Full Press Release Details
CERTAIN INFORMATION IN THIS EXHIBIT IDENTIFIED BY [***] IS CONFIDENTIAL AND HAS BEEN EXCLUDED BECAUSE IT (I) IS NOT MATERIAL AND
(II) THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS THAT INFORMATION AS PRIVATE OR CONFIDENTIAL.
RESEARCH AND COLLABORATION AGREEMENT
ASTRAZENECA IRELAND LIMITED
DATED NOVEMBER 1, 2023
| Article 1 Definitions | 1 | |||||
| Article 2 Research Programs | 19 | |||||
| 2.1 | Overview | 19 | ||||
| 2.2 | Target Pool | 19 | ||||
| 2.3 | Research Plans | 21 | ||||
| 2.4 | Conduct of Research Activities | 22 | ||||
| 2.5 | Development Candidates | 23 | ||||
| 2.6 | Records, Reports, and Materials | 24 | ||||
| Article 3 Option; Licenses; Exclusivity; Rights of Negotiation | 25 | |||||
| 3.1 | Option | 25 | ||||
| 3.2 | License Grants to AstraZeneca | 26 | ||||
| 3.3 | License Grant to Cellectis | 26 | ||||
| 3.4 | Sublicensing Rights | 26 | ||||
| 3.5 | Subcontractors | 27 | ||||
| 3.6 | Upstream Licenses | 27 | ||||
| 3.7 | Knowledge and Technology Transfer | 29 | ||||
| 3.8 | No Implied Licenses; Retained Rights | 29 | ||||
| 3.9 | Competing Product Exclusivity | 29 | ||||
| 3.10 | AstraZeneca Rights of Negotiation | 30 | ||||
| 3.11 | Cellectis Right to Negotiate | 31 | ||||
| Article 4 Governance | 32 | |||||
| 4.1 | Joint Steering Committee | 32 | ||||
| 4.2 | Joint Project Teams | 34 | ||||
| 4.3 | Alliance Managers | 35 | ||||
| 4.4 | Additional Participants | 35 | ||||
| 4.5 | Decision-Making | 35 | ||||
| 4.6 | General Authority | 36 | ||||
| 4.7 | Dispute Resolution | 36 | ||||
| Article 5 Development | 36 | |||||
| 5.1 | Licensed Product Development | 36 | ||||
| 5.2 | Development Diligence | 37 | ||||
| 5.3 | Development Reports | 37 | ||||
| 5.4 | [***] Findings Sharing | 37 |
| Article 6 Regulatory Affairs | 37 | |||||
| 6.1 | Regulatory Activities | 37 | ||||
| 6.2 | Cellectis Regulatory Support | 37 | ||||
| 6.3 | Assignment of Regulatory Documentation | 38 | ||||
| 6.4 | Right of Reference | 38 | ||||
| 6.5 | Recalls, Suspensions, or Withdrawals | 38 | ||||
| 6.6 | Global Safety Database | 38 | ||||
| Article 7 Manufacturing and Technology Transfer | 38 | |||||
| 7.1 | Pre-Option Exercise Date | 38 | ||||
| 7.2 | Post-Option Exercise Date | 39 | ||||
| 7.3 | AstraZeneca Option for Additional Cellectis Manufacturing Capacity | 39 | ||||
| 7.4 | Manufacturing Technology Transfers | 39 | ||||
| Article 8 Commercialization | 40 | |||||
| 8.1 | In General | 40 | ||||
| 8.2 | Booking of Net Sales | 40 | ||||
| 8.3 | Commercialization Diligence | 40 | ||||
| 8.4 | Licensed Product Trademarks | 41 | ||||
| Article 9 Financial Terms | 41 | |||||
| 9.1 | Upfront Payment | 41 | ||||
| 9.2 | Cellectis Research Costs | 41 | ||||
| 9.3 | Milestones | 42 | ||||
| 9.4 | Royalty Payments | 44 | ||||
| 9.5 | Sublicensing Revenue | 45 | ||||
| 9.6 | Combination Products Adjustment | 45 | ||||
| 9.7 | Royalty Reports; Payments | 46 | ||||
| 9.8 | Mode of Payment | 46 | ||||
| 9.9 | Taxes | 46 | ||||
| 9.10 | Interest on Late Payments | 48 | ||||
| 9.11 | Financial Records | 48 | ||||
| 9.12 | Audit | 48 | ||||
| 9.13 | Right to Offset | 49 | ||||
| Article 10 Intellectual Property | 49 | |||||
| 10.1 | Ownership of Intellectual Property | 49 | ||||
| 10.2 | Prosecution and Maintenance | 51 |
| 10.3 | Enforcement | 54 | ||||
| 10.4 | Defense | 56 | ||||
