Exhibit 10.3
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
SECOND AMENDED AND RESTATED COMMERCIAL MANUFACTURING SERVICES AGREEMENT
SECOND AMENDED AND RESTATED COMMERCIAL MANUFACTURING SERVICES AGREEMENT
THIS SECOND AMENDED AND RESTATED COMMERCIAL MANUFACTURING SERVICES AGREEMENT is made as of September 19, 2023 (“Effective Date”) by and between WuXi Biologics (Hong Kong) Limited, a corporation organized under the laws of Hong Kong, with its registered address at Flat/RM826, 8/F Ocean Centre Harbour City, 5 Canton Road TST, Hong Kong (“WuXi Biologics”), and Invivyd, Inc. (f/k/a Adagio Therapeutics, Inc.), with an address at 1601 Trapelo Road, Suite 178, Waltham, MA 02451 (“Client”). WuXi Biologics and Client may be referred to herein as a “Party” or, collectively, as “Parties.”
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RECITALS
WHEREAS, Client and its Affiliates are engaged in the discovery, development, manufacture and sale of biopharmaceutical products;
WHEREAS, WuXi Biologics has the requisite infrastructure, licenses, permits and capabilities, including trained and experienced personnel and technical skills, to manufacture and supply the Products (as defined below) to Client;
WHEREAS, the Parties entered into a Commercial Manufacturing Services Agreement effective on December 24, 2020 and as amended and restated for a first time on August 12, 2021 (the “Original Agreement”), pursuant to which Client engaged WuXi Biologics for services relating to the commercial manufacture of the drug substance of Products;
WHEREAS, both Parties desire to amend, restate, and replace in its entirety the Original Agreement with effect from the Effective Date of this Agreement, for WuXi Biologics to provide Client services relating to the commercial manufacture of the drug substance and drug product of Products as described in this Agreement (“Services”); and
WHEREAS, Client and WuXi Biologics entered a Cell Line License Agreement effective December 2, 2020 and amended February 2, 2023 (the “Cell Line License Agreement”);
NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
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WUXI BIOLOGICS’ OBLIGATIONS
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INTELLECTUAL PROPERTY
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FORECASTS AND ORDERS
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DELIVERY OF PRODUCT
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PRICE
INVOICE AND PAYMENT
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QUALITY ASSURANCE
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DEFECTIVE PRODUCTS
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PRODUCT LICENSES
CHANGES TO PRODUCT SPECIFICATIONS
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LABELING
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REGULATORY COMPLIANCE
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Each Party agrees to notify the other Party immediately, in the event that such Party or any of its officers, directors, employees, agents, or parties under contract to perform and work under this Agreement (i) becomes debarred, excluded or convicted, or (ii) receives notice of action with respect to its debarment, exclusion or conviction during the Term. Each Party hereby certifies that it has not utilized, and shall not utilize, in any capacity the services of any individual, corporation, partnership or association in the development of the Product or performance of activities related to this Agreement that has been (A) debarred, or to its knowledge has received notice of action with respect to debarment, under the Generic Drug Enforcement Act of 1992, 21 United States Code §335a(a) and (b), as amended or any foreign equivalent thereof, (B) excluded pursuant to 42 U.S.C. § 1320a-7 or relevant regulations in 42 C.F.R. Part 1001 or to its knowledge has received notice of exclusion or any foreign equivalent thereof or (C) otherwise convicted pursuant to (ii) above, or to its knowledge has received notice of conviction or any foreign equivalent thereof. In the event that either Party receives any notice of actions set forth in this Section 13.6 (with regard to the Party only, but not including an individual employee, officer, director, agent or subcontractor thereof), without limiting any other rights or remedies of the other Party, the other Party shall have the right to terminate this Agreement immediately pursuant to the provisions of this Agreement. Any
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termination by a Party pursuant to this Section 13.6 shall be deemed to be a termination by that Party for material breach of this Agreement by the other Party pursuant to Section 19.2.
PRODUCT COMPLAINTS AND ADVERSE EVENTS
CONFIDENTIALITY AND DATA PROTECTION
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AUDIT AND INSPECTION RIGHTS
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WARRANTIES
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INDEMNITY
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TERM AND TERMINATION
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EFFECTS OF TERMINATION
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DISASTER RECOVERY AND BUSINESS CONTINUITY
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DISPUTE RESOLUTION
MISCELLANEOUS PROVISIONS
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WuXi Biologics:
[***]
Client:
[***]
Unless there is evidence that it was received earlier, notices sent in accordance with this Section 23.9 are to be deemed to have been received: if delivered by hand or by courier, when left at the address referred to above; if sent by post to an address within the country of postage, [***] after posting it; if sent by airmail or overnight express courier to an address outside the country of postage, [***] after posting it; or if sent by fax, when transmitted, provided that if deemed receipt occurs before 9am on a Working Day the notice shall be deemed to have been received at 9am on that day, and if deemed receipt occurs after 5pm on a Working Day, or on a day which is not a Working Day, the notice shall be deemed to have been received at 9am on the next Working Day.
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed, by duly authorized representatives, as of the Effective Date.
Invivyd, Inc. | WuXi Biologics (Hong Kong) Limited
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By: /s/ [***]_________________ | By: /s/ [***]___________________ |
Name: [***]_________________ |
Name: [***]___________________ |
Title: [***]__________________ |
Title: [***]____________________ |
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SCHEDULE 1.a – DRUG SUBSTANCE PRODUCT AND PRICE
[***]
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SCHEDULE 1.b – DRUG PRODUCT AND PRICE
[***]
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SCHEDULE 2 – QUALITY AGREEMENT
[***]
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SCHEDULE 3 – KPIs
[***]
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SCHEDULE 4 –WuXi Biologics’ Affiliate Subcontractors and Scope of Work
[***]
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