DEVELOPMENT AND SUPPLY AGREEMENT by and between AMNEAL BIOPHARMA SOLUTIONS PRIVATE LIMITED and METSERA, INC. Effective as of September 30, 2024

Exhibit 10.16

EXECUTION VERSION

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.

DEVELOPMENT AND SUPPLY AGREEMENT

by and between

AMNEAL BIOPHARMA SOLUTIONS PRIVATE LIMITED

and

METSERA, INC.

Effective as of September 30, 2024

CONTENTS

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DEVELOPMENT AND SUPPLY AGREEMENT

This DEVELOPMENT AND SUPPLY AGREEMENT (this “Agreement”) is made as of September 30, 2024 (the “Effective Date”), by and between Amneal Biopharma Solutions Private Limited, organized under the laws of India located at ▇▇▇-▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇.▇.▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇- ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ (“Amneal”) and Metsera, Inc., a company organized under the laws of Delaware located at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“Metsera”). Amneal and Metsera are referred to in this Agreement individually as a “Party” and collectively as the “Parties”.

RECITALS

WHEREAS, Metsera is a biopharmaceutical company focused on the next generation of medicines for obesity and metabolic diseases;

WHEREAS, Amneal is a pharmaceutical company with existing infrastructure and expertise in the manufacture of pharmaceutical products;

WHEREAS, Amneal desires to Manufacture for Metsera, and Metsera desires to purchase from Amneal, Products, for clinical and commercial supply; and

WHEREAS, Amneal desires to construct a new facility to further support the supply of Products for Metsera and for the supply of products to Amneal and to Amneal’s other clients, and Metsera desires to provide limited funding in support of the construction of such new facility,

NOW, THEREFORE, in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

1.1 Unless specifically set forth to the contrary herein, the following terms shall have the respective meanings set forth below.

“Accounting Standards” means GAAP or IFRS, as applicable, consistently applied throughout the applicable Party’s organization. Each Party shall promptly notify the other Party in the event that it changes the Accounting Standards pursuant to which its records are maintained; provided, that each Party may only use internationally recognized accounting principles (e.g., IFRS, GAAP, etc.) as its Accounting Standards.

“Acquirer” has the meaning given to such term in Section 3.7(B).

“Acting Party” has the meaning given to such term in Section 7.4(A).

“Affiliate” means, with respect to any (a) Amneal, any other Person that now or hereinafter controls, is controlled by, or is under common control with, such Person, and (b) Metsera, any other Person that now or hereinafter is controlled by Metsera. For purposes of this definition, “control” shall mean direct or indirect ownership of at least fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (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 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 direct the management and policies of a corporation or other entity. The Parties acknowledge that, in the case of entities organized under the laws of certain countries where the maximum percentage ownership permitted by law for a foreign investor is less than fifty percent (50%), 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.

“Agreement” has the meaning given to such term in the Preamble.

“Amneal” has the meaning given to such term in the Preamble.

“Amneal Indemnitees” has the meaning given to such term in Section 24.1.

“Amneal Manufacturing Improvements” has the meaning given to such term in Section 25.3(C).

“Applicable Law” means, collectively, all applicable laws, statutes, rules, regulations, orders, judgments, or ordinances having the effect of law of any national, multinational, federal, state, provincial, county, city, or other political subdivision, including, to the extent applicable, GCP and GMP, all applicable data protection and privacy laws, rules, and regulations, including, to the extent applicable, the United States Department of Health and Human Services privacy rules under the Health Insurance Portability and Accountability Act and the Health Information Technology for Economic and Clinical Health Act and the EU Data Protection Directive (Council Directive 95/46/EC), applicable laws implementing the EU Data Protection Directive and the General Data Protection Regulation (2016/679), as well as all applicable laws, regulations, orders, judicial decisions, conventions, and international financial institution rules regarding corruption, bribery, ethical business conduct, money laundering, political contributions, gifts and gratuities, or lawful expenses to public officials, healthcare professionals, and private persons, agency relationships, commissions, lobbying, books and records, and financial controls, including the U.S. Foreign Corrupt Practices Act (15 U.S.C. § 78dd-1 et seq.), and the Applicable Standards, that, in each case, govern or otherwise apply to the applicable Person, activity or product.

“Applicable Standards” means good practice requirements and guidelines of the US, European Union, the UK, and any other geographical area applicable to the applicable Person, activity or product, including those listed below.

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“Audit Records” has the meaning given to such term in Section 21.2.

“Background Technology” means, with respect to a Party, any Intellectual Property Right that such Party or its Affiliates, Controls, owns, or has the right to use, that (a) existed on or prior to the Effective Date or (b) is developed or acquired by such Party after the Effective Date, outside of and unrelated to the performance of the activities under this Agreement without the use of the other Party’s Confidential Information. Background Technology owned or Controlled by Metsera shall be “Metsera Technology” and Background Technology owned or Controlled by Amneal shall be “Amneal Technology”.

“Batch” means a quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single cycle of Manufacture certified in a single Certificate of Analysis.

“Batch Record” means a document that records the details required by cGMP and the Quality Agreement about the Manufacture of each Batch of a Product under this Agreement.

“Business Day” means a day other than a Saturday, Sunday, or other day on which commercial banks are authorized or required to be closed, as the case may be, in New York City, New York or Ahmedabad, India.

“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31 during the Term or the applicable part thereof during the first or last calendar year of the Term.

“Calendar Year” means any calendar year ending on December 31 or the applicable part thereof during the first or last calendar year of the Term.

[***]

“Certificate of Analysis” means a certificate that meets all applicable requirements of cGMP and the Quality Agreement and is signed by a duly-authorized person pursuant to the Quality Agreement certifying that the Products to which it relates meet the applicable Specifications.

