Exhibit 10.17
Confidential – 04 October 2021
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.
LICENSE AGREEMENT
This License Agreement (“Agreement”) is made as of October 4, 2021 (“Effective Date”), by and between Novartis Pharma AG, a corporation organized under the laws of Switzerland, having a place of business at Lichtstrasse 35, CH-4056 Basel, Switzerland (“Novartis”), and Verve Therapeutics, Inc., a corporation company organized and existing under the laws of Delaware and located at 500 Technology Square, Suite 901, Cambridge, MA 02139 USA (“Licensee”). Novartis and Licensee are each referred to individually as a “Party” and together as the “Parties.”
RECITALS
Whereas, Novartis owns or controls the Licensed Patents (as defined below);
Whereas, Licensee wishes to obtain a non-exclusive license and right to practice the Licensed Patents in the Licensed Field (as defined below) for the development and commercialization of its own products; and
Whereas, Novartis wishes to grant such a license to Licensee for the consideration set forth herein.
Now therefore, in consideration of the mutual covenants and agreements herein contained, the Parties agree as follows.
“AAA” has the meaning set forth in Section 11.5(b).
“Accounting Standards” means, with respect to Novartis, International Financial Reporting Standards (“IFRS”), and with respect to Licensee, US Generally Accepted Accounting Practices (“US GAAP”), in each case as generally and consistently applied throughout the Party’s organization.
“Affiliate” means, with respect to a Party, any Person that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” shall mean, direct or indirect, ownership of 50% or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or 50% or more of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby the entity or person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity. In the case of entities organized under the laws of certain countries, the maximum percentage ownership permitted by law for a foreign investor may be less than 50%, and 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.
“Applicable Law” means any federal, state, local, or foreign law, statute or ordinance (including common law), or any rule, regulation, judgment, order, writ, or decree of or from any court or other Regulatory Authority having jurisdiction over or related to the subject item that may be in effect from time to time.
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“Auditor” has the meaning set forth in Section 5.4(b).
“Business Day” means any day that is not a Saturday, Sunday, or other day on which commercial banks are authorized or required to be closed, as the case may be, in Basel Switzerland, or Cambridge, Massachusetts USA, as applicable.
“Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30, and December 31.
“Calendar Year” means a period of twelve consecutive calendar months ending on December 31.
“Claims” means all Third Party demands, claims, actions, proceedings, and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, reasonable legal costs, and other reasonable expenses of any nature whatsoever.
“Commercialize” means to manufacture for commercial use, market, promote, distribute, import, export, offer to sell and/or sell one or more Product(s), as well as conducting all associated post-launch regulatory activities, including medical affairs oversight, and the term “Commercialization” means such commercialization activities relating to one or more Product(s).
“Develop” or “Development” means drug development activities, including, without limitation, manufacture of a Product for research and clinical trials, test method development and stability testing, assay development and audit development, toxicology, formulation, quality assurance/quality control development, statistical analysis, clinical studies, packaging development, regulatory affairs, and the preparation, filing, and prosecution of Regulatory Filings as necessary to obtain Regulatory Approval to market and/or sell a Product.
“Development Milestone” has the meaning set forth in Section 4.2.
“Development Milestone Payment” has the meaning set forth in Section 4.2.
“FDA” means the United States Food and Drug Administration, or any successor entity thereto.
“First Commercial Sale” means, with respect to a Product, the first arm’s length sale to a Third Party for use or consumption of any such Product in a country.
“FPFD” means first patient, first dose.
“Gene editor payload” means a payload that can edit a gene including [**].
“IND” means an Investigational New Drug application in the US filed with the FDA or the corresponding application for the investigation of Products in any other country or group of countries, as defined in the applicable laws and regulations and filed with the Regulatory Authority of a given country or group of countries.
“Information” means all confidential and/or proprietary information and data of a financial, commercial, or technical nature that the disclosing Party or any of its Affiliates has supplied or otherwise made available to the other Party or its Affiliates, whether made available orally, in writing or in electronic form, including information comprising or relating to concepts, discoveries, inventions, data, designs or formulae in relation to this Agreement.
“Insolvency Event” means:
(a) Licensee ceases to function as a going concern by suspending or discontinuing its business;
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(b) Licensee is the subject of voluntary or involuntary bankruptcy proceedings instituted on behalf of or against Licensee (except for involuntary bankruptcy proceedings that are dismissed within [**]);
(c) an administrative receiver, receiver and manager, interim receiver, custodian, sequestrator, or similar officer is appointed for Licensee; or
(d) Licensee makes any general assignment for the benefit of all of its creditors.
“Licensee Indemnitees” has the meaning set forth in Section 10.2.
“Licensed Field” means delivery of gene editor payloads for the prevention and treatment of [**]; provided, however, that the term “Licensed Field” excludes [**].
