co-Funded Products that Bind such Collaboration Target.
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(c) Upon the expiration of the Product Term for each such Product, on a Product Term-by-Product term basis, all royalty bearing exclusive licenses under Section 5.1 with respect to such Product shall become non-exclusive, fully paid up licenses.
22.2 Termination for Material Breach.
(a) This Agreement shall be terminable in its entirety by either Party if the other Party commits a material breach of this Agreement. For purposes of this Section 22.2(a), a material breach of this Agreement means a breach by a Party of its obligations in a manner that fundamentally frustrates the essential purpose, characteristics or value of the transactions contemplated by this Agreement as a whole, and for clarity is not limited to a specific Collaboration Target or a Product that Binds such Collaboration Target. Notwithstanding the foregoing, if the material breach relates to one or more Collaboration Targets or one or more Products that Bind to such Collaboration Targets and not to other Collaboration Targets or Products that Bind to such other Collaboration Targets, then the non-breaching Party shall not have the right to terminate this Agreement in its entirety, but shall have the right to terminate this Agreement with respect to Collaboration Targets and Products to which the breach pertains and cannot terminate this Agreement under this Section 22.2 with respect to the non-affected Products and Collaboration Targets. For purposes of this Section 22.2(a), a material breach related to a Collaboration Target or a Product that Binds such Collaboration Target means a breach by a Party of its obligations in a manner that fundamentally frustrates the essential purpose, characteristics or value of the transactions contemplated by this Agreement, solely as relevant to the applicable Collaboration Target or a Product that Binds such Collaboration Target; and for clarity is not deemed to be a material breach of this Agreement (as such term is defined above) with respect to the Agreement as a whole. In case of termination of this Agreement pursuant to the third sentence of this Section 22.2, termination of this Agreement shall be (i) solely with respect to the Collaboration Target(s) and all Collaboration ICPs, Co-Funded Products, Regeneron Royalty Products and Adicet Royalty Products that Bind to such Collaboration Target (such Collaboration ICPs and Products, Terminated Collaboration ICPs and Terminated ICP Products, respectively); (ii) solely with respect to the Non-Collaboration Target(s) and all Mice Derived Adicet ICPs and Mice Derived Adicet ICP Products that Bind to such Non-Collaboration Target (such Mice Derived Adicet ICPs and Products, Terminated Mice Derived Adicet ICPs and Terminated Mice Derived Adicet ICP Products, respectively), or (iii) solely with respect to Regeneron Non-ICP Products that Bind to such Non-Collaboration Target (Terminated Regeneron Non-ICP Products), in each case with respect to which such material breach pertains.
(b) The terminating Party shall provide the breaching Party with notice of such intended termination, which notice shall set forth in reasonable detail the facts underlying or constituting the alleged material breach (and specifically referencing the provisions of this Agreement alleged to have been breached) and specifically stating the scope of the intended termination, and the termination which is the subject of such notice shall be effective [***] after the date such notice is given unless the breaching Party shall have cured such breach within such [***] period (or, if such material breach, by its nature, is a curable breach but such breach is not curable within such [***]period, such longer period (not to exceed [***]) so long as the breaching
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party is using Commercially Reasonable Efforts to cure such breach, in which event if such breach has not been cured, such termination shall be effective on the earlier of the expiration of the [***] period or such time as the breaching party ceases to use Commercially Reasonable Efforts to cure such breach). Notwithstanding the foregoing, in the case of material breach of a payment obligation hereunder, the [***] period referred to in the immediately preceding sentence shall instead be thirty (30) days (and the immediately preceding parenthetical clause in the immediately preceding sentence shall not apply).
(c) Notwithstanding the foregoing clauses of this Section 22.2, in the event of a good faith dispute as to whether performance has been made by either Party pursuant to this Agreement, including any good faith dispute as to payments due under this Agreement, the cure period in Section 22.2(b) will be tolled from the date the non-terminating Party notifies the terminating Party of such good faith dispute, provided that the non-terminating Party notifies the terminating Party that it disputes the terminating Partys allegation of material breach within [***] of its receipt the written notice delivered by the terminating Party pursuant to Section 22.2(c) above, and through the resolution of such dispute in accordance with the applicable provisions of this Agreement (provided that if such dispute relates to payment, the cure period will only apply with respect to payment of disputed amounts, and not with respect to undisputed amounts). It is understood and agreed that during the pendency of such dispute, all of the terms and conditions of this Agreement will remain in effect and the Parties will continue to perform all of their respective obligations, and retain their respective rights, hereunder.
22.3 Termination of Co-Funded Products by Regeneron for Convenience. At any time, upon [***] advanced written notice, on a Collaboration Target-by-Collaboration Target basis, Regeneron may terminate its rights and obligations to develop and commercialize all Co-Funded Products that Bind to such Collaboration Target.
22.4 Termination of Co-Funding Term by Adicet for Convenience. At any time, upon [***] advanced written notice, on a Collaboration Target-by-Collaboration Target basis, Adicet may terminate the Co-Funding Term with respect to all Co-Funded Products that Bind to such Collaboration Target.
22.5 Termination of Regeneron Royalty Products by Regeneron for Convenience. At any time, [***] advanced written notice, on a Collaboration Target-by-Collaboration Target basis, Regeneron may terminate its licenses, rights and obligations to develop and commercialize all Regeneron Royalty Products that Bind to such Collaboration Target.
22.6 Termination of Adicet Royalty Products by Adicet for Convenience. At any time, upon [***] advanced written notice, on a Collaboration Target-by-Collaboration Target basis, Adicet may terminate its licenses, rights and obligations to develop and commercialize all Adicet Royalty Products that Bind to such Collaboration Target.
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22.7 Effects of Termination(a) .
(a) In the event Regeneron is the terminating Party pursuant to Section 22.2, then:
(1) If such termination is with respect to a Co-Funded Product:
i. the Co-Funding Arrangement will terminate, the license from Adicet to Regeneron in Section 5.1(a)(iv) shall survive with respect to such Terminated Product and the Parties will negotiate royalty rates payable by Regeneron to Adicet which are intended to allocate between the Parties, as nearly as practicable, the economic value of Co-Funded Products that are Commercialized by Regeneron following termination in accordance with the Co-Funding Percentage, adjusted for the costs and risks incurred by Regeneron in the Development of such Co-Funded Products. The Parties shall negotiate such agreements in good faith promptly following the effective date of termination pursuant to this Section 22.7(a). If the Parties have not reached agreement on such new commercial agreement within [***] following the effective date of termination, then notwithstanding the final sentence of Section 24.1, either Party may refer such agreement to an arbitration panel pursuant to Section 23.1.
ii. In the event the Parties are Co-Promoting such Terminated Product in the United States, then Adicet shall lose the right to Co-Promote in such country (provided, that Adicet shall be permitted to continue to Co-Promote as necessary to carry out the wind-down described in the remainder of this clause) for Terminated Products, any co-promotion agreement or amendment as described in Section 11.3(c) already entered with respect to such Co-Funded Product shall be terminated and without penalty or cost to Regeneron, and the Parties shall conduct a prompt wind-down of Adicets existing Co-Promote activities for Terminated Products, at Regenerons direction and Adicets reasonable cost, and including for example, the return or destruction of promotional materials in the possession of Adicet, and the diminishing of Adicets FTE efforts and Detailing activities until the transition to Regeneron is complete. In the event the Terminated Product is a Co-Funded Product, Adicet will not retain the Co-Promote option set forth in Article 11;
(2) If such termination is with respect to a Regeneron Royalty Product, the license from Adicet to Regeneron in Section 5.1(a)(iv) shall survive with respect to such Terminated Product, and Regeneron shall continue to pay royalties on Net Sales of such Terminated Products to Adicet upon the same terms and conditions that would be applicable pursuant to Section 14.4 for Regeneron Royalty Products.
(3) If such termination is with respect to an Adicet Royalty Product:
i. The licenses from Regeneron to Adicet in Section 5.1(a)(ii) shall terminate with respect to such Terminated Product except in connection with Adicets performance of its activities in accordance with this Section 22.7(a);
ii. Adicet hereby grants to Regeneron an exclusive (even as to Adicet and its Affiliates), non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under the Adicet Product IP and an exclusive, non-transferable
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(except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under any Intellectual Property Controlled by Adicet and incorporated into and made a part of the Terminated Product or otherwise used in connection with the Terminated Product as of the effective date of termination, to research, develop, make, have made, use, sell, have sold, and import Terminated Collaboration ICPs and Terminated Products, and Regeneron shall pay royalties on Terminated Products to Adicet upon the same terms and conditions that would be applicable pursuant to Section 14.4 for Regeneron Royalty Products, except that the royalty rate shall [***], and
iii. Promptly upon Regenerons request, Adicet shall commence, and shall promptly thereafter complete, a transfer of all promotional activities in such country(ies), including handling of collection and receivables and recording and booking of sales in such country, to Regeneron, at Regenerons direction and Adicets reasonable cost; provided, that in the interim period Adicet shall continue to perform such promotional activities at levels consistent with Adicets effort prior to termination as directed by Regeneron, and shall provide Regeneron assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Regeneron or assisting in obtaining new permits and Regulatory Filings necessary for Regeneron to conduct such promotional activities, assisting in negotiating Third Party agreements for such country similar to those then in place for Adicets promotional activities, and permitting Adicet if permissible under Applicable Law to use Adicet-branded promotional materials during the interim period as the Parties transition the promotional activities;
iv. Promptly upon Regenerons request, Adicet shall either at Adicets expense (i) commence the wind down of all clinical studies with respect to such Terminated Product or (ii) as soon as reasonably practicable thereafter complete, a transfer of all clinical activities, to Regeneron, at Regenerons direction; provided, that in the interim period Adicet shall continue to perform such clinical activities at levels consistent with Adicets effort prior to termination as directed by Regeneron (but in any event for no longer than for a period of [***], and shall provide Regeneron assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Regeneron or assisting in obtaining new permits and Regulatory Filings necessary for Regeneron to conduct such clinical trials.
(4) If such termination is with respect to a Mice Derived Adicet ICP Product, the license from Regeneron to Adicet in Section 5.1(d)(i)(A) and the license from Regeneron to Adicet in Section 5.1(d)(i)(B) shall terminate with respect to such Terminated Product and Adicet shall cease developing, commercializing and manufacturing such Terminated Product.
(5) If such termination is with respect to a Regeneron Non-ICP Product, the licenses from Adicet to Regeneron in Section 5.1(d)(iii) shall terminate with respect to such Terminated Product and Regeneron shall cease developing, commercializing and manufacturing such Terminated Product.
(6) At Regenerons request, Adicet shall perform a Manufacturing technology transfer pursuant to Section 13.4 at Adicets cost (i) for Terminated Products that were Co-Funded Products or Regeneron Royalty Products, in each case that Adicet was Manufacturing for Regeneron as of the effective date of termination or (ii) for Terminated Products that were Adicet Royalty Products.
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(7) At Regenerons request and only for the period of time reasonably necessary to ensure patients have access to Terminated Product not to exceed [***] (or such longer period as reasonable necessary to continue supply of such Terminated Product for reasons outside the reasonable control of Regeneron), (i) to the extent Adicet as of the effective date of termination is Manufacturing Terminated Products that were Co-Funded Products or Regeneron Royalty Products or (ii) for Adicet Royalty Products, Adicet shall use Commercially Reasonable Efforts to continue to Manufacture Co-Funded Products or Regeneron Royalty Products for Regeneron and its Affiliates and licensees, in each case at a purchase price equal to Adicets fully burdened cost.
(b) In the event Adicet is the terminating Party pursuant to Section 22.2 , then:
(1) If such termination is with respect to a Co-Funded Product:
i. the Co-Funding Arrangement will terminate,
ii. the licenses from Adicet to Regeneron in Section 5.1(a)(iv) shall terminate with respect to such Terminated Product except in connection with Regenerons performance of its activities in accordance with this Section 22.7(b);
iii. Regeneron hereby grants to Adicet an exclusive (even as to Regeneron and its Affiliates), non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under the Regeneron Product IP and an exclusive, non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under any Intellectual Property Controlled by Regeneron and incorporated into and made a part of the Terminated Product or otherwise used in connection with the Terminated Product as of the effective date of termination, to research, develop, make, have made, use, sell, have sold, and import Terminated Collaboration ICPs and Terminated Products;
iv. the Parties will negotiate royalty rates payable by Adicet to Regeneron which are intended to allocate between the Parties, as nearly as practicable, the economic value of Co-Funded Products that are Commercialized by Adicet following termination in accordance with the Co-Funding Percentage, adjusted for the costs and risks incurred by Adicet in the Development of such Co-Funded Products. The Parties shall negotiate such agreements in good faith promptly following the effective date of termination pursuant to this Section 22.7(b). If the Parties have not reached agreement on such new commercial agreement within [***] following the effective date of termination, then notwithstanding the final sentence of Section 24.1, either Party may refer such agreement to an arbitration panel pursuant to Section 23.1;
v. Promptly upon Adicets request, Regeneron shall commence, and shall promptly thereafter complete, a transfer of all promotional activities in such country(ies), including handling of collection and receivables and recording and booking of sales in such country, to Adicet, at Adicets direction and Regenerons reasonable cost; provided, that in the interim period Regeneron shall continue to perform such promotional activities at levels consistent with Regenerons effort prior to termination as directed by Adicet, and shall provide
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Adicet assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Adicet or assisting in obtaining new permits and Regulatory Filings necessary for Adicet to conduct such promotional activities, assisting in negotiating Third Party agreements for such country similar to those then in place for Regenerons promotional activities, and permitting Adicet if permissible under Applicable Law to use Regeneron-branded promotional materials during the interim period as the Parties transition the promotional activities;
vi. In the event the Parties are Co-Promoting such Terminated Product in the United States, any co-promotion agreement or amendment as described in Section 11.3(c) already entered with respect to such Terminated Product shall be terminated and without penalty or cost to Adicet, and the Parties shall conduct a prompt wind-down of Regenerons existing Co-Promote activities for Terminated Products, at Adicets direction and Regenerons reasonable cost, and including for example, the return or destruction of promotional materials in the possession of Regeneron, and the diminishing of Regenerons FTE efforts and Detailing activities until the transition to Adicet is complete.
vii. Promptly upon Adicets request, Regeneron shall either at Regenerons expense (i) commence the wind down of all clinical studies with respect to such Terminated Product or (ii) as soon as reasonably practicable thereafter complete, a transfer of all clinical activities, to Adicet, at Adicets direction; provided, that in the interim period Regeneron shall continue to perform such clinical activities at levels consistent with Regenerons effort prior to termination as directed by Adicet (but in any event for no longer than for a period of [***], and shall provide Adicet assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Adicet or assisting in obtaining new permits and Regulatory Filings necessary for Adicet to conduct such clinical trials.
(2) If such termination is with respect to a Regeneron Royalty Product, then Section 22.7(b)(1) ii, iii, v, vi and vii shall apply and Adicet shall pay royalties on Terminated Products to Regeneron upon the same terms and conditions that would be applicable pursuant to Section 14.3 for Adicet Royalty Products, except that the royalty rate shall [***].
(3) If such termination is with respect to an Adicet Royalty Product, the licenses from Regeneron to Adicet in Section 5.1(a)(ii) shall survive with respect to such Terminated Product, and Adicet shall continue to pay royalties on Net Sales of such Terminated Products to Regeneron upon the same terms and conditions that would be applicable pursuant to Section 14.3 for Adicet Royalty Products.
(4) If such termination is with respect to a Mice Derived Adicet ICP Product, the licenses from Regeneron to Adicet in Section 5.1(d) shall terminate with respect to such Terminated Product and Adicet shall cease developing, commercializing and manufacturing such Terminated Product.
(5) If such termination is with respect to a Regeneron Non-ICP Product, the licenses from Adicet to Regeneron in Section 5.1(d)(iii) shall terminate with respect to such Terminated Product and Regeneron shall cease developing, commercializing and manufacturing such Terminated Product.
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(6) At Adicets request, Regeneron shall perform a Manufacturing technology transfer pursuant to Section 13.4 at Regenerons cost for Terminated Products that were Co-Funded Products or Regeneron Royalty Products, in each case that Regeneron was Manufacturing for Regeneron as of the effective date of termination, and in such case all references in Section 13.4 to Regeneron shall be deemed to refer to Adicet and all references to Adicet shall be deemed to refer to Regeneron.
(7) At Adicets request and only for the period of time reasonably necessary to ensure patients have access to Terminated Product not to exceed [***] (or such longer period as reasonable necessary to continue supply of such Terminated Product for reasons outside the reasonable control of Adicet), to the extent Regeneron as of the effective date of termination is Manufacturing Terminated Products that were Co-Funded Products or Regeneron Royalty Products, Regeneron shall use Commercially Reasonable Efforts to continue to Manufacture such Terminated Products for Adicet and its Affiliates and licensees, in each case at a purchase price equal to Regenerons fully burdened cost.
(c) In the event Regeneron terminates this Agreement with respect to a Co-Funded Product pursuant to Section 22.3, then:
(1) Regeneron shall continue to be responsible for any Development Costs and Shared Commercial Expenses incurred in connection with the Co-Funded Product in accordance with the Development Budget set forth in the last Development Plan approved by the JSC prior to Regenerons notice of termination for a period of [***] after notice of termination was delivered by Adicet pursuant to Section 22.3, and the Parties shall share Profits, Development Costs, Shared Commercial Expenses and any other shared costs in accordance with their Co-Funding Percentage as described in Schedule 2 during such period (the Regeneron Funding Wind Down Period);
(2) the licenses from Adicet to Regeneron in Section 5.1(a)(iv) shall terminate with respect to such Terminated Product except in connection with Regenerons performance of its activities in accordance with this Section (c);
(3) Regeneron hereby grants to Adicet an exclusive (even as to Regeneron and its Affiliates), non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under the Regeneron Product IP and an exclusive, non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under any Intellectual Property Controlled by Regeneron and incorporated into and made a part of the Terminated Product or otherwise used in connection with the Terminated Product as of the effective date of termination, to research, develop, make, have made, use, sell, have sold, and import Terminated Collaboration ICPs and Terminated Products, and subject to the Regeneron Funding Wind Down Period, Adicet shall pay royalties on Terminated Products to Regeneron upon the same terms and conditions that would be applicable pursuant to Section 14.3 for Adicet Royalty Products; except that the applicable royalty rates shall be [***].
(4) Promptly upon Adicets request, Regeneron shall commence, and shall promptly thereafter complete, a transfer of all promotional activities in
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such country(ies), including handling of collection and receivables and recording and booking of sales in such country, to Adicet, at Adicets direction and Regenerons reasonable cost; provided, that in the interim period Regeneron shall continue to perform such promotional activities at levels consistent with Regenerons effort prior to termination as directed by Adicet, and shall provide Adicet assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Adicet or assisting in obtaining new permits and Regulatory Filings necessary for Adicet to conduct such promotional activities, assisting in negotiating Third Party agreements for such country similar to those then in place for Regenerons promotional activities, and permitting Adicet if permissible under Applicable Law to use Regeneron-branded promotional materials during the interim period as the Parties transition the promotional activities;
(5) Promptly upon Adicets request, Regeneron shall either at Regenerons expense (i) commence the wind down of all clinical studies with respect to such Terminated Product or (ii) as soon as reasonably practicable thereafter complete, a transfer of all clinical activities, to Adicet, at Adicets direction; provided, that in the interim period Regeneron shall continue to perform such clinical activities at levels consistent with Regenerons effort prior to termination as directed by Adicet (but in any event for no longer than for a period of [***], and shall provide Adicet assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Adicet or assisting in obtaining new permits and Regulatory Filings necessary for Adicet to conduct such clinical trials.
(6) In the event the Parties are Co-Promoting such Co-Funded Product, then any co-promotion agreement or amendment as described in Section 11.3(c) already entered with respect to such Co-Funded Product shall be terminated without penalty or cost to Adicet, and the Parties shall conduct a prompt wind-down of Regenerons existing Co-Promote activities for Terminated Products, at Adicets direction and Regenerons reasonable cost, and including for example, the return or destruction of promotional materials in the possession of Regeneron, and the diminishing of Regenerons FTE efforts and Detailing activities until the transition to Adicet is complete.
(7) At Adicets request, to the extent Regeneron is Manufacturing the Co-Funded Product, Regeneron shall perform a Manufacturing technology transfer pursuant to Section 13.4 at Adicets cost for Terminated Products that were Co-Funded Products if Regeneron was Manufacturing such Co-Funded Product of the effective date of termination, and in such case all references in Section 13.4 to Regeneron shall be deemed to refer to Adicet and all references to Adicet shall be deemed to refer to Regeneron.
(8) At Adicets request and only for the period of time reasonably necessary to ensure patients have access to Terminated Product not to exceed [***] (or such longer period as reasonable necessary to continue supply of such Terminated Product for reasons outside the reasonable control of Adicet), to the extent Regeneron as of the effective date of termination is Manufacturing Terminated Products that were Co-Funded Products, Regeneron shall use Commercially Reasonable Efforts to continue to Manufacture such Terminated Products for Adicet and its Affiliates and licensees, in each case at a purchase price equal to Regenerons fully burdened cost.
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(d) In the event Adicet terminates the Co-Funding Term with respect to a Co-Funded Product pursuant to Section 22.4, then:
(1) Adicet shall continue to be responsible for any Development Costs and Shared Commercial Expenses incurred in connection with the Co-Funded Product in accordance with the Development Budget set forth in the last Development Plan approved by the JSC prior to Adicets notice of termination for a period of [***] after notice of termination was delivered by Adicet pursuant to Section 22.4, and the Parties shall share Profits, Development Costs, Shared Commercial Expenses and any other shared costs in accordance with their Co-Funding Percentage as described in Schedule 2 during such period (the Adicet Funding Wind Down Period).
(2) the license from Adicet to Regeneron in Section 5.1(a)(iv) shall survive with respect to such Terminated Product, and subject to the Adicet Funding Wind Down Period Regeneron shall pay royalties on Terminated Products to Regeneron upon the same terms and conditions that would be applicable pursuant to Section 14.4 for Regeneron Royalty Products as adjusted pursuant to the following two sentences. [***].
(3) At Regenerons request, Adicet shall perform a Manufacturing technology transfer pursuant to Section 13.4 for Terminated Products that Adicet was Manufacturing for Regeneron pursuant to Article 13 as of the effective date of termination. Such Manufacturing technology transfer shall be at Regenerons cost.
(4) At Regenerons request and only for the period of time reasonably necessary to ensure patients have access to Terminated Product not to exceed [***] (or such longer period as reasonable necessary to continue supply of such Terminated Product for reasons outside the reasonable control of Regeneron), to the extent Adicet is Manufacturing Terminated Products as of the effective date of termination, Adicet shall Manufacture Co-Funded Products for Regeneron and its Affiliates and licensees, in each case at a purchase price equal to Adicets fully burdened cost.
(5) In the event the Parties are Co-Promoting a Terminated Product in the United States, then Adicet shall lose the right to Co-Promote in such country (provided, that Adicet shall be permitted to continue to Co-Promote as necessary to carry out the wind-down described in the remainder of this clause), any co-promotion agreement or amendment as described in Section 11.3(c) already entered with respect to such Co-Funded Product shall be terminated and without penalty or cost to Regeneron, and the Parties shall conduct a prompt wind-down of Adicets existing Co-Promote activities for Terminated Products, at Regenerons direction and Adicets reasonable cost, and including for example, the return or destruction of promotional materials in the possession of Adicet, and the diminishing of Adicets FTE efforts and Detailing activities until the transition to Regeneron is complete.
(e) In the event Regeneron terminates this Agreement with respect to a Regeneron Royalty Product pursuant to Section 22.5 then:
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(1) the licenses from Adicet to Regeneron in Section 5.1(a)(iv) shall terminate with respect to such Terminated Product, except in connection with Regenerons performance of its activities in accordance with this Section 22.7(e),
(2) Regeneron hereby grants to Adicet an exclusive (even as to Regeneron and its Affiliates), non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under the Regeneron Product IP and an exclusive, non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under any Intellectual Property Controlled by Regeneron and incorporated into and made a part of the Terminated Product or otherwise used in connection with the Terminated Product as of the effective date of termination, to research, develop, make, have made, use, sell, have sold, and import Terminated Collaboration ICPs and Terminated Products and Adicet shall pay royalties on such Terminated Products to Regeneron [***];
(3) Promptly upon Adicets request, Regeneron shall commence, and shall promptly thereafter complete, a transfer of all promotional activities in such country(ies), including handling of collection and receivables and recording and booking of sales in such country, to Adicet, at Adicets direction and Regenerons reasonable cost; provided, that in the interim period Regeneron shall continue to perform such promotional activities at levels consistent with Regenerons effort prior to termination as directed by Adicet, and shall provide Adicet assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Adicet or assisting in obtaining new permits and Regulatory Filings necessary for Adicet to conduct such promotional activities, assisting in negotiating Third Party agreements for such country similar to those then in place for Regenerons promotional activities, and permitting Adicet if permissible under Applicable Law to use Regeneron-branded promotional materials during the interim period as the Parties transition the promotional activities;
(4) Promptly upon Adicets request, Regeneron shall either at Regenerons expense (i) commence the wind down of all clinical studies with respect to such Terminated Product or (ii) as soon as reasonably practicable thereafter complete, a transfer of all clinical activities, to Adicet, at Adicets direction; provided, that in the interim period Regeneron shall continue to perform such clinical activities at levels consistent with Regenerons effort prior to termination as directed by Adicet (but in any event for no longer than for a period of [***]), and shall provide Adicet assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Adicet or assisting in obtaining new permits and Regulatory Filings necessary for Adicet to conduct such clinical trials.
(5) At Adicets request, to the extent Regeneron is Manufacturing the Regeneron Royalty Product as of the effective date of termination, Regeneron shall perform a Manufacturing technology transfer pursuant to Section 13.4 at Adicets cost for Terminated Products that were Regeneron Royalty Products if Regeneron was Manufacturing such Regeneron Royalty Products of the effective date of termination, and in such case all references in Section 13.4 to Regeneron shall be deemed to refer to Adicet and all references to Adicet shall be deemed to refer to Regeneron.
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(6) At Adicets request and only for the period of time reasonably necessary to ensure patients have access to Terminated Product not to exceed [***] (or such longer period as reasonable necessary to continue supply of such Terminated Product for reasons outside the reasonable control of Adicet), to the extent Regeneron as of the effective date of termination is Manufacturing Terminated Products that were Regeneron Royalty Products, Regeneron shall use Commercially Reasonable Efforts to continue to Manufacture such Terminated Products for Adicet and its Affiliates and licensees, in each case at a purchase price equal to Regenerons fully burdened cost.
(f) In the event Adicet terminates this Agreement with respect to an Adicet Royalty Product pursuant to Section 22.6 then:
(1) the licenses from Regeneron to Adicet in Section 5.1(a)(ii) shall terminate with respect to such Terminated Product except in connection with Adicets performance of its activities in accordance with this Section 22.7(f);
(2) Adicet hereby grants to Regeneron an exclusive (even as to Adicet and its Affiliates) , non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under the Adicet Product IP and an exclusive, non-transferable (except as permitted by Section 24.9), sublicensable in multiple tiers, worldwide license under any Intellectual Property Controlled by Adicet and incorporated into and made a part of the Terminated Product or otherwise used in connection with the Terminated Product as of the effective date of termination, to research, develop, make, have made, use, sell, have sold, and import Terminated Collaboration ICPs and Terminated Products and Regeneron shall pay royalties on such Terminated Products to Adicet [***].
(3) Promptly upon Regenerons request, Adicet shall commence, and shall promptly thereafter complete, a transfer of all promotional activities in such country(ies), including handling of collection and receivables and recording and booking of sales in such country, to Regeneron, at Regenerons direction and at Adicets reasonable cost; provided, that in the interim period Adicet shall continue to perform such promotional activities at levels consistent with Adicets effort prior to termination as directed by Regeneron, and shall provide Regeneron assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Regeneron or assisting in obtaining new permits and Regulatory Filings necessary for Regeneron to conduct such promotional activities, assisting in negotiating Third Party agreements for such country similar to those then in place for Adicets promotional activities, and permitting Regeneron if permissible under Applicable Law to use Adicet-branded promotional materials during the interim period as the Parties transition the promotional activities;
(4) Promptly upon Regeneron s request, Adicet shall either at Adicets expense (i) commence the wind down of all clinical studies with respect to such Terminated Product or (ii) as soon as reasonably practicable thereafter complete, a transfer of all clinical activities, to Regeneron, at Regenerons direction; provided, that in the interim period Adicet shall continue to perform such clinical activities at levels consistent with Adicets effort prior to termination as directed by Regeneron (but in any event for no longer than for a period of [***], and shall provide Regeneron assistance reasonably necessary to ensure an effective transition, including for example, transferring permits and Regulatory Filings to Regeneron or assisting in obtaining new permits and Regulatory Filings necessary for Regeneron to conduct such clinical trial;
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(5) At Regenerons request, Adicet shall perform a Manufacturing technology transfer pursuant to Section 13.4 at Regenerons cost for Terminated Products that Adicet was Manufacturing as of the effective date of termination.
(6) At Regenerons request and only for the period of time reasonably necessary to ensure patients have access to Terminated Product not to exceed [***] (or such longer period as reasonable necessary to continue supply of such Terminated Product for reasons outside the reasonable control of Regeneron), to the extent Adicet as of the effective date of termination is Manufacturing Terminated Products that were Adicet Royalty Products, Adicet shall use Commercially Reasonable Efforts to continue to Manufacture such Terminated Products for Regeneron and its Affiliates and licensees, in each case at a purchase price equal to Adicets fully burdened cost.
(g) Diligence and Exclusivity Obligations, Third Party Licenses and Requests. Regenerons diligence obligations in Section 7.2 and Section 8.2 shall not apply to Terminated Products. Adicets diligence obligations in Section 7.2 shall not apply to Terminated Products. Any licenses granted under this Section 22.7, shall not include the grant of a license for which payments are owed by Party or its Affiliates to Third Parties on account of the use of such license, unless the Party receiving such license expressly agrees to be responsible for all payments due to such Third Party on account of the use of such license in connection with the research, development, commercialization or manufacturing of Terminated Products. All requests for assistance or services made by a Party made pursuant to this Section 22.7 shall be made within [***] of the effective date of the termination with respect to such Terminated Product. Neither Party shall be subject to the exclusivity obligations set forth in Article 4 with respect to Terminated Products.
(h) Confidentiality. If there is Confidential Information of both Parties relating specifically to a Product directed to a Terminated Target, such Confidential Information shall become Confidential Information of the Party with continuing rights to develop Collaboration ICPs and Products against such Terminated Target as set forth in this Section 22.7.
22.8 Survival of Obligations. Except as otherwise provided below, upon expiration or termination of this Agreement, the rights and obligations of the Parties hereunder shall terminate, and this Agreement shall cease to be of further force or effect:
(a) Notwithstanding anything to the contrary in this Agreement, upon a termination of this Agreement by a Party with respect to a Terminated Product, upon the written request of the other Party, the terminating Party shall grant to any sublicensee of such other Party with respect to such Terminated Product on terms and conditions no less favorable than those granted to the other Party hereunder, provided that, if such termination were upon the breach hereof by such other Party, such breach shall not have resulted from any breach by such sublicensee hereof;
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(b) neither Adicet nor Regeneron shall be relieved of any obligations (including payment obligations) of such Party arising prior to such expiration or termination, including the payment of any non-cancelable costs and expenses incurred as part of the Research Program (even if such costs and expenses arise following termination or expiration, as the case may be);
(c) the obligations of the Parties set forth in Article 1, Article 17, Article 19 (excluding Section 19.4), Article 20, Article 23 and Article 24 and Section 5.1(b), Sections 14.8-14.11 and Section 22.7 as well as other provisions which by their nature are intended to survive any such expiration or termination, shall survive and continue to be enforceable; and
(d) such expiration or termination and this Article 22 shall be without prejudice to any rights or remedies a Party may have for breach of this Agreement.
22.9 Return of Confidential Information. Confidential Information disclosed by the Disclosing Party, including permitted copies, shall remain the property of the Disclosing Party. Subject to the principles set forth in Section 22.7, upon the earliest to occur of the termination of this Agreement, the expiration of the relevant Product Term or the Term, or the written request of the Disclosing Party, the Receiving Party shall promptly return to the Disclosing Party or, at the Disclosing Partys request, destroy, all documents or other tangible materials representing the Disclosing Partys Confidential Information (or any designated portion thereof); provided, that one (1) copy may be maintained in the confidential files of the Receiving Party for the purpose of complying with the terms of this Agreement; further provided that the Receiving Party may retain the Disclosing Partys Confidential Information that is reasonably necessary for the practice of any license from the Disclosing Party to the Receiving Party that survives expiration or termination, as applicable. The Receiving Party also shall certify in writing that it has satisfied its obligations under this Section 22.9 within [***] days of a written request by the Disclosing Party.
22.10 Change of Control of Adicet. In the event of a Change of Control of Adicet, Adicet shall deliver to Regeneron written notice of the closing of such transaction (the Change of Control Notice) within [***] following such closing. Regeneron shall have the right, exercisable at any time within [***] following receipt of the Change of Control Notice, to take any or all of the actions set forth below, upon delivery of written notice to Adicet (the Regeneron Election Notice):
(a) Terminate the Research Program Term. Regeneron may terminate the Research Program Term upon written notice pursuant to this Section 22.10(a), and in such case, the Research Program Term for any Collaboration Target for which the Parties have not previously finalized and approved the applicable Research Plan shall automatically terminate, whereupon all Collaboration Targets which are not the subject of Research Programs that are continued automatically shall become Terminated Targets. If Regeneron terminates the Research Program Term pursuant to this Section 22.10(a), with respect to a Research Program Term for any Collaboration Target for which the Parties have already finalized and approved the applicable Research Plan, the Research Program Term shall terminate for such Collaboration Target, but Regeneron shall use Commercially Reasonable Efforts to (i) deliver to Adicet a Regeneron CTM that Binds to such Collaboration Target in accordance with Section 2.1(d)(i)and (ii) perform all other material activities set forth in the Research Plan for the applicable Collaboration Target and all Collaboration ICPs that Bind such Collaboration Target shall be Declined Collaboration ICPs.
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(b) Revise the arrangement between the Parties with respect to Co-Funded Products as follows:
(i) Adicet will not retain the Co-Funding Option with respect to an Optioned Collaboration ICP.
(ii) Adicet will not retain the Co-Promote Option set forth in Section 11.3;
(iii) If the Parties are Co-Promoting a Co-Funded Product in the United States, then upon written notice from Regeneron, Adicet shall lose the right to Co-Promote (provided, that Adicet shall be permitted to continue to Co-Promote as necessary to carry out the wind-down described in the remainder of this clause), any co-promotion agreement or amendment as described in Section 11.3(c) already entered into shall be terminated upon Regeneron request and without penalty or cost to Regeneron, and the Parties shall conduct a prompt wind-down of Adicets existing Co-Promote activities for Terminated Products at Regenerons direction, and including for example, the return or destruction of promotional materials in the possession of Adicet, and the diminishing of Adicets FTE efforts and Detailing activities until the transition to Regeneron is complete. Regeneron shall, at Regenerons written election, either (A) promptly reimburse Adicet for the reasonable costs of such wind-down, or (B) allow Adicet to continue to Co-Promote such Co-Funded Product for an additional six (6) months after the date Regeneron delivers written notice to Adicet pursuant to this Section 22.10(b)(ii) (in which case Regeneron shall not be responsible for the costs set forth in clause (A) of this Section).
(iv) Adicet shall in its sole discretion determine to effect one of the following two (2) options by delivering express written notice to Regeneron within [***] after the occurrence of the Change of Control of Adicet:
(1) Terminate the Profit Split, in which case the Parties will negotiate royalty rates payable by Regeneron to Adicet which are intended to allocate between the Parties, as nearly as practicable, the economic value of Co-Funded Products that are Commercialized by Regeneron following the Change of Control in accordance with the Co-Funding Percentage, adjusted for the costs and risks incurred by Regeneron in the Development of such Co-Funded Products. The Parties shall negotiate such agreements in good faith promptly following Regenerons delivery of the Regeneron Election Notice and for clarity, upon such execution of such agreements the Profit Split shall terminate. If the Parties have not reached agreement on such new commercial agreement within [***] following delivery of the Regeneron Election Notice, then notwithstanding the final sentence of Section 24.1, either Party may refer such agreement to an arbitration panel pursuant to Section 23.3; or
(2) Maintain the Profit Split, but revise the arrangement between the Parties as follows: (A) the JSC shall dissolve and Regeneron shall no longer be obligated to consult and discuss with Adicet the matters previously under the auspices of the JSC except as otherwise expressly set forth in this Section 22.10(b); (B) Section 10.1 shall be amended such that the words under the oversight of the JSC shall be deleted; (C) Section 10.2 shall be amended such that Regeneron shall present an approved Development Plan to Adicet, provided that Regeneron shall not be obligated to consider in good faith any comments by Adicet regarding
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the Development Plan of a Co-Funded Product; (D) Section 10.3 shall be amended such that any references to the JSC shall mean the Parties; (E) Section 11.1 shall be amended such that the words under the oversight of the JSC shall be deleted; and (F) Section 11.2 shall be amended such that Regeneron shall present an approved Commercial Plan to Adicet, provided that Regeneron shall not be obligated to consider in good faith comments by Adicet regarding the Commercial Plan of a Co-Funded Product.
ARTICLE 23
DISPUTE RESOLUTION
23.1 Generally. The Parties shall cause their respective representatives on the JRC (if such matters are in connection with the Research Program) and the JSC (if such matters are within the authority of the JSC or any other Committee) to use their Commercially Reasonable Efforts to resolve all matters presented to them as expeditiously as possible.
23.2 Executive Officers Resolution of Disputes. In the event that the JRC or JSC, as applicable, is after a period of thirty (30) days from the date a matter is submitted to it for decision, unable to make a decision due to a lack of required unanimity, or the Parties are unable to agree on a Research Plan, Development Plan, or any other matter that must be resolved by the JRC or JSC, either Party may require that the matter be submitted to the Executive Officers for a joint decision. In such event, the co-chairpersons of the JRC or JSC, as applicable, by written notice to each Party delivered within [***] after receipt of the notice from a Party pursuant to the immediately preceding sentence, shall formally request that the dispute be resolved by the Executive Officers, specifying the nature of the dispute with sufficient specificity to permit adequate consideration by such Executive Officers. The Executive Officers shall diligently and in good faith, attempt to resolve the referred dispute within [***] of receiving such written notification or such longer period of time as the Executive Officers may agree in writing. All such referred disputes shall require a joint decision of both Parties Executive Officers, and if they cannot resolve such dispute pursuant within [***] or the other agreed period, then (i) to the extent the referred dispute relates to the Research Program, then the Party primarily responsible or that would be primarily responsible for conducting such activities shall finally decide the dispute, (ii) to the extent the referred dispute relates to the Development or Commercialization of Co-Funded Products, including decision making for operational matters regarding the implementation of the Development Plan, Regeneron shall finally decide the dispute, and (iii) all other disputes will be resolved in accordance with Section 24.1. Notwithstanding the previous sentence, neither Party shall have the right to exercise its final decision making authority over disputes regarding or affecting financial calculations hereunder or regarding Legal Disputes.
23.3 Failure on Parties to Agree on a Royalty Rate for Co-Funded Product After Termination. If despite using good faith efforts, pursuant to Section 22.7(a)(1)i or pursuant to Section 22.7(b)(1)iv, the Parties have not reached agreement on such new commercial agreement within [***] following the effective date of termination, then notwithstanding the final sentence of Section 24.1, either Party may refer such agreement to an arbitration panel pursuant to this Section 23.3. The arbitration shall be settled by arbitration administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules (Rules) and the procedures set forth in this Section 23.3. In the event of any inconsistency between the Rules of AAA and the procedures set forth below, the procedures set forth below shall control.
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(a) The arbitration shall be conducted in New York, New York by a panel of three neutral arbitrators who are independent and disinterested with respect to the Parties, this Agreement, and the outcome of the arbitration. Each Party shall appoint one neutral arbitrator, and these two arbitrators so selected by the Parties shall then select the third arbitrator. All arbitrators must have at least ten (10) years experience in biotechnology licensing and in mediating or arbitrating cases regarding the same or substantially similar subject matter as the dispute between the Parties. If one Party has given written notice to the other Party as to the identity of the arbitrator appointed by the Party, and the Party thereafter makes a written demand on the other Party to appoint its designated arbitrator within the next [***], and the other Party fails to appoint its designated arbitrator within [***] after receiving said written demand, then the arbitrator who has already been designated shall appoint the other two arbitrators.
(b) Within [***] after appointment of the arbitrators, each Party shall deliver to the arbitrators and the other Party a written report summarizing its position and explaining why its proposal is more appropriate than the other Partys proposal. The arbitrator will then determine how much, if any, discovery is appropriate, taking into consideration the need for such discovery and likely effect of such discovery on the prompt resolution of the dispute. Within [***] after appointment of the arbitrators, the arbitrators shall give each Party the opportunity to explain in person to the arbitrators why its proposal is more appropriate than the other Partys proposal. Within [***] after appointment of the arbitrators, the arbitrator shall determine the appropriate royalty rate to reflect a fair allocation of economic value on a risk-adjusted basis.
(c) The determination of the arbitrators shall be binding on the parties as if mutually agreed by the Parties. The arbitrators may not award damages or other monetary amounts to either Party in any proceeding conducted pursuant to this Section; provided, however, the cost of the arbitration shall be borne by the Party whose proposal was not accepted by the arbitrator.
(d) Except as set forth below, and as necessary to obtain or enforce a judgment upon any arbitration award, the Parties shall keep confidential the fact of the arbitration, the dispute being arbitrated, and the decision of the arbitrators. Notwithstanding the foregoing, the Parties may disclose information about the arbitration to persons who have a need to know, such as directors, trustees, management employees, witnesses, experts, investors, attorneys, lenders, insurers, and others who may be directly affected. Additionally, a Party may make such disclosures as are required by applicable securities laws or rules or, if such Party is publicly traded, regulations of any stock exchange upon which securities are traded or listed, but will use commercially reasonable efforts to seek confidential treatment for such disclosure.
23.4 Obligations of the Parties and their Affiliates. The Parties shall use Commercially Reasonable Efforts to cause their respective designees on the JRC and JSC and their respective Executive Officers to take the actions and make the decisions provided herein to be taken and made by such respective designees and Executive Officers in the manner and within the applicable time periods provided herein.
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ARTICLE 24
MISCELLANEOUS
24.1 Governing Law; Submission to Jurisdiction. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to the conflict of laws principles thereof that would require the application of the law of any other jurisdiction. The Parties irrevocably and unconditionally submit to the exclusive jurisdiction of the United States District Court for the Southern District of New York solely and specifically for the purposes of any action or proceeding arising out of or in connection with this Agreement.
24.2 Waiver. Waiver by a Party of a breach hereunder by the other Party shall not be construed as a waiver of any subsequent breach of the same or any other provision. No delay or omission by a Party in exercising or availing itself of any right, power or privilege hereunder shall preclude the later exercise of any such right, power or privilege by such Party. No waiver shall be effective unless made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the Party granting the waiver.
24.3 Notices. All notices, instructions and other communications required or permitted hereunder or in connection herewith shall be in writing, shall be sent to the address of the relevant Party set forth on Schedule 6 attached hereto and shall be (a) delivered personally, (b) sent via a reputable nationwide overnight courier service, or (c) sent by facsimile transmission, with a confirmation copy to be sent by registered or certified mail, return receipt requested, postage prepaid, except in the event this Agreement specifies the notice may be delivered by email. Any such notice, instruction or communication shall be deemed to have been delivered upon receipt if delivered by hand, one (2) Business Days after it is sent via a reputable nationwide overnight courier service or when transmitted with electronic confirmation of receipt, if transmitted by facsimile (or email, if email is permitted) (if such transmission is made during regular business hours of the recipient on a Business Day; or otherwise, on the next Business Day following such transmission). Either Party may change its address by giving notice to the other Party in the manner provided above.
24.4 Entire Agreement. This Agreement contains the complete understanding of the Parties with respect to the subject matter hereof and thereof and supersedes all prior understandings and writings relating to the subject matter hereof and thereof. For clarity, this Agreement supersedes the CDA.
24.5 Amendments. No provision in this Agreement shall be supplemented, deleted or amended except in a writing executed by an authorized representative of each of Adicet and Regeneron.
24.6 Interpretation. The captions to the several Articles and Sections of this Agreement are included only for convenience of reference and shall not in any way affect the construction of, or be taken into consideration in interpreting, this Agreement. In this Agreement: (a) the word including shall be deemed to be followed by the phrase without limitation or like expression; (b) references to the singular shall include the plural and vice versa; (c) references to masculine, feminine and neuter pronouns and expressions shall be interchangeable; (d) the words herein or hereunder relate to this Agreement; (e) the words shall and will have the same meaning; (f)
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references to a particular statute or regulation include all rules and regulations thereunder and any predecessor or successor statute, rules or regulation, in each case as amended or otherwise modified from time to time; (g) words in the singular or plural form include the plural and singular form, respectively; (h) references to a particular person include such persons successors and assigns to the extent not prohibited by this Agreement; (i) unless otherwise specified, $ is in reference to United States dollars; and (j) the word or has the inclusive meaning represented by the phrase and/or. Each accounting term used herein that is not specifically defined herein shall have the meaning given to it under GAAP, but only to the extent consistent with its usage and the other definitions in this Agreement.
24.7 Construction. The Parties acknowledge and agree that: (i) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (ii) the rule of construction to the effect that any ambiguities are resolved against the drafting Party will not be employed in the interpretation of this Agreement; and (iii) the terms and provisions of this Agreement will be construed fairly as to each Party and not in a favor of or against either Party, regardless of which Party was generally responsible for the preparation of this Agreement. The headings of clauses contained in this Agreement preceding the text of the sections, subsections and paragraphs hereof are inserted solely for convenience and ease of reference only and shall not constitute any part of this Agreement, or have any effect on its interpretation or construction. This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral or other communications between the parties regarding this Agreement shall be in the English language
24.8 Severability. If, under Applicable Laws, any provision hereof is held or otherwise determined to be invalid or unenforceable in any jurisdiction (Modified Clause), then, it is mutually agreed that this Agreement shall endure and that the Modified Clause shall be enforced in such jurisdiction to the maximum extent permitted under Applicable Laws in such jurisdiction; provided that the Parties shall consult and use all reasonable efforts to agree upon, and hereby consent to, any valid and enforceable modification of this Agreement as may be necessary to avoid any unjust enrichment of either Party and to match the intent of this Agreement as closely as possible, including the economic benefits and rights contemplated herein.
24.9 Assignment. Except as otherwise expressly provided herein, neither this Agreement nor any of the rights or obligations hereunder may be assigned by either Adicet or Regeneron without (a) the prior written consent of Regeneron in the case of any assignment by Adicet or (b) the prior written consent of Adicet in the case of an assignment by Regeneron, except in each case (i) to an Affiliate of the assigning Party that has and will continue to have the resources and financial wherewithal to fully meet its obligations under this Agreement, or (ii) subject to Section 22.10, to any Third Party who acquires all or substantially all of the business of the assigning Party by merger, sale of assets or otherwise, so long as such Affiliate or Third Party agrees in writing to be bound by the terms of this Agreement. Any attempted assignment in violation hereof shall be void.
24.10 Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns, and shall also inure to the benefit of the Regeneron Indemnitees and Adicet Indemnitees to the extent provided in the last sentence of Section 24.13 below.
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24.11 Performance Standards.
(a) Affiliates. Each Party may carry out its obligations under this Agreement through its Affiliates and absolutely, unconditionally and irrevocably guarantees to the other Party prompt performance when due and at all times thereafter of the responsibilities, liabilities, covenants, warranties, agreements and undertakings of its Affiliates pursuant to this Agreement. Without limiting the foregoing, neither Party shall cause or permit any of its Affiliates to commit any act (including any act or omission) which such Party is prohibited hereunder from committing directly. Each Party represents and warrants to the other Party that it has licensed or will license from its Affiliates the Patents and Know-How Controlled by its Affiliates that are to be licensed (or sublicensed) to the other Party under this Agreement.
(b) Subcontracts. Each Party may perform any of its obligations under this Agreement through one or more subcontractors, provided that (i) in the event that the subcontractor will be involved in Research Plan Activities, then such Party shall not subcontract without the prior written approval of the other Party, which shall not be unreasonably withheld or delayed; (ii) the subcontracting Party remains responsible for the work allocated to, and payment to, such subcontractors as it selects to the same extent it would if it had done such work itself; (iii) the subcontractor undertakes in writing obligations of confidentiality and non-use regarding Confidential Information, that are substantially the same as those undertaken by the Parties pursuant to Article 19 hereof; and (iv) the subcontractor agrees in writing to assign all inventions and intellectual property developed in the course of performing any such work under the Research Program or otherwise under this Agreement to the Party retaining such subcontractor, or as otherwise required under this Agreement and upon request to sign any documents to confirm or perfect such assignment and to cooperate in the preparation and prosecution of any such inventions. A Party may also subcontract work on terms other than those set forth in this Section 24.11(b), with the prior written approval of the other Party. To the extent any licenses are granted under any subcontract agreements, such agreements will be subject to Section 24.11(c).
(c) Sublicensees. Each Party shall enter sublicenses under the licenses granted in this Agreement only in compliance with Section 5.5 and the other applicable terms and conditions set forth in this Agreement. Each Party shall remain responsible and liable for the compliance by its sublicensees under the licensees granted herein with applicable terms and conditions set forth in this Agreement. Any such sublicense agreement will require the sublicensee of a Party to comply with the obligations of such Party as contained herein, including the confidentiality and non-use obligations set forth in Article 19, and will include, with respect to a sublicensee of either Party, an obligation of the sublicensee to account for and report its sales of Products to the sublicensing Party in a manner sufficient for such Party to comply with its reporting obligations under this Agreement. Each Party will notify the other Party of a sublicense to its Affiliate or any Third Party no later than [***] after the execution of such agreement. Each Party will forward to the other Party a complete copy of each applicable fully executed sublicense agreement (and any amendment(s) thereto) with a Third Party sublicensee (with financial and other confidential information redacted) no later than [***] after the execution of such agreement.
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(d) Further Assurances and Transaction Approvals. Upon the terms and subject to the conditions hereof, each of the Parties will (a) take, or cause to be taken, all actions necessary, proper or advisable under Applicable Laws or otherwise to consummate and make effective the transactions contemplated by this Agreement, (b) obtain from the requisite Governmental Authorities any consents, licenses, permits, waivers, approvals, authorizations, or orders required to be obtained or made in connection with the authorization, execution, and delivery of this Agreement and the consummation of the transactions contemplated by this Agreement, and (c) make all necessary filings, and thereafter make any other advisable submissions, with respect to this Agreement and the transactions contemplated by this Agreement required under Applicable Laws. The Parties will cooperate with each other in connection with the making of all such filings, including by providing copies of all such documents to the other Party and its advisors prior to the filing and, if requested, by accepting all reasonable additions, deletions, or changes suggested in connection therewith. At the request and expense of a Party, the other Party will furnish all information in such other Partys Control that is required for any applicable or other filing to be made by the requesting Party pursuant to the rules and regulations of any Applicable Laws in connection with the transactions contemplated by this Agreement. For clarity, if specific provisions of this Agreement conflict with the foregoing (for example, if one party is given sole decision-making authority) then the specific provision of this Agreement shall control.
24.12 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original but which together shall constitute one and the same instrument.
24.13 Third Party Beneficiaries. None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party, including any creditor of any Party hereto. No Third Party shall obtain any right under any provision of this Agreement or shall by reason of any such provision make any claim in respect of any debt, liability or obligation (or otherwise) against any Party hereto. Notwithstanding the foregoing, Article 20 is intended to benefit, in addition to the Parties, the other Regeneron Indemnitees and Adicet Indemnitees as if they were parties hereto, but this Agreement is enforceable only by the Parties.
24.14 Relationship of the Parties. Each Party shall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other Party except as expressly provided in this Agreement. Neither Adicet nor Regeneron shall have any responsibility for the hiring, termination or compensation of the other Partys employees or for any employee compensation or benefits of the other Partys employees. No employee or representative of a Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without said Partys approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, Regenerons legal relationship under this Agreement to Adicet, and Adicets legal relationship under this Agreement to Regeneron, shall be that of an independent contractor. Nothing in this Agreement shall be construed to establish a relationship of partners or joint ventures between the Parties or any of their respective Affiliates.
24.15 Limitation of Damages. IN NO EVENT SHALL REGENERON OR ADICET BE LIABLE FOR SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, LOSS OF PROFITS) SUFFERED BY THE OTHER PARTY, REGARDLESS OF THE THEORY OF LIABILITY (INCLUDING
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CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE) AND REGARDLESS OF ANY PRIOR NOTICE OF SUCH DAMAGES. HOWEVER, NOTHING IN THIS SECTION 24.15 IS INTENDED TO LIMIT OR RESTRICT (A) LIABILITY FOR BREACH OF SECTION 4.1 OR 19.1 OR (B) THE INDEMNIFICATION RIGHTS AND OBLIGATIONS OF EITHER PARTY HEREUNDER WITH RESPECT TO THIRD PARTY CLAIMS.
24.16 Injunctive or Other Equity Relief. Nothing contained in this Agreement shall deny any Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm.
24.17 Rights in Bankruptcy. The Parties agree that all intellectual property rights licensed hereunder, including any Patent Rights in any country of a Party covered by the license grants under this Agreement, are part of the intellectual property as defined under Section 101(35(A)) of the Bankruptcy Code subject to the protections afforded the non-bankrupt Party under Section 365(n) of the Bankruptcy Code, and any similar Law or regulation in any other country.
24.18 Non-Exclusive Remedies. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as and to the extent expressly set forth herein.
[Remainder of page intentionally left blank; signature page follows]
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IN WITNESS WHEREOF, Regeneron and Adicet have caused this Agreement to be executed by their duly authorized representatives as of the day and year first above written.
REGENERON PHARMACEUTICALS, INC. | ||
By |
/s/ Michael Aberman | |
Name: Michael Aberman | ||
Title: SVP, Strategy & IR |
ADICET BIO, INC. | ||
By |
/s/ Aya Jakobovits | |
Name: Aya Jakobovits | ||
Title: President and Chief Executive Officer |
[Signature page to License and Collaboration agreement]
Schedules and Exhibits
Schedule 1 | Manufacturing Cost | |
Schedule 2 | Quarterly True-Up | |
Schedule 3 | Licensed Mice | |
Schedule 4 | Key Adicet Personnel | |
Schedule 5 | Existing Regeneron Target List | |
Schedule 6 | Notices | |
Schedule 18.3(a)) | Regeneron Litigation |
SCHEDULE 1
Manufacturing Cost
Manufacturing Cost as used in this Agreement with respect to Co-Funded Products or Royalty Products shall be determined as provided in this Schedule 1.
The following terms shall have the respective meanings set forth below:
[***]
SCHEDULE 2
Aggregate Quarterly True-Up
General Provisions:
In no event shall the same costs be included more than once in the Quarterly Profit True-Up and Quarterly Development True-Up, collectively, even if such costs are of benefit to multiple Co-Funded Products or could conceivably be applied to either reconciliation of Development Costs or the Profit Split.
At the end of each applicable Quarter, with respect to any Co-Funded Product, Regeneron will calculate the Quarterly Development True-Up and/or Quarterly Profit True-Up (each, as defined below) for such Co-Funded Product pursuant to Sections 10.3 and 14.7(b), which are the net payment(s) that each Party shall be required to make to the other Party as described in this Schedule 2.
The Aggregate Quarterly True-Up is the sum of (i) the Quarterly Development True-Up for Co-Funded Product A, (ii) the Quarterly Development True-Up for Co-Funded Product B, (iii) the Quarterly Profit True-Up for Co-Funded Product A, (iv) the Quarterly Profit True-Up for Co-Funded Product B, and (v) the Aggregate Adicet Commercial Supply Costs for all Co-Funded Products. For the purposes of this example, the Aggregate Quarterly True-Up assumed that there were two Co-Funded Products. For Clarity, the Aggregate Quarterly True-Up will include a Quarterly Development True-Up and a Quarterly Profit True-Up for each Co-Funded Product.
In the event that the Aggregate Quarterly True-Up is an amount greater than zero, such amount shall be payable by Regeneron to Adicet. If the amount of the Aggregate Quarterly True-up is less than zero, then the absolute value of such amount will be payable by Adicet to Regeneron. Any payment due to a Party shall be made in accordance with the terms set forth in Article 14.
Definitions:
As used in this Agreement, the following terms shall have the following meanings:
Total Development Costs means the aggregate of Development Costs incurred by both Regeneron and Adicet for a Co-Funded Product in the applicable Co-Funding Territory.
In the event that there are Total Development Costs for a Co-Funded Product for a Quarter, the Quarterly Development True-Up means the Development Costs incurred by Adicet for a Co-Funded Product minus the product of (i) Total Development Costs and (ii) the applicable Adicet Co-Funding Percentage for such Quarter.
Profits in a Quarter means for a particular Co-Funded Product the Co-Funded Product Net Sales recorded by Regeneron in the Co-Funding Territory in the Quarter less the sum of (a) Cost of Goods Sold incurred by Regeneron in the Co-Funding Territory in the Quarter, (b) Shared Commercial Expenses incurred by both Parties in the Quarter, and (c) Other Shared Expenses incurred by both Parties in the Quarter.
The sum of the amounts in (a), (b) and (c) in the definition of Profits that are incurred by Adicet in a Quarter for a Co-Funded Product shall be the Adicet Quarterly Expenses. The sum of the amounts in (a), (b) and (c) in the definition of Profits that are incurred by Regeneron in a Quarter for a Co-Funded Product shall be the Regeneron Quarterly Expenses.
Profit Split for a Co-Funded Product means the product of (i) Profits in a Quarter in the Co-Funded-Territory and (ii) the Adicet Co-Funding Percentage.
The Quarterly Profit True-Up for a Co-Funded Product means the sum of (i) the Profit Split and (ii) Adicet Quarterly Expenses.
[***]
Combination Products.
In the event a Co-Funded Product is a Combination Product having any API that is not controlled by a Party (i.e., a generic or Third Party agent), then the full amount of net sales realized from the sale of such Combination Product shall be included in Net Sales (to the extent provided for in such definition) for the Co-Funded Product and the incremental costs of manufacturing or procuring such other API shall be included as an element of Clinical Supply Costs, Cost of Goods Sold or Shared Commercial Expenses, as appropriate.
In the event a Co-Funded Product is a Combination Product that includes an API that is controlled by a Party, then (1) if the ICP component and the other API component of such Product each are sold separately in the applicable country and the applicable period, then Net Sales of such Product will be calculated by multiplying the Net Sales (as described above) of the Combination Product by the fraction A/(A+B), where A is the weighted average Net Sales price of the ICP component thereof sold separately in such country during such period in the same formulation and dosage, and B is the weighted average Net Sales price of the other API component thereof sold separately in such country during such period in the same formulation and dosage, and (2) otherwise, the Parties (through the JSC) shall agree on the allocation of the relative value of the ICP component and the other API component of such Combination Product prior to the First Commercial Sale of such Combination Product, in which case only the agreed portion of Net Sales attributable to the ICP component of such Combination Product shall be included in Net Sales for the Co-Funded Product and the remaining portion of Net Sales shall be deemed attributable to the other API and be retained by, or paid to, as applicable, the Party controlling such other API component of such Combination Product.
SCHEDULE 3
Licensed Mice
[***]
SCHEDULE 4
Key Adicet Personnel
[***]
-1-
SCHEDULE 5
Existing Regeneron Target List
[***]
-2-
SCHEDULE 6
Notices
If to Regeneron:
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
Attention: President & CEO
Copy: General Counsel
If to Adicet:
Adicet Bio, Inc.
200 Constitution Drive
Menlo Park, California 94025
Attention: President
-3-
SCHEDULE 18.3(a)
Regeneron Litigation
[***]
-4-
Exhibit 10.31
EXECUTION COPY
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH [***].
SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
AMENDMENT NO. 1 TO
LICENSE AND COLLABORATION AGREEMENT
THIS AMENDMENT NO. 1 TO LICENSE AND COLLABORATION AGREEMENT (this Amendment) dated as of April 4th, 2019 (the Amendment Date), is entered into between REGENERON PHARMACEUTICALS, INC., a New York corporation (Regeneron), with a place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591, and ADICET BIO, INC. , a Delaware corporation (Adicet), with a place of business at 200 Constitution Drive, Menlo Park, California 94025 (with each of Regeneron and Adicet referred to herein individually as a Party and collectively as the Parties).:
A. The Parties entered into the License and Collaboration Agreement dated as of July 29, 2016 (the Agreement). All terms used, but not defined, herein shall have the respective meanings set forth in the Agreement.
B. The parties now desire to amend the Agreement in certain respects on the terms and conditions set forth below.
NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the Parties hereby amend the Agreement and otherwise agree as follows:
1. Amendments.
1.1 Section 1.48 of the Agreement is amended and restated to read in full as follows:
1.48 Competing Product shall mean with respect to a Collaboration Target , an ICP [***] (i) that comprises at least [***] human immune gamma delta T cells, and that contains a Targeting Moiety that Binds to such Collaboration Target, but (ii) that is not a Co-Funded Product or a Royalty Product.
1.2 Section 1.92 of the Agreement is amended to add the following sentence immediately following the end thereof:
Mice Derived Adicet Targeting Moiety additionally shall include a Targeting Moiety (x)(i) that Binds to a Target that becomes a Terminated Target pursuant to clause (i) of Section 4.1(f); but only if Adicet has designated an ICP comprising such Targeting Moiety as a clinical product candidate meeting the candidate declaration criteria set forth on Schedule 7 and has requested a meeting with a Regulatory Authority regarding such
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ICP before such Collaboration Target becomes a Terminated Target, and (ii) that was transferred by Regeneron to Adicet in the course of the Research Program with respect to such Target and was actually incorporated into such clinical product candidate; or (y) that is a derivative, fragment or modification of a molecule described in the foregoing subclause (x) made by or on behalf of Adicet and Binds to the same Terminated Target as the molecule described in subclause (x).
1.3 Section 1.140(a) of the Agreement is amended and restated as follows:
(a) With respect to each Adicet Royalty Product or Mice Derived Adicet ICP Product incorporating a Mice Derived Adicet Targeting Moiety covered by the second sentence of Section 1.92 (and for clarity, Section 1.140(d) shall not apply), in each country, the period commencing on the First Commercial Sale of such Adicet Royalty Product in such country and continuing until the later of (i) the expiration of the last Valid Claim Covering [***] such Adicet Royalty Product included in the Patent Rights comprising Adicet Product IP or the Patent Right licensed by Regeneron to Adicet in accordance with Section 5.1, or (ii) twelve (12) from the First Commercial Sale of such Adicet Royalty Product in such country;
1.4 Section 2.2(b) of the Agreement is amended and restated to read in full as follows:
(b) Regeneron may, by written notice to Adicet given at any time after [***], terminate the Research Program in its entirety and end all performance of the Research Plan Activities, in each case upon at least [***] advance written notice.
1.5 Section 2.2(d) of the Agreement is deleted in its entirety.
1.6 Section 2.5(d) of the Agreement is deleted in its entirety.
1.7 Section 2.5(e)(ii) of the Agreement is amended and restated to read in full as follows:
(ii) Rejected Targets. If a Party does not agree to include a Target nominated by the other Party as a Collaboration Target within [***] after such Target is nominated in writing by the other Party, then such rejected Target shall be subject to the exclusivity restrictions set forth in Section 4.1(d) or Section 4.1(e) (as applicable).
1.8 Section 4.1(d)(i) of the Agreement is amended to remove the words or Evaluation Target.
1.9 Section 4.1(d)(ii) of the Agreement is amended to remove the words or Evaluation Target.
1.10 Section 4.1(e) of the Agreement is amended to remove the words or Evaluation Target.
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1.11 Section 5.1(a)(ii) is amended to add the following sentence immediately following the end thereof:
This license from Regeneron to Adicet in this Section 5.1(a)(ii) for Adicet Royalty Products is only for Adicet Royalty Product that is an ICP [***] comprising of at least [***] human immune gamma delta T cells (Gamma Delta ICP). For clarity, Regeneron grants no rights to Adicet under this Section 5.1(a)(ii) under the Regeneron IP to ICPs other than Gamma Delta ICPs.
1.12 The first sentence of Section 5.1(d)(i) of the Agreement is amended to read in full as follows:
During the Target Selection Term and thereafter until [***], Regeneron hereby grants to Adicet: (A) a worldwide non-exclusive license, without the right sub-license, to use the Class 1 Licensed Mice or Class 2 Licensed Mice set forth on Schedule 3 to generate and the Class 3 Licensed Mice to test (but not generate) (i) during the Target Selection Term, Mice Derived Adicet Targeting Moieties against up to [***]Non-Collaboration Targets, except that without limiting Adicets exclusivity obligations in Article 4, the foregoing limitation shall not apply to Class 3 Licensed Mice and (ii) thereafter until [***], Mice Derived Adicet Targeting Moieties against Non-Collaboration Targets; and (B) a worldwide non-exclusive license with the right to sublicense to make, use and import the Mice Derived Adicet Targeting Moieties generated or tested pursuant to clause (i) of this Section 5.1(d)(i)(A) and Mice Derived Adicet Targeting Moieties described in the second sentence of Section 1.92 (i) to develop, make, have made, use and import Mice Derived Adicet ICP Products, (ii) to offer for sale and sell Mice Derived Adicet ICP Products in Finished Product Form, and (iii) to sell or transfer Mice Derived Adicet ICP Products (other than in Finished Product Form) solely to its Affiliates or sublicensees for such Affiliates or sublicensees developing, making, having made, using and importing Mice Derived Adicet ICP Products, and offering for sale or selling Mice Derived Adicet ICP Products in Finished Product Form, in each case during the Term, in accordance with the terms of this Agreement, anywhere in the world and for no other purpose.
1.13 Section 5.1(d)(ii) is amended to add the following sentence immediately following the end thereof:
The provisions of this Section 5.1(d)(ii) shall not apply to any Mice Derived Adicet Targeting Moiety described in the second sentence of Section 1.92.
1.14 Section 5.4 is amended to add the following sentence immediately following the end thereof:
For clarity, Regeneron grants no rights to Adicet under Section 5.1(a)(ii) under the Regeneron IP to ICPs other than Gamma Delta ICPs.
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1.15 Section 14.2 of the Agreement is amended and restated to read in full as follows:
14.2 Research Program Funding. Unless the Research Program is terminated pursuant to Section 2.2, (a) Regeneron shall pay Adicet an annual research funding fee of five million Dollars ($5,000,000) on each of the first and second anniversaries of the Effective Date, (b) Regeneron shall pay Adicet the additional one-time fee of [***] upon the filing of the first IND for a Collaboration ICP, provided that such IND filing occurs on or before [***]; and (c) Regeneron shall pay Adicet the additional one-time fee of [***] upon the designation by Adicet of a second Collaboration ICP as a clinical product candidate hereunder meeting the candidate declaration criteria set forth on Schedule 7 and the request by Adicet of a meeting with a Regulatory Authority regarding such ICP, provided that such designation and request occurs on or before [***]. Adicet shall submit to Regeneron an invoice for each payment and Regeneron shall remit payment by the later of the date specified in the preceding sentence or ten (10) Business Days after receipt of such invoice, except that if the milestone in clause (c) in the previous sentence is achieved prior to [***], Regeneron shall not be obligated to make the payment associated with such milestone until [***]. Adicet shall use the research funding fees it receives from Regeneron pursuant to this Section 14.2 to fund activities related to the Research Program.
1.16 The first sentence of Section 14.3(a) is amended to read in full as follows:
For each Quarter during the applicable Royalty Term, Adicet shall pay non-refundable, non-creditable royalties to Regeneron on Net Sales of Adicet Royalty Products or Mice Derived Adicet ICP Product incorporating a Mice Derived Adicet Targeting Moiety covered by the second sentence of Section 1.92 during such Quarter (and for clarity, Section 14.6 shall not apply), on a Collaboration Target-by-Collaboration Target basis, equal to the following percentage of Net Sales:
1.17 The Agreement is amended to add Section 16.1(g), immediately following 16.1(f):
(g) With respect to a Mice Derived Adicet ICP Product incorporating a Mice Derived Adicet Targeting Moiety covered by the second sentence of Section 1.92 (and for clarity, Section 16.1(b) shall not apply) Regeneron shall continue to own all right, title and interest in such Mice Derived Adicet Targeting Moiety and Adicet shall have no rights under this Article 16 with respect thereto;
1.18 Section 16.4(h) of the Agreement is amended and restated to read in full as follows:
(h) In the event there is a Product Infringement where (i) at the time of notice of such Product Infringement, a Party or its Affiliate or licensee is developing or selling a product that is not a Product and which is covered by one or more of the potentially infringed Patents involved in the Product Infringement, and (ii) such Party reasonably believes the pursuit of such litigation with respect to such Product Infringement is
4
reasonably likely to have a material adverse effect on such other product, then (A) such Party, upon notice to the other Party, shall have the right not to pursue litigation with respect to such Product Infringement or shall have the right to require the other Party not to pursue litigation with respect to such Product Infringement, and (B) the other Party shall not have any rights to assume the Lead Litigation Party status with respect to such Product Infringement or to otherwise pursue such Product Infringement, and thereafter the potentially infringed Patents involved in the Product Infringement shall no longer be considered for purposes of calculating the Royalty Term for any Product.
1.19 The Agreement hereby is amended to add Schedule 7, in the form attached hereto as Schedule 7, immediately following Schedule 6.
2. Miscellaneous.
2.1 This Amendment shall be effective for all purposes as of the Amendment Date. Except as otherwise expressly modified by this Amendment, the Agreement shall remain in full force and effect in accordance with its terms.
2.2 This Amendment may be executed in counterparts, each of which shall be deemed to be an original and together shall be deemed to be one and the same agreement.
2.3 This Amendment shall be governed by and construed in accordance with the laws of the State of New York, without regard to the conflicts of law provisions thereof.
2.4 The effectiveness of this Amendment is contingent upon Regeneron investing at least ten million Dollars ($10,000,000) in the next Qualified Financing (as defined in the Side Letter Agreement dated as of July 29, 2016 between the Parties) by Adicet under the terms that are generally consistent with the term sheet attached hereto as Exhibit A, including that existing investors of Adicet other than Regeneron invest at least $20,000,000 and new investors invest at least $10,000,000, provided that the applicable Qualified Financing Stock Purchase Agreement (as defined in the Side Letter Agreement dated as of July 29, 2016 between the Parties) is signed by Adicet and all investors therein (other than Regeneron) an closes by October 15, 2019 (and only if an initial closing occurs by then, such conditions are met by the initial closing) . If the conditions set forth in the previous sentence are met, but Regeneron fails to so invest in accordance with the previous sentence, then at the time of closing such round of equity financing by Adicet, this Amendment automatically shall terminate and be void ab initio.
[THE REMAINDER OF THIS PAGE INTENTIONALLY BLANK]
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IN WITNESS WHEREOF, the parties have duly executed and delivered this Amendment as of the date first set forth above.
REGENERON PHARMACEUTICALS, INC. | ||
By: | /s/ Nouhad Husseini | |
Name: | Nouhad Husseini | |
Title: | VP, Business Development |
ADICET BIO, INC. | ||
By: | /s/ Anne Altmeyer | |
Name: | Anne Altmeyer | |
Title: | Chief Business Officer |
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SCHEDULE 7
CANDIDATE DECLARATION CRITERIA
[***]
7
EXHIBIT A
SERIES B TERM SHEET ATTACHED
[ATTACHED]
8
Exhibit 10.32
FIRST AMENDMENT
TO
LOAN AND SECURITY AGREEMENT
This First Amendment to Loan and Security Agreement (this Amendment) is made and entered into as of July 8, 2020, by and between PACIFIC WESTERN BANK, a California state chartered bank (Bank), and ADICET BIO, INC. (Borrower).