“Change of Control” means, with respect to a Party: (a) a merger, reorganization, combination or consolidation of such Party with a Third Party that results in the holders of beneficial ownership of the voting securities or other voting interests of such Party immediately prior to such merger, reorganization, combination or consolidation ceasing to hold beneficial ownership of at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, combination or consolidation; (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities or other voting interest of such Party; or (c) the sale or other transfer (in one (1) transaction or a series of related transactions) to a Third Party of all or substantially all of such Party’s or its parent company’s assets.

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“Change of Control Date” has the meaning given to such term in Section 29.5.

“CMO” means a Third Party contract manufacturing organization.

“Competing Compound” has the meaning given to such term in Section 29.4.

“Competing Product” has the meaning given to such term in Section 3.7(A).

“Competitive Entity” has the meaning given to such term in Section 29.4.

“Components” means the materials (including media, raw ingredients, intermediates, excipients, processing aids, consumables, prepacked columns, peptides, precursors, enhancers, packaging materials, reagents for testing, containers, pens, vials, injectors, and other devices) required to Manufacture the Product in accordance with the Specifications.

“Confidential Information” means, with respect to a Party, all Know-How and other proprietary information and data of a financial, commercial or technical nature that is disclosed by or on behalf of such Party or any of its Affiliates or otherwise made available to the other Party or any of its Affiliates, whether made available orally, in writing or in electronic form, in connection with this Agreement on or after the Effective Date or under the Prior CDA, including any such Know-How, proprietary information or data comprising or relating to concepts, discoveries, inventions, data, designs, information or formulae.

“Construction Addendum” means the Construction Addendum attached hereto as Schedule A.

“Construction Rebate” has the meaning given to such term in Section 7.5.

“Control” or “Controlled” means, with respect to any Know-How, Patents, other intellectual property rights, or any proprietary or trade secret information, the legal authority or right (whether by ownership, license or otherwise) of a Party or its Affiliates to grant a license or a sublicense of or under, or access to or right to use, such Know-How, Patents, or intellectual property rights to another Person, or to otherwise disclose such proprietary or trade secret information to another Person, without breaching the terms of any agreement with a Third Party. Notwithstanding the foregoing, a Party and its Affiliates will not be deemed to “Control” any Patents, Know-How or Confidential Information that, prior to the consummation of a Change of Control of such Party, is owned or in-licensed by a Third Party prior to such Change of Control unless (a) prior to the consummation of such Change of Control, such acquired Party or any of its Affiliates also Controlled such Patents, Know-How or Confidential Information, or (b) the Patents, Know-How or Confidential Information owned or in-licensed by such Third Party were not used in the performance of activities under this Agreement prior to the consummation of such Change of Control, but after the consummation of such Change of Control, the acquired Party or any of its Affiliates uses any such Patents, Know-How or Confidential Information in the performance of its obligations or exercise of its rights under this Agreement, in each of which cases (a) and (b), such Patents, Know-How or Confidential Information will be “Controlled” by such Party for purposes of this Agreement.

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“Damages” means all losses, liabilities, costs (including legal costs and experts’ and consultants’ fees), charges, expenses, actions, proceedings, claims and demands.

“Data Integrity” means data (paper or electronic) is attributable, legible, contemporaneously recorded, original, accurate, complete, consistent, available and enduring throughout the data lifecycle as the data is created, reviewed, modified, maintained, retrieved, processed, transferred, etc.

“Defective” means, with respect to a Product, that such Product: (a) was not Manufactured, prepared, handled or shipped in compliance with applicable cGxPs, Applicable Standards, the Quality Agreement, master Batch Records, applicable Marketing Authorizations or any procedure or document agreed upon by the Parties in writing that specifically sets forth a distinct method for determining whether a Product is non-conforming or (b) does not conform to the Specifications. “Defect” shall be construed accordingly. For clarity, any Product that Metsera is entitled to reject pursuant to the Quality Agreement shall be regarded as Defective for the purpose of this Agreement.

“Designated Officer” means (i) with respect to ▇▇▇▇▇▇, (a) with respect to commercial matters, [***] and (b) with respect to all other matters, [***] and (ii) with respect to Metsera, (a) with respect to commercial matters, [***] and (b) with respect to all other matters, [***].

“Development Budget” has the meaning given to such term in Section 2.1.

“Development Plan” has the meaning given to such term in Section 2.1.

“Direct Labor and Benefits” means that portion of basic wages, labor and related payroll taxes and employee benefits spent in performing [***], all determined in accordance with the Accounting Standards.

“Direct Overhead” means [***]

“Disclosing Party” has the meaning given to such term in Section 19.1(A).

“DP” and “Drug Product” means Injectable Drug Product or Oral Drug Product, as context requires.

“DS” and “Drug Substance” mean the nutrient-stimulated hormone drug substances listed in Schedule B, as may be updated by Metsera from time to time, meeting the applicable Specifications set forth in Schedule C.

“Earn-Out Report” has the meaning given to such term in Section 8.2.

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“Effective Date” has the meaning given to such term in the Preamble.

“EMA” has the meaning given to such term in the definition of a Regulatory Authority.

“Event of Loss” has the meaning given to such term in Section 4.3(A).

“Executive Officers” means, (a) for Metsera, [***], and (b) for Amneal, the [***]; provided, that, in each case ((a) and (b)), such person is not a member of the JST or JMT or a Designated Officer at the time that the applicable disagreement or dispute arises.

“Facility” or “Facilities” means the facilities of Amneal or its Affiliates or Permitted Subcontractors where Product will be Manufactured on behalf of Metsera, including the New Facility in accordance with Section 4.2.