“Licensed Patents” means the Patent Rights identified in Exhibit A.
“Net Sales” means the [**].
“Novartis Indemnitees” has the meaning set forth in Section 10.1.
“Patent Right” means: (a) patent applications, including any provisional patent applications, in any country; (b) any patent application claiming priority from such patent application or provisional application, including all divisionals, continuations, substitutions, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (c) any patent that has issued or in the future issues from any of the foregoing patent applications, including any utility model, petty patent, design patent, and certificate of invention; (d) any re-examinations, reissues, additions, renewals, extensions, registrations, supplemental protection certificates of any of the foregoing patents or patent applications ((a), (b), and (c)); and (e) any similar rights, including so-called pipeline protection, or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any such foregoing patent application or patent.
“Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.
“Phase 2 Clinical Trial” means a clinical study of a Product in patients designed to establish the dosing range for such Product and the safety and efficacy of such Product, as further defined in 21 C.F.R. §312.21(b) (or the non-United States equivalent thereof).
“Phase 3 Clinical Trial” means a controlled clinical study of a Product in patients designed to establish efficacy and safety of such Product for the purpose of preparing and submitting a filing for BLA approval in the US, or European Regulatory Approval, as further defined in 21 C.F.R. §312.21(c) (or the non-United States equivalent thereof).
“Product” means, on a country-by-country basis, any product, the manufacture, use, sale, importation, or offer for sale of which would infringe a Valid Claim of the Licensed Patents in the country in question (but for the license granted pursuant to this Agreement).
“Regulatory Approval” means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.
“Regulatory Authority” means any governmental authority or agency responsible for authorizing or approving the marketing and/or sale of products in a jurisdiction (e.g., the United States FDA; the European Medicines Agency; the United Kingdom’s Medicines and Healthcare Products Regulatory Agency; the Japanese Ministry of Health, Labor and Welfare; the Chinese National Medical Products Administration, and corresponding national or regional regulatory agencies or organizations).
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“Regulatory Filing” means, with respect to a Product, any submission to a Regulatory Authority of any appropriate regulatory application, and will include, without limitation, any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto. Regulatory Filings will include any IND, Clinical Trial Application, Biologics Licensing Application, Marketing Authorisation Application, or the corresponding application in any other country or group of countries.
“Royalty Term” means, on a country-by-country and Product-by-Product basis, the period commencing on the First Commercial Sale of such Product in such country until the latest of the expiration of the last to expire Valid Claim of the Licensed Patents that, but for the licenses granted in this Agreement, would be infringed by the manufacture, use, sale, offer for sale, or import of such Product in such country (or if the last such Valid Claim with respect to such Licensed Product in such country is a pending Valid Claim, the date such pending Valid Claim ceases to be a Valid Claim).
“Sales Milestone” has the meaning set forth in Section 4.3.
“Sales Milestone Payment” has the meaning set forth in Section 4.3.
“Sales & Royalty Report” means a written report or reports showing each of: (a) the gross sales of Product during the relevant Calendar Quarter; (b) the computations and deductions used to determine Net Sales from gross sales; (c) the royalties payable, in United States Dollars, which shall have accrued hereunder with respect to such Net Sales; and (d) to the extent applicable, any Sales Milestones that have been achieved.
“Senior Officer” means, for Novartis, [**], and for Licensee, [**].
“Sublicensee” has the meaning set forth in Section 2.2.
“Tax” or “Taxes” means any form of tax or taxation, levy, duty, charge, social security charge, contribution, or withholding in the nature of a tax (including any related fine, penalty, surcharge or interest) imposed by, or payable to, a governmental authority.
“Third Party” means any Person other than a Party or an Affiliate of a Party.
“United States” or “US” means the United States of America, its territories and possessions.
“USD” or “US$” means the lawful currency of the United States.
“Valid Claim” means:
(a) claim of an issued and unexpired patent included within the Licensed Patents that:
(i) covers the manufacture, use, sale, importation, or offer for sale of a Product in the relevant jurisdiction;
(ii) has not been irrevocably or unappealably disclaimed or abandoned, or been held unenforceable, unpatentable, or invalid by a decision of a court or other governmental agency of competent jurisdiction; and
(iii) has not been admitted to be invalid or unenforceable through reissue, disclaimer, or otherwise; or
(b) a claim included in a patent application included within the Licensed Patents that:
(i) would cover manufacture, use, sale, importation, or offer for sale of the relevant Product in the relevant jurisdiction if such claim was to issue; and
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(ii) has not been cancelled, withdrawn, or abandoned, nor been pending for more than [**] from the first substantive office action with respect to such patent application in the relevant jurisdiction.