RECITALS
Borrower and Bank are parties to that certain Loan and Security Agreement dated as of April 28, 2020 (as amended from time to time, the Agreement). The parties desire to amend the Agreement in accordance with the terms of this Amendment.
NOW, THEREFORE, the parties agree as follows:
1) | A new Section 2.1(c) is hereby added to the Agreement, as follows: |
(c) Usage of Credit Card Services Under the Credit Card Line.
(i) Usage Period. Subject to and upon the terms and conditions of this Agreement, at any time from the First Amendment Effective Date through the Credit Card Maturity Date, Borrower may use the Credit Card Services (as defined below) in amounts and upon terms as provided in Section 2.1(c)(ii) below.
(ii) Credit Card Services. Subject to and upon the terms and conditions of this Agreement, Borrower may request corporate credit cards and standard and e-commerce merchant account services from Bank (collectively, the Credit Card Services). The aggregate limit of the corporate credit cards and merchant credit card processing reserves shall not exceed the Credit Card Line. The terms and conditions (including repayment and fees) of such Credit Card Services shall be subject to the terms and conditions of Banks standard forms of application and agreement for the Credit Card Services, which Borrower hereby agrees to execute.
(iii) Collateralization of Obligations Extending Beyond Maturity. Borrower shall take such actions as Bank may request to cause its obligations with respect to any Credit Card Services to be secured to Banks satisfaction as of the Credit Card Maturity Date. If Borrower has not cash secured its obligations with respect to any Credit Card Services by the Credit Card Maturity Date, then, effective as of such date, the balance in any of Borrowers deposit accounts held by Bank and the certificates of deposit or time deposit accounts issued by Bank in Borrowers name (and any interest paid thereon or proceeds thereof, including any amounts payable upon the maturity or liquidation of such certificates or accounts), shall automatically secure such obligations to the extent of the then continuing or outstanding Credit Card Services. Borrower authorizes Bank to hold such balances in pledge and to decline to honor any drafts thereon or any requests by Borrower or any other Person to pay or otherwise transfer any part of such balances for so long as the applicable Credit Card Services are outstanding or continue.
1 | ||||
Adicet Bio, Inc. 1st Amendment to LSA |
2) | The following defined terms are hereby added in Exhibit A to the Agreement, as follows: |
Credit Card Line means a Credit Extension of up to $150,000, to be used exclusively for the provision of Credit Card Services.
Credit Card Maturity Date means July 7, 2021.
First Amendment Effective Date means July 8, 2020.
3) | The following defined term in Exhibit A to the Agreement is hereby amended and restated, as follows: |
Credit Extension means each Term Loan, the Credit Card Services provided under the Credit Card Line, or any other extension of credit by Bank to or for the benefit of Borrower hereunder.
4) | Unless otherwise defined, all initially capitalized terms in this Amendment shall be as defined in the Agreement. The Agreement, as amended hereby, shall be and remain in full force and effect in accordance with its respective terms and hereby is ratified and confirmed in all respects. Except as expressly set forth herein, the execution, delivery, and performance of this Amendment shall not operate as a waiver of, or as an amendment of, any right, power, or remedy of Bank under the Agreement, as in effect prior to the date hereof. Borrower ratifies and reaffirms the continuing effectiveness of all agreements entered into in connection with the Agreement. |
5) | Borrower represents and warrants that the representations and warranties contained in the Agreement are true and correct as of the date of this Amendment. |
6) | This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument. |
7) | As a condition to the effectiveness of this Amendment, Bank shall have received, in form and substance satisfactory to Bank, the following: |
a) | this Amendment, duly executed by Borrower; |
b) | payment for all Bank Expenses incurred through the date of this Amendment, including Banks expenses for the documentation of this Amendment and any UCC, good standing or intellectual property search or filing fees, which may be debited from any of Borrowers accounts; and |
c) | such other documents and completion of such other matters, as Bank may reasonably deem necessary or appropriate. |
2 | ||||
Adicet Bio, Inc. 1st Amendment to LSA |
IN WITNESS WHEREOF, the undersigned have executed this Amendment as of the first date above written.
ADICET BIO, INC. | PACIFIC WESTERN BANK | |||||||
By: | /s/ Anil Singhal |
By: | /s/ Steve Kent | |||||
Name: | Anil Singhal | Name: | Steve Kent | |||||
Title: | President and CEO | Title: | Vice President |
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Adicet Bio, Inc. 1st Amendment to LSA |
Exhibit 10.33
FIRST AMENDMENT TO THE RESTORBIO, INC.
2018 STOCK OPTION AND INCENTIVE PLAN
This First Amendment (this Amendment) to the resTORbio, Inc. 2018 Stock Option and Incentive Plan (the Plan), of resTORbio, Inc. (the Company) is effective as of the date of approval effective as of September 15, 2020 (the Effective Date) by the Companys stockholders (the Effective Date). Capitalized terms used herein and not otherwise defined shall have the meanings ascribed to such terms in the Plan.
As of the Effective Date, the Plan shall be amended as follows:
1. | Section 3(a) of the Plan is hereby deleted in its entirety and replaced with the following: |
(a) | Stock Issuable. The maximum number of shares of Stock reserved and available for issuance under the Plan shall be 19,635,419 shares of Stock (the Initial Limit), subject to adjustment as provided in Section 3(c), plus on January 1, 2021 and each January 1 thereafter, the number of shares of Stock reserved and available for issuance under the Plan shall be cumulatively increased by 4% of the number of shares of Stock issued and outstanding on the immediately preceding December 31 (the Annual Increase). Subject to such overall limitation, the maximum aggregate number of shares of Stock that may be issued in the form of Incentive Stock Options shall not exceed the Initial Limit cumulatively increased on January 1, 2021 and on each January 1 thereafter by the lesser of the Annual Increase for such year or 12,135,175 shares of Stock, subject in all cases to adjustment as provided in Section 3(c). For purposes of this limitation, the shares of Stock underlying any Awards that are forfeited, canceled, held back upon exercise of an Option or settlement of an Award to cover the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of Stock or otherwise terminated (other than by exercise) under each of the Plan and the 2017 Plan shall be added back to the shares of Stock available for issuance under the Plan. In the event the Company repurchases shares of Stock on the open market, such shares shall not be added to the shares of Stock available for issuance under the Plan. Subject to such overall limitations, shares of Stock may be issued up to such maximum number pursuant to any type or types of Award. The shares available for issuance under the Plan may be authorized but unissued shares of Stock or shares of Stock reacquired by the Company. |
2. | Except as expressly amended by this Amendment, the Plan shall continue in full force and effect in accordance with the provisions thereof. |
[signature page to follow]
1
IN WITNESS WHEREOF, the Company has caused this Amendment to be duly executed as of the date first written above.
RESTORBIO, INC. | ||
By: | /s/ Chen Schor | |
Name: Chen Schor Title: Chief Executive Officer |
2
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (No. 333-222746 and No. 333-230363) and Form S-3 (No. 333-229499) of Adicet Bio, Inc. (formerly known as resTORbio, Inc.) of our report dated June 23, 2020 relating to the financial statements of Adicet Bio, Inc., which appears in this Current Report on Form 8-K.
/s/ PricewaterhouseCoopers LLP
San Jose, California
September 15, 2020
Allogeneic Gamma Delta T Cells Engineered to Fight Cancer September 16, 2020 Exhibit 99.1
Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: future product development plans and projected timelines for the initiation and completion of preclinical and clinical trials and other activities of Adicet Bio, Inc. (the “Company” or “Adicet”); the potential for the results of ongoing preclinical or clinical trials and the efficacy of Adicet’s drug candidates; our expectations of the potential impact of COVID-19 on strategy, future operations, and the timing of our clinical trials, including potential impacts on enrollment and initiation; and future product development and regulatory strategies, including with respect to specific indications. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” and other similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Adicet’s current beliefs, expectations and assumptions regarding the future of Adicet’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: (i) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; (ii) unanticipated difficulties or expenditures relating to the merger, the response of business partners and competitors to the announcement or completion of the merger, and/or potential difficulties in employee retention as a result of the announcement or completion of the merger; (iii) the combined company’s listing on the Nasdaq Global Market; (iv) the adequacy of the combined company’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; (v) the nature, strategy and focus of the combined company; (vi) the difficulty in predicting the time and cost of development of Adicet’s product candidates; (vii) Adicet’s plans to develop and commercialize its product candidates, including, but not limited to, ADI-001 and ADI-002; (viii) the timing of initiation of Adicet’s planned clinical trials; (ix) the timing of the availability of data from Adicet’s clinical trials; (x) the timing of any planned investigational new drug application or new drug application; (xi) Adicet’s plans to research, develop and commercialize its current and future product candidates; (xii) Adicet’s ability to enter into new collaborations, and to fulfill its obligations under any such collaboration agreements; (xiii) the clinical utility, potential benefits and market acceptance of Adicet’s product candidates; (xiv) Adicet’s commercialization, marketing and manufacturing capabilities and strategy; (xv) Adicet’s ability to identify additional products or product candidates with significant commercial potential and to expand its pipeline in oncology and other diseases; (xvi) developments and projections relating to Adicet’s competitors and its industry; (xvii) the impact of government laws and regulations; (xviii) the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, which has been labeled a pandemic by the World Health Organization, the timing and anticipated results of our clinical trials; (xix) the risk that the results of our clinical trials may not be predictive of future results in connection with future clinical trials; (xx) the timing and outcome of our planned interactions with regulatory authorities; (xxi) Adicet’s ability to protect its intellectual property position; (xxii) Adicet’s estimates regarding future revenue, expenses, capital requirements and need for additional financing; and (xxiii) those risks detailed in resTORbio’s, Inc.’s definitive proxy statement/prospectus/information statement filed with the SEC on August 21, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. None of Adicet, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. Industry and Market Information Information regarding market share, market position and industry data pertaining to Adicet’s business contained in this presentation consists of estimates based on data and reports compiled by industry professional organizations and analysts and Adicet’s knowledge of their industry. Although Adicet believes the industry and market data to be reliable, this information could prove to be inaccurate. You should carefully consider the inherent risks and uncertainties associated with the market and other industry data contained in this presentation. Forward-looking information obtained from third-party sources is subject to the same qualifications and the additional uncertainties as the other forward-looking statements in this presentation.
Developing off-the-shelf, engineered Gamma-Delta (γδ) CAR-T cells for oncology and other indications Presence of γδ T cells in tumors was observed to strongly correlate with improved overall prognosis, survival and progression free survival Express T-cell and NK cell receptors, facilitating adaptive and innate anti-tumor immune responses with more limited ability for tumor escape Intrinsically home to and function in tissues and solid malignancies Allogeneic and off-the-shelf with potential to re-dose patients and no expected GvHD Potential for outpatient administration Proprietary T Cell Receptor-Like (TCR-L) monoclonal platform targeting intracellular targets presented on MHC complexes $123 million pro forma cash, cash equivalent and marketable securities June 30, 2020 Multiple near-term milestones Key Investors: OrbiMed, Novartis, JNJ, Regeneron, aMoon Adicet Bio: Leaders in Engineered Gamma-Delta CAR-T Cell Therapy CAR: Chimeric Antigen Receptors; NK: Natural Killer; GvHD: Graft Versus Host Disease; MHC: Major Histocompatibility Complex; NKG2D: NK Group 2D; NCR=Natural Cytotoxicity Receptors; DNAM-1: DNAX accessory molecule-1
Adicet Bio Post Merger Leadership Team Chen Schor President and CEO Stewart Abbot, PhD Chief Scientific and Operating Officer Carrie Krehlik Chief Human Resource Officer Lloyd Klickstein, MD, PhD Chief Innovation Officer Francesco Galimi, MD, PhD Chief Medical Officer Nick Harvey Chief Financial Officer
Improving Cancer Immunotherapy Presence of γδ T Cells Observed to Strongly Correlate with Positive Clinical Outcomes Meraviglia et al. 2017 Improved Disease Free Progression Colorectal Cancer γδ T cell hi γδ T cell lo γδ T cell lo / IFNγ lo Pan-Cancer: Improved Overall Prognosis Gentles et al. 2015 Godder et al. 2007 Post-HSCT Improved Survival γδ T cell hi γδ T cell lo Overall Survival HSCT: Hematopoietic Stem Cell Transplantation p<0.0001
NH: Non-Hodgkin’s ; HCC: hepatocellular carcinoma Building a Broad Pipeline of First in Class γδ CAR T Cell Therapy Program Target Indication Discovery Preclinical IND Phase 1 Phase 2 ADI-001 CD20 NH Lymphoma ADI-002 GPC3 HCC ADI-00x Undisclosed Solid Tumors ADI-00x Multiple Solid and Heme
Multiple Expected Near-Term Milestones File IND for ADI-001 CD20 gamma-delta CAR-T Phase 1 clinical study in non-Hodgkin’s lymphoma ADI-001 expansion in DLBCL and/or MCL Phase 1 in HCC and other solid tumors Expand pipeline in oncology and other diseases File IND for ADI-002 GPC3 gamma-delta CAR-T DLBCL: Diffuse Large B Cell Lymphoma; MCL: Mantle Cell Lymphoma
ADI-001: Allogeneic CD20-CAR-γδ T Cell
Key Anticipated Advantages of Adicet’s Allogeneic γδ1 T Cell Platform Innate and adaptive immunity imparted by TCR and NK receptors May mitigate tumor relapse MHC-independent tumor targeting Off-the-shelf product, potential to re-dose No / low potential to cause GvHD Potent IFNγ production Potential for integrin-mediated trafficking to solid tumors Scalable manufacturing from healthy donors Not compromised by patient’s immune system dysfunction MICA / B B7-H6, etc. MHC- unrestricted antigens CD20 Nectin-2, etc. Galectin-3, NKp44L, etc.
Adicet CAR γδ T Cell Platform Anticipated Advantages: Engineered to address activity, tumor homing, safety, and COGs limitations Allogeneic CAR αβ T Cells Allogeneic CAR NK Cells Allogeneic CAR γδ T Cells Activity Innate anti-tumor response Adaptive anti-tumor response Active tumor homing Predominantly activating receptor expression (Limited number) (Balance with inactivating) Preclinical persistence by repeat tumor challenge Prognostic value of tumor infiltration Safety Low GvHD risk (Requires αβ TCR deletion) Low risk of cytokine release syndrome ≥ grade 3 risk COGS No gene editing required (May affect efficacy) Scalable manufacturing Limited without exhaustion
Large-Scale Manufacture of γδ T Cells Proprietary AM3579 activating antibody to expand γδ1 T cells, Proprietary Vectors, Proprietary Scalable Process
Anticipated Consistent Proprietary Large-Scale Expansion Fully cGMP-compliant manufacturing process Available on demand for single or repeated dosing Consistent clinical-scale manufacture >6,000 fold expansion of Vδ1 T cells at clinical scale Highly cost efficient: Up to 1,000 doses / batch Data above are from full-scale clinical productions conducted by Adicet and cGMP-compliant contract manufacturing organization
CD20 CAR γδ T Cells Effectively Control Aggressive Lymphoma Tumors in Mice† Untreated animals succumb to highly aggressive tumors within 3 weeks 2nd generation (employing two co-stimulation domains) CD20 CAR γδ T cells effectively control multiple disseminated (iv) and localized (sc) tumors γδ T cell treatment initiated* when tumor volume ≥ 200mm3 Intravenous Raji Tumor Growth * Subcutaneous Raji Tumor Growth * -5 0 5 10 15 20 25 30 35 0 1×10 10 2×10 10 3×10 10 4×10 10 5×10 10 6×10 10 7×10 10 M e a n T o t a l F l u x ( p / s ) + / - S E M Intravenous Granta Tumor Growth * Subcutaneous Mino Tumor Growth * †internal Adicet study
CD20 γδ CAR-T Cells Effectively Control Repeat Lymphoma Challenges and Demonstrate Functional Persistence for 100 Days Repeat tumor challenge is one of the most stringent tests of anti-tumor activity CD20 CAR γδ T cell treatment initiated* when tumor volume ≥ 200mm3 Excellent tumor control in all animals at day 55 Secondary tumor challenge at day 60 CD20 CAR γδ T demonstrate functional persistence and control tumor growth to 100 days * †internal Adicet study † In Vivo Subcutaneous Raji Tumor Killing † 1˚ Tumor Challenge 2˚ Tumor Challenge Mean Tumor Volume (mm3)+/- SEM
CD20 CAR γδ T Cells Proliferate in Response to Activation in Tumors Substantial and specific target-mediated proliferation of CD20 CAR γδ T cells in localized lymphoma tumors at 6 days post treatment † Blood Spleen Liver Bone marrow Tumor Cell Number T cell Proliferation Day 2 Post-treatment CAR-T γδ Day 6 Post-treatment CAR-T γδ Blood Spleen Liver Tumor Bone marrow T cell Proliferation T cell Proliferation Day 6 Post-treatment CAR-T αβ †internal Adicet study 103 104 105 106 103 104 105 106 103 104 105 106
Intravenous Raji Tumor in SRG-15 Mice† Absence of GvHD with CD20 CAR γδ T Cells No GvHD observed in mice treated with γδ T cells γδ T cells not expected to induce GvHD in clinical study No gene editing required to overcome GvHD with γδ T cells αβ CAR-T cell group succumbed to GvHD αβ CART cells CAR γδ T cells Tumor alone Days Post Treatment Percentage Surviving †internal Adicet study; SRG-15 mice express human IL-15 transgene
ADI-001 (Off-the-shelf CD20 CAR γδ T cells) Opportunity Significant unmet medical need following CAR-T approvals Gr3+ CRS: 13-49%; Gr3+ neurotoxicity: 18-31% Limited number of specialized centers can treat patients; Suboptimal patient access Significant percentage of patients in pivotal trials didn’t receive cells (primarily due to mfg. challenges or wait time) 40% of patients treated with approved autologous CD19 CAR T therapy show durable responses ADI-001 Target product profile Effective (ORR, PFS/OS) in CD20 expressing NHL Facilitating adaptive and innate anti-tumor immune responses with more limited ability for tumor escape Potential alternative to autologous therapies and/or line of therapy before/after CD19 cell therapy relapse Significantly lower cytokine release syndrome; No GvHD Potential for outpatient administration Sources: Kymriah and Yescara package inserts; Neelapu et al. N Eng J Med 2017
First in Human Study for ADI-001 (CD20 CAR γδ T cells) Follow-up Day -5 Day 0 Day 28 Month 12 Lymphodepletion Regimen: Flu/Cy Fludarabine: 30 mg/m2/d x 3 days, Cyclophosphamide 500 mg/m2/d x 3 days Phase 1 study design NHL patients relapsing from 2 or more prior lines of treatment 3 cohorts expected for dose escalation/safety Up to 50 patients at the selected dose Optional ADI-001 retreatment Potential DLBCL dose expansion / Pivotal study Potential MCL dose expansion / Pivotal study Long-term follow-up study Lympho- depletion Treatment Enrollment ADI-001 Infusion Response & Safety Assessment End of Study Response & Safety Assessment Months 3, 6, 9, 12 (*) (*) Dose escalation study
ADI-002: Allogeneic GPC3-CAR-γδ T Cell for Solid Tumors
Anticipated Advantages of Adicet’s γδ CAR-T Cell Therapy in Solid Tumors Solid Tumor Challenges Adicet γδ CAR-T Cell Anticipated Advantage Avoiding autologous cell exhaustion / dysfunction Healthy CMV-negative donor derived product preserves Vδ1 proliferative capacity Potential for >30 population doublings ex vivo / in vivo Specific tumor-induced activation & proliferation Activation-induced PD-1 expression is reversible without exhaustion CAR-designs minimize tonic signaling Cells Infiltration into Tumor Chemokine receptor and adhesion molecule mediated infiltration Immunosuppressive Tumor Microenvironment Further engineering can improve responses to tumor microenvironment factors γδ T cells can survive and function in hypoxic / low nutrient conditions Loss of HLA or Target Antigen(s) Expression HLA-independent γδ T cell innate receptor-mediated tumor recognition Paucity of tractable targets Ability to target intracellular antigens CMV: Cytomegalovirus; HLA: Human Leukocyte Antigen
ADI-002: GPC3 is highly expressed on a broad range of solid tumors, with limited expression levels on normal tissues Baumhoer et al., Am J Clin Pathol 2008;129:899-906 Ho et al., PLoS ONE 2012; 7: e37159 IHC Detection of GPC3 in human HCC vs normal liver Adicet Bio Confidential Tumor Non-tumor
Secretion of IL-15 Enhances Potency of ADI-002 Cells in Solid Tumors GPC3-CAR / sIL-15 γδ T cells control subcutaneous hepatocellular carcinoma growth in NSG mice
Dose Dependent Anti-Tumor Effect of Vδ1 CAR-T Cells with GPC3-Targeting sIL15 CAR γδ1 T Cells in Liver Cancer Model † GPC3-targeting chimeric antigen receptor construct also encodes secretion of IL15 Single dose CAR γδ T cell treatment was initiated* when tumor volumes reached ~200mm3 Excellent CAR γδ T dose-dependent control of tumor growth Tumor alone GPC3 CAR γδT – low dose GPC3 CAR γδT– medium dose GPC3 CAR γδT– high dose Adicet Bio Confidential †internal Adicet study
Anticipated Advantage of ADI-002 in HCC Potential to address low target tumor densities CAR-dependent and CAR-independent tumor targeting Optimizing γδ T cells to overcome tumor microenvironment-mediated immunosuppression Enhancing persistence of CAR-γδ T cells Favorable preclinical results Opportunities in multiple tumor types Adicet Bio Confidential
TCR-L Platform: Intracellular Solid Tumor Targets
TCR-L Platform: CAR-T Using Intracellular Solid Tumor Targets Challenge Lack of disease-specific cell surface targets in solid tumors TCR-L Proposed Solution Ability to target disease-specific intracellular proteins via peptide MHC complexes highly expands the target pool Unlikely to express on normal cells Adicet has generated multiple TCR-Like (TCR-L) antibodies to various intracellular targets in key solid tumor indications Mimic TCR specificity with higher affinity of mAbs scFv for chimeric antigen receptors for cellular therapy Tyr CAR γδ T cells Tumor alone Day Post Treatment WM266.4 Tumor Growth in NSG Mice †internal Adicet study †
Developing off-the-shelf, engineered Gamma-Delta (γδ) CAR-T cells for oncology and other indications Presence of γδ T cells in tumors was observed to strongly correlate with improved overall prognosis, survival and progression free survival Express T-cell and NK cell receptors, facilitating adaptive and innate anti-tumor immune responses with more limited ability for tumor escape Intrinsically home to and function in tissues and solid malignancies Allogeneic and off-the-shelf with potential to re-dose patients and no expected GvHD Potential for outpatient administration Proprietary T Cell Receptor-Like (TCR-L) monoclonal platform targeting intracellular targets presented on MHC complexes $123 million pro forma cash, cash equivalent and marketable securities June 30, 2020 Multiple near-term milestones Key Investors: OrbiMed, Novartis, JNJ, Regeneron, aMoon Adicet Bio: Leaders in Engineered Gamma-Delta CAR-T Cell Therapy CAR: Chimeric Antigen Receptors; NK: Natural Killer; GvHD: Graft Versus Host Disease; MHC: Major Histocompatibility Complex; NKG2D: NK Group 2D; NCR=Natural Cytotoxicity Receptors; DNAM-1: DNAX accessory molecule-1
Backup Slides
CD20 CAR γδ T Cells Potently Kill Multiple Lymphoma Cell Lines in vitro † Potent activity against tumors expressing high and low levels of CD20 Potent activity against tumors expressing HLA-Class 1 or HLA-Class 1 null CD20 CAR potentiates initial innate tumor recognition and killing Will-2 cells were originally derived from a Rituxan -Resistant Patient Raji (~54,000 CD20 /cell) Mino (>90,000 CD20/cell) WILL-2 (<1000 CD20 /cell) CD20 CAR Vδ1 cells Un-engineered Vδ1 cells †internal Adicet study Daudi (>50,000 CD20 /cell, HLA-null)
Adicet: Leader in CAR & TCR Engineered γδ1 T cells Adicet is a leader in the development of CAR-modified healthy donor-derived γδ1 T cell therapies Source: Adapted from Immuno-Oncology Technology 1 (2019) 3–10 Company T-cell type Source Gadeta αβ Blood GammaDelta Therapeutics γδ1 Skin/Blood TC Biopharm γδ1, γδ2 Blood Immatics γδ2 Blood IN8bio (Incysus) γδ2 Blood
Intellectual Property Platform γδ T cell Expansion Multiple pending patent applications Compositions and methods of expansion/treatment Expiry 2035 to 2037 γδ T cell Optimized Constructs Multiple pending patent applications Compositions and methods of treatment Expiry 2038 to 2039 Novel Targeting Ligand Platform TCR-like Antibody Platform Multiple issued and Pending Patents Expiry 2021 to 2036 Pipeline Provisional application pending Directed to methods of treatment and adoptive γδ T cell support TCR-like Antibodies Carcinoma Target Multiple pending patent applications Compositions and methods of treatment Expiry 2036 to 2037 Melanoma and Glioblastoma Target Multiple pending patent applications Compositions and methods of treatment Expiry 2036 ADI-001 Hematological Target Multiple pending patent applications Compositions and methods of treatment Expiry 2038 to 2039 ADI-002 Solid Tumor Target Multiple pending patent applications Compositions and methods of treatment Expiry 2038 to 2039
Regeneron Collaboration In conjunction with Regeneron, Adicet discovers and develops γδ T cells engineered with CARs and TCRs Adicet has the right to use certain of Regeneron’s proprietary mice Five-year research collaboration signed July 2016 Adicet has the right to develop and commercialize the first collaboration target (ADI-001) At IND, Regeneron has an option to exercise exclusive rights for ADI-002 and potentially for additional targets to be mutually agreed upon In case Regeneron exercises an option, Adicet will receive an option exercise fee and has the right to co-fund, co-promote and profit-share in such product OR receive royalties
Adicet’s Key Anticipated Differentiation From γδ T cell Competitors Robust and practical proprietary antibody-based manufacturing method for γδ T cells Unique ability to selectively expand multiple γδ T cell subpopulations Large-scale expansion of blood-derived γδ T cells Production of highly potent Vδ1 (tumor cytolysis and cytokine production) Ability to kill tumor cells expressing low level of target antigens (~100 copies per cell) No potentially pro-tumorigenic Th17-type responses in Adicet’s Vδ1 subpopulation In-house chimeric antigen receptor (CAR) target identification and verification process Ability to effectively target tumor-specific intracellular protein-derived peptides using proprietary T cell receptor-like antibodies (TCRLs) Capacity to develop TCRLs as CARs, bispecific antibodies or ADCs
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAR-T Cell Therapy Journey 2015 Adicet Bio Founded ~2017 Yescarta approved by US FDA for r/r DLBCL 2012 U. Penn CART19 assets acquired by Novartis 2017 Kite Pharma acquired for $11.9B 2013 Juno Therapeutics founded 2009 Kite Pharma Founded 2017-19 Adicet Bio preclinical data 2021 Adicet Bio clinical data expected 2018 Allogene IPO 2018 Juno Therapeutics acquired for $9B 2017 Allogene founded Adicet Bio Confidential ~2017 Kymriah approved by US FDA for r/r ALL
Exhibit 99.2
Risks Related to Adicets Business and Industry
Adicet has a limited operating history and faces significant challenges and expense as it builds its capabilities.
Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. Adicet began operation in November 2014. Adicet has a limited operating history upon which you can evaluate Adicets business and prospects and is subject to the risks inherent in any early stage company, including, among other things, risks that Adicet may not be able to hire sufficient qualified personnel and establish operating controls and procedures. Adicet currently does not have complete in-house resources to enable its gamma delta T cell platform. As Adicet builds its own capabilities, it expects to encounter risks and uncertainties frequently experienced by growing companies in new and rapidly evolving fields, including the risks and uncertainties described herein. Consequently, any predictions made about Adicets future success or viability may not be as accurate as they could be if Adicet had a history of successfully developing and commercializing biopharmaceutical products.
Adicet has incurred net losses in every period since its inception and anticipates that it will incur substantial net losses in the future.
Adicet is a pre-clinical stage biopharmaceutical company. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. Adicets programs, including ADI-001 and ADI-002, remain in the pre-clinical stage. Adicet has no products approved for commercial sale and has not generated any revenue from product sales to date, and it will continue to incur significant research and development and other expenses related to its ongoing operations. As a result, Adicet is not profitable and has incurred net losses in each period since Adicets inception. For the years ended December 31, 2019 and 2018, Adicet reported net losses of $28.1 million and $9.3 million, respectively. As of June 30, 2020, Adicet had an accumulated deficit of $82.6 million.
Adicet expects to incur significant expenditures for the foreseeable future, and it expects these expenditures to increase as it continues its research and development of, and seek regulatory approvals for, product candidates based on its gamma delta T cell platform, including ADI-001 and ADI-002. Even if Adicet succeeds in commercializing one or more of its product candidates, it will continue to incur substantial research and development and other expenditures to develop and market additional product candidates. Adicet may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. The size of Adicets future net losses will depend, in part, on the rate of future growth of its expenses and its ability to generate revenue. Adicets prior losses and expected future losses have had and will continue to have an adverse effect on its stockholders equity and working capital. Further, even if Adicet does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. Adicets failure to become and remain profitable would depress the value of the combined company and could impair its ability to raise capital, expand its business, maintain its research and development efforts, diversify its product candidates or even continue its operations, any of which could have a material adverse effect on Adicets business, financial condition, results of operations, and prospects and cause you to lose all or part of your investment.
Adicets history of recurring losses and anticipated expenditures raise substantial doubts about its ability to continue as a going concern. Adicets ability to continue as a going concern requires that it obtain sufficient funding to finance its operations.
Adicet has incurred operating losses to date and it is possible Adicet will never generate a profit. Adicet has concluded that substantial doubt exists regarding its ability to continue as a going concern. Adicets financial statements included elsewhere in this proxy statement/prospectus/information statement have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. These financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of these uncertainties related to Adicets ability to operate on a going concern basis.
The report of Adicets independent registered public accounting firm on its financial statements as of and for the years ended December 31, 2019 and 2018 includes an explanatory paragraph indicating that there is substantial doubt about Adicets ability to continue as a going concern. If Adicet is unable to raise sufficient capital when needed, Adicets business, financial condition and results of operations will be harmed, and Adicet will need to significantly modify its operational plans to continue as a going concern. If Adicet is unable to continue as a going concern, Adicet might have to liquidate its assets and the values it receives for its assets in liquidation or
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dissolution could be significantly lower than the values reflected in its financial statements. The inclusion of a going concern explanatory paragraph by Adicets auditors, its lack of cash resources and its potential inability to continue as a going concern may negatively impact Adicets share price and its ability to raise new capital or to enter into critical contractual relations with third parties due to concerns about its ability to meet its contractual obligations.
Adicets gamma delta T cell candidates represent a novel approach to cancer treatment that creates significant challenges for Adicet.
Adicet is developing a pipeline of gamma delta T cell product candidates and a novel antibody platform that are intended for use in patient with certain cancers. Advancing these novel product candidates creates significant challenges for Adicet, including:
| manufacturing its product candidates to its specifications and in a timely manner to support its future clinical trials, and, if approved, commercialization; |
| sourcing future clinical and, if approved, commercial supplies for the raw materials used to manufacture its product candidates; |
| understanding and addressing variability in the quality of a donors T cells, which could ultimately affect its ability to produce product in a reliable and consistent manner; |
| inability to achieve efficacy in cancer patients following treatment with Adicets product candidates; |
| achieving a side effect profile, including GvHD, from Adicet product candidates that makes them commercially unattractive for further development; |
| educating medical personnel regarding the potential side effect profile of its product candidates, if approved; |
| using medicines to manage adverse side effects of its product candidates which may not adequately control the side effects and/or may have a detrimental impact on the efficacy of the treatment; |
| conditioning patients with chemotherapy or other lymphodepletion agents in advance of administering Adicets product candidates, which may increase the risk of adverse side effects; |
| obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with development of allogeneic T cell therapies for cancer; and |
| establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy. |
The success of Adicets business, including its ability to obtain financing and generate any revenue in the future, will primarily depend on the successful development, manufacturing, positive efficacy and safety profile in its clinical trials, regulatory approval and commercialization of Adicets novel product candidates, which may never occur. Adicet has not yet succeeded and may not succeed in demonstrating efficacy and safety for any of its product candidates in clinical trials or in obtaining marketing approval thereafter. Given Adicets early stage of development, it may be several years, if at all, before Adicet has demonstrated the safety and efficacy of a product candidate sufficient to warrant approval for commercialization. If Adicet is unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize its product candidates, Adicet may not be able to generate sufficient revenue to continue its business, which could have a material adverse effect on Adicets results of operations and prospects.
Adicets product candidates are based on novel technologies, which makes it difficult to predict the likely success of such product candidates and the time and cost of product candidate development and obtaining regulatory approval.
Adicet has concentrated its research and development efforts on its allogeneic gamma delta T cell therapy and Adicets future success depends on the successful development of this therapeutic approach. Adicet is in the
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early stages of developing its platform and product candidates and there can be no assurance that any development problems Adicet has experienced or may experience in the future will not cause significant delays or result in unforeseen issues or unanticipated costs, or that any such development problems or issues can be overcome. Adicet may also experience delays in developing a sustainable, reproducible and scalable manufacturing process or transferring that process to commercial partners, which may prevent it from completing Adicets future clinical studies or commercializing its products on a timely or profitable basis, if at all. In addition, Adicets expectations with regard to the advantages of an allogenic gamma delta T cell therapy platform relative to other therapies may not materialize or materialize to the degree Adicet anticipates. Further, Adicets scalability and costs of manufacturing may vary significantly as Adicet develops its product candidates and understands these critical factors.
In addition, the clinical study requirements of the FDA, EMA and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate are determined according to the type, complexity, novelty and intended use and market of the potential products. The regulatory approval process for novel product candidates such as Adicets can be more complex and consequently more expensive and take longer than for other, better known or extensively studied pharmaceutical or other product candidates. Approvals by the EMA and FDA for existing autologous CAR-T therapies, such as Kymriah® and Yescarta®, may not be indicative of what these regulators may require for approval of Adicets therapies. Also, while Adicet expects reduced variability in its products candidates compared to autologous products, Adicet does not have significant clinical data supporting any benefit of lower variability. More generally, approvals by any regulatory agency may not be indicative of what any other regulatory agency may require for approval or what such regulatory agencies may require for approval in connection with new product candidates.
Adicets product candidates may also not perform successfully in clinical trials or may be associated with adverse events that distinguish them from the autologous CAR-T therapies that have previously been approved or alpha beta T cell therapies that may be approved in the future. Unexpected clinical outcomes could materially and adversely affect Adicets business, results of operations and prospects.
Adicets business is highly dependent on the success of ADI-001 and ADI-002. If Adicet is unable to obtain approval for ADI-001 or ADI-002 and effectively commercialize ADI-001 or ADI-002 for the treatment of patients in its approved indications, its business would be significantly harmed.
Adicets business and future success depends on its ability to obtain regulatory approval of, and then successfully commercialize, its most advanced product candidates, ADI-001 and ADI-002. ADI-001 is in the early stages of development and Adicet intends to file an IND application with the FDA in 2020 and, subject to the FDA regulatory process for review of INDs, initiate a clinical trial of ADI-001 targeting CD20 for the treatment of patients with Non-Hodgkins Lymphoma and treat the first patient in the first half of 2021. ADI-002 is also in the early stage of development and Adicet intends to file an IND application with the FDA in 2021 for ADI-002 and, subject to the FDA regulatory process for review of INDs, initiate a clinical trial and treat the first patient with ADI-002 in 2021.
Adicets pre-clinical results to date may not predict results for its planned trials or any future studies of ADI-001 and ADI-002 or any other allogeneic gamma delta T cell product candidate. Because of the lack of evaluation of allogeneic products and gamma delta T cell therapy products in the clinic to date, any such products failure, or the failure of other allogeneic T cell therapies or gamma delta T cell therapies, may significantly influence physicians and regulators opinions in regards to the viability of Adicets entire pipeline of allogeneic T cell therapies, which could have a material adverse effect on Adicets reputation. If Adicets gamma delta T cell therapy is viewed as less safe or effective than autologous therapies or other allogeneic T cell therapies, Adicets ability to develop other allogeneic gamma delta T cell therapies may be significantly harmed.
All of Adicets product candidates, including ADI-001 and ADI-002, will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access
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to sufficient commercial manufacturing capacity and significant marketing efforts before Adicet can generate any revenue from product sales. In addition, because ADI-001 is Adicets most advanced product candidate, and because its other product candidates are based on similar technology, if ADI-001 encounters safety or efficacy problems, manufacturing problems, developmental delays, regulatory issues or other problems, Adicets development plans and business would be significantly harmed, which could have a material adverse effect on Adicets business, reputation and prospects.
Adicets product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
Undesirable or unacceptable side effects caused by Adicets product candidates could cause Adicet or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities. Results of Adicets clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Approved autologous CAR T therapies and those under development have shown frequent rates of cytokine release syndrome and neurotoxicity, and adverse events have resulted in the death of patients. While Adicet believes its gamma delta T cell therapy may lessen such results, similar or other adverse events for its allogeneic gamma delta T cell product candidates may occur. In addition, while Adicet anticipates its focus on gamma delta T cells may lessen the likelihood of GvHD relative to therapies relying on unrelated alpha beta T cells, similar or other adverse events for its allogeneic gamma delta T cell product candidates may occur.
If unacceptable toxicities arise in the development of Adicets product candidates, Adicet could suspend or terminate its trials or the FDA or comparable foreign regulatory authorities could order it to cease clinical trials or deny approval of its product candidates for any or all targeted indications. The data safety monitoring board may also suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials. Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Novel therapeutic candidates, such as those developed by Adicet, may result in novel side effect profiles that may not be appropriately recognized or managed by the treating medical staff. Adicet anticipates having to train medical personnel using Adicets product candidates to understand the side effect profile of Adicets product candidates for Adicets clinical trials and upon any commercialization of any of Adicets product candidates. Inadequate training in recognizing or managing the potential side effects of Adicets product candidates could result in serious adverse events including patient deaths. Based on available preclinical data and on managements clinical experience with other cell therapy agents, the safety profile of Adicets pipeline product candidates are expected to include cytokine release syndrome, neurotoxicity, and possibly additional adverse events. Any of these occurrences may have a material adverse effect Adicets business, financial condition and prospects.
Adicets clinical trials may fail to demonstrate the safety and efficacy of any of its product candidates, which would prevent or delay regulatory approval and commercialization.
Before obtaining regulatory approvals for the commercial sale of Adicets product candidates, including ADI-001 and ADI-002, Adicet must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that its product candidates are both safe and effective for use in each target indication. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of Adicets product candidates may not be predictive of the results of later-stage clinical trials.
There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in
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the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy, insufficient durability of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that commence clinical trials are never approved as products.
In addition, for ADI-001 and ADI-002 and any future trials that may be completed, Adicet cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as Adicet does, and more trials could be required before Adicet submits its product candidates for approval. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of Adicets product candidates may be significantly delayed, or Adicet may be required to expend significant additional resources, which may not be available to it, to conduct additional trials in support of potential approval of Adicets product candidates. Any of the foregoing could have a material adverse effect on Adicets business, prospects and financial condition.
Interim top line and preliminary data from Adicets clinical trials that Adicet may announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
From time to time, Adicet may publish interim top line or preliminary data from Adicets clinical studies. Interim data from clinical trials that Adicet may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
Preliminary or top line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data Adicet previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm Adicets business prospects.
Adicet may not be able to file INDs to commence additional clinical trials on the timelines it expects, and even if Adicet is able to, the FDA may not permit it to proceed.
Adicet plans to submit an IND to the FDA in 2020 and, subject to the FDA regulatory process for review of INDs, initiate a clinical trial of ADI-001 targeting CD20 for the treatment of patients with Non-Hodgkins Lymphoma and treat the first patient in the first half of 2021. Additionally, Adicet intends to file an IND application with the FDA in 2021 for ADI-002 and, subject to the FDA regulatory process for review of INDs, initiate a clinical trial and treat the first patient with ADI-002 in 2021. Adicet currently expects to submit INDs for additional product candidates in its pipeline in 2022 and 2023. However, Adicets timing of filing on these product candidates is dependent on further pre-clinical and manufacturing success, which Adicet works on with various third parties, as well as on timing of research and development with respect to product candidates that are in the early stages of development. Adicet cannot be sure that it will be able to submit its IND in a timely manner, if at all, or that submission of an IND or IND amendment will result in the FDA allowing testing and clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate such clinical trials. Additionally, even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND or clinical trial application, Adicet cannot guarantee that such regulatory authorities will not change their requirements in the future. The inability to initiate a clinical trial on ADI-001 or ADI-002, or any of Adicets additional product candidates, on the timelines currently anticipated or at all could have a material adverse effect on Adicets business, results of operations and prospects.
Adicet may encounter substantial delays in its clinical trials, or may not be able to conduct its trials on the timelines Adicet expects.
Clinical testing is expensive, time consuming and subject to uncertainty. Adicet cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. Even if these trials begin as planned, issues may arise that could suspend or terminate such clinical trials. A failure of one or more clinical
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studies can occur at any stage of testing, and Adicets future clinical studies may not be successful. Events that may prevent successful or timely completion of clinical development include:
| inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation of clinical studies; |
| delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for advanced clinical trials; |
| delays in developing suitable assays for screening patients for eligibility for trials with respect to certain product candidates; |
| delays in reaching a consensus with regulatory agencies on study design; |
| delays in reaching agreement on acceptable terms with prospective CROs and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical study sites; |
| delays in obtaining required institutional review board (IRB) approval at each clinical study site; |
| imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND application or amendment, or equivalent application or amendment; as a result of a safety finding that presents unreasonable risk to clinical trial participants; a negative finding from an inspection of Adicets clinical study operations or study sites; developments on trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly; or if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives; |
| delays in recruiting suitable patients to participate in Adicets clinical studies; |
| difficulty collaborating with patient groups and investigators; |
| failure by Adicet CROs, other third parties or it to adhere to clinical study requirements; |
| failure to perform in accordance with the FDAs good clinical practice (GCP) requirements or applicable regulatory guidelines in other countries; |
| transfer of manufacturing processes to any new clinical manufacturing organization (referred to as a CMO) or Adicets own manufacturing facilities or any other development or commercialization partner for the manufacture of product candidates; |
| delays in having patients complete participation in a study or return for post-treatment follow-up; |
| patients dropping out of a study; |
| occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits; |
| changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; |
| changes in the standard of care on which a clinical development plan was based, which may require new or additional trials; |
| the cost of clinical studies of Adicets product candidates being greater than Adicet anticipates; |
| clinical studies of Adicets product candidates producing negative or inconclusive results, which may result in Adicet deciding, or regulators requiring Adicet, to conduct additional clinical studies or abandon product development programs; |
| delays or failure to secure supply agreements with suitable raw material suppliers, or any failures by suppliers to meet Adicet quantity or quality requirements for necessary raw materials; and |
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| delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of Adicets product candidates for use in clinical studies or the inability to do any of the foregoing. |
Adicets timing of filing on these product candidates is dependent on further pre-clinical and manufacturing success, which Adicet works on with various third parties. Adicet cannot be sure that it will be able to submit its IND in a timely manner, if at all, or that submission of an IND or IND amendment will result in the FDA allowing testing and clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate such clinical trials. Additionally, even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND or clinical trial application, Adicet cannot guarantee that such regulatory authorities will not change their requirements in the future.
Any inability to successfully complete preclinical and clinical development could result in additional costs to Adicet or impair Adicets ability to generate revenue. In addition, if Adicet makes manufacturing or formulation changes to its product candidates, Adicet may be required to or Adicet may elect to conduct additional studies to bridge Adicets modified product candidates to earlier versions. Clinical study delays could also shorten any periods during which Adicets products have patent protection and may allow Adicets competitors to bring products to market before Adicet does, which could impair Adicets ability to successfully commercialize Adicets product candidates and may harm Adicets business and results of operations.
Monitoring safety of patients receiving Adicets product candidates is challenging, which could adversely affect Adicets ability to obtain regulatory approval and commercialize.
In Adicets planned clinical trials of its product candidates, Adicet has contracted with and is expected to continue to contract with academic medical centers and hospitals experienced in the assessment and management of toxicities arising during clinical trials. Nonetheless, these centers and hospitals may have difficulty observing patients and treating toxicities, which may be more challenging due to personnel changes, inexperience, shift changes, house staff coverage or related issues. This could lead to more severe or prolonged toxicities or even patient deaths, which could result in Adicet or the FDA delaying, suspending or terminating one or more of Adicets clinical trials, and which could jeopardize regulatory approval. Medicines used at centers to help manage adverse side effects of ADI-001 and ADI-002 may not adequately control the side effects and/or may have a detrimental impact on the efficacy of the treatment. Use of these medicines may increase with new physicians and centers administering Adicets product candidates, any of which could have a material adverse effect on Adicets ability to obtain regulatory approval and commercialize on the timelines anticipated or at all, which could have a material adverse effect on Adicets business and results of operations.
If Adicet encounters difficulties enrolling patients in Adicets clinical trials, Adicets clinical development activities could be delayed or otherwise adversely affected.
Adicet may experience difficulties in patient enrollment in Adicets clinical trials for a variety of reasons, including, without limitation, the impact of the COVID-19 pandemic. The timely completion of clinical trials in accordance with their protocols depends, among other things, on Adicets ability to enroll a sufficient number of patients who remain in the study until its conclusion. The enrollment of patients depends on many factors, including:
| the patient eligibility criteria defined in the protocol; |
| the size of the patient population required for analysis of the trials primary endpoints; |
| the proximity of patients to study sites; |
| the design of the trial; |
| Adicets ability to recruit clinical trial investigators with the appropriate competencies and experience; |
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| Adicets ability to obtain and maintain patient consents; and |
| the risk that patients enrolled in clinical trials will drop out of the trials before the infusion of Adicets product candidates or trial completion. |
Adicet intends to conduct a number of clinical trials for product candidates in the fields of cancer and other indications in geographies which are affected by COVID-19 pandemic. Adicet believes that the coronavirus pandemic will have an impact on various aspects of its future clinical trials. For example, investigators may not want to take the risk of exposing cancer patients to COVID-19 since the dosing of patients is conducted within an in-patient setting. Other potential impacts of the COVID-19 pandemic on Adicets future various clinical trials include patient dosing and study monitoring, which may be paused or delayed due to changes in policies at various clinical sites, federal, state, local or foreign laws, rules and regulations, including quarantines or other travel restrictions, prioritization of healthcare resources toward pandemic efforts, including diminished attention of physicians serving as Adicets clinical trial investigators and reduced availability of site staff supporting the conduct of its clinical trials, interruption or delays in the operations of the government regulators, or other reasons related to the COVID-19 pandemic. It is unknown how long these pauses or disruptions could continue.
In addition, Adicets clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as Adicets product candidates, and this competition will reduce the number and types of patients available to Adicet because some patients who might have opted to enroll in Adicet trials may instead opt to enroll in a trial being conducted by one of Adicets competitors. Since the number of qualified clinical investigators is limited, some of Adicets clinical trial sites are also being used by some of Adicets competitors, which may reduce the number of patients who are available for Adicets clinical trials in that clinical trial site.
Moreover, because Adicets product candidates represent unproven methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy and hematopoietic cell transplantation or autologous CAR-T cell therapies, rather than enroll patients in Adicets clinical trial. Patients eligible for allogeneic CAR-T cell therapies but ineligible for autologous CAR T cell therapies due to aggressive cancer and inability to wait for autologous CAR-T cell therapies may be at greater risk for complications and death from therapy.
Delays in patient enrollment may result in increased costs or may affect the timing or outcome of Adicets ongoing clinical trial and planned clinical trials, which could prevent completion of these trials and adversely affect Adicets ability to advance the development of Adicets product candidates.
Clinical trials are expensive, time-consuming and difficult to design and implement.
Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Because Adicets gamma delta T cell product candidates are based on new technologies and will require the creation of inventory of mass-produced, off-the-shelf products, Adicet expects that it will require extensive research and development and have substantial manufacturing and processing costs. In addition, costs to treat patients with Non Hodgkins lymphoma cancer and to treat potential side effects that may result from Adicets product candidates can be significant. Accordingly, Adicets clinical trial costs are likely to be significantly higher than for more conventional therapeutic technologies or drug products, which is expected to have a material adverse effect on Adicets financial position and ability to achieve profitability.
The market opportunities for Adicets product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small.
The FDA often approves new therapies initially only for use in patients who are currently not adequately treated with currently approved therapies. Adicet expects to initially seek approval of ADI-001 and ADI-002 and Adicets other product candidates in this setting. Subsequently, for those products that prove to be sufficiently
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beneficial, if any, Adicet would expect to seek approval in earlier lines of treatment and potentially as a first line therapy. There is no guarantee that Adicets product candidates, even if approved, would be approved for earlier lines of therapy, and, prior to any such approvals, Adicet will have to conduct additional clinical trials, including potentially comparative trials against approved therapies. Adicet is also targeting a similar patient population as autologous CART product candidates, including approved autologous CART products. Adicets therapies may not be as safe and effective as autologous CART therapies and may only be approved for patients who are ineligible for autologous CART therapy.
Adicets projections of both the number of people who have the cancers Adicet is targeting, as well as the subset of people with these cancers in a position to receive second or later lines of therapy and who have the potential to benefit from treatment with Adicets product candidates, are based on Adicets beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, patient foundations, or market research and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these cancers. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for Adicets product candidates may be limited or may not be amenable to treatment with Adicets product candidates. Even if Adicet obtains significant market share for its product candidates, because the potential target populations are small, Adicet may never achieve profitability without obtaining regulatory approval for additional indications.
If Adicet fails to develop additional product candidates, Adicets commercial opportunity will be limited.
One of Adicets core strategies is to pursue clinical development of additional product candidates beyond ADI-001 and ADI-002. Developing, obtaining regulatory approval and commercializing additional gamma delta T cell product candidates will require substantial additional funding and is prone to the risks of failure inherent in medical product development. Adicet cannot provide you any assurance that it will be able to successfully advance any of these additional product candidates through the development process.
Even if Adicet receives FDA approval to market additional product candidates for the treatment of cancer, Adicet cannot assure you that any such product candidates will be successfully commercialized, widely accepted in the marketplace or more effective than other commercially available alternatives. If Adicet is unable to successfully develop and commercialize additional product candidates, Adicets commercial opportunity will be limited. Moreover, a failure in obtaining regulatory approval of additional product candidates may have a negative effect on the approval process of any other, or result in losing approval of any approved, product candidate which could have a material adverse effect on Adicets business and prospects.
Adicet does not currently operate its own manufacturing facility, which would require significant resources and any failure to successful manufacture its products could adversely affect Adicets clinical trials and the commercial viability of Adicets product candidates.
Adicet may not be able to achieve clinical or commercial manufacturing and cell processing on its own or through its CMOs, including mass-producing off-the-shelf product to satisfy demands for any of Adicets product candidates. Very few companies have experience in manufacturing gamma delta T cell therapy derived from blood of healthy donors and gamma delta T cells require several complex manufacturing steps before being available as a mass-produced, off-the-shelf product. While Adicet believes its manufacturing and processing approaches are appropriate to support Adicets clinical product development, Adicet has limited experience in managing the allogeneic gamma delta T cell engineering process, and Adicets allogeneic processes may be more difficult or more expensive than the approaches taken by Adicets competitors. Adicet cannot be sure that the manufacturing processes employed by or on its behalf will result in T cells that will be safe and effective.
Adicets operations remain subject to review and oversight by the FDA and the FDA could object to Adicets use of any manufacturing facilities. Adicet must first receive approval from the FDA prior to licensure to manufacture Adicets product candidates, which Adicet may never obtain. Even if approved, Adicet would be
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subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with current good manufacturing practices (cGMPs) and other government regulations. Adicets license to manufacture product candidates will be subject to continued regulatory review.
Adicets cost of goods development is at an early stage. The actual cost to manufacture and process Adicets product candidates could be greater than Adicet expects and could materially and adversely affect the commercial viability of its product candidates.
The manufacture of biopharmaceutical products is complex and requires significant expertise, including the development of advanced manufacturing techniques and process controls. Manufacturers of cell therapy products often encounter difficulties in production, particularly in scaling out and validating initial production and ensuring the absence of contamination. These problems include difficulties with production costs and yields, quality control, including stability of the product, quality assurance testing, operator error, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if contaminants are discovered in Adicets supply of product candidates or in the manufacturing facilities, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. Adicet cannot assure you that any stability or other issues relating to the manufacture of Adicets product candidates will not occur in the future.
Adicet may fail to manage the logistics of storing and shipping Adicets product candidates. Storage failures and shipment delays and problems caused by Adicet, Adicets vendors or other factors not in Adicets control, such as weather, could result in loss of usable product or prevent or delay the delivery of product candidates to patients.
Adicet may also experience manufacturing difficulties due to resource constraints or as a result of labor disputes. If Adicet were to encounter any of these difficulties, Adicets ability to provide Adicets product candidates to patients would be jeopardized, which could have a material adverse effect on Adicets business, results of operations and prospects.
Adicet currently has no marketing and sales organization and as a company has no experience in marketing products. If Adicet is unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell Adicets product candidates, Adicet may not be able to generate product revenue.
Adicet currently has no sales, marketing or distribution capabilities and as a company has no experience in marketing products. Adicet may develop a marketing organization and sales force, which will require significant capital expenditures, management resources and time. Adicet will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.
If Adicet is unable or decides not to establish internal sales, marketing and distribution capabilities, Adicet will pursue collaborative arrangements regarding the sales and marketing of Adicets products; however, there can be no assurance that Adicet will be able to establish or maintain such collaborative arrangements, or if Adicet is able to do so, that it will have effective sales forces. Any revenue Adicet receives will depend upon the efforts of such third parties, which may not be successful. Adicet may have little or no control over the marketing and sales efforts of such third parties and Adicets revenue from product sales may be lower than if Adicet had commercialized Adicets product candidates themselves. Adicet also faces competition in its search for third parties to assist it with the sales and marketing efforts of Adicets product candidates.
There can be no assurance that Adicet will be able to develop in-house sales and distribution capabilities or establish or maintain relationships with third-party collaborators to commercialize any product that receives regulatory approval in the United States or overseas. If Adicet is unable to successfully market and distribute its products, Adicets business, results of operations and prospects could be materially adversely effected.
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A variety of risks associated with conducting research and clinical trials abroad and marketing Adicets product candidates internationally could materially adversely affect Adicets business.
Adicet plans to globally develop its product candidates. Accordingly, Adicet expects that it will be subject to additional risks related to operating in foreign countries, including:
| differing regulatory requirements in foreign countries; |
| unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; |
| increased difficulties in managing the logistics and transportation of storing and shipping product candidates produced in the United States and shipping the product candidate to the patient abroad; |
| import and export requirements and restrictions; |
| economic weakness, including inflation, or political instability in particular foreign economies and markets; |
| compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
| foreign taxes, including withholding of payroll taxes; |
| foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; |
| difficulties staffing and managing foreign operations; |
| workforce uncertainty in countries where labor unrest is more common than in the United States; |
| differing payor reimbursement regimes, governmental payors or patient self-pay systems, and price controls; |
| potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign regulations; |
| challenges enforcing Adicets contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States; |
| production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
| business interruptions resulting from geo-political actions, including war and terrorism. |
These and other risks associated with Adicets potential international operations may materially adversely affect Adicets ability to attain or maintain profitable operations, which could have a material adverse effect on Adicets business and results of operations.
Adicet faces significant competition from other biotechnology and pharmaceutical companies, and Adicets operating results will suffer if Adicet fails to compete effectively.
The biopharmaceutical industry, and the immuno-oncology industry specifically, is characterized by intense competition and rapid innovation. Adicets competitors may be able to develop other compounds or drugs that are able to achieve similar or better results. Adicets potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions. Many of Adicets competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations and well-established sales forces. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.
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Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in its competitors. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Adicets competitors, either alone or with collaborative partners, may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or less costly than Adicets product candidates or may develop proprietary technologies or secure patent protection that Adicet may need for the development of Adicets technologies and products.
Specifically, engineered T cells face significant competition in both the CAR and TCR technology space from multiple companies. Even if Adicet obtains regulatory approval of Adicets product candidates, the availability and price of Adicets competitors products could limit the demand and the price Adicet is able to charge for Adicets product candidates. Adicet may not be able to implement its business plan if the acceptance of its product candidates is affected by price competition or the reluctance of physicians to switch from existing methods of treatment to Adicets product candidates, or if physicians switch to other new drug or biologic products or choose to reserve Adicets product candidates for use in limited circumstances.
Adicet is highly dependent on Adicets key personnel, and if Adicet is not successful in attracting and retaining highly qualified personnel, Adicet may not be able to successfully implement its business strategy.
Adicets ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon its ability to attract and retain highly qualified managerial, scientific and medical personnel. Adicet is highly dependent on Adicets management, scientific and medical personnel. The loss of the services of any of Adicets executive officers, other key employees, and other scientific and medical advisors, and its inability to find suitable replacements could result in delays in product development and harm Adicets business.
Adicet conducts substantially all of its operations at its facilities in the San Francisco Bay Area. This region is headquarters to many other biopharmaceutical companies and many academic and research institutions. Competition for skilled personnel in this market is intense and may limit Adicets ability to hire and retain highly qualified personnel on acceptable terms or at all.
To induce valuable employees to remain at the company, in addition to salary and cash incentives, Adicet has provided stock options that vest over time. The value to employees of stock options that vest over time may be significantly affected by fluctuations in Adicets stock price that are beyond Adicets control and may at any time be insufficient to counteract more lucrative offers from other companies. Despite Adicets efforts to retain valuable employees, members of Adicets management, scientific and development teams may terminate their employment with Adicet on short notice. Although Adicet has employment agreements with its key employees, these employment agreements provide for at-will employment, which means that any of Adicets employees could leave Adicets employment at any time, with or without notice. Adicet does not maintain key person insurance policies on the lives of these individuals or the lives of any of Adicets other employees. Adicets success also depends on Adicets ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-level and senior scientific and medical personnel.
Adicet has grown rapidly and will need to continue to grow the size of its organization, and it may experience difficulties in managing this growth.
As Adicets development and commercialization plans and strategies develop, and as Adicet transitions into operating as a public company, Adicet has rapidly expanded its employee base and expects to continue to add managerial, operational, sales, research and development, marketing, financial and other personnel. Current and future growth imposes significant added responsibilities on members of management, including:
| identifying, recruiting, integrating, maintaining and motivating additional employees; |
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| managing Adicets internal development efforts effectively, including the clinical and FDA review process for Adicets product candidates, while complying with Adicets contractual obligations to contractors and other third parties; and |
| improving Adicets operational, financial and management controls, reporting systems and procedures. |
Adicets future financial performance and its ability to commercialize Adicets product candidates will depend, in part, on its ability to effectively manage its growth, and Adicets management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.
Adicet currently relies, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants, which expire after a certain period of time, to provide certain services, including certain research and development as well as general and administrative support. There can be no assurance that the services of independent organizations, advisors and consultants will continue to be available to Adicet on a timely basis when needed, or that Adicet can find qualified replacements. In addition, if Adicet is unable to effectively manage Adicets outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, Adicets clinical trials may be extended, delayed or terminated, and Adicet may not be able to obtain regulatory approval of its product candidates or otherwise advance its business. There can be no assurance that Adicet will be able to manage Adicets existing consultants or find other competent outside contractors and consultants on economically reasonable terms, or at all.
If Adicet is not able to effectively expand its organization by hiring new employees and expanding Adicets groups of consultants and contractors, Adicet may not be able to successfully implement the tasks necessary to further develop and commercialize Adicets product candidates and, accordingly, may not achieve its research, development and commercialization goals, which could have a material adverse effect on Adicets business, results of operations and prospects.
Adicet may form or seek strategic alliances or enter into additional licensing arrangements in the future, and Adicet may not realize the benefits of such alliances or licensing arrangements.
Adicet may form or seek strategic alliances, create joint ventures or collaborations or enter into additional licensing arrangements with third parties that Adicet believes will complement or augment Adicet development and commercialization efforts with respect to Adicets product candidates and any future product candidates that Adicet may develop. Any of these relationships may require Adicet to incur non-recurring and other charges, increase its near and long-term expenditures, issue securities that dilute Adicets existing stockholders or disrupt its management and business. In addition, Adicet faces significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, Adicet may not be successful in its efforts to establish a strategic partnership or other alternative arrangements for Adicets product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view Adicets product candidates as having the requisite potential to demonstrate safety and efficacy. Any delays in entering into new strategic partnership agreements related to Adicets product candidates could delay the development and commercialization of Adicets product candidates in certain geographies for certain indications, which would harm Adicets business prospects, financial condition and results of operations.
If Adicet licenses products or businesses, Adicet may not be able to realize the benefit of such transactions if Adicet is unable to successfully integrate them with Adicets existing operations and company culture. For instance, Adicets Exclusive License and Collaboration Agreement with Regeneron requires significant research and development commitments that may not result in the development and commercialization of product candidates. Adicet cannot be certain that, following a strategic transaction or license, Adicet will achieve the results, revenue or specific net income that justifies such transaction, which could have a material adverse effect on Adicets business and results of operations.
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Adicet will need substantial additional financing to develop Adicets products and implement Adicets operating plans. If Adicet fails to obtain additional financing, Adicet may be unable to complete the development and commercialization of Adicets product candidates.
Adicet expects to spend a substantial amount of capital in the clinical development of Adicets product candidates, including the planned clinical trials for ADI-001 and ADI-002. Adicet will need substantial additional financing to develop Adicets products and implement Adicets operating plans. In particular, Adicet will require substantial additional financing to enable commercial production of Adicets products and initiate and complete registration trials for multiple products. Further, if approved, Adicet will require significant additional amounts in order to launch and commercialize Adicets product candidates.
Adicet believes that its cash, cash equivalents and marketable debt securities will not be sufficient for Adicet to continue as a going concern for at least one year from the issuance date of the accompanying consolidated financial statements. However with funding that Adicet expects to receive under its existing collaborations, together with the existing cash, cash equivalents and investments of resTORbio, assuming the successful completion of the merger, Adicet expects it will be able to fund its operating expenses and capital expenditure requirements through at least December 31, 2021. However, changing circumstances may cause it to consume capital significantly faster than Adicet currently anticipates, and Adicet may need to spend more money than currently expected because of circumstances beyond its control. Adicet may require additional capital for the further development and commercialization of its product candidates, including funding Adicet internal manufacturing capabilities and may need to raise additional funds sooner if Adicet chooses to expand more rapidly than Adicet presently anticipates.
Adicet cannot be certain that additional funding will be available on acceptable terms, or at all. Other than the funding agreement and its loan agreement with Pacific Western Bank, Adicet has no committed source of additional capital and if it is unable to raise additional capital in sufficient amounts or on terms acceptable to it, Adicet may have to significantly delay, scale back or discontinue the development or commercialization of Adicets product candidates or other research and development initiatives. Adicets license agreements may also be terminated if Adicet is unable to meet the payment obligations under the agreements. Adicet could be required to seek collaborators for Adicets product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms Adicets rights to Adicets product candidates in markets where Adicet otherwise would seek to pursue development or commercialization themselves. Additionally, Adicet may not be able to incur indebtedness if the ongoing macroeconomic effects of the COVID-19 pandemic, including certain actions taken by U.S. or other governmental authorities, such as decreases in short-term interest rates as announced by the Federal Reserve, cause the closure of banks for an extended period of time or a sudden increase in requests for indebtedness at one time by many potential borrowers, either or both of which could overwhelm the banking industry.
Any of the above events could significantly harm Adicets business, prospects, financial condition and results of operations and cause the price of the combined companys common stock to decline.
Business disruptions could seriously harm Adicets future revenue and financial condition and increase Adicets costs and expenses.
Adicets operations, and those of Adicets CMO, CROs and other contractors and consultants, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics, such as the COVID-19 pandemic, and other natural or man-made disasters or business interruptions. The occurrence of any of these business disruptions could seriously harm Adicets operations and financial condition and increase its costs and expenses.
Adicets ability to manufacture Adicets product candidates could be disrupted if Adicets operations or those of Adicets suppliers are affected by a man-made or natural disaster or other business interruption. Adicets
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corporate headquarters are located in California near major earthquake faults and fire zones. The ultimate impact on Adicet, its significant suppliers and its general infrastructure of being located near major earthquake faults and fire zones and being consolidated in certain geographical areas is unknown, but Adicets operations and financial condition could suffer in the event of a major earthquake, fire or other natural disaster.
A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect Adicets business and operations.
Adicets business, financial position, results of operations or cash flows may be affected by the ongoing global COVID-19 pandemic and the resulting volatility and uncertainty it has caused, and is likely to continue to cause, in the U.S. and international markets, including as a result of prolonged economic downturn or recession. On March 11, 2020, the World Health Organization declared the recent outbreak of COVID-19 a pandemic. As a result, national, state and local authorities have recommended social distancing and imposed or are considering quarantine, shelter-in-place, curfew and similar isolation measures, including government orders and other restrictions on the conduct of business operations, which has resulted in significant unemployment levels, decreased productivity, decreases in certain non-COVID-19 healthcare activities and healthcare utilization. Such measures have had, and are likely to continue to have, adverse impacts on the U.S. economy of uncertain severity and duration and may negatively impact Adicets operations and those of third parties on which Adicet relies, including by causing disruptions in the supply of its product candidates and the conduct of current and future clinical trials. In addition, the COVID-19 pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals, including with respect to Adicets product candidates. The evolving COVID-19 pandemic is also likely to directly or indirectly impact the pace of enrollment in Adicets future clinical trials as patients may avoid or may not be able to travel to healthcare facilities and physicians offices unless due to a health emergency, and clinical trial sites may be less willing to enroll patients in clinical trials that may compromise a persons immune system. Such facilities and offices may also be required to focus limited resources on non-clinical trial matters, including treatment of COVID-19 patients, and may not be available, in whole or in part, for clinical trial services related to ADI-001 or ADI-002 or Adicets other product candidates. Additionally, while the potential economic impact brought by, and the duration of the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce Adicets ability to access capital, which could negatively impact Adicets short-term and long-term liquidity. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. Due to the uncertain and rapidly evolving nature of current conditions in the United States and around the world, Adicet cannot reasonably estimate the length or severity of the COVID-19 pandemic or the related response, including the length of time it may take for normal economic and operating conditions to resume. Adicet does not yet know the full extent of potential delays or impacts on its business, financing or clinical trial activities or on healthcare systems or the global economy as a whole. However, any of the foregoing risks, or other unforeseen risks related to the COVID-19 pandemic, could have a material impact on Adicets liquidity, capital resources, operations and business and those of the third parties on which it relies.
Inadequate funding for the FDA and other government agencies, or disruptions in their staffing levels related to the COVID-19 global pandemic, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the approval of Adicets product candidates rely, which would negatively impact its business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, adequate staffing, furloughs, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies on which its operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
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Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect Adicets business. For example, over the last several years, including beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process its regulatory submissions, which could have a material adverse effect on Adicets business, including Adicets ability to access the public markets and obtain necessary capital in order to properly capitalize and continue its operations.
Adicets relationships with customers, physicians including clinical investigators, clinical research organizations and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, transparency laws, government price reporting and other healthcare laws and regulations. If Adicet or Adicets employees, independent contractors, consultants, commercial partners, vendors, or other agents violate these laws, Adicet could face substantial penalties.
These laws may impact, among other things, Adicets clinical research program, as well as Adicets proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services is subject to extensive laws and regulations designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive and other business arrangements. Adicet may also be subject to federal, state and foreign laws governing the privacy and security of identifiable patient information. The U.S. healthcare laws and regulations that may affect Adicets ability to operate include, but are not limited to:
| the federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully, offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, the purchasing, leasing, ordering or arranging for the purchase, lease, or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term remuneration has been broadly interpreted to include anything of value. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that may be alleged to be intended to induce prescribing, purchases or recommendations, include any payments of more than fair market value, and may be subject to scrutiny if they do not qualify for an exception or safe harbor. In addition, a person or entity does not need to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act and the civil monetary penalties statute; |
| federal civil and criminal false claims laws and civil monetary penalty laws, including the federal civil False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal government programs that are false or fraudulent or knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government, including federal healthcare programs; |
| the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by any trick, scheme or device, a material fact or making any |
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materially false, fictitious or fraudulent statements in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; |
| HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information; |
| the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Childrens Health Insurance Program (with certain exceptions) to report annually to the United States Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) information related to payments or other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and |
| federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers. |
Additionally, Adicet may be subject to analogous state and foreign healthcare laws described above, among others, some of which may be broader in scope. For example, Adicet may be subject to the following: state anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers, or that apply regardless of payor; state laws that require pharmaceutical companies to comply with the pharmaceutical industrys voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; state and local laws requiring the registration of pharmaceutical sales and medical representatives; and state and foreign laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. Furthermore, Adicet is subject to General Data Protection Regulation (GDPR) and other ex-US protections, as discussed further below.
Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of Adicets business activities, or Adicets arrangements with physicians, could be subject to challenge under one or more of such laws. If Adicet or Adicets employees, independent contractors, consultants, commercial partners and vendors violate these laws, Adicet may be subject to investigations, enforcement actions and/or significant penalties.
Adicet has adopted or will have adopted after the merger, a code of business conduct and ethics, but it is not always possible to identify and deter employee misconduct or business noncompliance, and the precautions Adicet takes to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting Adicet from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Efforts to ensure that Adicets business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that Adicets business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against Adicet, and Adicet is not successful in defending themselves or asserting its rights, those actions could have a significant impact on its business, including the
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imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and/or oversight if Adicet becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment of Adicet operations, any of which could adversely affect Adicets ability to operate its business and its results of operations. In addition, the approval and commercialization of any of Adicets product candidates outside the United States will also likely subject Adicet to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.
Data protection, privacy and similar laws restrict access, use, and disclosure of information, and failure to comply with or adapt to changes in these laws could materially and adversely harm Adicets business.
Adicet is subject to federal and state data privacy and security laws and regulations and Laws and expectations relating to privacy continue to evolve. Changes in these laws may limit Adicets data access, use, and disclosure, and may require increased expenditures. In addition, data protection, privacy and similar laws protect more than patient information and, although they vary by jurisdiction, these laws can extend to employee information, business contact information, provider information, and other information relating to identifiable individuals. For example, the California Consumer Privacy Act requires covered businesses to, among other things, provide disclosures to California consumers regarding the collection, use and disclosure of such consumers personal information and afford such consumers new rights with respect to their personal information, including the right to opt out of certain sales of personal information. Adicet believes that further increased regulation in additional jurisdictions is likely in the area of data privacy. Any of the foregoing may have a material adverse effect on Adicets ability to provide services to patients and, in turn, Adicets results of operations
The collection and use of personal data in the European Union (EU) are governed by the General Data Protection Regulation (GDPR). The GDPR imposes stringent requirements for controllers and processors of personal data, including, for example, more robust disclosures to individuals and a strengthened individual data rights regime, shortened timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to special categories of data, such as health data, and additional obligations when Adicet contract with third-party processors in connection with the processing of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the European Union to the United States and other third countries. In addition, the GDPR provides that EU member states may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric or health data.
The GDPR applies extraterritorially, and Adicet may be subject to the GDPR because of Adicets data processing activities that involve the personal data of individuals located in the European Union, such as in connection with Adicets EU clinical trials. Failure to comply with the requirements of the GDPR and the applicable national data protection laws of the EU member states may result in fines of up to 20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties. GDPR regulations may impose additional responsibility and liability in relation to the personal data that Adicet processes and Adicet may be required to put in place additional mechanisms to ensure compliance with the new data protection rules. This may be onerous and may interrupt or delay Adicets development activities, and adversely affect Adicets business, financial condition, results of operations and prospects.
Data protection, privacy and similar laws protect more than patient information and, although they vary by jurisdiction, these laws can extend to employee information, business contact information, provider information, and other information relating to identifiable individuals. Failure to comply with these laws may result in, among other things, civil and criminal liability, negative publicity, damage to Adicets reputation, and liability under contractual provisions. In addition, compliance with such laws may require increased costs to Adicet or may dictate that Adicet not offer certain types of services in the future.