“FDA” has the meaning given to such term in the definition of Regulatory Authority.

“Firm Order(s)” has the meaning given to such term in Section 5.4(A).

“Firm Zone” means, subject to Section 5.3(C), the first [***] of each Forecast Schedule for each commercial Product (or such other period as may be agreed between the Parties), specifying quantities in bottles or devices, as applicable for Drug Product.

“First Commercial Sale” means the first sale of a Drug Product by Metsera, its Affiliate, or sublicensee to a Third Party in an arms’ length transaction in a country following Regulatory Approval for sale of such Product in such country. Notwithstanding the foregoing, sales or transfers of reasonable quantities of a Product for development, or for compassionate or similar use, shall not be considered a First Commercial Sale, even if reimbursed.

“Force Majeure” has the meaning given to such term in Article 20.

“Forecast Schedule” has the meaning given to such term in Section 5.3.

“Generic/Biosimilar Product” means, with respect to a given Product in a particular country, after Regulatory Approval of such Product in such country, any other therapeutic drug product designated for human use which (a) (i) contains the same or highly similar principal molecular structural features as (but not necessarily all of the same structural features as) such Product except for minor differences in clinically inactive components, (ii) has no clinically meaningful differences from such Product in terms of purity, potency, safety, mechanism of action, route of administration, dosage form and strength, and (iii) is approved for use pursuant to a regulatory approval process in such country that is based on the indications and conditions of use on an unrelated party’s previously approved version of that same product (i.e., a product meeting the standards set forth in the foregoing clauses (i) and (ii)), whether or not such regulatory approval was based upon data generated by the parties filed with the applicable governmental authority in such country or was obtained using an abbreviated, expedited or other process, and (iv) is authorized for sale or sold in the same country (or is commercially available in the same country via import from another country) as the Product by a Party or any Third Party, as applicable or (b) (i) contains the same active ingredient as the Product and is approved for use in such country by a Regulatory Authority through an Abbreviated New Drug Application as defined in the FD&C Act,

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pursuant to Article 10.1 of Directive 2001/83/EC of the European Parliament and Council of 6 November 2001, or any enabling legislation thereof, or pursuant to any similar abbreviated route of approval in any other countries; or (ii) contains the same active ingredient as the Product and is approved for use in such country by a Regulatory Authority through a regulatory pathway referencing clinical data first submitted by Metsera or its Affiliates for obtaining Regulatory Approval for such Product.

“Governmental Authority” means any national, international, federal, state, provincial or local government, or political subdivision thereof, any multinational organization or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or any tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body).

“Gross Profit” means [***].

“Guarantor” has the meaning given in Section 29.7.

“ICC” has the meaning given in Section 29.10.

“ICC Rules” has the meaning given in Section 29.10.

“Improvement” means any new or improved process, technique, method, formula, invention, Know-How or other embodiment of an Intellectual Property Right that arises out of the performance of this Agreement or the Quality Agreement, in each case, that is devised, made or conceived either solely or jointly by or on behalf of Amneal or Metsera, or members of their respective Affiliates or Permitted Subcontractors, in each case, during the Term.

“Indemnification Claim Notice” has the meaning given to such term in Section 24.3.

“Indemnitee” has the meaning given to such term in Section 24.3.

“Indemnitor” has the meaning given to such term in Section 24.3.

“Independent Expert” means an independent testing laboratory mutually agreed upon by the Parties.

“Indirect Tax” has the meaning given to such term in Section 7.4(B).

“Initial Renewal Term” has the meaning given to such term in Section 27.1.

“Initial Term” has the meaning given to such term in Section 27.1.

“Injectable Drug Product” means [***].

“Insolvency Event” has the meaning given to such term in Section 27.2(B).

“Intellectual Property Rights” means all: (a) Patents; (b) Know-How; (c) trademarks; (d) internet domain names; (e) copyrights; (f) rights in designs; (g) database rights; and (h) all rights or forms of protection, anywhere in the world, having equivalent or similar effect to the rights referred to in clauses (a) to (h) above, in each case whether registered or unregistered and including applications for registration of any such thing.

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“Invoice Currency” means USD.

“Joint Manufacturing Team” or “JMT” has the meaning give to such term in Section 11.2.

“Joint Supply Team” or “JST” has the meaning given to such term in Section 11.4.

“Know-How” means any and all commercial, technical, scientific and other types of (a) data (including datasets), documents, information, conclusions, inventions (whether patentable or not), discoveries, know-how, technology, protocols, assays, methods, processes, formulae, instructions, techniques, designs, drawings or specifications (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical, analytical, preclinical, clinical, safety, manufacturing and quality control data and information).

“Latent Defect” means a Defect other than an Obvious Defect.

“License Agreement” means the License Agreement dated on or around the date hereof by and among Metsera, ▇▇▇▇▇▇▇’s Affiliate and Amneal.

“Major European Markets” means [***].

“Manufacture” or “Manufacturing” means activities related to the manufacturing of a product or any component or ingredient thereof, including producing, synthesizing, manufacturing, processing, compounding, storing, filling, finishing, packaging, sterilization, labelling, serializing, supplying, disposing of waste, releasing and sample retention of Product, leafleting, shipping, and holding of product or any intermediate thereof, including process development, process qualification and validation, scale-up, commercial manufacture and analytic development, formulation development, product characterization, stability studies and testing, quality assurance, and quality control.

“Manufacturer’s Release” means [***].

“Manufacturing Licenses” means all licenses, permits, approvals, authorizations and consents necessary for, or required in connection with, the lawful Manufacture and supply of the Products at the Facilities.

“Manufacturing TT” has the meaning given to such term in Section 26.