| 10.5 | Common Ownership Under Joint Research Agreements | 56 | ||||
| 10.6 | UPC | 56 | ||||
| Article 11 Confidentiality | 56 | |||||
| 11.1 | Confidential Information | 56 | ||||
| 11.2 | Exceptions | 57 | ||||
| 11.3 | Permitted Disclosures | 57 | ||||
| 11.4 | Publicity | 59 | ||||
| 11.5 | No Use of Name | 59 | ||||
| 11.6 | Publications and Presentations | 59 | ||||
| Article 12 Representations and Warranties; Covenants | 60 | |||||
| 12.1 | Mutual Representations and Warranties | 60 | ||||
| 12.2 | Additional Representations of Cellectis as of the Effective Date | 61 | ||||
| 12.3 | Additional Representations of Cellectis as of the Option Exercise Date | 62 | ||||
| 12.4 | Compliance Covenants | 65 | ||||
| 12.5 | Additional Covenants of Cellectis | 66 | ||||
| 12.6 | Disclaimer | 66 | ||||
| Article 13 Indemnification; Limitation of Liability; Insurance | 66 | |||||
| 13.1 | Indemnification of Cellectis by AstraZeneca | 66 | ||||
| 13.2 | Indemnification of AstraZeneca by Cellectis | 67 | ||||
| 13.3 | Conditions to Indemnification | 67 | ||||
| 13.4 | Limitation of Liability | 67 | ||||
| 13.5 | Insurance | 68 | ||||
| Article 14 Term and Termination | 68 | |||||
| 14.1 | Term | 68 | ||||
| 14.2 | Termination | 68 | ||||
| 14.3 | Effects of Termination | 69 | ||||
| 14.4 | Survival of Sublicenses | 71 | ||||
| 14.5 | Remedies | 72 | ||||
| 14.6 | Accrued Rights | 72 | ||||
| 14.7 | Surviving Obligations | 72 | ||||
| 14.8 | Sell-Off Right | 72 | ||||
| 14.9 | Confidential Information | 73 |
| Article 15 Miscellaneous | 73 | |||||
| 15.1 | Dispute Resolution | 73 | ||||
| 15.2 | Governing Law | 74 | ||||
| 15.3 | Designation of Affiliates | 74 | ||||
| 15.4 | Injunctive Relief | 74 | ||||
| 15.5 | Cumulative Remedies | 75 | ||||
| 15.6 | Notices | 75 | ||||
| 15.7 | Amendment; Waiver | 75 | ||||
| 15.8 | Assignment and Successors | 76 | ||||
| 15.9 | Force Majeure | 76 | ||||
| 15.10 | Interpretation | 76 | ||||
| 15.11 | Integration | 76 | ||||
| 15.12 | Severability | 77 | ||||
| 15.13 | Further Assurances | 77 | ||||
| 15.14 | Rights in Bankruptcy | 77 | ||||
| 15.15 | Counterparts | 77 | ||||
| 15.16 | Relationship of the Parties | 77 | ||||
| 15.17 | English Language | 78 | ||||
| 15.18 | No Third Party Beneficiaries | 78 | ||||
| 15.19 | Change of Control of Cellectis | 78 |
| Schedule 1.93: | Existing Upstream Licenses | |
| Schedule 1.208: | [***] Patent Rights | |
| Schedule 1.230: | [***] | |
| Schedule 2.2.1: | Initial Target Pool and Target Encumbrances | |
| Schedule 3.6.1: | Certain Terms of Existing Upstream Licenses | |
| Schedule 12.2: | Exceptions to Additional Representations of Cellectis as of the Effective Date | |
| Schedule 14.3: | [***] |
JOINT RESEARCH AND COLLABORATION AGREEMENT
This JOINT RESEARCH AND COLLABORATION
AGREEMENT (this Agreement ) is entered into November 1, 2023 (the Effective Date ), by and between Cellectis S.A., a Corporation under the laws of the France having a place
of business at 8, rue de la Croix Jarry, 75013 Paris, France ( Cellectis ), and AstraZeneca Ireland Limited, a company incorporated in Ireland under no. 734129, whose registered office is at College Business and Technology Park,
Blanchardstown, Dublin 15, D15 R925, Ireland ( AstraZeneca ). Cellectis and AstraZeneca are sometimes referred to herein individually as a Party and collectively as the Parties.
