Exhibit 10.1
Execution Version
Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions.
RESEARCH AND COLLABORATION AGREEMENT
between
VERVE THERAPEUTICS, INC.
and
ELI LILLY AND COMPANY
Dated as of June 14, 2023
RESEARCH AND COLLABORATION AGREEMENT
This Research and Collaboration Agreement (this “Agreement”) is made and entered into as of June 14, 2023 (the “Execution Date”) by and between Verve Therapeutics, Inc., a Delaware corporation (“Verve”), and Eli Lilly and Company, an Indiana corporation (“Lilly”). Verve and Lilly are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Verve owns and controls certain intellectual property rights with respect to gene editing products and technology and expertise in the development and manufacturing of gene editing products;
WHEREAS, Lilly and its Affiliates (defined below) have expertise in the research, development, manufacturing and commercialization of pharmaceutical products;
WHEREAS, the Parties wish to collaborate on certain activities aimed at research and development of Licensed Products (defined below) in accordance with the terms set forth below; and
WHEREAS, Verve wishes to grant to Lilly, and Lilly wishes to obtain, exclusive licenses under certain of Verve’s intellectual property rights to Exploit (defined below) Licensed Products, in accordance with the terms and conditions set forth below.
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, hereby agree as follows:
Definitions
Unless otherwise specifically provided herein, the following terms shall have the meanings set forth in this Article 1:
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[**];
in each case (1.59.1 through 1.59.7), to the extent such costs are calculated in accordance with Accounting Standards and incurred by a Party either (x) during the Cost-Sharing Term or (y) in the [**] period prior to the applicable Cost-Sharing Option Effective Date primarily in furtherance of Phase 2 Clinical Trials or later activities for such Co-Funded Product. Notwithstanding anything to the contrary set forth in this Agreement, “Development Costs” in all cases will exclude [**].
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Notwithstanding anything to the contrary set forth above, “Eligible Costs” are exclusive of and do not include [**] or any cost for which a Party is solely responsible under this Agreement. Except to the extent already included in Internal Qualified Expenses, “Eligible Costs” shall not include either Party’s costs [**].
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[**];
Such amounts shall be determined from the books and records of Lilly or its Affiliate or Sublicensee, maintained in accordance with U.S. GAAP or, in the case of Sublicensees, such similar accounting principles, consistently applied. Lilly further agrees in determining such amounts, it will use Lilly’s then current standard procedures and methodology, including Lilly’s then current standard exchange rate methodology for the translation of foreign currency sales into U.S. Dollars or, in the case of Sublicensees, such similar methodology, consistently applied.
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A qualifying amount may be deducted only once regardless of the number of the preceding categories that describes such amount. Sales between or among Lilly, its Affiliates and Sublicensees will be excluded from the computation of Net Sales if such sales are not intended for end use, but Net Sales will include the subsequent final sales to Third Parties by Lilly or any such Affiliates or Sublicensees.
In the event that the Licensed Product is sold in the form of a Combination Licensed Product (where “Combination Licensed Product” means any Licensed Product containing one or more other therapeutically active compound(s) or ingredients that is not a Verve Gene Editor or Verve Delivery Element (“Other Product”)), the Net Sales of the Licensed Product, for the purposes of determining royalty payments, shall be determined by [**].
In the event that the weighted average sale price of the [**] Product can be determined but the weighted average sale price of the Other Product cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by [**].
In the event that the weighted average sale price of the Other Product can be determined but the weighted average sale price of the [**] Product cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by [**].
In the event that the weighted average sale price of both the [**] Product and the Other Product in the Combination Licensed Product cannot be determined, the Net Sales of the Licensed Product shall be calculated by [**].
The weighted average sale price for a Licensed Product, other compound(s) or ingredients, or Combination Licensed Product shall be calculated [**] and such price shall be used during all applicable royalty reporting periods for the [**]. When determining the weighted average sale price of a Licensed Product, other compound(s) or ingredients, or Combination Licensed Product, the weighted average sale price shall be calculated by dividing the sales amount (translated into U.S. dollars) by the units of active ingredient sold during the [**] for the respective Licensed Product, other compound(s) or ingredients, or Combination Licensed Product. In the [**], a forecasted weighted average sale price will be used for the Licensed Product, other compound(s) or ingredients, or Combination Licensed Product. Any over or under payment due to a difference between forecasted and actual weighted average sale prices will be paid or credited in the first royalty payment of the [**].