“Marketing Authorization” means, in respect of a Product, such marketing authorization, biologics license application, approval, license, registration or other authorization issued by the FDA, EMA, or any equivalent filing in a country or regulatory jurisdiction other than the United States or the European Union with the applicable Regulatory Authority, in connection with obtaining marketing approval of that Product on the market in the relevant Territory, (or, as applicable, a finished product Manufactured using that Product), including a New Drug Application (NDA), Biologics License Application (BLA), Investigational New Drug application (IND) or Investigational Medicinal Product Dossier (IMPD), or any equivalent filing in any country or jurisdiction.

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“Metsera” has the meaning given to such term in the Preamble.

“Metsera Improvements” has the meaning given to such term in Section 25.3(B).

“Metsera Indemnitees” has the meaning given to such term in Section 24.2.

“MHRA” has the meaning given to such term in the definition of a Regulatory Authority.

“Minimum Order Quantity” has the meaning given to such term in Section 5.5.

“Minimum Remaining Shelf Life” means, on a Product-by-Product basis, a minimum remaining shelf life upon delivery as set forth on Schedule G.

“Net Sales” means for Drug Product Manufactured by Amneal for Metsera under the Agreement, the total gross sales of such Drug Product by Metsera, its Affiliates and its and their sublicensees to independent third party customers, less the following deductions as accrued, as determined in accordance with the Accounting Standards:

Net Sales shall not be imputed to [***].

If a Drug Product is sold in combination with [***].

“New Facility” has the meaning given to such term in Section 4.2.

“Non-Acting Party” has the meaning given to such term in Section 7.4(A).

[***]

“Obvious Defect” means a Defect that is easily detectable by a visual inspection and without any analysis in a laboratory.

“Oral Drug Product” means [***].

“Out-of-Pocket Costs” means, [***]

“Parent Guaranty” has the meaning given in Section 29.7.

“Parties” and “Party” have the meanings given to such terms in the Preamble.

“Patent(s)” means all patents and patent applications, including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, reissues, additions, renewals, extensions, registrations, supplemental protection certificates, utility models, design patents and the like of any of the foregoing.

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“Permitted Subcontractor” has the meaning given to such term in Section 3.5.

“Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.

“Prior CDA” means [***].

[***]

“Product” means Drug Product or Drug Substance, as context requires.

“Product Action” means a recall or withdrawal with respect to any Product supplied to Metsera under this Agreement.

“Quality Agreement” means the quality assurance agreement with regard to quality matters entered into by and between the Parties on the date hereof and attached hereto as Schedule D.

“Quality Standards” means, with respect to Products that are or shall be Manufactured, compliance with the Specifications, this Agreement, the Quality Agreement, Applicable Standards and Applicable Law.

“R&D Cost” means, collectively, [***]

“R&D Support” has the meaning given to such term in Section 2.1.

“R&D Support Fee” means R&D Cost plus [***].

“Receiving Party” has the meaning given to such term in Section 19.1(A).

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“Regulatory Approval” means, with respect to a Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registration, license, or authorization from a Regulatory Authority in such country or jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

“Regulatory Authority” means any national or supranational Governmental Authority, including the U.S. Food and Drug Administration (and any successor entity thereto) (the “FDA”) in the United States, the European Medicines Agency (and any successor entity thereto) (the “EMA”) or the European Commission (and any successor entity thereto), as applicable, in the European Union, and the Medicines and Healthcare Products Regulatory Agency (the “MHRA”) in the United Kingdom, or any health regulatory authority in any country that is a counterpart to the foregoing agencies, in each case, that holds responsibility for development and commercialization of, and the granting of Regulatory Approval for, pharmaceutical product in such country.

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“Relationship Manager” has the meaning given to such term in Article 11.

“Release Documentation” means, for any Batch, the certificate of analysis, confirmation of compliance (as set forth in the Quality Agreement) and such further documentation as outlined/listed in the Quality Agreement as being made available concurrently with the Manufacturer’s Release that are necessary to confirm that each Batch of Product shipped has been subject to required quality tests and release and stability testing and is in compliance with the applicable Specifications.

“Renewal Term” has the meaning given to such term in Section 27.1.

“Results” has the meaning given to such term in Section 2.2.

“Safety Stock” means any stock of Drug Product or a Component that is held in accordance with Section 18 to cover for repeatable and regular variations in Manufacture, transportation and demand, or other unpredictable events.

“SDEA” has the meaning given to such term in Section 16.

“Specification(s)” means, with respect to the applicable Product, the applicable specifications set forth in Schedule C.

“Supply Failure” has the meaning given to such term in Section 13.2.

“Supply Price” has the meaning given to such term in Section 7.1.

“Supply Threshold(s)” has the meaning given to such term in Section 3.2.

“Tax Action” has the meaning given to such term in Section 7.4(A).

“Term” has the meaning given to such term in Section 27.1.

“Territory” means worldwide, other than [***].

“Third Party” means any Person other than Amneal or Metsera that is not an Affiliate of Amneal or of Metsera.

“Third Party Acquirer Product” has the meaning given to such term in Section 3.7(B).

“Third Party Assignment” has the meaning given to such term in Section 29.4(C).

“Third Party Claim” means any and all suits, claims, actions, proceedings, or demands brought by a Third Party.

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“Trademarks” means trademarks, service marks, trade names, certification marks, service names, industrial designs, brand names, brand marks, trade dress rights, identifying symbols, logos, emblems, and signs or insignia.

“Unit” has the meaning given to such term in Schedule F.

“Unit Equivalent” has the meaning given to such term in Schedule F.

“USD” or “US$” means the lawful currency of the United States of America.