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If product liability lawsuits are brought against Adicet, Adicet may incur substantial liabilities and may be required to limit commercialization of Adicets product candidates.
Adicet faces an inherent risk of product liability as a result of the future clinical testing of Adicets product candidates and will face an even greater risk if Adicet commercializes any products. For example, Adicet may be sued if Adicets product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If Adicet cannot successfully defend themselves against product liability claims, Adicet may incur substantial liabilities or be required to limit commercialization of Adicets product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:
| decreased demand for Adicets product candidates; |
| injury to Adicets reputation; |
| withdrawal of clinical trial participants; |
| initiation of investigations by regulators; |
| costs to defend the related litigation; |
| a diversion of managements time and Adicets resources; |
| substantial monetary awards to trial participants or patients; |
| product recalls, withdrawals or labeling, marketing or promotional restrictions; |
| loss of revenue; |
| exhaustion of any available insurance and Adicets capital resources; and |
| the inability to commercialize any product candidate. |
Adicets inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products Adicet develop, alone or with corporate collaborators. Adicets insurance policies may also have various exclusions, and Adicet may be subject to a product liability claim for which Adicet has no coverage. Assuming Adicet obtains clinical trial insurance for its clinical trials, Adicet may have to pay amounts awarded by a court or negotiated in a settlement that exceed Adicets coverage limitations or that are not covered by its insurance, and Adicet may not have, or be able to obtain, sufficient capital to pay such amounts. Even if Adicets agreements with any future corporate collaborators entitle it to indemnification against losses, such indemnification may not be available or adequate should any claim arise.
Unstable market and economic conditions may have serious adverse consequences on Adicets business, financial condition and stock price.
The global credit and financial markets have experienced extreme volatility and disruptions in the past several years, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. Adicet believes that the state of global economic conditions are particularly volatile and uncertain, not only in light of the COVID-19 pandemic and the potential global recession resulting therefrom, but also due to recent and expected shifts in political, legislative and regulatory conditions concerning, among other matters, international trade and taxation, and that an uneven recovery or a renewed global downturn may negatively impact Adicets ability to conduct clinical trials on the scale and timelines anticipated. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. Adicets general business
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strategy may be adversely affected by any such economic downturn, volatile business environment or continued unpredictable and unstable market conditions. If the current equity and credit markets deteriorate, it may make obtaining any necessary debt or equity financing more difficult, more costly and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on Adicets growth strategy, financial performance and stock price and could require Adicet to delay or abandon clinical development plans. In addition, there is a risk that one or more of Adicets current service providers, manufacturers and other partners may not survive an economic downturn, which could directly affect Adicets ability to attain Adicets operating goals on schedule and on budget. To the extent that Adicets profitability and strategies are negatively affected by downturns or volatility in general economic conditions, Adicets business and results of operations may be materially adversely affected.
Legal, regulatory, political and economic uncertainty surrounding the exit of the U.K. from the European Union may be a source of instability in international markets, create significant currency fluctuations, adversely affect operations in the U.K. and pose additional risks to Adicets business.
Following the result of a referendum in 2016, the U.K. left the EU on January 31, 2020, commonly referred to as Brexit. Pursuant to the formal withdrawal arrangements agreed between the U.K. and the EU, the U.K. will be subject to a transition period until December 31, 2020 (Transition Period), during which EU rules will continue to apply. Negotiations between the U.K. and the EU are expected to continue in relation to the customs and trading relationship between the U.K. and the EU following the expiry of the Transition Period. Such a withdrawal from the EU is unprecedented, and it is unclear how the U.Ks access to the European single market for goods, capital, services and labor within the EU, or single market, and the wider commercial, legal and regulatory environment, will impact its business.
The uncertainty concerning the U.Ks legal, regulatory, political and economic relationship with the EU after the Transition Period may be a source of instability in the international markets, create significant currency fluctuations, and/or otherwise adversely affect trading agreements or similar cross-border co-operation arrangements (whether economic, tax, fiscal, legal, regulatory or otherwise). It could also lead to a period of considerable uncertainty in relation to the regulatory process for drug development and approval in Europe, and make it more costly or difficult to advance Adicets product candidates in the EU and U.K.
Adicets ability to use net operating losses and research and development credits to offset future taxable income may be subject to certain limitations as a result of the merger.
As of December 31, 2019, Adicet had federal net operating loss carryforwards of $39.0 million, all of which can be carried forward indefinitely. As of December 31, 2019, Adicet had state net operating loss carryforwards of $4.9 million, which begin to expire in various amounts in 2035. A portion of these net operating loss carryforwards could expire unused and be unavailable to offset future income tax liabilities. In addition, in general, under Sections 382 and 383 of the Code, a corporation that undergoes an ownership change is subject to limitations on its ability to utilize its pre-change net operating losses or tax credits, or NOLs or credits, to offset future taxable income or taxes. For these purposes, an ownership change generally occurs where the aggregate stock ownership of one or more stockholders or groups of stockholders who owns at least 5% of a corporations stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period. Adicet has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Companys stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. In addition, the merger, if consummated, may constitute
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an ownership change under Sections 382 and 383 of the Code. Adicets NOLs or credits may also be impaired under state law. Accordingly, Adicet may not be able to utilize a material portion of Adicets NOLs or credits.
The ability of the combined company to utilize Adicets NOLs or credits following the merger is conditioned upon the combined company attaining profitability and generating U.S. federal and state taxable income. As described above under the sections entitled Risk FactorsRisk Factors-Risks Related to resTORbios Financial Position and Need for Capital and Risk FactorsRisks Related to Adicets Business and Industry on pages 36 and 100, respectively, of this proxy statement/prospectus/information statement, each of resTORbio and Adicet has incurred significant net losses since inception and it is anticipated that each will continue to incur significant losses for the foreseeable future; and therefore, resTORbio does not know whether or when the combined company will generate the U.S. federal or state taxable income necessary to utilize Adicets NOL or credit carryforwards that may be or may become subject to limitation by Sections 382 and 383 of the Code.
Raising funds through lending arrangements may restrict Adicets operations or produce other adverse results.
On April 28, 2020, Adicet entered into a Loan and Security Agreement with Pacific Western Bank for a term loan not exceeding $12.0 million (as amended, referred to as the Loan Agreement) to finance leasehold improvements for its new corporate headquarters in Redwood City, California and other purposes permitted under the Loan Agreement, with an interest rate equal to the greater of 0.25% above the Prime Rate (as defined in the Loan Agreement) or 5.00%. The Loan Agreement granted to Pacific Western Bank a security interest on substantially all of Adicets assets other than intellectual property to secure the performance of Adicets obligations under the Loan Agreement, and contains a variety of affirmative and negative covenants, including required financial reporting, limitations on certain dispositions of assets or distributions, limitations on the incurrence of additional debt or liens and other customary requirements.
In connection with the entrance into the Loan Agreement, Adicet issued Pacific Western Bank a warrant to purchase shares of its Series B redeemable convertible preferred stock (described below) at an exercise price of $1.4034 per share (referred to as the Existing PacWest Warrant) which was later assigned to an affiliate of Pacific Western Bank. The Existing PacWest Warrant is initially exercisable for 42,753 shares of Adicets Series B redeemable convertible preferred stock and shall be exercisable for an additional number of shares of its Series B redeemable convertible preferred stock equal to 1.00% of the aggregate original principal amount of all term loans made pursuant to the Loan Agreement (up to an aggregate maximum of 128,259 shares). Pursuant to the terms of the Existing PacWest Warrant and the merger agreement, at the effective time of the merger, resTORbio will issue a new warrant to the holder of the Existing PacWest Warrant (referred to as the New PacWest Warrant) which will replace the Existing PacWest Warrant. The New PacWest Warrant will be exercisable solely for shares of resTORbio common stock and the number of shares of resTORbio common stock subject to the warrant shall be determined by multiplying (x) the number of shares of Adicet capital stock that were subject to the Existing PacWest Warrant (on an as-converted basis with respect to shares of Adicet preferred stock), as in effect immediately prior to the effective time of the merger, by (y) the exchange ratio, and rounding the resulting number down to the nearest whole number of shares of resTORbio common stock. The per share exercise price for the resTORbio common stock issuable upon exercise of the New PacWest Warrant shall be determined by dividing (x) the exercise price per share of Adicet capital stock subject to the Existing PacWest Warrant (on an asconverted basis), as in effect immediately prior to the effective time of the merger, by (y) the exchange ratio, and rounding the resulting exercise price up to the nearest whole cent. Any restriction on the exercise set forth in the Existing PacWest Warrant shall continue in full force and effect in the New PacWest Warrant and the term, exercisability, vesting schedule and other provisions of the Existing PacWest warrant shall otherwise remain unchanged in the New PacWest Warrant.
Adicets failure to comply with the covenants in the Loan Agreement, the occurrence of a material impairment in its operations, business or financial condition, its ability to repay the loan, or in the value, perfection or priority of Pacific Western Banks lien on Adicets assets, as determined by Pacific Western Bank, or the occurrence of certain other specified events could result in an event of default that, if not cured or waived, could result in the acceleration of all or a substantial portion of its debt, potential foreclosure on its assets and other adverse results. Additionally, Adicet is bound by certain negative covenants setting forth actions that are not permitted to be taken during the term of the Loan Agreement without consent of Pacific Western Bank, including, without limitation, incurring certain
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additional indebtedness, making certain asset dispositions or distributions, entering into certain mergers, acquisitions or other business combination transactions or incurring any non-permitted lien or other encumbrance on its assets. Pursuant to the terms of the Loan Agreement, Pacific Western Bank has consented in principle to the consummation of the merger as a Permitted Transaction (as defined in the Loan Agreement) subject to certain conditions, including: (i) that the merger is consummated in accordance with the merger agreement (unless otherwise approved by Pacific Western Bank in writing), (ii) Adicet providing copies of all material transaction documents to Pacific Western Bank, (iii) Adicet providing any diligence materials reasonably requested by Pacific Western Bank, (iv) resTORbio entering into a secured guaranty agreement in form and substance satisfactory to Pacific Western Bank and granting Pacific Western Bank a security interest in substantially all of its assets other than its intellectual property and (v) resTORbio issuing the New PacWest Warrant to the holder of the Existing PacWest Warrant pursuant to the terms of the merger agreement and the Existing PacWest Warrant. The foregoing prohibitions and constraints on its operations could result in Adicets inability to: (a) acquire promising intellectual property or other assets on desired timelines or terms; (b) reduce costs by disposing of assets or business segments no longer deemed advantageous to retain; (c) stimulate further corporate growth or development through the assumption of additional debt; or (d) enter into other arrangements that necessitate the imposition of a lien on corporate assets. Moreover, if the conditions set forth in the consent provided by Pacific Western Bank are not satisfied, Adicet would effectively need to terminate the Loan Agreement and repay any outstanding loan funds or refinance the facility with another lender. As of the date of this proxy statement/prospectus/information statement, no amounts have been drawn under the Loan Agreement.
Adicets internal computer systems, or those used by Adicets CROs or other contractors or consultants, may fail or suffer security breaches.
Adicets internal computer systems and the systems of Adicets CROs, contractors and consultants are vulnerable to damage from computer viruses and unauthorized access. Additionally, as a result of the ongoing COVID-19 pandemic, Adicet has transitioned certain of its workforce to a remote working model. As Adicets employees and Adicets business partners employees work from home and access Adicets systems remotely, Adicet may be subject to heightened security and privacy risks, including the risks of cyberattacks and privacy incidents. While Adicet has not experienced any such material system failure or security breach to date, if such an event were to occur and cause interruptions in Adicets operations, it could result in a material disruption of Adicets development programs and Adicets business operations. For example, the loss of clinical trial data from future clinical trials could result in delays in Adicets regulatory approval efforts and significantly increase Adicets costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, Adicets data or applications, or inappropriate disclosure of confidential or proprietary information, Adicet could incur liability and the further development and commercialization of Adicets product candidates could be delayed.
Adicet may not realize the benefits of acquired assets or other strategic transactions.
Adicet actively evaluates various strategic transactions on an ongoing basis. Adicet may acquire other businesses, products or technologies as well as pursue joint ventures or investments in complementary businesses. The success of Adicets strategic transactions, and any future strategic transactions depends on the risks and uncertainties involved including:
| unanticipated liabilities related to acquired companies or joint ventures; |
| difficulties integrating acquired personnel, technologies and operations into Adicets existing business; |
| retention of key employees; |
| diversion of management time and focus from operating its business to management of strategic alliances or joint ventures or acquisition integration challenges; |
| increases in Adicets expenses and reductions in Adicets cash available for operations and other uses; |
| disruption in Adicets relationships with collaborators or suppliers as a result of such a transaction; and |
| possible write-offs or impairment charges relating to acquired businesses or joint ventures. |
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If any of these risks or uncertainties occur, Adicet may not realize the anticipated benefit of any acquisition or strategic transaction. Additionally, foreign acquisitions and joint ventures are subject to additional risks, including those related to integration of operations across different cultures and languages, currency risks, potentially adverse tax consequences of overseas operations and the particular economic, political and regulatory risks associated with specific countries.
Future acquisitions or dispositions could result in potentially dilutive issuances of Adicets equity securities, the incurrence of debt, contingent liabilities or amortization expenses or write-offs of goodwill, any of which could have a material adverse effect on Adicets financial condition.
Adicet has identified material weaknesses in its internal control over financial reporting. Failure to achieve and maintain effective internal control over financial reporting could harm its business and negatively impact the value of its common stock.
Adicet has identified material weaknesses in its internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of Adicets annual or interim financial statements will not be prevented or detected on a timely basis. In connection with the audit of Adicets financial statements as of and for the years ended December 31, 2019 and 2018, Adicet identified material weaknesses in its internal control over financial reporting. The material weaknesses Adicet identified were as follows: (i) Adicet did not design or maintain an effective control environment commensurate with its financial reporting requirements due to lack of a sufficient number of accounting professionals with the appropriate level of experience and training; (ii) Adicet did not design and maintain formal accounting policies, procedures and controls to achieve complete, accurate and timely financial accounting, reporting and disclosures, and monitoring controls maintained at the corporate level were not at a sufficient level of precision to provide for the appropriate level of oversight of activities related to Adicets internal control over financial reporting; (iii) Adicet did not design and maintain effective controls over segregation of duties with respect to the preparation and review of account reconciliations as well as creating and posting manual journal entries; and (iv) Adicet did not design and maintain formal accounting policies, processes and controls to analyze, account for and disclose complex transactions.
Additionally, each of the control deficiencies could result in a misstatement of Adicets accounts or disclosures that would result in a material misstatement of its annual or interim financial statements that would not be prevented or detected, and accordingly, Adicet determined that these control deficiencies constitute material weaknesses.
Risks Related to Adicets Reliance on Third Parties
If Adicets collaboration with Regeneron is terminated, or if Regeneron materially breaches its obligations thereunder, Adicets business, prospects, operating results, and financial condition would be materially harmed.
Adicets financial performance may be significantly affected by its Regeneron collaboration that it has entered into to develop next-generation engineered immune-cell therapeutics with fully human chimeric antigen receptors (referred to as CARs) and T-cell receptors (referred to as TCRs) directed to disease-specific cell surface antigens in order to enable the precise engagement and killing of tumor cells. Under Adicets agreement with Regeneron, Regeneron provided Adicet with an upfront payment of $25 million and additional payments for research funding and Adicet will collaborate with Regeneron to identify and validate targets and develop a pipeline of engineered immune-cell therapeutics for selected targets. Regeneron has the option to obtain development and commercial rights for a certain number of the product candidates developed by the parties, subject to an option payment for each product candidate. If Regeneron exercises its option on a given product candidate, Adicet then has an option to participate in the development and commercialization for such product. If Adicet does not exercise its option, Adicet will be entitled to royalties on any future sales of such products by Regeneron. In addition to developing CARs and TCRs for use in novel immune-cell therapies as part of the collaboration, Regeneron will have the right to use these CARs and TCRs in its other antibody programs outside of the collaboration. Regeneron will also be entitled to royalties on any future sales of products developed and commercialized by Adicet under the agreement. If Regeneron were to terminate its collaboration agreement with
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Adicet, Adicet may not have the resources or skills to replace those of its collaborator, which could require Adicet to seek additional funding or another collaboration that might not be available on favorable terms or at all, and could cause significant delays in development and/or commercialization efforts and result in substantial additional costs to Adicet. Termination of such collaboration agreement or the loss of rights provided to Adicet under such agreement may create substantial new and additional risks to the successful development and commercialization of its products and could materially harm its financial condition and operating results.
Regeneron may change its strategic focus or pursue alternative technologies in a manner that results in reduced, delayed or no revenue to Adicet under the agreement. Regeneron has a variety of marketed products and product candidates either by itself or under collaboration with other companies, including some of Adicets competitors, and the corporate objectives of Regeneron may not be consistent with Adicets best interests. Regeneron may change its position regarding its participation and funding of Adicet and Regeneron joint activities, which may impact Adicets ability to successfully pursue the program.
Adicets existing and future collaborations will be important to its business. If Adicet is unable to maintain any of these collaborations, or if these collaborations are not successful, its business could be adversely affected.
Adicet has entered, and plans to enter, into collaborations with other companies, including its collaboration agreement with Regeneron, that Adicet believes can provide it with additional capabilities beneficial to its business. The collaboration with Regeneron provides Adicet with important technologies, expertise and funding for Adicets programs and technology, and Adicet expects to receive additional technologies, expertise and funding under this and other collaborations in the future. Adicets existing therapeutic collaborations, and any future collaborations it enters into, may pose a number of risks, including the following:
| collaborators have significant discretion in determining the efforts and resources that they will apply; |
| collaborators may not perform their obligations as expected; |
| collaborators may dispute the amounts of payments owed; |
| collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs or license arrangements based on clinical trial results, changes in the collaborators strategic focus or available funding, or external factors, such as a strategic transaction that may divert resources or create competing priorities; |
| collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; |
| collaborators could develop independently, or with third parties, products that compete directly or indirectly with Adicets products and product candidates if the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than Adicets; |
| product candidates discovered in collaboration with Adicet may be viewed by its collaborators as competitive with its own product candidates or products, which may cause collaborators to cease to devote resources to the development or commercialization of its product candidates; |
| collaborators may dispute ownership or rights in jointly developed technologies or intellectual property; |
| collaborators may fail to comply with applicable legal and regulatory requirements regarding the development, manufacture, sale, distribution or marketing of a product candidate or product; |
| collaborators with sales, marketing, manufacturing and distribution rights to one or more of Adicets product candidates that achieve regulatory approval may not commit sufficient resources to the sale, marketing, manufacturing and distribution of such product or products; |
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| disagreements with collaborators, including disagreements over proprietary rights, contract interpretation, payment obligations or the preferred course of discovery, development, sales or marketing, might cause delays or terminations of the research, development or commercialization of product candidates, might lead to additional and burdensome responsibilities for Adicet with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; |
| collaborators may not properly maintain or defend their or Adicets relevant intellectual property rights or may use Adicets proprietary information in such a way as to invite litigation that could jeopardize or invalidate Adicets intellectual property or proprietary information or expose Adicet to potential litigation and liability; |
| collaborators may infringe the intellectual property rights of third parties, which may expose Adicet to litigation and potential liability; |
| if a collaborator of Adicets is involved in a business combination or cessation, the collaborator might deemphasize or terminate the development or commercialization of any product candidate licensed to it by Adicet; and |
| collaborations may be terminated by the collaborator, and, if terminated, Adicet could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates, or potentially lose access to the collaborators intellectual property. |
If Adicets therapeutic collaborations do not result in the successful discovery, development and commercialization of products or if one of its collaborators terminates its agreement with Adicet, it may not receive any future research funding or milestone or royalty payments under the collaboration. If Adicet does not receive the funding it expects under these agreements, its development and commercialization of its technology and product candidates could be delayed and Adicet may need additional resources to develop product candidates and its technology. All of the risks relating to product discovery, development, regulatory approval and commercialization described in these risk factors also apply to the activities of Adicets therapeutic collaborators.
In addition to the Regeneron collaboration described above, for some of Adicets programs, it may in the future determine to collaborate with pharmaceutical and biotechnology companies for discovery, development and potential commercialization of therapeutic products. Adicet faces significant competition in seeking appropriate collaborators because, for example, third-parties also have rights to allogeneic T-cell technologies. For example, in April 2020, Johnson & Johnson entered into a collaboration agreement with Fate Therapeutics, a company that is also using allogeneic T-cell technologies, for up to four CAR NK and CAR-T cell therapies. Adicets ability to reach a definitive agreement for a collaboration will depend, among other things, upon its assessment of the collaborators resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborators evaluation of a number of factors. If Adicet is unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, it may have to curtail discovery efforts or the development of a product candidate, reduce or delay its development program or one or more of its other development programs, delay its potential manufacture or commercialization, or reduce the scope of any sales or marketing activities, or increase its expenditures and undertake development or commercialization activities at its expense. If Adicet elects to fund and undertake discovery, development, manufacturing or commercialization activities on its own, it may need to obtain additional expertise and additional capital, which may not be available to it on acceptable terms or at all. If Adicet fails to enter into collaborations and does not have sufficient funds or expertise to undertake the necessary discovery, development, manufacturing and commercialization activities, it may not be able to further develop its product candidates, manufacture the product candidates, bring them to market or continue to develop its technology and Adicets business may be materially and adversely affected.
Adicet is subject to certain exclusivity obligations under its agreement with Regeneron.
During the five year period following the effective date of the Regeneron agreement, with certain limited exceptions, Adicet may not directly or indirectly research, develop, manufacture or commercialize a gamma delta immune cell
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therapeutic (referred to as an ICP), or grant a license to do the foregoing, except pursuant to the terms of the Regeneron agreement. Both parties also have obligations not to research, develop, manufacture or commercialize an ICP with the same target as one being developed under a research program or commercialized by a party (and royalty bearing under the agreement), for so long as such activities are occurring. These exclusivity obligations are limited to engineered gamma delta immune cells to targets reasonably considered to have therapeutic relevance in oncology. If Adicets collaboration with Regeneron is not successful, including any failure caused by the risks listed in the preceding paragraphs, and the agreement and research programs are not terminated, Adicet may not be able to enter into collaborations with other companies with respect to ICPs and its business could be adversely affected.
As a result, Adicets ability to advance any gamma delta immune cell therapeutics outside of the scope of the research plan agreed on with Regeneron is limited through July 29, 2021. Adicet may have to forego business opportunities, and will also be limited in the gamma delta immune cell therapeutics it can advance on its own. The restrictions on internal development may also prevent Adicet from, outside of the scope of research conducted with Regeneron, improving its own technologies relating to gamma delta immune cells. These limitations could lead to delays in Adicets ability to discover and develop gamma delta immune cell therapeutics for targets not covered by the collaboration with Regeneron and loss of opportunities to obtain additional research funding and advance its own technologies separately from the Regeneron collaboration. If Adicet is delayed in its ability to advance its technologies, its business could be harmed.
Adicet relies and will continue to rely on third parties to conduct Adicets clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, Adicet may not be able to obtain regulatory approval of or commercialize Adicets product candidates.
Adicet depends and will continue to depend upon independent investigators and collaborators, such as universities, medical institutions, CROs and strategic partners to conduct Adicets preclinical and clinical trials under agreements with Adicet.
Adicet negotiates budgets and contracts with CROs and study sites, which may result in delays to Adicets development timelines and increased costs. Adicet will rely heavily on these third parties over the course of Adicets clinical trials, and Adicet controls only certain aspects of their activities. Nevertheless, Adicet is responsible for ensuring that each of its studies is conducted in accordance with applicable protocol, legal, regulatory and scientific standards, and its reliance on third parties does not relieve Adicet of its regulatory responsibilities. Adicet and these third parties are required to comply with GCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If Adicet or any of these third parties fail to comply with applicable GCP regulations, the clinical data generated in Adicets clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Adicet to perform additional clinical trials before approving Adicets marketing applications. Adicet cannot assure you that, upon inspection, such regulatory authorities will determine that any of Adicets clinical trials comply with the GCP regulations. In addition, Adicets clinical trials must be conducted with biologic product produced under cGMPs and will require a large number of test patients. Adicets failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require Adicet to repeat clinical trials, which would delay the regulatory approval process. Moreover, Adicets business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.
Any third parties conducting Adicets clinical trials are and will not be Adicets employees and, except for remedies available to Adicet under its agreements with such third parties, Adicet cannot control whether or not they devote sufficient time and resources to Adicets ongoing preclinical, clinical and nonclinical programs. These third parties may also have relationships with other commercial entities, including Adicets competitors, for whom they may also be conducting clinical studies or other drug development activities, which could affect their performance on Adicets behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to Adicets clinical protocols or regulatory requirements or for other
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reasons, Adicets clinical trials may be extended, delayed or terminated and Adicet may not be able to complete development of, obtain regulatory approval of or successfully commercialize Adicets product candidates. As a result, Adicets financial results and the commercial prospects for Adicets product candidates would be harmed, Adicets costs could increase and Adicets ability to generate revenue could be delayed.
If any of Adicets relationships with trial sites, or any CRO that Adicet may use in the future, terminates, Adicet may not be able to enter into arrangements with alternative trial sites or CROs or do so on commercially reasonable terms. Switching or adding third parties to conduct Adicets clinical trials will involve substantial cost and require extensive management time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, delays occur, which can materially impact Adicets ability to meet its desired clinical development timelines.
Adicet may rely on third parties to manufacture Adicets clinical product supplies, and Adicet may have to rely on third parties to produce and process Adicets product candidates, if approved.
Adicet must currently rely on outside vendors to manufacture supplies and process Adicets product candidates. Adicet has not yet caused its product candidates to be manufactured or processed on a commercial scale and may not be able to achieve manufacturing and processing and may be unable to create an inventory of mass-produced, off-the-shelf product to satisfy demands for any of Adicets product candidates.
Adicet does not yet have sufficient information to reliably estimate the cost of the commercial manufacturing and processing of Adicets product candidates, and the actual cost to manufacture and process Adicets product candidates could materially and adversely affect the commercial viability of its product candidates. As a result, Adicet may never be able to develop a commercially viable product.
In addition, Adicet anticipates reliance on a limited number of third-party manufacturers exposes it to the following risks:
| Adicet may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA may have questions regarding any replacement contractor. This may require new testing and regulatory interactions. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of Adicets products after receipt of FDA questions, if any. |
| Adicets third-party manufacturers might be unable to timely formulate and manufacture Adicets product or produce the quantity and quality required to meet Adicets clinical and commercial needs, if any. |
| Contract manufacturers may not be able to execute Adicets manufacturing procedures appropriately. |
| Adicets future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply Adicets clinical trials or to successfully produce, store and distribute Adicets products. |
| Manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the Drug Enforcement Administration and corresponding state agencies to ensure strict compliance with cGMP and other government regulations and corresponding foreign standards. Adicet does not have control over third-party manufacturers compliance with these regulations and standards. |
| Adicet may not own, or may have to share, the intellectual property rights to any improvements made by Adicets third-party manufacturers in the manufacturing process for Adicets products. |
| Adicets third-party manufacturers could breach or terminate their agreement(s) with Adicet. |
Adicets contract manufacturers would also be subject to the same risks Adicet faces in developing its own manufacturing capabilities, as described above. Each of these risks could delay Adicets clinical trials, the
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approval, if any, of Adicets product candidates by the FDA or the commercialization of Adicets product candidates or result in higher costs or deprive Adicet of potential product revenue. In addition, Adicet will rely on third parties to perform release tests on Adicets product candidates prior to delivery to patients. If these tests are not appropriately done and test data are not reliable, patients could be put at risk of serious harm.
Cell-based therapies rely on the availability of specialty raw materials, which may not be available to Adicet on acceptable terms or at all.
Adicets product candidates require many specialty raw materials, including viral vectors that deliver the targeting moiety (CAR) and other genes to the product candidate. Adicet currently manufactures through contract manufacturers, some of which are manufactured by companies with limited resources and experience to support a commercial product, and the suppliers may not be able to deliver raw materials to Adicets specifications. In addition, those suppliers normally support blood-based hospital businesses and generally do not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms. The suppliers may be ill-equipped to support Adicets needs, especially in non-routine circumstances like an FDA inspection or medical crisis, such as widespread contamination. Adicet also does not have contracts with many of these suppliers, and Adicet may not be able to contract with them on acceptable terms or at all. Accordingly, Adicet may experience delays in receiving key raw materials to support clinical or commercial manufacturing.
In addition, some raw materials utilized in the manufacture of Adicets candidates are currently available from a single supplier, or a small number of suppliers. Adicet cannot be sure that these suppliers will remain in business or that they will not be purchased by one of Adicets competitors or another company that is not interested in continuing to produce these materials for Adicets intended purpose. In addition, the lead time needed to establish a relationship with a new supplier can be lengthy, and Adicet may experience delays in meeting demand in the event Adicet must switch to a new supplier. The time and effort to qualify a new supplier could result in additional costs, diversion of resources or reduced manufacturing yields, any of which would negatively impact Adicets operating results. Further, Adicet may be unable to enter into agreements with a new supplier on commercially reasonable terms, which could have a material adverse impact on Adicets business.
If Adicet or Adicets third-party suppliers use hazardous, non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, Adicet may be liable for damages.
Adicets research and development activities involve the controlled use of potentially hazardous substances, including chemical and biological materials. Adicet and its suppliers are subject to federal, state and local laws and regulations in the United States governing the use, manufacture, storage, handling and disposal of medical and hazardous materials. Although Adicet believes that its and its suppliers procedures for using, handling, storing and disposing of these materials comply with legally prescribed standards, Adicet and its suppliers cannot completely eliminate the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, Adicet may incur liability or local, city, state or federal authorities may curtail the use of these materials and interrupt Adicets business operations. In the event of an accident, Adicet could be held liable for damages or penalized with fines, and the liability could exceed Adicets resources. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair Adicets research, development and production efforts, which could harm Adicets business, prospects, financial condition or results of operations.
Risks Related to Government Regulation
The FDA regulatory approval process is lengthy and time-consuming, and Adicet may experience significant delays in the clinical development and regulatory approval of Adicets product candidates.
The research, testing, manufacturing, labeling, approval, selling, import, export, marketing, and distribution of drug products, including biologics, are subject to extensive regulation by the FDA and other regulatory authorities in the United States. Adicet is not permitted to market any biological drug product in the United States until it receives approval of a biologics license application (referred to as a BLA) from the FDA. Adicet
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has not previously submitted a BLA to the FDA, or similar approval filings to comparable foreign authorities. A BLA must include extensive preclinical and clinical data and sufficient supporting information to establish the product candidates safety and effectiveness for each desired indication. The BLA must also include significant information regarding the chemistry, manufacturing and controls for the product.
Adicet expects the novel nature of Adicets product candidates to create further challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercial development of allogeneic T cell therapies for cancer. Adicet may also request regulatory approval of future product candidates by target, regardless of cancer type or origin, which the FDA may have difficulty accepting if Adicets clinical trials only involved cancers of certain origins. The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure. The opinion of the Advisory Committee, although not binding, may have a significant impact on Adicets ability to obtain licensure of the product candidates based on the completed clinical trials, as the FDA often adheres to the Advisory Committees recommendations. Accordingly, the regulatory approval pathway for Adicets product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.
Adicet may also experience delays in obtaining regulatory approvals, including but not limited to:
| obtaining regulatory authorization to begin a trial, if applicable; |
| redesigning its study protocols and need to conduct additional studies as may be required by a regulator; |
| governmental or regulatory delays and changes in regulation or policy relating to the development and commercialization of its product candidate by the FDA or other comparable foreign regulatory authorities; |
| the outcome, timing and cost of meeting regulatory requirements established by the FDA, and other comparable foreign regulatory authorities; |
| the availability of financial resources to commence and complete the planned trials; |
| negotiating the terms of any collaboration agreements Adicet may choose to initiate or conclude; |
| reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
| failure of third-party contractors, such as CROs, or investigators to comply with regulatory requirements, including good clinical practice standards (GCPs); |
| clinical sites deviating from trial protocol or dropping out of a trial; |
| delay or failure in obtaining the necessary approvals from regulators or institutional review boards, or IRBs, in order to commence a clinical trial at a prospective trial site, or their suspension or termination of a clinical trial once commenced; |
| Inability to recruit and enroll suitable patients to participate in a trial; |
| having patients complete a trial, including having patients enrolled in clinical trials dropping out of the trial before the product candidate is manufactured and returned to the site, or return for post-treatment follow-up; |
| difficulty in having patients complete a trial or return for post-treatment follow-up; |
| clinical trial sites deviating from trial protocol or dropping out of a trial; |
| addressing any patient safety concerns that arise during the course of a trial; |
| inability to add new clinical trial sites; or |
| varying interpretations of the data generated from its preclinical or clinical trials; |
| the cost of defending intellectual property disputes, including patent infringement actions brought by third parties; |
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| the effect of competing technological and market developments; |
| the cost and timing of establishing, expanding and scaling manufacturing capabilities; |
| inability to manufacture, or obtain from third parties, sufficient quantities of qualified materials under Current Good Manufacturing Practice standards (cGMPs), for the completion in pre-clinical and clinical studies; |
| problems with biopharmaceutical product candidate storage, stability and distribution resulting in global supply chain disruptions; |
| the cost of establishing sales, marketing and distribution capabilities for any product candidate for which Adicet may receive regulatory approval in regions where Adicet chooses to commercialize its products on its own; or |
| potential unforeseen business disruptions or market fluctuations that delay its product development or clinical trials and increase its costs or expenses, such as business or operational disruptions, delays, or system failures due to malware, unauthorized access, terrorism, war, natural disasters, strikes, geopolitical conflicts, restrictions on trade, import or export restrictions, or public health crises, such as the current COVID-19 pandemic. |
Adicet could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of Adicets product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles. Further, a clinical trial may be suspended or terminated by Adicet, the IRBs for the institutions in which such trials are being conducted or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or Adicet clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions, lack of adequate funding to continue the clinical trial, or based on a recommendation by the Data Safety Monitoring Committee. If Adicet experiences termination of, or delays in the completion of, any clinical trial of Adicets product candidates, the commercial prospects for Adicets product candidates will be harmed, and Adicets ability to generate product revenue will be delayed. In addition, any delays in completing Adicets clinical trials will increase Adicets costs, slow down Adicets product development and approval process and jeopardize Adicets ability to commence product sales and generate revenue.
Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of Adicets product candidates.
Adicet expects the product candidates it develops will be regulated as biological products, or biologics, and therefore they may be subject to competition sooner than anticipated.
The Biologics Price Competition and Innovation Act of 2009 (referred to as BPCIA) was enacted as part of the Affordable Care Act to establish an abbreviated pathway for the approval of biosimilar and interchangeable biological products. The regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as interchangeable based on its similarity to an approved biologic. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the reference product was approved under a BLA. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain when such processes intended to implement the BPCIA may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for Adicet biological products.
Adicet believes that any of the product candidates Adicet develops that are approved in the United States as a biological product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that
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this exclusivity could be shortened due to congressional action or otherwise, potentially creating the opportunity for generic competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of the reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.
The regulatory landscape that will govern Adicets product candidates is uncertain; regulations relating to more established cell therapy products are still developing, and changes in regulatory requirements could result in delays or discontinuation of development of Adicets product candidates or unexpected costs in obtaining regulatory approval.
Government authorities in the United States at the federal, state and local level and in other countries regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug and biological products. Generally, before a new drug or biologic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved by the regulatory authority.
Because Adicet is developing novel allogeneic cell immunotherapy product candidates, the regulatory requirements that Adicet will be subject to are not entirely clear. Even with respect to more established products that fit into the category of cell therapies, the regulatory landscape is still developing. For example, regulatory requirements governing cell therapy products have changed frequently and may continue to change in the future. Moreover, there is substantial, and sometimes uncoordinated, overlap in those responsible for regulation of existing cell therapy products.
Complex regulatory environments exist in other jurisdictions in which Adicet might consider seeking regulatory approvals for Adicets product candidates, further complicating the regulatory landscape. For example, in the EU a special committee called the Committee for Advanced Therapies (referred to as CAT) was established within the EMA in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products (referred to as ATMPs) to assess the quality, safety and efficacy of ATMPs, and to follow scientific developments in the field. ATMPs include somatic cell therapy products and tissue engineered products. These various regulatory review committees and advisory groups and new or revised guidelines that they promulgate from time to time may lengthen the regulatory review process, require Adicet to perform additional studies, increase Adicets development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of Adicets product candidates or lead to significant post-approval limitations or restrictions. Because the regulatory landscape for Adicets gamma delta CAR-T cell product candidates are new, Adicet may face even more cumbersome and complex regulations than those emerging for cell therapy products. Furthermore, even if Adicets product candidates obtain required regulatory approvals, such approvals may later be withdrawn as a result of changes in regulations or the interpretation of regulations by applicable regulatory agencies.
Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential product to market could decrease Adicets ability to generate sufficient product revenue to maintain Adicets business.
The FDA may disagree with Adicets regulatory plan and Adicet may fail to obtain regulatory approval of Adicets product candidates.
The general approach for FDA approval of a new biologic or drug is for the sponsor to provide dispositive data from two well-controlled, Phase 3 clinical studies of the relevant biologic or drug in the relevant patient population. Phase 3 clinical studies typically involve hundreds of patients, have significant costs and take years to complete. Adicet expects registrational trials for ADI-001 and ADI-002 to be designed to evaluate the efficacy
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of the product candidate in an open-label, non-comparative, two-stage, pivotal, multicenter, single-arm clinical trial in patients who have exhausted available treatment options. If the results are sufficiently compelling, Adicet intends to discuss with the FDA submission of a BLA for the relevant product candidate. However, Adicet does not have any agreement or guidance from the FDA that its regulatory development plans will be sufficient for submission of a BLA. In addition, the FDA may only allow Adicet to evaluate patients that have failed or who are ineligible for autologous therapy, which are extremely difficult patients to treat and patients with advanced and aggressive cancer, and Adicets product candidates may fail to improve outcomes for such patients.
Given the molecular similarities between ADI-001 and ADI-002, Adicet may have additional difficulties progressing any clinical trial of ADI-002, if emerging data from future clinical trials of ADI-001 have safety or other issues.
The FDA may grant accelerated approval for Adicets product candidates and, as a condition for accelerated approval, the FDA may require a sponsor of a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biologic may be subject to withdrawal procedures by the FDA that are more accelerated than those available for regular approvals. In addition, the standard of care may change with the approval of new products in the same indications that Adicet is studying. This may result in the FDA or other regulatory agencies requesting additional studies to show that Adicets product candidate are superior to the new products.
Adicets clinical trial results may also not support approval. In addition, Adicets product candidates could fail to receive regulatory approval for many reasons, including the following:
| the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of Adicets clinical trials; |
| Adicet may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that Adicets product candidates are safe and effective for any of their proposed indications; |
| the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval, including due to the heterogeneity of patient populations; |
| Adicet may be unable to demonstrate that Adicets product candidates clinical and other benefits outweigh their safety risks; |
| the FDA or comparable foreign regulatory authorities may disagree with Adicets interpretation of data from preclinical studies or clinical trials; |
| the data collected from clinical trials of Adicets product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere; |
| the FDA or comparable foreign regulatory authorities will inspect Adicets commercial manufacturing facility and may not approve Adicets facility; and |
| the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering Adicets clinical data insufficient for approval. |
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Adicet may seek orphan drug designation for some or all of Adicets product candidates across various indications, but Adicet may be unable to obtain such designations or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause Adicets revenue, if any, to be reduced.
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. In order to obtain orphan drug designation, the request must be made before submitting a BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
If a product that has orphan drug designation subsequently receives the first FDA approval of that particular product for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a BLA, to market the same biologic (meaning, a product with the same principal molecular structural features) for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. As a result, even if one of Adicets product candidates receives orphan exclusivity, the FDA can still approve other biologics that do not have the same principal molecular structural features for use in treating the same indication or disease or the same biologic for a different indication or disease during the exclusivity period. Furthermore, the FDA can waive orphan exclusivity if Adicet is unable to manufacture sufficient supply of Adicets product or if a subsequent applicant demonstrates clinical superiority over Adicets products.
Adicet may seek orphan drug designation for some or all of Adicets product candidates in specific orphan indications in which there is a medically plausible basis for the use of these products. Even if Adicet obtains orphan drug designation, exclusive marketing rights in the United States may be limited if Adicet seeks approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if Adicet is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition, or if a subsequent applicant demonstrates clinical superiority over Adicets products, if approved. In addition, although Adicet may seek orphan drug designation for other product candidates, Adicet may never receive such designations.
Regenerative Medicine Advanced Therapy designation, even if granted for any of Adicets product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that its product candidates will receive marketing approval.
Adicet may seek Regenerative Medicine Advanced Therapy (referred to as RMAT) designation for one or more of its product candidates. In 2017, the FDA established the RMAT designation to expedite review of a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the potential to address unmet medical needs for such a disease or condition. RMAT designation provides potential benefits that include more frequent meetings with FDA to discuss the development plan for the product candidate, and eligibility for rolling review and priority review. Products granted RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably likely to predict long-term
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clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites. There is no assurance that Adicet will be able to obtain RMAT designation for any of its product candidates. RMAT designation does not change the FDAs standards for product approval, and there is no assurance that such designation will result in expedited review or approval or that the approved indication will not be narrower than the indication covered by the designation. Additionally, RMAT designation can be revoked if the criteria for eligibility cease to be met as clinical data emerges.
Positive results from early preclinical studies and clinical trials are not necessarily predictive of the results of any future clinical trials of its product candidate. If Adicet cannot replicate the positive results from its earlier preclinical studies and clinical trials of its product candidate in its future clinical trials, Adicet may be unable to successfully develop, obtain regulatory approval for and commercialize its product candidate.
Any positive results from Adicets preclinical studies and future clinical trials of Adicets product candidate may not necessarily be predictive of the results from required later clinical trials. Similarly, even if Adicet is able to complete its planned preclinical studies or any future clinical trials according to its current development timeline, the positive results from such preclinical studies and clinical trials may not be replicated in subsequent preclinical studies or clinical trial results.
Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and Adicet cannot be certain that it will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway, or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidate performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or similar regulatory approval.
Obtaining and maintaining regulatory approval of Adicets product candidates in one jurisdiction does not mean that Adicet will be successful in obtaining regulatory approval of Adicets product candidates in other jurisdictions.
Obtaining and maintaining regulatory approval of Adicets product candidates in one jurisdiction does not guarantee that Adicet will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that Adicet intends to charge for Adicets products is also subject to approval.
Adicet may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which Adicet must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for Adicet and could delay or prevent the introduction of Adicets products in certain countries. If Adicet fails to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, Adicets target market will be reduced and Adicets ability to realize the full market potential of Adicets product candidates will be harmed.
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Even if Adicet receives regulatory approval of Adicets product candidates, Adicet will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and Adicet may be subject to penalties if Adicet fails to comply with regulatory requirements or experience unanticipated problems with Adicets product candidates.
Any regulatory approvals that Adicet receives for Adicets product candidates will require post-market surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a risk evaluation and mitigation strategy, or REMS, in order to approve Adicets product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves Adicets product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for Adicets product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and cGCPs for any clinical trials that Adicet conducts post-approval. As such, Adicet and its contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any BLA, other marketing application and previous responses to inspectional observations. Accordingly, Adicet and others with whom Adicets work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. In addition, the FDA could require Adicet to conduct another study to obtain additional safety or biomarker information.
Further, Adicet will be required to comply with FDA promotion and advertising rules, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the products approved uses (known as off-label use), limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet and social media. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label may be subject to significant liability. However, physicians may, in their independent medical judgment, prescribe legally available products for off-label uses. The FDA does not regulate the behavior of physicians in their choice of treatments but the FDA does restrict manufacturers communications on the subject of off-label use of their products. Later discovery of previously unknown problems with Adicets product candidates, including adverse events of unanticipated severity or frequency, or with Adicets third-party suppliers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:
| restrictions on the marketing or manufacturing of Adicets product candidates, withdrawal of the product from the market or voluntary or mandatory product recalls; |
| fines, warning letters or holds on clinical trials; |
| refusal by the FDA to approve pending applications or supplements to approved applications filed by Adicet or suspension or revocation of license approvals; |
| product seizure or detention, or refusal to permit the import or export of Adicets product candidates; and |
| injunctions or the imposition of civil or criminal penalties. |
The FDAs and other regulatory authorities policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of Adicets product candidates. Adicet cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. For example, certain policies of the
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current U.S. Presidents administration may impact Adicets business and industry. Namely, the current U.S. Presidents administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, FDAs ability to engage in routine oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications. It is difficult to predict how these orders will be implemented, and the extent to which they will impact the FDAs ability to exercise its regulatory authority. If these executive actions impose restrictions on FDAs ability to engage in oversight and implementation activities in the normal course, Adicets business may be negatively impacted. If Adicet is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Adicet is not able to maintain regulatory compliance, Adicet may lose any marketing approval that Adicet may have obtained and Adicet may not achieve or sustain profitability.
Even if Adicet obtains regulatory approval of Adicets product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community, adversely affecting Adicets ability to achieve its commercial and financial projections.
The use of engineered gamma delta T cells as a potential cancer treatment is a recent development and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers and others in the medical community. Adicet expects physicians in the large bone marrow transplant centers to be particularly important to the market acceptance of its products and Adicet may not be able to educate them on the benefits of using its product candidates for many reasons. Additional factors will influence whether Adicets product candidates are accepted in the market, including:
| the clinical indications for which Adicets product candidates are approved; |
| physicians, hospitals, cancer treatment centers and patients considering Adicets product candidates as a safe and effective treatment; |
| the potential and perceived advantages of Adicets product candidates over alternative treatments; |
| the prevalence and severity of any side effects; |
| product labeling or product insert requirements of the FDA or other regulatory authorities; |
| limitations or warnings contained in the labeling approved by the FDA; |
| the timing of market introduction of Adicets product candidates as well as competitive products; |
| the cost of treatment in relation to alternative treatments; |
| the availability of coverage and adequate reimbursement and pricing by third-party payors and government authorities; |
| the willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors and government authorities; |
| relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and |
| the effectiveness of Adicets sales and marketing efforts. |
If Adicets product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medical community, Adicet will not be able to generate significant revenue. Even if Adicets products achieve market acceptance, Adicet may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than Adicets products, are more cost effective or render Adicets products obsolete.
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Coverage and reimbursement may be limited or unavailable in certain market segments for Adicets product candidates, which could make it difficult for Adicet to sell its product candidates, if approved, profitably.
Successful sales of Adicets product candidates, if approved, depend on the availability of coverage and adequate reimbursement from third-party payors including governmental healthcare programs, such as Medicare and Medicaid, managed care organizations and commercial payors, among others. Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which Adicet obtains regulatory approval. In addition, because Adicets product candidates represent new approaches to the treatment of cancer, Adicet cannot accurately estimate the potential revenue from Adicets product candidates.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Obtaining coverage and adequate reimbursement from third-party payors is critical to new product acceptance.
Third-party payors decide which drugs and treatments they will cover and the amount of reimbursement. Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payors determination that use of a product is:
| a covered benefit under its health plan; |
| safe, effective and medically necessary; |
| appropriate for the specific patient; |
| cost-effective; and |
| neither experimental nor investigational. |
Obtaining coverage and reimbursement of a product from a government or other third-party payor is a time-consuming and costly process that could require Adicet to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of Adicets products. Even if Adicet obtains coverage for a given product, if the resulting reimbursement rates are insufficient, hospitals may not approve Adicets product for use in their facility or third-party payors may require co-payments that patients find unacceptably high. Patients are unlikely to use Adicets product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of Adicets product candidates. Separate reimbursement for the product itself may or may not be available. Instead, the hospital or administering physician may be reimbursed only for providing the treatment or procedure in which Adicets product is used. Further, from time to time, CMS revises the reimbursement systems used to reimburse health care providers, including the Medicare Physician Fee Schedule and Outpatient Prospective Payment System, which may result in reduced Medicare payments. In some cases, private third-party payers rely on all or portions of Medicare payment systems to determine payment rates. Changes to government healthcare programs that reduce payments under these programs may negatively impact payments from private third-party payers, and reduce the willingness of physicians to use Adicets product candidates.
In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. Further, one payors determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Adequate third-party reimbursement may not be available to enable Adicet to maintain price levels sufficient to realize an appropriate return on Adicets investment in product development. Because its product candidate may have a higher cost of goods than conventional therapies, and may require long-term follow-up evaluations, the risk that coverage and reimbursement rates may be inadequate for Adicet to achieve profitability may be greater. There is significant uncertainty related to insurance coverage and reimbursement of newly approved products. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for its product candidate. Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. Additional state and
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federal healthcare reform measures are expected to be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for certain pharmaceutical products or additional pricing pressures. Specifically, there have been several U.S. Congressional inquiries and federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. Adicet expects to experience pricing pressures in connection with the sale of any of its product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, cost containment initiatives and additional legislative changes.
Adicet intends to seek approval to market Adicets product candidates in both the United States and in selected foreign jurisdictions. Increased efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for its product candidate. If Adicet obtains approval in one or more foreign jurisdictions for Adicets product candidates, Adicet will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly those in Europe, the pricing of biologics is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. Some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on health care costs has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
The marketability of any product candidates for which Adicet receives regulatory approval for commercial sale may suffer if government and other third-party payors fail to provide coverage and adequate reimbursement. Adicet expects downward pressure on pharmaceutical pricing to continue. Further, coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which Adicet receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
The advancement of healthcare reform may negatively impact Adicets ability to sell Adicets product candidates, if approved, profitably.
Third-party payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact Adicets ability to sell its product candidates, if approved, profitably. In particular, in 2010 the Affordable Care Act was enacted. The Affordable Care Act and its implementing regulations, among other things, revised the methodology by which rebates owed by manufacturers to the state and federal government for covered outpatient drugs and certain biologics, including Adicets product candidates, under the Medicaid drug rebate program are calculated, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid drug rebate program, extended the Medicaid drug rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, and provided incentives to programs that increase the federal governments comparative effectiveness research. Additionally, the Affordable Care Act allowed states to implement expanded eligibility criteria for Medicaid programs, imposed a new Medicare Part D coverage gap discount program, expanded the entities eligible for discounts under the Public Health Service pharmaceutical pricing program and implemented a new Patient-Centered Outcomes Research Institute. Adicet is still unsure of the full impact that the Affordable Care Act will have on its business.
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There remain legal and political challenges to certain aspects of the Affordable Care Act. Since January 2017, the U.S. President has signed two Executive Orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the Affordable Care Act. In December 2017, Congress repealed the tax penalty for an individuals failure to maintain Affordable Care Act-mandated health insurance, commonly known as the individual mandate, as part of the Tax Cuts and Jobs Act of 2017 (Tax Act). In addition, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the Affordable Care Acts mandated Cadillac tax on high-cost employer-sponsored health coverage and medical device tax and, effective January 1, 2021, also eliminates the health insurer tax. The Bipartisan Budget Act of 2018 (BBA), among other things, amended the Affordable Care Act, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the donut hole. In December 2018, CMS published a final rule permitting further collections and payments to and from certain Affordable Care Act qualified health plans and health insurance issuers under the Affordable Care Act risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment. On December 14, 2018, a Texas U.S. District Court Judge ruled that the Affordable Care Act is unconstitutional in its entirety because the individual mandate was repealed by Congress as part of the Tax Act. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the Affordable Care Act are invalid as well. It is unclear how this decision, future decisions, subsequent appeals, and other efforts to repeal and replace the Affordable Care Act will impact the Affordable Care Act and Adicets business.
Further legislation or regulation could be passed that could harm Adicets business, financial condition and results of operations. Other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. For example, in August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years 2012 through 2021, triggering the legislations automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect beginning on April 1, 2013 and will stay in effect through 2029, unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. The implementation of cost containment measures or other healthcare reforms may prevent Adicet from being able to generate revenue, attain profitability, or commercialize its products. Such reforms could have an adverse effect on anticipated revenue from product candidates that Adicet may successfully develop and for which Adicet may obtain regulatory approval and may affect its overall financial condition and ability to develop product candidates.
In addition, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient assistance programs, and reform government program reimbursement methodologies for drugs. At the federal level, the U.S. Presidents administrations budget proposal for fiscal year 2020 contains further drug price control measures that could be enacted during the budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. Further, the current U.S. Presidents administration released a Blueprint, or plan, to lower drug prices and reduce out of pocket costs of
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drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers. HHS has solicited feedback on some of these measures and has implemented others under its existing authority. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage plans the option to use step therapy for Part B drugs beginning January 1, 2020. This final rule codified CMSs policy change that was effective January 1, 2019. While some of these and other measures may require additional authorization to become effective, Congress and the current U.S. Presidents administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Adicet cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:
| the demand for Adicets product candidates, if it obtains regulatory approval; |
| Adicets ability to set a price that it believes is fair for its products; |
| Adicets ability to generate revenue and achieve or maintain profitability; |
| the level of taxes that Adicet is required to pay; and |
| the availability of capital. |
Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect Adicets future profitability.
Risks Related to Adicet Intellectual Property
Adicet depends on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which would harm Adicets business.
Adicet is dependent on patents, know-how and proprietary technology, both its own and licensed from others. Adicet depends substantially on Adicets license agreements with Regeneron and Technion. These licenses may be terminated upon certain conditions. Any termination of these licenses could result in the loss of significant rights and could harm Adicets ability to commercialize its product candidates. To the extent these licensors fail to meet their obligations under their license agreements, which Adicet is not in control of, Adicet may lose the benefits of its license agreements with these licensors. In the future, Adicet may also enter into additional license agreements that are material to the development of Adicets product candidates.
Disputes may also arise between Adicet and its licensors regarding intellectual property subject to a license agreement, including those related to:
| the scope of rights granted under the license agreement and other interpretation-related issues; |
| whether and the extent to which Adicets technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
| Adicets right to sublicense patent and other rights to third parties under collaborative development relationships; |
| Adicets diligence obligations with respect to the use of the licensed technology in relation to Adicets development and commercialization of Adicets product candidates, and what activities satisfy those diligence obligations; and |
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| the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by Adicet licensors and Adicet and Adicet partners. |
If disputes over intellectual property that Adicet has licensed, or licenses in the future, prevent or impair Adicets ability to maintain its current licensing arrangements on acceptable terms, Adicet may be unable to successfully develop and commercialize the affected product candidates.
Adicet is generally also subject to all of the same risks with respect to protection of intellectual property that Adicet licenses, as Adicet is for intellectual property that it owns, which are described below. If Adicet or its licensors fails to adequately protect this intellectual property, Adicets ability to commercialize products could suffer.
If Adicets efforts to protect the proprietary nature of the intellectual property related to its technologies are not adequate, Adicet may not be able to compete effectively in its market.
Adicet relies upon a combination of patents, trade secret protection and license agreements to protect the intellectual property related to its technologies. Any disclosure to or misappropriation by third parties of Adicets confidential proprietary information could enable competitors to quickly duplicate or surpass Adicets technological achievements, thus eroding Adicets competitive position in its market.
Additional patent applications have been filed, and Adicet anticipates additional patent applications will be filed, both in the United States and in other countries, as appropriate. However, Adicet cannot predict:
| if and when patents will issue; |
| the degree and range of protection any issued patents will afford Adicet against competitors including whether third parties will find ways to invalidate or otherwise circumvent Adicets patents; |
| whether or not others will obtain patents claiming aspects similar to those covered by Adicets patents and patent applications; or |
| whether Adicet will need to initiate litigation or administrative proceedings which may be costly whether Adicet wins or loses. |
Composition of matter patents for biological and pharmaceutical products such as CAR-based product candidates often provide a strong form of intellectual property protection for those types of products, as such patents provide protection without regard to any method of use. Adicet cannot be certain that the claims in Adicets pending patent applications covering composition of matter of Adicets product candidates will be considered patentable by the United States Patent and Trademark Office (USPTO) or by patent offices in foreign countries, or that the claims in any of Adicets issued patents will be considered valid and enforceable by courts in the United States or foreign countries. Method of use patents protect the use of a product for the specified method. This type of patent does not prevent a competitor from making and marketing a product that is identical to Adicets product for an indication that is outside the scope of the patented method. Moreover, even if competitors do not actively promote their product for Adicets targeted indications, physicians may prescribe these products off-label. Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.
The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that Adicet owns or in-licenses may fail to result in issued patents with claims that cover Adicets product candidates or uses thereof in the United States or in other foreign countries. Even if the patents do successfully issue, third parties may challenge the patentability, validity, enforceability or scope thereof, for example through inter partes review (IPR) post-grant review or ex parte reexamination before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions, which may result in such patents being cancelled, narrowed, invalidated or held unenforceable. Furthermore,
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even if they are unchallenged, Adicets patents and patent applications may not adequately protect Adicets intellectual property or prevent others from designing their products to avoid being covered by Adicets claims. If the breadth or strength of protection provided by the patents and patent applications Adicet holds with respect to Adicets product candidates is threatened, it could dissuade companies from collaborating with Adicet to develop, and threaten Adicets ability to commercialize, Adicets product candidates. Further, if Adicet encounters delays in its clinical trials, the period of time during which Adicet could market Adicets product candidates under patent protection would be reduced. United States patent applications containing or that at any time contained a claim not entitled to a priority date before March 16, 2013 are subject to the first to file system implemented by the America Invents Act (2011).
This first to file system will require Adicet to be cognizant going forward of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing, Adicet cannot be certain that it was the first to file any patent application related to Adicets product candidates. Furthermore, for United States applications in which all claims are entitled to a priority date before March 16, 2013, an interference proceeding can be provoked by a third-party or instituted by the USPTO, to determine who was the first to invent any of the subject matter covered by the patent claims of Adicets applications. For United States applications containing a claim not entitled to priority before March 16, 2013, there is a greater level of uncertainty in the patent law in view of the passage of the America Invents Act, which brought into effect significant changes to the United States patent laws, including new procedures for challenging patent applications and issued patents.
Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.
In addition to the protection afforded by patents, Adicet seeks to rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of Adicets product discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. Trade secrets, however, may be difficult to protect. Although Adicet requires all of its employees to assign their inventions to Adicet, and requires all of Adicets employees and key consultants who have access to Adicets proprietary know-how, information, or technology to enter into confidentiality agreements, Adicet cannot be certain that its trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to Adicets trade secrets or independently develop substantially equivalent information and techniques. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, Adicet may encounter significant problems in protecting and defending Adicets intellectual property both in the United States and abroad. If Adicet is unable to prevent unauthorized material disclosure of its intellectual property to third parties, Adicet will not be able to establish or maintain a competitive advantage in its market, which could materially adversely affect its business, operating results and financial condition.
Third-party claims of intellectual property infringement may prevent or delay Adicets product discovery and development efforts.
Adicets commercial success depends in part on Adicet avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which Adicet is developing Adicets product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that Adicets product candidates may give rise to claims of infringement of the patent rights of others.
Adicet is aware of U.S. and foreign patents held by a third parties relating to gamma delta T cell expansion protocols and related compositions which, on information and belief, are invalid and/or not infringed. In the
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event that these patents are successfully asserted against its product candidates, such as ADI-001 and ADI-002, or the use of its precursor cells in manufacture of these product candidates, such litigation may negatively impact its ability to commercialize these product candidates in such jurisdictions. Adicet is also aware of several U.S. and foreign patents held by third parties relating to certain CAR compositions of matter, methods of making and methods of use which, on information and belief, are invalid and/or not infringed. Nevertheless, third parties may assert that Adicet infringes their patents or are otherwise employing their proprietary technology without authorization and may sue Adicet. Generally, conducting clinical trials and other development activities in the United States is not considered an act of infringement. If and when ADI-001 or ADI-002 or another CAR-based product candidate is approved by the FDA, third parties may then seek to enforce their patents by filing a patent infringement lawsuit against Adicet. Patents issued in the United States by law enjoy a presumption of validity that can be rebutted only with evidence that is clear and convincing, a heightened standard of proof. Adicet may not be able to prove in litigation that any patent enforced against it is invalid and/or not infringed.
Additionally, there may be third-party patents of which Adicet is currently unaware with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of Adicets product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that Adicets product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of Adicet technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of Adicets product candidates, constructs or molecules used in or formed during the manufacturing process, or any final product itself, the holders of any such patents may be able to block Adicets ability to commercialize the product candidate unless Adicet obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held not infringed, unpatentable, invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of Adicets formulations, processes for manufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patent may be able to block Adicets ability to develop and commercialize the product candidate unless Adicet obtained a license or until such patent expires or is finally determined to be held not infringed, unpatentable, invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If Adicet is unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, Adicets ability to commercialize its product candidates may be impaired or delayed, which could in turn significantly harm its business.
Parties making claims against Adicet may seek and obtain injunctive or other equitable relief, which could effectively block Adicets ability to further develop and commercialize Adicets product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from Adicets business and may impact its reputation. In the event of a successful claim of infringement against Adicet, Adicet may have to pay substantial damages, including treble damages and attorneys fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign Adicet infringing products, which may be impossible or require substantial time and monetary expenditure. Adicet cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, Adicet may need to obtain licenses from third parties to advance its research or allow commercialization of Adicets product candidates. Adicet may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, Adicet would be unable to further develop and commercialize Adicets product candidates, which could harm its business significantly.
Adicet may not be successful in obtaining or maintaining necessary rights to product components and processes for its development pipeline through acquisitions and in-licenses.
Adicet may require access to additional intellectual property to develop its current or future product candidates. Accordingly, the growth of Adicets business will likely depend in part on its ability to acquire, in-license or use these proprietary rights.
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Adicets product candidates may also require specific formulations to work effectively and efficiently and these rights may be held by others. Adicet may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that Adicet identifies. Adicet may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, which would harm its business. Even if Adicet is able to obtain a license, it may be non-exclusive, thereby giving its competitors access to the same technologies licensed to Adicet. In that event, Adicet may be required to expend significant time and resources to develop or license replacement technology. Adicet may need to cease use of the compositions or methods covered by such third-party intellectual property rights.
The licensing and acquisition of third-party intellectual property rights is a competitive area, and companies, which may be more established, or have greater resources than Adicet does, may also be pursuing strategies to license or acquire third-party intellectual property rights that Adicet may consider necessary or attractive in order to commercialize Adicets product candidates. More established companies may have a competitive advantage over Adicet due to their size, cash resources and greater clinical development and commercialization capabilities.
Adicet may be involved in lawsuits to protect or enforce Adicets patents or the patents of its licensors, which could be expensive, time-consuming and unsuccessful.
Competitors may infringe Adicets patents or the patents of its licensors. To counter infringement or unauthorized use, Adicet may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of its patents is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that Adicets patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of Adicets patents at risk of being invalidated, held unenforceable or interpreted narrowly and could put Adicets patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from Adicets business. In the event of a successful claim of infringement against Adicet, Adicet may have to pay substantial damages, including treble damages and attorneys fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign Adicets infringing products, which may be impossible or require substantial time and monetary expenditure.
Interference proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to Adicets patents or patent applications or those of its licensors. An unfavorable outcome could result in a loss of Adicets current patent rights and could require Adicet to cease using the related technology or to attempt to license rights to it from the prevailing party. Adicets business could be harmed if the prevailing party does not offer Adicet a license on commercially reasonable terms. Litigation or interference proceedings may result in a decision adverse to Adicets interests and, even if Adicet is successful, may result in substantial costs and distract Adicets management and other employees. Adicet may not be able to prevent, alone or with Adicets licensors, misappropriation of Adicets trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Adicets confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of Adicets common stock.
Obtaining and maintaining Adicets patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and Adicets patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies
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require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, Adicets competitors might be able to enter the market, which would have a material adverse effect on Adicets business.
The lives of Adicets patents may not be sufficient to effectively protect its products and business.
Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first effective filing date. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. For example, certain patents relating to Adicets TCRL platform technology will expire in 2021. If Adicets other issued patents, or patents that are expected to issue from pending applications, fail to sufficiently cover Adicets product candidates notwithstanding the expiring patents, Adicets business and results of operations will be adversely effected. Even if patents covering Adicets product candidates are obtained, once the patent life has expired for a product, Adicet may be open to competition from biosimilar or generic medications. In addition, although upon issuance in the United States a patents life can be increased based on certain delays caused by the USPTO, this increase can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. If Adicet does not have sufficient patent life to protect its products, Adicets business and results of operations will be adversely affected.
Adicet may be subject to claims challenging the inventorship of Adicets patents and other intellectual property.
Adicet may in the future be subject to claims that former employees, collaborators, or other third parties have an interest in Adicets patents or other intellectual property as an inventor or co-inventor. For example, Adicet may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing Adicets product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship. If Adicet fails in defending any such claims, in addition to paying monetary damages, Adicet may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on Adicets business. Even if Adicet is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
Issued patents covering Adicets product candidates could be found unpatentable, invalid or unenforceable if challenged in court or the USPTO.
If Adicet or one of its licensing partners initiate legal proceedings against a third party to enforce a patent covering one of Adicets product candidates, the defendant could counterclaim that the patent covering Adicets product candidate, as applicable, is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include IPR, ex parte re-examination and post grant review in the United States, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation or amendment to Adicets patents in such a way that they no longer cover and protect Adicets product candidates. The outcome following legal assertions of unpatentability, invalidity and unenforceability is unpredictable. With respect to the validity question, for example, Adicet cannot be certain that there is no invalidating prior art, of which Adicet, Adicets patent counsel and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of unpatentability, invalidity and/or
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unenforceability, Adicet would lose at least part, and perhaps all, of the patent protection on Adicets product candidates. Such a loss of patent protection could have a material adverse impact on its business.
Changes in U.S. patent law could diminish the value of patents in general, thereby impairing Adicets ability to protect its products.
As is the case with other biopharmaceutical companies, Adicets success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to Adicets ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken Adicets ability to obtain new patents or to enforce Adicets existing patents and patents that Adicet might obtain in the future.
Adicet may not be able to protect its intellectual property rights throughout the world.
Adicet may not be able to protect its intellectual property rights outside the United States. Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and Adicets intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, Adicet may not be able to prevent third parties from practicing Adicets inventions in all countries outside the United States, or from selling or importing products made using Adicets inventions in and into the United States or other jurisdictions. Competitors may use Adicets technologies in jurisdictions where Adicet has not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where Adicet has patent protection, but enforcement is not as strong as that in the United States. These products may compete with Adicets products and Adicets patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for Adicet to stop the infringement of Adicets patents or marketing of competing products in violation of Adicets proprietary rights generally. Proceedings to enforce Adicets patent rights in foreign jurisdictions could result in substantial costs and divert Adicets efforts and attention from other aspects of its business, could put Adicets patents at risk of being invalidated or interpreted narrowly and Adicets patent applications at risk of not issuing and could provoke third parties to assert claims against Adicet. Adicet may not prevail in any lawsuits that it initiates and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, Adicets efforts to enforce its intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that it develops or licenses.
Adicet may be subject to claims that its employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
Adicet has received confidential and proprietary information from third parties. In addition, Adicet employ individuals who were previously employed at other biotechnology or pharmaceutical companies. Adicet may be subject to claims that Adicet or Adicets employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or Adicets employees former employers. Litigation may be necessary to defend against these claims. Even if Adicet is successful in defending against these claims, litigation could result in substantial cost and be a distraction to Adicets management and employees.
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Exhibit 99.3
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS OF ADICET
The following discussion and analysis of Adicets financial condition and results of operations should be read in conjunction with Adicets financial statements, accompanying notes and other financial information appearing elsewhere in this proxy statement/prospectus/information statement. This Managements Discussion and Analysis of Financial Condition and Results of Operations of Adicet contains forward-looking statements that involve risks and uncertainties. Adicets actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors. Please see Forward-Looking Statements for additional factors relating to such statements and see Risk FactorsRisks Related to Adicet for a discussion of certain risk factors applicable to Adicets business, financial condition and results of operations. Operating results are not necessarily indicative of results that may occur in future periods. In this Managements Discussion and Analysis of Financial Condition and Results of Operations of Adicet, unless the context implies otherwise, the use of Adicet, and the company refer to Adicet Bio, Inc.
Overview
Adicet is a biotechnology company that is advancing a new generation of chimeric antigen receptor (CAR)-modified-T cell therapies in oncology and other indications. Adicets approach is based on gamma delta T cells, an immune cell population that the company believes has potentially significant advantages over alpha beta T cells, which are the basis of standard CAR-T cell therapies. Adicet believes that it is at the forefront to take tumor targeting gamma delta CAR-T cell product candidates into IND-enabling studies and clinical trials for specific tumor types. Adicet is developing proprietary processes for engineering and manufacturing product candidates based on gamma delta T cells from the blood of healthy donors, resulting in high yields of cells with efficacious tumor-killing activity in preclinical experiments. The ability to administer product candidates based on gamma delta T cells to patients without inducing a graft versus host immune response means that Adicets products can potentially be produced as off-the-shelf therapies. This is in contrast to products based on alpha beta T cells, which either must be manufactured for each patient from his or her own T cells or which require significant gene editing to manufacture allogeneic therapies, that is, therapies that are based on T cells derived from donors that are unrelated to the patient. Based on what Adicet believes in the enormous promise of these cells and associated modifications, Adicet is initially developing product candidates in oncology, both for hematological malignancies and for solid tumor indications. Due to certain unique properties of gamma delta T cells, Adicet believes that its product candidates will have an inherent capacity to recognize and kill circulating tumor cells and to infiltrate and kill solid tumors, the cause of over 90% of all cancer deaths as estimated by the American Cancer Society in 2020. Adicet intends to file an IND application with the FDA in 2020 for ADI-001, the companys lead product candidate, in Non-Hodgkins Lymphoma, or NHL. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-001 in the first half of 2021. Adicet expects initial clinical results from this trial in 2021. Adicet intends to file an IND application with the FDA in 2021 for ADI-002 the companys first solid tumor product candidate. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-002 in 2021.
ADI-001 is a gamma delta T cell product candidate into which Adicet introduced a CAR that specifically recognizes CD20, a highly expressed surface protein found on the majority of non-Hodgkin lymphomas, or NHLs. Adicet is developing a highly efficient and robust process to activate, engineer and manufacture product candidates derived from peripheral blood cells of healthy donors. Adicet believes that ADI-001 has the potential to benefit the majority of patients that have NHL while also providing clinical validation of Adicets gamma delta T cell platform technology. In addition to potentially providing access to immunocellular therapies to a broader set of patients with hematological malignancies, Adicet believes that its platform technology is well-positioned to bring these therapies to patients with solid tumors. ADI-002 is a product candidate containing a CAR directed against Glypican-3, or GPC3, a tumor antigen that is highly expressed in hepatocellular carcinoma, or HCC, and other tumors such as gastric cancer and squamous cell carcinoma of the lung. ADI-002 has dose-dependent antitumor activity in animal models.
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Adicets solid tumor efforts are further complemented by the companys proprietary T cell receptor-like antibody, or TCRL, technology, a monoclonal antibody technology which enables the generation of CARs that recognize tumor antigens inside tumor cells, also known as intracellular proteins. Adicet believes that the ability to selectively bind to tumor antigens derived specifically from intracellular proteins is a critical advantage to immunocellular therapy due to the scarcity of tumor-specific surface antigens on solid tumors. Adicets approach to generating CARs for some product candidates takes advantage of this ability.
Since Adicets formation in November 2014, the company has incurred significant operating losses. Adicets net losses were $12.9 million and $6.8 million for the six months ended June 30, 2020 and 2019, respectively and $28.1 million and $9.3 million for the years ended December 31, 2019 and 2018, respectively. As of June 30, 2020, Adicet had an accumulated deficit of $82.6 million.