[**]; and
Any sublicense granted by Verve to any rights licensed to it hereunder shall terminate immediately upon the termination of this Agreement, provided if (a) the license set forth in Section 2.1 is sublicensed in connection with a divestment of a Product by Verve; (b) such Sublicensee is not in material default of its obligations under this Agreement (including as if it were Licensee hereunder),
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then, upon written notice by such sublicensee, the relevant subliensee and Novartis will enter into a license agreement substantially similar to this Agreement with respect to the rights sublicensed hereunder, substituting such Sublicensee for Verve such that any payments previously made by Verve would be credited to the substituted Sublicensee.
The Development and Commercialization of any Product hereunder by Licensee shall be in Licensee’s sole discretion and expense; provided, however, that, in the course of such activities, Licensee shall have, and maintain at all times during the term of this Agreement, a governance policy that requires the Licensee to comply in all material aspects with applicable laws and regulations relating to the research, Development, and Commercialization of pharmaceutical products, as well as laws and regulations relating to health, safety, and the environment, fair labor practices, anti-corruption, and anti-bribery.
| Development Milestone | Development Milestone Payment
|
1. | [**] | [**] |
2. | [**] | [**] |
3. | [**] | [**] |
4. | [**] | [**] |
5. | [**] | [**] |
6. | [**] | [**] |
7. | [**] | [**] |
[**].
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| Aggregate Net Sales of Products in any Calendar Year | Sales Milestone Payment |
1. | Annual Net Sales equal to or greater than USD$[**] | USD$[**] |
2. | Annual Net Sales equal to or greater than USD$[**] | USD$[**] |
3. | Annual Net Sales equal to or greater than USD$[**] | USD$[**] |
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If Licensee reasonably determines that, in order to avoid infringement or misappropriation of any Patent Right not licensed hereunder that covers a Product, and Licensee or any of its Affiliates or sublicensees acquires or licenses such rights from a Third Party and is required to pay a royalty to such Third Party, Licensee will have the right to deduct [**]% of the royalty payments actually paid by Licensee to such Third Party for such license from the royalty due to Novartis under Section 4.4; provided, however, that in no event will such reduction cause the royalty rate to be paid to Novartis to be less than [**]%.
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Specific aspects or details of Information will not be deemed to be within the public domain or in the possession of the recipient Party merely because the Information is embraced by more general information in the public domain or in the possession of the recipient Party. Further, any combination of Information will not be considered in the public domain or in the possession of the recipient Party merely because individual elements of such Information are in the public domain or in the possession of the recipient Party unless the combination and its principles are in the public domain or in the possession of the recipient Party. Information regarding the composition, manufacture, or other attributes of a Product and whether any such Product does or does not fall within the scope of any patent, patent application, or Patent Right shall be retained as Confidential Information and the disclosure thereof to the other Party shall not be a basis for challenging the confidential or privileged status of such information, including attorney-client and work product privileges that would otherwise be held by the disclosing Party as to the other Party or a third party.
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[**]
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provided, however, that Licensee will not be obliged to so indemnify, defend and hold harmless the Novartis Indemnitees for any Claims for which Novartis has an obligation to indemnify Licensee Indemnitees pursuant to Section 10.2 or to the extent that such Claims arise from the breach, negligence, or willful misconduct of Novartis or the Novartis Indemnitees.
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If to Licensee:
Verve Therapeutics, Inc.
500 Technology Square, Suite 901,
Cambridge, MA 02139 USA
Attn: Legal
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with contemporaneous email copies to: [**]
If to Novartis:
Novartis Pharma AG
Lichtstrasse 35
CH-4056 Basel
Switzerland
with a required copy to:
Novartis Institutes for BioMedical Research, Inc.
250 Massachusetts Avenue
Cambridge, MA 02139 USA
Attn: General Counsel
And by email to: [**]
[Signature Page Follows]
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License Agreement - Signature Page
In witness whereof, the Parties, intending to be bound, have caused this Agreement to be executed by their duly authorized representatives.
NOVARTIS PHARMA AG
| Verve Therapeutics, Inc. |
By: /s/ Simone Pfirter | By: /s/ Andrew Ashe |
Name: Simone Pfirter | Name: Andrew Ashe |
Title: Head NIBR General Legal Europe | Title: President & COO |
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By: /s/ Petra Grohmann |
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Name: Petra Grohmann |
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Title: Authorized Signatory |
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FIRST AMENDMENT TO LICENSE AGREEMENT
This First Amendment having an effective date of June 15, 2022 (the “First Amendment Effective Date”) is made by and between Novartis Pharma AG, located at Lichtstrasse 35, CH- 4056 Basel, Switzerland, (“Novartis”), and Verve Therapeutics, Inc., having a principal office at
500 Technology Square, Suite 901, Cambridge, MA 02139 (“Licensee”) (each a “Party”, collectively the “Parties”).
WHEREAS, the Parties entered into a License Agreement dated October 4, 2021 (the “Agreement”).