“Working Hours” means, in relation to a notice served or audit performed under this Agreement, 09:00 to 17:00 in the place of receipt of such notice or place of such audit on a day which is not a Saturday, a Sunday or a public holiday in the jurisdiction in which the notice is to be received or the audit be performed, but excluding any day in the period from December 24 to January 1 (inclusive).

2.1 Development & R&D Support. Metsera shall determine if and when a Product will be developed, and the JMT shall determine at which Facility Amneal shall develop a Product. Amneal shall be responsible for development work, including, process development, process qualification and validation, scale-up, analytic development, formulation development, product characterization, stability studies and testing, on a Product-by-Product basis (“R&D Support”) in accordance with a development plan describing the activities, specifications, schedule and timelines, information and reports required, technology transfer, and any other matters agreed to by the Parties in writing (the “Development Plan”). The Development Plan will include a budget for all R&D Support Fees under such Development Plan (the “Development Budget”). R&D Support will also include Amneal Manufacturing and supplying Product for Metsera’s clinical trials, and may include Amneal transferring-in Manufacturing processes developed by Third Parties. An initial Development Plan (including Development Budget) will be prepared and agreed to by the Parties within [***] following the Effective Date (or such other period as agreed by the Parties in writing) and attached hereto as Schedule E. The Development Plan and Development Budget may be amended from time to time upon mutual agreement by the Parties via the JMT. Amneal shall perform the R&D Support set forth in the Development Plan in compliance with (a) any specifications set forth in the Development Plan, (b) the terms and conditions of this Agreement and the Development Plan, and (c) all Applicable Laws. Amneal shall use [***] to complete the R&D Support and its obligations and activities under the Development Plan in accordance with the schedule and timelines set forth therein. Should any of the terms of any Development Plan conflict with the general terms and conditions of this Agreement, the terms and conditions of this Agreement shall govern. In the event of any disagreement between the Parties related to the Development Plan, the Development Budget, or the R&D Support, such matter shall be escalated to the JMT.

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2.2 R&D Support Records. Amneal shall provide written research reports to Metsera describing with sufficient detail experimental procedures, analyses, data and results conducted and obtained in the performance of the R&D Support (“Results”), in accordance with the procedures and timelines in the Development Plan. Amneal shall maintain current and accurate records of all R&D Support activities conducted by it under a Development Plan and all data and other information resulting from such work. Such records shall accurately reflect all work done and Results achieved in the performance of such R&D Support activities in sufficient detail and in good scientific manner appropriate for regulatory and patent purposes and in accordance with Applicable Laws. Amneal shall retain experimental records, laboratory notebooks or laboratory notebook pages containing Results for not less than [***] from the creation thereof. After this time period, upon ▇▇▇▇▇▇▇’s written request and at Metsera’s sole expense, Amneal shall provide to Metsera: (a) for non-cGMP projects, copies of applicable specific laboratory notebooks, laboratory notebook pages or other documentation, as mutually agreed upon in writing by the Parties, for retention in Metsera’s archives; and (b) for cGMP projects, copies of executed batch records, deviation reports, investigation reports and analytical testing results of Products or other documentation as mutually agreed upon in writing by the Parties. At Amneal, all such records will be maintained in accordance with Amneal’s notebook policy, and in a secure area reasonably protected from fire, theft and destruction consistent with Amneal’s policies and procedures.

2.3 Development Costs. In consideration of the R&D Support, Metsera shall pay to Amneal the R&D Support Fee in accordance with Article 9, provided that the R&D Support Fee does not exceed the applicable Development Budget by [***]. In the event that Amneal anticipates that additional activities are necessary to complete a Development Plan which may cause the R&D Support Fee to exceed the applicable Development Budget by more than [***], Amneal shall promptly inform the JMT of the same and provide an estimate of the costs and expenses arising from the reasonably necessary additional activities needed to complete the Development Plan. Amneal will perform such reasonably necessary additional activities to complete the applicable Development Plan if Metsera agrees to pay the additional costs for performing such activities. [***]

2.4 Filing of Marketing Authorization; Ownership. Metsera shall be solely responsible for the registration activities for the Products in the Territory, including but not limited to compiling, submitting and maintaining the Marketing Authorization, filing the application, interacting with Regulatory Authorities and obtaining Regulatory Approval for the Drug Products which shall be in Metsera’s name, at its sole cost and expense.

3.1 Engagement. Metsera shall decide if and when a Product will be Manufactured, and the JMT shall determine at which Facility Amneal shall Manufacture a Product. During the Term, Amneal agrees to Manufacture and supply the Product designated by Metsera at the designated Facility for clinical use and commercialization in the Territory in the quantities that Metsera orders pursuant to Article 5, and Metsera agrees to purchase such ordered quantities of Product from Amneal in accordance with the terms and conditions hereof. In the event that Metsera desires for Amneal to Manufacture and supply product that is not Drug Substance or not Drug Product hereunder, the Parties shall discuss and agree in good faith on inclusion of such products hereunder.