Adicet expects to continue to incur significant expenses with ongoing activities, operating as a public company, and as the company:
| Continues to advance Adicets product candidates through preclinical and clinical development, seeks regulatory approval, and prepares for and, if approved, proceeds to commercialization; |
| Acquires, discovers, validates and develops additional product candidates; |
| Obtains, maintains, protects and enforces its intellectual property portfolio; |
| Implements operational, financial and management systems; and |
| Attracts, hires and retains additional administrative, clinical, regulatory and scientific personnel. |
As a result, Adicet will need additional financing to support its continuing operations. Adicet does not have any products approved for sale and has not generated any product revenue since inception. From inception, Adicet has funded its operations through a collaboration and licensing arrangement with Regeneron, as well as through the private placement of equity securities. In July, August and September 2019, Adicet raised aggregate net proceeds of approximately $74.8 million from the sale of shares of Series B redeemable convertible preferred stock. In July 2020, Adicet received an additional payment of $10.0 million dollars from Regeneron for timely achieving a milestone relating to the selection of a clinical candidate related to the second collaboration target. Adicets ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of its product candidates. Until such time as Adicet can generate significant revenue from product sales, if ever, the company expects to finance its operations through the sale of equity, debt financings, collaborative or other arrangements with corporate or other sources of financing. Adequate funding may not be available to Adicet on acceptable terms, or at all. If Adicet fails to raise capital or enter into such agreements as and when needed, the company may have to significantly delay, scale back or discontinue the development and commercialization of its product candidates.
Adicet plans to continue to use third-party service providers, including costs for contract manufacturing organizations (CMOs) and costs for contract research organizations (CROs), to carry out its preclinical and clinical development and to manufacture and supply the materials to be used during the development of its product candidates.
On April 28, 2020, Adicet entered into an agreement and plan of merger with resTORbio, Inc., a Delaware corporation (resTORbio), and Project Oasis Merger Sub, Inc., a Delaware corporation and a direct, wholly owned subsidiary of resTORbio (Merger Sub), pursuant to which, subject to the satisfaction or waiver of the conditions therein, Merger Sub will merge with and into Adicet, with Adicet surviving as a wholly owned subsidiary of resTORbio. The merger remains subject to certain conditions, including the approval of resTORbio stockholders. Upon closing of the merger, resTORbio will be renamed Adicet Bio, Inc.
Immediately after the merger, Adicets security holders as of immediately prior to the effective time of the merger expect to own approximately 75% of the fully-diluted common stock of the combined company and resTORbio security holders as of immediately prior to the effective time of the merger expect to own
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approximately 25% of the fully-diluted common stock of the combined company (in each case excluding equity incentives available for grant). The relative percentage ownership of the combined company as specified by the exchange ratio described below was derived using a stipulated value of Adicet in the merger agreement of approximately $220.0 million and of resTORbio in the merger agreement of approximately $73.3 million.
Subject to the terms and conditions set forth in the merger agreement, each share of Adicets common stock and redeemable convertible preferred stock issued and outstanding immediately prior to the effective time of the merger (excluding any shares that are held in treasury and any dissenting shares held by stockholders who have exercised and perfected appraisal rights) will be converted into the right to receive approximately 0.8555 shares of resTORbio common stock, subject to adjustment to account for the reverse stock split. This exchange ratio is an estimate only and is based upon resTORbios and Adicets capitalization as of August 4, 2020. The final exchange ratio will be determined pursuant to a formula described in more detail in the merger agreement.
Recent Developments
Impact of COVID-19 Pandemic
In December 2019, a novel strain of coronavirus, COVID-19, was reported in China. Since then, COVID-19 has spread globally. The spread of COVID-19 from China to other countries has resulted in the World Health Organization, or WHO, declaring the outbreak of COVID-19 as a pandemic, or a worldwide spread of a new disease, on March 11, 2020. Many countries around the world have imposed quarantines and restrictions on travel and mass gatherings to slow the spread of the virus and have closed non-essential businesses.
As local jurisdictions continue to put restrictions in place, Adicets ability to continue to operate its business may also be limited. Such events may result in a period of business, supply and drug product manufacturing disruption, and in reduced operations, any of which could materially affect Adicets business, financial condition and results of operations. In response to the COVID-19 pandemic, Adicet implemented remote working and thus far has not experienced a significant disruption or delay in its operations as it relates to the clinical development of its drug candidates. However, Adicet anticipates that the impact of the COVID-19 pandemic may create difficulties in its clinical trials for a variety of reasons, including future regulations regarding, or the inability or unwillingness of patients to, travel to participate in clinical trials, or participate in clinical trials that are administered in medical facilities that also treat COVID-19, potential delays in the FDAs review and approval processes and/or shortages of medical supplies that may force medical professionals to focus on non-clinical procedures, including treatment of COVID-19. The duration and ultimate impact of the COVID-19 pandemic on clinical trials generally, and on Adicets trials particularly, is unknown at this time.
In addition, the spread of COVID-19, which has caused a broad impact globally, may materially affect Adicet economically. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global financial markets, reducing Adicets ability to access capital, which could in the future negatively affect its liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect Adicets business. Possible effects may also include absenteeism in Adicets labor workforce, unavailability of products and supplies used in operations, and a decline in value of assets held by Adicet, including inventories, property and equipment, and marketable debt securities.
Financial Operations Overview
Revenue
Adicet has no products approved for commercial sale and does not expect to generate revenue from product sales unless and until it successfully completes development and obtains regulatory approval for its product candidates, which the company expects will not be for several years, if ever. Adicets revenues to date are generated from the Regeneron Agreement. The primary purpose of the Regeneron Agreement is to establish a
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strategic relationship to identify and validate appropriate targets and work together to develop a pipeline of engineered immune cell products (referred to as Collaboration ICPs) for the selected targets. The Regeneron Agreement includes the following: (i) licenses to Adicets technology, (ii) research and development services, (iii) services or obligations in connection with participation in the research committee, (iv) information sharing, and (v) manufacturing services to manufacture of Collaboration ICPs for the research programs. The Regeneron Agreement provides Regeneron an option to obtain an exclusive, royalty-bearing development and commercial license under Adicets intellectual property to develop and commercialize the optioned Collaboration ICPs ready for an IND submission.
Adicet received a non-refundable upfront payment of $25.0 million from Regeneron upon execution of the Regeneron Agreement, an aggregate of $10.0 million of additional payments for research funding from Regeneron as of June 30, 2020 and an additional payment of $10.0 million dollars in July 2020 from Regeneron for timely achievement of a milestone relating to the selection of a clinical candidate. In addition, Regeneron may have to pay Adicet additional amounts in the future consisting of up to an aggregate of $100.0 million of option exercise fees, as specified in the Regeneron Agreement. Regeneron must also pay Adicet high single digit royalties as a percentage of net sales for ICPs to targets for which it has exclusive rights and low single digit royalties as a percentage of net sales on any non-ICP product comprising a targeting moiety generated by Adicet through the use of Regenerons proprietary mice. Adicet must pay Regeneron mid-single to low double digit, but less than teens, royalties as a percentage of net sales of ICPs to targets for which it has exercised exclusive rights, and low to mid-single digit royalties as a percentage of net sales of targeting moieties generated from its license to use Regenerons proprietary mice. Royalties are payable until the longer of the expiration or invalidity of the licensed patent rights or twelve (12) years from first commercial sale.
Adicet uses a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize under the Regeneron Agreement. In applying the cost-based input method of revenue recognition, Adicet uses actual costs incurred relative to budgeted costs to fulfill the combined performance obligation. Revenue is recognized based on actual costs incurred as a percentage of total budgeted costs as Adicet completes its performance obligations over the research term of five years. A cost-based input method of revenue recognition requires Adicet to estimate costs to complete its performance obligations, which requires significant judgment to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete Adicets performance obligations is recorded in the period in which changes are identified and amounts can be reasonably estimated.
Operating Expenses
Research and Development Expenses
Research and development expenses, which consist primarily of costs incurred in connection with the development of Adicets product candidates, are expensed as incurred. Research and development expenses consist primarily of:
| employee related costs, including salaries, bonuses, benefits and stock-based compensation expenses for research and development employees; |
| costs incurred under agreements with consultants, CMOs, and CROs; |
| lab materials, supplies, and maintenance of equipment used for research and development activities; and |
| allocated facility-related costs, such as rent, utilities, insurance, repairs and maintenance, depreciation and amortization, information technology costs and general support services. |
Adicet does not allocate its costs by product candidate, as a significant amount of research and development expenses are not tracked by product candidate, and Adicet believes the allocation of such costs would be
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arbitrary and would not provide a meaningful assessment as it has used its employee and infrastructure resources across multiple product candidate research and development programs.
Adicet is focusing substantially all of its resources on the development of its product candidates. At this time, Adicet cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of its product candidates. Adicet is also unable to predict when, if ever, material net cash inflows will commence from sales of its product candidates. The duration, costs, and timing of clinical trials and development of Adicets product candidates will depend on a variety of factors, including:
| the scope, rate of progress and expense of clinical trials and other research and development activities; |
| clinical trial results; |
| uncertainties in clinical trial enrollment rate or design; |
| significant and changing government regulation; |
| the timing and receipt of any regulatory approvals; |
| the FDAs or other regulatory authoritys influence on clinical trial design; |
| establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; |
| commercializing product candidates, if and when approved, whether alone or in collaboration with others; |
| obtaining and maintaining patent and trade secret protection and regulatory exclusivity for product candidates; |
| continued applicable safety profiles of the products following approval; and |
| retention of key research and development personnel. |
A change in the outcome of any of these variables with respect to the development of a product candidate could significantly change the costs, timing and viability associated with the development of that product candidate. For example, if the FDA, or another regulatory authority, were to require Adicet to conduct clinical trials beyond those that it currently anticipates will be required for the completion of clinical development of a product candidate, or if the company experiences significant delays in enrollment in any of its clinical trials, it could be required to expend significant additional financial resources and time on the completion of clinical development. Furthermore, Adicet is unable to predict when or if its product candidates will receive regulatory approval with any certainty.
Adicet intends to file an IND application with the FDA in 2020 for ADI-001, the companys lead product candidate, in Non-Hodgkins Lymphoma, or NHL. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-001 in the first half of 2021. Adicet intends to file an IND application with the FDA in 2021 for ADI-002, the companys first solid tumor product candidate. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-002 in 2021.
Adicet is focusing substantially all of its resources on the development of its product candidates. Adicet expects its research and development expenses to increase substantially during the next few years, as it seeks to initiate clinical trials for its product candidates, complete its clinical program, pursue regulatory approval of its product candidates and prepare for a possible commercial launch. Predicting the timing or the cost to complete its clinical program or validation of its commercial manufacturing and supply processes is difficult and delays may occur because of many factors, including factors outside of Adicets control.
General and Administrative Expenses
General and administrative expenses consist principally of payroll and personnel expenses, including salaries, bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and
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tax services, allocated overhead expenses, including rent, equipment, depreciation, information technology costs and utilities, and other general operating expenses not otherwise classified as research and development expenses.
Adicet anticipates that its general and administrative expenses will increase for the foreseeable future due to anticipated expenses related to the merger and as a result of operating as a public company, including expenses related to personnel costs, expanded infrastructure and higher consulting, legal and accounting services costs associated with complying with the applicable Nasdaq and SEC requirements, investor relations costs and director and officer insurance premiums.
Interest Income
Interest income consists primarily of interest income earned on Adicets cash and cash equivalents and marketable debt securities.
Interest Expense
Interest expense consists of amortization of debt issuance costs related to the Loan Agreement (as defined below).
Other Income, Net
Other income, net primarily consists of changes in the fair value of Adicets redeemable convertible preferred stock tranche liability and redeemable convertible preferred stock warrant liability.
Results of Operations
The following table summarizes Adicets results of operations for the periods indicated (in thousands, except percentages):
Comparison of the Six Months Ended June 30, 2020 and 2019
Six Months Ended June 30, |
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2020 | 2019 | Change | % Change | |||||||||||||
Revenue |
$ | 9,465 | $ | 6,073 | $ | 3,392 | 56 | % | ||||||||
Operating expenses |
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Research and development |
15,709 | 10,837 | 4,872 | 45 | % | |||||||||||
General and administrative |
9,943 | 4,222 | 5,721 | 136 | % | |||||||||||
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Total operating expenses |
25,652 | 15,059 | 10,593 | 70 | % | |||||||||||
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Loss from operations |
(16,187 | ) | (8,986 | ) | (7,201 | ) | 80 | % | ||||||||
Interest income |
551 | 285 | 266 | 93 | % | |||||||||||
Interest expense |
(34 | ) | | (34 | ) | 100 | % | |||||||||
Other income, net |
50 | 1,920 | (1,870 | ) | (97 | %) | ||||||||||
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Loss before income tax expense (benefit) |
(15,620 | ) | (6,781 | ) | (8,839 | ) | 130 | % | ||||||||
Income tax benefit |
(2,679 | ) | 1 | (2,680 | ) | * | % | |||||||||
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Net loss |
$ | (12,941 | ) | $ | (6,782 | ) | $ | (6,159 | ) | 91 | % | |||||
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* | Not meaningful |
Revenue increased by $3.4 million, or 56%, from the six months ended June 30, 2019 to the six months ended June 30, 2020 resulting from the increase in revenue recognized under the Regeneron Agreement. The increase in
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revenue recognized under the Regeneron Agreement for the six months ended June 30, 2020 was primarily due to the following reasons:
| In April 2019, Adicet executed an amendment to the Regeneron Agreement, according to which the future research program fees that were due on the third and fourth anniversaries of the Regeneron Agreement were replaced with payments based on achievement of certain development and regulatory milestones. After the amendment became effective in July 2019, these payments were accounted for as variable consideration and excluded from the transaction price due to substantial uncertainties related to achieving the milestones and, as a result, earning such payments. This resulted in a decrease in the cumulative revenue recognized under the Regeneron Agreement in the third quarter of 2019. However, in June 2020, Adicet achieved a milestone relating to the selection of a clinical candidate resulting in an increase in the transaction price by $10.0 million. Adicet increased the transaction price of the Regeneron Agreement in June 2020 when it achieved the milestone for the selection of a clinical candidate, resulting in an recognition of cumulative revenue of $5.0 million during the six months ended June 30, 2020 (see critical accounting policy below). |
| Additionally, the proportional performance under the Regeneron Agreement measured, using a cost-based input method, was higher during the six months ended June 30, 2020 as compared to the six months ended June 30, 2019 due to increased research and development activities. |
Research and development
Six months Ended June 30, |
||||||||
2020 | 2019 | |||||||
Payroll and personnel expenses(1) |
$ | 6,597 | $ | 4,771 | ||||
Costs incurred under agreements with consultants, CMOs, and CROs |
$ | 5,476 | $ | 2,051 | ||||
Lab materials, supplies, and maintenance of equipment used for research and development activities |
$ | 2,062 | $ | 2,729 | ||||
Other research and development expenses(2) |
$ | 1,574 | $ | 1,286 | ||||
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Total research and development expenses |
$ | 15,709 | $ | 10,837 | ||||
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(1) | Employee related costs, including salaries, bonuses, benefits and stock-based compensation expenses for research and development employees. |
(2) | Allocated facility-related costs, such as rent, utilities, insurance, repairs and maintenance, depreciation and amortization, information technology costs and general support services. |
Research and development expenses increased by $4.9 million, or 44%, for the six months ended June 30, 2020 compared to the six months ended June 30, 2019. The increase in research and development expenses was primarily due to an increase of $3.4 million in fees paid to CROs and CMOs due to increased manufacture and preclinical development, an increase of $1.8 million in payroll and personnel expenses, including salaries, bonuses, benefits and stock-based compensation expenses due to increases in headcount of employees involved in research and development activities, and an increase of $0.4 million in allocated facility-related costs and other general support services offset by a decrease of $0.7 million in laboratory materials, supplies, and maintenance of equipment used for research and development activities.
General and administrative
General and administrative expenses increased by $5.7 million, or 136%, for the six months ended June 30, 2020 compared to the six months ended June 30, 2019. The increase in general and administrative expenses was primarily due to an increase of $4.7 million of professional fees for legal, consulting, accounting, tax and other
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services, an increase of $0.3 million in depreciation, rent, travel and other expenses, and an increase of $0.7 million of payroll and personnel expenses, including salaries, bonuses, benefits and stock-based compensation expenses due to an increase in compensation for temporary employees offset by a decrease of recruiting expenses for employees involved in general and administrative activities. The increase in professional fees resulted primarily from the transaction costs incurred in connection with the merger with resTORbio.
Interest income
Interest income increased by $0.3 million, or 93%, for the six months ended June 30, 2020 compared to the six months ended June 30, 2019, which was primarily attributable to interest income from the increase in cash and cash equivalents and marketable debt securities as a result of the proceeds received from the sale of shares of Series B redeemable convertible preferred stock in the third quarter of 2019.
Interest expense
Interest expense of less than $0.1 million for the six months ended June 30, 2020 is attributable to amortization of issuance costs of the Loan Agreement (as defined below) entered in April 2020.
Other income, net
Other income, net decreased by $1.9 million, or 97%, for the six months ended June 30, 2020 compared to the six months ended June 30, 2019, which was primarily due to decreases in other income resulting from the change in fair value of redeemable convertible preferred stock tranche liability and from the change in fair value of redeemable convertible preferred stock warrant liability.
Income tax benefit
Income tax benefit increased by $2.7 million for the six months ended June 30, 2020 compared to the six months ended June 30, 2019. The income tax benefit during the six months ended June 30, 2020 was a result of the recognition of a net operating loss carryback under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) which was enacted on March 27, 2020 in response to the COVID-19 pandemic and generated a refund of income taxes paid by Adicet for the year ended December 31, 2017. Adicet records the effect of an enacted change in a tax law in the period that includes the enactment date in accordance with Accounting Standards Codification (ASC) 740, Income Taxes.
The tax relief measures under the CARES Act for businesses include a five-year net operating loss carryback, suspension of annual deduction limitation of 80% of taxable income from net operating losses generated in a tax year beginning after December 31, 2017, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property.
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Comparison of the Years Ended December 31, 2019 and 2018
The following table summarizes Adicets results of operations for the periods indicated (in thousands, except percentages):
Year Ended December 31, |
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2019 | 2018 | Change | % Change | |||||||||||||
Revenue |
$ | 995 | $ | 8,181 | $ | (7,186 | ) | (88 | %) | |||||||
Operating expenses |
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Research and development |
23,691 | 14,717 | 8,974 | 61 | % | |||||||||||
General and administrative |
8,692 | 8,428 | 264 | 3 | % | |||||||||||
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Total operating expenses |
32,383 | 23,145 | 9,238 | 40 | % | |||||||||||
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Loss from operations |
(31,388 | ) | (14,964 | ) | (16,424 | ) | 110 | % | ||||||||
Interest income |
938 | 543 | 395 | 73 | % | |||||||||||
Other income, net |
2,331 | 4,533 | (2,202 | ) | (49 | %) | ||||||||||
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Loss before income tax expense (benefit) |
(28,119 | ) | (9,888 | ) | (18,231 | ) | 184 | % | ||||||||
Income tax expense (benefit) |
19 | (589 | ) | 608 | (103 | %) | ||||||||||
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Net loss |
$ | (28,138 | ) | $ | (9,299 | ) | $ | (18,839 | ) | 203 | % | |||||
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Revenue
Revenue decreased by $7.2 million, or 88%, for the year ended December 31, 2019 compared to the year ended December 31, 2018 resulting from the decrease in revenue recognized under the Regeneron Agreement.
The decrease in revenue recognized under the Regeneron Agreement during the year ended December 31, 2019 was primarily due to the following reasons:
| In April 2019, Adicet executed an amendment to the Regeneron Agreement according to which future research program fees that were due on the third and fourth anniversaries of the Regeneron Agreement were replaced with the payments based on achievement of certain development and regulatory milestones. After the amendment became effective in July 2019, these payments were accounted for as variable consideration and excluded from the transaction price due to substantial uncertainties related to achieving the milestones and, as a result, earning with such payments. This resulted in a decrease in the cumulative revenue recognized under the Regeneron Agreement (see critical accounting policy on revenue recognition below). |
| Additionally, the total estimated costs of research and development expenses to fulfill the obligations under the Regeneron Agreement have increased in 2019 due to updated estimated CMO and CRO costs, including additional costs for adding second source providers. This also resulted in a decrease in the cumulative revenue amount recognized under the Regeneron Agreement. |
Research and development
Year Ended December 31, | ||||||||
2019 | 2018 | |||||||
Payroll and personnel expenses(1) |
$ | 10,104 | $ | 7,449 | ||||
Costs incurred under agreements with consultants, CMOs, and CROs |
$ | 5,982 | $ | 1,054 | ||||
Lab materials, supplies, and maintenance of equipment used for research and development activities |
$ | 4,961 | $ | 3,857 | ||||
Other research and development expenses(2) |
$ | 2,644 | $ | 2,357 | ||||
Total research and development expenses |
$ | 23,691 | $ | 14,717 |
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(1) | Employee related costs, including salaries, bonuses, benefits and stock-based compensation expenses for research and development employees. |
(2) | Allocated facility-related costs, such as rent, utilities, insurance, repairs and maintenance, depreciation and amortization, information technology costs and general support services. |
Research and development expenses increased by $9.0 million, or 61%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. The increase in research and development expenses was primarily due to an increase of $4.9 million in fees paid to CROs and CMOs due to initiating and ramping up manufacturing and preclinical development activities related to Adicets first product candidate, an increase of $2.7 million in payroll and personnel expenses, including salaries, bonuses, benefits and stock-based compensation expenses due to increases in headcount of employees involved in research and development activities, an increase of $1.1 million in laboratory materials, supplies, and maintenance of equipment used for research and development activities, and an increase of $0.3 million in facility-related costs and other general support services.
General and administrative
General and administrative expenses increased by $0.3 million, or 3%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. The increase in general and administrative expenses was primarily due to an increase of $0.7 million of professional fees for legal, consulting, accounting, tax and other services and an increase of $0.4 million in depreciation, rent, travel and other expenses, offset by a decrease of $0.8 million of payroll and personnel expenses, including salaries, bonuses, benefits and stock-based compensation expenses largely due to a decrease in stock-based compensation expenses resulting from accounting for forfeitures of unvested stock options of terminated employees during the year that was partly offset by increases in headcount at the senior management level.
Interest income
Interest income increased by $0.4 million, or 73%, for the year ended December 31, 2019 compared to the year ended December 31, 2018, which was primarily attributable to interest income from an increase in cash and cash equivalents and marketable debt securities as a result of the proceeds received from the sale of shares of Series B redeemable convertible preferred stock in the third quarter of 2019.
Other income, net
Other income, net decreased by $2.2 million, or 49%, for the year ended December 31, 2019 compared to the year ended December 31, 2018, which was primarily due to a decrease in fair value of redeemable convertible preferred stock tranche liability by $2.5 million, partially offset by an increase in fair value of redeemable convertible preferred stock warrant liability of $0.3 million.
Income tax expense (benefit)
During the year ended December 31, 2019, Adicet recorded income tax expense of less than $0.1 million. For the year ended December 31, 2018, Adicet recorded an income tax benefit of $0.6 million which was primarily due to the New York state net operating loss carryback, which generated a refund of income taxes paid for the year ended December 31, 2017.
Liquidity and Capital Resources
Sources of Liquidity
Since Adicets formation in 2014, the company has funded its operations with an aggregate of $116.3 million in gross cash proceeds from the sale of redeemable convertible preferred stock and an aggregate of $45.0 million received to date from Regeneron under the Regeneron Agreement. As of June 30, 2020, Adicet had cash, cash equivalents and marketable debt securities of $52.3 million.
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Redeemable Convertible Preferred Stock
Series A Redeemable Convertible Preferred Stock
In August 2015, Adicet entered into a Series A redeemable convertible preferred stock purchase agreement (referred to as the Purchase Agreement) with an investor (referred to as the Investor) to issue and sell 12,187,500 shares of its Series A redeemable convertible preferred stock at $1.20 per share (referred to as the Series A Purchase Price) for total gross proceeds of $14.6 million. The Purchase Agreement also provided for the issuance and sale to the Investor of an additional 12,812,500 shares of Series A redeemable convertible preferred stock at the Series A Purchase Price upon achieving certain milestone conditions (referred to as the Milestone Closing). Further, from and after the occurrence of the Milestone Closing, at any time prior to the earliest to occur of (A) the two year anniversary of the Milestone Closing, (B) a liquidation or deemed liquidation or (C) an initial public offering by Adicet, the Investor had an option to purchase up to an additional 8,333,334 shares of Series A redeemable convertible preferred stock at the Series A Purchase Price (referred to as the Additional Closing).
In January 2016, Adicet amended the Purchase Agreement (referred to as the the Amended Purchase Agreement) with certain purchasers, including the Investor, to issue and sell an additional 9,015,425 shares of its Series A redeemable convertible preferred stock at the Series A Purchase Price for total gross proceeds of $10.8 million. The Amended Purchase Agreement was entered in contemplation of Adicets acquisition of Applied Immune Technologies, Ltd. (referred to as AIT) that closed on the same day and as part of the purchase consideration, Adicet issued 6,400,879 Series A redeemable convertible preferred stock shares to the former shareholders of AIT.
Per the terms of the Amended Purchase Agreement, the number of shares of Series A redeemable convertible preferred stock to be issued and sold at the Milestone Closing and Additional Closing was reduced to 9,020,833 shares and 5,875,000 shares, respectively. In November 2018, Adicet issued 9,020,833 shares of Series A redeemable convertible preferred stock at $1.20 per share for gross proceeds of $10.8 million in connection with the Milestone Closing. In July 2019, as part of the Series B redeemable convertible preferred stock purchase agreement (as described below), the Additional Closing was terminated.
Adicet also issued 411,892 and 67,656 shares of its Series A redeemable convertible preferred stock in connection with an amendment of a license agreement in February 2016 and February 2019, respectively.
In January 2016 and February 2016, Adicet issued 629,633 shares of its Series A-1 redeemable convertible preferred stock and 2,428,688 shares of Series A-2 redeemable convertible preferred stock as part of the purchase consideration for AIT.
Series B Redeemable Convertible Preferred Stock
In July 2019, Adicet issued 37,765,426 shares of Series B redeemable convertible preferred stock at $1.4034 per share for gross proceeds of $53.0 million.
In August 2019, Adicet issued 4,987,885 shares of Series B redeemable convertible preferred stock at $1.4034 per share for gross proceeds of $7.0 million.
In September 2019, Adicet issued 14,251,104 of Series B redeemable convertible preferred stock at $1.4034 per share for gross proceeds of $20.0 million.
As part of the Series B redeemable convertible preferred stock purchase agreement by and among Adicet and certain investors, including the Investor, the Investors option to purchase additional shares of Series A redeemable convertible preferred stock at the Series A Purchase Price was cancelled for no consideration.
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In connection with Series B redeemable convertible preferred stock financing transactions, Adicet issued to its financial advisor warrants to purchase 1,781,387 shares of its Series B redeemable convertible preferred stock at an exercise price of at $1.4034 per share. These warrants will terminate at the earlier of the seven-year anniversary from the issuance date and a liquidation of the company.
Loan Agreement
On April 28, 2020, Adicet entered into a Loan and Security Agreement with Pacific Western Bank for a term loan not exceeding $12.0 million (as amended, referred to as the Loan Agreement) to finance leasehold improvements for its new corporate headquarters in Redwood City, California and other purposes permitted under the Loan Agreement, with an interest rate equal to the greater of 0.25% above the Prime Rate (as defined in the Loan Agreement) or 5.00%. The Loan Agreement granted to Pacific Western Bank a security interest on substantially all of Adicets assets other than intellectual property to secure the performance of Adicets obligations under the Loan Agreement, and contains a variety of affirmative and negative covenants, including required financial reporting, limitations on certain dispositions of assets or distributions, limitations on the incurrence of additional debt or liens and other customary requirements. Pacific Western Bank consented to the delivery of audited consolidated financial statements that include a going concern explanatory paragraph by Adicets independent registered public accounting firm for the year ended December 31, 2019 in accordance with the terms of the financial statement covenants set forth in the Loan Agreement. Therefore, as of the date of this proxy statement/prospectus/information statement, Adicet was in compliance with such covenants and had no indebtedness outstanding under the Loan Agreement.
In connection with the entrance into the Loan Agreement, Adicet issued Pacific Western Bank a warrant to purchase shares of its Series B redeemable convertible preferred stock (described below) at an exercise price of $1.4034 per share (referred to as the Existing PacWest Warrant), which was later assigned to an affiliate of Pacific Western Bank. The Existing PacWest Warrant is initially exercisable for 42,753 shares of Adicets Series B redeemable convertible preferred stock and shall be exercisable for an additional number of shares of its Series B redeemable convertible preferred stock equal to 1.00% of the aggregate original principal amount of all term loans made pursuant to the Loan Agreement (up to an aggregate maximum of 128,259 shares). Pursuant to the terms of the Existing PacWest Warrant and the merger agreement, at the effective time of the merger, resTORbio will issue a new warrant to the holder of the Existing PacWest Warrant (referred to as the New PacWest Warrant) which will replace the Existing PacWest Warrant. The New PacWest Warrant will be exercisable solely for shares of resTORbio common stock and the number of shares of resTORbio common stock subject to the warrant shall be determined by multiplying (x) the number of shares of Adicet capital stock that were subject to the Existing PacWest Warrant (on an as-converted basis with respect to shares of Adicet preferred stock), as in effect immediately prior to the effective time of the merger, by (y) the exchange ratio, and rounding the resulting number down to the nearest whole number of shares of resTORbio common stock. The per share exercise price for the resTORbio common stock issuable upon exercise of the New PacWest Warrant shall be determined by dividing (x) the exercise price per share of Adicet capital stock subject to the Existing PacWest Warrant (on an as-converted basis), as in effect immediately prior to the effective time of the merger, by (y) the exchange ratio, and rounding the resulting exercise price up to the nearest whole cent. Any restriction on the exercise set forth in the Existing PacWest Warrant shall continue in full force and effect in the New PacWest Warrant and the term, exercisability, vesting schedule and other provisions of the Existing PacWest warrant shall otherwise remain unchanged in the New PacWest Warrant. Adicet accounted for the fair value of $0.1 million of the Existing PacWest Warrant issued as a deferred asset on the consolidated balance sheet that will be amortized on a straight-line basis until Availability End Date.
Pursuant to the terms of the Loan Agreement, Pacific Western Bank has consented in principle to the consummation of the merger as a Permitted Transaction (as defined in the Loan Agreement) subject to certain conditions, including: (i) that the merger is consummated in accordance with the merger agreement (unless otherwise approved by Pacific Western Bank in writing), (ii) Adicet providing copies of all material transaction documents to Pacific Western Bank, (iii) Adicet providing any diligence materials reasonably requested by
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Pacific Western Bank, (iv) resTORbio entering into a secured guaranty agreement in form and substance satisfactory to Pacific Western Bank and granting Pacific Western Bank a security interest in substantially all of its assets other than its intellectual property and (v) resTORbio issuing the New PacWest Warrant to the holder of the Existing PacWest Warrant pursuant to the terms of the merger agreement and the Existing PacWest Warrant. If the conditions set forth in the consent provided by Pacific Western Bank are not satisfied, Adicet would effectively need to terminate the Loan Agreement and repay any outstanding loan funds or refinance the facility with another lender.
Future Funding Requirements
Adicet has incurred losses of $12.9 million and $6.8 million for the six months ended June 30, 2020 and 2019, respectively, and $28.1 million and $9.3 million for the years ended December 31, 2019 and 2018, respectively. As of June 30, 2020, Adicet had an accumulated deficit of $82.6 million.
As of June 30, 2020, Adicet had cash, cash equivalents and marketable debt securities of $52.3 million. Adicet believes that its cash, cash equivalents and marketable debt securities will not be sufficient for it to continue as a going concern for at least one year from the issuance date of Adicets consolidated financial statements as of and for the year ended December 31, 2019 and Adicets condensed consolidated financial statements as of and for the six months ended June 30, 2020 included elsewhere in this proxy statement/prospectus/information statement. Adicet believes that this raises substantial doubt about its ability to continue as a going concern. As a result, Adicet will be required to raise additional capital, however, there can be no assurance as to whether additional financing will be available on terms acceptable to the company, if at all. If sufficient funds on acceptable terms are not available when needed, Adicet could be required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. Failure to manage discretionary spending or raise additional financing, as needed, may adversely impact Adicets ability to achieve its intended business objectives and have an adverse effect on its results of operations and future prospects.
Adicets consolidated financial statements as of and for the year ended December 31, 2019 and condensed consolidated financial statements as of and for the six months ended June 30, 2020 have been prepared assuming that it will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. Adicets consolidated financial statements as of and for the year ended December 31, 2019 and Adicets condensed consolidated financial statements as of and for the six months ended June 30, 2020 do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if Adicet is unable to continue as a going concern.
All of Adicets revenue to date is generated from the Regeneron Agreement, which is a collaboration and license agreement. Adicet does not expect to generate any significant product revenue until it obtains regulatory approval of and commercialize any of Adicets product candidates or enter into additional collaborative agreements with third parties, and it does not know when, or if, either will occur. Adicet expects to continue to incur significant losses for the foreseeable future, and it expects the losses to increase as the company continues the development of, and seek regulatory approvals for, its product candidates and begin to commercialize any approved products. Adicet is subject to all of the risks typically related to the development of new product candidates, and it may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business.
Adicet will continue to require additional capital to develop its product candidates and fund operations for the foreseeable future. Adicet may seek to raise capital through private or public equity or debt financings, collaborative or other arrangements with corporate sources, or through other sources of financing. Adicet anticipates that it will need to raise substantial additional capital, the requirements for which will depend on many factors, including:
| the scope, timing, rate of progress and costs of Adicets drug discovery efforts, preclinical development activities, laboratory testing and clinical trials for Adicets product candidates; |
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| the number and scope of clinical programs Adicet decides to pursue; |
| the cost, timing and outcome of preparing for and undergoing regulatory review of Adicets product candidates; |
| the scope and costs of development and commercial manufacturing activities; |
| the cost and timing associated with commercializing Adicets product candidates, if they receive marketing approval; |
| the extent to which Adicet acquires or in-license other product candidates and technologies; |
| the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing Adicets intellectual property rights and defending intellectual property-related claims; |
| Adicets ability to establish and maintain collaborations on favorable terms, if at all; |
| Adicets efforts to enhance operational systems and its ability to attract, hire and retain qualified personnel, including personnel to support the development of Adicets product candidates and, ultimately, the sale of its products, following FDA approval; |
| Adicets implementation of operational, financial and management systems; |
| the impact of the COVID-19 pandemic on U.S. and global economic conditions that may impact Adicets ability to access capital on terms anticipated, or at all; and |
| after the consummation of the merger, the costs associated with being a public company. |
A change in the outcome of any of these or other variables with respect to the development of any of Adicets product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, Adicets operating plans may change in the future, and it will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans.
Adequate funding may not be available to Adicet on acceptable terms or at all. Adicets failure to raise capital as and when needed could have a negative impact on its financial condition and Adicets ability to pursue its business strategies. If Adicet is unable to raise additional funds when needed, it may be required to delay, reduce, or terminate some or all of Adicets development programs and clinical trials or it may also be required to sell or license to others rights to Adicets product candidates in certain territories or indications that it would prefer to develop and commercialize itself. If Adicet is required to enter into collaborations and other arrangements to supplement its funds, Adicet may have to give up certain rights that limit its ability to develop and commercialize Adicets product candidates or may have other terms that are not favorable to it or its stockholders, which could materially affect Adicets business and financial condition.
See the section of this proxy statement/prospectus/information statement titled Risk FactorsRisks Related to Adicet for additional risks associated with Adicets substantial capital requirements.
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Summary Statement of Cash Flows
The following table sets forth the primary sources and uses of Adicets cash, cash equivalents, and restricted cash for each of the periods presented below (in thousands):
Six Months Ended June 30, |
Years Ended December 31, |
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2020 | 2019 | 2019 | 2018 | |||||||||||||
Net cash (used in) provided by: |
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Operating activities |
$ | (20,358 | ) | $ | (13,384 | ) | $ | (27,882 | ) | $ | (18,180 | ) | ||||
Investing activities |
28,123 | 9,840 | (47,931 | ) | (16,058 | ) | ||||||||||
Financing activities |
(108 | ) | 16 | 76,945 | 11,046 | |||||||||||
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Net (decrease) increase in cash, cash equivalents and restricted cash |
$ | 7,657 | $ | (3,528 | ) | $ | 1,132 | $ | (23,192 | ) | ||||||
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Cash Flows from Operating Activities
Net cash used in operating activities was $20.4 million for the six months ended June 30, 2020. Cash used in operating activities was primarily due to the use of funds in Adicets operations to develop its product candidates and transaction costs incurred in connection with the merger with resTORbio resulting in a net loss of $12.9 million, adjusted for an increase in accounts receivable as a result of $10.0 million receivable under the Regeneron Agreement, the payment for which was received in July 2020, an increase in prepaid expenses and other current assets of $2.9 million and an increase in other non-current assets of $0.7 million, partially offset by non-cash charges for depreciation and amortization expense of $0.6 million, stock-based compensation expense of $0.7 million, an increase in accounts payable of $1.1 million, an increase in contract liabilities of $0.5 million and an increase in accrued and other current liabilities of $3.5 million. The increase in prepaid expenses and other current assets and increases in accounts payable and accrued and other liabilities resulted from the timing of payments to Adicets service providers.
Net cash used in operating activities was $13.4 million for the six months ended June 30, 2019. Cash used in operating activities was primarily due to the use of funds in Adicets operations to develop its product candidates resulting in a net loss of $6.8 million, adjusted for a non-cash change in the fair value of redeemable convertible preferred stock tranche liability of $1.9 million, a decrease in contract liabilities of $6.1 million due to revenue recognized for the six months ended June 30, 2019, and a decrease in accrued and other current liabilities of $0.9 million, partially offset by depreciation expense of $0.6 million, stock-based compensation expense of $0.5 million, a decrease in prepaid expenses and other current assets of $0.8 million, and an increase in accounts payable of $0.6 million. The decrease in prepaid expenses and other current assets and accrued and other current liabilities and increase in accounts payable resulted from the timing of payments to Adicets service providers.
Net cash used in operating activities was $27.9 million for the year ended December 31, 2019. Cash used in operating activities was primarily due to the use of funds in Adicets operations to develop its product candidates resulting in a net loss of $28.1 million, adjusted for a non-cash change in fair value of the redeemable convertible preferred stock tranche liability and TRDF liability of $2.0 million, a non-cash change in fair value of redeemable convertible preferred stock warrant liability of $0.3 million, a decrease in contract liabilities of $1.0 million, and a decrease in accrued and other current liabilities of $0.4 million, partially offset by depreciation expense of $1.2 million, stock-based compensation expense of $1.2 million, a decrease in prepaid expenses and other current assets of $1.4 million, and an increase in accounts payable of $0.5 million. The decrease in prepaid expenses and other current assets, decrease in accrued and other current liabilities, and increase in accounts payable resulted from the timing of payments to Adicets service providers.
Net cash used in operating activities was $18.2 million for the year ended December 31, 2018. Cash used in operating activities was primarily due to the use of funds in Adicets operations to develop its product candidates
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resulting in a net loss of $9.3 million, adjusted for a non-cash change in fair value of redeemable convertible preferred stock tranche liability and TRDF liability of $4.5 million, a decrease in contract liabilities of $3.2 million, an increase in prepaid expenses and other current assets of $2.8 million, a decrease in accrued and other current liabilities of $1.3 million, a decrease in accounts payable of $0.3 million, and an increase in other non-current assets of $0.3 million, partially offset by non-cash depreciation expense of $1.2 million and stock-based compensation expense of $2.5 million. The increase in prepaid expenses and other current assets and decreases in accounts payable and accrued and other current liabilities resulted from the timing of payments to Adicets service providers.
Cash Flows from Investing Activities
Net cash provided by investing activities was $28.1 million for the six months ended June 30, 2020, which consisted of proceeds from maturities of marketable debt securities of $34.2 million, partially offset by purchases of marketable debt securities of $5.7 million and purchases of property and equipment of $0.4 million.
Net cash provided by investing activities was $9.8 million for the six months ended June 30, 2019, which consisted of proceeds from maturities of marketable debt securities of $12.8 million, partially offset by purchases of marketable debt securities of $2.4 million and purchases of property and equipment of $0.5 million.
Net cash used in investing activities was $47.9 million for the year ended December 31, 2019, which related to purchases of marketable debt securities of $76.1 million and purchases of property and equipment of $1.1 million, partially offset by proceeds from maturities of marketable debt securities of $29.1 million.
Net cash used in investing activities was $16.1 million for the year ended December 31, 2018, which related to purchases of marketable debt securities of $15.2 million and purchases of property and equipment of $0.9 million.
Cash Flows from Financing Activities
Net cash used in financing activities was $0.1 million for the six months ended June 30, 2020, primarily due to cash paid for debt issuance costs of $0.2 million, partly offset by cash proceeds from the exercise of stock options of less than $0.1 million.
Net cash provided by financing activities was less than $0.1 million for the six months ended June 30, 2019, primarily due to cash proceeds from the exercise of stock options.
Net cash provided by financing activities was $76.9 million for the year ended December 31, 2019, primarily due to net proceeds from the sale of Series B redeemable convertible preferred stock.
Net cash provided by financing activities was $11.0 million for the year ended December 31, 2018, due to net proceeds from the sale of Series A redeemable convertible preferred stock of $10.8 million and cash proceeds of $0.2 million from exercise of stock options.
Contractual Obligations and Commitments
The following table summarizes Adicets contractual obligations as of December 31, 2019 (in thousands):
Payments Due by Period | ||||||||||||||||||||
Less than 1 year |
1 to 3 years |
3 to 5 years |
More than 5 years |
Total | ||||||||||||||||
Operating lease obligations(1) |
$ | 2,721 | $ | 6,460 | $ | 5,680 | $ | 16,328 | $ | 31,189 |
(1) | Adicet leases its office facility in Menlo Park, California under a non-cancellable operating leases with an expiration date of March 31, 2022 (subject to any optional extension), which lease was amended on |
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September 30, 2019 to include additional office space, with an expiration date of March 31, 2021 (subject to any optional extension). On October 28, 2018, Adicet executed a non-cancelable lease agreement for a new office and laboratory facility in Redwood City that has not yet commenced with an expiration date of February 28, 2030. The minimum lease payments above do not include any related common area maintenance charges or real estate taxes. |
Adicet enters into contracts in the normal course of business with CROs and CMOs for preclinical and clinical studies and testing, manufacture and supply of its preclinical materials and other services and products used for operating purposes. These contracts generally provide for termination following a certain period after notice, and therefore, Adicet believes that its non-cancelable obligations under these agreements are not material.
Critical Accounting Policies, Significant Judgments and Use of Estimates
Adicets financial statements have been prepared in accordance with U.S. generally accepted accounting principles, (U.S. GAAP). The preparation of these financial statements requires Adicet to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported expenses incurred during the reporting periods. Adicets estimates are based on its historical experience and on various other factors that Adicet believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Adicet believes that the accounting policies discussed below are critical to understanding its historical and future performance, as these policies relate to the more significant areas involving managements judgments and estimates. For more detail on Adicets critical accounting policies, see Note 2 Summary of Significant Accounting Policies to Adicets audited financial statements included elsewhere in this proxy statement/prospectus/information statement.
Revenue Recognition
Adicets revenues are derived through the Regeneron Agreement and are accounted for in accordance with Accounting Standards Codification (ASC) 606. The terms of the Regeneron Agreement include (1) a research license, (2) a collaboration invention license, (3) a trademark license, (4) research and development services during the research term, (5) manufacturing services to manufacture collaboration ICPs for the research programs, (6) participation in the joint research committee, and (7) information sharing during the research term. Adicet considered that the licenses granted under the Regeneron Agreement are not capable of being distinct and are not distinct from the research and development and manufacturing services within the context of the Regeneron Agreement, because 1) such licenses are for the research and development effort during the research term, unless Regeneron exercises its option under the Regeneron Agreement, 2) the research and development services significantly increase the utility of such licenses, and 3) research and development services require collaboration ICPs being manufactured. Specifically, the licenses granted by Adicet can only provide benefit to Regeneron in combination with the research and development and manufacturing services provided by Adicet, to discover the collaboration ICPs. Similarly, the participation in the joint research committee and information sharing are not capable of being distinct and are not distinct from the research and development and manufacturing services within the context of the agreement, because the participation in the joint research committee is for monitoring and governing of the research and development efforts and the information sharing is for sharing results of such research and development efforts. Therefore, Adicet concluded all of the above promises are combined into a single performance obligation.
Adicet received a non-refundable upfront payment of $25.0 million from Regeneron upon execution of the Regeneron Agreement, an aggregate of $10.0 million of additional payments for research funding from Regeneron as of June 30, 2020 and received an additional payment of $10.0 million dollars in July 2020 from Regeneron for timely achievement of a milestone relating to the selection of a clinical candidate in June 2020. In addition, Regeneron may have to pay Adicet additional amounts in the future consisting of up to an aggregate of
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$100.0 million of option exercise fees, as specified in the Regeneron Agreement. Regeneron must also pay Adicet high single digit royalties as a percentage of net sales for ICPs to targets for which it has exclusive rights, and low single digit royalties as a percentage of net sales on any non-ICP product comprising a targeting moiety generated by Adicet through the use of Regenerons proprietary mice. Adicet must pay Regeneron mid-single to low double digit, but less than teens, of royalties as a percentage of net sales of ICPs to targets for which Adicet has exercised exclusive rights, and low to mid-single digit of royalties as a percentage of net sales of targeting moieties generated from Adicets license to use Regenerons proprietary mice. Royalties are payable until the longer of the expiration or invalidity of the licensed patent rights or twelve (12) years from first commercial sale.
Adicet also evaluated whether the option provided to Regeneron represents a material right that would require separate deferral and recognition. The option exercise will provide Regeneron with a development and commercial license to develop and commercialize the optioned collaboration ICPs. Adicet concluded that the $25.0 million upfront payment to it was not negotiated to provide incremental discount for the future option fees payable upon Regenerons exercise of the option.
Regeneron could decide not to exercise the option at its own discretion. The exercise of the option by Regeneron is not certain and is dependent on many factors, such as progress made on the specific option-eligible collaboration ICP, Regenerons overall assessment of commercial feasibility of the further research, development and commercialization of the Option products, availability and cost of alternative programs and products. The option provides Regeneron with a license for intellectual property that will be improved from the inception of the Regeneron Agreement. In addition, the option fee is significant compared to the sum total of the upfront payment and research funding fees in the original Regeneron Agreement. Therefore, the company determined that the option provided to Regeneron does not represent a material right and that any potential exercise of the option should be accounted as a separate contract. Hence, upon the option exercise by Regeneron the option fee would be allocated to the development and commercial license which would be the only performance obligation in that separate contract, and recognized as revenue when control of the license rights is transferred to Regeneron.
As of June 30, 2020, it is not probable that Adicet will exercise its co-funding option for the optioned collaboration ICPs. If, as a result of changes in facts and circumstances, it becomes probable that Adicet will exercise its co-funding option for an optioned collaboration ICP, then Adicet will reassess the accounting of the option fees for such optioned collaboration ICP, including if the nature of its relationship with Regeneron has changed from customer-vendor to collaboration partners.
For revenue recognition purposes, Adicet determined that the duration of the contract is the same as the research term of five (5) years beginning on the execution of the Regeneron Agreement on July 29, 2016. The contract duration is defined as the period during which parties to the contract have present and enforceable rights and obligations. Adicet determined that Regeneron faces significant in-substance penalties were it to terminate the Regeneron Agreement prior to the end of the research term.
In order to determine the transaction price, Adicet evaluated all the payments and licenses to be received from Regeneron during the duration of the contract. At contract inception, Adicet determined a transaction price of the Regeneron Agreement consisting of the $25.0 million upfront payment and the aggregate research funding fees payable over the research term. Per the terms of the original Regeneron Agreement prior to the amendment effective from July 2019, the research funding fees were payable merely due to passage of time and therefore did not represent a variable consideration. After the amendment became effective in July 2019, certain of these fees became contingent upon Adicet meeting certain development and regulatory milestones. Therefore, Adicet concluded that after the amendment such potential payments became variable consideration, the receipt of which was subject to substantial uncertainty and therefore excluded from the transaction price upon the effective date of the amendment. As a result, Adicet recorded $6.6 million as a reduction to cumulative revenue recognized prior to the amendment effective date. Adicet will re-evaluate the transaction price if there is a significant change in facts and circumstances but at least at the end of each reporting period. Adicet increased the transaction price in June 2020 when it achieved the milestone for the selection of a clinical candidate to the second collaboration
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target under the Regeneron Agreement, resulting in a recognition of cumulative revenue of $5.2 million during the six months ended June 30, 2020.
Adicet also considered the existence of any significant financing component within the Regeneron Agreement given its upfront payment structure. Based upon this assessment, Adicet concluded that the up-front payment was provided for valid business reasons and not for the purpose of providing financing. The reason for the initial advance payment at the beginning of the contract is not to provide financing to Adicet, but to ensure Regenerons commitment to the contract and to provide assurance that the customer will perform its obligations under the contract. Accordingly, Adicet has concluded that the upfront payment structure of the Regeneron Agreement does not result in the existence of a significant financing component.
The royalty payments will be recognized when the related sales occur as they were determined to relate predominantly to the intellectual property licenses granted to Regeneron and therefore have also been excluded from the transaction price.
Adicet has determined that the combined performance obligation is satisfied over time. ASC 606 requires Adicet to select a single revenue recognition method for the performance obligation that depicts Adicets performance in transferring control of the services. Accordingly, Adicet utilizes a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. Adicet believes this is the best measure of progress because it reflects how Adicet transfers its performance obligation to Regeneron. In applying the cost-based input method of revenue recognition, Adicet uses actual costs incurred relative to budgeted costs to fulfill the combined performance obligation. These costs consist primarily of internal full-time equivalent effort and third-party contract costs. Revenue is recognized based on actual costs incurred as a percentage of total budgeted costs as Adicet completes its performance obligations over the research term of five years. A cost-based input method of revenue recognition requires management to make estimates of costs to complete Adicets performance obligations. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete Adicets performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. A significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods.
Payments or reimbursements for Adicets research and development efforts where such efforts are considered as performance obligations are recognized as the services are performed and are presented on a gross basis.
Upfront payments are recorded as contract liabilities upon receipt or when due and require deferral of revenue recognition to a future period until Adicet performs its obligations under these arrangements. Amounts payable to Adicet are recorded as accounts receivable when its right to consideration is unconditional. Adicet does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, Adicet recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, Adicet has not recognized any royalty revenue resulting from its license and collaboration arrangement.
Accrued Research and Development
Adicet has entered into various agreements with CMOs and CROs. Adicets research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced,
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are included in accrued and other current liabilities on the consolidated balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, Adicet will adjust the accrual accordingly. Payments made to CMOs and CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets on the consolidated balance sheets until the services are rendered. To date, Adicets estimated accruals have not differed materially from the actual costs.
Stock-Based Compensation
Adicet uses a fair value-based method to account for all stock-based compensation arrangements with employees and non-employees, including stock options and restricted stock awards. Adicets determination of the fair value of stock options on the date of grant utilizes the Black-Scholes option pricing model. The fair value of the option granted is recognized on a straight-line basis over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period, which usually is the vesting period. Adicet accounts for forfeitures as they occur. In determining fair value of the stock options granted, Adicet uses the BlackScholes option-pricing model, which requires the input of subjective assumptions. These assumptions include estimating the length of time employees will retain their vested stock options before exercising them (expected term), the estimated volatility of Adicets common stock price over the expected term (expected volatility), risk-free interest rate and expected dividends. Changes in the following assumptions can materially affect the estimate of fair value and ultimately how much stock-based compensation expense is recognized; and the resulting change in fair value, if any, is recognized in Adicets consolidated statement of operations and comprehensive loss during the period the related services are rendered. These inputs are subjective and generally require significant analysis and judgment to develop. Changes in the following assumptions can materially affect the estimate of the fair value of stock-based compensation:
| Expected TermThe expected term is calculated using the simplified method which is used when there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting-tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. |
| Expected VolatilityAdicet uses an average historical stock price volatility of a peer group of comparable publicly traded companies in biotechnology and pharmaceutical related industries to be representative of its expected future stock price volatility, as it does not have any trading history for its common stock. For purposes of identifying these peer companies, Adicet considers the industry, stage of development, size and financial leverage of potential comparable companies. For each grant, Adicet measures historical volatility over a period equivalent to the expected term. |
| Risk-Free Interest RateThe risk-free interest rate is based on the implied yield currently available on U.S. Treasury zero-coupon issues with a remaining term equivalent to the expected term of the stock award. |
| Expected Dividend RateAdicet has not paid and does not anticipate paying dividends in the near future. Accordingly, Adicet estimates the dividend yield to be zero. |
Common Stock Valuations
The estimated fair value of the common stock underlying Adicets stock options and stock awards was determined at each grant date by its board of directors, with input from management and a third-party valuation specialist. All options to purchase shares of Adicets common stock are intended to be exercisable at a price per share not less than the per-share fair value of its common stock underlying those options on the date of grant.
In the absence of a public trading market for Adicets common stock, on each grant date, Adicet develops an estimate of the fair value of its common stock based on the information known to Adicet on the date of grant,
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upon a review of any recent events and their potential impact on the estimated fair value per share of the common stock, and valuations from an independent third-party valuation firm.
Adicets valuations of its common stock were determined in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation, or the Practice Aid.
The assumptions used to determine the estimated fair value of Adicets common stock are based on numerous objective and subjective factors, combined with management judgment, including:
| external market conditions affecting the pharmaceutical and biotechnology industry and trends within the industry; |
| Adicets stage of development and business strategy; |
| the rights, preferences and privileges of Adicets redeemable convertible preferred stock relative to those of its common stock; |
| the prices at which Adicet sold shares of its redeemable convertible preferred stock; |
| Adicets financial condition and operating results, including its levels of available capital resources; |
| the progress of Adicets research and development efforts; |
| equity market conditions affecting comparable public companies; and |
| general U.S. market conditions and the lack of marketability of Adicets common stock. |
The Practice Aid identifies various available methods for allocating enterprise value across classes and series of capital stock to determine the estimated fair value of common stock at each valuation date. In accordance with the Practice Aid, Adicet considered the following methods:
| Option Pricing Method. Under the option pricing method, or OPM, shares are valued by creating a series of call options with exercise prices based on the liquidation preferences and conversion terms of each equity class. The estimated fair values of the preferred and common stock are inferred by analyzing these. |
| Probability-Weighted Expected Return Method. The probability-weighted expected return method, or PWERM, is a scenario-based analysis that estimates value per share based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to Adicet, as well as the economic and control rights of each share class. |
Based on Adicets early stage of development and other relevant factors, Adicet determined that the OPM method as well as a hybrid approach of the OPM and the PWERM methods were the most appropriate methods for allocating Adicets enterprise value to determine the estimated fair value of its common stock. In determining the estimated fair value of Adicets common stock, its board of directors also considered the fact that Adicets stockholders could not freely trade its common stock in the public markets. Accordingly, Adicet applied discounts to reflect the lack of marketability of its common stock based on the weighted-average expected time to liquidity. The estimated fair value of Adicets common stock at each grant date reflected a non-marketability discount partially based on the anticipated likelihood and timing of a future liquidity event.
Following the completion of the merger, the fair value of Adicets common stock will be based on the closing quoted market price of the common stock of the combined company on the date of grant.
Income Taxes
Adicet provides for income taxes under the asset and liability method. Current income tax expense or benefit represents the amount of income taxes expected to be payable or refundable for the current year. Deferred
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income tax assets and liabilities arise due to differences between when assets or liabilities are recognized for tax purposes and when they are recognized for financial reporting purposes. Net operating losses and credit carryforwards are also deferred tax assets. Deferred tax assets and liabilities are measured using the enacted tax rates and laws that will be in effect when such items are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when management determines it is more likely than not that some or all of the tax benefits will not be realized.
Adicet assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination that the position meets the more-likely-than-not threshold and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement.
As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and Adicet will determine whether the factors underlying the more-likely-than-not threshold assertion have changed and the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available.
Utilization of the net operating loss carryforwards and research and development tax credit carryforwards may be subject to an annual limitation under Section 382 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Companys stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. Further, until a study is completed and any limitation is known, no amounts are being presented as an uncertain tax position.
As of December 31, 2019, Adicet had unrecognized tax benefits of $0.8 million related to the transfer of certain intellectual property from its Israeli subsidiary to the parent company, none of which would affect Adicets effective tax rate if recognized due to full valuation allowance. It is unlikely that the amount of liability for unrecognized tax benefits will significantly change over the next 12 months.
Adicet recognizes interest expense and penalties related to the above unrecognized tax benefits within income tax expense (benefit). Management determined that no accrual for interest and penalties was required as of December 31, 2019.
Redeemable Convertible Preferred Stock
Adicet records all shares of its redeemable convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs, if applicable. Adicets redeemable convertible preferred stock is recorded outside of permanent equity because while it is not mandatorily redeemable, in certain events considered not solely within its control, such as a merger, acquisition, or sale of all or substantially all of the companys assets (each, a deemed liquidation event), Adicets redeemable convertible preferred stock will become redeemable at
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the option of the holders of at least a majority of the then outstanding shares. Adicet has not adjusted the carrying values of its redeemable convertible preferred stock to its liquidation preference because a deemed liquidation event obligating Adicet to pay the liquidation preferences to holders of shares of redeemable convertible preferred stock is not probable of occurring. Subsequent adjustments to the carrying values to the liquidation preferences will be made only when it becomes probable that such a deemed liquidation event will occur.
Redeemable Convertible Preferred Stock Tranche Liability
Adicet determined that its obligations to issue additional shares of redeemable convertible preferred stock upon the achievement of certain milestones or at the option of the respective holders of such shares represented freestanding financial instruments. These instruments were initially measured at fair value and were subject to remeasurement with changes in fair value recognized in other income, net in the consolidated statements of operations and comprehensive loss until they were exercised, terminated or settled.
Redeemable Convertible Preferred Stock Warrants
Adicets redeemable convertible preferred stock warrants require liability classification and accounting as the underlying redeemable convertible preferred stock is considered contingently redeemable and may obligate Adicet to transfer assets to the holders at a future date upon the occurrence of a deemed liquidation event. The warrants are recorded at fair value upon issuance and are subject to remeasurement to fair value at each balance sheet date, with any changes in fair value recognized in other income, net in the consolidated statements of operations and comprehensive loss. Adicet will continue to adjust the warrant liability for changes in fair value until the earlier of the exercise or expiration of the redeemable convertible preferred stock warrants, the occurrence of a deemed liquidation event or the conversion of redeemable convertible preferred stock into common stock.
Off-Balance Sheet Arrangements
Since Adicets inception, it has not engaged in any off-balance sheet arrangements.
Indemnification Agreements
Adicet enters into standard indemnification arrangements in the ordinary course of business. Pursuant to these arrangements, Adicet indemnify, hold harmless and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, including in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third-party with respect to its technology. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The maximum potential amount of future payments Adicet could be required to make under these arrangements is not determinable. Adicet has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. As a result, Adicet believes the fair value of these agreements is minimal.
Adicet has also agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the companys request in such capacity. The indemnification period covers all pertinent events and occurrences during the directors or officers service. The maximum potential amount of future payments Adicet could be required to make under these indemnification agreements is not specified in the agreements; however, the company has director and officer insurance coverage that reduces its exposure and enables Adicet to recover a portion of any future amounts paid. Adicet believes the estimated fair value of these indemnification agreements in excess of applicable insurance coverage is minimal.
Recent Accounting Pronouncements
See the section titled Summary of Significant Accounting Policies in Note 2 to Adicets audited financial statements included elsewhere in this proxy statement/prospectus/information statement for additional information.
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Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Sensitivity
The market risk inherent in Adicets financial instruments and in its financial position represents the potential loss arising from adverse changes in interest rates. As of June 30, 2020, Adicet had cash and cash equivalents and marketable debt securities of $52.3 million, consisting of interest-bearing money market funds, asset-backed securities, corporate debt securities, commercial paper, and U.S. Government agency bonds, for which the fair value would be affected by changes in the general level of U.S. interest rates. However, due to the short-term maturities and the low-risk profile of Adicets cash equivalents, an immediate 10% relative change in interest rates would not have a material effect on the fair value of its cash equivalents or on its future interest income.
Adicet does not believe that inflation, interest rate changes or foreign currency exchange rate fluctuations have had a significant impact on its results of operations for any periods presented herein.
Internal Control Over Financial Reporting
During the preparation of Adicets consolidated financial statements as of and for the years ended December 31, 2019 and 2018, the company identified material weaknesses in its internal control over financial reporting. A companys internal control over financial reporting is a process designed by, or under the supervision of, a companys principal executive and principal financial officers, or persons performing similar functions, and effected by a companys board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles. Under standards established by the Public Company Accounting Oversight Board, a material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of Adicets annual or interim financial statements will not be prevented or detected and corrected on a timely basis.
In connection with the audit of Adicets financial statements as of and for the years ended December 31, 2019 and 2018, Adicet identified material weaknesses in its internal control over financial reporting. The material weaknesses Adicet identified were as follows:
(i) | Adicet did not design or maintain an effective control environment commensurate with its financial reporting requirements due to lack of a sufficient number of accounting professionals with the appropriate level of experience and training; |
(ii) | Adicet did not design and maintain formal accounting policies, procedures and controls to achieve complete, accurate and timely financial accounting, reporting and disclosures, and monitoring controls maintained at the corporate level were not at a sufficient level of precision to provide for the appropriate level of oversight of activities related to its internal control over financial reporting; |
(iii) | Adicet did not design and maintain effective controls over segregation of duties with respect to the preparation and review of account reconciliations as well as creating and posting manual journal entries; and |
(iv) | Adicet did not design and maintain formal accounting policies, processes and controls to analyze, account for and disclose complex transactions. |
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Remediation of Material Weaknesses in Internal Control over Financial Reporting
Adicets management, under the supervision of its Chief Executive Officer and Chief Financial Officer, has undertaken a plan to remediate the material weaknesses identified above. The remediation efforts summarized below, which are either implemented or in the process of being implemented, are intended to address the identified material weaknesses.
| Adicet has engaged a temporary Corporate Controller, and is actively seeking to engage a permanent Corporate Controller, whose primary responsibilities include working with third-party consultants to improve the design, implementation, execution and supervision of the companys internal control over financial reporting, including development of formal accounting policies, procedures and controls; |
| Ensure key accounting personnel have appropriate training; |
| Implement formalized training of accounting personnel responsible for preparation and review of account reconciliations and the posting and reviewing manual journal entries, to be held on a periodic basis, and ensure appropriate segregation of duties are implemented; and |
| Following the merger, engage additional accounting staff with appropriate experience, certification, education and training with respect to public company accounting. |
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Exhibit 99.4
ADICET BUSINESS
Overview
Adicet is a biotechnology company that is advancing a new generation of chimeric antigen receptor, or CAR, modified-T cell therapies in oncology and other indications. Adicets approach is based on gamma delta T cells, an immune cell population that Adicet believes has potentially significant advantages over alpha beta T cells, which are the basis of standard CAR-T cell therapies. Adicet believes that it is at the forefront to take tumor targeting gamma delta CAR-T cell product candidates into Investigational New Drug, or IND, enabling studies and clinical trials for specific tumor types. Adicet is focused on developing proprietary processes for engineering and manufacturing product candidates based on gamma delta T cells from the blood of healthy donors, resulting in high yields of cells with efficacious tumor-killing activity as observed in preclinical experiments. The ability to administer product candidates based on gamma delta T cells to patients without inducing a graft versus host immune response means that Adicets products can potentially be produced as off-the-shelf therapies. This is in contrast to products based on alpha beta T cells, which either must be manufactured for each patient from his or her own T cells or which require significant gene editing to manufacture allogeneic therapies, that is, therapies that are based on T cells derived from donors that are unrelated to the patient. Based on what Adicet believes is the enormous promise of these cells and associated modifications, Adicet is initially developing product candidates in oncology, both for hematological malignancies and for solid tumor indications. Due to certain unique properties of gamma delta T cells, Adicet believes that its product candidates will have an inherent capacity to recognize and kill circulating tumor cells and to infiltrate and kill solid tumors, the cause of over 90% of all cancer deaths as estimated by the American Cancer Society in 2020. Adicet intends to file an IND application with the FDA in 2020 for ADI-001, the companys lead product candidate, in Non-Hodgkins Lymphoma, or NHL. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-001 in the first half of 2021. Adicet expects initial clinical results from this trial in 2021. Adicet intends to file an IND application with the FDA in 2021 for ADI-002, the companys first solid tumor product candidate. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-002 in 2021.
Gamma delta T cells have unique attributes that Adicet believes make them especially well-suited to be used for cancer therapy. Approximately 95% of T cells in circulation are so-called alpha beta T cells, named after the proteins that make up the cells T cell receptor, or TCR. The remaining T cells include a population that makes up between 1% and 5% of all T cells, the gamma delta T cells, along with a few other cell types. Distinct among immune cell populations, gamma delta T cells have the following combination of attributes:
| Can be used off-the-shelf after being expanded from healthy donors; |
| Are actively cytotoxic to tumor cells; |
| Can replicate in an appropriate and measured way after manufacture; |
| Can have their specificity for tumor cells enhanced further by the addition of a CAR; |
| Express both T cell and natural killer, or NK, cell receptors, facilitating both adaptive and innate anti-tumor immune responses; and |
| Can be manufactured in large numbers to facilitate the treatment of many patients and to avoid the cumbersome nature and expense of isolating T cells from each patient. |
By contrast, approved CAR-T cell therapies, as well as the majority of CAR-T cell therapies in clinical development, are based on a different population of T cells, known as alpha beta T cells, which have the ability to attack healthy tissues if they are not immunologically matched to the patient. For this reason, the majority of alpha-beta-T-cell-derived CAR-T cell products are custom-generated from cells isolated from each patient. Gamma delta T cells, by contrast, do not in principle require immunological matching to be safe and effective and therefore cells isolated from healthy donors can be administered to any patient. This enables cell therapy products based on gamma
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delta T cells to be manufactured in bulk and be distributed as readily available off-the-shelf products. In animal models and early clinical trials, gamma delta T cells do not expand in healthy tissues, indicating that they may be associated with a lower risk of life-threatening immune responses. In addition to their ability to circulate, gamma delta T cells have an inherent capacity to locate in tissues and recognize and attack cancerous cells.
ADI-001 is a gamma delta T-cell product candidate into which Adicet introduced a CAR that specifically recognizes CD20, a highly expressed surface protein found on the majority of NHLs. Adicet is developing a highly efficient and robust process to activate, engineer and manufacture product candidates derived from peripheral blood cells of healthy donors. Adicet is developing processes that can produce these cells in bulk under conditions that meet current Good Manufacturing Practices, that is, are cGMP-compliant, to generate an inventory of cell product that is readily available to patients on demand at clinical sites. Gamma delta T cells engineered with anti-CD20 CAR have highly potent antitumor activity in preclinical models, leading to effective long-term control of tumor growth. Adicet intends to file an IND application with the FDA in 2020 for ADI-001. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-001 in the first half of 2021. Adicet believes that ADI-001 has the potential to benefit the majority of patients that have NHL while also providing clinical validation of Adicets gamma delta T-cell platform technology.
In addition to potentially providing access to immunocellular therapies to a broader set of patients with hematological malignancies, Adicet believes that its technology is well-positioned to bring these therapies to patients with solid tumors. ADI-002 is a product candidate containing a CAR directed against Glypican-3, or GPC3, a tumor antigen that is highly expressed in hepatocellular carcinoma, or HCC, and other tumors such as gastric cancer and squamous cell carcinoma of the lung. ADI-002 has dose-dependent antitumor activity in animal models Adicet intends to file an IND application with the FDA in 2021 for ADI-002. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-002 in 2021.
Adicets solid tumor efforts are further complemented by the companys proprietary T cell receptor-like antibody, or TCRL, platform technology, a monoclonal antibody technology which enables the generation of CARs that recognize tumor antigens inside tumor cells, also known as intracellular proteins. Adicet believes that the ability to selectively bind to tumor antigens derived specifically from intracellular proteins is a critical advantage to immunocellular therapy due to the scarcity of tumor-specific surface antigens on solid tumors. Adicets approach to generating CARs for some product candidates takes advantage of this ability.
The Adicet management team has extensive experience in the discovery and development of immunocellular therapies with prior experience at leading biopharmaceutical organizations including AbbVie, Fate, Celgene, Amgen and Onyx. The founder and former President and CEO of Adicet, Aya Jakobovits, was the President and founding CEO of Kite Pharma Inc., or Kite Pharma. As of the date of this proxy statement/prospectus/information statement, Adicet has received investments valued at an aggregate of approximately $124 million from investors that include aMoon, Consensus Business Group, DSC Investment, Handok, Johnson & Johnson Innovation- JJDC, KB Investment, OCI Enterprises, Novartis Venture Fund, OrbiMed, OCI Enterprises, Pontifax, Regeneron Pharmaceuticals, Samsung Venture Investment and SBI JI Innovation Fund.
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Pipeline
Adicet has a pipeline of wholly owned preclinical assets. Adicet intends to file an IND application with the FDA in 2020 for ADI-001, the companys lead product candidate, in Non-Hodgkins Lymphoma, or NHL. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-001 in the first half of 2021. ADI-002 is Adicets second most advanced CAR-modified gamma delta T cell product and selectively targets Glypican-3, or GPC-3, via an engineered CAR. GPC-3 is differentially expressed on hepatocellular carcinoma, or HCC, and a number of other tumors. As part of a five-year collaboration between Adicet and Regeneron Pharmceuticals, Inc., or Regeneron, signed in 2016, Regeneron has the option to obtain development and commercial rights for a certain number of product candidates, and Adicet has an option to participate in the development and commercialization of these potential products or is entitled to royalty payments by Regeneron. Immune cell therapy product candidates developed and commercialized by Adicet under the Regeneron Agreement (as defined below) will be subject to payment of royalties to Regeneron. This collaboration is ongoing. To date, Regeneron has not exercised an option on any of Adicets candidates. For additional information on Adicets agreement with Regeneron, please see Adicet BusinessStrategic Agreements beginning on page 311 of this proxy statement/prospectus/information statement. Adicets pipeline of additional product candidates includes ADI-00x, for which the company expects to file an IND for solid tumor indications in 2022, and an IND for solid tumor and hematological indications in 2023.
Strategies
Adicets objective is to be the leading biotechnology company developing oncology and other therapies based on CAR-modified gamma delta T cells. The companys strategy to achieve this is as follows:
| Target clinical development, regulatory approval and commercialization of Adicets lead ADI-001 product candidate. Adicet intends to achieve two key objectives with the development program for ADI-001: |
| Bring a meaningful product to patients by developing ADI-001 in NHL and demonstrating its safety and efficacy; and |
| Validate the gamma delta T cell platform, showing both safety and efficacy, to enable rapid application to additional oncology indications. |
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To achieve these objectives, Adicet intends to demonstrate in its clinical trials an efficacy and safety profile that is similar or better than the currently approved autologous (manufactured from the patients own cells) alpha-beta based T-cell therapy in similar patient populations of NHL while making the product available off the shelf.
| Advance ADI-002 into clinical development. ADI-002, Adicets lead solid tumor product candidate, is currently undergoing preclinical studies. Adicet intends to file an IND application with the FDA in 2021 for ADI-002. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-002 in 2021. The companys goal is to develop ADI-002, both in monotherapy and in combination with standard of care agents, in a number of solid tumors that express high levels of glypican 3 protein, or GPC3, the cell surface molecule targeted by the product. |
| Continue to innovate and invest in the gamma delta T cell platform and pipeline. The company expects to continue to develop product candidates in oncology based on the gamma delta T cell platform using either previously validated antigens or those that Adicet identifies and targets using the companys TCRL technology. The company may utilize additional genetic engineering and editing technologies to further improve its products for greater cell persistence that may lead to greater efficacy. A key strength of Adicets gamma delta T cell therapy platform lies in the companys ability to target antigens of both known and unknown potential and devote the companys clinical development resources to those antigens that show the most promise in preclinical in vivo analyses and early human trials. |
| Expand and protect the companys intellectual property. Adicet will continue to aggressively protect the gamma delta T cell production methodology the company has developed as well as specific product candidates based on proprietary antigen-binding domains. For more information on Adicets intellectual property, see Adicet BusinessAdicet Intellectual Property on page 310 of this proxy statement/prospectus/information statement. |
| Potential for outpatient administration. While Adicet expects that the initial subjects treated with gamma delta T cell-based therapies in clinical studies will be hospitalized for a minimum of 24 hours observation after infusion, a favorable tolerability profile may allow administration of such therapies in an outpatient setting. This would represent a significant competitive advantage for gamma delta T cell-based therapies as compared to existing approved CAR-T cell therapies. |
Background
Anticancer immune cell therapy
In recent years, the field of immuno-oncology has transformed the treatment of cancer. Immuno-oncology deploys the immune system to attack and, in some cases, to eliminate cancer. One of the key breakthroughs in immuno-oncology involved using T cells, a key element of the immune system, and turned them into even more potent, tumor-cell-specific killers. Researchers have achieved this improvement and targeting by loading the T cells with a gene encoding a CAR. These engineered receptors represent a powerful combination of, first, a region that binds to a target on a cancer cell and tethers the T cell to it; and, second, a signal that activates the T cell to eliminate the tethered cancer cell. To the companys knowledge, all marketed CAR-T cells contain predominantly alpha beta T cells. While Adicet believes the use of CAR-T cell therapies is extremely promising, conventional CAR-T cell therapies also have some key flaws that, Adicet believes, can be addressed by using a cell population, specifically, gamma delta T cells rather than alpha beta T cells.