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in each case ((a) and (b)), which period may be extended by Lilly pursuant to Section 2.3 or by mutual agreement of the Parties.
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[**];
[**]. Notwithstanding anything to the contrary, the Supply Price will not include (x) [**] or (y) [**].
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Overview; Programs and Research and Development Plans
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Research and Development Program
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Later DEVELOPMENT and COMMERCIALIZATION
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Manufacturing
Cost-Sharing Option; Co-Funded Products
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Governance
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LICENSE RIGHTS
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EXClUSIVITY
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Fees, Royalties, & Payments
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Table 10.3.1 – Research and Development Milestone Payments
| Milestone Event | Milestone Payment |
(1) | [**] | [**] |
(2) | [**] | [**] |
(3) | [**] | [**] |
(4) | [**] | [**] |
(5) | [**] | [**] |
(6) | [**] | [**] |
(7A) | [**] | [**] |
(7B) | [**] | [**] |
Table 10.3.2 – Commercial Milestone Payments
| Milestone Event | Milestone Payment |
(1) | Calendar Year Net Sales Exceed USD $[**] | USD $[**] |
(2) | Calendar Year Net Sales Exceed USD $[**] | USD $[**] |
(3) | Calendar Year Net Sales Exceed USD $[**] | USD $[**] |
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| Milestone Event | Milestone Payment |
(4) | Calendar Year Net Sales Exceed USD $[**] | USD $[**] |
Table 10.4.1 – Royalty Rates
Net Sales in a Calendar Year | Royalty Rate |
Net Sales in a Calendar Year less than [**] Dollars (USD $[**]) | [**]% |
Net Sales in a Calendar Year greater than or equal to [**] Dollars (USD $[**]) but less than [**] Dollars (USD $[**]) | [**]% |
Net Sales in a Calendar Year greater than or equal to [**] Dollars (USD $[**]) | [**]% |
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INTELLECTUAL PROPERTY
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Representations, Warranties and Covenants
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INDEMNIFICATION
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CONFIDENTIALITY
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If a Party is required to make a disclosure of the other Party’s Confidential Proprietary Information pursuant to Section 14.1.4(c) or Section 14.1.4(d), it shall, except where impracticable, give reasonable advance notice to the other Party of such disclosure and use efforts to secure confidential treatment of such Confidential Proprietary Information at least as diligent as such Party would use to protect its own Confidential Proprietary Information, but in no event less than reasonable efforts. Any information disclosed pursuant to this Section 14.1.4 remains Confidential Proprietary Information and subject to the restrictions set forth in this Agreement, including the foregoing provisions of this Article 14. Notwithstanding anything to the contrary set forth herein, no summary, abstract, compendium, survey, overview, notes or other report delivered by a Party pursuant to an obligation set forth under this Agreement, or otherwise shared between the Parties in connection with discussions of the JSC or its subcommittees, shall be disclosed by a Party to a Third Party without the prior written consent of the other Party.
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HSR FILINGS AND CLOSING
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TERM & TERMINATION
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GOVERNING LAW; DISPUTE RESOLUTION
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MISCELLANEOUS
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If to Verve: | Verve Therapeutics, Inc. 201 Brookline Avenue Boston, MA 02215 Attn: Business Development Email: [**]
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| With copies (which shall not constitute notice) to:
Wilmer Cutler Pickering Hale and Dorr LLP 60 State Street Boston, MA 02109 Attn: Sarah Tegan Hogan and Craig Hilts Email: [**] and [**] |
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If to Lilly: | Eli Lilly and Company Lilly Corporate Center |
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| Indianapolis, Indiana 46285 Attn: [**] With copies (which shall not constitute notice) to:
Eli Lilly and Company |
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[Signature page follows.]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Execution Date.
VERVE THERAPEUTICS, INC.
By: /s/ Andrew Ashe________________ Name: Andrew Ashe Title: President and Chief Operating Officer Date: June 13, 2023
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[Signature Page to Research and Collaboration Agreement]
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Execution Date.
ELI LILLY AND COMPANY
By: _/s/ David A. Ricks______________ Name: David A. Ricks Title: Chairman and Chief Executive Officer Date: June 14, 2023
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[Signature Page to Research and Collaboration Agreement]