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3.2 Preferred Supplier. During the Term, Amneal shall be Metsera’s preferred supplier with respect to the supply of commercial Product, and Metsera shall be required to purchase (and Amneal shall supply) (a) at least [***] of Metsera’s, its Affiliates, and its or their sublicensee’s [***] annual requirements of commercial Drug Product and (b) at least [***] of Metsera’s, its Affiliates and its or their sublicensee’s [***] annual requirements of commercial Drug Substance (each of (a) and (b), a “Supply Threshold” and collectively, the “Supply Thresholds”); provided, however, that if Metsera can demonstrate through reasonable written evidence that it has a Third Party supplier, on a Drug Substance-by-Drug Substance basis, of commercial Drug Substance at a lower price to Metsera than the Supply Price combined with the applicable mark-up then Metsera may use such alternative supplier for commercial Drug Substance for any or all of its requirements for commercial Drug Substance, and the Drug Substance Supply Threshold shall be reduced accordingly, provided, further, that in the event that Amneal can beat (taking into account the Supply Price combined with the applicable mark-up) the lower price obtained by Metsera at any time, Metsera and Amneal shall discuss in good faith a plan for Metsera to place future orders for at least [***] of Metsera’s, its Affiliates, and its or their sublicensee’s [***] annual requirements for such commercial Drug Substance with Amneal, subject to any commitments Metsera has with its Third Party supplier. In the event that Metsera sublicenses rights to commercialize all Drug Products that exist at the time such sublicense agreement becomes effective in the entirety of the United States or in the entirety of the European Union to a Third Party and Metsera does not supply at least one Drug Product supplied by Amneal pursuant to this Agreement to such Third Party sublicensee for commercialization in either the United States or the European Union (“Drug Product Outlicense”), (i) Metsera shall provide Amneal with written notice within [***] following the execution of such Drug Product Outlicense and (ii) within [***] following the execution date of such Drug Product Outlicense, Metsera may elect, upon written notice to Amneal, to reduce the Supply Thresholds for the duration of the Term from the levels then in effect as of the effective date of the first commercial sale of the first Drug Product pursuant to the Drug Product Outlicense in accordance with the following, as calculated in twelve (12)-month periods commencing on the effective date of the Drug Product Outlicense:

3.3 Priority Supply. Notwithstanding the Supply Thresholds, Metsera may request, and Amneal shall use reasonable, diligent efforts to supply, (a) one hundred percent (100%) of Metsera’s and its Affiliates’ and their sublicensees’ [***] requirements for Drug Product, up to the maximum annual capacity of two (2) Drug Product Manufacturing lines at the New Facility dedicated to the Manufacture of Metsera Drug Product (the “Dedicated Lines”), reasonably apportioned on a month-by-month basis, and (b) one hundred percent (100%) of Metsera’s and its Affiliate’s and their sublicensees’ [***] requirements for Drug Substance, up to the maximum annual capacity of the New Facility for Drug Substance Manufacturing, reasonably apportioned on a month-by-month basis. In furtherance of the foregoing, if ▇▇▇▇▇▇▇’s Forecast Schedules are

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consistently in excess of the maximum annual capacity of the Dedicated Lines or in excess of the maximum annual capacity of the New Facility for Drug Substance Manufacturing such that an increase to Amneal’s Manufacturing capacity would be warranted to meet such Forecast Schedules, Amneal shall use [***] to increase its applicable Manufacturing capacity at the New Facility; provided, that (i) the Parties shall in good faith agree on a capacity increase schedule, (ii) Amneal has at least [***] to implement such capacity increase, and (iii) Amneal’s inability to add Manufacturing capacity despite its [***] to do so shall not be a breach of this Agreement. If Amneal is unable to meet ▇▇▇▇▇▇▇’s Forecast Schedules in excess of the maximum annual capacity of the Dedicated Lines or in excess of the maximum annual capacity of the New Facility for Drug Substance Manufacturing, Metsera may, in its sole discretion, decrease the applicable Supply Threshold(s) to correspond with Amneal’s capacity. The maximum annual capacity of the Dedicated Lines shall be at least one hundred million (100,000,000) Units of cartridge-based Injectable Drug Product annually. [***] The maximum annual capacity of the New Facility for Drug Substance Manufacturing will be agreed to by the Parties pursuant to the Construction Addendum.

3.4 Manufacture. Amneal shall (and shall procure that a Permitted Subcontractor or Affiliate shall) Manufacture the Products at the Facilities in accordance with:

3.5 Subcontracting. Amneal shall not subcontract the Manufacture of Products (or any material part thereof) under this Agreement to any Third Party without the prior written consent of Metsera, such consent not to be unreasonably withheld, conditioned or delayed, provided that Metsera’s consent shall not be required for any subcontract to a Third Party that is presented to the JMT for review if such subcontracted activities are not direct, substantive Manufacturing activities or are for activities that only support the Manufacturing process, including, by way of example, the calibration of equipment; provided, further, that if any such subcontracted activities could reasonably be expected to reduce Manufacturing capacity or have a material impact on the Product or the Regulatory Approval thereof, Metsera’s prior written consent shall be required. For the avoidance of doubt, any subcontracted activity or change thereto that would be required to be included in a regulatory filing, or would require an amendment to an existing regulatory filing,

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shall be deemed to have a material impact on Regulatory Approval. In the event that Amneal subcontracts an immaterial part of the Manufacturing process to a Third Party, or Metsera approves a Third Party to subcontract any material part of the Manufacture of Products (each such Third Party, a “Permitted Subcontractor”) in accordance with the foregoing sentence, Amneal shall ensure that all such Permitted Subcontractors: (a) act in compliance with the terms and conditions of this Agreement and the Quality Agreement to the same extent as Amneal, relevant to the activities to be performed by such Permitted Subcontractor and (b) are subject to confidentiality and nonuse obligations that are no less restrictive than those set forth in Article 19. The engagement of Permitted Subcontractors shall not relieve Amneal from any of its liabilities or obligations under this Agreement, and Amneal shall remain solely and fully responsible and liable as primary obligor to Metsera for the acts or omissions of all Permitted Subcontractors, or their respective personnel to the same extent as if they were the acts or omissions of Amneal or Amneal’s employees, whether arising from breach, negligence, gross negligence or intentional misconduct, and shall remain exclusively responsible for all costs associated with any subcontract or supply relationship (including costs and expenses arising from or related to the appointment of Permitted Subcontractors).