As of the date of this proxy statement/prospectus/information statement, two CD19-targeting CAR-T cell therapies have been approved by the FDA: axicabtagene ciloleucel, or Yescarta®, developed by Kite Pharma (now Gilead); and tisagenlecleucel, or Kymriah®, developed by Novartis. These therapies are highly effective in many patients. Among the 101 patients with diffuse large B cell lymphoma, or DLBCL, treated with Yescarta® in a clinical trial, an objective response rate of 82% was observed with 54% of patients achieving a complete response. This high efficacy, however, is associated with significant adverse events, with 13% of patients
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experiencing grade 3 or higher cytokine release syndrome and 28% of patients experiencing grade 3 or higher neurologic events. In the Yescarta® clinical trial, three patients died due to adverse events during treatment and ten patients who were enrolled in the trial were not able to be treated due to disease progression or complications that arose during the period of time required to generate the patient-specific therapy or because of the inability to generate the desired CAR-T cells from the patients cells. Despite these known adverse events, in 2017 and 2018, leading CAR-T cell companies Kite Pharma and Juno Therapeutics, Inc., or Juno, were acquired for a total of $20.9 billion by Gilead and Celgene, now Bristol Myers-Squibb, respectively. Adicet believes these acquisitions were a result of a combination of the ability of Kite Pharma and Juno to treat cancer immediately through the initial product candidates and projected to generate numerous additional candidates. Adicet believes that, despite their progress to date, currently available CAR-T cell therapies have not reached their full promise, and the Adicet gamma delta CAR-T cell approach has the potential to be a significant improvement.
The current generation of CAR-T cell therapies represented by Yescarta® and Kymriah® are autologous cell therapies, that is, they are based on immune cells isolated from a patient, modified and expanded in a laboratory and then reintroduced into the same patient. One key reason for taking this autologous approach is that the cytotoxic, or cell-killing, predominantly alpha beta T cells that are used to generate these therapies are cells that the immune system uses to recognize and attack foreign cells. If these types of T cells were to be introduced into a patient from an unrelated donor, the donor T cells would attack healthy tissues throughout the patient in a process known as graft versus host disease, or GvHD, potentially causing multiple organ failure and death.
The T cells used for first-generation CAR-T cell therapies were derived from a well-known and highly abundant subclass of T cells known as alpha beta T cells. Alpha beta T cells, which comprise approximately 95% of the T cells in circulation in the body, are able to distinguish whether cells that they encounter are normal cells that belong in the body or foreign or damaged cells that need to be destroyed. Alpha beta T cells have a receptor on their surface called a T cell receptor, or TCR, which is made up of alpha and beta protein chains. These TCRs recognize targets, also known as antigens, on cells that are presented by antigen-presenting molecules encoded by the major histocompatibility complex, or MHC. The MHC contains genes that encode a number of proteins with multiple variants, or alleles, such that most individuals have a distinct MHC profile. During normal T cell development, those T cells that recognize the combination of the specific MHC profile and antigens that are presented by healthy cells of the specific individual are eliminated, resulting in a population of T cells that circulate throughout the body, vigilantly checking for abnormal antigens or foreign cells, including from another individual.
In one type of cellular immunotherapy known as adoptive cell therapy, naturally occurring immune cells from a patient are isolated and are activated using cytokines and tumor-specific antigens to stimulate the growth and expansion of antitumor T cells that already exist at low abundance in the patient. After activation and expansion in the laboratory, large numbers of T cells that are primed to recognize the tumor are reintroduced into the same patient.
CAR-T cell therapies are a variant of this adoptive cell therapy in which, instead of trying to activate T cells based on the ability of naturally occurring TCRs to recognize tumor antigens, a chimeric antigen receptor, or CAR, that is designed to recognize a specific tumor antigen is genetically introduced into T cells. These CAR-T cells are then able to destroy any cells expressing the appropriate antigen completely independent of MHC. However, CAR-T cells derived from alpha beta T cells still have endogenous TCRs which restrict their use to the original patient.
Limitations of autologous cell therapies
Autologous cell therapies, such as those developed by Kite Pharma and Novartis, have a number of limitations, including but not limited to the following:
| Treatment delays imposed by individualized manufacturing. Due to the individualized manufacturing process, patients must wait up to three to four weeks for the individualized products to |
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be manufactured and administered. In the registrational trials for Yescarta® and Kymriah®, up to 31% of intended patients ultimately did not receive treatment primarily due to complications from the underlying disease that occurred during manufacturing or due to manufacturing failures. |
| Manufacturing variability and failure. It was reported by Novartis in 2018 that variability in product specifications had been observed in the production of Kymriah®. In addition, in approximately 9% of the cases, no product could be shipped to patients at all due to out-of-specification issues or from manufacturing failures. |
| High cost limits patient access. The high cost of therapy and payer policies can limit access to autologous CAR-T cell therapies. According to a 2019 article published in the journal Managed Care, treating physicians estimate that the costs of autologous CAR-T cell therapies combined with patient care services are approximately $1 million per patient, generating reluctance of payers to approve these therapies for patients before they have exhausted other options. These therapies are then relegated to the most heavily pretreated patients who may be unable to withstand the severe side effects. |
| Scalability. Because each patient requires a custom manufacturing batch, the production of autologous CAR-T cells at the scale needed to meet commercial demand and anticipated label and geographic expansions may be challenging. |
Autologous cell therapies, such as CAR-T cells derived from alpha beta T cells, have been successful in their initial use in hematological malignancies. Furthermore, they have provided critical data that demonstrates the potential of immunocellular cancer therapies. However, manufacturing of these cells imposes some critical limitations that could be minimized if similar allogeneic cell therapies that can be given to any patient, regardless of the donor of cells, are developed. Adicet believes that allogeneic cell therapies offer great promise for optimizing the access to therapy, overcoming manufacturing-related and cost-related limitations of autologous cell therapies.
Gamma delta T cells and their allogeneic potential
Gamma delta T cells are a subset of T cells that have TCRs comprising gamma and delta receptor chains. In contrast to alpha beta T cells, gamma delta T cells are not selective for patient-specific MHC molecules. Therefore, gamma delta T cells from an unrelated donor can be administered to a patient without inducing GvHD. Gamma delta T cells primarily reside in tissues and comprise between 1% and 5% of circulating T cells.
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Gamma delta T cells correlate with improved outcomes
An analysis of the transcriptional profiles of 5,872 patient tumor samples across 25 malignancies published in Nature Medicine in 2015 found that gene signatures consistent with gamma delta T cells were the strongest predictors of overall survival. The association of gamma delta T cells with overall survival in solid tumors had a z-score over three, meaning it was over three standard deviations above the mean, corresponding to a p value less than 0.001.
Figure 1. Analysis of the immune cell composition of tumor samples that gamma delta T cells were highly predictive of overall survival. Adapted from Gentles et al., Nat Med. 2015 August; 21(8).
Additionally, high levels of gamma delta T cells have been associated with improved overall survival in acute leukemia patients who received hematopoietic stem cell transplants, or HSCT. In a study published by KT Godder et al. in 2007 in the journal Bone Marrow Transplantation, those patients with high levels of gamma delta T cells after the transplant had a leukemia free survival at five-years of 54.4% and overall survival of 70.8%. Those with low levels of gamma delta T cells had a significantly lower five-year leukemia free survival of 19.1% and a five-year overall survival of 19.6%.
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Figure 2. HSCT patients who develop high levels of gamma delta T cells have improved survival. Adapted from Godder et al., Bone Marrow Transplantation (2007) 39.
The correlation between high levels of gamma delta T cells and disease-free survival extends to patients with solid tumors. In a study published by Meraviglia et al in 2017 in the journal OncoImmunology, across a cohort of 557 patients with colorectal cancer, those with high gamma delta T cell levels had a ten-year disease-free survival rate of over 80%, while those with lower levels had a rate of approximately 50%.
Figure 3. High levels of gamma delta T cells are correlated with increased disease-free survival in colorectal cancer patients. Adapted from Meraviglia et al Oncoimmunology 2017, VOL. 6, NO. 10.
Adicet believes that these studies and others point to an important role of gamma delta T cells in disease control and overall survival and indicate that gamma delta T cell-based therapies have the potential to deliver clinically meaningful results.
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Advantages of gamma delta T cell-based therapies
Immunotherapies developed using gamma delta T cells have a number of advantages over other therapies developed using other cell types, including the following:
| Lack of GvHD. A body of published evidence, mainly in the field of HSCT, indicates the safety of transfer of allogeneic gamma delta T cells from donors to unrelated patient recipients. HSCT procedures containing significant numbers of gamma delta T cells were able to proceed with no signs of acute or chronic GvHD. In many cases, the presence of gamma delta T cells in the HSCT products correlated with improved clinical outcomes, indicating the antitumor potential of gamma delta T cells. Additionally, a study performed by Martin Wilhelm and colleagues in 2014 indicated that gamma delta T cells from haploidentical donors could be successfully expanded and infused in large numbers (2.17x106 cells / kg (range, 0.9-3.84)), followed by further expansion (mean, 68-fold) in the patients without any observed GvHD. |
| Tumor localization. In addition to being present in the circulation at low frequency, gamma delta T cells have an inherent propensity to home to tissues and tumors. Their ability to be activated in environments with low levels of oxygen such as those found in the tumor microenvironment has the potential to increase the efficacy of gamma delta T cells in solid tumors. |
| Limited cytokine secretion. Unlike alpha beta T cells, gamma delta T cells can be made to secrete lower levels of certain cytokines such as interleukin 2, or IL-2. This, combined with lack of recognition of normal, non-malignant, cells by of gamma delta T cells, may lower the risk of life-threatening cytokine release syndrome. |
| Limited ability for tumors to escape. Although the initial responses to immunotherapies such as antibodies and CAR-T cells are often impressive, many patients become refractory or relapse. A common mechanism for the relapse to these therapies is loss of the expression of the CAR-targeted antigen such as CD19 from tumor cells. Because gamma delta T cells also express innate cytotoxic immune receptors, they can recognize and kill tumor cells even in the absence of the CAR-targeted tumor antigen. |
| Ability to manufacture more efficiently and cost-effectively. Unlike alpha beta T cells, therapies based on gamma delta T cells can in principle be manufactured in bulk and used in the allogeneic or off-the-shelf setting, addressing many of the shortcomings of conventional alpha beta T cell therapy. |
| Potential for superior cytotoxic activity. T cells from some cancer patients, for example those with chronic lymphocytic leukemia, often display an exhausted, or otherwise dysfunctional, phenotype and CAR-T cell products from these cells may perform poorly. The Adicet allogenic cell therapy is manufactured from healthy donors whose T cells have been proven to generate highly active CAR-T cell product. |
| Potential for re-dosing. Along with increased availability of material due to the ability to utilize off-the-shelf healthy allogeneic donor-derived starting material compared to conventional CAR-T cell therapies, the lack of MHC-dependent GvHD also opens up the possibility of being able to re-dose patients to achieve prolonged efficacy if they do not obtain an adequate clinical response from initial treatment or if they relapse. A number of studies with other CAR-T cell therapies have linked the development of cytokine release syndrome with high numbers of circulating CAR T cells following rapid alpha beta T cell proliferation. Having the option to retreat patients with gamma delta T cells provides the option of starting with a low dose and redosing if required. |
Adicets CAR gamma delta T-cell technology
Human gamma delta T cells can be divided into three main subsets based on their TCR delta chain usage: Vd1, Vd2 and Vd3. The most abundant subset of gamma delta T cells in the circulatory system, the Vd2 cells, is the most well-studied. However, it is the Vd1 subset which primarily resides in tissues and is the subset that Adicet is developing proprietary methods to activate and manufacture.
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Vd1 gamma delta T cells
Vd1 cells have properties of both the innate and adaptive immune system, meaning that they can be activated by tumor-specific antigens as well as by general activators common to damaged or otherwise abnormal cells. Similar to other T cells, they express TCRs, but also express cytotoxicity receptors that are found on innate immune cells such as natural killer, or NK, cells. These gamma delta T cells can induce tumor cell death through multiple mechanisms including the secretion of cytotoxic proteins such as granzymes and perforin as well as through the section of cytokines such as interferon gamma, or IFNg, and tumor necrosis factor alpha, or TNFa.
In in vitro and in vivo preclinical cancer models, Vd1 cells are more cytotoxic and have a longer durability than Vd2 cells. Vd1 cells are also more resistant to activation induced cell death, or AICD, which has posed significant problems in clinical trials following chronic stimulation of Vd2 cells. Vd1 cells normally reside within tissues and they are able to adapt to lower nutrient availability and decreased oxygen levels, conditions which are similar to those in the microenvironments or localized areas associated with certain solid tumors. Incubation of these gamma delta T cells in conditions of low oxygen, or hypoxia, that are typical of tumors has been shown to enhance their cytotoxicity.
Anticipated advantages of Vd1 gamma delta T cells over other approaches to generate allogeneic CAR-T cells
An alternate approach to the development of allogeneic CAR T cells consists of introducing genetic modifications that disable the TCR in alpha beta T cells derived from donors that are not related to the patient. This process prevents these cells from attacking the patients healthy cells. Adicet believes that the healthy donor-derived gamma delta T cell technology it uses, which lacks the ability to attack healthy cells from unrelated individuals, has a number of advantages over this approach. In an allogeneic paradigm, unlike alpha beta T cells, Vd1 gamma delta T-cells have the following advantages:
| Do not rely on genetic manipulations to inactivate the alpha beta TCR; |
| Display properties of both adaptive and innate immune systems and are capable of killing cells even if their specifically targeted CAR antigen is expressed at low levels or not present; |
| May not be prone to exhaustion and are likely to persist longer; |
| May inherently home to tissues and tumors rather than predominantly residing in circulation; and |
| May be less likely to induce cytokine release syndrome due to more limited endogenous IL-2 secretion by activated cells. |
Adicet believes these advantages position gamma delta T cell based therapies to become an attractive and potentially superior alternative to alpha beta T cell based therapies.
Anticipated advantages of Vd1 gamma delta T cells over bispecific antibody T cell recruitment for tumor immunotherapy
An alternate approach to the development of allogeneic CAR T cells consists of bispecific antibodies that are designed to crosslink T cells to specific targets on the tumor. This approach generally requires healthy and functional T cells able to attack the tumor when guided to the tumor expressing the target antigen. Adicet believes that the healthy donor-derived gamma delta T cell technology it uses has a number of advantages over this approach. Unlike bispecific antibodies, Vd1 gamma delta T cells have the following advantages:
| Do not rely on functional T cells derived from the patient; |
| Display properties of both adaptive and innate immune systems and are capable of killing cells even if their specifically targeted CAR antigen is not present; |
| May inherently home to tissues and tumors rather than predominantly residing in circulation; and |
| May be less likely to induce cytokine release syndrome due to more limited endogenous IL-2 secretion by activated cells. |
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Adicet believes these advantages position gamma delta T cell-based therapies to become an attractive and potentially superior alternative to bispecific-based therapies for many oncology indications and lines of therapy.
Anticipated advantages of Vd1 gamma delta T cells over NK cell based therapies
An alternate approach to the development of allogeneic CAR T cells consists of engineered natural killer, or NK, cell-based therapy. While both gamma delta T cell and NK cell therapy generally are not expected to cause graft versus host disease, NK cells express a broad repertoire of both inhibitory and activating receptors and have more limited tumor induced secretion of multiple cytokines. Adicet believes that the gamma delta T cell technology it uses has a number of advantages over this approach. Unlike engineered NK cells, Vd1 gamma delta T-cells have the following advantages:
| Express activating receptors more predominantly; |
| Can display tumor-induced secretion of multiple cytokines including expressing high levels of interferon-gamma; |
| The presence of gamma delta cells in tumors is strongly correlated with positive clinical outcomes; and |
| Can be produced as highly homogeneous cell populations. |
Adicet believes these advantages position gamma delta T cell-based therapies to become an attractive and potentially superior alternative to NK based therapies for many oncology indications and lines of therapy.
Adicets key anticipated differentiation from gamma delta T cell competitors
Adicet believes that the gamma delta T cell technology that it is developing has a number of anticipated advantages over the technology of gamma delta T cell competitor companies, including the following:
| Robust and practical proprietary antibody-based manufacturing method for gamma delta T cells |
| Large-scale expansion of blood-derived gamma delta T cells |
| Ability to selectively expand multiple gamma delta T cell subpopulations including highly potent Vd1 cells |
| No potentially pro-tumorigenic Th17-type responses in Adicets Vd1 subpopulation |
| In-house chimeric antigen receptor target identification and verification process |
| Ability to effectively target tumor-specific intracellular protein-derived peptides using proprietary T cell receptor-like antibodies |
Adicet believes these advantages position its gamma delta T-cell based therapies to become an attractive and potentially superior approach to the technologies used by other gamma delta T cell competitor companies.
Production of gamma delta T cells
To produce gamma delta T cell based product candidates, Adicet isolates peripheral blood mononuclear cells, or PBMCs, from healthy donors that meet all the safety criteria for human cells, tissues, and cellular and tissue-based products, or HCT/P, criteria for donors as outlined by the FDA in 21 CFR Part 1271. Adicet then activates Vd1 gamma delta T cells using a proprietary agonistic antibody and cytokines and expands these cells before introduction of replication-incompetent retroviral vectors containing the coding sequence for CAR constructs. These CAR-modified cells are further expanded, routinely greater than 6,000 fold at clinical scale, resulting in cell cultures that primarily consist of the desired gamma delta T cells. To reduce the chance of a patient developing GvHD, the remaining alpha beta T cells are then depleted using alpha-beta-specific, antibody-based
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techniques. The resulting gamma delta T cells are then formulated in an infusible solution to form the final drug product, which is filled into vials and then frozen to enable delivery of a post-thaw cell dose from each vial of CAR-T cells.
Figure 4. Production process for Adicets CAR gamma delta T cell products.
Figure 5. Fold expansion of gamma delta T cells.
Adicet believes that its manufacturing process, including the generation of the antibodies and retroviral vectors, meets current Good Manufacturing Practices, i.e. is a cGMP-compliant process. Adicet expects to be able to produce tens to hundreds of doses from a single donor, greatly increasing the efficiency of manufacturing compared to autologous alpha beta T cell therapies. The company has chosen to partner with a number of contract manufacturing organizations in the United States and Europe to access specific capabilities to ensure that the manufacturing process is highly scalable, and fully cGMP-compliant with the potential to treat up to 1,000 patients per batch.
Preclinical data
To estimate the tumor killing potential of Vd1 gamma delta T cells even before tumor-specific CARs are introduced, the Adicet team uses the Polyfunctional Strength Index, or PSI. The PSI is a measure of the cytokine production activity associated with immune cells. It is derived by multiplying the number of cytokines secreted per cell by the amount of each cytokine to identify the most potent immunotherapies. This metric has shown that the immune cells of patients who respond to CAR-T cell therapies have significantly higher PSI scores. In the responders, 20% to 25% of T cells were found to be polyfunctional. The major cytokines produced were cytotoxic and inflammatory cytokines including IFNg; macrophage inflammatory protein 1-alpha, or MIP-1a;
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interleukin 8, or IL-8; and granzyme B. Ex vivo stimulation of patient-isolated T cells with interleukin 15, or IL-15, further differentiated the PSI scores of the responders versus non-responders.
Figure 6. Pre-infusion PSI of CAR-T cells stimulated with CD19 with high PSI is associated with clinical response.
Adicet believes that this result holds great promise for the application of the companys selected cell population, the tumor-induced PSI scores of Vd1 gamma delta T cells produced by Adicets proprietary manufacturing process are approximately three times higher than those of unstimulated cells.
Figure 7. Adicets Vd1 gamma delta T cells demonstrate high tumor-stimulated PSI scores.
ADI-001, an anti-CD20 CAR gamma delta T-cell therapy
ADI-001 is an allogeneic Vd1 gamma delta T cell product candidate containing an anti-CD20 CAR. Adicet is developing ADI-001 for the treatment of NHL. Adicet intends to file an IND application with the FDA in 2020 for ADI-001. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-001 in the first half of 2021. Adicet expects initial clinical results from this trial in 2021.
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B cell NHL overview
NHL is the most common cancer of the lymphatic system. An estimated 77,240 new cases are expected to be diagnosed in the United States in 2020, according to the web site of the U.S. National Institutes of Health. According to the cancer.net web site maintained by the American Society for Clinical Oncology, approximately 90% of NHL patients in western countries have B cell lymphomas of various types and diffuse large B cell lymphoma, or DLBCL, is the most common and aggressive type of NHL, accounting for 30% of NHL. The second most common type is follicular lymphoma, or FL, which occurs in 20% of NHL patients. Mantle cell lymphoma, or MCL, is diagnosed in 5% to 7% of NHL cases.
Although B cell NHLs represent a heterogeneous set of lymphomas, many cell surface antigens are shared among them, including CD19 and CD20. First line therapy for patients with aggressive B cell NHLs, such as DLBCL, is chemotherapy in combination with radiation or rituximab, an antibody that targets CD20. According to the rituximab label as published on the FDA web site, the addition of rituximab to chemotherapy results in an approximately 10% to 15% overall increase in survival at one year compared to chemotherapy alone with almost no increase in toxicity. According to an article published by K.T. Godder et al. in the journal Bone Marrow Transplantation in 2007, up to 50% of patients become refractory or relapse after treatment. Of those, according to an article published by Andrew R. Rezvani and David G. Maloney in the journal Best Practice & Research Clinical Haematology in 2011, approximately 60% percent are resistant to rituximab upon relapse. Subsequent chemotherapy-based therapies typically have limited efficacy in these patients and, at that point, they become candidates for treatment with allogeneic HSCT or anti-CD19 CAR-T cell therapy. Approximately 35% of patients treated with anti-CD19 CAR-T cell therapies relapse within one year, according to the label for Kymriah® published on the Novartis web site.
Adicets solution, ADI-001
ADI-001 is a gamma delta T cell product candidate that targets malignant B-cells via an anti-CD20 CAR and via the gamma delta T cell endogenous receptors, which the company is developing as an allogeneic immunocellular therapy for the treatment of B-cell NHL. ADI-001 is created from Vd1 gamma delta T cells isolated from healthy donors. It is manufactured in bulk under cGMP-compliant conditions and is intended to be supplied as an immediately available off-the-shelf anti-CD20 CAR-T cell therapy. Adicet intends to file an IND application with the FDA in 2020 for ADI-001. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-001 in the first half of 2021.
ADI-001 contains an anti-CD20 CAR that has a proprietary antigen-binding domain that recognizes a region of CD20 distinct from that recognized by rituximab. Similar to other CAR-Ts cells including the one used to create Kymriah®, the Adicet CAR-T cells contain the clinically validated costimulatory domain from 4-1BB and the CD3z.
Preclinical data
All preclinical experiments were conducting using anti-CD20 CAR-modified gamma delta T cells, a research version of ADI-001. Adicet evaluated the in vitro potency of its anti-CD20 CAR gamma delta T cells using human-derived laboratory cell lines, known as Raji and Daudi human Burkitts lymphoma cell lines, which are known to express high levels of CD20. Mixing the tumor cells with the anti-CD20 CAR gamma delta T cells resulted in apoptosis, or cell death, of the tumor cells after four hours. Increasing the ratio of the number of anti-CD20 CAR gamma delta T cells to tumor cells resulted in a higher percentage of dying tumor cells. Similar potency in the killing of target cells by anti CD20 CAR gamma delta T cells was observed in both Mino cells, a human mantle cell lymphoma line that expresses high levels of CD20; and WILL-2 cells, cells derived from a rituximab-resistant patient with B cell lymphoma that expresses low levels of CD20. These results suggest that anti-CD20 CAR gamma delta cells can be highly efficient at recognizing and eliminating tumor cells that express any level of CD20. In all the cases, Adicets gamma delta T cells that did not have anti-CD20 CAR expression also caused tumor cell death due to innate cytotoxic receptors.
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Figure 8. Anti-CD20 CAR gamma delta T cells demonstrated potent cell killing activity across multiple human tumor cell lines.
Adicet has tested the antitumor activity of the companys anti-CD20 CAR gamma delta T cells in multiple tumor models in immunocompromised mice including Raji tumor models, a Mino tumor model and a Granta tumor model derived from a mantle cell tumor. Five to seven days after tumors were implanted into these mice, anti-CD20 CAR gamma delta T cells were administered as a single intravenous dose. Human recombinant IL-2 was administered three times a week for the duration of the study to stimulate the gamma delta T cells. In all cases, treatment using the companys anti-CD20 CAR gamma delta T cells was able to arrest tumor growth. The absolute duration of these studies was not pre-specified, however each of the studies were terminated when the growth of tumors in any of the animals in the no-treatment control group (tumor-only) exceeded a pre-specified limit; in subcutaneous tumor models this limit was generally tumor growth exceeding 4000mm3. This resulted in the individual studies being run for slightly different durations.
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Figure 9. Anti-CD20 CAR gamma delta T cells inhibited tumor growth in multiple animal models.
Treatment of Raji tumors in mice with anti-CD20 CAR gamma delta T cells resulted in the complete elimination of tumors in four out of six mice. Sixty days after the original and only dose of anti-CD20 CAR gamma delta T cells, the four mice with complete responses were re-challenged with Raji tumor cells. Growth of these newly introduced tumors continued to be suppressed at least until the end of the experiment at day 100. Adicet believes that these results suggest that the Adicet gamma delta cells had a long persistence in vivo and remain active. Other preclinical experiments have shown that they can undergo up to twenty cell doublings and can have antitumor activity that can extend to six months in animal models.
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Figure 10. Gamma delta T cells retained their antitumor activity for at least 90 days in a Raji tumor model. Four of the six mice in the primary tumor challenge exhibited complete responses, and these four mice were given a second tumor challenge without additional gamma delta CAR T cells.
The Adicet team performed a direct analysis of the ability of Adicets gamma delta CAR-T cells to migrate and proliferate in tumors using a fluorescent dye technology to examine cell division. Gamma delta CAR-T cells were treated with a fluorescent dye that attaches to cellular proteins. As these fluorescent cells divided, the molecules modified with the fluorescent dye were split among the mother and daughter cells. This resulted in a reduction in the average fluorescence signal per cell. Quantification of the amount of fluorescence per cell was then used as a surrogate for the number of divisions that a cell has undergone.
Using this assay, the Adicet team observed that, within six days, the companys CAR gamma delta T cells had undergone significant cell divisions in tumors with little replication in blood, spleen, bone marrow or liver. By contrast, in a similar experiment using CAR alpha beta T cells, it was observed that replication occurred in all tissues examined. Adicet believes that this selective replication in tumors by CAR gamma delta T cells, compared to CAR alpha beta T cells, may contribute to increased antitumor efficacy and a lower risk of developing life-threatening systemic immune responses such as cytokine release syndrome.
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Figure 11. Proliferation of CAR gamma delta T cells was primarily localized in tumors, while the proliferation of CAR alpha beta T cells was observed in all tissues examined.
Interleukin 15, or IL-15, is a cytokine that preferentially stimulates T cell and NK cell activation, proliferation and cytolytic activity. These functional activities of IL-15 translate to enhanced antitumor responses in multiple tumor models. IL-15 is closely related to a cytokine that is a known activator of immune responses, IL-2. Both cytokines have the potential to stimulate gamma delta T cells. IL-15 plays a more important role in maintaining T cell responses that are long-lasting and show high affinity for cancer cell targets, while IL-2 has a more significant role in activating cytotoxic responses.
The antitumor activity of the companys anti-CD20 CAR gamma delta T cells was tested in SRG-15 mice. These are mice that lack much of their mouse immune system but that do express human IL-15. In these studies, potent antitumor activity against Raji tumors in was observed. Furthermore, this activity was not accompanied by the development of GvHD. In contrast, mice treated with anti-CD20 CAR alpha beta T cells had antitumor responses, but subsequently experienced increased mortality due to the development of GvHD.
Figure 12. Anti-CD20 CAR gamma delta T cells do not induce GvHD, whereas treatment with anti-CD20 CAR alpha beta cells caused GvHD that led to increased mortality.
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ADI-001 clinical plans
Adicet intends to file an IND application with the FDA in 2020 for ADI-001, the companys lead product candidate, in Non-Hodgkins Lymphoma, or NHL. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-001 in the first half of 2021. Part 1 of this trial will be a dose escalation trial with the primary objectives of defining the incidence of dose-limiting toxicities and the selection of a recommended Phase 2 dose to be delivered as a single administration. The company anticipates enrolling twelve patients in this dose-escalation phase. Secondary endpoints in this trial will include monitoring the levels and persistence of ADI-001, immunogenicity and efficacy. The company also plan to monitor changes in serum cytokine and chemokine levels, CD20 tumor antigen expression and blood cell composition.
The company intends to enroll patients with relapsed or refractory B cell malignancies including DBLCL, MCL and FL. Included in this trial will be patients that were not able to receive approved autologous CAR-T cell therapies due to medical, technical, logistical or financial reasons, as well as patients who relapsed after receiving autologous CAR-T cell therapies.
Patients enrolled in the trial will undergo chemotherapy-based lymphodepletion for three days followed by ADI-001 dosing by infusion on day five. Patients will be evaluated at four weeks, twelve weeks and then every three months for the first year and at months 18 and 24 after treatment. Once a recommended dose has been selected, up to 36 patients will be enrolled in indication-specific dose expansion cohorts: DLBCL, MCL, and one for all other B cell malignancies. Select patients experiencing clinical benefit with ADI-001 may be eligible for retreatment.
An additional cohort in this trial will investigate the potential of IL-2 therapy to boost the efficacy and durability of ADI-001. Treatment with IL-2 is supported by preclinical data that the company has generated demonstrating that IL-2 improves the antitumor activity of the companys gamma delta T cells both in vitro and in vivo. Treatment of HSCT patients with IL-2 has also been shown to stimulate the proliferation of gamma delta T cells in the clinic.
(*) | Dose escalation study |
Figure 13. Phase 1 study patient flow.
ADI-002, an anti-GPC3 CAR gamma delta T-cell therapy
ADI-002 is a gamma delta T cell containing a CAR that is specific for glypican 3 protein, or GPC3, a protein that is highly expressed on the surface of multiple solid tumors including hepatocellular carcinoma, or HCC, gastric cancer, and squamous cell carcinoma of the lung, or SCCL. Adicet intends to file an IND application with the FDA in 2021 for ADI-002. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-002 in 2021.
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HCC disease background
Hepatocellular carcinoma, or HCC, is the most prevalent form of liver cancer. The risk of HCC development is increased by a number of environmental and lifestyle factors such as hepatitis B and hepatitis C virus, alcohol drinking, tobacco smoking, aflatoxin exposure, obesity and diabetes. These factors lead to wide disparities in disease incidence across geographies. According to a 2013 publication by Sahil Mittal and Hashem B. El-Serag in the Journal of Clinical Gastroenterology, in the United States, the incidence is approximately six per 100,000 per year, while in sub-Saharan Africa and Eastern Asia the incidence is over 20 per 100,000 per year.
Patients diagnosed with HCC generally have a poor prognosis. The majority of patients are diagnosed with advanced disease and they have a five-year survival rate of approximately 11%, according to cancer.net, the web site of the American Society of Clinical Oncology. Patients are initially treated with combinations of cytotoxic drugs or radiation. In some cases, they may also receive targeted therapies including kinase inhibitors such as lenvatinib, marketed as Lenvima® by Eisai; and sorafenib, marketed as Nexavar® by Bayer and subsequently cabozantinib, marketed as Cabometyx® by Exelixis. These therapies, however, have significant toxicities and limited clinical benefit with progression free survival of less than eight months. Checkpoint immunotherapies such as pembrolizumab and nivolumab have demonstrated some efficacy in HCC, although response rates are less than 20% according to the label for pembrolizumab, marketed by Merck as Keytruda®. The combination of both nivolumab and ipilimumab, despite increased toxicities, increased this response rate to 33%. Adicet believes these results demonstrate that there is significant unmet need in HCC and that there is potential to treat HCC with immunotherapy.
GPC3, a tumor-associated antigen
Glypican-3, or GPC3, is a tumor-associated antigen that is expressed in many tumors but in almost no other normal tissues other than embryonic liver and kidney or placenta.
Glypican 3 Expression in Tumors*
No. (%) Staining | ||||||
Tumor Entity |
No. of Cases | Negative | Positive | |||
Hepatocellular carcinoma |
44 | 15 (34) | 29 (66) | |||
Squamous cell carcinoma of the lung |
50 | 23 (46) | 27 (54) | |||
Liposarcoma |
29 | 14 (48) | 15 (52) | |||
Testicular nonseminomatous germ cell tumor |
62 | 30 (48) | 32 (52) | |||
Cervical intraepithelial neoplasia (grade 3) |
29 | 17 (59) | 12 (41) | |||
Malignant melanoma |
48 | 34 (71) | 14 (29) | |||
Adenoma of the adrenal gland |
15 | 11 (73) | 4 (27) | |||
Schwannoma |
46 | 34 (74) | 12 (26) | |||
Malignant fibrous histiocytoma |
29 | 22 (76) | 7 (24) | |||
Adenocarcinoma of the stomach (intestinal subtype) |
45 | 36 (80) | 9 (20) | |||
Chromophobe renal cell carcinoma |
15 | 12 (80) | 3 (20) | |||
Invasive lobular carcinoma of the breast |
46 | 37 (80) | 9 (20) | |||
Medullary carcinoma of the breast |
30 | 25 (83) | 5 (17) | |||
Squamous cell carcinoma of the larynx |
49 | 41 (84) | 8 (16) | |||
Small cell carcinoma of the lung |
49 | 41 (84) | 8 (16) | |||
Invasive transitional cell carcinoma of the urinary bladder |
43 | 36 (84) | 7 (16) | |||
Mucinous carcinoma of the breast |
26 | 22 (85) | 4 (15) | |||
Squamous cell carcinoma of the cervix |
41 | 35 (85) | 6 (15) |
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Figure 14. Screening of a panel of over 4,000 tumor samples found that GPC3 is expressed in numerous cancers. Baumhoer et al., Am J Clin Pathol 2008;129:899-906.
In a trial conducted by David Ho at the University of Hong Kong and colleagues and published in the journal PLOS One in 2012, high levels of GPC3 are detected by immunohistochemistry in a large proportion of HCC tumor tissue samples, but no GPC3 can be detected in adjacent normal cells.
Figure 15. Immunohistochemistry detected strong signals of GPC3 in liver tumor tissue, but negative staining for GPC3 was detected in the adjacent non-tumorous tissue. Adapted from Ho et al., PLoS One. 2012;7(5).
Adicets solution, ADI-002
ADI-002 is an anti-GPC3 CAR gamma delta T cell product candidate that Adicet is developing for the treatment of solid tumors. The company believes that modification of Vg1 gamma delta T cells, which have an inherent tumor homing ability, with a CAR that is specific for GPC3, will result in a therapeutic product able to have potent antitumor activity in patients suffering from multiple solid tumors. Adicet intends to file an IND application with the FDA in 2021 for ADI-002. Subject to the FDA regulatory process for review of INDs, Adicet intends to initiate a clinical trial and treat the first patient with ADI-002 in 2021.
To enhance the proliferative ability and durability of the companys anti-GPC3 CAR gamma delta T cells, Adicet engineered these cells to express soluble IL-15. The company anticipates that the tumor homing ability of gamma delta T cells will result in expression of IL-15 predominantly in tumors. In combination with the inherent secretion of factors such as interferon gamma from activated gamma delta T cells, the secretion of IL-15 is anticipated to lead to reversal of immunosuppressive effects in the tumor microenvironment and direct stimulation of the gamma delta T cells.
Adicet demonstrated in in vitro assays that the companys anti-GPC3 CAR gamma delta T cells have potent and GPC3-antigen-dependent cell killing activity. When Adicets anti-GPC3 CAR-T cells were added to HepG2 cells, a cell line expressing GPC3 that was derived from a patient with HCC, an increase in tumor cell killing was observed. Gamma delta T cells prepared without the addition of the companys anti-GPC3 CAR were still able to kill the HepG2 cells, only with less potency at 18 hours. The company believes that this CAR-independent killing activity was driven by innate receptors on the companys gamma delta T cells and that this innate antitumor activity may provide meaningful antitumor clinical activity in cases in which tumors may lose the expression of the targeted GPC3 antigen. Loss of tumor-expressed antigens represents a significant mechanism of escape from antitumor activities from other immunotherapies such as anti-CD19 CAR-T cell therapies. The ability to continue to have antitumor activity driven by the innate immune cell properties of the companys gamma delta T cells is a distinct advantage compared to alpha beta T cells, which lack this capability. Adicets gamma delta T cells had no cell killing activity when added to RAT2 normal fibroblasts that do not express GPC3.
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Figure 16. Expression of an anti-GPC3 CAR in gamma delta T cells led to potentiation of killing of HepG2 hepatocellular carcinoma cell line.
Anti-GPC3 CAR gamma delta T cells had dose-dependent antitumor activity in HepG2 tumors in immunodeficient mice. HepG2 tumor cells were inoculated into immunocompromised mice and allowed to grow to a volume of 200 mm3 over a period of approximately eight days. A single dose of anti-GPC3 CAR gamma delta T cells was then administered and tumor growth at day 37 was assessed. High doses of anti-GPC3 gamma delta T cells led to complete suppression of tumor growth.
Figure 17. Dose-dependent inhibition of HepG2 tumor growth by anti-GPC3 gamma delta T cells
Future clinical candidates in solid tumors.
In addition to the product candidates described above, the Adicet team anticipates many further opportunities for developing product candidates based on the companys gamma delta T cell technology. Adicet believes that the
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spectrum of indications that products such as CAR-T cell therapies have been able to address has been limited by two factors: the weak ability of alpha beta T cell-based therapies to penetrate solid tumors, and the scarcity of tumor-specific antigens on the cell surface that can be targeted by antibody-derived binding domains that are an essential component of the CAR constructs. Adicet believes that the tumor homing ability of its gamma delta T cell technology represents a potential solution to the solid tumor localization problem and its TRC-like, or TCRL, antibody technology can be used to identify and target tumor-specific antigens.
The tumor recognition challenge
Therapeutics such as antibodies and CARs recognize cell surface molecules. In HCC and select other tumors, there are proteins such as GPC3 which are selectively expressed on the surface of tumors cells that can be used as antigens for immune-targeted therapy. The lack of their expression on normal cells limits the potential of on-target, off-tumor systemic toxicities. Surface-expressed proteins that are strictly expressed only on tumor cells are, however, rare. In most cases surface expressed antigens such as CD19 and CD20 are expressed both on hematopoietic tumor and normal cells. Therapies that target CD19 or CD20 therefore result in killing of both tumor and normal cells. In hematological malignancies these therapies result in systemic depletion of normal B cells. However, this is mechanism-based toxicity can be managed in clinical practice. Challenges arise with antigens such as epidermal growth factor receptor, or EGFR, that is overexpressed on some types of tumor cells, but also expressed on normal epithelial cells elsewhere in the body. Dosing with anti-EGFR antibodies has led to significant dermatological and cardiac toxicities.
Intracellular proteins represent nearly half of the proteins found in human cells. These proteins provide an untapped reservoir of potential tumor-specific antigens that are inaccessible to traditional antibody-binding domains. Immune surveillance for these intracellular proteins is normally done by alpha beta T cells. These intracellular proteins are chopped up by a cell component known as the proteasome into short peptides between eight and ten amino acids long. These short peptides are then presented to the T cells by the MHC. TCRs on the T cells are then able to recognize the complex of the peptide and the MHC, triggering creation of T-cell populations prepared to attack these specific sequences.
Gamma delta T cells have advantages compared to alpha beta T cells with regard to their potential as allogeneic therapies, their ability to localize to tumors and their retention of innate immune signaling pathways. However, to be most effective they need to be able to be engineered to attack specific tumors.
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Adicets solution, TCRLs
Adicet has developed an antibody platform that enables the discovery of TCR-like, or TCRL, antibodies that recognize peptides that are presented on the cell surface by specific MHC molecules. In effect, Adicets TCRL antibodies have the same antigen recognition properties as TCRs but are highly specific for a single tumor antigen and MHC molecule. They do not recognize other MHC molecules or antigens that may be expressed by healthy cells.
Figure 18. Schematic diagram of the interaction between the companys TCRL antibodies and tumor-specific peptides presented by the MHC.
TCRLs are conventional antibodies with antigen binding domains that specifically recognize peptide-MHC complexes that can be used to create CARs. Introduction of these CARs into Adicets gamma delta T cells enables them to target tumors expressing intracellular tumor antigens when these antigens are selectively presented by MHC on the surface of tumor cells. Gamma delta CAR-T cells generated using TCRLs open up the potential to bring immune cell therapy to tumors that lack tumor-specific surface antigens, a group that includes most solid tumors.
The TCRL discovery process starts by carrying out an analysis of the peptides expressed by MHC receptors in a panel of hundreds of tumor and normal tissues. In searching for candidate peptides, the company focuses on differentially expressed peptides that are broadly expressed in tumors but that are not found in normal tissues. Candidate peptides are then validated by expression analysis both in other tissues as well as in databases. Those peptides that, based on bioinformatic analysis, are predicted to have minimal cross-reactivity with peptides from normal cells are then further prioritized. This peptide discovery process leads, step-by-step, to the narrowing of the list of potential candidates by approximately one thousand-fold. Once a tractable number of remaining candidates has been identified, a population that includes the most promising ones, antibodies are then created that are specific to the complex of an MHC receptor and the bound peptides. These antibodies mimic key aspects of tumor as recognized by the immune system. By creating CARs that incorporate these antigen-recognition templates in gamma delta T cell-based product candidates, the company creates a set of candidates designed to specifically attack tumors by virtue of their intracellular proteins.
Tyrosinase is a well-validated tumor-expressed antigen for which Adicet has developed TCRLs. The specificity for a mouse and a humanized version of one of these TCRLs was determined by comparing their binding affinity
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to that of a series of peptides that contained single amino acid changes. It was learned that changes to any of the internal eight amino acid positions to the amino acid alanine led to reductions in binding of 70% or greater. Substituting any amino acid in a non-anchor position resulted in substantial loss of binding, and indicates the high degree of specificity that the TCRL antibody has for the targeted MHC peptide complex.
Figure 19. Single amino acid changes to the targeted peptide reduced binding by at least 70 percent.
The antigen-binding domain from a tyrosinase TCRL was incorporated into a CAR and introduced into the companys gamma delta T cells to assess cell killing activity against tumor cell lines. These anti-Tyr CAR gamma delta T cells led to cell killing of WM266.4 human metastatic melanoma tumor cells, which are known to express tyrosinase. Anti-Tyr CAR gamma delta T cells, however, had no cell killing activity when tested against ten other cell lines from tumors such as colon, bladder and pancreatic cancers, B cell leukemia and retinoblastoma all of which do not express tyrosinase. That observation points to a desirable level of specificity for the companys anti-Tyr CAR gamma delta T cells and to an important in vitro proof of concept.
Furthermore, these anti-Tyr CAR gamma delta T cells had potent antitumor activity in a WM266.4 tumor model leading to tumor shrinkage within five days of administration and a durable antitumor response through 27 days. Although the TCRL-based CAR that is generated binds to a MHC-peptide complex, it does not induce the GvHD that is seen with alpha beta T cells because it recognizes a single peptide that has been selected to be highly specific for tumor cells.
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Figure 20. Anti-Tyr CAR gamma delta T cells showed potent antitumor activity in a WM266.4 melanoma model.
Adicet has generated TCRLs against a number of solid tumor antigens which are being evaluating in animal models. Adicet intends to advance at least one candidate from these early stage programs into IND-enabling studies in 2021. Adicet believes that the combination of the companys gamma delta and TCRL technology provides the basis for a new generation of CAR-T cell therapies that have the potential to transform the treatment of solid tumors.
Adicet Intellectual Property
Adicets gamma delta T cell-based product candidates and substantially all of Adicets intellectual property have been developed by Adicet, with certain antigen binding domains derived from its collaboration with Regeneron. Additional intellectual portfolio assets were acquired via acquisition of Applied Immune Technologies Ltd. in 2016. Adicet strives to protect and enhance the proprietary technology, inventions and improvements that are commercially material to Adicets business, including seeking, maintaining and defending Adicets patent rights.
Adicets policy is to develop and maintain protection of Adicets proprietary position by, among other methods, filing or in-licensing U.S. and foreign patents and applications related to Adicets technology, inventions, and improvements that are material to the development and implementation of Adicets business. Adicet also relies on trademarks, trade secrets, know-how, continuing technological innovation, confidentiality agreements, and invention assignment agreements to develop and maintain Adicets proprietary position.
Adicets patent portfolio includes protection for Adicets lead product candidates, ADI-001 and ADI-002, as well as Adicets other research-stage candidates. As of the date of this proxy statement/prospectus/information statement, there are multiple patent families comprising three pending U.S. non-provisional applications and over 20 foreign patent applications pending in such jurisdictions as Australia, Canada, China, Europe, Japan, Russia, and South Africa with claims directed to reagents and related protocols for gamma delta T cell expansion and resulting compositions of matter encompassing both ADI-001 and ADI-002, which, if issued, are expected to expire between 2035 and 2037. As of the date of this proxy statement/prospectus/information statement, there are also two international patent applications, or PCT applications, with claims directed to CAR constructs and antigen binding domains relating to ADI-001 and ADI-002, as well as their methods of use for certain indications, preconditioning methods, and dosing regimens, where applications claiming the benefit of these PCT applications, if issued, would expire between 2038 and 2039. With respect to ADI-001, Adicet has a collaboration with Regeneron which grants Adicet access to certain proprietary antigen binding domains covered by Regenerons patent rights, including in particular the antigen binding domain incorporated into ADI-001. Additionally, there are multiple granted patents and pending patent applications in the U.S. and internationally directed to Adicets TCRL platform technology as previously referenced on page 308 of this proxy statement/prospectus/information statement, with actual and, in the case of pending applications, anticipated expiration dates between 2021 and 2037. Although certain earlier patents relating to Adicets TCRL platform technology will expire in 2021, other patents covering this technology remain in force, or are expected to issue from pending applications, including three pending patent families directed to certain carcinoma, melanoma and glioblastoma targets, including tyrosinase referenced on page 309 of this proxy statement/prospectus/information statement, which, if issued, are expected to expire between 2036 and 2037. As a result, Adicet does not expect that the expiration of the earlier patents in its TCRL portfolio, individually or in the aggregate, will have a material adverse effect on its future operations or financial position.
The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which Adicet files, the patent term is 20 years from the date of filing of the first non-provisional application to which priority is claimed. In the United States, patent term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the United States Patent and Trademark Office in granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier-filed patent. In the United States, the term of a patent that covers an FDA-approved drug may also be eligible for a patent term extension of up to five years under the Hatch-Waxman Act, which is designed to compensate for the patent term lost during the FDA regulatory review process. The length of the patent term extension involves a complex calculation based on the length of time it takes for regulatory review. A patent term extension under the Hatch-Waxman Act cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one patent applicable to an approved drug may be extended. Moreover, a patent can
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only be extended once, and thus, if a single patent is applicable to multiple products, it can only be extended based on one product. Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug.
Adicets commercial success depends in part on Adicets ability to obtain and maintain proprietary protection for Adicets product candidates, as well as novel discoveries, core technologies, and know-how, as well as its ability to operate without infringing on the proprietary rights of others and to prevent others from infringing Adicets proprietary rights.
The patent positions of companies like Adicet are generally uncertain and involve complex legal, scientific and factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Consequently, Adicet does not know whether any of its product candidates will be protectable or remain protected by enforceable patents, or will be commercially useful in protecting Adicets commercial products and methods of using and manufacturing the same. Adicet also cannot predict whether the patent applications it is currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient proprietary protection from competitors. Any patents that Adicet holds or controls may be challenged, circumvented or invalidated by third parties. In addition, while Adicet has confidence in Adicets agreements and security measures, either may be breached, and Adicet may not have adequate remedies. Further, Adicets trade secrets may otherwise become known or independently discovered by competitors.
Adicet has licensed various intellectual property and trade secrets to third parties for purposes of collaboration, product development and research and development.
Strategic Agreements
License and Collaboration Agreement with Regeneron
On July 29, 2016, Adicet entered into a license and collaboration agreement with Regeneron, which was amended in April 2019, with such amendment becoming effective in connection with Regenerons investment in the companys Series B preferred stock private placement transaction in July 2019 (as amended, referred to as the Regeneron Agreement).
Agreement Structure. The Regeneron Agreement has two principal components: (a) a research collaboration component under which the parties will research, develop, and commercialize next-generation engineered gamma delta immune cell therapeutics, or ICPs, namely engineered gamma delta immune cells with CARs and TCRs directed to disease-specific cell surface antigens, which includes the grant of certain licenses to intellectual property between the two parties, and (b) for a certain period following the effective date, a license to Adicet to use certain of Regenerons proprietary mice to develop and commercialize ICPs generated by Adicet, with certain limitations relating to targets under the Regeneron Agreement.
Research Collaboration. Research activities under the collaboration are governed by research plans, which include the strategy, goals, activities, and responsibilities of the parties with respect to a target. Adicet is primarily responsible for generating, validating, and optimizing ICPs, developing processes for manufacture of ICPs, and certain preclinical and clinical manufacturing activities for ICPs; Regenerons key responsibility is generating, validating, and optimizing CARs and TCRs that bind to the applicable target. The parties have formed a joint research committee to monitor and govern the research and development efforts during the research program term.
Rights to Research Targets. Under the terms of the five-year research collaboration, the parties will conduct research on mutually agreed upon targets. Regeneron may obtain exclusive rights for the targets that it chooses in accordance with the target selection mechanism set forth in the Regeneron Agreement, and Adicet similarly may obtain exclusive rights for targets it chooses in accordance with such target selection mechanism. Adicet has the right to develop and commercialize ICPs to the first collaboration target to come out of the research program. In connection with an IND submission, Regeneron has an option to exercise exclusive rights for ADI-002 and potentially for additional targets to be mutually agreed upon. For those targets it does not have an option to
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license, Regeneron has a right of first negotiation for up to two targets. Regeneron has the right to terminate the research program in its entirety (a) for convenience on six months prior written notice given at any time after December 31, 2019, or (b) following a change of control (as defined in the Regeneron Agreement) of Adicet. The parties mutually agreed to their first product declaration criteria for collaboration ICP, CD20, in 2018.
Rights to Adicet-Developed Targets. Regeneron has an exclusive license to use targeting moieties generated by Adicet by its use of Regenerons proprietary mice to develop and commercialize non-ICPs.
Exclusivity. During the five-year target selection period, Adicet may not directly or indirectly research, develop, manufacture or commercialize an ICP, or grant a license to do the foregoing, except pursuant to the Regeneron Agreement. For so long as either party is researching or developing an ICP to a target under the research program, neither party may research, develop, manufacture or commercialize any other ICP to such target, or grant a license to do the foregoing. And for so long as a party is researching, developing or commercializing an ICP to target that is licensed to it (and royalty bearing) under the agreement, neither party may research, develop, manufacture or commercialize any other ICP to such target, or grant a license to permit another party to do the foregoing. These exclusivity obligations are limited to engineered gamma delta immune cells to targets reasonably considered to have therapeutic relevance in oncology. The Regeneron Agreement includes certain exceptions to the exclusivity obligations of the parties, including with respect to targets that are rejected by one party in the target selection process, as well as protections in the event of a change of control of a party where the acquirer has a competing program.
Co-Funding and Profit Sharing. Adicet has an option to co-fund specified portions of the future development costs for, and to co-promote, ICPs to a target for which Regeneron has exercised an option, and to participate in the profits for such target. Adicet has the right to exercise this right in various geographic regions, including on a worldwide basis. In the event Adicet exercises such right, the parties will share further development costs and revenues proportionally to their co-funding percentages.
Financial Terms. Adicet received a non-refundable upfront payment of $25.0 million from Regeneron upon execution of the Regeneron Agreement, received an aggregate of $10.0 million of additional payments for research funding from Regeneron as of June 30, 2020 and received an additional payment of $10.0 million dollars from Regeneron in July 2020 for timely achieving a milestone relating to the selection of a clinical candidate related to the second collaboration target. In addition, Regeneron may have to pay Adicet additional amounts in the future consisting of up to an aggregate of $100.0 million of option exercise fees, as specified in the Regeneron Agreement. Regeneron must also pay Adicet high single digit royalties as a percentage of net sales for ICPs to targets for which it has exclusive rights, and low single digit royalties as a percentage of net sales on any non-ICP product comprising a targeting moiety generated by Adicet through the use of Regenerons proprietary mice. Adicet must pay Regeneron mid-single to low double digit, but less than teens, of royalties as a percentage of net sales of ICPs to targets for which Adicet has exercised exclusive rights, and low to mid-single digit of royalties as a percentage of net sales of targeting moieties generated from Adicets license to use Regenerons proprietary mice. Royalties are payable until the longer of the expiration or invalidity of the licensed patent rights or twelve (12) years from first commercial sale.
Other Terms. The Regeneron Agreement contains customary representations, warranties and covenants by Adicet and Regeneron and includes (i) an obligation of Adicet to use commercially reasonable efforts to develop and commercialize at least one product based on a collaboration ICP that is not an optioned collaboration ICP for each collaboration target and (ii) an obligation of Regeneron to use commercially reasonable efforts to develop and commercialize at least one product based on an optioned collaboration ICP for each collaboration target. Adicet and Regeneron are required to indemnify the other party against all losses and expenses related to breaches of its representations, warranties and covenants under the Regeneron Agreement.
Term and Termination. The term of the Regeneron Agreement expires, on a product by product basis, on the expiration of the obligation to pay royalties for such product. The Regeneron Agreement is subject to early termination by either party upon uncured material breach by the other party. The licenses to develop and
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commercialize an ICP to a target that one party has exclusively licensed may be terminated by such party for convenience.
Equity Investments. In connection with its collaboration, Regeneron and Adicet entered into a side letter pursuant to which, among other matters, Regeneron was granted certain stockholder rights and investment rights in connection with Adicets next equity financing that met certain criteria and in connection with an initial public offering by Adicet. Regeneron exercised its investment right and purchased approximately $10.0 million of Adicets Series B preferred stock in a private placement transaction in July 2019. The remaining obligations under the side letter agreement will terminate immediately prior to the effective time of the merger.
License Agreement with TRDF
Adicet and its wholly owned subsidiary, Adicet Bio Israel, Ltd. (formerly Applied Immune Technology Ltd.), are parties to an Amended and Restated License Agreement dated May 21, 2014, as was amended in June 2015 and January 2016, with Technion Research and Development Foundation Ltd., or TRDF, the technology transfer subsidiary of Technion Israel Institute of Technology, or Technion. The license agreement provides Adicet with an exclusive, royalty-bearing, worldwide license, with a right to grant sublicenses, to make use of certain TRDF patents and know-how relating to moieties that recognize and bind to TCRLs, along with certain improvements and research results developed at TRDF and relating to either the licensed patents and know-how of TCRL, in each case for the purposes of research, development, and commercialization of specified products. Adicet further obtained joint ownership rights in improvements, developments, and inventions developed in the laboratory of a specified professor under certain conditions, including where Adicet provided specified amounts of funding for research specific to TCRL compounds. TRDF also grants Adicet an exclusive, worldwide, assignable, sublicensable license to TRDFs rights in such jointly owned improvements, developments, and inventions. Technion further agrees not to enforce against Adicet any TCRL-related technology owned by Technion but not licensed to Adicet under the agreement, and to require its licensees to agree to the same. Adicet is required to meet certain diligence obligations to preserve its exclusive licenses. Either Adicet or Technion may terminate the agreement or a specific license if the other party materially breaches its obligations under the agreement or with respect to a specific license granted under it, and fails to cure that breach. Adicet has the right to terminate the agreement at any time by providing notice to TRDF.
In return for the license, Adicet is required to pay TRDF, for ten (10) years after the first commercial sale of a product for which it owes royalties under the agreement, on a licensed-product-by-licensed-product basis, (i) certain royalties in the low single-digit percentages of all net sales by Adicet and any of its controlled affiliates, and (ii) the lesser of (a) a low single-digit percentage of net sales of Adicets sublicensees, or (b) low double-digit percentage of amounts received by Adicet or its controlled affiliates in the form of royalties on net sales from its sublicensees, subject to certain reductions. Furthermore, Adicet agreed to pay for all patent filing and maintenance expenses for the patents included in the licenses granted to Adicet by TRDF, with limited exceptions.
Under the agreement, TRDF reserves the right, for itself, alone or with other certain academic institutions, to utilize the licensed technology solely for educational and non-commercial research purposes.
The license agreement continues in full force and effect on a product-by-product and country-by-country basis until the expiration of all payment obligations for any licensed product as described above. Upon the expiration, Adicet will have a fully paid-up, worldwide, non-exclusive license (with the right to grant sublicenses) to develop, have developed, manufacture, have manufactured, use, market, offer for sale, sell, have sold, import, export, and otherwise transfer physical possession or title to products for which royalties would have otherwise been due under the agreement.
Manufacturing
Adicet is developing and enabling scalable and propriety cGMP-compliant manufacturing processes. Adicet has invested resources to optimize its manufacturing process and plans to continue to invest to continuously improve its production and supply chain capabilities over time.
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Adicet manufactures cell-based immunotherapy products based on gamma delta T cells that are obtained from the blood of healthy donors who are unrelated to the patients that will be treated. These products are classed as allogeneic cell therapy products. Donor-derived blood is fractionated and the fractions containing gamma delta T cells are frozen prior to use in future manufacturing campaigns. Adicet believes that its freezing and storing of the donor blood products allows Adicet to efficiently schedule subsequent manufacturing steps. After obtaining blood products from healthy donors the manufacturing process begins with the activation of a subpopulation of gamma delta T cells using an antibody that is proprietary to Adicet. This antibody, in combination with other factors including the cytokine, IL-2, induces gamma delta T cells to proliferate, whereupon Adicet exposes the cells to a viral vector that transfers a gene sequence encoding a CAR, or other gene sequences, to the proliferating cells. This step is referred to as the transduction step. Following the transduction step gamma delta T cells are induced to proliferate further with IL-2 before an enrichment step that increases the proportion of gamma delta T cells, removes unwanted residual alpha beta T cells and results in the CAR-modified gamma delta T cells drug product. CAR-modified gamma delta T cell products are then frozen in single-use vials for long-term storage at cryogenic temperatures. These storage conditions are designed to ensure stability of the cell-based drug products for protracted periods of time. The storage in singe use vials is designed to simplify the handling and treatment administration. Just prior to administration of treatment, the vials will be thawed and then the contents infused into the patient. Adicet believes that the single manufacturing process it is developing will be able to be completed in approximately two weeks and will result in sufficient quantities of drug product to treat numerous patients.
To date, Adicet currently relies, and expects to continue to rely, on third parties for the manufacture of its product candidates and any products that it may develop. Adicet has chosen to partner with a number of contract manufacturing organizations in the United States and Europe to access specific capabilities to ensure that the manufacturing process is highly scalable, closed and fully cGMP-compliant. This strategy allows Adicet to maintain a more flexible infrastructure while focusing its expertise on developing its products. In addition to the quality management systems utilized by strategic manufacturing partners, Adicet has established a quality control and quality assurance program, which includes a set of standard operating procedures and specifications designed to ensure that Adicets products are manufactured in accordance with cGMPs, and other applicable domestic and foreign regulations.
For example, Adicet currently engages a single US-based third-party manufacturer to provide the active pharmaceutical ingredient for ADI-001. Adicet also utilizes separate third party contractors to manufacture cGMP-compliant starting and critical materials that are used for the manufacturing of its product candidates, such as donor blood products, gamma delta T cell activating antibody and viral vectors that are used to deliver the applicable CAR gene into the T cells. Adicet believes all materials and components utilized in the production of the cell line, viral vector and final gamma delta T cell product are available from qualified suppliers and suitable for pivotal process development in readiness for registration and commercialization. Going forward, Adicet intends to continue to expand its manufacturing capability through agreements with leading cell therapy contract manufacturing organizations.
If any of Adicets current manufacturers becomes unavailable to Adicet for any reason, Adicet believes that there are a number of potential replacements, although Adicet would likely incur some delay in identifying and qualifying such replacements. Adicet plans to continue to create a robust supply chain with redundant sources of supply comprised of both internal and external infrastructure.
Competition
The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. Adicet faces potential competition from many different sources, including existing and novel therapies developed by biopharmaceutical companies, academic research institutions, governmental agencies and public and private research institutions, in addition to standard of care treatments.
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Novartis and Kite Pharma were the first to achieve FDA approval for autologous T cell therapies. In August 2017, Novartis obtained FDA approval to commercialize Kymriah®, for the treatment of children and young adults with B-cell ALL that is refractory or has relapsed at least twice. In May 2018, Kymriah® received FDA approval for adults with R/R large B-cell lymphoma. In October 2017, Kite Pharma obtained FDA approval to commercialize Yescarta®, the first CAR T cell product candidate for the treatment of adult patients with R/R large B-cell lymphoma.
Due to the promising therapeutic effect of T cell therapies in clinical trials, Adicet anticipates increasing competition from existing and new companies developing these therapies, as well as in the development of allogeneic T cell therapies generally. Potential T cell therapy competitors include, but are not limited to:
| Allogeneic T cell therapy competition: Atara Biotherapeutics, Inc., Allogene Therapeutics, Inc., Cellectis, S.A., Celyad S.A., CRISPR Therapeutics AG, Editas Medicine, Inc., Fate Therapeutics Inc., Gilead Sciences, Inc. (acquired Kite Pharma), Intellia Therapeutics, Inc., Poseida Therapeutics, Inc., Precision Biosciences, Inc., Immatics Biotechnologies GmbH, GammaDelta Therapeutics Limited, TC BioPharm Limited, Incysus Therapeutics, Inc. and Gadeta BV. |
| Autologous T cell therapy competition: Adaptimmune Therapeutics PLC, Autolus Therapeutics plc, bluebird bio, Inc., Bristol-Myers Squibb Company, Gilead Sciences, Inc., Johnson & Johnson, Iovance Biotherapeutics, Inc., Mustang Bio, Inc., Novartis International AG, TCR² Therapeutics Inc. and Tmunity Therapeutics, Inc. |
Although Adicet believes Adicet is currently unique in Adicets development of proprietary processes for engineering and manufacturing gamma delta T cells expressing CARs due to what Adicet believes is the enormous promise of these cells, it is likely that additional competition may arise from existing companies currently focusing on development of alpha beta or gamma delta T-cell therapies, or from new entrants in the field.
Competition may also arise from non-cell based immune oncology platforms. For instance, Adicet may experience competition from companies, such as Amgen Inc., Bristol-Myers Squibb Company, F. Hoffmann-La Roche AG, Genmab A/S, GlaxoSmithKline plc, MacroGenics, Inc., Merus N.V., Regeneron Pharmaceuticals, Inc., and Xencor Inc., that are pursuing bispecific antibodies, which target both the cancer antigen and T-cell receptor, thus bringing both cancer cells and T cells in close proximity to maximize the likelihood of an immune response to the cancer cells. Additionally, companies, such as Amgen Inc., AbbVie, Daiichi Sankyo Company, Limited, GlaxoSmithKline plc, ImmunoGen, Inc., Immunomedics, Inc., and Seattle Genetics, Inc., are pursuing antibody drug conjugates, which utilize the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.
Many of Adicets competitors, either alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development, pre-clinical testing, clinical trials, manufacturing, and marketing than Adicet does. Future collaborations and mergers and acquisitions may result in further resource concentration among a smaller number of competitors.
Adicets commercial potential could be reduced or eliminated if Adicets competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than products that Adicet may develop. Adicets competitors also may obtain FDA or other regulatory approval for their products more rapidly than Adicet may obtain approval for its own products, which could result in Adicets competitors establishing a strong market position before Adicet is able to enter the market or make Adicets development more complicated. The key competitive factors affecting the success of all of Adicets programs are likely to be efficacy, safety and tolerability profile, convenience, price, reimbursement and cost of manufacturing.
These competitors may also vie for a similar pool of qualified scientific and management talent, sites and patient populations for clinical trials, and investor capital, as well as for technologies complementary to, or necessary for, Adicets programs.
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Government Regulation and Product Approval
As a biopharmaceutical company that operates in the United States, Adicet is subject to extensive regulation. Adicets cell products will be regulated as biologics. With this classification, commercial production of Adicets products will need to occur in registered facilities in compliance with cGMP for biologics. The FDA categorizes human cell- or tissue-based products as either minimally manipulated or more than minimally manipulated, and has determined that more than minimally manipulated products require clinical trials to demonstrate product safety and efficacy and the submission of a Biologics License Application, or BLA, to the FDA for marketing authorization. Adicets products are considered more than minimally manipulated and will require evaluation in clinical trials and the submission and approval of a BLA before Adicet can market them. Generally, before a new drug or biologic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved by the regulatory authority.
Government authorities in the United States (at the federal, state and local level) and in other countries extensively regulate, among other things, the research, development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of biopharmaceutical products such as those Adicet is developing. Adicets product candidates must be approved by the FDA before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in foreign countries. Generally, Adicets activities in other countries will be subject to regulation that is similar in nature and scope as that imposed in the United States, although there can be important differences. Additionally, some significant aspects of regulation in Europe are addressed in a centralized way but country-specific regulation remains essential in many respects. The process for obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.
U.S. Product Development Process
In the United States, the FDA regulates pharmaceutical and biological products under the Federal Food, Drug and Cosmetic Act, or the FDCA, the Public Health Service Act, or the PHSA, and their implemented regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. FDA sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on Adicet. The process required by the FDA before a biological product may be marketed in the United States generally involves the following:
| completion of nonclinical laboratory tests and key animal studies according to good laboratory practices, or GLPs, and applicable requirements for the humane use of laboratory animals or other applicable regulations; |
| submission to the FDA of an IND application, which is subject to a waiting period of thirty (30) calendar days, must become effective before human clinical trials may begin; |
| approval by an independent Institutional Review Board, or IRB, or ethics committee for each clinical site before the trial is commenced; |
| performance of adequate and well-controlled human clinical trials according to the FDAs regulations commonly referred to as good clinical practices, or GCPs, and any additional requirements for the |
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protection of human research patients and their health information, to establish the safety and efficacy of the proposed biological product for its intended use; |
| submission to the FDA of a BLA for marketing approval that includes substantial evidence of safety, purity, and potency from results of nonclinical testing and clinical trials; |
| satisfactory completion of an FDA Advisory Committee review, if applicable; |
| satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with cGMP, to assure that the facilities, methods and controls are adequate to preserve the biological products identity, strength, quality and purity and, if applicable, the FDAs current good tissue practices, or GTPs, for the use of human cellular and tissue products; |
| potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA; and |
| FDA review and approval, or licensure, of the BLA prior to any commercial marketing or sale of the biologic in the United States. |
Before testing any biological product candidate, including Adicets product candidates, in humans, the product candidate enters the preclinical testing stage. Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the product candidate. The conduct of the key preclinical tests must comply with federal regulations and requirements including GLPs. An IND is a request for authorization from the FDA to administer an investigational product to humans and must become effective before human clinical trials may begin. The clinical trial sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective thirty (30) days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and requests additional information and or places the trial on a clinical hold within that 30-day time period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA may also impose clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns or non-compliance. If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by the FDA. Accordingly, Adicet cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate such trials.
Clinical trials involve the administration of the biological product candidate to patients under the supervision of qualified investigators at independent clinical sites/hospitals, physicians not employed by or under the trial sponsors control. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events should occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. Clinical trials must be conducted and monitored in accordance with the FDAs regulations comprising the GCP requirements, including the requirement that all research patients provide informed consent. Further, each clinical trial must be reviewed and approved by an independent IRB at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the
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study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries.
A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical trial to the FDA in support of a BLA. A clinical trial outside the United States may also be conducted under the authorization of similar regulatory authorities of the country/region. The FDA will accept a well-designed and well-conducted foreign clinical study not conducted under an IND if the study was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed necessary.
Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
| Phase 1. The biological product is typically introduced into healthy human subjects and tested for safety. However, in the case of some products for severe or life-threatening diseases, such as cancer or hematological malignancies that Adicet aspires to treat, initial human testing is routinely conducted directly in ill patients with the approval of relevant ethics committee(s) under the supervision of a licensed physician. |
| Phase 2. The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule. |
| Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk to benefit ratio of the product and provide an adequate basis for product labeling. |
Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. In case of an accelerated BLA approval based on limited clinical data, FDA may mandate a Phase 4 clinical trial prior to full approval. During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA. Written IND safety reports must be promptly submitted to the FDA, and the investigators for serious and unexpected adverse events, any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant risk for human patients, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within fifteen (15) calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven (7) calendar days after the sponsors initial receipt of the information.
Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRBs requirements or if the biological product has been associated with unexpected serious harm to patients.
Concurrently with clinical trials, companies usually complete additional studies and must also develop additional information about the physical characteristics of the biological product as well as finalize a process for
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manufacturing the product in commercial quantities in accordance with cGMP requirements. To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological product according to the requirements of the phase of clinical development. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.
Further, as a result of the COVID-19 pandemic, the extent and length of which is uncertain, Adicet will be required to develop and implement additional clinical study policies and procedures designed to help protect study participants from the COVID-19 virus, which may include using telemedicine visits and remote monitoring of patients and clinical sites. Adicet will also need to ensure data from its clinical studies that may be disrupted as a result of the pandemic is collected pursuant to the study protocol and is consistent with GCPs, with any material protocol deviation reviewed and approved by the site IRB. Patients who may miss scheduled appointments, any interruption in study drug supply, or other consequence that may result in incomplete data being generated during a study as a result of the pandemic must be adequately documented and justified. For example, on March 18, 2020, the FDA issued a guidance on conducting clinical trials during the pandemic, which describe a number of considerations for sponsors of clinical trials impacted by the pandemic, including the requirement to include in the clinical study report (or as a separate document) contingency measures implemented to manage the study, and any disruption of the study as a result of COVID-19; a list of all study participants affected by COVID-19-related study disruption by unique subject identifier and by investigational site, and a description of how the individuals participation was altered; and analyses and corresponding discussions that address the impact of implemented contingency measures (e.g., participant discontinuation from investigational product and/or study, alternative procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the study. As of August 4, 2020, the FDA continues to update and revise its guidance for ongoing clinical trials.
U.S. Review and Approval Processes
After the completion of clinical trials of a biological product, FDA approval of a BLA must be obtained before commercial marketing of the biological product. The BLA submission must include results of product safety, efficacy, development, laboratory and animal studies, human trials, information on the manufacture and composition of the product, proposed labeling and other relevant information. The testing and approval processes require substantial time and effort and there can be no assurance or guarantee that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.
Under the Prescription Drug User Fee Act, or PDUFA, as amended, each BLA must be accompanied by a significant user fee. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual program fee for biological products. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.