WHEREAS, Cellectis is a clinical-stage biopharmaceutical company that harnesses the immune system to target and eradicate cancer cells;
WHEREAS, AstraZeneca is a global pharmaceutical company focused on developing and commercializing biopharmaceutical products;
WHEREAS, on the date of this Agreement, an Affiliate of AstraZeneca has entered into that certain initial investment agreement with Cellectis
for the subscription of sixteen million (16,000,000) ordinary shares in Cellectis in consideration for eighty Million Dollars ($80,000,000) (the Initial Investment )
WHEREAS, on the date of this Agreement, the Parties have entered into that certain memorandum of understanding (the MOU ),
which set forth the status of their negotiations and the contemplated next steps with respect to certain transactions, including the proposed further investment by AstraZeneca, directly or indirectly through its Affiliates, in Cellectis s share
capital, as further set out in that certain subsequent investment agreement;
WHEREAS, each of this Agreement, the Initial Investment, and
the MOU constitute components of the same transaction; and
WHEREAS, the Parties desire to enter into a collaboration to Develop certain
Candidate Products, and AstraZeneca desires to obtain, and Cellectis desires to grant, certain options to obtain exclusive licenses, under the Licensed Technology, to Exploit Licensed Products in the Field in the Territory (each, as defined below),
in each case, under the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and the mutual promises
and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1.1 Accounting Standards means, with respect to a Party or its Affiliates or its or their Sublicensees, United States
generally accepted accounting principles, International Financial Reporting Standards, or such other similar national standards as such Party, Affiliate, or its or their Sublicensee adopts, in each case, consistently applied.
1.2 Additional DC Activities has the meaning set forth in Section 2.5.5 (Additional DC Activities).
1.3 Additional Indication has the meaning set forth in
Section 2.3.4 (Additional Research Plans).
1.4 Additional Research Plan has the meaning set forth in
Section 2.3.4 (Additional Research Plans).
1.6 Affiliate means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more
intermediaries, controls, is controlled by, or is under common control with such Party. For purposes of this Section 1.6 (Affiliate), control and, with correlative meanings, the terms controlled by and under common
control with , means: (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or
corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of fifty percent (50%) or more of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other
similar entity, its general partner or controlling entity). Notwithstanding the foregoing, a Party and its Affiliates shall not constitute Affiliates of the other Party or such other Party s Affiliates.
1.7 Agreement has the meaning set forth in the Preamble.
1.8 Alliance Manager has the meaning set forth in Section 4.3 (Alliance Managers).
1.9 AMF means the France Autorit des March s Financiers or any successor thereto.
1.10 Applicable Law means applicable laws, rules and regulations, statutes, ordinances, treaties, directives,
administrative interpretations, rules of national stock exchanges, and any rules, regulations, guidelines, or other requirements of any relevant Regulatory Authority or Governmental Authority, in each case, that may be in effect from time to time,
including the applicable regulations and guidances of the FDA and EMA (and national implementations thereof) that constitute cGLP, cGMP, and cGCP (and, to the extent appropriate under the circumstances, International Conference on Harmonization
(ICH) guidance or other comparable regulation and guidance of any applicable Regulatory Authority in the Territory).
Arbitration Notice has the meaning set forth in Section 15.1.1 (Executive Officer Negotiations).