3.6 Changes to Manufacturing.

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3.7 Non-Compete.

4.1 Change of Facility. Subject to Amneal’s rights set forth in Section 4.3(B), Amneal shall, upon reasonably advanced prior written notice to Metsera, be permitted to make a change or permit the change within any Facility or production line within a Facility, where Products are Manufactured; provided, however, that if any such change could reasonably be expected to reduce Manufacturing capacity or have a material impact on the Product or the Regulatory Approval thereof (for the avoidance of doubt, any decision or change that would be required to be included in a regulatory filing, or would require an amendment to an existing regulatory filing, shall be deemed to have a material impact on Regulatory Approval), Metsera’s prior written consent shall be required. Any change in or to a Facility shall be subject to any applicable change control provisions set out in the Quality Agreement and shall comply with Applicable Law. Amneal will bear any expenses (including technical transfer and validation costs) with respect to any change of such Facility initiated by Amneal, its Affiliates or any Permitted Subcontractor. Subject to Section 4.3, any change to the site (i.e., a Product would be Manufactured at a different facility) of Manufacture of Products shall require the prior written consent of Metsera, such consent not to be unreasonably withheld, conditioned or delayed.

4.2 Construction of the New Facility. Amneal agrees to construct a vertically integrated peptide active pharmaceutical ingredient and finished dosage form manufacturing plant located in India for the Manufacture of Drug Substance and Injectable Drug Product (the “New Facility”) in accordance with the terms set forth in the Construction Addendum. For clarity, following completion of the construction of the New Facility, (a) Amneal shall be responsible at its cost and expense for qualifying the New Facility for the manufacture of Injectable Drug Products and Drug Substance and obtaining all Manufacturing Licenses and (b) subject to the Supply Thresholds and Sections 3.3, 3.7 and 13.3, Amneal shall be permitted to utilize the New Facility to Manufacture its own and Third Party products.

4.3 Event of Loss at New Facility.

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5.1 General. Manufacturing and supply of commercial Product under this Agreement shall, in each case, be pursuant to the Firm Zone of the Forecast Schedules and Firm Orders submitted by Metsera, as further described below.

5.2 Amneal Capacity Forecast. Following completion of the New Facility, commencing on the first day of the immediately following Calendar Quarter, Amneal shall provide to Metsera and the JST on a quarterly basis and no later than [***] after the start of each Calendar Quarter, a non-binding forecast of its anticipated monthly commitments for the Manufacture of drug substance and drug product at the New Facility for itself and Third Parties for the immediately following [***], broken down by Calendar Quarter.

5.3 Commercial Forecast Schedule.

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5.4 Purchase Orders.

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5.5 Minimum Order Quantities. Following the First Commercial Sale of the first Injectable Drug Product Manufactured at the New Facility, the JST shall determine the minimum aggregate quantity for Injectable Drug Product that Metsera will be obligated to order annually from Amneal beginning the following year (the “Minimum Order Quantity”), which Minimum Order Quantity shall be no more than [***] Injectable Drug Product. Thereafter, in each Calendar Year where the aggregate quantity of Injectable Drug Product ordered by Metsera in such Calendar Year is less than the applicable Minimum Order Quantity of Injectable Drug Product, Metsera shall pay to Amneal [***]. Any payments made by Metsera to Amneal pursuant to this Section 5.5 shall be credited on a pro rata basis against the applicable Supply Threshold and be entitled to a Construction Rebate. Where Injectable Drug Product ordered in any Calendar Year is in excess of the applicable Minimum Order Quantity, such excess will carry forward and be credited towards ▇▇▇▇▇▇▇’s Minimum Order Quantity for the following Calendar Year. Notwithstanding anything to the contrary herein, Metsera will not be obligated to order the Minimum Order Quantity for any Injectable Drug Product for which there has been a Supply Failure or a notice of potential delay provided pursuant to Section 13.1.

[***].

6.1 Delivery. Amneal shall deliver, or shall cause its Affiliate or Permitted Subcontractor to deliver, all quantities of Product ordered by Metsera pursuant to a Firm Order on the date specified for delivery by Metsera in the applicable Firm Order [***]. Each such shipment of commercial Product shall include the full amounts of Product ordered under such Firm Order; provided, however, that the quantity of Products delivered by Amneal may vary [***] from the quantities specified by Metsera in the applicable Firm Order, provided that any shortfall is received by Metsera within [***] of the date specified for delivery. Shipments of Products will be made [***] of Amneal or its Affiliate or Permitted Subcontractor, as applicable, unless otherwise mutually agreed by the Parties. As between the Parties, risk of loss or of damage to Products will remain with Amneal until Amneal or its Affiliate or Permitted Subcontractor loads the Products onto the carrier’s vehicle for shipment at the shipping point at which time risk of loss or damage will transfer to Metsera. Notwithstanding the foregoing, Amneal will, or will require its Affiliate or Permitted Subcontractors to, in accordance with Metsera’s reasonable instructions and as agent for Metsera, (a) arrange for shipping (such shipping to be paid by Metsera) and (b) at Metsera’s expense, obtain any other official authorization necessary to export the Products. Metsera will arrange for insurance and will select the freight carrier used by Amneal or its Affiliate or Permitted Subcontractor to ship Products. Products will be transported in accordance with the Specifications. Upon each shipment of the Product, Amneal will provide to Metsera the Release Documentation

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and such other documentation in English as is required to meet Applicable Law, or such other documentation as the Parties may agree upon in writing. The Parties shall cooperate reasonably to obtain all licenses or permits necessary to ship the Product (the evaluation of which licenses or permits required shall be performed by Metsera or its designee). Metsera or its designee is responsible for import control compliance. On the date of shipment, the Products shall have at least the Minimum Remaining Shelf Life.