Within 60 or 74 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Under the goals and policies agreed to by the FDA under PDUFA, the FDA has 10 months from the filing date to complete its initial review of an original BLA and respond to the applicant, and six months from the filing date of an original BLA designated for priority review. The FDA does not always meet its PDUFA goal dates for standard and priority BLAs, and the review process is often extended by FDA requests for additional information or clarification.
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Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA. The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the products identity, safety, strength, quality, potency and purity. The FDA may refer applications for novel biological products or biological products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
During the biological product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy, or REMS, is necessary to assure the safe use of the biological product. A REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS. The FDA will not approve a BLA without a REMS, if required. Both Kymriah® and Yescarta® were approved with a REMS.
Before approving a BLA, the FDA will inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. For cellular immunotherapy products, the FDA also will not approve the product if the manufacturer is not in compliance with the cGTP, to the extent applicable. These are FDA regulations and guidance documents that in part govern the methods used in, and the facilities and controls used for, the manufacture of human cells, tissue, and cellular and tissue based products, or HCT/Ps, which are human cells or tissue intended for implantation, transplant, infusion, or transfer into a human recipient. The primary intent of the GTP requirements is to ensure that cell and tissue based products are manufactured in a manner designed to prevent the introduction, transmission and spread of communicable disease. FDA regulations also require tissue establishments to register and list their HCT/Ps with the FDA and, when applicable, to evaluate donors through screening and testing. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements and GCP requirements. To assure cGMP, GTP and GCP compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.
Notwithstanding the submission of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval and deny approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than Adicet interprets the same data. If the agency decides not to approve the BLA in its present form, the FDA will issue a complete response letter that describes all of the specific deficiencies in the BLA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for example, requiring additional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant might take to place the application in a condition for approval. If a complete response letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.
If a product receives regulatory approval, the approval may be limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a risk management plan, or otherwise limit the scope of any approval. In addition, the FDA may require post marketing clinical trials, sometimes referred to as Phase 4 clinical trials, designed to further assess a biological products safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized.
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Pediatric Information
In addition, under the Pediatric Research Equity Act, or PREA, a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. A sponsor who is planning to submit a marketing application for a drug that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration must submit an initial Pediatric Study Plan, or PSP, within sixty (60) days of an end-of-Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 study. The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials and/or other clinical development programs.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that drug or biologic. Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.
If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA application user fee.
A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
Expedited Development and Review Programs
The FDA has a fast track program that is intended to expedite or facilitate the process for reviewing new products that meet certain criteria. Specifically, new products are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast track designation applies to the combination of the product and the specific indication for which it is being studied. Unique to a fast track product, the FDA may consider for review
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sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.
Any product submitted to the FDA for approval, including a product with a fast track designation, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. A product is eligible for priority review if it has the potential to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention of a disease compared to marketed products. The FDA will attempt to direct additional resources to the evaluation of an application for a new product designated for priority review in an effort to facilitate the review. Additionally, a product may be eligible for accelerated approval. Products studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require that a sponsor of a drug or biological product receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.
Regenerative Medicine Advanced Therapy, or RMAT, designation was established by the FDA in 2017 to facilitate an efficient development program for, and expedite review of, any drug that meets the following criteria: (1) it qualifies as a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions; (2) it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and (3) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition. RMAT designation provides potential benefits that include more frequent meetings with FDA to discuss the development plan for the product candidate and eligibility for rolling review and priority review. Products granted RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites. Once approved, when appropriate, the FDA can permit fulfillment of post-approval requirements under accelerated approval through the submission of clinical evidence, clinical studies, patient registries, or other sources of real world evidence such as electronic health records; through the collection of larger confirmatory datasets; or through post-approval monitoring of all patients treated with the therapy prior to approval.
Breakthrough therapy designation is also intended to expedite the development and review of products that treat serious or life-threatening conditions. The designation by FDA requires preliminary clinical evidence that a product candidate, alone or in combination with other drugs and biologics, demonstrates substantial improvement over currently available therapy on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Breakthrough therapy designation comes with all of the benefits of fast track designation, which means that the sponsor may file sections of the BLA for review on a rolling basis if certain conditions are satisfied, including an agreement with FDA on the proposed schedule for submission of portions of the application and the payment of applicable user fees before the FDA may initiate a review.
Fast Track designation, priority review, RMAT and breakthrough therapy designation do not change the standards for approval but may expedite the development or regulatory approval process for Adicets products.
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Post-Approval Requirements
Any products for which Adicet receives FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the products approved uses (known as off-label use), limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet. Although a physician may prescribe a legally available product for an off-label use, if the physicians deems such product to be appropriate in his/her professional medical judgment, a manufacturer may not market or promote off-label uses. However, it is permissible to share in certain circumstances truthful and not misleading information that is consistent with the products approved labeling.
Further, additional FDA limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing. Newly discovered or developed safety or effectiveness data may require changes to a products approved labeling, including the addition of new warnings and contraindications, and may also require the implementation of other risk management measures, including a REMS, or the conduct of post-marketing studies to assess a newly discovered safety issue.
In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the adequate stability of the product. cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers and other entities involved in the manufacture and distribution of approved products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including, among other things, recall or withdrawal of the product from the market. In addition, changes to the manufacturing process are strictly regulated, and depending on the significance of the change, may require prior FDA approval before being implemented. Other types of changes to the approved product, such as adding new indications and claims, are also subject to further FDA review and approval.
Adicet relies, and expects to continue to rely, on third parties to produce clinical and commercial quantities of Adicets products in accordance with cGMP regulations. These manufacturers must comply with cGMP regulations that require, among other things, quality control and quality assurance, the maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers and other entities involved in the manufacture and distribution of approved biologics are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP requirements and other laws.
The FDA also may require post-marketing testing, known as Phase 4 testing, and surveillance to monitor the effects of an approved product. Discovery of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties, among others. Newly discovered or developed safety or effectiveness data may require changes to a products approved labeling, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures. Also, new government requirements, including those resulting from new legislation, may be established, or the
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FDAs policies may change, which could delay or prevent regulatory approval of Adicets products under development.
U.S. Marketing Exclusivity
The Biologics Price Competition and Innovation Act, or BPCIA, amended the PHSA to authorize the FDA to approve similar versions of innovative biologics, commonly known as biosimilars. A competitor seeking approval of a biosimilar must file an application to establish its molecule as highly similar to an approved innovator biologic, among other requirements. The BPCIA, however, bars the FDA from approving biosimilar applications for 12 years after an innovator biological product receives initial marketing approval. This 12-year period of data exclusivity may be extended by six months, for a total of 12.5 years, if the FDA requests that the innovator company conduct pediatric clinical investigations of the product.
Depending upon the timing, duration and specifics of the FDA approval of the use of Adicets product candidates, some of Adicets U.S. patents, if granted, may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to five years, as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the products approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of a BLA plus the time between the submission date of a BLA and the approval of that application. Only one patent applicable to an approved product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, Adicet may intend to apply for restoration of patent term for one of Adicets currently owned or licensed patents to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.
Pediatric exclusivity is another type of regulatory market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued Written Request for such a trial.
Other U.S. Healthcare Laws and Compliance Requirements
In the United States, Adicets activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare & Medicaid Services, or CMS, other divisions of the U.S. Department of Health and Human Services, or HHS, (e.g., the Office of Inspector General, the U.S. Department of Justice, or DOJ, and individual U.S. Attorney offices within the DOJ, and state and local governments). For example, Adicets business practices, including any of Adicets research and future sales, marketing and scientific/educational grant programs may be required to comply with the anti-fraud and abuse provisions of the Social Security Act, the false claims laws, the patient data privacy and security provisions of the Health Insurance Portability and Accountability Act, or HIPAA, transparency requirements, and similar state, local and foreign laws, each as amended.
The federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item, good, facility or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term remuneration has been interpreted broadly to include anything of value. The federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, formulary managers, and other individuals and entities on the other. There are a
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number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. The exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Adicets practices may not in all cases meet all of the criteria for protection under a statutory exception or regulatory safe harbor.
Additionally, the intent standard under the federal Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, collectively, the Affordable Care Act, to a stricter standard such that a person or entity no longer needs to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. Rather, if one purpose of the remuneration is to induce referrals, the federal Anti-Kickback Statute is violated. In addition, the Affordable Care Act codified case law that a claim that includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (discussed below).
The civil monetary penalties statute imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to, among others, a federal healthcare program that the person knows or should know is for a medical or other item or service that was not provided as claimed or is false or fraudulent.
The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to, or approval by, the federal government or knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes any request or demand for money or property presented to the U.S. government. For example, pharmaceutical and other healthcare companies have been, and continue to be, investigated or prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product and for causing false claims to be submitted because of the companies marketing of the product for unapproved, and thus non-reimbursable, uses.
HIPAA created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
Also, many states have similar fraud and abuse statutes or regulations, such as state anti-kickback and false claims laws, which may be broader in scope and apply regardless of payor. These laws are enforced by various state agencies and through private actions. Some state laws require pharmaceutical companies to comply with the pharmaceutical industrys voluntary compliance guidelines and the relevant federal government compliance guidance, require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, and restrict marketing practices or require disclosure of marketing expenditures. In addition, certain state and local laws require the registration of pharmaceutical sales representatives.
Adicet may be subject to data privacy and security regulations by both the federal government and the states in which Adicet conducts their business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations, imposes requirements on certain types
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of individuals and entities relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAAs privacy and security standards directly applicable to business associates that are independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
Additionally, the federal Physician Payments Sunshine Act within the Affordable Care Act, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Childrens Health Insurance Program (with certain exceptions) annually report information to CMS related to certain payments or other transfers of value made or distributed to physicians, as defined by such law, and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, physicians and teaching hospitals and certain ownership and investment interests held by physicians and their immediate family members.
In order to distribute products commercially, Adicet must comply with state laws that require the registration of manufacturers and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. All of Adicets activities are potentially subject to federal and state consumer protection and unfair competition laws.
If Adicets operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental regulations that apply to Adicet, Adicet may be subject to penalties, including without limitation, civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government programs, such as Medicare and Medicaid, refusal to allow Adicet to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, additional reporting requirements and/or oversight if Adicet becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of Adicets operations, any of which could adversely affect Adicets ability to operate Adicets business and Adicets results of operations.
Coverage, Pricing and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which Adicet obtains regulatory approval. In the United States and markets in other countries, sales of any products for which Adicet receives regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors provide coverage, and establish adequate reimbursement levels for such products. In the United States, third-party payors include federal and state healthcare programs, private managed care providers, health insurers and other organizations. The process for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price of a product or for establishing the
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reimbursement rate that such a payor will pay for the product. Third-party payors may limit coverage to specific products on an approved list, or also known as a formulary, which might not include all of the FDA-approved products for a particular indication. Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy. Adicet may need to conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of Adicets products, in addition to the costs required to obtain the FDA approvals. Adicets product candidates may not be considered medically necessary or cost-effective. A payors decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Further, one payors determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Adequate third-party reimbursement may not be available to enable Adicet to maintain price levels sufficient to realize an appropriate return on Adicets investment in product development.
Different pricing and reimbursement schemes exist in other countries. In the EU, governments influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national health care systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on health care costs has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
The marketability of any product candidates for which Adicet receives regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. In addition, emphasis on managed care in the United States has increased and Adicet expects will continue to increase the pressure on healthcare pricing. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which Adicet receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Healthcare Reform
In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect the ability to profitably sell product candidates for which marketing approval is obtained. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
For example, the Affordable Care Act has substantially changed healthcare financing and delivery by both governmental and private insurers. Among the Affordable Care Act provisions of importance to the pharmaceutical and biotechnology industries, in addition to those otherwise described above, are the following:
| created an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs that began in 2011; |
| increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, retroactive to January 1, 2010, to 23.1% and 13% of the average manufacturer price for most |
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branded and generic drugs, respectively, and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP; |
| created a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70% point-of-sale discounts, off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturers outpatient drugs to be covered under Medicare Part D; |
| extended manufacturers Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |
| expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and added new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers Medicaid rebate liability; |
| expanded the entities eligible for discounts under the 340B Drug Discount Program; |
| created a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; |
| expanded healthcare fraud and abuse laws, including the Anti-Kickback Statute and the FCPA, created new government investigative powers, and enhanced penalties for noncompliance; |
| created a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected; |
| required reporting of certain financial arrangements with physicians and teaching hospitals; |
| required annual reporting of certain information regarding drug samples that manufacturers and distributors provide to physicians; |
| established a Center for Medicare and Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending; and |
| created a licensure framework for follow on biologic products. |
There remain legal and political challenges to certain aspects of the Affordable Care Act. Since January 2017, the current U.S. President has signed two executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the Affordable Care Act. In December 2017, Congress repealed the tax penalty for an individuals failure to maintain Affordable Care Act-mandated health insurance, commonly known as the individual mandate, as part of the Tax Cuts and Jobs Act of 2017 (Tax Act). In addition, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the Affordable Care Acts mandated Cadillac tax on high-cost employer-sponsored health coverage and medical device tax and, effective January 1, 2021, also eliminates the health insurer tax.
The Bipartisan Budget Act of 2018, or BBA, among other things, amended the Affordable Care Act, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the donut hole. In December 2018, CMS published a final rule permitting further collections and payments to and from certain Affordable Care Act qualified health plans and health insurance issuers under the Affordable Care Act risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment. On December 14, 2018, a Texas U.S. District Court Judge ruled that the Affordable Care Act is unconstitutional in its entirety because the individual mandate was repealed by Congress as part of the Tax Act. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the Affordable Care Act are invalid as well. It is unclear how this decision, future decisions, subsequent appeals, and other efforts to repeal and replace the Affordable Care Act will impact the Affordable Care Act.
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Further legislation or regulation could be passed that could harm Adicets business, financial condition and results of operations. Other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. For example, in August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years 2012 through 2021, triggering the legislations automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect beginning on April 1, 2013 and will stay in effect through 2029 unless additional Congressional action is taken. The Middle Class Tax Relief and Job Creation Act of 2012 required that CMS reduce the Medicare clinical laboratory fee schedule by 2% in 2013, which served as a base for 2014 and subsequent years. In addition, effective January 1, 2014, CMS also began bundling the Medicare payments for certain laboratory tests ordered while a patient received services in a hospital outpatient setting. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
At the federal level, the U.S. Presidents administrations budget proposal for fiscal year 2020 contains further drug price control measures that could be enacted during the budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. Moreover, the U.S. Presidential administrations budget proposal for the fiscal year 2021 includes a $135 billion allowance to support legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs. For example, on September 25, 2019, the Senate Finance Committee introduced the Prescription Drug Pricing Reduction Action of 2019, a bill intended to reduce Medicare and Medicaid prescription drug prices. The proposed legislation would restructure the Part D benefit, modify payment methodologies for certain drugs, and impose an inflation cap on drug price increases. An even more restrictive bill, the Lower Drug Costs Now Act of 2019, was introduced in the House of Representatives on September 19, 2019, and would require the HHS to directly negotiate drug prices with manufacturers. The Lower Drugs Costs Now Act of 2019 has passed out of the House and was delivered to the Senate in December 2019. However, it is unclear whether either of these bills will make it through both chambers and be signed into law, and if either is enacted, what effect it would have on Adicets business. Additionally, Congress and the current U.S. Presidents administration released a Blueprint to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. HHS has solicited feedback on some of these measures and has implemented others under its existing authority. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage plans the option to use step therapy for Part B drugs beginning January 1, 2020. This final rule codified CMSs policy change that was effective January 1, 2019. While some of these and other measures may require additional authorization to become effective, Congress and the U.S. Presidents administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
Individual states in the United States have also increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in
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some cases, designed to encourage importation from other countries and bulk purchasing. Individual states in the United States have also been increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Adicet anticipates that these and other healthcare reform efforts will continue to result in additional downward pressure on coverage and the price that Adicet receives for any approved product, and could materially harm Adicets business. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent Adicet from being able to generate revenue, attain profitability, or commercialize Adicets products. Such reforms could have an adverse effect on anticipated revenue from product candidates that Adicet may successfully develop and for which Adicet may obtain regulatory approval and may affect Adicets overall financial condition and ability to develop product candidates.
The Foreign Corrupt Practices Act
The FCPA prohibits any U.S. individual or business from offering, paying, promising to pay, or authorizing payment of money or anything of value, to any person, while knowing that all or a portion of such money or thing of value will be offered, given or promised, directly or indirectly, to any foreign official, political party or candidate to influence the foreign official in his or her official capacity, induce the foreign official to do or omit to do an act in violation of his or her lawful duty, or to secure any improper advantage in order to assist the individual or business in obtaining or retaining business.
The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls. Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are owned and operated by the government, and doctors and other hospital employees are considered foreign officials for the purposes of the statute. Certain payments made in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions. Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products.
Accordingly, if Adicet expands its presence outside of the United States, it will need to dedicate additional resources to complying with the laws and regulations in each jurisdiction in which it plans to operate. Therefore, this may preclude Adicet from developing, manufacturing, or selling certain products and product candidates outside of the United States, which could limit Adicets growth potential and increase its development costs.
Packaging and Distribution in the United States
If Adicets products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act. Manufacturing, sales, promotion and other activities also are potentially subject to federal and state consumer protection and unfair competition laws.
The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products. The failure to comply with any of these laws or regulatory requirements subjects
46
firms to possible legal or regulatory action. Depending on the circumstances, failure to meet applicable regulatory requirements can result in criminal prosecution, fines or other penalties, injunctions, exclusion from federal healthcare programs, requests for recall, seizure of products, total or partial suspension of production, denial or withdrawal of product approvals, or refusal to allow a firm to enter into supply contracts, including government contracts. Any action against Adicet for violation of these laws, even if Adicet successfully defends against it, could cause Adicet to incur significant legal expenses and divert Adicets managements attention from the operation of its business. Prohibitions or restrictions on sales or withdrawal of future products marketed by Adicet could materially affect its business in an adverse way.
Changes in regulations, statutes or the interpretation of existing regulations could impact Adicets business in the future by requiring, for example: (i) changes to Adicets manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of Adicets products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of Adicets business.
Additional Regulation
In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservancy and Recovery Act and the Toxic Substances Control Act, affect Adicets business. These and other laws govern Adicets use, handling and disposal of various biological, chemical and radioactive substances used in, and wastes generated by, Adicets operations.
Even if Adicet contracts with third parties for the disposal of these materials and waste products, Adicet cannot completely eliminate the risk of contamination or injury resulting from these materials. If Adicets operations result in contamination of the environment or expose individuals to hazardous substances, Adicet could be liable for damages and governmental fines, and any liability could exceed Adicets resources. Adicet also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations. Adicet maintains workers compensation insurance to cover costs and expenses it may incur due to injuries to its employees, but this insurance may not provide adequate coverage against potential liabilities. However, Adicet does not maintain insurance for environmental liability or toxic tort claims that may be asserted against it. In addition, Adicet may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Current or future environmental laws and regulations may impair Adicets research, development or production efforts. In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions.
Adicet believes that Adicet is in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse effect on Adicets business. Adicet cannot predict, however, how changes in these laws may affect Adicets future operations.
Europe / Rest of World Government Regulation
In addition to regulations in the United States, Adicet will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and distribution of Adicets products. Whether or not Adicet obtains FDA approval of a product, Adicet must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United States have a similar process that requires the submission of a clinical trial application much like the IND prior to the commencement of human clinical trials. In the EU, for example, a clinical trial application must be submitted to each countrys national health authority and an independent ethics committee, much like the FDA and IRB, respectively. Once the clinical trial application is approved in accordance with a countrys requirements, clinical trial development may proceed. Because biologically sourced raw materials are subject to unique contamination risks, their use may be restricted in some countries.
47
The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, the clinical trials must be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
To obtain regulatory approval of an investigational drug or biological product under EU regulatory systems, Adicet must submit an MAA. The application used to file the BLA in the United States is similar to that required in the EU, with the exception of, among other things, country-specific document requirements.
For other countries outside of the EU, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials must be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
If Adicet or Adicets potential collaborators fail to comply with applicable foreign regulatory requirements, Adicet may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
European Union General Data Protection Regulation
In addition to EU regulations related to the approval and commercialization of Adicets products, Adicet may be subject to the EUs General Data Protection Regulation, or GDPR. The GDPR imposes stringent requirements for controllers and processors of personal data of persons in the EU, including, for example, more robust disclosures to individuals and a strengthened individual data rights regime, shortened timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to special categories of data, such as health data, and additional obligations when Adicet contracts with third-party processors in connection with the processing of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the European Union to the United States and other third countries. In addition, the GDPR provides that EU member states may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric or health data.
The GDPR applies extraterritorially, and Adicet may be subject to the GDPR because of Adicets data processing activities that involve the personal data of individuals located in the European Union, such as in connection with Adicets EU clinical trials. Failure to comply with the requirements of the GDPR and the applicable national data protection laws of the EU member states may result in fines of up to 20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties. GDPR regulations may impose additional responsibility and liability in relation to the personal data that Adicet processes and Adicet may be required to put in place additional mechanisms to ensure compliance with the new data protection rules.
California Consumer Privacy Act
California recently enacted legislation, effective January 1, 2020, that has been dubbed the first GDPR-like law in the United States. Known as the California Consumer Privacy Act, or CCPA, it creates new individual privacy rights for consumers (as that word is broadly defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA requires covered companies to provide new disclosures to California consumers, provides such consumers new ways to opt-out of certain sales of personal information, and allows for a new cause of action for data breaches. As Adicets business progresses, the CCPA may impact (possibly significantly) Adicets business activities and exemplifies the vulnerability of Adicets business to the evolving regulatory environment related to personal data and protected health information.
48
Corporate Information
Adicet was formed as a Delaware corporation on November 26, 2014.
Employees
As of August 4, 2020, Adicet had 69 full-time employees, one part-time employee, and 17 consultants. None of Adicets employees are represented by labor unions or covered by collective bargaining agreements. Adicet considers Adicets relationship with Adicets employees to be good.
Facilities
Adicets corporate headquarters are located at 200 Constitution Drive, Menlo Park, California 94025. In October 2018, Adicet entered into a new lease for office and laboratory space in Redwood City, California. Adicet expects to complete occupancy in the new facility in second half of 2021.
Legal proceedings
In connection with the merger, a putative class action lawsuit, Plumley v. resTORbio Inc., et al., 1:20-cv-00858, was filed on June 26, 2020 by purported Company stockholder Patrick Plumley against resTORbio, its directors, Adicet, and Merger Sub in the U.S. District Court for the District of Delaware. The Plumley merger action generally alleges that the resTORbios proxy statement/prospectus/information statement filed with the SEC on June 23, 2020 misrepresents and/or omits certain purportedly material information relating to financial projections, analysis performed by JMP, past engagements of JMP, and the process leading up to the execution of the merger agreement. The Plumley merger action also asserts violations of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder against the resTORbio and its directors and violations of Section 20(a) of the Exchange Act against the resTORbios directors. The Plumley merger action also asserts violations of Section 20(a) of the Exchange Act against Adicet and Merger Sub. The Plumley merger action seeks, among other things: an injunction enjoining consummation of the merger, costs of the action, including plaintiffs attorneys fees and experts fees, declaratory relief, and any other relief the court may deem just and proper.
It is possible that additional similar cases could be filed in connection with the merger.
49
Exhibit 99.5
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page | ||||
F2-2 | ||||
Consolidated Financial Statements |
||||
Consolidated Balance Sheets as of December 31, 2019 and 2018 |
F2-3 | |||
F2-4 | ||||
F2-5 | ||||
Consolidated Statements of Cash Flows for the years ended December 31, 2019 and 2018 |
F2-6 | |||
F2-7 |
F2-1
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Adicet Bio, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Adicet Bio, Inc. and its subsidiary (the Company) as of December 31, 2019 and 2018, and the related consolidated statements of operations and comprehensive loss, of redeemable convertible preferred stock and stockholders deficit, and of cash flows for the years then ended, including the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2019 and 2018, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt About the Companys Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred significant net operating losses and negative cash flows from operations since inception that raise substantial doubt about its ability to continue as a going concern. Managements plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on the Companys consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
San Jose, California
June 23, 2020
We have served as the Companys auditor since 2016.
F2-2
ADICET BIO, INC.
(in thousands, except share and per share amounts)
December 31, | ||||||||
2019 | 2018 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 10,607 | $ | 9,475 | ||||
Short-term marketable debt securities |
51,793 | 15,169 | ||||||
Prepaid expenses and other current assets |
1,786 | 3,191 | ||||||
|
|
|
|
|||||
Total current assets |
64,186 | 27,835 | ||||||
Property and equipment, net |
2,121 | 2,250 | ||||||
Restricted cash |
4,282 | 4,282 | ||||||
Long-term marketable debt securities |
10,588 | | ||||||
Other non-current assets |
410 | 322 | ||||||
|
|
|
|
|||||
Total assets |
$ | 81,587 | $ | 34,689 | ||||
|
|
|
|
|||||
Liabilities, redeemable convertible preferred stock, and stockholders
|
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,052 | $ | 538 | ||||
Contract liabilitiesrelated party, current |
10,993 | 14,372 | ||||||
Accrued and other current liabilities |
2,820 | 3,067 | ||||||
|
|
|
|
|||||
Total current liabilities |
14,865 | 17,977 | ||||||
Contract liabilitiesrelated party, net of current portion |
10,890 | 8,506 | ||||||
Redeemable convertible preferred stock tranche liability and TRDF liability |
| 3,255 | ||||||
Deferred rent, net of current portion |
234 | 399 | ||||||
Redeemable convertible preferred stock warrant liability |
1,881 | | ||||||
|
|
|
|
|||||
Total liabilities |
27,870 | 30,137 | ||||||
|
|
|
|
|||||
Commitments and contingencies (Note 9) |
||||||||
Redeemable convertible preferred stock, $0.0001 par value; 99,363,444 and 46,089,344 shares authorized as of December 31, 2019 and December 31, 2018, respectively; 97,166,921 and 40,094,850 shares issued and outstanding as of December 31, 2019 and December 31, 2018, respectively; liquidation preference $128,195 and $48,114 as of December 31, 2019 and December 31, 2018, respectively |
114,083 | 38,068 | ||||||
Stockholders deficit: |
||||||||
Common stock, $0.0001 par value; 140,200,938 and 80,000,000 shares authorized as of December 31, 2019 and December 31, 2018, respectively; 17,383,619 and 17,264,217 shares issued and outstanding as of December 31, 2019 and December 31, 2018, respectively |
2 | 2 | ||||||
Additional paid-in capital |
9,256 | 8,004 | ||||||
Accumulated deficit |
(69,647 | ) | (41,509 | ) | ||||
Accumulated other comprehensive income (loss) |
23 | (13 | ) | |||||
|
|
|
|
|||||
Total stockholders deficit |
(60,366 | ) | (33,516 | ) | ||||
|
|
|
|
|||||
Total liabilities, redeemable convertible preferred stock, and stockholders deficit |
$ | 81,587 | $ | 34,689 | ||||
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F2-3
ADICET BIO, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
Year ended December 31, | ||||||||
2019 | 2018 | |||||||
Revenuerelated party |
$ | 995 | $ | 8,181 | ||||
Operating expenses: |
||||||||
Research and development |
23,691 | 14,717 | ||||||
General and administrative |
8,692 | 8,428 | ||||||
|
|
|
|
|||||
Total operating expenses |
32,383 | 23,145 | ||||||
|
|
|
|
|||||
Loss from operations |
(31,388 | ) | (14,964 | ) | ||||
Interest income |
938 | 543 | ||||||
Other income, net |
2,331 | 4,533 | ||||||
|
|
|
|
|||||
Loss before income tax expense (benefit) |
(28,119 | ) | (9,888 | ) | ||||
Income tax expense (benefit) |
19 | (589 | ) | |||||
|
|
|
|
|||||
Net loss |
$ | (28,138 | ) | $ | (9,299 | ) | ||
|
|
|
|
|||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | (1.63 | ) | $ | (0.59 | ) | ||
|
|
|
|
|||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
17,249,656 | 15,701,158 | ||||||
|
|
|
|
|||||
Other comprehensive income (loss): |
||||||||
Unrealized gain (loss) on marketable debt securities, net of tax |
36 | (13 | ) | |||||
|
|
|
|
|||||
Total other comprehensive income (loss) |
36 | (13 | ) | |||||
|
|
|
|
|||||
Comprehensive loss |
$ | (28,102 | ) | $ | (9,312 | ) | ||
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F2-4
ADICET BIO, Inc.
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders Deficit
(in thousands, except share amounts)
Redeemable Convertible Preferred Stock |
Common Stock | Additional Paid-In Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Income (Loss) |
Total Stockholders Deficit |
|||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||
Balance at January 1, 2018 |
31,074,017 | $ | 26,341 | 16,264,529 | $ | 2 | $ | 5,260 | $ | (32,210 | ) | $ | | $ | (26,948 | ) | ||||||||||||||||||
Net loss |
| | | | | (9,299 | ) | | (9,299 | ) | ||||||||||||||||||||||||
Issuance of Series A redeemable convertible preferred stock |
9,020,833 | 10,825 | | | | | | | ||||||||||||||||||||||||||
Exercise of the redeemable convertible preferred stock tranche liability |
| 902 | | | | | | | ||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options |
| | 999,688 | | 221 | | | 221 | ||||||||||||||||||||||||||
Vesting of early exercised stock options |
| | | | 44 | | | 44 | ||||||||||||||||||||||||||
Stock-based compensation expense |
| | | | 2,479 | | | 2,479 | ||||||||||||||||||||||||||
Other comprehensive loss |
| | | | | | (13 | ) | (13 | ) | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance at December 31, 2018 |
40,094,850 | $ | 38,068 | 17,264,217 | $ | 2 | $ | 8,004 | $ | (41,509 | ) | $ | (13 | ) | $ | (33,516 | ) | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Net loss |
| | | | | (28,138 | ) | | (28,138 | ) | ||||||||||||||||||||||||
Issuance of Series A redeemable convertible preferred stock related to TRDF liability (Note 12) |
67,656 | 88 | | | | | | | ||||||||||||||||||||||||||
Issuance of Series B redeemable convertible preferred stock, net of issuance cost of $5,216 |
57,004,415 | 74,784 | | | | | | | ||||||||||||||||||||||||||
Termination of redeemable convertible preferred stock tranche liability |
| 1,143 | | | | | | | ||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options |
| | 119,402 | | 30 | | | 30 | ||||||||||||||||||||||||||
Vesting of early exercised stock options |
| | | | 47 | | | 47 | ||||||||||||||||||||||||||
Stock-based compensation expense |
| | | | 1,175 | | | 1,175 | ||||||||||||||||||||||||||
Other comprehensive income |
| | | | | | 36 | 36 | ||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance at December 31, 2019 |
97,166,921 | $ | 114,083 | 17,383,619 | $ | 2 | $ | 9,256 | $ | (69,647 | ) | $ | 23 | $ | (60,366 | ) | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F2-5
ADICET BIO, Inc.
Consolidated Statements of Cash Flows
(in thousands)
Year ended December 31, |
||||||||
2019 | 2018 | |||||||
Cash flows from operating activities |
||||||||
Net loss |
$ | (28,138 | ) | $ | (9,299 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities |
||||||||
Depreciation and amortization expense |
1,238 | 1,222 | ||||||
Stock-based compensation expense |
1,175 | 2,479 | ||||||
Gain on disposal of property and equipment |
(27 | ) | | |||||
Net amortization of premiums and accretion of discounts on investments |
(197 | ) | | |||||
Change in fair value of redeemable convertible preferred stock tranche liability and TRDF liability |
(2,024 | ) | (4,536 | ) | ||||
Change in fair value of redeemable convertible preferred stock warrant liability |
(250 | ) | | |||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
1,405 | (2,825 | ) | |||||
Other non-current assets |
(88 | ) | (302 | ) | ||||
Accounts payable |
527 | (282 | ) | |||||
Contract liabilitiesrelated party |
(995 | ) | (3,181 | ) | ||||
Deferred rent |
(148 | ) | (132 | ) | ||||
Accrued and other current liabilities |
(360 | ) | (1,324 | ) | ||||
|
|
|
|
|||||
Net cash used in operating activities |
(27,882 | ) | (18,180 | ) | ||||
|
|
|
|
|||||
Cash flows from investing activities |
||||||||
Purchases of marketable debt securities |
(76,078 | ) | (15,182 | ) | ||||
Proceeds from maturities of marketable debt securities |
29,099 | | ||||||
Proceeds from sale of property and equipment |
118 | | ||||||
Purchase of property and equipment |
(1,070 | ) | (876 | ) | ||||
|
|
|
|
|||||
Net cash used in investing activities |
(47,931 | ) | (16,058 | ) | ||||
|
|
|
|
|||||
Cash flow from financing activities |
||||||||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs |
76,915 | 10,825 | ||||||
Proceeds from exercise of stock options |
30 | 221 | ||||||
|
|
|
|
|||||
Net cash provided by financing activities |
76,945 | 11,046 | ||||||
|
|
|
|
|||||
Net change in cash, cash equivalents and restricted cash |
1,132 | (23,192 | ) | |||||
Cash, cash equivalents and restricted cash, at the beginning of the period |
13,757 | 36,949 | ||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash, at the end of the period |
$ | 14,889 | $ | 13,757 | ||||
|
|
|
|
|||||
Reconciliation of cash, cash equivalents and restricted cash to consolidated balance sheets: |
||||||||
Cash and cash equivalents |
$ | 10,607 | $ | 9,475 | ||||
Restricted cash |
4,282 | 4,282 | ||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash in consolidated balance sheets |
$ | 14,889 | $ | 13,757 | ||||
|
|
|
|
|||||
Supplemental cash flow information |
||||||||
Cash paid for income taxes |
$ | 1 | $ | 5,109 | ||||
Supplemental disclosures of noncash investing and financing activities |
||||||||
Purchase of property and equipment included in accounts payable |
$ | 48 | $ | 61 | ||||
Vesting of early exercised stock options |
$ | 47 | $ | 44 | ||||
Exercise of redeemable convertible preferred stock tranche liability |
$ | | $ | 902 | ||||
Termination of redeemable convertible preferred stock tranche liability |
$ | 1,143 | $ | | ||||
Settlement of TRDF liability |
$ | 88 | $ | | ||||
Redeemable convertible preferred stock warrants issued in exchange of services in connection with issuance of Series B redeemable convertible preferred stock recorded as issuance costs |
$ | 2,131 | $ | |
The accompanying notes are an integral part of these financial statements
F2-6
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
1. Organization and Nature of the Business
Adicet Bio, Inc. (the Company) is a pre-clinical stage biotechnology company engaged in the design and development of a new generation of allogeneic immunotherapies for cancer and other diseases. The Company was incorporated in November 2014 in Delaware and is headquartered in Menlo Park, California.
Adicet Bio Israel Ltd. (formerly Applied Immune Technologies Ltd.) (Adicet Israel) is a wholly owned subsidiary of the Company and is located in Haifa, Israel. Adicet Israel was founded in 2006 and is a drug development company specializing in T-Cell Receptor-Like (TCRL) antibodies that are targeted to intracellular-derived peptides for a variety of therapeutic and diagnostic applications. In 2019, the Company consolidated its operations, including research and development activities, in the United States and as a result substantially reduced its operations in Israel.
Liquidity and Going Concern
The Company has incurred significant net operating losses and negative cash flows from operations since inception and had an accumulated deficit of $69.6 million as of December 31, 2019. The Company has historically financed its operations primarily through a collaboration and licensing arrangement, as well as through the private placement of equity securities. To date, none of the Companys product candidates have been approved for sale and therefore the Company has not generated any revenue from product sales. Management expects operating losses and negative cash flows to continue for the foreseeable future, until such time, if ever, that it can generate significant sales of its product candidates currently in development.
Management believes that the Companys cash, cash equivalents and marketable debt securities will not be sufficient for the Company to continue as a going concern for at least one year from the issuance date of these accompanying consolidated financial statements. The Company believes that this raises substantial doubt about its ability to continue as a going concern. As a result, the Company will be required to raise additional capital, however, there can be no assurance as to whether additional financing will be available on terms acceptable to the Company, if at all. If sufficient funds on acceptable terms are not available when needed, the Company could be required to significantly reduce its operating expenses and delay, reduce the scope of or eliminate one or more of its development programs. Failure to manage discretionary spending or raise additional financing, as needed, may adversely impact the Companys ability to achieve its intended business objectives and have an adverse effect on its results of operations and future prospects.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying consolidated financial statements do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements and related disclosures have been prepared in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP).
Reclassifications
Certain prior year amounts have been reclassified for consistency with the current year presentation. An adjustment has been made to the consolidated statement of operations and comprehensive loss for the year ended December 31, 2018, to reclassify interest income from general and administrative to other income, net. An
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
adjustment has also been made to the consolidated balance sheet for the year ended December 31, 2018, to reclassify balances recorded within prepaid expenses and other current assets and accrued and other current liabilities to deferred rent, net of current portion.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. The functional and reporting currency of the Company and its subsidiary is the U.S. dollar.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements as well as the reported amounts of revenues and expenses during the reporting period. Such estimates include the valuation of the redeemable convertible preferred stock warrant liability, the redeemable convertible preferred stock tranche liability, the Technion Research and Development Foundation liability (TRDF Liability) (see Note 12), deferred tax assets, useful lives of property and equipment, accruals for research and development activities, revenue recognition and stock-based compensation. Actual results could differ from those estimates.
Segments
The Company operates and manages its business as one reportable and operating segment, which is the business of research and development of allogeneic immunotherapies for cancer and other diseases. The Companys Chief Executive Officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance.
Concentration of Credit Risk
Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents, restricted cash, and marketable debt securities. The Companys cash and cash equivalents are held at two financial institutions in the United States of America and one financial institution in Israel and such amounts may, at times, exceed insured limits. The Company invests its cash equivalents and marketable debt securities in money market funds, U.S. government securities, commercial paper, corporate bonds, and asset-backed securities. The Company limits its credit risk associated with cash equivalents and marketable debt securities by placing them with banks and institutions it believes are highly creditworthy and in highly rated investments. The Company has not experienced any losses on its deposits of cash and cash equivalents and marketable debt securities to date.
The Company has one customer, Regeneron Pharmaceuticals, Inc. (Regeneron), which represents 100% of the Companys total revenue during the years ended December 31, 2019 and 2018 (see Note 8).
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies, clinical trials and
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting.
The Companys product candidates are still in development and, to date, none of the Companys product candidates have been approved for sale and, therefore, the Company has not generated any revenue from product sales.
There can be no assurance that the Companys research and development will be successfully completed, that adequate protection for the Companys intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Companys product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies.
The current COVID-19 (coronavirus) pandemic, which is impacting worldwide economic activity, poses risk that the Company or its employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, including due to shutdowns that may be requested or mandated by governmental authorities. The extent to which the coronavirus impacts the Companys operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information that will emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. COVID-19 may impact the timing of regulatory approval of the INDs for clinical trials, the enrollment of any clinical trials that are approved, the availability of clinical trial materials and regulatory approval and commercialization of our products. COVID-19 may also impact the Companys ability to access capital, which could negatively impact short-term and long-term liquidity.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with maturities of three months or less from the purchase date to be cash equivalents. As of December 31, 2019 and 2018, cash and cash equivalents consist of cash deposited with a bank, investments in money market funds, investments in corporate debt securities and commercial paper with maturities of three months or less from the date of purchase.
Marketable Debt Securities
The Companys marketable debt securities consist of U.S. government securities, commercial paper, corporate bonds, and asset-backed securities. The Company designates all investments as available-for-sale and therefore reports them at fair value, based on quoted marked prices, with unrealized gains and losses recorded in accumulated other comprehensive income (loss) as a component of stockholders equity until realized. The cost of securities sold is based on the specific-identification method. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in other income, net. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income, net. Interest and dividends on securities classified as available-for-sale are included in other income, net. Management determines the appropriate classification of the securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. Marketable debt securities with contractual maturities greater than 12 months are presented as long-term marketable debt securities on the consolidated balance sheets.
The Company regularly reviews all its marketable debt securities for other-than-temporary declines in fair value. The review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
that the Company will be required to sell the securities before the recovery of their amortized cost basis. If a debt security is in an unrealized loss position and the Company has the intent to sell the debt security, or it is more likely than not that the Company will have to sell the debt security before recovery of its amortized cost basis, the decline in value is deemed to be other-than-temporary and is recorded to other-than-temporary impairment losses recognized in other income, net in the consolidated statements of income. For impaired debt securities that the Company does not intend to sell or it is more likely than not that the Company will not have to sell such securities, but the Company expects that it will not fully recover the amortized cost basis, the credit component of the other-than-temporary impairment is recognized other income, net in the consolidated statements of operations and comprehensive loss and the non-credit component of the other-than-temporary impairment is recognized in other comprehensive loss. No other-than-temporary decline in the fair value of marketable debt securities has been recognized to date.
Restricted Cash
Restricted cash is comprised of cash that is restricted as to withdrawal or use under the terms of certain contractual agreements. Restricted cash for years ended December 31, 2019 and 2018 consists of collateral for letters of credit issued in connection with the real estate leases (see Note 9).
Fair Value of Financial Instruments
The carrying amounts of certain financial instruments of the Company, including cash equivalents, restricted cash, accounts payable and accrued and other current liabilities approximate fair value due to their relatively short maturities. The Companys marketable debt securities, redeemable convertible preferred stock warrant liability, redeemable convertible preferred stock tranche liability and TRDF Liability are carried at fair value (see Notes 3 and 4).
Redeemable Convertible Preferred Stock
The Company records all shares of redeemable convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs, if applicable. The redeemable convertible preferred stock is recorded outside of permanent equity because while it is not mandatorily redeemable, in certain events considered not solely within the Companys control, such as a merger, acquisition or sale of all or substantially all of the Companys assets (each, a deemed liquidation event), the redeemable convertible preferred stock will become redeemable at the option of the holders of at least a majority of the then outstanding shares. The Company has not adjusted the carrying values of the redeemable convertible preferred stock to its liquidation preference because a deemed liquidation event obligating the Company to pay the liquidation preferences to holders of shares of redeemable convertible preferred stock is not probable of occurring. Subsequent adjustments to the carrying values to the liquidation preferences will be made only when it becomes probable that such a deemed liquidation event will occur.
Redeemable Convertible Preferred Stock Tranche Liability
The Company determined that its obligations to issue additional shares of redeemable convertible preferred stock upon the achievement of certain milestones or at the option of the respective holders of such shares represent freestanding financial instruments. These instruments were initially measured at fair value and were subject to remeasurement with changes in fair value recognized in other income, net in the consolidated statements of operations and comprehensive loss until they were exercised, terminated or settled (see Note 11).
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
Redeemable Convertible Preferred Stock Warrants
The Companys redeemable convertible preferred stock warrants require liability classification and accounting as the underlying redeemable convertible preferred stock is considered contingently redeemable and may obligate the Company to transfer assets to the holders at a future date upon occurrence of a deemed liquidation event. The warrants are recorded at fair value upon issuance and are subject to remeasurement to fair value at each balance sheet date, with any changes in fair value recognized in other income, net in the consolidated statements of operations and comprehensive loss. The Company will continue to adjust the warrant liability for changes in fair value until the earlier of the exercise or expiration of the redeemable convertible preferred stock warrants, the occurrence of a deemed liquidation event or the conversion of redeemable convertible preferred stock into common stock.
Property and Equipment, Net
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed on a straight-line basis over the estimated useful lives of the related assets, generally three years. Leasehold improvements are amortized using the straight-line method over the shorter of the assets estimated useful lives or the remaining term of the lease. Maintenance and repairs are charged to operations as incurred. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is reflected in the consolidated statements of operations and comprehensive loss in the period realized.
Impairment of Long-Lived Assets
The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. Recoverability is measured by comparison of the carrying amount of the asset or asset group to the future net cash flows which the asset or asset group is expected to generate. If such asset or asset group is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset or asset group exceeds the fair value of the asset or asset group. There has been no such impairment of long-lived assets during the years ended December 31, 2019 and 2018.
Revenue Recognition
Under Accounting Standards Codification 606, Revenue from Contracts with Customers (ASC 606), the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps as prescribed by ASC 606:
(i) | identify the contract(s) with a customer; |
(ii) | identify the performance obligations in the contract; |
(iii) | determine the transaction price; |
(iv) | allocate the transaction price to the performance obligations in the contract; and |
(v) | recognize revenue when (or as) the Company satisfies a performance obligation. |
A contract with a customer exists when (i) the Company enters into a legally enforceable contract with a customer that defines each partys rights regarding the products or services to be transferred and identifies the payment terms related to these products or services, (ii) the contract has commercial substance and (iii) the
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
Company determines that collection of substantially all consideration for products or services that are transferred is probable based on the customers intent and ability to pay the promised consideration.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company identifies the goods or services promised and determines the performance obligations by assessing whether each promised good or service is distinct. Goods or services that are not distinct are bundled with other goods or services in the contract until a bundle of goods or services that is distinct is created. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
All of the Companys revenues are derived through a license and collaboration agreement (see Note 8).
For revenue recognition purposes, the Company determines the term of its license or collaboration agreements by evaluating the period during which present and enforceable rights and obligations exist. This determination is impacted by the existence of substantive termination penalties, among other factors.
The Company recognizes revenue under the Companys license or collaboration agreements that are within the scope of ASC 606. The Companys contract with customer includes promises related to licenses to intellectual property and research and development services. If the license to the Companys intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgement to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. Accordingly, the transaction price is generally comprised of a fixed fee due at contract inception and at specified future dates, variable consideration in the form of milestone payments due upon the achievement of specified events and tiered royalties earned when customers recognize net sales of licensed products. The Company measures the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes the most likely amount method to estimate the amount of variable consideration to which it will be entitled for the contract (see Note 8). Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. At the inception of each arrangement that includes development and regulatory milestone payments, the Company evaluates whether the associated event is considered most likely to be achieved and estimates the amount to be included in the transaction price.
Payments or reimbursements for the Companys research and development efforts where such efforts are considered part of or a single performance obligation are recognized over time using a measure of progress that best reflects the Companys performance in satisfying the obligation and are presented on a gross basis.
Upfront payments are recorded as contract liabilities upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligation under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Companys right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from its collaboration arrangement.
Research and Development Expenses
Research and development expenses include costs directly attributable to the conduct of research and development programs, including payroll and related expenses, costs for contract manufacturing organizations (CMOs), costs for contract research organizations (CROs), materials, supplies, depreciation on and maintenance of research equipment, consulting costs, and the allocated portions of facility costs, such as rent, utilities, insurance, repairs and maintenance, depreciation, information technology costs and general support services. All costs associated with research and development are expensed within the consolidated statements of operations and comprehensive loss as incurred.
Costs incurred in obtaining technology licenses are charged to research and development expense as acquired in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use.
Accrued Research and Development
The Company has entered into various agreements with CMOs and CROs. The Companys research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced are included in accrued and other current liabilities on the consolidated balance sheets. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to CMOs and CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets on the consolidated balance sheets until the services are rendered. Through December 31, 2019 there had been no material adjustments to the Companys prior period estimates of accrued research and development expenses.
Leases
The Company categorizes leases at their inception as either operating or capital leases. Where leases contain escalation clauses, rent abatements or concessions, such as rent holidays and landlord or tenant incentives or allowances, the Company applies them in the determination of straight-line rent expense over the non-cancellable lease term.
The Company records the difference between the rent paid and the straight-line rent expense as a deferred rent liability on the consolidated balance sheets. Leasehold improvements funded by landlord incentives or allowances are recorded as leasehold improvement assets and a corresponding deferred rent liability on the consolidated balance sheets. The leasehold improvement asset is amortized over the shorter of the term of the lease or the useful life of the asset. The deferred rent liability is amortized on a straight-line basis as a reduction to rent expense over the lease term. The current portion of deferred rent is recorded within accrued and other current liabilities on the consolidated balance sheets.
Leasehold improvements funded by the Company that are considered landlords assets are recorded as prepaid rent and is amortized on a straight-line basis as an increase to rent expense over the lease term.
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
Rent paid before the lease commences is recorded as prepaid rent and is amortized on a straight-line basis as an increase of rent expense over the lease term.
Fair Value of Common Stock
The fair value of the Companys common stock is determined by its Board of Directors with input from management and third-party valuation specialists. The Companys approach to estimate the fair value of the Companys common stock is consistent with the methods outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Determining the best estimated fair value of the Companys common stock requires significant judgement and management considers several factors, including the Companys stage of development, equity market conditions affecting comparable public companies, significant milestones and progress of research and development efforts.
Stock-Based Compensation
The Company accounts for stock-based compensation arrangements with employees and non-employees using a fair value method which requires the recognition of compensation expense for costs related to all stock-based payments including stock options. The fair value method requires the Company to estimate the fair value of stock-based payment awards on the date of grant using an option-pricing model. The Company uses the Black-Scholes option-pricing model to estimate the fair value of options granted that are expensed on a straight-line basis over the requisite service period, which is generally the vesting period. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes option-pricing model, require the input of several assumptions. Changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award.
Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences attributable to differences between carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax reporting purposes and for operating loss and tax credit carryforwards. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes.
The Companys deferred tax assets and liabilities are measured using enacted tax rates expected to apply in the years in which these temporary differences are expected to be recovered or settled. A valuation allowance is recorded to reduce deferred tax assets if it is determined that it is more likely than not that all or a portion of the deferred tax asset will not be realized. The Company considers many factors when assessing the likelihood of future realization of deferred tax assets, including recent earnings results, expectations of future taxable income, carryforward periods available and other relevant factors. The Company records changes in the required valuation allowance in the period that the determination is made.
The Company assesses its income tax positions and records tax benefits for all years subject to examination based upon managements evaluation of the facts, circumstances and information available as of the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50% likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, the Company does not recognize a tax benefit in the financial statements. The Company records interest and penalties related to uncertain tax positions, if applicable, as a component of income tax expense (benefit).
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as a change in equity of a business enterprise during a period, resulting from transactions from non-owner sources. The other comprehensive loss disclosed in the Companys consolidated statements of operations and comprehensive loss for the years ended December 31, 2019 and 2018 consists of changes in unrealized gains and losses on marketable debt securities.
Net Loss per Share Attributable to Common Stockholders
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common stock outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, the redeemable convertible preferred stock, redeemable convertible preferred stock warrants, redeemable convertible preferred stock tranche liability, common stock subject to repurchase and stock options are considered to be potentially dilutive securities. Basic and diluted net loss per share attributable to common stockholders is presented in conformity with the two-class method required for participating securities as the redeemable convertible preferred stock and early exercised stock options are considered to be participating securities. The two-class method determines net income (loss) per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income (loss) available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to share in undistributed earnings as if all income (loss) for the period had been distributed. The Companys participating securities do not have a contractual obligation to share in the Companys losses. As such, the net loss is attributed entirely to common stockholders. Since the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the FASB) under its Accounting Standard Codifications (ASC) or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below.
Recently Adopted Accounting Pronouncements
In August 2016, the FASB issued Accounting Standards Update (ASU) 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. This ASU clarifies how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The Company adopted this ASU effective January 1, 2019. The adoption of this ASU did not have a material effect on the Companys consolidated financial statements and related disclosures.
In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. This ASU requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash. Therefore, amounts generally described as restricted cash should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The Company adopted ASU 2016-18 as of January 1, 2018 using a retrospective transition method to each period presented. As a result, net cash used in investing activities for the year ended December 31, 2017 was adjusted to exclude the change in restricted cash.
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
Restricted cash amount as of December 31, 2017 was primarily related to security deposit and collateral for letter of credit.
In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. This ASU simplifies the accounting for certain financial instruments with down round features, a provision in an equity-linked financial instrument (or embedded feature) that provides a downward adjustment of the current exercise price based on the price of future equity offerings. Down round features are common in warrants, preferred shares and convertible debt instruments issued by private companies and early-stage public companies. This update requires companies to disregard the down round feature when assessing whether the instrument is indexed to its own stock, for purposes of determining liability or equity classification. The amendments in Part I should be applied (1) retrospectively to outstanding financial instruments with a down round feature by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the first fiscal year and interim periods; (2) retrospectively to outstanding financial instruments with a down round feature for each prior reporting period presented. The amendments in Part II do not require any transition guidance because those amendments do not have an accounting effect. The Company adopted this ASU effective January 1, 2019. The adoption of this ASU did not have a material effect on the Companys consolidated financial statements and related disclosures.
In March 2018, the FASB issued ASU No. 2018-05, Income Taxes (Topic 740)Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118. This ASU amends ASC 740, Income Taxes, to provide guidance on accounting for the tax effects of the Tax Cuts and Jobs Act (the Tax Act) pursuant to Staff Accounting Bulletin No. 118, which allows companies to complete the accounting under ASC 740 within a one-year measurement period from the Tax Act enactment date. This ASU was effective upon issuance. The Company has applied the guidance in this ASU during the year ended December 31, 2018 (see Note 17).
Accounting Pronouncements Not Yet Adopted
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (ASC 842), which sets out the principles for the recognition, measurement, presentation, and disclosure of leases for both parties to a contract (i.e. lessees and lessors). In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842, Leases, which provides clarification to ASU 2016-02. In March 2019, the FASB issued ASU 2019-01, which provides clarification on implementation issues associated with adopting ASU 2016-02. These ASUs (collectively the new leasing standard) requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. ASC 842 provides a lessee with an option to not account for leases with a term of 12 month or less as leases in the scope of ASC 842. ASC 842 supersedes the previous leases standard, ASC 840 Leases. The new leasing standard is effective for public business entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, and should be applied through a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption is permitted. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which allows entities to elect an optional transition method where entities may continue to apply the existing lease guidance during the comparative periods and apply the new lease requirements through a cumulative effect adjustment in the period of adoptions rather than in the earliest period presented. In June 2020, the FASB issued ASU 2020-05, which delays the adoption dates for ASU 2016-02 for
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ADICET BIO, Inc.
Notes to Consolidated Financial Statements
non-public entities to fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. Early application continues to be allowed. The Company is currently evaluating the impact the adoption of these ASUs will have on its financial statements and related disclosures. The Company expects to recognize a right-of-use asset and corresponding lease liability for its real estate operating leases upon adoption, expecting to use the modified retrospective approach for the ASU adoption.
In June 2016, the FASB issued ASU No. 2016-13, Financial InstrumentsCredit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. This ASU replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes will result in earlier recognition of credit losses. For public business entities that meet the definition of a Securities and Exchange Commission (SEC) filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, adoption is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. For SEC filers that are eligible to be smaller reporting companies and for all other entities, this ASU is effective for fiscal years beginning after December 15, 2022, and interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.
In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure FrameworkChanges to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements. The new disclosure requirements include disclosure related to changes in unrealized gains or losses included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of each reporting period and the explicit requirement to disclose the range and weighted-average of significant unobservable inputs used for Level 3 fair value measurements. This ASU removes the requirement to disclose: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the policy for timing of transfers between levels; and the valuation processes for Level 3 fair value measurements. For all entities, this ASU is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.
In November 2018, FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which is intended to clarify the circumstances under which certain transactions in collaborative arrangements should be accounted for under the revenue recognition standard. Certain transactions between collaboration arrangement participants should be accounted for as revenue under ASC Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. For public business entities, this ASU is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. For all other entities, this ASU is effective for fiscal years and interim periods within those years beginning after December 15, 2020. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740)Simplifying the Accounting for Income Taxes, which simplify various aspects related to the accounting for income taxes. This ASU removes exceptions to the general principles in Topic 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. For public companies, this ASU is effective for interim and annual reporting periods beginning after December 15, 2020. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after
F2-17
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
December 15, 2022. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.
3. Fair Value Measurements
The Company determines the fair value of financial and non-financial assets and liabilities using the fair value hierarchy which establishes three level of inputs that may be used to measure fair value, as follows:
Level 1 Observable inputs, such as quoted prices in active markets for identical assets or liabilities.
Level 2 Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 Unobservable inputs which reflect managements best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Companys assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
The following tables present information about the Companys financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
December 31, 2019 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: |
||||||||||||||||
Money market funds |
$ | 7,232 | $ | | $ | | $ | 7,232 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Cash equivalents(1) |
7,232 | | | 7,232 | ||||||||||||
Asset-backed securities |
| 19,598 | | 19,598 | ||||||||||||
Corporate debt securities |
| 19,394 | | 19,394 | ||||||||||||
Commercial paper |
| 17,892 | | 17,892 | ||||||||||||
U.S. Government agency bonds |
| 5,497 | | 5,497 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Marketable debt securities |
| 62,381 | | 62,381 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value of assets |
$ | 7,232 | $ | 62,381 | $ | | $ | 69,613 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities: |
||||||||||||||||
Redeemable convertible preferred stock warrant liability |
$ | | $ | | $ | 1,881 | $ | 1,881 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value of liabilities |
$ | | $ | | $ | 1,881 | $ | 1,881 | ||||||||
|
|
|
|
|
|
|
|
F2-18
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
December 31, 2018 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: |
||||||||||||||||
Money market funds |
$ | 2,868 | $ | | $ | | $ | 2,868 | ||||||||
Corporate debt securities |
| 1,250 | | 1,250 | ||||||||||||
Commercial paper |
| 997 | | 997 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Cash equivalents(1) |
2,868 | 2,247 | | 5,115 | ||||||||||||
Asset-backed securities |
| 4,725 | | 4,725 | ||||||||||||
Corporate debt securities |
| 4,525 | | 4,525 | ||||||||||||
Commercial paper |
| 5,919 | | 5,919 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Marketable debt securities |
| 15,169 | | 15,169 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value of assets |
$ | 2,868 | $ | 17,416 | $ | | $ | 20,284 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities: |
||||||||||||||||
Redeemable convertible preferred stock tranche liability |
$ | | $ | | $ | 3,113 | $ | 3,113 | ||||||||
TRDF liability |
| | 142 | 142 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value of liabilities |
$ | | $ | | $ | 3,255 | $ | 3,255 | ||||||||
|
|
|
|
|
|
|
|
(1) | Included in cash and cash equivalents in the consolidated balance sheets |
Money market funds are included within Level 1 of the fair value hierarchy because they are valued using quoted market prices. Corporate debt securities, U.S. government agency bonds, commercial paper and asset-backed securities are classified within Level 2 of the fair value hierarchy as they take into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income-based and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate the fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data and other observable inputs.
The following table presents a summary of the changes in the fair value of the Companys Level 3 financial instrument (in thousands):
Redeemable Convertible Preferred Stock Tranche Liability |
TRDF Liability |
Redeemable Convertible Preferred Stock Warrant Liability |
||||||||||
Fair value as of January 1, 2018 |
$ | 8,557 | $ | 136 | $ | | ||||||
Change in the fair value included in other income, net |
(4,542 | ) | 6 | | ||||||||
Exercise |
(902 | ) | | | ||||||||
|
|
|
|
|
|
|||||||
Fair value as of December 31, 2018 |
3,113 | 142 | | |||||||||
Recognition of preferred stock warrant liabilities |
| | 2,131 | |||||||||
Settlement |
| (88 | ) | | ||||||||
Change in the fair value included in other income, net |
(1,970 | ) | (54 | ) | (250 | ) | ||||||
Termination |
(1,143 | ) | | | ||||||||
|
|
|
|
|
|
|||||||
Fair value as of December 31, 2019 |
$ | | $ | | $ | 1,881 | ||||||
|
|
|
|
|
|
F2-19
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
The fair value of the redeemable convertible preferred stock tranche liability, TRDF Liability and the redeemable convertible preferred stock warrant liability are based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. In determining the fair value of the redeemable convertible preferred stock tranche liability and redeemable convertible preferred stock warrants, the Company used the Black-Scholes option pricing model to estimate the fair value using unobservable inputs including the expected term, expected volatility, risk-free interest rate and dividend yield (see Notes 11 and 13). The fair value of the TRDF Liability was determined based on the fair value of the Companys Series A redeemable convertible preferred stock (see Note 12). There were no transfers between Level 1 and Level 2 during the years ended December 31, 2019 and 2018.
4. Marketable Debt Securities
The following tables summarize the Companys marketable debt securities (in thousands):
December 31, 2019 | ||||||||||||||||
Amortized Cost |
Unrealized Losses |
Unrealized Gains |
Fair Value |
|||||||||||||
Asset-backed securities |
$ | 19,589 | $ | (1 | ) | $ | 10 | $ | 19,598 | |||||||
Corporate debt securities |
19,387 | (3 | ) | 9 | 19,393 | |||||||||||
Commercial paper |
17,882 | | 11 | 17,893 | ||||||||||||
U.S. Government agency bonds |
5,500 | (3 | ) | | 5,497 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 62,358 | $ | (7 | ) | $ | 30 | $ | 62,381 | |||||||
|
|
|
|
|
|
|
|
|||||||||
December 31, 2018 | ||||||||||||||||
Amortized Cost |
Unrealized Losses |
Unrealized Gains |
Fair Value |
|||||||||||||
Asset-backed securities |
$ | 4,730 | $ | (5 | ) | $ | | $ | 4,725 | |||||||
Corporate debt securities |
5,778 | (3 | ) | | 5,775 | |||||||||||
Commercial paper |
6,921 | (5 | ) | | 6,916 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 17,429 | $ | (13 | ) | $ | | $ | 17,416 | |||||||
|
|
|
|
|
|
|
|
The following table summarizes the Companys marketable debt securities by contractual maturity (in thousands):
December 31, 2019 | ||||||||
Amortized Cost |
Fair Value |
|||||||
Within one year |
$ | 51,777 | $ | 51,793 | ||||
After one year through five years |
10,581 | 10,588 | ||||||
After five years |
| | ||||||
|
|
|
|
|||||
Total |
$ | 62,358 | $ | 62,381 | ||||
|
|
|
|
The following table summarizes the classification of the Companys marketable debt securities in the consolidated balance sheets (in thousands):
December 31 | ||||||||
2019 | 2018 | |||||||
Cash and cash equivalents |
$ | | $ | 2,247 | ||||
Short-term marketable debt securities |
51,793 | 15,169 | ||||||
Long-term marketable debt securities |
10,588 | | ||||||
|
|
|
|
|||||
Total |
$ | 62,381 | $ | 17,416 | ||||
|
|
|
|
F2-20
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
December 31 | ||||||||
2019 | 2018 | |||||||
Prepaid expenses |
$ | 672 | $ | 923 | ||||
Tax receivable |
722 | 2,143 | ||||||
Interest receivable |
213 | 67 | ||||||
Other current assets |
179 | 58 | ||||||
|
|
|
|
|||||
Total |
$ | 1,786 | $ | 3,191 | ||||
|
|
|
|
6. Property and Equipment, net
Property and equipment, net consisted of the following (in thousands):
As of December 31, | ||||||||||||
Useful life (years) | 2019 | 2018 | ||||||||||
Laboratory equipment |
3 | $ | 3,872 | $ | 3,952 | |||||||
Leasehold improvements |
|
Lesser of useful life or lease term |
|
1,327 | 1,350 | |||||||
Furniture and fixtures |
3 | 68 | 167 | |||||||||
Construction in progress |
| 300 | 168 | |||||||||
Computer equipment |
3 | 42 | 130 | |||||||||
Software |
3 | 150 | 140 | |||||||||
|
|
|
|
|||||||||
5,759 | 5,907 | |||||||||||
Less: Accumulated depreciation and amortization |
(3,638 | ) | (3,657 | ) | ||||||||
|
|
|
|
|||||||||
Property and equipment, net |
$ | 2,121 | $ | 2,250 | ||||||||
|
|
|
|
Depreciation and amortization expense for each of the years ended December 31, 2019 and 2018 was $1.2 million. All of the Companys property and equipment as of December 31, 2019 is located in the U.S. As of December 31, 2018, the carrying value of property and equipment located in the U.S. and Israel was $2.1 million and $0.2 million, respectively.
7. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
December 31 | ||||||||
2019 | 2018 | |||||||
Accrued compensation |
$ | 1,359 | $ | 1,665 | ||||
Accrued research and development expenses |
450 | 556 | ||||||
Accrued professional services |
301 | 446 | ||||||
Early exercised stock option liability |
| 47 | ||||||
Accrued other liabilities |
710 | 353 | ||||||
|
|
|
|
|||||
Total |
$ | 2,820 | $ | 3,067 | ||||
|
|
|
|
F2-21
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
8. Regeneron License and Collaboration Arrangement
Agreement Terms
On July 29, 2016, the Company entered into a license and collaboration agreement with Regeneron Pharmaceuticals, Inc. (Regeneron), which was amended in April 2019, with such amendment becoming effective in connection with Regenerons investment in the Companys Series B redeemable convertible preferred stock private placement transaction in July 2019 (as amended, the Regeneron Agreement).
Agreement Structure. The Regeneron Agreement has two principal components: (a) a research collaboration component under which the parties will research, develop, and commercialize next-generation engineered gamma delta immune cell therapeutics (ICPs), namely engineered gamma delta immune cells with chimeric antigen receptors (CARs) and T-cell receptors (TCRs) directed to disease-specific cell surface antigens, which includes the grant of certain licenses to intellectual property between the two parties, and (b) for a certain period following the effective date, a license to the Company to use certain of Regenerons proprietary mice to develop and commercialize ICPs generated by the Company, with certain limitations relating to targets under the Regeneron Agreement.
Research Collaboration. Research activities under the collaboration are governed by research plans, which include the strategy, goals, activities, and responsibilities of the parties with respect to a target. The Company is primarily responsible for generating, validating, and optimizing ICPs, developing processes for manufacture of ICPs, and certain preclinical and clinical manufacturing activities for ICPs; Regenerons key responsibility is generating, validating, and optimizing CARs and TCRs that bind to the applicable target. The parties have formed a joint research committee to monitor and govern the research and development efforts during the research program term.
Rights to Research Targets. Under the terms of the five-year research collaboration, the parties will conduct research on mutually agreed upon targets. Regeneron may obtain exclusive rights for the targets that it chooses in accordance with the target selection mechanism set forth in the Regeneron Agreement, and the Company similarly may obtain exclusive rights for targets it chooses in accordance with such target selection mechanism. The Company has the right to develop and commercialize ICPs to the first collaboration target to come out of the research program. In connection with an IND submission, Regeneron has an option to exercise exclusive rights for ADI-002 and potentially for additional targets to be mutually agreed upon. For those targets it does not have an option to license, Regeneron has a right of first negotiation for up to two targets. Regeneron has the right to terminate the research program in its entirety (a) for convenience on six months prior written notice given at any time after December 31, 2019, or (b) following a change of control (as defined in the Regeneron Agreement) of the Company. The parties mutually agreed to their first product declaration criteria for collaboration ICP, CD20, in 2018.
Rights to Company-Developed Targets. Regeneron has an exclusive license to use targeting moieties generated by the Company by its use of Regenerons proprietary mice to develop and commercialize non-ICPs.
Exclusivity. During the five-year target selection period, the Company may not directly or indirectly research, develop, manufacture or commercialize an ICP, or grant a license to do the foregoing, except pursuant to the agreement. For so long as either party is researching or developing an ICP to a target under the research program, neither party may research, develop, manufacture or commercialize any other ICP to such target, or grant a license to do the foregoing. And for so long as a party is researching, developing or commercializing an ICP to target that is licensed to it (and royalty bearing) under the agreement, neither party may research, develop, manufacture or commercialize any other ICP to such target, or grant a license to permit another party to do the foregoing. These exclusivity obligations are limited to engineered gamma delta immune cells to targets
F2-22
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
reasonably considered to have therapeutic relevance in oncology. The Regeneron Agreement includes certain exceptions to the exclusivity obligations of the parties, including with respect to targets that are rejected by one party in the target selection process, as well as protections in the event of a change of control of a party where the acquirer has a competing program.
Co-Funding and Profit Sharing. The Company has an option to co-fund specified portions of the future development costs for, and to co-promote, ICPs to a target for which Regeneron has exercised an option, and to participate in the profits for such target. The Company has the right to exercise this right in various geographic regions, including on a worldwide basis. In the event the Company exercises such right, the parties will share further development costs and revenues proportionally to their co-funding percentages.
Financial Terms. The Company received a non-refundable upfront payment of $25.0 million from Regeneron upon execution of the Regeneron Agreement, has received an aggregate of $10.0 million of additional payments for research funding from Regeneron as of December 31, 2019. In addition, Regeneron may have to pay the Company additional amounts in the future consisting of up to an aggregate of $100.0 million of option exercise fees, as specified in the Regeneron Agreement. Regeneron must also pay the Company high single digit royalties as a percentage of net sales for ICPs to targets for which it has exclusive rights, and low single digit royalties as a percentage of net sales on any non-ICP product comprising a targeting moiety generated by the Company through the use of Regenerons proprietary mice. The Company must pay Regeneron mid-single to low double digit, but less than teens, of royalties as a percentage of net sales of ICPs to targets for which the Company has exercised exclusive rights, and low to mid-single digit of royalties as a percentage of net sales of targeting moieties generated from the Companys license to use Regenerons proprietary mice. Royalties are payable until the longer of the expiration or invalidity of the licensed patent rights or twelve (12) years from first commercial sale.
Other Terms. The Regeneron Agreement contains customary representations, warranties and covenants by the Company and Regeneron and includes (i) an obligation of the Company to use commercially reasonable efforts to develop and commercialize at least one product based on a collaboration ICP that is not an optioned collaboration ICP for each collaboration target and (ii) an obligation of Regeneron to use commercially reasonable efforts to develop and commercialize at least one product based on an optioned collaboration ICP for each collaboration target. The Company and Regeneron are required to indemnify the other party against all losses and expenses related to breaches of its representations, warranties and covenants under the Regeneron Agreement.
Term and Termination. The term of the Regeneron Agreement expires, on a product by product basis, on the expiration of the obligation to pay royalties for such product. The Regeneron Agreement is subject to early termination by either party upon uncured material breach by the other party. The licenses to develop and commercialize an ICP to a target that one party has exclusively licensed may be terminated by such party for convenience.
Equity Investments. In connection with its collaboration, Regeneron and the Company entered into a side letter pursuant to which, among other matters, Regeneron was granted certain stockholder rights and investment rights in connection with the Companys next equity financing that met certain criteria and in connection with an initial public offering by the Company. Regeneron exercised its investment right and purchased approximately $10.0 million of the Companys Series B redeemable convertible preferred stock in a private placement transaction in July 2019. The remaining obligations under the side letter agreement will terminate immediately prior to the effective time of the resTORbio Merger (as defined in Note 20).
F2-23
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
Revenue Recognition
The Company identified the following material promises under the Regeneron Agreement: (1) a research license, (2) a collaboration invention license, (3) a trademark license, (4) research and development services during the research term, (5) manufacturing services to manufacture collaboration ICPs for the research programs, (6) participation in the joint research committee, and (7) information sharing during the research term. The Company considered that the licenses granted under the Regeneron Agreement are not capable of being distinct and are not distinct from the research and development and manufacturing services within the context of the Regeneron Agreement, because 1) such licenses are for the research and development effort during the research term, unless Regeneron exercises its option under the Regeneron Agreement, 2) the research and development services significantly increase the utility of such licenses, and 3) research and development services require collaboration ICPs being manufactured. Specifically, the Companys granted licenses can only provide benefit to Regeneron in combination with the Companys research and development and manufacturing services to discover the collaboration ICPs. Similarly, the participation in the joint research committee and information sharing are not capable of being distinct and are not distinct from the research and development and manufacturing services within the context of the agreement, because the participation in the joint research committee is for monitoring and governing of the research and development efforts and the information sharing is for sharing results of such research and development efforts. Therefore, all of the promises above are combined into a single performance obligation.
The Company also evaluated whether the option provided to Regeneron represents a material right that would require separate deferral and recognition. The option exercise will provide Regeneron with a development and commercial license to develop and commercialize the optioned collaboration ICPs. The Company concluded that the $25.0 million upfront payment to the Company was not negotiated to provide incremental discount for the future option fees payable upon Regenerons exercise of the option.