Arbitrators has the meaning set forth in Section 15.1.2(a).
1.13 AstraZeneca has the
meaning set forth in the Preamble.
1.14 AstraZeneca Background
Know-How means all Know-How Controlled by AstraZeneca or any of its Affiliates: (a) as of the Effective Date; or (b) during the Term independently of
the activities under this Agreement.
1.15 AstraZeneca Background Patent Rights means all Patent Rights
Controlled by AstraZeneca or any of its Affiliates that claim or otherwise Cover any AstraZeneca Background Know-How.
1.16 AstraZeneca Background Technology means, collectively, the AstraZeneca Background Patent Rights and the
AstraZeneca Background Know-How.
1.18 AstraZeneca Foreground Know-How has the meaning set forth in
1.19 AstraZeneca Foreground Patent Right has the meaning set forth in
1.20 AstraZeneca Foreground Technology has the meaning set forth in
1.21 AstraZeneca Indemnitees has the meaning set forth in Section 13.2
(Indemnification of AstraZeneca by Cellectis).
1.22 AstraZeneca Licensed Technology means all Patent Rights and
Know-How Controlled by AstraZeneca or any of its Affiliates as of the Effective Date or during the Term that, in each case, claim or otherwise Cover, or are otherwise are necessary for, the performance of the
Cellectis Research Activities.
1.23 AstraZeneca Patent Rights has the meaning set forth in Section 10.2.2
(AstraZeneca Patent Rights).
1.24 AstraZeneca Research Activities means, with respect to a given Research Plan,
the Research Activities expressly allocated to AstraZeneca under such Research Plan.
1.25 Bankruptcy Code has
the meaning set forth in Section 15.14 (Rights in Bankruptcy).
1.26 Biosimilar Application has the meaning
set forth in Section 10.3.5 (Biosimilar Litigation).
1.27 BLA means a Biologics License Application (as
more fully described in 21 C.F.R. Part 601, et seq., or its successor regulation) filed with the FDA or abbreviated processes relating to the foregoing, any successor application to the foregoing, or the foreign equivalent of any such application in
any other country or group of countries filed with a Regulatory Authority to obtain marketing approval for a biopharmaceutical product, including a marketing authorization application filed with the EMA.
1.28 Brief has the meaning set forth in [***].
1.29 Business Day means a day that is not a Saturday, Sunday, or a day on which banking institutions in Paris,
France, Dublin, Ireland, New York, New York, and London, England are authorized or required by Applicable Law to remain closed.
1.30 Calendar Quarter means each successive period of three (3) calendar months commencing on January 1,
April 1, July 1, and October 1. Notwithstanding the foregoing, the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1,
July 1 or October 1 after the Effective Date, and the last Calendar Quarter of the Term shall end on the last day of the Term.
1.31 Calendar Year means each successive period of twelve (12) calendar months commencing on January 1 and
ending on December 31. Notwithstanding the foregoing, the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurred, and the last Calendar Year of the Term shall
commence on January 1 of the year in which the Term ends and end on the last day of the Term.
1.32 Candidate Product has the meaning provided in
Section 2.3.1 (Research Plans In General).
1.33 Candidate Product Approval Date means, on a Candidate
Product-by-Candidate Product basis, the date of JSC approval of the corresponding Research Plan pursuant to Section 2.3.1 (Research Plans In General).
1.34 Cellectis has the meaning set forth in the Preamble.
1.35 Cellectis Acquiror has the meaning set forth in Section 15.19 (Change of Control of
1.36 Cellectis Background Know-How means all Know-How Controlled by Cellectis or any of its Affiliates: (a) as of the Effective Date; or (b) during the Term independently of the activities under this Agreement.
1.37 Cellectis Background Patent Rights means all Patent Rights Controlled by Cellectis or any of its
Affiliates that claim or otherwise Cover any Cellectis Background Know-How.
Cellectis Background Technology means, collectively, the Cellectis Background Patent Rights and the Cellectis Background Know-How.
1.39 Cellectis Foreground Know-How has the meaning set forth in
1.40 Cellectis Foreground Patent Right has the meaning set forth in