WHEREAS, the Parties desire to amend the Agreement to add up to three additional licensed fields to the scope of the non-exclusive license granted under the Agreement.
The Parties agree to the following:
““Licensed Field” means delivery of gene editor payloads for the prevention and treatment of [**].”
“Added Fields” means [**], subject to provisions of Section 2.6 of the Agreement.
“CRO” has the meaning set forth in Section 9.1(f).
“Divestment” means, with respect to any Product researched, Developed or Commercialized by Licensee under this Agreement, the transfer to one or more Third Parties (including by license, sublicense, assignment or sale) of rights to Develop or Commercialize such Product, independently or in collaboration with Licensee.
“LNP” means lipid nanoparticle.
“Proposed Additional Field” has the meaning set forth in Section 2.5.
1
“2.2 Sublicense Rights. Licensee may sublicense (through multiple tiers) the rights granted to it by Novartis under this Agreement to its Affiliates and one or more Third Party contractors and/or bona fide Third Party collaborators or licensees (each, “Sublicensees”) solely for the purpose of researching, Developing, making, having made, using, importing, offering for sale, selling, having sold, and otherwise Commercializing Products in the Licensed Field by or on behalf of Licensee or in connection with the Divestment of a Product by Licensee; provided, that for any sublicense to Third Parties:
[**]; and
Any sublicense granted by Licensee to any rights licensed to it hereunder shall terminate immediately upon the termination of this Agreement, provided if (a) the license set forth in Section 2.1 is sublicensed in connection with a Divestment of a Product by Licensee; and (b) such Sublicensee is not in material default of its obligations under this Agreement (including as if it were Licensee hereunder), then, upon written notice by such Sublicensee, the relevant Sublicensee and Novartis will enter into a license agreement substantially similar to this Agreement with respect to the rights sublicensed hereunder, substituting such Sublicensee for Licensee such that any payments previously made by Licensee would be credited to the substituted Sublicensee.”
“2.5 Proposed Additional Field.
[**].
“2.6 Changes to Added Fields.
[**].”
“(b) Payment for Added Fields and Proposed Additional Field. In consideration of the addition of the Added Fields and the option to add the Proposed Additional Field to the license granted hereunder, Licensee shall make a one-time, non- refundable, non-creditable upfront payment to Novartis of US$2,750,000.
Payment will be made within [**] after the First Amendment Effective Date and otherwise in accordance with Section 5.1.”
2
“Each Development Milestone Payment will be deemed earned as of the first achievement of the corresponding Development Milestone. Each Development Milestone Payment will be paid once for the original Licensed Field, once for each of the two Added Fields, once for the Proposed Additional Indication if the Licensed Field is expanded as set forth in Section 2.4, and once for the Proposed Additional Field if the Licensed Field is expanded as set forth in Section 2.5.”
“(c) Each Development Milestone Payment in the table above will be paid once for the original Licensed Field, once for each of the two Added Fields, once for the Proposed Additional Indication if the Licensed Field is expanded as set forth in Section 2.4, and once for the Proposed Additional Field if the Licensed Field is expanded as set forth in Section 2.5. The total potential Development Milestone Payments that may be paid under this Section 4.2 is USD$10,000,000 per field or up to five times (USD$50,000,000) in total [**].
“(d) The total potential Sales Milestone Payments that may be paid under this Section
4.3 is USD$35,000,000 unless the Licensed Field is expanded as set forth in Sections 2.4 or 2.5, in which case the total potential Sales Milestone Payments that may be paid under this Section 4.3 is USD$[**].
“(f) it will not interfere with or enter into any agreement that limits the other Party’s ability to engage with a contract research organization, contract development organization, or contract manufacturing organization (collectively, “CRO(s)”) to provide services relating to LNPs and the intellectual property that is licensed pursuant to the Agreement. If requested, each Party will provide written confirmation of such agreement to the other Party and the relevant CRO. For the avoidance of doubt, this provision will not authorize either Party to use the other Party’s intellectual property in connection with such activities, except as expressly provided in this Agreement.”
3
[Signature page follows.]
4
IN WITNESS HEREOF, the Parties have executed this First Amendment as of the First Amendment Effective Date set forth above.
Verve Therapeutics, Inc. |
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Novartis Pharma AG |
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By: /s/ Sekar Kathiresan |
| By: /s/ Simone Pfirter |
Name: Sekar Kathiresan |
| Name: Simone Pfirter |
Title: CEO |
| Title: Head NIBR General Legal Europe |
Date: 6/22/2022 |
| Date: 22-Jun-22 | 2:51:35 PM GMT |
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/s/ Allison Dorval |
| By: /s/ Petra Grohmann-Moesching |
Allison Dorval |
| Name: Petra Grohmann-Moesching |
CFO |
| Title: Head Finance NIBR Europe |
6/17/2022 |
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Date: 22-Jun-22 | 2:02:12 PM GM
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