Regeneron could decide not to exercise the option at its own discretion. The exercise of the option by Regeneron is not certain and is dependent on many factors, such as progress made on the specific option-eligible collaboration ICP, Regenerons overall assessment of commercial feasibility of the further research, development and commercialization of the Option products, availability and cost of alternative programs and products. The option provides Regeneron with a license for intellectual property that will be improved from the inception of the Regeneron Agreement. In addition, the option fee is significant compared to the sum total of the upfront payment and research funding fees in the original Regeneron Agreement. Therefore, the Company determined that the option provided to Regeneron does not represent a material right and that any potential exercise of the option should be accounted as a separate contract. Hence, upon the option exercise by Regeneron the option fee would be allocated to the development and commercial license which would be the only performance obligation in that separate contract, and recognized as revenue when control of the license rights is transferred to Regeneron.
As of December 31, 2019, it is not probable that the Company will exercise its co-funding option for the optioned collaboration ICPs. If, as a result of changes in facts and circumstances, it becomes probable that the Company will exercise its co-funding option for an optioned collaboration ICP, then the Company will reassess the accounting of the option fees for such optioned collaboration ICP, including if nature of its relationship with Regeneron has changed from customer-vendor to collaboration partners.
For revenue recognition purposes, the Company determined that the duration of the contract is the same as the research term of five (5) years beginning on the execution of the Regeneron Agreement on July 29, 2016. The contract duration is defined as the period during which parties to the contract have present and enforceable rights and obligations. The Company determined that Regeneron faces significant in-substance penalties were it to terminate the Regeneron Agreement prior to the end of the research term.
F2-24
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
In order to determine the transaction price, the Company evaluated all the payments and licenses to be received from Regeneron during the duration of the contract. At contract inception, the Company determined a transaction price of the Regeneron Agreement consisting of the $25.0 million upfront payment and the aggregate research funding fees payable over the research term. Per the terms of the original Regeneron Agreement prior to the amendment effective from July 2019, the research funding fees were payable merely due to passage of time and therefore did not represent a variable consideration. After the amendment became effective in July 2019, certain of these fees became contingent upon the Company meeting certain development and regulatory milestones. Therefore, the Company concluded that after the amendment such potential payments became variable consideration, the receipt of which was subject to substantial uncertainty and therefore excluded from the transaction price upon the effective date of the amendment. As a result, the Company recorded $6.6 million as a reduction to cumulative revenue recognized prior to the amendment effective date. The Company will re-evaluate the transaction price if there is a significant change in facts and circumstances but at least at the end of each reporting period.
The Company also considered the existence of any significant financing component within the Regeneron Agreement given its upfront payment structure. Based upon this assessment, the Company concluded that the up-front payment was provided for valid business reasons and not for the purpose of providing financing. The reason for the initial advance payment at the beginning of the contract is not to provide financing to the Company, but to ensure Regenerons commitment to the contract and to provide assurance that the customer will perform its obligations under the contract. Accordingly, the Company has concluded that the upfront payment structure of the Regeneron Agreement does not result in the existence of a significant financing component.
The royalty payments will be recognized when the related sales occur as they were determined to relate predominantly to the intellectual property licenses granted to Regeneron and therefore have also been excluded from the transaction price.
The Company has determined that the combined performance obligation is satisfied over time. ASC 606 requires the Company to select a single revenue recognition method for the performance obligation that depicts the Companys performance in transferring control of the services. Accordingly, the Company utilizes a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. The Company believes this is the best measure of progress because it reflects how the Company transfers its performance obligation to Regeneron. In applying the cost-based input method of revenue recognition, the Company uses actual costs incurred relative to budgeted costs to fulfill the combined performance obligation. These costs consist primarily of internal full-time equivalent effort and third-party contract costs. Revenue is recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completes its performance obligations over the research term of five years. A cost-based input method of revenue recognition requires management to make estimates of costs to complete the Companys performance obligations. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete the Companys performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. A significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods.
For the years ended December 31, 2019 and 2018, the Company recognized $1.0 million and $8.2 million of license and collaboration revenue representing revenue recognized under the Regeneron Agreement based on proportional performance.
F2-25
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
The following table presents changes in the Companys contract liabilities (in thousands):
Year ended December 31, 2019 |
Balance at beginning of period |
Additions | Deductions(1) | Balance at end of period |
||||||||||||
Contract liability |
$ | 22,878 | $ | | $ | (995) | $ | 21,883 | ||||||||
Year ended December 31, 2018 |
Balance at beginning of period |
Additions | Deductions | Balance at end of period |
||||||||||||
Contract liability |
$ | 26,059 | $ | 5,000 | $ | (8,181 | ) | $ | 22,878 |
(1) | Deductions to contract liabilities relate to deferred revenue recognized as revenue during the reporting period. |
Contract liabilities related to the Regeneron Agreement of $21.9 million and $22.9 million as of December 31, 2019 and 2018, respectively, which was comprised of the $25.0 million upfront payment and additional $5.0 million research funding fees in each of 2017 and 2018, less $13.1 million and $12.1 million of license and collaboration revenue recognized from the inception of the Regeneron Agreement as of December 31, 2019 and 2018, respectively, will be recognized as the combined performance obligation is satisfied.
During the years ended December 31, 2019 and 2018, the Company recognized $1.0 million and $8.2 million of license and collaboration revenue, respectively, from amounts included in the contract liability balances at the beginning of the period. There were no costs to obtain or fulfill the contract that meet the criteria to be capitalized.
9. Commitments and Contingencies
Operating Leases
On September 30, 2015, the Company entered into a lease agreement (the Menlo Park Lease) to lease approximately 17,352 square feet of office and laboratory space located in Menlo Park, California for its corporate headquarters. The total base lease payments over the life of the lease is $3.4 million, offset by $0.8 million in tenant improvement allowance. The lease expires on March 31, 2022.
The landlord maintains responsibility for maintenance and risk of loss throughout the term of the lease agreement. The lease is recorded as an operating lease.
On September 30, 2019, the Company entered into an amendment to the Menlo Park lease agreement for the office and laboratory space in Menlo Park to lease from the same landlord an additional nearby building with approximately 7,973 square feet of office and laboratory space. The lease commenced on October 1, 2019 and expires on March 31, 2021. The Company has an option to extend the lease term for one year commencing from April 1, 2021. The total base lease payments over the life of the lease is $0.4 million excluding payments for extended lease period.
In 2014, the Company signed an extension agreement to lease approximately 3,230 square feet of office and laboratory space located in Haifa, Israel. The term of the lease was 5 years commencing on January 1, 2014. The total lease payments over the life of the lease was $0.2 million. Subsequently, in June 2018, the Company signed an extension agreement No. 2 for a term of one year commencing on January 1, 2019 with an annual option to extend the term for an additional year up to four years. The lease was terminated on December 31, 2019.
In October 28, 2018, the Company entered into a new lease agreement to lease approximately 50,305 square feet of office and laboratory space located in Redwood City, California for its new corporate headquarters. The total base lease payments over the life of the lease is $29.5 million, offset by $3.0 million in tenant improvement allowance. The lease has not commenced as the office and laboratory space is not available for use by the Company. The lease expires on February 28, 2030.
F2-26
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
The Company recognizes rent expense on a straight-line basis over the lease period. Rent expense recognized under all leases was $0.7 million and $0.5 million for the years ended December 31, 2019 and 2018, respectively.
The future minimum lease payments under all non-cancelable operating lease obligations as of December 31, 2019 were as follows (in thousands):
2020 |
$ | 2,721 | ||
2021 |
3,518 | |||
2022 |
2,942 | |||
2023 |
2,798 | |||
2024 |
2,882 | |||
2025 and thereafter |
16,328 | |||
|
|
|||
Total |
$ | 31,189 | ||
|
|
In conjunction with the Menlo Park lease agreement, the Company issued a cash-collateralized letter of credit in lieu of security deposit of $0.2 million, which cash-collateral is included in restricted cash on the consolidated balance sheets as of December 31, 2019 and 2018. In addition, a cash-collateralized letter of credit for $4.1 million was issued in 2018 for the new office lease in Redwood City and the cash-collateral is also included in the restricted cash balance as of December 31, 2019 and 2018. As of December 31, 2019 and 2018, the restricted cash balances were classified as long-term assets due to the contractual terms of both lease agreements in relation to which the letters of credit were issued exceeding twelve months as of the reporting dates.
Indemnification Agreements
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. The Company currently has directors and officers liability insurance.
Legal Proceedings
The Company is subject to claims and assessments from time to time in the ordinary course of business but is not aware of any such matters, individually or in the aggregate, that could have a material adverse effect on the Companys financial position, results of operations or cash flows.
10. Redeemable Convertible Preferred Stock
Under the Companys Certificate of Incorporation, as amended, the Companys redeemable convertible preferred stock is issuable in series. The Companys Board of Directors is authorized to determine the rights, preferences and terms of each series.
F2-27
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
As of December 31, 2019, redeemable convertible preferred stock consists of the following (in thousands, except per share and share amounts):
Shares Authorized |
Original Issue Price |
Shares Issued and Outstanding |
Carrying Value |
Liquidation Preference |
||||||||||||||||
Series A |
37,104,185 | $ | 1.20 | 37,104,185 | $ | 35,960 | $ | 44,525 | ||||||||||||
Series A-1 |
629,633 | 1.20 | 629,633 | 447 | 756 | |||||||||||||||
Series A-2 |
2,428,688 | 1.20 | 2,428,688 | 1,749 | 2,914 | |||||||||||||||
Series B |
59,200,938 | 1.4034 | 57,004,415 | 75,927 | 80,000 | |||||||||||||||
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99,363,444 | 97,166,921 | $114,083 | $128,195 | |||||||||||||||||
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As of December 31, 2018, redeemable convertible preferred stock consists of the following (in thousands, except per share and share amounts):
Shares Authorized |
Original Issue Price |
Shares Issued and Outstanding |
Carrying Value |
Liquidation Preference |
||||||||||||||||
Series A |
43,031,023 | $ | 1.20 | 37,036,529 | $ | 35,872 | $ | 44,444 | ||||||||||||
Series A-1 |
629,633 | 1.20 | 629,633 | 447 | 756 | |||||||||||||||
Series A-2 |
2,428,688 | 1.20 | 2,428,688 | 1,749 | 2,914 | |||||||||||||||
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|||||||||||||
46,089,344 | 40,094,850 | $38,068 | $48,114 | |||||||||||||||||
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The original issuance price in the tables above reflect the stated issuance price per the respective purchase agreements.
Series A Redeemable Convertible Preferred Stock
In August 2015, the Company entered into a Series A redeemable convertible preferred stock purchase agreement (the Purchase Agreement) with OrbiMed Private Investments V, LP, a related party (the Investor) to issue and sell 12,187,500 shares of Series A redeemable convertible preferred stock at $1.20 per share (the Series A Purchase Price) for total gross proceeds of $14.6 million.
The Purchase Agreement also provided for the issuance and sale to the Investor of an additional 12,812,500 shares of Series A redeemable convertible preferred stock at the Series A Purchase Price upon achieving certain milestone conditions (the Milestone Closing). Further, from and after the occurrence of the Milestone Closing, at any time prior to the earliest to occur of (A) the two year anniversary of the Milestone Closing, (B) a liquidation or deemed liquidation, and (C) an initial public offering (IPO), the Investor had an option to purchase up to an additional 8,333,334 Series A Shares at the Series A Purchase Price (the Additional Closing).
The issuance of Series A redeemable convertible preferred stock was recorded at the amount of proceeds received less issuance costs and the amounts allocated to the Milestone Closing liability and Additional Closing liability (together the redeemable convertible preferred stock tranche liability) (see Note 11).
In January 2016, the Company entered into an amended Purchase Agreement (the Amended Purchase Agreement) with certain purchasers, including the Investor, to issue and sell an additional 9,015,425 shares of Series A redeemable convertible preferred stock at the Series A Purchase Price for total gross proceeds of $10.8 million. The Amended Purchase Agreement was entered into in contemplation of an asset acquisition that closed on the same day and as part of the purchase consideration, the Company issued 6,400,879 shares of Series A redeemable convertible preferred stock to former stockholders of the acquiree.
F2-28
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
Per the terms of the Amended Purchase Agreement, the number of Series A redeemable convertible preferred stock shares to be issued and sold at the Milestone Closing and Additional Closing was reduced to 9,020,833 shares and 5,875,000 shares, respectively. In November 2018, on the achievement of certain milestones, the portion of the redeemable convertible preferred stock tranche liability pertaining to the Milestone Closing was exercised and the Company issued 9,020,833 shares of Series A redeemable convertible preferred stock at $1.20 per share for gross proceeds of $10.8 million. In July 2019, as part of the Series B redeemable convertible preferred stock purchase agreement the redeemable convertible preferred stock tranche liability pertaining to the Additional Closing was terminated. The fair value of the related redeemable convertible preferred stock tranche liability as of the cancellation date of $1.1 million was reclassified to the redeemable convertible preferred stock.
The Company also issued 411,892 and 67,656 shares of Series A redeemable convertible preferred stock in connection with an amendment of a license agreement in February 2016 and February 2019, respectively (see Note 12).
In January 2016 and February 2016, the Company issued 629,633 shares of Series A-1 redeemable convertible preferred stock and 2,428,688 shares of Series A-2 redeemable convertible preferred stock as part of the purchase consideration for an asset acquisition, respectively.
The issuances of Series A-1 and A-2 redeemable convertible preferred stock were recorded at their fair values. There were no issuance costs related to the issuances of the Series A redeemable convertible preferred stock in the years ended December 31, 2019 and 2018.
Series B Redeemable Convertible Preferred Stock
In July 2019, the Company issued 37,765,426 shares of Series B redeemable convertible preferred stock at $1.4034 per share for gross proceeds of $53.0 million.
In August 2019, the Company issued 4,987,885 shares of Series B redeemable convertible preferred stock at $1.4034 per share for gross proceeds of $7.0 million.
In September 2019, the Company issued 14,251,104 shares of Series B redeemable convertible preferred stock at $1.4034 per share for gross proceeds of $20.0 million.
In connection with Series B redeemable convertible preferred stock financing transactions, the Company issued to its financial advisor warrants to purchase 1,781,387 shares of Series B redeemable convertible preferred stock at an exercise price of at $1.4034 per share. The issuance of Series B redeemable convertible preferred stock was recorded at the amount of proceeds received less issuance costs and amounts allocated to the redeemable convertible preferred stock warrant liability (see Note 13).
The rights, preferences, privileges and restrictions granted to or imposed on the respective classes of the Companys capital stock or the holders thereof are as follows:
Voting Rights
Each share of redeemable convertible preferred stock has the same voting rights as the number of shares of common stock into which it is convertible and vote together with the holders of common stock as a single class.
The holders of shares of Series A redeemable convertible preferred stock shall be entitled, voting separately as a single class, to elect two directors of the Company (the Series A Directors). The holders of shares of
F2-29
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
redeemable convertible preferred stock shall be entitled, voting separately as a single class on an as-converted basis, to elect two directors of the Company (together with the Series A Directors, the Preferred Directors). The holders of shares of common stock shall be entitled, voting separately as a single class, to elect one director of the Company. The holders of shares of common stock and convertible redeemable preferred stock shall be entitled, voting together, to elect the remaining directors of the Company.
Dividends
Holders of outstanding shares of Series B redeemable convertible preferred stock are entitled to receive dividends, when, as and if declared by the Board of Directors, at the annual rate of $0.1123 per share as adjusted for any stock combination, stock split, stock dividend, recapitalization or other similar transaction (recapitalizations), payable in preference and priority to any declaration or payment of any distribution on Series A redeemable convertible preferred stock, Series A-2 redeemable convertible preferred stock, Series A-1 redeemable convertible preferred stock or common stock of the Company in such calendar year.
The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company in any fiscal year unless the holders of the Series B redeemable convertible preferred stock then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share of Series B redeemable convertible preferred stock in an amount at least equal to all declared but unpaid dividends with respect to all outstanding shares of Series B redeemable convertible preferred stock and the amount of the dividends then accrued on such share of Series B redeemable convertible preferred stock with respect to such fiscal year.
After payment of the full amount of any dividends payable described above, the holders of shares of Series A redeemable convertible preferred stock are entitled to receive dividends, when, as and if declared by the Board of Directors, at the annual rate of $0.096 per share as adjusted for any recapitalizations, payable in preference and priority to any declaration or payment of any distribution on Series A-2 redeemable convertible preferred stock, Series A-1 redeemable convertible preferred stock or common stock of the Company in such calendar year.
The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company in any fiscal year unless the holders of the Series A redeemable convertible preferred stock then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share of Series A redeemable convertible preferred stock in an amount at least equal to all declared but unpaid dividends with respect to all outstanding shares of Series A redeemable convertible preferred stock and the amount of the dividends then accrued on such share of Series A redeemable convertible preferred stock with respect to such fiscal year.
After payment of the full amount of any dividends payable described above, the holders of shares of Series A-2 redeemable convertible preferred stock are entitled to receive dividends, when, as and if declared by the Board of Directors, at the annual rate of $0.096 per share adjusted for any recapitalizations, payable in preference and priority to any declaration or payment of any distribution on Series A-1 redeemable convertible preferred stock or common stock of the Company in such calendar year.
The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company (other than dividends on shares of the Series B redeemable convertible preferred stock and Series A redeemable convertible preferred stock as indicated above) in any fiscal year unless the holders of the Series A-2 redeemable convertible preferred stock then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share of Series A-2 redeemable convertible preferred
F2-30
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
stock in an amount at least equal to all declared but unpaid dividends with respect to all outstanding shares of Series A-2 redeemable convertible preferred stock and the amount of the dividends then accrued on such share of Series A-2 redeemable convertible preferred stock with respect to such fiscal year.
After payment of the full amount of any dividends pursuant to the paragraphs above, any additional dividends shall be distributed among all holders of common stock and all holders of redeemable convertible preferred stock in proportion to the number of shares of common stock which would be held by each such holder if all shares of each such series of redeemable convertible preferred stock were converted to common stock at the then effective conversion rate.
Dividends are noncumulative, and none were declared as of December 31, 2019.
Liquidation
In the event of any liquidation, dissolution or winding up of the Company, or deemed liquidation event, either voluntary or involuntary (Liquidation), the holders of Series B redeemable convertible preferred stock shall be entitled to receive, prior and in preference to any distribution of any of the assets of the Company to the holders of any other series of redeemable convertible preferred stock or common stock an amount per share equal to the greater of (i) the sum of $1.4034, adjusted for any recapitalizations for each outstanding share of Series B redeemable convertible preferred stock and an amount equal to all declared but unpaid dividends on such share and (ii) such amount per share as would have been payable had all shares of Series B redeemable convertible preferred stock been converted into common stock pursuant to the conversion right immediately prior to such Liquidation (see below for the conversion rights).
After full payment to the holders of Series B redeemable convertible preferred stock, the holders of Series A redeemable convertible preferred stock shall be entitled to receive, prior and in preference to any distribution from the assets of the Company to the holders of Series A-2 and A-1 redeemable convertible preferred stock or common stock an amount per share equal to the greater of (i) the sum of $1.20, adjusted for any recapitalizations, for each outstanding share of Series A redeemable convertible preferred stock and an amount equal to all declared but unpaid dividends on such share and (ii) such amount per share as would have been payable had all shares of Series A redeemable convertible preferred stock been converted into common stock pursuant to the conversion right immediately prior to such Liquidation (see below for the conversion rights).
After full payment to holders of Series B and A redeemable convertible preferred stock, the holders of Series A-2 redeemable convertible preferred stock shall be entitled to receive, prior and in preference to any distribution of any of the assets of the Company to the holders of Series A-1 redeemable convertible preferred stock or common stock an amount per share equal to the greater of (i) the sum of $1.20, adjusted for any recapitalizations, for each outstanding share of Series A-2 redeemable convertible preferred stock and an amount equal to all declared but unpaid dividends on such share and (ii) such amount per share as would have been payable had all shares of Series A-2 redeemable convertible preferred stock been converted into common stock pursuant to the conversion right immediately prior to such Liquidation (see below for the conversion rights).
After full payment to holders of the Series B, A and A-2 redeemable convertible preferred stock, the holders of Series A-1 redeemable convertible preferred stock shall be entitled to receive, prior and in preference to any distribution of any of the assets of the Company to the holders of common stock an amount per share equal to the greater of (i) the sum of $1.20, adjusted for any recapitalizations, for each outstanding share of Series A-1 redeemable convertible preferred stock and an amount equal to all declared but unpaid dividends on such share and (ii) such amount per share as would have been payable had all shares of Series A-1 redeemable convertible preferred stock been converted into common stock pursuant to the conversion right immediately prior to such Liquidation (see below for the conversion rights).
F2-31
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
After the payment to the holders of redeemable convertible preferred stock of the full preferential amounts specified above, all of the remaining assets of the Company available for distribution to stockholders shall be distributed among the holders of common stock pro rata based on the number of shares of common stock held by each such holder.
Conversion
Each share of redeemable convertible preferred stock is convertible, at the option of the holder, into the number of fully-paid and non-assessable shares of common stock that result from dividing the applicable original issue price per share by the applicable conversion price per share at the time of conversion, as adjusted for recapitalizations. If, after the issuance date of the Series B redeemable convertible preferred stock, the Company issues or sells, or is deemed to have sold, additional shares of common stock without consideration or for a consideration per share less than the conversion price for a particular series of preferred stock (other than the Series A-1 redeemable convertible preferred stock) in effect immediately prior to the issuance of such additional shares of common stock, except for certain exceptions allowed, the conversion price of the redeemable convertible preferred stock would be adjusted. As of December 31, 2019, each series of the Companys redeemable convertible preferred stock was convertible into the Companys shares of common stock on a one-for-one basis.
Each share of redeemable convertible preferred stock is convertible into common stock automatically immediately upon the earlier of (i) the Companys sale of its common stock in a firm commitment underwritten public offering pursuant to a registration statement under the Securities Act, the public offering price of which is not less than $2.40 per share, as adjusted for recapitalizations and which results in proceeds to the Company of at least $50 million in the aggregate (before deduction of underwriting discounts and commissions) (a Qualified IPO) or (ii) the Companys receipt of a written request for such conversion from the holders of the majority of the then outstanding shares of redeemable convertible preferred stock on an as-converted to common stock basis; provided, however, that in respect of (ii), the vote or written consent of the vote or written consent of the holders of a majority of the Series B redeemable convertible preferred stock, voting together as a single class on an as-converted basis shall also be required to effect such conversion solely in the event such conversion both: (A) is being effected in connection with a specific proposed Liquidation changing the allocation of proceeds distributable to the Companys stockholders in such Liquidation and (B) would result in a holder of Series B redeemable convertible preferred stock receiving less in distributions from such transaction for a share of Series B redeemable convertible preferred stock in such Liquidation than such holder would have received if such conversion was not effected and the proceeds were distributed for such share in such Liquidation in accordance with liquidation preferences described above.
Redemption and Balance Sheet Classification
The redeemable convertible preferred stock is recorded within mezzanine equity because while it is not mandatorily redeemable, it will become redeemable at the option of the stockholders upon the occurrence of certain deemed liquidation events that are considered not solely within the Companys control.
11. Redeemable Convertible Preferred Stock Tranche Liability
The Company determined that the obligations to issue additional shares of Series A redeemable convertible preferred stock at the Milestone Closing and Additional Closing were freestanding instruments that are required to be accounted as a liability initially recorded and subsequently remeasured at fair value until such instruments are exercised or expire. The Milestone Closing liability and Additional Closing liability were initially recorded at $6.2 million and $5.0 million, respectively.
F2-32
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
The Milestone Closing liability was settled in November 2018 upon the Milestone Closing and the related TRDF liability was settled in March 2019 (see Note 12). In July 2019, as part of the Series B redeemable convertible preferred stock purchase agreement the Additional Closing liability and the related TRDF liability were terminated. The Company recorded $2.0 million gain and $4.5 million gain from the remeasurement of the redeemable convertible preferred stock tranche liability in other income, net in its consolidated statements of operations and comprehensive loss during the years ended December 31, 2019 and 2018, respectively.
The Milestone Closing liability and Additional Closing liability were valued using the Black-Scholes option-pricing method which considered as inputs (a) the estimated fair value of the Series A redeemable convertible preferred stock (b) estimated price volatility of the underlying preferred stock, (c) the expected term of the tranche, (d) the risk-free interest rate and (e) expected dividends are assumed to be zero as dividends have never paid and there are no current plans to pay dividends on preferred stock.
The Milestone Closing liability and Additional Closing liabilities were valued using the following assumptions under the option-pricing method:
Milestone Closing liability | Fair Value of Series A Preferred Stock |
Term | Interest rate |
Volatility | ||||||||||||
August 14, 2015 (upon issuance) |
$ | 1.00 | 3.25 years | 1.10 | % | 78.2 | % | |||||||||
December 31, 2017 |
$ | 1.42 | 0.88 years | 1.72 | % | 69.5 | % | |||||||||
November 27, 2018 |
$ | 1.30 | 0 years | N/A | N/A | |||||||||||
Additional Closing liability | Fair Value of Series A Preferred Stock |
Term | Interest rate |
Volatility | ||||||||||||
August 14, 2015 (upon issuance) |
$ | 1.00 | 5.25 years | 1.70 | % | 75.7 | % | |||||||||
December 31, 2017 |
$ | 1.42 | 2.88 years | 1.99 | % | 73.2 | % | |||||||||
December 31, 2018 |
$ | 1.30 | 1.88 years | 2.50 | % | 69.8 | % | |||||||||
July 25, 2019 |
$ | 0.89 | 1.31 years | 1.95 | % | 69.1 | % |
12. TRDF Liability
In connection with an asset acquisition in 2016, the Company had an obligation upon the Milestone Closing and Additional Closings (see Note 10) to issue to Technion Research and Development Foundation Ltd. (TRDF) 67,656 and 51,838 shares of Series A redeemable convertible preferred stock issued in such closings, respectively, for no consideration. The TRDF Liability is reported as a part of redeemable convertible preferred stock tranche liability in the consolidated balance sheets. The Company determined the fair value of the TRDF Liability based on the estimated fair value of its Series A redeemable convertible preferred stock. The Company has determined that the TRDF Liability of $0.1 million as of December 31, 2018 represented a contingent consideration which should be recorded at fair value until settled or expired. In March 2019, the obligation to issue 67,656 shares of Series A redeemable convertible preferred stock to TRDF related to the Milestone Closing was settled for no consideration. In July 2019, as part of the Series B redeemable convertible preferred stock purchase agreement, the obligation to issue 51,838 shares of Series A redeemable preferred stock to TRDF related to the Additional Closing was terminated. The fair value of the TRDF Liability was zero as at the termination.
13. Redeemable Convertible Preferred Stock Warrant Liability
During the period from July 2019 to September 2019, in connection with the issuance of Series B redeemable convertible preferred stock, the Company issued to its financial advisor warrants to purchase 1,781,387 shares of Series B redeemable convertible preferred stock at an exercise price of $1.4034 per share (the Series B Warrants), which were accounted for as Series B redeemable convertible preferred stock issuance costs.
F2-33
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
The Series B Warrants will terminate at the earlier of the seven year anniversary from the issuance date and Liquidation of the Company. These warrants have a net exercise provision under which their holders may, in lieu of payment of the exercise price in cash, surrender the warrant and receive a net amount of shares based on the fair market value of the Companys stock at the time of exercise of the warrants after deduction of the aggregate exercise price. The Series B Warrants contain provisions for adjustment of the exercise price and number of shares issuable upon the exercise of warrants in the event of certain stock dividends, stock splits, reorganizations, reclassifications, and consolidations.
The fair value of the Series B Warrants was recorded on the date of issuance. The Series B Warrants had a fair value of $2.1 million and $1.9 million as of the issuance date and December 31, 2019, respectively. The change in fair value of $0.2 million during the year ended December 31, 2019 was recorded as a component of other income, net in the consolidated statement of operations and comprehensive loss.
The redeemable convertible preferred stock warrant liability was valued using the following assumptions under the Black-Scholes option-pricing model:
Issuance Date | December 31, 2019 |
|||||||
Stock price |
$ | 1.40 | $ | 1.40 | ||||
Expected term (years) |
7.00 | 6.57-6.74 | ||||||
Expected volatility |
104.38%-109.24% | 82.1%-93.3% | ||||||
Risk-free interest rate |
1.54%-1.95% | 1.53%-1.93% | ||||||
Dividend yield |
0% | 0% |
14. Common Stock
The Companys Certificate of Incorporation, as amended, authorizes the Company to issue 140,200,938 shares of $0.0001 par value common stock as of December 31, 2019.
Common stockholders are entitled to dividends if and when declared by the Board of Directors subject to the prior rights of the preferred stockholders. As of December 31, 2019 and 2018, no dividends on common stock had been declared by the Board of Directors.
The Company has the following shares of common stock reserved for future issuance:
December 31 | ||||||||
2019 | 2018 | |||||||
Conversion of redeemable convertible preferred stock |
97,166,921 | 40,094,850 | ||||||
Conversion of additional authorized and unissued redeemable convertible preferred stock |
415,136 | | ||||||
Stock options available for future grant |
5,267,201 | 6,596,705 | ||||||
Stock options issued and outstanding |
15,005,410 | 7,230,538 | ||||||
Redeemable convertible preferred stock warrants issued and outstanding |
1,781,387 | | ||||||
Redeemable convertible preferred stock tranche liability |
| 5,875,000 | ||||||
TRDF liability |
| 119,494 | ||||||
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Total common stock reserved |
119,636,055 | 59,916,587 | ||||||
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F2-34
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
15. Stock-Based Compensation
In 2015, the Company adopted the 2015 Stock Incentive Plan (2015 Plan), under which the Board of Directors can issue stock options. As of December 31, 2019 and 2018, there were 21,594,044 and 15,028,041 shares authorized and reserved for issuance under the 2015 plan. Shares available for future grants as of December 31, 2019 and 2018 were 5,267,201 and 6,596,705, respectively.
Under the 2015 Plan, the Board of Directors is authorized to issue incentive stock options (ISOs) and non-qualified stock options (NSOs). ISOs may be granted only to employees and directors of the Board, and NSO may be granted to employees, directors and to consultants. The Board of Directors has the authority to determine to whom options will be granted, the number of shares, the term, and the exercise price, which cannot be less than the fair market value at the date of grant for incentive stock options. Stock options generally include a one-year cliff vest of 25% of the respective award, followed by monthly vesting in equal installments over the next 36 months, and grants that vest monthly over 48 months. All grants expire no later than ten years from the date of grant.
Options
A summary of stock option activity is set forth below (in thousands, except share and per share data):
Outstanding Awards | ||||||||||||||||||||
Number of Shares Available for Grant |
Number of Shares Underlying Outstanding Options |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term (in years) |
Aggregate Intrinsic Value |
||||||||||||||||
Outstanding, January 1, 2018 |
306,782 | 7,770,149 | $ | 0.25 | 9.27 | $ | 4,977 | |||||||||||||
Options authorized |
6,750,000 | |||||||||||||||||||
Options granted |
(1,697,200 | ) | 1,697,200 | $ | 0.28 | |||||||||||||||
Options exercised |
| (999,688 | ) | $ | 0.24 | |||||||||||||||
Options forfeited or cancelled |
1,237,123 | (1,237,123 | ) | $ | 0.28 | |||||||||||||||
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|||||||||||||||||
Outstanding, December 31, 2018 |
6,596,705 | 7,230,538 | $ | 0.25 | 8.57 | $ | 2,436 | |||||||||||||
|
|
|
|
|||||||||||||||||
Options authorized |
6,566,003 | |||||||||||||||||||
Options granted |
(9,068,002 | ) | 9,068,002 | $ | 0.67 | |||||||||||||||
Options exercised |
| (119,402 | ) | $ | 0.26 | |||||||||||||||
Options forfeited or cancelled |
1,172,495 | (1,173,728 | ) | $ | 0.27 | |||||||||||||||
|
|
|
|
|||||||||||||||||
Outstanding, December 31, 2019 |
5,267,201 | 15,005,410 | $ | 0.50 | 8.53 | $ | 5,812 | |||||||||||||
|
|
|
|
|||||||||||||||||
Shares exercisable December 31, 2019 |
5,414,170 | $ | 0.27 | 6.86 | $ | 3,348 | ||||||||||||||
Vested and expected to vest, December 31, 2019 |
15,005,410 | $ | 0.50 | 8.53 | $ | 5,812 |
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the fair value of the Companys common stock for stock options that were in-the-money at December 31, 2019 and 2018.
The aggregate intrinsic value of stock options exercised during the years ended on December 31, 2019 and 2018 was $0.1 million and $0.4 million, respectively.
The total fair value of options that vested during the years ended December 31, 2019 and 2018 was $0.9 million and $1.8 million, respectively. The options granted during the years ended December 31, 2019 and
F2-35
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
2018 had a weighted- average per share grant-date fair value of $0.37 per share and $0.49 per share, respectively. As of December 31, 2019, the total unrecognized stock-based compensation expense related to unvested stock options was $3.4 million, which is expected to be recognized over the remaining weighted-average vesting period of 3.2 years.
Early Exercise of Stock Options
The terms of 2015 Plan permit the exercise of certain options granted under 2015 Plan prior to vesting, subject to required approvals. The shares are subject to the Companys lapsing repurchase right upon termination of employment at the original purchase price. The proceeds initially are recorded in accrued and other current liabilities from the early exercise of stock options and are reclassified to additional paid-in capital as the Companys repurchase right lapses. During the years ended December 31, 2019 and December 31, 2018, the Company had no repurchases of common stock. As of December 31, 2019, there were no shares subject to repurchase. As of December 31, 2018, there were 223,480 shares that were subject to repurchase. The aggregate exercise prices of early exercised shares as of December 31, 2019 and December 31, 2018 was zero and less than $0.1 million, respectively, which were recorded in accrued and other current liabilities on the consolidated balance sheets.
Restricted Stock
Activity with respect to restricted stock was as follows:
Number of Shares Underlying Outstanding Restricted Stock |
Weighted Average Grant Date Fair Value |
|||||||
Unvested, January 1, 2018 |
1,336,290 | $ | 0.52 | |||||
Vested |
(1,084,812 | ) | $ | 0.52 | ||||
|
|
|||||||
Unvested, December 31, 2018 |
251,478 | $ | 0.52 | |||||
Vested |
(251,478 | ) | $ | 0.52 | ||||
|
|
|||||||
Unvested, December 31, 2019 |
| $ | | |||||
|
|
As of December 31, 2019, there was no unrecognized compensation cost related to restricted stock.
The fair value of restricted stock vested during the years ended December 31, 2019 and 2018 was $0.1 million and $0.6 million, respectively.
Stock-Based Compensation Associated with Awards to Employees and Non-Employees
Total stock-based compensation expense recognized was as follows (in thousands):
Year Ended December 31, |
||||||||
2019 | 2018 | |||||||
Research and development |
$ | 274 | $ | 285 | ||||
General and administrative |
901 | 2,194 | ||||||
|
|
|
|
|||||
Total stock-based compensation |
$ | 1,175 | $ | 2,479 | ||||
|
|
|
|
F2-36
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
The Company estimated the fair value of stock options using the Black Scholes option-pricing model. The fair value of stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value of stock options was estimated using the following weighted-average assumptions:
Year Ended December 31, | ||||
2019 | 2018 | |||
Expected volatility |
71.5%-86.5% | 73.3%-74% | ||
Risk-free interest rate |
1.6%-2.5% | 2.7%-2.8% | ||
Dividend yield |
0% | 0% | ||
Expected term |
5.15-6.08 years | 6.02-6.08 years |
The assumptions are as follows:
| Expected volatility. The expected volatility was determined by examining the historical volatilities for comparable publicly traded companies within the biotechnology and pharmaceutical industry using an average of historical volatilities of the Companys industry peers. |
| Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield with a maturity equal to the expected term of the option in effect at the time of grant. |
| Dividend yield. The expected dividend is assumed to be zero as dividends have never been paid and there are no current plans to pay dividends on common stock. |
| Expected term. The expected term represents the period that the stock-based awards are expected to be outstanding. The expected term is calculated using the simplified method which is used when there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting-tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. |
In addition to the assumptions used in the Black-Scholes option-pricing model, the Company recognizes the actual forfeitures by reducing the employee stock-based compensation expense in the same period the forfeiture occurs.
The Company will continue to use judgment in evaluating the expected volatility, risk-free interest rates, dividend yield and expected term, utilized for stock-based compensation on a prospective basis.
F2-37
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
16. Net Loss Per Share
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders, which excludes unvested restricted shares and shares which are legally outstanding, but subject to repurchase by the Company (in thousands, except share and per share data):
Year ended December 31, | ||||||||
2019 | 2018 | |||||||
Numerator: |
||||||||
Net loss attributable to common stockholders |
$ | (28,138 | ) | $ | (9,299 | ) | ||
|
|
|
|
|||||
Denominator: |
||||||||
Weighted-average shares outstanding |
17,324,999 | 16,529,416 | ||||||
Less: weighted-average unvested restricted shares and shares subject to repurchase |
(75,343 | ) | (828,258 | ) | ||||
|
|
|
|
|||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
17,249,656 | 15,701,158 | ||||||
|
|
|
|
|||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | (1.63 | ) | $ | (0.59 | ) | ||
|
|
|
|
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the period presented because including them would have been antidilutive:
December 31, | ||||||||
2019 | 2018 | |||||||
Redeemable convertible preferred stock |
97,166,921 | 40,094,850 | ||||||
Options to purchase common stock |
15,005,410 | 7,230,538 | ||||||
Redeemable convertible preferred stock warrants |
1,781,387 | | ||||||
Unvested early exercised common stock options |
| 223,480 | ||||||
Unvested restricted stock awards |
| 251,478 | ||||||
Redeemable convertible preferred stock tranche liability and TRDF obligation |
| 5,994,494 | ||||||
|
|
|
|
|||||
Total |
113,953,718 | 53,794,840 | ||||||
|
|
|
|
F2-38
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
17. Income Taxes
The components of the provision (benefit from) for income taxes are as follows (in thousands):
Year Ended December 31, | ||||||||
2019 | 2018 | |||||||
Current: |
||||||||
Federal |
$ | | $ | | ||||
State |
1 | (589 | ) | |||||
Foreign |
18 | | ||||||
|
|
|
|
|||||
Total current |
19 | (589 | ) | |||||
Deferred: |
| | ||||||
Federal |
| | ||||||
State |
| | ||||||
Foreign |
| | ||||||
|
|
|
|
|||||
Total deferred |
| | ||||||
|
|
|
|
|||||
Provision for (benefit from) income taxes |
$ | 19 | $ | (589 | ) | |||
|
|
|
|
The provision for income taxes differs from the amount expected by applying the federal statutory rate to the loss before taxes as follows:
Year Ended December 31, | ||||||||
2019 | 2018 | |||||||
Federal statutory income tax rate |
21.0 | % | 21.0 | % | ||||
Other permanent differences |
(0.1 | )% | (0.1 | )% | ||||
State income taxes |
5.1 | % | 3.8 | % | ||||
Foreign rate differential |
0.0 | % | 0.2 | % | ||||
Foreign loss |
(0.2 | )% | (2.2 | )% | ||||
Change in valuation allowance |
(27.7 | )% | (20.0 | )% | ||||
Change in fair value of redeemable convertible preferred stock tranche liability and TRDF liability |
1.7 | % | 8.7 | % | ||||
Stock-based compensation |
0.1 | % | (6.0 | )% | ||||
|
|
|
|
|||||
Provision for income taxes |
(0.1 | )% | 5.4 | % | ||||
|
|
|
|
On December 22, 2017, the Tax Cuts and Jobs Act (Tax Act) was signed into law making significant changes to the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 35% to 21% effective for tax years beginning after December 31, 2017, the transition of U.S international taxation from a worldwide tax system to a territorial system, and a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings. In the fourth quarter of 2018, the Company completed its analysis to determine the effect of the Tax Act and no material adjustments were recognized as of December 31, 2018.
F2-39
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
The tax effects of temporary differences and carryforwards of the deferred tax assets are presented below (in thousands):
December 31, | ||||||||
2019 | 2018 | |||||||
Deferred Tax Assets: |
||||||||
Net operating loss carryforwards |
$ | 12,510 | $ | 5,233 | ||||
Deferred revenue |
5,719 | 5,125 | ||||||
Stock-based compensation |
509 | 274 | ||||||
Intangible assets |
609 | 804 | ||||||
Accruals and reserves |
446 | 431 | ||||||
Research and development credit carryforwards |
26 | 26 | ||||||
|
|
|
|
|||||
Gross deferred tax assets |
19,819 | 11,893 | ||||||
Less: Valuation allowance |
(19,815 | ) | (11,739 | ) | ||||
|
|
|
|
|||||
Deferred tax assets, net of valuation allowance |
4 | 154 | ||||||
Deferred tax liabilities: |
||||||||
Fixed assets |
(4 | ) | (154 | ) | ||||
|
|
|
|
|||||
Net deferred tax assets |
$ | | $ | | ||||
|
|
|
|
The Company has established a valuation allowance against its deferred tax assets due to the uncertainty surrounding the realization of such assets.
ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is more likely than not. Realization of the future tax benefits is dependent on the Companys ability to generate sufficient taxable income within the carryforward period. Because of the Companys recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a valuation allowance.
The valuation allowance increased by $8.1 million during 2019 and $1.7 million during 2018.
As of December 31, 2019, the Company had net operating loss carryforwards of $39.0 million, $31.6 million and $15.2 million to reduce future taxable income, if any, for federal, state and foreign income tax purposes, respectively. If not utilized, the state carryforwards will begin to expire in 2035. Federal carryforwards do not expire.
The Company also had California research and development credit carryforwards of less than $0.1 million as of December 31, 2019. The California research credit can be carried forward indefinitely.
Utilization of the net operating loss carryforwards and research and development tax credit carryforwards may be subject to an annual limitation under Section 382 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as
F2-40
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Companys stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. Further, until a study is completed and any limitation is known, no liability related to uncertain tax positions is recorded in the consolidated financial statements. The Company does not expect its unrecognized tax benefit balance to change materially over the next 12 months.
The Company files income tax returns in the U.S. federal jurisdiction, California, New York and Israel. The tax years 2015 to 2019 remains open to U.S. federal and state examination to the extent of the utilization of net operating loss and credit carryovers.
As of December 31, 2019, the Company had unrecognized tax benefits of $0.8 million related to the transfer of certain intellectual property from its Israeli subsidiary.
A reconciliation of the beginning and ending unrecognized tax benefit amount is as follows (in thousands):
Year Ended December 31, | ||||||||
2019 | 2018 | |||||||
Balance at the beginning of the year |
$ | 797 | $ | 866 | ||||
Adjustment based on tax positions related to prior years |
| (69 | ) | |||||
|
|
|
|
|||||
Balance at the end of the year |
$ | 797 | $ | 797 | ||||
|
|
|
|
The Company recognizes interest expense and penalties related to the above unrecognized tax benefits within income tax expense (benefit). Management determined that no accrual for interest and penalties was required as of December 31, 2019.
18. Defined Contribution Plan
The Company maintains a defined contribution plan under Section 401(k) of the Internal Revenue Code covering substantially all full-time U.S. employees. Employee contributions are voluntary and are determined on an individual basis subject to the maximum allowable under federal tax regulations. The Company does not make contributions to the 401(k) plan.
19. Related Party Transaction
As of December 31, 2019 and 2018, Regeneron owned 7,125,552 shares and no shares of the Companys redeemable convertible preferred stock, respectively. Regeneron became a related party in July 2019 as a result of Series B redeemable convertible preferred stock financing. For the year ended December 31, 2019 and 2018, the Company recorded revenue of $1.0 million and $8.2 million, respectively, and as of December 31, 2019, the Company recorded deferred revenue of $21.9 million related to the Regeneron Agreement. See Note 8 for a discussion of the Regeneron Agreement.
20. Subsequent Events
For its consolidated financial statements as of December 31, 2019 and for the year then ended, the Company evaluated subsequent events through June 23, 2020, the date on which those financial statements were issued.
F2-41
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
On April 28, 2020, Adicet entered into a Loan and Security Agreement with Pacific Western Bank for a term loan not exceeding $12.0 million (as amended, referred to as the Loan Agreement) to finance leasehold improvements for its new corporate headquarters in Redwood City, California and other purposes permitted under the Loan Agreement, with an interest rate equal to the greater of 0.25% above the Prime Rate (as defined in the Loan Agreement) or 5.00%. The Loan Agreement granted to Pacific Western Bank a security interest on substantially all of Adicets assets other than intellectual property to secure the performance of Adicets obligations under the Loan Agreement, and contains a variety of affirmative and negative covenants, including required financial reporting, limitations on certain dispositions of assets or distributions, limitations on the incurrence of additional debt or liens and other customary requirements. In connection with the entrance into the Loan Agreement, Adicet issued Pacific Western Bank a warrant to purchase shares of its Series B redeemable convertible preferred stock (described below) at an exercise price of $1.4034 per share (referred to as the Existing PacWest Warrant). The Existing PacWest Warrant is initially exercisable for 42,753 shares of Adicets Series B redeemable convertible preferred stock and shall be exercisable for an additional number of shares of its Series B redeemable convertible preferred stock equal to 1.00% of the aggregate original principal amount of all term loans made pursuant to the Loan Agreement (up to an aggregate maximum of 128,259 shares). To date, no amounts have been drawn under the Loan Agreement.
On April 28, 2020, the Company entered into a definitive merger agreement with resTORbio, Inc. (resTORbio) to create a combined publicly-traded biotechnology company whose anticipated focus will be on the development of the Companys off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications. Under the terms of the merger agreement, the Company will merge with a wholly owned subsidiary of resTORbio in an all-stock transaction (the resTORbio Merger). Under the exchange ratio formula in the merger agreement, immediately following the effective time of the resTORbio Merger, the former security holders of the Company as of immediately prior to the effective time of the resTORbio Merger are expected to own approximately 75% of the outstanding shares of resTORbios common stock on a fully-diluted basis and security holders of resTORbio as of immediately prior to the effective time of the resTORbio Merger are expected to own approximately 25% of the outstanding shares of resTORbio Common Stock on a fully-diluted basis (in each case excluding equity incentives available for grant). The Company has concluded that the transaction represents a business combination pursuant to FASB ASC Topic 805, Business Combinations. Further, the Company was determined to be the accounting acquirer based upon the terms of the resTORbio Merger and other factors including: (i) the Companys security holders will own approximately 75% of the voting rights of the combined company (on a fully-diluted basis excluding equity incentives available for grant); (ii) the Company will designate a majority (five of seven) of the initial members of the board of directors of the combined company; and (iii) the terms of the exchange of equity interests based on the exchange ratio at the announcement of the resTORbio Merger factored in an implied premium to resTORbios stockholders. The composition of senior management of the combined company was determined to be a neutral factor in the accounting acquirer determination, as the combined company will leverage the expertise of the senior management of both companies.
Pursuant to a transition agreement between Anil Singhal, the Companys Chief Executive Officer and President, and the Company, dated April 28, 2020, as amended, Dr. Singhal will transition from his role as Chief Executive Officer and President of the Company prior to the closing of the resTORbio Merger to an advisory role. In accordance with such agreement, Dr. Singhal is entitled to the following, subject to his continued service through the completion of the resTORbio Merger and contingent on completion of the resTORbio Merger and his execution of a release of claims: (1) cash payments of (i) $470,000 within 60 days following the closing of the resTORbio Merger, (ii) an amount equal to his pro-rated bonus for the 2020 calendar year payable within 60 days following the closing of the resTORbio Merger, (iii) $250,000 payable in one lump sum on January 1, 2021 and (iv) $24,000 payable within 60 days following the closing of the resTORbio Merger, (2) 12 months of accelerated vesting of his unvested options to purchase the Companys common stock upon completion of the resTORbio Merger, and (3) a 12-month post-termination exercise period following termination of his independent contractor services agreement,
F2-42
ADICET BIO, Inc.
Notes to Consolidated Financial Statements
dated April 28, 2020 (the ICSA), subject to any earlier expiration of the options to purchase the Companys common stock by their terms. In addition, Dr. Singhal is entitled to reimbursement of up to $15,000 of his reasonable and documented legal expenses incurred in connection with such transition agreement. Pursuant to such agreement, subject to Dr. Singhals continued service through the completion of the resTORbio Merger and contingent on completion of the resTORbio Merger, Dr. Singhals continued service for purposes of vesting of his options to purchase the Companys common stock will continue until the earlier of (i) May 7, 2021 or (ii) termination of the ICSA, provided, however, if the ICSA is terminated early without cause, Dr. Singhal is entitled to accelerated vesting of unvested options that would have vested from the date of such termination through May 7, 2021. In addition, Dr. Singhals existing options acceleration provisions will terminate. Pursuant to the ICSA, Dr. Singhal will provide certain advisory services to the Company for a term of 12 months following the closing of the merger and is entitled to payments of $12,500 per month for such services.
The Company has issued an aggregate of 65,000 stock options to purchase the Companys common stock during the period from January 1, 2020 to May 29, 2020 at an exercise price of $0.74 per share pursuant to the 2015 Plan.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The tax relief measures under the CARES Act for businesses include a five-year net operating loss carryback, suspension of annual deduction limitation of 80% of taxable income from net operating losses generated in a tax year beginning after December 31, 2017, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property. The Company recorded an income tax benefit of $2.7 million during the three months ended March 31, 2020. The income tax benefit during the three months ended March 31, 2020 was generated as a result of the recognition of net operating loss carryback under the CARES Act.
Events Subsequent to Original Issuance of Consolidated Financial Statements (Unaudited)
In connection with the reissuance of the consolidated financial statements, the Company has evaluated subsequent events through August 12, 2020, the date the consolidated financial statements were available to be reissued.
On July 14, 2020, the Companys Board of Directors confirmed that the conditions for Dr. Singhals Second Target Milestone Option (as defined in Dr. Singhals employment agreement with the Company) had been fulfilled as the Company achieved the milestone for the selection of a clinical candidate to the second collaboration target under the Regeneron Agreement. Subject to approval by the Companys Board of Directors, Dr. Singhal is entitled to receive an option to purchase 182,056 shares of Adicet common stock following the closing of the Merger at an exercise price equal to the fair market value of the combined companys common stock on the date of grant.
The Company achieved the milestone for the selection of a clinical candidate to the second collaboration target under the Regeneron Agreement during June 2020 and received a payment of $10 million from Regeneron in July 2020.
In connection with the Merger, a putative class action lawsuit has been filed against resTORbio, its directors, the Company, and Merger Sub by purported resTORbio stockholder Patrick Plumley. The lawsuit generally alleges that the resTORbio proxy statement/prospectus/information statement filed with the SEC on June 23, 2020 misrepresents and/or omits certain purportedly material information relating to financial projections, analysis performed by JMP, past engagements of JMP, and the process leading up to the execution of the Merger Agreement. The lawsuit seeks, among other things: an injunction enjoining consummation of the Merger, costs of the action, including plaintiffs attorneys fees and experts fees, declaratory relief, and any other relief the court may deem just and proper. The Company believes the lawsuit to be without merit and plans to seek dismissal.
F2-43
Exhibit 99.6
ADICET BIO, INC.
INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Condensed Consolidated Financial Statements (Unaudited) |
||||
Condensed Consolidated Balance Sheets as of June 30, 2020 and 2019 |
F3-2 | |||
F3-3 | ||||
F3-4 | ||||
Condensed Consolidated Statements of Cash Flows for the periods ended June 30, 2020 and 2019 |
F3-5 | |||
F3-6 |
F3-1
ADICET BIO, INC.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(unaudited)
June 30, 2020 |
December 31, 2019 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 18,264 | $ | 10,607 | ||||
Short-term marketable debt securities |
34,049 | 51,793 | ||||||
Accounts receivablerelated party |
10,000 | | ||||||
Prepaid expenses and other current assets |
4,683 | 1,786 | ||||||
|
|
|
|
|||||
Total current assets |
66,996 | 64,186 | ||||||
Property and equipment, net |
1,759 | 2,121 | ||||||
Restricted cash |
4,282 | 4,282 | ||||||
Long-term marketable debt securities |
| 10,588 | ||||||
Other non-current assets |
1,459 | 410 | ||||||
|
|
|
|
|||||
Total assets |
$ | 74,496 | $ | 81,587 | ||||
|
|
|
|
|||||
Liabilities, redeemable convertible preferred stock, and stockholders deficit |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,161 | $ | 1,052 | ||||
Contract liabilitiesrelated party, current |
17,955 | 10,993 | ||||||
Accrued and other current liabilities |
6,153 | 2,820 | ||||||
|
|
|
|
|||||
Total current liabilities |
26,269 | 14,865 | ||||||
Contract liabilitiesrelated party, net of current portion |
4,463 | 10,890 | ||||||
Deferred rent, net of current portion |
147 | 234 | ||||||
Redeemable convertible preferred stock warrant liability |
1,968 | 1,881 | ||||||
|
|
|
|
|||||
Total liabilities |
$ | 32,847 | $ | 27,870 | ||||
|
|
|
|
|||||
Commitments and contingencies (Note 11) |
||||||||
Redeemable convertible preferred stock, $0.0001 par value; 99,363,444 shares authorized as of June 30, 2020 and December 31, 2019; 97,166,921 shares issued and outstanding as of June 30, 2020 and December 31, 2019; liquidation preference $128,195 as of June 30, 2020 and December 31, 2019 |
114,083 | 114,083 | ||||||
Stockholders deficit: |
||||||||
Common stock, $0.0001 par value; 140,200,938 shares authorized as of June 30, 2020 and December 31, 2019; 17,569,569 and 17,383,619 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively |
2 | 2 | ||||||
Additional paid-in capital |
9,955 | 9,256 | ||||||
Accumulated deficit |
(82,588 | ) | (69,647 | ) | ||||
Accumulated other comprehensive income |
197 | 23 | ||||||
|
|
|
|
|||||
Total stockholders deficit |
(72,434 | ) | (60,366 | ) | ||||
|
|
|
|
|||||
Total liabilities, redeemable convertible preferred stock, and stockholders deficit |
$ | 74,496 | $ | 81,587 | ||||
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
F3-2
ADICET BIO, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
Six months ended June 30, |
||||||||
2020 | 2019 | |||||||
Revenuerelated party |
$ | 9,465 | $ | 6,073 | ||||
Operating expenses: |
||||||||
Research and development |
15,709 | 10,837 | ||||||
General and administrative |
9,943 | 4,222 | ||||||
|
|
|
|
|||||
Total operating expenses |
25,652 | 15,059 | ||||||
|
|
|
|
|||||
Loss from operations |
(16,187 | ) | (8,986 | ) | ||||
Interest income |
551 | 285 | ||||||
Interest expense |
(34 | ) | | |||||
Other income, net |
50 | 1,920 | ||||||
|
|
|
|
|||||
Loss before income tax benefit |
(15,620 | ) | (6,781 | ) | ||||
Income tax expense (benefit) |
(2,679 | ) | 1 | |||||
|
|
|
|
|||||
Net loss |
(12,941 | ) | (6,782 | ) | ||||
|
|
|
|
|||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | (0.74 | ) | $ | (0.40 | ) | ||
|
|
|
|
|||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
17,502,411 | 17,139,657 | ||||||
|
|
|
|
|||||
Other comprehensive income: |
||||||||
Unrealized gain on marketable debt securities, net of tax |
174 | 16 | ||||||
|
|
|
|
|||||
Total other comprehensive income |
174 | 16 | ||||||
|
|
|
|
|||||
Comprehensive loss |
$ | (12,767 | ) | $ | (6,766 | ) | ||
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
F3-3
ADICET BIO, Inc.
Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders Deficit
(in thousands, except share amounts)
(unaudited)
Redeemable Convertible Preferred Stock |
Common Stock | Additional Paid-In Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Income (Loss) |
Total Stockholders Deficit |
|||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||
Balance at December 31, 2018 |
40,094,850 | $ | 38,068 | 17,264,217 | $ | 2 | $ | 8,004 | $ | (41,509 | ) | $ | (13 | ) | $ | (33,516 | ) | |||||||||||||||||||
Net loss |
| | | | | (6,782 | ) | | (6,782 | ) | ||||||||||||||||||||||||||
Issuance of Series A redeemable convertible preferred stock related to TRDF liability |
67,656 | 88 | | | | | | | ||||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options |
| | 61,159 | | 16 | | | 16 | ||||||||||||||||||||||||||||
Vesting of early exercised stock options |
| | | | 47 | | | 47 | ||||||||||||||||||||||||||||
Stock-based compensation expense |
| | | | 474 | | | 474 | ||||||||||||||||||||||||||||
Other comprehensive income |
| | | | | | 16 | 16 | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Balance at June 30, 2019 |
40,162,506 | $ | 38,156 | 17,325,376 | $ | 2 | $ | 8,541 | $ | (48,291 | ) | $ | 3 | $ | (39,745 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable Convertible Preferred Stock |
Common Stock | Additional Paid-In Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Income |
Total Stockholders Deficit |
|||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||
Balance at December 31, 2019 |
97,166,921 | $ | 114,083 | 17,383,619 | $ | 2 | $ | 9,256 | $ | (69,647 | ) | $ | 23 | $ | (60,366 | ) | ||||||||||||||||||||
Net loss |
| | | | | (12,941 | ) | | (12,941 | ) | ||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options |
| | 185,950 | | 49 | | | 49 | ||||||||||||||||||||||||||||
Stock-based compensation expense |
| | | | 650 | | | 650 | ||||||||||||||||||||||||||||
Other comprehensive income |
| | | | | | 174 | 174 | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Balance at June 30, 2020 |
97,166,921 | 114,083 | 17,569,569 | 2 | 9,955 | (82,588 | ) | 197 | (72,434 | ) | ||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
F3-4
ADICET BIO, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
Six months ended June 30, |
||||||||
2020 | 2019 | |||||||
Cash flows from operating activities |
||||||||
Net loss |
$ | (12,941 | ) | $ | (6,782 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities |
||||||||
Depreciation and amortization expense |
626 | 648 | ||||||
Stock-based compensation expense |
650 | 474 | ||||||
Net amortization of premiums and accretion of discounts on investments |
(29 | ) | (112 | ) | ||||
Change in fair value of redeemable convertible preferred stock tranche liability |
| (1,935 | ) | |||||
Change in fair value of redeemable convertible preferred stock warrant liability |
(57 | ) | | |||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable related party |
(10,000 | ) | | |||||
Prepaid expenses and other current assets |
(2,897 | ) | 781 | |||||
Other non-current assets |
(748 | ) | 18 | |||||
Accounts payable |
1,114 | 561 | ||||||
Contract liabilities related party |
535 | (6,073 | ) | |||||
Deferred rent |
(87 | ) | (83 | ) | ||||
Accrued and other current liabilities |
3,476 | (881 | ) | |||||
|
|
|
|
|||||
Net cash used in operating activities |
(20,358 | ) | (13,384 | ) | ||||
|
|
|
|
|||||
Cash flows from investing activities |
||||||||
Purchases of marketable debt securities |
(5,700 | ) | (2,442 | ) | ||||
Proceeds from maturities of marketable debt securities |
34,235 | 12,750 | ||||||
Purchases of property and equipment |
(412 | ) | (468 | ) | ||||
|
|
|
|
|||||
Net cash provided by investing activities |
28,123 | 9,840 | ||||||
|
|
|
|
|||||
Cash flows from financing activities |
||||||||
Proceeds from exercise of stock options |
49 | 16 | ||||||
Deferred debt issuance costs |
(157 | ) | | |||||
|
|
|
|
|||||
Net cash provided by (used in) financing activities |
(108 | ) | 16 | |||||
|
|
|
|
|||||
Net change in cash, cash equivalents and restricted cash |
7,657 | (3,528 | ) | |||||
Cash, cash equivalents and restricted cash, at the beginning of the period |
14,889 | 13,757 | ||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash, at the end of the period |
$ | 22,546 | $ | 10,229 | ||||
|
|
|
|
|||||
Reconciliation of cash, cash equivalents and restricted cash to condensed consolidated balance sheets: |
||||||||
Cash and cash equivalents |
$ | 18,264 | $ | 5,947 | ||||
Restricted cash |
4,282 | 4,282 | ||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash in condensed consolidated balance sheets |
$ | 22,546 | $ | 10,229 | ||||
|
|
|
|
|||||
Supplemental disclosures of noncash investing and financing activities |
||||||||
Purchases of property and equipment included in accounts payable |
$ | 43 | $ | 93 | ||||
Issuance of redeemable convertible preferred stock warrants in connection with the Loan Agreement |
$ | 144 | $ | | ||||
Exercise of TRDF Liability |
$ | | $ | 88 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
F3-5
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
1. Organization and Nature of the Business
Adicet Bio, Inc. (the Company) is a pre-clinical stage biotechnology company engaged in the design and development of a new generation of allogeneic immunotherapies for cancer and other diseases. The Company was incorporated in November 2014 in Delaware and is headquartered in Menlo Park, California.
Adicet Bio Israel Ltd. (formerly Applied Immune Technologies Ltd.) (Adicet Israel) is a wholly owned subsidiary of the Company and is located in Haifa, Israel. Adicet Israel was founded in 2006 and is a drug development company specializing in T-Cell Receptor-Like (TCRL) antibodies that are targeted to intracellular-derived peptides for a variety of therapeutic and diagnostic applications. During 2019, the Company consolidated its operations, including research and development activities, in the United States and as a result substantially reduced its operations in Israel.
On April 28, 2020, the Company entered into a definitive merger agreement with resTORbio, Inc. (resTORbio) to create a combined publicly-traded biotechnology company whose anticipated focus will be on the development of the Companys off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications (see Note 10).
Liquidity
The Company has incurred significant net operating losses and negative cash flows from operations since inception and had an accumulated deficit of $82.6 million as of June 30, 2020. The Company has historically financed its operations primarily through a collaboration and licensing arrangement, as well as through the private placement of equity securities. To date, none of the Companys product candidates have been approved for sale and therefore the Company has not generated any revenue from product sales. Management expects operating losses and negative cash flows to continue for the foreseeable future, until such time, if ever, that it can generate significant sales of its product candidates currently in development.
Management believes that the Companys cash, cash equivalents and marketable debt securities will not be sufficient for the Company to continue as a going concern for at least one year from the issuance date of these interim condensed consolidated financial statements. The Company believes that this raises substantial doubt about its ability to continue as a going concern. As a result, the Company will be required to raise additional capital, however, there can be no assurance as to whether additional financing will be available on terms acceptable to the Company, if at all. If sufficient funds on acceptable terms are not available when needed, the Company could be required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. Failure to manage discretionary spending or raise additional financing, as needed, may adversely impact the Companys ability to achieve its intended business objectives and have an adverse effect on its results of operations and future prospects.
The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying condensed consolidated financial statements do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.
F3-6
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
2. Summary of Significant Accounting Policies
Basis of Presentation
The unaudited interim condensed consolidated financial statements and related disclosures have been prepared in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP).
Principles of Consolidation
The interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. The U.S. dollar is the functional and reporting currency of the Company and its subsidiary.
Unaudited Interim Financial Information
The accompanying condensed consolidated balance sheet as of June 30, 2020, the condensed consolidated statements of operations and comprehensive loss, the condensed consolidated statements of redeemable convertible preferred stock and stockholders deficit and condensed consolidated statements of cash flows for the six months ended June 30, 2020 and 2019 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Companys financial position as of June 30, 2020 and the results of its operations and its cash flows for the six months ended June 30, 2020 and 2019. The financial data and other information disclosed in these notes related to the six months ended June 30, 2020 and 2019 are also unaudited. The results for the six months ended June 30, 2020 are not necessarily indicative of results to be expected for the year ending December 31, 2020, any other interim periods, or any future year or period. The balance sheet as of December 31, 2019 included herein was derived from the audited consolidated financial statements as of that date. Certain disclosures have been condensed or omitted from the interim condensed consolidated financial statements. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements and related notes.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial statements as well as the reported amounts of revenues and expenses during the reporting period. Such estimates include the valuation of the redeemable convertible preferred stock warrant liability, redeemable convertible preferred stock tranche liability, the Technion Research and Development Foundation liability (TRDF Liability), term loan, deferred tax assets, useful lives of property and equipment, accruals for research and development activities, revenue recognition and stock-based compensation. Actual results could differ from those estimates. The current COVID-19 (coronavirus) pandemic, which is impacting worldwide economic activity, poses risk that the Company or its employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, including due to shutdowns that may be requested or mandated by governmental authorities. The extent to which the coronavirus impacts the Companys operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information that will emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. COVID-19 may impact the timing of regulatory approval of the
F3-7
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
INDs for clinical trials, the enrollment of any clinical trials that are approved, the availability of clinical trial materials and regulatory approval and commercialization of our products. COVID-19 may also impact the Companys ability to access capital, which could negatively impact short-term and long-term liquidity.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the FASB) under its Accounting Standard Codifications (ASC) or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below.
Recently Adopted Accounting Pronouncements
In August 2018, the FASB issued Accounting Standards Update (ASU) No. 2018-13, Fair Value Measurement (Topic 820): Disclosure FrameworkChanges to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements. The new disclosure requirements include disclosure related to changes in unrealized gains or losses included in other comprehensive income (loss) for recurring Level 3 fair value measurements held at the end of each reporting period and the explicit requirement to disclose the range and weighted-average of significant unobservable inputs used for Level 3 fair value measurements. This ASU removes the requirement to disclose: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the policy for timing of transfers between levels; and the valuation processes for Level 3 fair value measurements. For all entities, this ASU is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The Company adopted this ASU effective January 1, 2020. The adoption of this ASU did not have a material effect on the Companys consolidated financial statements and related disclosures.
3. Fair Value Measurements
The Company determines the fair value of financial and non-financial assets and liabilities using the fair value hierarchy which establishes three level of inputs that may be used to measure fair value, as follows:
Level 1Observable inputs, such as quoted prices in active markets for identical assets or liabilities.
Level 2Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3Unobservable inputs which reflect managements best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
F3-8
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
The following tables present information about the Companys financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
June 30, 2020 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: |
||||||||||||||||
Money market funds |
$ | 14,361 | $ | | $ | | $ | 14,361 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Cash equivalents(1) |
14,361 | | | 14,361 | ||||||||||||
Asset-backed securities |
| 18,024 | | 18,024 | ||||||||||||
Corporate debt securities |
| 11,780 | | 11,780 | ||||||||||||
Commercial paper |
| 4,245 | | 4,245 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Marketable debt securities |
| 34,049 | | 34,049 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value of assets |
$ | 14,361 | $ | 34,049 | $ | | $ | 48,410 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities: |
||||||||||||||||
Redeemable convertible preferred stock warrant liability |
$ | | $ | | $ | 1,968 | $ | 1,968 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value of liabilities |
$ | | $ | | $ | 1,968 | $ | 1,968 | ||||||||
|
|
|
|
|
|
|
|
December 31, 2019 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: |
||||||||||||||||
Money market funds |
$ | 7,232 | $ | | $ | | $ | 7,232 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Cash equivalents(1) |
7,232 | | | 7,232 | ||||||||||||
Asset-backed securities |
| 19,598 | | 19,598 | ||||||||||||
Corporate debt securities |
| 19,394 | | 19,394 | ||||||||||||
Commercial paper |
| 17,892 | | 17,892 | ||||||||||||
U.S. Government agency bonds |
| 5,497 | | 5,497 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Marketable debt securities |
| 62,381 | | 62,381 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value of assets |
$ | 7,232 | $ | 62,381 | $ | | $ | 69,613 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities: |
||||||||||||||||
Redeemable convertible preferred stock warrant liability |
$ | | $ | | $ | 1,881 | $ | 1,881 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total fair value of liabilities |
$ | | $ | | $ | 1,881 | $ | 1,881 | ||||||||
|
|
|
|
|
|
|
|
(1) | Included in cash and cash equivalents in the condensed consolidated balance sheets |
F3-9
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
The following tables presents a summary of the changes in the fair value of the Companys Level 3 financial instruments (in thousands):
Redeemable Convertible Preferred Stock Warrant Liability |
||||
Fair Value as of December 31, 2019 |
$ | 1,881 | ||
Recognition of preferred stock warrant liability |
144 | |||
Change in the fair value included in other income, net |
(57 | ) | ||
|
|
|||
Fair Value as of June 30, 2020 |
$ | 1,968 | ||
|
|
Redeemable Convertible Preferred Stock Tranche Liability |
TRDF Liability | |||||||
Fair Value as of December 31, 2018 |
3,113 | 142 | ||||||
Settlement |
| (88 | ) | |||||
Change in the fair value included in other income, net |
(1,918 | ) | (17 | ) | ||||
|
|
|
|
|||||
Fair Value as of June 30, 2019 |
$ | 1,195 | $ | 37 | ||||
|
|
|
|
The fair values of the redeemable convertible preferred stock tranche liability, the TRDF Liability and the redeemable convertible preferred stock warrant liability are based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. In determining the fair values of the redeemable convertible preferred stock tranche liability and the redeemable convertible preferred stock warrants, the Company used the Black-Scholes option-pricing model to estimate the fair value using unobservable inputs including the expected term, expected volatility, risk-free interest rate and dividend yield (see Note 13). The fair value of the redeemable convertible warrant liability was determined based on the fair value of the Companys Series B redeemable convertible preferred stock. The fair value of the TRDF Liability was determined based on fair value of the Companys Series A redeemable convertible preferred stock.
4. Marketable Debt Securities
The following tables summarizes the Companys marketable debt securities (in thousands):
June 30, 2020 | ||||||||||||||||
Amortized Cost | Unrealized Losses | Unrealized Gains | Fair Value | |||||||||||||
Asset-backed securities |
$ | 17,907 | $ | | $ | 117 | $ | 18,024 | ||||||||
Corporate debt securities |
11,721 | | 59 | 11,780 | ||||||||||||
Commercial paper |
4,224 | | 21 | 4,245 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 33,852 | $ | | $ | 197 | $ | 34,049 | ||||||||
|
|
|
|
|
|
|
|
F3-10
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
December 31, 2019 | ||||||||||||||||
Amortized Cost | Unrealized Losses | Unrealized Gains | Fair Value | |||||||||||||
Asset-backed securities |
19,589 | (1 | ) | 10 | 19,598 | |||||||||||
Corporate debt securities |
19,387 | (3 | ) | 9 | 19,393 | |||||||||||
Commercial paper |
17,882 | | 11 | 17,893 | ||||||||||||
U.S. Government agency bonds |
5,500 | (3 | ) | | 5,497 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 62,358 | $ | (7 | ) | $ | 30 | $ | 62,381 | |||||||
|
|
|
|
|
|
|
|
The following table summarizes the Companys marketable debt securities by contractual maturity (in thousands):
June 30, 2020 | ||||||||
Amortized Cost | Fair Value | |||||||
Within one year |
$ | 33,852 | $ | 34,049 | ||||
After one year through five years |
| | ||||||
After five years |
| | ||||||
|
|
|
|
|||||
Total |
$ | 33,852 | $ | 34,049 | ||||
|
|
|
|
The following table summarizes the classification of the Companys marketable debt securities in the condensed consolidated balance sheets (in thousands):
June 30, 2020 |
December 31, 2019 |
|||||||
Short-term marketable debt securities |
$ | 34,049 | $ | 51,793 | ||||
Long-term marketable debt securities |
| 10,588 | ||||||
|
|
|
|
|||||
Total |
$ | 34,049 | $ | 62,381 | ||||
|
|
|
|
5. Prepaid expenses and other current assets
Prepaid expenses and other current assets consisted of the following (in thousands):
June 30, 2020 |
December 31, 2019 |
|||||||
Prepaid expenses |
$ | 1,184 | $ | 672 | ||||
Tax receivable |
3,400 | 722 | ||||||
Interest receivable |
89 | 213 | ||||||
Other current assets |
10 | 179 | ||||||
|
|
|
|
|||||
Total prepaid expenses and other current assets |
$ | 4,683 | $ | 1,786 | ||||
|
|
|
|
F3-11
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
6. Property and Equipment, net
Property and equipment, net consisted of the following (in thousands):
Useful life (years) |
June 30, 2020 |
December 31, 2019 |
||||||||||
Laboratory equipment |
3 | $ | 4,062 | $ | 3,872 | |||||||
Lesser of useful life | ||||||||||||
Leasehold improvements |
or lease term | 1,395 | 1,327 | |||||||||
Furniture and fixtures |
3 | 260 | 68 | |||||||||
Construction in progress |
| 114 | 300 | |||||||||
Computer equipment |
3 | 42 | 42 | |||||||||
Software |
3 | 150 | 150 | |||||||||
|
|
|
|
|||||||||
$ | 6,023 | $ | 5,759 | |||||||||
Less: Accumulated depreciation and amortization |
(4,264 | ) | (3,638 | ) | ||||||||
|
|
|
|
|||||||||
Property and equipment, net |
$ | 1,759 | $ | 2,121 | ||||||||
|
|
|
|
Depreciation and amortization expense was $0.6 million for each of the six months ended June 30, 2020 and 2019. All of the Companys property and equipment as of June 30, 2020 and December 31, 2019 was located in the United States.
7. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
As of June 30, 2020 |
As of December 31, 2019 |
|||||||
Accrued compensation |
$ | 2,095 | $ | 1,359 | ||||
Accrued research and development expenses |
1,494 | 450 | ||||||
Accrued professional services |
2,293 | 301 | ||||||
Accrued other liabilities |
271 | 710 | ||||||
|
|
|
|
|||||
Total accrued and other liabilities |
$ | 6,153 | $ | 2,820 | ||||
|
|
|
|
8. Regeneron License and Collaboration Arrangement
Agreement Terms
On July 29, 2016, the Company entered into a License and Collaboration Agreement with Regeneron Pharmaceuticals, Inc. (Regeneron) to develop engineered immune-cell therapeutics using the universal immune cell therapies platform, which was amended in April 2019, with such amendment becoming effective in connection with Regenerons investment in the Companys Series B redeemable convertible preferred stock private placement transaction in July 2019 (as amended, the Regeneron Agreement).
The Company received a non-refundable upfront payment of $25.0 million from Regeneron upon execution of the Regeneron Agreement, an aggregate of $10.0 million of additional payments for research funding from Regeneron under the Regeneron agreement as of June 30, 2020. In June 2020, the Company achieved the
F3-12
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
milestone for the selection of a clinical candidate to the second collaboration target under the Regeneron Agreement and invoiced an amount of $10.0 million to Regeneron, which is presented as accounts receivable related party on the condensed consolidated balance sheets as of June 30, 2020. The Company received the payment from Regeneron in July 2020 (See Note 18). In addition, Regeneron may have to pay the Company additional amounts in the future consisting of up to an aggregate of $100.0 million of option exercise fees as specified in the Regeneron Agreement. Regeneron must also pay the Company high single digit royalties as a percentage of net sales for immune cell therapeutics (ICPs) to targets for which it has exclusive rights, and low single digit royalties as a percentage of net sales on any non-ICP product comprising a targeting moiety generated by the Company through the use of Regenerons proprietary mice. The Company must pay Regeneron mid-single to low double digit, but less than teens, royalties as a percentage of net sales of ICPs to targets for which the Company has exercised exclusive rights, and low to mid-single digit royalties as a percentage of net sales of targeting moieties generated from the Companys license to use Regenerons proprietary mice. Royalties are payable until the longer of the expiration or invalidity of the licensed patent rights or twelve (12) years from first commercial sale.
Revenue Recognition
For revenue recognition purposes, the Company determined that the duration of the contract is the same as the research term of five (5) years beginning on the execution of the Regeneron Agreement on July 29, 2016. The contract duration is defined as the period during which parties to the contract have present and enforceable rights and obligations. The Company determined that Regeneron faces significant in-substance penalties were it to terminate the Regeneron Agreement prior to the end of the research.
At contract inception, the Company determined a transaction price of the Regeneron consisting of the $25.0 million upfront payment and the aggregate research funding fees payable over the research term. In order to determine the transaction price, the Company evaluated all the payments to be received during the duration of the contract. Per the terms of the original Regeneron Agreement prior to the amendment effective from July 2019, the research funding fees were payable merely due to passage of time and therefore did not represent a variable consideration. After the amendment became effective in July 2019, certain of these fees became contingent upon the Company meeting certain development and regulatory milestones. Therefore, the Company concluded that after the amendment such potential payments became variable consideration the receipt of which was subject to substantial uncertainty and therefore excluded from the transaction price upon the effective date of the amendment. The Company will re-evaluate the transaction price if there is a significant change in facts and circumstances at least at the end of each reporting period. The Company increased the transaction price in June 2020 when it achieved the milestone for the selection of a clinical candidate to the second collaboration target under the Regeneron Agreement, resulting in a recognition of cumulative revenue of $5.0 million during the six months ended June 30, 2020.
For the six months ended June 30, 2020 and 2019, the Company recognized $9.5 million and $6.1 million of license and collaboration revenue, respectively, representing revenue recognized under the Regeneron Agreement based on proportional performance.
F3-13
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
The following table presents changes in the Companys contract assets and contract liabilities for the six months ended June 30, 2020 and 2019 (in thousands):
Six months ended June 30, 2020 |
Balance at beginning of period |
Additions | Deductions(1) | Balance at end of period |
||||||||||||
Contract asset: |
$ | | $ | 10,000 | $ | $ | 10,000 | |||||||||
Contract liability: |
$ | 21,883 | $ | 10,000 | $(9,465) | $ | 22,418 | |||||||||
Six months ended June 30, 2019 |
Balance at beginning of period |
Additions | Deductions(1) | Balance at end of period |
||||||||||||
Contract liability: |
$ | 22,878 | $ | | $(6,073) | $ | 16,805 |
(1) | Deductions to contract liabilities relate to deferred revenue recognized as revenue during the reporting period. |
Contract assets are reflected as accounts receivablerelated party on the condensed consolidated balance sheet. The Company achieved the milestone for the selection of a clinical candidate to the second collaboration target under the Regeneron Agreement in June 2020 and was entitled to receive a payment of $10.0 million from Regeneron. The Company received the payment from Regeneron in July 2020 (See Note 18).
Contract liabilities related to the Regeneron Agreement of $22.4 million and $16.8 million as of June 30, 2020 and as of June 30, 2019, respectively, which were comprised of the $25.0 million upfront payment, additional $5.0 million research funding fees in each of 2017 and 2018, and $10.0 million for achievement of the milestone for the selection of a clinical candidate to the second collaboration target in June 2020, less $22.6 million and $18.2 million of license and collaboration revenue recognized from the inception of the Regeneron Agreement as of June 30, 2020 and as of June 30, 2019, respectively, will be recognized as the combined performance obligation is satisfied.
9. Term Loan
On April 28, 2020, the Company entered into a Loan and Security Agreement with Pacific Western Bank for a term loan not exceeding $12.0 million (as amended, referred to as the Loan Agreement) to finance leasehold improvements for its new corporate headquarters in Redwood City, California and other purposes permitted under the Loan Agreement, with an interest rate equal to the greater of 0.25% above the Prime Rate (as defined in the Loan Agreement) or 5.00%. The Loan Agreement granted to Pacific Western Bank a security interest on substantially all of the Companys assets other than intellectual property to secure the performance of the Companys obligations under the Loan Agreement, and contains a variety of affirmative and negative covenants, including required financial reporting, limitations on certain dispositions of assets or distributions, limitations on the incurrence of additional debt or liens and other customary requirements. Pacific Western Bank consented to the delivery of audited consolidated financial statements that include a going concern explanatory paragraph by the Companys independent registered public accounting firm for the year ended December 31, 2019 in accordance with the terms of the financial statement covenants set forth in the Loan Agreement. Therefore, as of June 30, 2020, the Company was in compliance with such covenants and had no indebtedness outstanding under the Loan Agreement.
In connection with the entering into the Loan Agreement, the Company issued Pacific Western Bank a warrant to purchase shares of its Series B redeemable convertible preferred stock at an exercise price of $1.4034 per share (referred to as the Existing PacWest Warrant), which was later assigned to an affiliate of Pacific Western Bank. The Existing PacWest Warrant is initially exercisable for 42,753 shares of the Companys Series B redeemable convertible preferred stock and shall be exercisable for an additional number of shares of its Series
F3-14
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
B redeemable convertible preferred stock equal to 1.00% of the aggregate original principal amount of all term loans made pursuant to the Loan Agreement (up to an aggregate maximum of 128,259 shares). Pursuant to the terms of the Existing PacWest Warrant and the merger agreement (see Note 10), at the effective time of the merger, resTORbio will issue a new warrant to the holder of the Existing PacWest Warrant (referred to as the New PacWest Warrant) which will replace the Existing PacWest Warrant. The New PacWest Warrant will be exercisable solely for shares of resTORbio common stock and the number of shares of resTORbio common stock subject to the warrant shall be determined by multiplying (x) the number of shares of the Companys capital stock that were subject to the Existing PacWest Warrant (on an as-converted basis with respect to shares of the Companys preferred stock), as in effect immediately prior to the effective time of the merger, by (y) the exchange ratio, and rounding the resulting number down to the nearest whole number of shares of resTORbio common stock. The per share exercise price for the resTORbio common stock issuable upon exercise of the New PacWest Warrant shall be determined by dividing (x) the exercise price per share of the Companys capital stock subject to the Existing PacWest Warrant (on an as- converted basis), as in effect immediately prior to the effective time of the merger, by (y) the exchange ratio, and rounding the resulting exercise price up to the nearest whole cent. Any restriction on the exercise set forth in the Existing PacWest Warrant shall continue in full force and effect in the New PacWest Warrant and the term, exercisability, vesting schedule and other provisions of the Existing PacWest warrant shall otherwise remain unchanged in the New PacWest Warrant.
Pursuant to the terms of the Loan Agreement, Pacific Western Bank has consented in principle to the consummation of the merger as a Permitted Transaction (as defined in the Loan Agreement) subject to certain conditions, including: (i) that the merger is consummated in accordance with the merger agreement (unless otherwise approved by Pacific Western Bank in writing), (ii) the Company providing copies of all material transaction documents to Pacific Western Bank, (iii) the Company providing any diligence materials reasonably requested by Pacific Western Bank, (iv) resTORbio entering into a secured guaranty agreement in form and substance satisfactory to Pacific Western Bank and granting Pacific Western Bank a security interest in substantially all of its assets other than its intellectual property and (v) resTORbio issuing the New PacWest Warrant to the holder of the Existing PacWest Warrant pursuant to the terms of the merger agreement and the Existing PacWest Warrant. If the conditions set forth in the consent provided by Pacific Western Bank are not satisfied, the Company would effectively need to terminate the Loan Agreement and repay any outstanding loan funds or refinance the facility with another lender.
The Company may request to draw upon the term loan at any time through the date eighteen months after the date of the Loan Agreement (Availability End Date), which is October 28, 2021. To date, no amounts have been drawn under the Loan Agreement.
The Company accounted for the fair value of the Existing PacWest Warrant issued and the debt issuance costs as a deferred asset on the consolidated balance sheet that will be amortized on a straight-line basis until Availability End Date in interest expenses.
Upon each draw of the term loan, the Company will derecognize the proportionate unamortized amount of the deferred asset and account for it as a debt discount to the drawn term loan. The debt discount will be presented in the consolidated balance sheet as a direct adjustment to the carrying value of the term loan. The debt discount will be amortized using the effective interest rate method over the term of the debt and recorded as an interest expense.
As of June 30, 2020, the deferred debt issuance costs were $0.3 million and are included in other non-current assets on the Companys condensed balance sheet.
F3-15
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
10. Merger
On April 28, 2020, the Company entered into a definitive merger agreement with resTORbio to create a combined publicly-traded biotechnology company whose anticipated focus will be on the development of the Companys off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications. Under the terms of the merger agreement, the Company will merge with a wholly owned subsidiary of resTORbio in an all-stock transaction (the resTORbio Merger). Under the exchange ratio formula in the merger agreement, immediately following the effective time of the resTORbio Merger, the former securityholders of the Company as of immediately prior to the effective time of the resTORbio Merger are expected to own approximately 75% of the outstanding shares of resTORbios common stock on a fully-diluted basis and securityholders of resTORbio as of immediately prior to the effective time of the resTORbio Merger are expected to own approximately 25% of the outstanding shares of resTORbio Common Stock on a fully-diluted basis (in each case excluding equity incentives available for grant). The Company has concluded that the transaction represents a business combination pursuant to FASB ASC Topic 805, Business Combinations. Further, the Company was determined to be the accounting acquirer based upon the terms of the resTORbio Merger and other factors including: (i) the Companys securityholders will own approximately 75% of the voting rights of the combined company (on a fully-diluted basis excluding equity incentives available for grant); (ii) the Company will designate a majority (five of seven) of the initial members of the board of directors of the combined company; and (iii) the terms of the exchange of equity interests based on the exchange ratio at the announcement of the resTORbio Merger factored in an implied premium to resTORbios stockholders. The composition of senior management of the combined company was determined to be a neutral factor in the accounting acquirer determination, as the combined company will leverage the expertise of the senior management of both companies.
On April 28, 2020, in connection with the resTORbio Merger the Company entered into a transition agreement with Anil Singhal, the Companys Chief Executive Officer and President, pursuant to which Dr. Singhal will transition from his role as Chief Executive Officer and President of the Company prior to the closing of the resTORbio Merger to an advisory role immediately after the closing of the resTORbio Merger. In accordance with such agreement, Dr. Singhal is entitled to the following compensation, subject to his continued service through the completion of the resTORbio Merger and contingent on completion of the resTORbio Merger and his execution of a release of claims: (1) cash payments of (i) $470,000 within 60 days following the closing of the resTORbio Merger, (ii) an amount equal to his pro-rated bonus for the 2020 calendar year payable within 60 days following the closing of the resTORbio Merger, (iii) $250,000 payable in one lump sum on January 1, 2021 and (iv) $24,000 payable within 60 days following the closing of the resTORbio Merger, (2) 12 months of accelerated vesting of his unvested options to purchase the Companys common stock upon completion of the resTORbio Merger, and (3) a 12-month post-termination exercise period following termination of his independent contractor services agreement, dated April 28, 2020 (the ICSA), subject to any earlier expiration of the options to purchase the Companys common stock by their terms. In addition, Dr. Singhal is entitled to reimbursement of up to $15,000 of his reasonable and documented legal expenses incurred in connection with such transition agreement. Pursuant to such agreement, subject to Dr. Singhals continued service through the completion of the resTORbio Merger and contingent on completion of the resTORbio Merger, Dr. Singhals continued service for purposes of vesting of his options to purchase the Companys common stock will continue until the earlier of (i) May 7, 2021 or (ii) termination of the ICSA, provided, however, if the ICSA is terminated early without cause, Dr. Singhal is entitled to accelerated vesting of unvested options that would have vested from the date of such termination through May 7, 2021. In addition, Dr. Singhals existing options acceleration provisions will terminate. Pursuant to the ICSA, Dr. Singhal will provide certain advisory services to the Company for a term of 12 months following the closing of the merger and is entitled to payments of $12,500 per month for such services.
F3-16
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
11. Commitments and Contingencies
Operating Leases
The future minimum lease payments under all non-cancelable operating lease obligations as of June 30, 2020 were as follows (in thousands):
2020 (remaining six months) |
1,722 | |||
2021 |
3,518 | |||
2022 |
2,942 | |||
2023 |
2,798 | |||
2024 |
2,882 | |||
2025 and thereafter |
16,328 | |||
|
|
|||
Total |
$ | 30,190 | ||
|
|
In conjunction with the Menlo Park lease agreement, the Company issued a cash-collateralized letter of credit in lieu of security deposit of $0.2 million which cash-collateral is included in restricted cash on the balance sheets as of June 30, 2020 and December 31, 2019. In addition, the Company issued a cash-collateralized letter of credit for $4.1 million in 2018 for the new office lease in Redwood City and the cash-collateral is also included in the restricted cash balance as of June 30, 2020 and December 31, 2019.
Litigation
In connection with the Merger, a putative class action lawsuit has been filed against resTORbio, its directors, the Company, and Merger Sub by purported resTORbio stockholder Patrick Plumley. The lawsuit generally alleges that the resTORbio proxy statement/prospectus/information statement filed with the SEC on June 23, 2020 misrepresents and/or omits certain purportedly material information relating to financial projections, analysis performed by JMP, past engagements of JMP, and the process leading up to the execution of the Merger Agreement. The lawsuit seeks, among other things: an injunction enjoining consummation of the Merger, costs of the action, including plaintiffs attorneys fees and experts fees, declaratory relief, and any other relief the court may deem just and proper. The Company believes the lawsuit to be without merit and plans to seek dismissal.
The Company is subject to claims and assessments from time to time in the ordinary course of business but is not aware of any such matters, individually or in the aggregate, that could have a material adverse effect on the Companys financial position, results of operations or cash flows.
12. Redeemable Convertible Preferred Stock
Under the Companys Certificate of Incorporation, as amended, the Companys redeemable convertible preferred stock is issuable in series. The Companys Board of Directors is authorized to determine the rights, preferences and terms of each series.
As of June 30, 2020 and December 31, 2019, redeemable convertible preferred stock consists of the following (in thousands, except per share and share amounts):
Shares Authorized |
Original Issue Price |
Shares Issued and Outstanding |
Carrying Value |
Liquidation Preference |
||||||||||||||||
Series A |
37,104,185 | $ | 1.20 | 37,104,185 | $ | 35,960 | $ | 44,525 | ||||||||||||
Series A-1 |
629,633 | 1.20 | 629,633 | 447 | 756 | |||||||||||||||
Series A-2 |
2,428,688 | 1.20 | 2,428,688 | 1,749 | 2,914 | |||||||||||||||
Series B |
59,200,938 | 1.4034 | 57,004,415 | 75,927 | 80,000 | |||||||||||||||
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99,363,444 | 97,166,921 | $ | 114,083 | $ | 128,195 | |||||||||||||||
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F3-17
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
The original issuance price in the tables above reflect the stated issuance price per the respective purchase agreements.
Voting Rights
Each share of redeemable convertible preferred stock has the same voting rights as the number of shares of common stock into which it is convertible and vote together with the holders of common stock as a single class.
The holders of shares of Series A redeemable convertible preferred stock shall be entitled, voting separately as a single class, to elect two directors of the Company (the Series A Directors). The holders of shares of redeemable convertible preferred stock shall be entitled, voting separately as a single class on an as-converted basis, to elect two directors of the Company (together with the Series A Directors, the Preferred Directors). The holders of shares of common stock shall be entitled, voting separately as a single class, to elect one director of the Company. The holders of shares of common stock and convertible redeemable preferred stock shall be entitled, voting together, to elect the remaining directors of the Company.
Dividends
Holders of outstanding shares of Series B redeemable convertible preferred stock are entitled to receive dividends, when, as and if declared by the Board of Directors, at the annual rate of $0.1123 per share as adjusted for any stock combination, stock split, stock dividend, recapitalization or other similar transaction (recapitalizations), payable in preference and priority to any declaration or payment of any distribution on Series A redeemable convertible preferred stock, Series A-2 redeemable convertible preferred stock, Series A-1 redeemable convertible preferred stock or common stock of the Company in such calendar year.
The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company in any fiscal year unless the holders of the Series B redeemable convertible preferred stock then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share of Series B redeemable convertible preferred stock in an amount at least equal to all declared but unpaid dividends with respect to all outstanding shares of Series B redeemable convertible preferred stock and the amount of the dividends then accrued on such share of Series B redeemable convertible preferred stock with respect to such fiscal year.
After payment of the full amount of any dividends payable described above, the holders of shares of Series A redeemable convertible preferred stock are entitled to receive dividends, when, as and if declared by the Board of Directors, at the annual rate of $0.096 per share as adjusted for any recapitalization adjustments, payable in preference and priority to any declaration or payment of any distribution on Series A-2 redeemable convertible preferred stock, Series A-1 redeemable convertible preferred stock or common stock of the Company in such calendar year.
The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company in any fiscal year unless the holders of the Series A redeemable convertible preferred stock then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share of Series A redeemable convertible preferred stock in an amount at least equal to all declared but unpaid dividends with respect to all outstanding shares of Series A redeemable convertible preferred stock and the amount of the dividends then accrued on such share of Series A redeemable convertible preferred stock with respect to such fiscal year.
F3-18
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
After payment of the full amount of any dividends payable described above, the holders of shares of Series A-2 redeemable convertible preferred stock are entitled to receive dividends, when, as and if declared by the Board of Directors, at the annual rate of $0.096 per share adjusted for any recapitalization adjustments, payable in preference and priority to any declaration or payment of any distribution on Series A-1 redeemable convertible preferred stock or common stock of the Company in such calendar year.
The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company (other than dividends on shares of the Series B redeemable convertible preferred stock and Series A redeemable convertible preferred stock as indicated above) in any fiscal year unless the holders of the Series A-2 redeemable convertible preferred stock then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share of Series A-2 redeemable convertible preferred stock in an amount at least equal to all declared but unpaid dividends with respect to all outstanding shares of Series A-2 redeemable convertible preferred stock and the amount of the dividends then accrued on such share of Series A-2 redeemable convertible preferred stock with respect to such fiscal year.
After payment of the full amount of any dividends pursuant to the paragraphs above, any additional dividends shall be distributed among all holders of common stock and all holders of redeemable convertible preferred stock in proportion to the number of shares of common stock which would be held by each such holder if all shares of each such series of redeemable convertible preferred stock were converted to common stock at the then effective conversion rate.
Dividends are noncumulative, and none were declared as of June 30, 2020.
Liquidation
In the event of any liquidation, dissolution or winding up of the Company, or deemed liquidation event, either voluntary or involuntary (Liquidation), the holders of Series B redeemable convertible preferred stock shall be entitled to receive, prior and in preference to any distribution of any of the assets of the Company to the holders of any other series of redeemable convertible preferred stock or common stock an amount per share equal to the greater of (i) the sum of $1.4034, adjusted for any recapitalization adjustments for each outstanding share of Series B redeemable convertible preferred stock and an amount equal to all declared but unpaid dividends on such share and (ii) such amount per share as would have been payable had all shares of Series B redeemable convertible preferred stock been converted into common stock pursuant to the conversion right immediately prior to such Liquidation (see below for the conversion rights).
After full payment to the holders of Series B redeemable convertible preferred stock, the holders of Series A redeemable convertible preferred stock shall be entitled to receive, prior and in preference to any distribution from the assets of the Company to the holders of Series A-2 and A-1 redeemable convertible preferred stock or common stock an amount per share equal to the greater of (i) the sum of $1.20, adjusted for any recapitalization adjustments, for each outstanding share of Series A redeemable convertible preferred stock and an amount equal to all declared but unpaid dividends on such share and (ii) such amount per share as would have been payable had all shares of Series A redeemable convertible preferred stock been converted into common stock pursuant to the conversion right immediately prior to such Liquidation (see below for the conversion rights).
After full payment to holders of Series B and A redeemable convertible preferred stock, the holders of Series A-2 redeemable convertible preferred stock shall be entitled to receive, prior and in preference to any distribution of any of the assets of the Company to the holders of Series A-1 redeemable convertible preferred stock or common stock an amount per share equal to the greater of (i) the sum of $1.20, adjusted for any
F3-19
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
recapitalization adjustments, for each outstanding share of Series A-2 redeemable convertible preferred stock and an amount equal to all declared but unpaid dividends on such share and (ii) such amount per share as would have been payable had all shares of Series A-2 redeemable convertible preferred stock been converted into common stock pursuant to the conversion right immediately prior to such Liquidation (see below for the conversion rights).
After full payment to holders of the Series B, A and A-2 redeemable convertible preferred stock, the holders of Series A-1 redeemable convertible preferred stock shall be entitled to receive, prior and in preference to any distribution of any of the assets of the Company to the holders of common stock an amount per share equal to the greater of (i) the sum of $1.20, adjusted for any recapitalization adjustments, for each outstanding share of Series A-1 redeemable convertible preferred stock and an amount equal to all declared but unpaid dividends on such share and (ii) such amount per share as would have been payable had all shares of Series A-1 redeemable convertible preferred stock been converted into common stock pursuant to the conversion right immediately prior to such Liquidation (see below for the conversion rights).
After the payment to the holders of redeemable convertible preferred stock of the full preferential amounts specified above, all of the remaining assets of the Company available for distribution to stockholders shall be distributed among the holders of common Stock pro rata based on the number of shares of common Stock held by each such holder.
Conversion
Each share of redeemable convertible preferred stock is convertible, at the option of the holder, into the number of fully-paid and non-assessable shares of common stock that result from dividing the applicable original issue price per share by the applicable conversion price per share at the time of conversion, as adjusted for any recapitalization adjustments. If, after the issuance date of the Series B redeemable convertible preferred stock, the Company issues or sells, or is deemed to have sold, additional shares of common stock without consideration or for a consideration per share less than the conversion price for a particular series of preferred stock (other than the Series A-1 redeemable convertible preferred stock) in effect immediately prior to the issuance of such additional shares of common stock, except for certain exceptions allowed, the conversion price of the redeemable convertible preferred stock would be adjusted. As of June 30, 2020, each series of the Companys redeemable convertible preferred stock was convertible into the Companys shares of common stock on a one-for-one basis.
Each share of redeemable convertible preferred stock is convertible into common stock and automatically immediately upon the earlier of (i) the Companys sale of its common stock in a firm commitment underwritten public offering pursuant to a registration statement under the Securities Act, the public offering price of which is not less than $2.40 per share, as adjusted for recapitalization adjustments and which results in proceeds to the Company of at least $50 million in the aggregate (before deduction of underwriting discounts and commissions) (a Qualified IPO) or (ii) the Companys receipt of a written request for such conversion from the holders of the majority of the then outstanding shares of redeemable convertible preferred stock as determined on an as-converted to common stock basis; provided, however, that in respect of (ii), the vote or written consent of the vote or written consent of the holders of a majority of the Series B redeemable convertible preferred stock, voting together as a single class on an as-converted basis shall also be required to effect such conversion solely in the event such conversion both: (A) is being effected in connection with a specific proposed Liquidation changing the allocation of proceeds distributable to the Companys stockholders in such Liquidation and (B) would result in a holder of Series B redeemable convertible preferred stock receiving less in distributions from such transaction for a share of Series B redeemable convertible preferred stock in such Liquidation than such holder would have received if such conversion was not effected and the proceeds were distributed for such share in such Liquidation in accordance with liquidation preferences described above.
F3-20
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
Redemption and Balance Sheet Classification
The redeemable convertible preferred stock is recorded within mezzanine equity because while it is not mandatorily redeemable, it will become redeemable at the option of the stockholders upon the occurrence of certain deemed liquidation events that are considered not solely within the Companys control.
13. Redeemable Convertible Preferred Stock Warrant Liability
During the period from July 2019 to September 2019, in connection with the issuance of Series B redeemable convertible preferred stock, the Company issued to its financial advisor warrants to purchase 1,781,387 shares of Series B redeemable convertible preferred stock at an exercise price of $1.4034 per share (the Series B Warrants), which was accounted as preferred stock issuance costs.
The Series B Warrants will terminate at the earlier of the seven-year anniversary from the issuance date and Liquidation of the Company. These warrants have a settlement provision under which their holders may, in lieu of payment of the exercise price in cash, surrender the warrant and receive a net amount of shares based on the fair market value of the Companys stock at the time of exercise of the warrants after deduction of the aggregate exercise price. The Series B Warrants contain provisions for adjustment of the exercise price and number of shares issuable upon the exercise of warrants in the event of certain stock dividends, stock splits, reorganizations, reclassifications, and consolidations.
On April 28, 2020, in connection with the entering into the Loan Agreement, the Company issued Pacific Western Bank a warrant to purchase shares of Series B redeemable convertible preferred stock at an exercise price of $1.4034 per share, which was accounted as deferred debt issuance costs. Such warrant is initially exercisable for 42,753 shares of Series B redeemable convertible preferred stock and shall be exercisable for an additional number of shares of Series B redeemable convertible preferred stock equal to 1.00% of the aggregate original principal amount of all term loans made pursuant to the Loan Agreement (up to an aggregate maximum of 128,259 shares) (see Note 9).
The fair value of the Series B Warrants and the Existing PacWest Warrant were recorded on the date of issuance. The Series B Warrants and the Existing PacWest Warrant had a combined fair value of $2.0 million and $1.9 million as of June 30, 2020 and December 31, 2019, respectively. The change in fair value of $0.1 million during the six months ended June 30, 2020 was recorded as a component of other income, net in the condensed consolidated statement of operations and comprehensive loss.
The redeemable convertible preferred stock warrant liability was valued using the following assumptions under the Black-Scholes option-pricing model:
June 30, 2020 |
April 28, 2020 (Issuance Date) |
December 31, 2019 |
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Stock price |
$ | 1.48 | $ | 1.44 | $ | 1.40 | ||||||
Expected term (years) |
6.07 - 6.83 | 7.00 | 6.57 - 6.74 | |||||||||
Expected volatility |
80.31% - 82.58 | % | 91.17 | % | 82.1% - 93.3 | % | ||||||
Risk-free interest rate |
0.40% - 0.47 | % | 0.52 | % | 1.53% - 1.93 | % | ||||||
Dividend yield |
0 | % | 0 | % | 0 | % |
Assumptions under the Black-Scholes option-pricing model on April 28, 2020 relates only to Existing PacWest Warrant.
F3-21
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
14. Stock-based Compensation
A summary of stock option activity for the six months ended June 30, 2020 is set forth below (in thousands, except share and per share data):
Outstanding Awards | ||||||||||||||||||||
Number of Shares Available for Grant |
Number of Shares Underlying Outstanding Options |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term (in years) |
Aggregate Intrinsic Value |
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Outstanding, December 31, 2019 |
5,267,201 | 15,005,410 | $ | 0.50 | 8.53 | $ | 5,812 | |||||||||||||
Options granted |
(65,000 | ) | 65,000 | $ | 0.74 | |||||||||||||||
Options exercised |
(185,950 | ) | $ | 0.26 | ||||||||||||||||
Options forfeited or cancelled |
11,939 | (11,939 | ) | $ | 0.28 | |||||||||||||||
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|||||||||||||||||
Outstanding, June 30, 2020 |
5,214,140 | 14,872,521 | $ | 0.51 | 8.09 | $ | 12,094 | |||||||||||||
|
|
|
|
|||||||||||||||||
Shares exercisable June 30, 2020 |
7,344,611 | $ | 0.37 | 7.15 | $ | 6,980 | ||||||||||||||
Vested and expected to vest, June 30, 2020 |
14,872,521 | $ | 0.51 | 8.09 | $ | 12,094 |
Total stock-based compensation expense recognized was as follows (in thousands):
Six months ended June 30, |
||||||||
2020 | 2019 | |||||||
Research and development |
$ | 174 | $ | 137 | ||||
General and Administrative |
476 | 337 | ||||||
|
|
|
|
|||||
Total Stock-based compensation |
$ | 650 | $ | 474 | ||||
|
|
|
|
F3-22
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
15. Net Loss Per Share
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders, which excludes unvested restricted shares and shares which are legally outstanding, but subject to repurchase by the Company (in thousands, except share and per share data):
Six months ended June 30, | ||||||||
2020 | 2019 | |||||||
Numerator: |
||||||||
Net loss attributable to common stockholders |
$ | (12,941 | ) | $ | (6,782 | ) | ||
|
|
|
|
|||||
Denominator: |
||||||||
Weighted-average shares outstanding |
17,502,411 | 17,291,592 | ||||||
Less: weighted-average unvested restricted shares and shares subject to repurchase |
| (151,935 | ) | |||||
|
|
|
|
|||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
17,502,411 | 17,139,657 | ||||||
|
|
|
|
|||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | (0.74 | ) | $ | (0.40 | ) | ||
|
|
|
|
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the period presented because including them would have been antidilutive:
June 30, | ||||||||
2020 | 2019 | |||||||
Redeemable convertible preferred stock |
97,166,921 | 40,162,506 | ||||||
Options to purchase common stock |
14,872,521 | 10,751,526 | ||||||
Redeemable convertible preferred stock tranche liability and TRDF obligation |
| 5,926,838 | ||||||
Redeemable convertible preferred stock warrants |
1,824,140 | | ||||||
|
|
|
|
|||||
Total |
113,863,582 | 56,840,870 | ||||||
|
|
|
|
16. Income Taxes
The Company recorded an income tax benefit of $2.7 million during the six months ended June 30, 2020.
The income tax benefit during the six months ended June 30, 2020 was generated as a result of the recognition of net operating loss carryback under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) which was enacted on March 27, 2020 in response to the COVID-19 (coronavirus) pandemic and generates a refund of income taxes paid for the year ended December 31, 2017. The Company records the effect of an enacted change in a tax law in the period that includes the enactment date in accordance with ASC 740, Income Taxes.
The tax relief measures under the CARES Act for businesses include a five-year net operating loss carryback, suspension of annual deduction limitation of 80% of taxable income from net operating losses
F3-23
ADICET BIO, Inc.
Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
generated in a tax year beginning after December 31, 2017, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property.
The Company maintains a full valuation allowance against its net deferred tax assets due to the Companys history of losses as of June 30, 2020.
17. Related Party
As of June 30, 2020 and December 31, 2019, Regeneron owned 7,125,552 shares of the Companys redeemable convertible preferred stock, respectively. Regeneron became a related party in July 2019 as a result of Series B redeemable convertible preferred stock financing. For the six months ended June 30, 2020 and June 30, 2019, the Company recorded revenue of $9.5 million and $6.1 million, respectively, and as of June 30, 2020, the Company recorded accounts receivable of $10.0 million and deferred revenue of $22.4 million related to the Regeneron Agreement. See Note 8 for a discussion of the Regeneron Agreement.
18. Subsequent Events
For its interim condensed consolidated financial statements as of June 30, 2020 and for the six months then ended, the Company evaluated subsequent events through August 12, 2020, the date on which those financial statements were issued.
On July 14, 2020, the Companys Board of Directors confirmed that the conditions for Dr. Singhals Second Target Milestone Option (as defined in Dr. Singhals employment agreement with the Company) had been fulfilled as the Company achieved the milestone for the selection of a clinical candidate to the second collaboration target under the Regeneron Agreement. Subject to approval by the Companys Board of Directors, Dr. Singhal is entitled to receive an option to purchase 182,056 shares of Adicet common stock following the closing of the Merger at an exercise price equal to the fair market value of the combined companys common stock on the date of grant.
On July 30, 2020, the Company received a payment of $10.0 million from Regeneron for the selection of a clinical candidate to the second collaboration target under the Regeneron Agreement during June 2020.
F3-24
Exhibit 99.7
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION
On April 28, 2020, resTORbio and Adicet entered into the merger agreement pursuant to which Project Oasis Merger Sub, Inc., a wholly owned subsidiary of resTORbio, will merge with and into Adicet, with Adicet surviving as a wholly owned subsidiary of resTORbio.
The following unaudited pro forma condensed combined financial information is based on Adicets historical consolidated financial statements and resTORbios historical consolidated financial statements, and was prepared using the acquisition method of accounting under U.S. GAAP and has been adjusted to give effect to the merger between resTORbio and Adicet. The merger will be accounted for as a reverse acquisition with Adicet being deemed the acquiring company for accounting purposes. Adicet was determined to be the accounting acquirer based upon the terms of the merger and other factors including: (i) Adicets security holders as of immediately prior to the effective time of the merger will own approximately 75% of the voting rights of the combined company (on a fully-diluted basis excluding equity incentives available for grant); (ii) Adicet will designate a majority (five of seven) of the initial members of the board of directors of the combined company; and (iii) the terms of the exchange of equity interests based on the exchange ratio at the announcement of the merger factored in an implied premium to resTORbios stockholders. The composition of senior management of the combined company was determined to be a neutral factor in the accounting acquirer determination, as the combined company will leverage the expertise of the senior management of both companies.
As a result of Adicet being treated as the accounting acquirer, Adicets assets and liabilities will be recorded at their precombination carrying amounts and the historical consolidated operations that are reflected in the unaudited pro forma condensed combined financial information will be those of Adicet. resTORbios assets and liabilities will be measured and recognized at their fair values as of the effective date of the merger, and combined with the assets, liabilities and results of operations of Adicet after the consummation of the merger. As a result, upon consummation of the merger, the historical consolidated financial statements of Adicet will become the historical consolidated financial statements of the combined company.
The following information does not give effect to the proposed reverse stock split pursuant to Proposal No. 2, or the option pool increase pursuant to Proposal No. 3, as described in the section titled Matters Being Submitted to a Vote of resTORbio Stockholders, beginning on page 238 of this proxy statement/prospectus/information statement. In addition, the following unaudited pro forma condensed combined financial information does not give effect to the proposed issuance of resTORbio common stock pursuant to the funding agreement, as described in the section titled Agreements Related to the Merger beginning on page 229 of this proxy statement/prospectus/information statement.
The unaudited pro forma condensed combined balance sheet as of June 30, 2020 gives effect to the merger as if it took place on June 30, 2020 and combines the historical consolidated balance sheets of Adicet and resTORbio as of June 30, 2020. The unaudited pro forma condensed combined statements of operations for the six months ended June 30, 2020 and the year ended December 31, 2019 gives effect to the merger as if it took place as of January 1, 2019 and combines the historical consolidated results of Adicet and resTORbio for the six months ended June 30, 2020 and the year ended December 31, 2019. The historical consolidated financial statements of Adicet and resTORbio have been adjusted to give pro forma effect to events that are (i) directly attributable to the merger, (ii) factually supportable, and (iii) with respect to the unaudited pro forma condensed combined statements of operations, expected to have a continuing impact on the combined results.
The unaudited pro forma condensed combined financial information is based on the assumptions and adjustments that are described in the accompanying notes. The application of the acquisition method of accounting is dependent upon certain valuations and other studies of in-process research and development, inventory, and contingent consideration for the contingent value right described in the section titled Agreements Related to the Merger beginning on page 229 of this proxy statement/prospectus/information statement that have yet to be completed. Accordingly, the pro forma adjustments reflected in the unaudited pro forma condensed combined
1
financial information are preliminary and based on estimates, subject to further revision as additional information becomes available and additional analyses are performed and have been made solely for the purpose of providing unaudited pro forma condensed combined financial information. Differences between these preliminary adjustments reflected in the unaudited pro forma condensed combined financial information and the final application of the acquisition accounting, which is expected to be completed as soon as practicable after the closing of the merger, may occur and those differences could have a material impact on the accompanying unaudited pro forma condensed combined financial information and the combined companys future results of operations and financial position. In addition, differences between the preliminary and final adjustments will likely occur as a result of the amount of cash used in resTORbios operations from the date of the unaudited pro forma condensed combined balance sheet through the consummation of the merger, as well as other changes in resTORbios assets and liabilities between June 30, 2020 and the closing of the merger. In addition, differences between the preliminary and final estimated purchase price will likely occur between August 4, 2020 and the closing of the merger due to changes in resTORbios stock price including those related to potential changes in the fair value of the contingent value right. Finally, differences between the preliminary and final exchange ratio will likely occur between August 4, 2020 and the closing of the merger as result of changes to resTORbios and Adicets capitalization, if any, during such period.
The unaudited pro forma condensed combined financial information does not give effect to the potential impact of operating efficiencies or other savings or expenses that may be associated with the integration of the two companies. The unaudited pro forma condensed combined financial information has been prepared for illustrative purposes only and is not necessarily indicative of the financial position or results of operations in future periods or the results that actually would have been realized had Adicet and resTORbio been a combined company during the specified periods.
The unaudited pro forma condensed combined financial information, including the notes thereto, should be read in conjunction with the separate historical consolidated financial statements of Adicet and resTORbio and their respective Managements Discussion and Analysis of Financial Condition and Results of Operations, included elsewhere in this proxy statement/prospectus/information statement.
2
Unaudited Pro Forma Condensed Combined Balance Sheet
As of June 30, 2020
(in thousands)
Historical | ||||||||||||||||||
Adicet | resTORbio | Pro Forma Adjustments |
Note 5 |
Pro Forma Combined |
||||||||||||||
Assets |
||||||||||||||||||
Current assets: |
||||||||||||||||||
Cash and cash equivalents |
$ | 18,264 | $ | 70,889 | $ | | $ | 89,153 | ||||||||||
Short-term marketable debt securities |
34,049 | | | 34,049 | ||||||||||||||
Inventory |
| | | A(1), F | | |||||||||||||
Accounts receivable related party |
10,000 | | | 10,000 | ||||||||||||||
Prepaid expenses and other current assets |
4,683 | 2,860 | | 7,543 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total current assets |
66,996 | 73,749 | | 140,745 | ||||||||||||||
Property and equipment, net |
1,759 | 348 | | 2,107 | ||||||||||||||
Goodwill |
| | 24,978 | A(2) | 24,978 | |||||||||||||
In-process research and development |
| | 3,810 | A(3) | 3,810 | |||||||||||||
Restricted cash |
4,282 | 245 | | 4,527 | ||||||||||||||
Other non-current assets |
1,459 | | | 1,459 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total assets |
$ | 74,496 | $ | 74,342 | $ | 28,788 | $ | 177,626 | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Liabilities, redeemable convertible preferred stock, and stockholders deficit |
||||||||||||||||||
Current Liabilities: |
||||||||||||||||||
Accounts payable |
$ | 2,161 | $ | 2,467 | $ | | $ | 4,628 | ||||||||||
Contract liabilities, current |
17,955 | | | 17,955 | ||||||||||||||
Accrued and other current liabilities |
6,153 | 1,097 | 6,915 | A(4), B | 14,165 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total current liabilities |
26,269 | 3,564 | 6,915 | 36,748 | ||||||||||||||
Contract liabilities, net of current portion |
4,463 | | | 4,463 | ||||||||||||||
Deferred rent, net of current portion |
147 | 34 | (34 | ) | A(5) | 147 | ||||||||||||
Redeemable convertible preferred stock warrant liability |
1,968 | | (1,968 | ) | D | | ||||||||||||
Deferred tax liability |
| | 401 | A(6) | 401 | |||||||||||||
CVR liability |
| | 3,140 | A(7) | 3,140 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total liabilities |
32,847 | 3,598 | 8,454 | 44,899 | ||||||||||||||
Redeemable convertible preferred stock |
114,083 | | (114,083 | ) | C | | ||||||||||||
Stockholders deficit: |
||||||||||||||||||
Common stock |
2 | 4 | 8 | A(8), A(10), C | 14 | |||||||||||||
Additional paid-in capital |
9,955 | 237,509 | (26,318 | ) | A(8), A(9), A(10), C, D, E, G | 221,146 | ||||||||||||
Accumulated deficit |
(82,588 | ) | (166,769 | ) | 160,727 | A(10), B, E, F, G | (88,630 | ) | ||||||||||
Accumulated other comprehensive income |
197 | | 197 | |||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total stockholders equity (deficit) |
(72,434 | ) | 70,744 | 134,417 | 132,727 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total liabilities, redeemable convertible preferred stock, and stockholders deficit |
$ | 74,496 | $ | 74,342 | $ | 28,788 | $ | 177,626 | ||||||||||
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the unaudited pro forma condensed combined financial information
3
Unaudited Pro Forma Condensed Combined Statement of Operations
For the Six Months Ended June 30, 2020
(in thousands, except share and per share amounts)
Historical | ||||||||||||||||||
Adicet | resTORbio | Pro Forma Adjustments |
Note 5 |
Pro Forma Combined |
||||||||||||||
Revenue |
$ | 9,465 | $ | | $ | | $ | 9,465 | ||||||||||
Operating expenses: |
||||||||||||||||||
Research and development |
15,709 | 6,629 | | 22,338 | ||||||||||||||
General and administrative |
9,943 | 6,403 | (7,330 | ) | J | 9,016 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total operating expense |
25,652 | 13,032 | (7,330 | ) | 31,354 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Loss from operations |
(16,187 | ) | (13,032 | ) | 7,330 | (21,889 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Interest income |
551 | 353 | | 904 | ||||||||||||||
Interest expense |
(34 | ) | | | (34 | ) | ||||||||||||
Other income (expense), net |
50 | 50 | (57 | ) | H | 43 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Loss before income tax (benefit) expense |
(15,620 | ) | (12,629 | ) | 7,273 | (20,976 | ) | |||||||||||
Income tax (benefit) expense |
(2,679 | ) | 8 | | (2,671 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Net loss |
$ | (12,941 | ) | $ | (12,637 | ) | $ | 7,273 | $ | (18,305 | ) | |||||||
|
|
|
|
|
|
|
|
|||||||||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | (0.74 | ) | $ | (0.35 | ) | $ | (0.14 | ) | |||||||||
|
|
|
|
|
|
|||||||||||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
17,502,411 | 36,445,460 | K | 134,929,020 | ||||||||||||||
|
|
|
|
|
|
The accompanying notes are an integral part of the unaudited pro forma condensed combined financial information
4
Unaudited Pro Forma Condensed Combined Statement of Operations
For the Year Ended December 31, 2019
(in thousands, except share and per share amounts)
Historical | ||||||||||||||||||||
Adicet | resTORbio | Pro Forma Adjustments |
Note 5 | Pro Forma Combined |
||||||||||||||||
Revenue |
$ | 995 | $ | | $ | | $ | 995 | ||||||||||||
Operating expenses: |
||||||||||||||||||||
Research and development |
23,691 | 73,634 | | 97,325 | ||||||||||||||||
General and administrative |
8,692 | 11,823 | | 20,515 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Total operating expense |
32,383 | 85,457 | | 117,840 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Loss from operations |
(31,388 | ) | (85,457 | ) | | (116,845 | ) | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Interest income |
938 | 2,817 | | 3,755 | ||||||||||||||||
Other income (expense), net |
2,331 | (63 | ) | (2,274 | ) | H, I | (6 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Loss before income tax expense |
(28,119 | ) | (82,703 | ) | (2,274 | ) | (113,096 | ) | ||||||||||||
Income tax expense |
19 | 36 | | 55 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Net loss |
$ | (28,138 | ) | $ | (82,739 | ) | $ | (2,274 | ) | $ | (113,151 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | (1.63 | ) | $ | (2.41 | ) | $ | (1.10 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
17,249,656 | 34,306,374 | K | 102,596,519 | ||||||||||||||||
|
|
|
|
|
|
The accompanying notes are an integral part of the unaudited pro forma condensed combined financial information
5
Notes to Unaudited Pro Forma Condensed Combined Financial Information
1. Description of the Merger
On April 28, 2020, Adicet Bio, Inc., a Delaware corporation (Adicet), entered into an agreement and plan of merger (the merger agreement) with resTORbio, Inc., a Delaware corporation (resTORbio), and Project Oasis Merger Sub, Inc., a Delaware corporation and a direct, wholly owned subsidiary of resTORbio (Merger Sub), pursuant to which, subject to the satisfaction or waiver of the conditions therein, Merger Sub will merge with and into Adicet, with Adicet surviving as a wholly owned subsidiary of resTORbio. Pursuant to the merger agreement, Adicets security holders, as of immediately prior to the effective time of the merger, will own approximately 75% of the fully-diluted common stock of the combined company and resTORbios security holders, as of immediately prior to the effective time of the merger, will own approximately 25% of the fully-diluted common stock of the combined company (in each case excluding equity incentives available for grant). The relative percentage ownership of the combined company immediately following the effective time of the merger was derived using a stipulated value of Adicet of approximately $220.0 million and of resTORbio of approximately $73.3 million.
Subject to the terms and conditions set forth in the merger agreement, each share of Adicets common stock and redeemable convertible preferred stock issued and outstanding immediately prior to the effective time of the merger (excluding any shares that are held in treasury and any dissenting shares held by stockholders who have exercised and perfected appraisal rights) will be converted into the right to receive approximately 0.8555 shares of resTORbio common stock, subject to adjustment to account for the reverse stock split. This exchange ratio (the exchange ratio) is an estimate only and is based upon resTORbios and Adicets capitalization as of August 4, 2020. The final exchange ratio will be determined pursuant to a formula described in more detail in the merger agreement. Each outstanding and unexercised option with respect to Adicets common stock under Adicets 2015 Stock Incentive Plan and a subset of options pursuant to Adicets 2014 Share Option Plan will be converted into options to purchase a number of shares of resTORbio common stock based on the exchange ratio, subject to the terms and adjustments in the merger agreement. All rights with respect to Adicets capital stock under the redeemable convertible preferred stock warrants shall be converted into warrants to acquire a certain number of shares of resTORbio common stock based on the exchange ratio, subject to the terms and adjustments in the merger agreement and the applicable warrant.
resTORbios stockholders will continue to own and hold their existing shares of resTORbio common stock. The vesting of all outstanding resTORbio options will be accelerated in full as of immediately prior to the effective time of the merger. All out-of-the-money resTORbio options will be cancelled for no consideration. All in-the-money resTORbio options will remain outstanding after the completion of the merger in accordance with their terms. In addition, all outstanding unvested resTORbio restricted stock units will be accelerated in full as of immediately prior to the effective time of the merger, and for each outstanding and unsettled resTORbio restricted stock unit, the holder thereof shall receive a number of shares of resTORbio common stock equal to the number of vested and unsettled shares underlying such resTORbio restricted stock units (reduced by the number of shares of resTORbio common stock necessary to satisfy applicable tax withholding obligations at the maximum statutory rate).
The terms of the merger contemplate that each holder of resTORbio common stock as of immediately prior to the completion of the merger shall be entitled to one contractual contingent value right (CVR) issued by resTORbio, subject to and in accordance with the terms and conditions of the CVR Agreement (as defined below), for each share of resTORbio common stock held by such holder as of immediately prior to the effective time of the merger. The CVR holders are entitled to receive net proceeds from the commercialization, if any, received from a third-party commercial partner of RTB101, resTORbios small molecule product candidate that is a potent inhibitor of target of rapamycin complex 1 (TORC1), for a COVID-19 related indication. The terms and conditions of the CVRs will be established pursuant to a CVR agreement by and among resTORbio, the Holders Representative and the Rights Agent, expected to be entered into immediately prior to the closing of the merger (the CVR Agreement).
6
Notes to Unaudited Pro Forma Condensed Combined Financial Information
2. Basis of Presentation
The accompanying unaudited pro forma condensed combined financial information was prepared in accordance with U.S. GAAP and pursuant to the rules and regulations of Article 11 of SEC Regulation S-X. The unaudited pro forma condensed combined balance sheet as of June 30, 2020 was derived from the historical consolidated balance sheets of Adicet and resTORbio as of June 30, 2020 and has been adjusted to give effect to the merger as if it occurred on June 30, 2020. The unaudited pro forma condensed combined statements of operations for the six months ended June 30, 2020 and the year ended December 31, 2019 were derived from the historical consolidated statements of operations and comprehensive loss of Adicet and resTORbio for the six months ended June 30, 2020 and the year ended December 31, 2019 and have been adjusted to give effect to the merger as if it occurred on January 1, 2019.
Adicet and resTORbio have concluded that the merger represents a business combination pursuant to Financial Accounting Standards Board Accounting Standards Codification Topic 805, Business Combinations (ASC 805). In addition, because Adicet has been determined to be the accounting acquirer in the merger, but not the legal acquirer, the merger is deemed a reverse acquisition under the guidance of ASC 805. Management has not yet completed a final valuation analysis of the fair value of resTORbios assets to be acquired and liabilities to be assumed. Using the estimated total consideration for the merger, management has preliminarily allocated such consideration to the assets acquired and liabilities assumed of resTORbio in the merger based on a preliminary valuation analysis and purchase price allocation. The final purchase price allocation will be determined when management has determined the final consideration paid in the merger and completed the detailed valuations and other studies of in-process research and development (IPR&D), inventory, and contingent consideration for the CVR. The final purchase price allocation could differ materially from the preliminary purchase price allocation used to prepare the pro forma adjustments and unaudited pro forma condensed combined financial information. The final purchase price allocation may include (1) changes to assets acquired and liabilities assumed, including goodwill, based on the results of certain valuations and other studies of IPR&D, inventory, and contingent consideration for the CVR that have yet to be completed, (2) changes to assets acquired and liabilities assumed, that will occur through the date of the closing of the merger and (3) changes to the fair value of purchase consideration, which will be impacted by changes in resTORbios common stock outstanding, the share price of resTORbios common stock on the closing date of the merger including those related to potential changes in the fair value of the CVR.
The unaudited pro forma condensed combined financial information does not include the impact of any cost savings due to operating synergies that may result from the merger or any related restructuring costs that may be contemplated and does not give effect to the proposed reverse stock split because the proposed reverse stock split is a range and is not definitive. In addition, the unaudited pro forma condensed combined financial information does not give effect to the proposed issuance of resTORbio common stock pursuant to the funding agreement as the timing of funding is not definitive.
3. Preliminary Purchase Price
Pursuant to the merger agreement, at the closing of the merger, resTORbio expects to issue to Adicets common and preferred stockholders a number of shares of resTORbio common stock, as well as issue to holders of Adicets stock options and redeemable convertible preferred stock warrants a number of options and common stock warrants of resTORbio, representing approximately 75% of the resTORbio outstanding common stock on a fully-diluted basis (excluding equity incentives available for grant). The estimated preliminary purchase price is calculated based on the fair value of resTORbio common stock that the resTORbio stockholders will own as of the closing date of the merger because, with no active trading market for shares of Adicet, the fair value of the resTORbio common stock represents a more reliable measure of the fair value of consideration transferred in the merger. Accordingly, the accompanying unaudited pro forma condensed combined financial information reflects
7
Notes to Unaudited Pro Forma Condensed Combined Financial Information
an estimated purchase price of approximately $95.1 million, which consists of the following (in thousands, except share and per share amounts):
Fair value of common stock shares of the combined company owned by resTORbio stockholders (1) |
$ | 91,276 | ||
Fair value of contingent consideration liability with respect to CVR (2) |
3,140 | |||
Estimated fair value of modified stock options and restricted stock units attributable to precombination services (3) |
674 | |||
|
|
|||
Estimated purchase price |
$ | 95,090 | ||
|
|
(1) | Represents the estimated share consideration of the combined company that the resTORbio stockholders would own as of the closing of the merger. |
Estimated number of shares of the combined company to be owned by resTORbio stockholders (a) |
36,453,882 | |||
Multiplied by the fair value per share of resTORbio common stock (b) |
$ | 2.59 | ||
Estimated acquisition date fair value of resTORbio |
94,416 | |||
Less: portion of the fair value to be distributed as CVR (c) |
(3,140 | ) | ||
|
|
|||
Estimated fair value of shares of the combined company owned by resTORbio stockholders |
$ | 91,276 | ||
|
|
a. | Represents the number of shares of common stock of the combined company that the resTORbio stockholders would own as of the closing of the merger. This amount is calculated, for purposes of this unaudited pro forma condensed combined financial information, as 36,453,882 shares of resTORbio common stock outstanding as of August 4, 2020. |
b. | The estimated purchase price was based on the closing price of resTORbio common stock on August 4, 2020. The requirement to base the final purchase price on the number of shares of resTORbio common stock outstanding and the fair value of resTORbio common stock immediately prior to the closing of the merger could result in a purchase price and goodwill different from that assumed in this unaudited pro forma condensed combined financial information, and that difference may be material. A 10% increase (decrease) to the resTORbio share price would increase (decrease) the purchase price by $9.4 million, with a corresponding change to goodwill. Therefore, the estimated consideration expected to be transferred reflected in this unaudited pro forma condensed combined financial information does not purport to represent what the actual transferred consideration will be when the transaction is completed. The actual purchase price will fluctuate until the closing date of the merger and the final valuation could differ materially from the current estimate. |
c. | The fair value of resTORbio common stock was further adjusted to remove the estimated fair value of the CVR embedded within the closing price, as each holder of resTORbio stock will receive one contractual CVR immediately prior to the merger. |
(2) | Each holder of resTORbio common stock as of immediately prior to the completion of the merger shall be entitled to one CVR issued by resTORbio, subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of resTORbio common stock held by such holder as of immediately prior to the effective time of the merger (see Note 5 Pro Forma Adjustment A(7) related to estimated fair value of CVR). |
8
Notes to Unaudited Pro Forma Condensed Combined Financial Information
(3) | Based on the capitalization of resTORbio as of August 4, 2020, 639,911 outstanding unvested resTORbio restricted stock units will be accelerated in connection with the merger and holders of the restricted stock units will be issued approximately 383,947 shares of resTORbio common stock on a net settlement basis. Similarly, in connection with the merger, vesting of outstanding resTORbio stock options will be accelerated in full and the stock options that will not be the in-the-money on the close of the merger will be canceled, resulting in approximately 656,651 surviving stock options. The acquisition date fair value of these modified resTORbio restricted stock units and resTORbio stock options attributable to the precombination services is included in the estimated purchase price. The acquisition date fair value of these modified resTORbio restricted stock units and resTORbio stock options is calculated based on the number of such resTORbio restricted stock units and resTORbio stock options expected to vest assuming that the merger will close on August 31, 2020. |
Under the acquisition method of accounting, the total purchase price is allocated to the acquired tangible and intangible assets and assumed liabilities of resTORbio based on their estimated fair values as of the closing date of the merger. The excess of the acquisition consideration paid over the estimated fair values of net assets acquired has been recorded as goodwill in the accompanying unaudited pro forma condensed combined balance sheet.
The preliminary allocation of the estimated purchase price to the acquired net assets of resTORbio, based on the estimated fair values as of June 30, 2020, as well as changes in accrued and other current liabilities through the closing of the merger related to costs directly attributable to the transaction that are expected to be incurred by resTORbio between June 30, 2020 and the closing of the merger (see Note 5 Pro Forma Adjustment A(4)), is as follows (in thousands):
Net assets acquired |
||||
Cash and cash equivalents |
$ | 70,889 | ||
Prepaid expenses and other current assets |
2,860 | |||
Inventory |
81 | |||
Property and equipment |
348 | |||
IPR&D |
3,810 | |||
Restricted cash |
245 | |||
Accounts payable |
(2,467 | ) | ||
Accrued and other current liabilities |
(5,253 | ) | ||
Deferred tax liability |
401 | |||
Goodwill |
24,978 | |||
|
|
|||
$ | 95,090 | |||
|
|
The application of the acquisition method of accounting is dependent upon certain valuations and other studies of IPR&D, inventory, and contingent consideration for the CVR that have yet to be completed. The purchase price allocation will remain preliminary until Adicets management determines the fair values of the assets acquired and liabilities assumed. The final determination of the purchase price allocation is anticipated to be completed as soon as practicable after completion of the merger, but no later than one year after the consummation of the merger, and will be based on the fair values of the assets acquired and liabilities assumed as of the closing of the merger. The final amounts allocated to the assets acquired and liabilities assumed as of the closing date of the merger will change due to the amount of cash used in resTORbios operations for research and development activities and general and administrative expenses including transaction-related costs after June 30, 2020 to the merger closing date and other changes in resTORbios assets and liabilities that occur through the merger closing date. The final amounts allocated to assets acquired and liabilities assumed could differ materially from the amounts presented in the unaudited pro forma condensed combined financial information.
9
Notes to Unaudited Pro Forma Condensed Combined Financial Information
4. Shares of resTORbio Common Stock Issued to Adicets Stockholders upon Closing of the Merger
At the closing of the merger, resTORbio (the legal acquirer) will issue to Adicets common and preferred stockholders shares of its common stock based on the exchange ratio determined in accordance with the merger agreement. The estimated exchange ratio for purposes of the unaudited pro forma condensed combined financial information was derived on a fully-diluted basis as of August 4, 2020 using a stipulated value of Adicet of approximately $220.0 million and of resTORbio of approximately $73.3 million. The estimated number of shares of common stock resTORbio expects to issue to Adicets common and preferred stockholders as of August 4, 2020 (ignoring rounding of fractional shares) is determined as follows:
Shares of Adicet common stock |
17,569,569 | |||
Shares of Adicet redeemable convertible preferred stock |
97,166,921 | |||
|
|
|||
114,736,490 | ||||
Exchange ratio |
0.8555 | |||
|
|
|||
Estimated shares of resTORbio common stock issued to Adicet security holders upon closing of transaction |
98,157,067 | |||
|
|
As the reverse stock split is a range and is not definitive and will occur immediately prior to the consummation of the merger, the exchange ratio and estimated shares of resTORbio common stock issued to Adicet security holders have not been adjusted to give retrospective effect to the reverse stock split. Upon the effectiveness of the reverse stock split, the outstanding shares of resTORbio common stock will be combined into a lesser number of shares such that one share of resTORbio common stock will be issued for a specified number of shares, which shall be equal to or greater than four (4) and equal to or less than twelve (12), with the exact number within the range to be mutually determined by resTORbio and Adicet prior to the effective time. The exchange ratio will then be subject to adjustment to account for the effect of the reverse stock split of resTORbio common stock. Assuming a reverse stock split of resTORbio common stock 1:4 or 1:12, the estimated shares of resTORbio common stock issued to Adicet security holders would be 24,452,135 or 8,180,712 shares, respectively.
5. Pro Forma Adjustments
The unaudited pro forma condensed combined financial information includes pro forma adjustments that are (i) directly attributable to the merger, (ii) factually supportable, and (iii) with respect to the unaudited pro forma condensed combined statements of operations and comprehensive loss, expected to have a continuing impact on the results of operations of the combined company. The pro forma adjustments are based on preliminary estimates and assumptions that are subject to change.
Based on Adicet managements review of resTORbios summary of significant accounting policies, the nature and amount of any adjustments to the historical consolidated financial statements of resTORbio to conform to the accounting policies of Adicet are not expected to be significant.
The unaudited pro forma condensed combined financial information does not reflect the proposed reverse stock split that is expected to be effected immediately prior to consummation of the merger. In addition, the unaudited pro forma condensed combined financial information does not give effect to the proposed issuance of resTORbio common stock pursuant to the funding agreement dated April 28, 2020, by and among Adicet, resTORbio and certain investors of Adicet (the funding agreement) pursuant to which such investors committed to fund up to an aggregate of $15 million into an escrow account at or prior to the time of the completion of the merger, which will be used to subscribe for shares of resTORbio common stock in a private placement upon the occurrence of a qualified financing, as such term is described therein.
10
Notes to Unaudited Pro Forma Condensed Combined Financial Information
The pro forma adjustments, based on preliminary estimates that may change materially as additional information is obtained, are as follows:
A. | The pro forma adjustments to reflect the fair value of the assets and liabilities acquired in connection with the merger consist of the following: |
(1) | To reflect the acquired inventory fair value of $0.1 million to be used in research and development. |
(2) | To record goodwill resulting from the merger. Goodwill is comprised of the purchase price of the acquisition in excess of the fair value assigned at acquisition to the net tangible and identifiable intangible assets acquired (see Note 3). |
(3) | To reflect the fair value of acquired IPR&D related to the research and development of RTB101 for a COVID-19 related indication. The RTB101 compound IPR&D project was valued using an income approach, specifically a discounted cash flow method, adjusted for the probability of technical success (PTS). Key inputs include forecast of potential cash flows to be generated by the project and resulting asset, which was developed utilizing estimates of total patient population, market penetration rates, demand risk adjustment factors, product pricing, costs of goods sold, research and development expenses, selling, general and administrative expenses, cash flow adjustments and partner profit split. The projected cash flows were then adjusted using PTS factors that were selected considering both the current state of clinical development and the nature of the proposed indication, (i.e., respiratory therapeutics.) Finally, the resulting probability adjusted cash flows were discounted to a present value using a risk-adjusted discount rate, developed considering the market risk present in the forecast and the size of the asset. IPR&D is accounted for as an indefinite-lived intangible asset until completion or abandonment of the related project. Therefore, no pro forma adjustment for related amortization has been reflected in the unaudited pro forma combined statements of operations and comprehensive loss. The IPR&D intangible assets are subject to testing for impairment annually and upon other triggering events. |
(4) | To reflect changes in accrued and other current liabilities through the closing of the merger related to costs directly attributable to the transaction that are expected to be incurred by resTORbio between June 30, 2020 and the closing of the merger: |
| Approximately $2.1 million for directors and officers tail insurance coverage to be purchased by resTORbio prior to closing. This adjustment will result in a reduction of net assets acquired by Adicet at closing. |
| Estimated costs to complete the transaction of approximately $2.0 million consisting of legal fees, advisory fees, accounting and audit fees and other expenses to be incurred by resTORbio prior to closing. This adjustment will result in a reduction of net assets acquired by Adicet at closing. |
(5) | To eliminate resTORbio deferred rent liability that is not a liability assumed in the merger. |
(6) | To record deferred tax liability in connection with the merger related to the acquired IPR&D. |
(7) | To reflect the fair value of the contingent consideration liability for the CVR. The contingent consideration for the CVR was valued using an income approach, leveraging the forecasted cash flows that would accrue to the combining company and then deducting the administrative fee to be retained by the combined company and other permitted deductions in order to arrive at the net cash expected to be paid out to the CVR holders. These cash flows were then discounted to present value using the same discount rate applied in the valuation of the IPR&D. |
(8) | Represents estimated purchase consideration of approximately $91.3 million for the 36,453,882 shares of the combined company that the existing shareholders of resTORbio are estimated to own after the closing of the merger. |
11
Notes to Unaudited Pro Forma Condensed Combined Financial Information
As the reverse stock split will occur immediately prior to the consummation of the merger and the final split ratio has not been determined as of the date of this filing the pro forma combined common stock capital accounts have not been adjusted to give retrospective effect to the reverse stock split. The reverse stock split will not affect the pro forma combined common stock capital accounts, however, because the par value per share will remain unchanged on the effective date of the reverse stock split, the components that make up the common stock capital accounts will change by offsetting amounts. Depending on the size of the reverse stock split that resTORbio and Adicet decide to implement, the common stock account will be decreased and additional paid-in capital will be increased by offsetting amounts.
(9) | Represents estimated purchase consideration of approximately $0.7 million attributable to precombination services for the resTORbio employee stock options and restricted stock units. |
(10) | To eliminate resTORbios historical shareholders equity. |
B. | Represents an adjustment to accrued and other current liabilities to reflect those that are directly attributable to the closing of the merger, including: |
(1) | Approximately $1.2 million in severance obligations for resTORbios employees. The payment of these arrangements is contingent on the employees providing service over the transition periods, which is expected to be completed within nine months and will be recognized in the combined companys financial statements following the closing of the merger. |
(2) | Approximately $0.9 million in obligations under the Transition Agreement executed with Adicets current President and Chief Executive Officer, Anil Singhal, in connection with the merger Agreement (the Transition Agreement) which will be recorded by the combined company following the closing of the merger. |
(3) | Estimated costs to complete the transaction of approximately $0.7 million consisting of legal fees, advisory fees, accounting and audit fees and other expenses to be incurred by Adicet. |
These pro forma adjustments are not reflected in the unaudited pro forma condensed combined statements of operations and comprehensive loss as these amounts are not expected to have a continuing effect on the operating results of the combined company.
C. | Represents an adjustment to reflect the reclassification from redeemable convertible preferred stock to common stock and additional paid-in capital resulting from the conversion of shares of Adicet into shares of resTORbio common stock based on the exchange ratio. |
D. | Represents an adjustment to reclassify Adicets redeemable convertible preferred stock warrant liability of $2.0 million to additional paid-in capital as a result of the conversion of the warrant being exercisable for resTORbioss common stock rather than Adicets redeemable convertible preferred stock. The warrants exercisable for resTORbios common stock will be classified within equity. |
E. | Represents an adjustment to record post-combination stock compensation expense of approximately $2.3 million for the acceleration of resTORbio employee stock options and restricted stock units, outstanding immediately prior to the closing of the merger in accordance with the terms of the merger agreement for which there is no future service requirement. This amount is excluded from the unaudited pro forma condensed combined statements of operations and comprehensive loss because it will not have a continuing impact on the combined organizations operations; however, the amount is reflected as an increase to accumulated deficit and additional paid-in capital in the unaudited condensed combined pro forma balance sheet because the amount is directly attributable to the merger. |
F. | Represents an adjustment to write-off acquired inventory of material to be used in research and development of the CVR product. This pro forma adjustment is not reflected in the unaudited pro forma condensed combined statements of operations and comprehensive loss as this amount is not expected to have a continuing effect on the operating results of the combined company. |
12
Notes to Unaudited Pro Forma Condensed Combined Financial Information
G. | Represents an adjustment to record post-combination stock expense of approximately $0.9 million for modification of Adicets current President and Chief Executive Officers stock options in connection with the Transition Agreement. This amount is excluded from the unaudited pro forma condensed combined statements of operations and comprehensive loss because it will not have a continuing impact on the combined organizations operations; however, the amount is reflected as an increase to accumulated deficit and additional paid-in capital in the unaudited pro forma balance sheet because the amount is directly attributable to the merger. |
H. | Represents an adjustment to eliminate the impact of the change in the fair value of Adicet redeemable convertible preferred stock warrant liability of $0.1 million for six months ended June 30, 2020 and $0.3 million for the year ended December 31, 2019 for warrants issued by Adicet as all warrants will become exercisable for resTORbio common stock pursuant to the merger agreement. As a result, the Adicet redeemable convertible preferred stock warrants would no longer be subject to fair value accounting following the assumed closing of the merger. |
I. | Represents an adjustment to eliminate the impact of the change in the fair value of Adicets redeemable convertible preferred stock tranche liability and Technion Research and Development Foundation Ltd. (referred to as TRDF) liability of $2.0 million during the year ended December 31, 2019. As the redeemable convertible preferred stock tranche liability and TRDF liability would not exist once the redeemable convertible preferred stock are converted to common stock in the merger and therefore the changes in the fair value of redeemable convertible preferred stock tranche liability and TRDF liability are removed from the unaudited pro forma condensed combined statements of operations. |
J. | Represents an adjustment to eliminate non-recurring transaction costs of $2.0 million and $5.3 million incurred by resTORbio and Adicet, respectively, in connection with the merger and recorded as expense in their respective historical consolidated statements of operations and comprehensive loss for the six months ended June 30, 2020 as these expenses are not expected to have a continuing effect on the operating results of the combined company. |
K. | The weighted average shares outstanding for the period have been adjusted to give effect to the issuance of resTORbio common stock in connection with the merger as of January 1, 2019 or the date of issuance of Adicet preferred stock, if later. As the combined company is in a net loss position, any adjustment for potentially dilutive shares would be anti-dilutive, and as such basic and diluted loss per share are the same. The following table presents the calculation of the pro forma weighted average number of common stock outstanding without giving effect to the proposed reverse stock split: |
Six Months Ended June 30, 2020 |
Year Ended December 31, 2019 |
|||||||
Weighted average Adicet shares outstanding |
17,502,411 | 17,249,656 | ||||||
Weighted average shares of Adicet redeemable convertible preferred stock |
97,166,921 | 62,555,395 | ||||||
|
|
|
|
|||||
114,669,332 | 79,805,051 | |||||||
Weighted average Adicet shares outstanding adjusted for exchange ratio |
98,099,613 | 68,273,221 | ||||||
Weighted average resTORbio shares outstanding |
36,445,460 | 34,306,374 | ||||||
Net shares of resTORbio common stock to be issued with respect to outstanding resTORbio RSUs |
383,947 | 16,924 | ||||||
|
|
|
|
|||||
Pro forma combined weighted average number of shares of common stockbasic and diluted |
134,929,020 | 102,596,519 | ||||||
|
|
|
|
13
Notes to Unaudited Pro Forma Condensed Combined Financial Information
As the reverse stock split is a range and is not definitive and will occur immediately prior to the consummation of the merger, resTORbios historical weighted average shares outstanding and the pro forma combined weighted average shares outstanding have not been adjusted to give retrospective effect to the reverse stock split. Upon the effectiveness of the reverse stock split, the outstanding shares of resTORbio common stock will be combined into a lesser number of shares such that one share of resTORbio common stock will be issued for a specified number of shares, which shall be equal to or greater than four (4) and equal to or less than twelve (12), with the exact number within the range to be mutually determined by resTORbio and Adicet prior to the effective time. The exchange ratio will then be subject to adjustment to account for the effect of the reverse stock split of resTORbio common stock. The following table is presented for illustrative purposes to give effect to the range of the proposed reverse stock split on the pro forma combined net loss per share attributable to common stockholders, basic and diluted, as the pro forma condensed combined financial information does not reflect the proposed reverse stock split that is expected to be effected immediately prior to consummation of the merger.
Pro forma combined net loss per share attributable |
Six months Ended June 30, 2020 |
Year Ended December 31, 2019 |
||||||
1:4 reverse stock split |
$ | (0.54 | ) | $ | (4.41 | ) | ||
1:12 reverse stock split |
$ | (1.63 | ) | $ | (13.23 | ) |
14