[***]

7.1 Supply Price. Subject to the provisions of this Section 7.1 and Sections 7.2 and 7.5, the “Supply Price” for each of commercial Drug Product and Drug Substance shall be the “Supply Price per Unit” or the “Supply Price in [***] Dollars per Gram” as set forth in the left-hand columns on Schedule F. [***] The Manufacture and supply of clinical Product shall be deemed R&D Support, and the Supply Price for such clinical Product shall be determined as of the date on which Metsera submits a purchase order [***] for clinical Product to Amneal pursuant to Section 5.4(A), and shall be calculated in accordance with the Accounting Standard. [***] Amneal shall use good faith efforts to identify and implement continuous improvement opportunities for the Manufacture and supply of commercial Drug Product, with the objective to reduce the Supply Price during the Term, subject at all times to the minimum and maximum prices set forth on Schedule F.

7.2 Annual True-up.

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7.3 Annual Review of Supply ▇▇▇▇▇, ▇▇▇▇-Up. Commencing in [***], no later than [***] prior to the end of each Calendar Year, the Parties shall, via the JST, discuss in good faith and agree (such agreement not to be unreasonably withheld, conditioned or delayed), on any revisions to the pricing and mark-up tiers set forth on Schedule F to ensure that the Supply Price and mark-up reflects an appropriate balance between the Supply Price and mark-up payable under Section 8, taking into account [***]. For clarity, any adjustments to the Supply Price shall be subject to the minimum and maximum prices set forth on Schedule F, provided, however, that at the last annual review of the Supply Price immediately preceding anticipated First Commercial Sale, the Parties shall conduct a one (1)-time revaluation of the minimum and maximum prices set forth on Schedule F.

7.4 Taxes and Withholding; Indirect Taxes.

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7.5 Supply Price Rebate. In consideration of the Metsera Construction Costs as set forth in the Construction Addendum, (a) following the First Commercial Sale of Injectable Drug Product manufactured at the New Facility, Metsera shall receive a rebate against the Supply Price for all commercial Injectable Drug Products of [***] (the “Construction Rebate”) and (b) Amneal shall pay to Metsera [***] (the “Non-Metsera Product Offset Amount”) of any drug product manufactured at the New Facility for any Third Party or for Amneal or its Affiliates. At such time as (i) the Construction Rebate actually credited against the Supply Price and (ii) the Non-Metsera Product Offset Amount actually paid to Metsera together total an aggregate amount of One Hundred Million Dollars (USD $100,000,000) (the “Recoupment Date”), (x) no further Construction Rebate will be applied to the Supply Price for commercial Injectable Drug Product, and the full Supply Price for commercial Injectable Drug Product shall be reinstated and (y) no further Non-Metsera Product Offset Amount shall be payable. [***]

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8.1 Earn-Out Rate. In partial consideration of the Manufacturing and supply of Products hereunder, during the Term, Metsera shall make [***] earn-out payments to Amneal at the rate(s) set forth on Schedule F based on [***].

8.2 Earn-Out Notice and Payment. Within [***] after the end of each Calendar Quarter during the Term, Metsera shall provide Amneal with a report containing [***] (an “Earn-Out Report”). Following receipt of such Earn-Out Report, Amneal shall promptly submit an invoice to Metsera with respect to the earn-out amount shown therein. Metsera shall pay such earn-out amount within [***] following delivery of the applicable Earn-Out Report.

8.3 Earn-Out Reduction(A) . Without limitation to Section 8.1 above, in the event that in any country or other jurisdiction in the Territory there is Generic/Biosimilar Competition with respect to a Drug Product then, for such Drug Product in each such country or other jurisdiction, the earn-out payable to Amneal for the [***] shall be reduced by [***] for such Drug Product in such country during any Calendar Quarter in which there is Generic/Biosimilar Competition. For purposes herein, “Generic/Biosimilar Competition” means, on a country or other jurisdiction and Drug Product basis, the unit volume of a Generic/Biosimilar Product(s) sold in a country or other jurisdiction by one (1) or more Third Party(ies) in a Calendar Quarter is at least [t***] of the unit volume of such Drug Product sold in that country or other jurisdiction by Metsera, its Affiliates and (sub)licensees;

8.4 Recordkeeping. Metsera shall keep, and shall require its Affiliates and (sub)licensees to keep, complete and accurate records pertaining to Net Sales of Drug Products in sufficient detail to permit Amneal to confirm the accuracy of any earn-out payments due under this Agreement. Metsera will keep such books and records for [***] following the Calendar Year to which they pertain, or such longer period of time as may be required by Applicable Law.

9.1 Issuance of Invoices. Amneal shall issues invoices to Metsera (or its relevant Affiliate) (a) for the development of Products pursuant to Section 2, on a quarterly basis and (b) for Products Manufactured and supplied under this Agreement, upon or following shipment of such Products at the Supply Price in effect at the time the applicable Firm Order was placed.

9.2 Invoice. Each invoice issued pursuant to Section 9.1 shall be in a form mutually agreed by the Parties, provided that, at a minimum, each invoice for the Manufacture and supply of Products shall specify:

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9.3 Payment of Invoice for Supply Price. Subject to Section 9.5, Metsera shall pay or procure the payment of undisputed invoices issued by Amneal pursuant to Section 9.1(b) in the Invoice Currency for the Supply Price and, to the extent provided in Section 7.4(B), the applicable portion of any associated Indirect Taxes for Product delivered pursuant to orders within [***] after receipt of such invoice by electronic transfer to the account identified by Amneal in the invoice.

9.4 Payment of Other Invoices. Any amounts reimbursable to Amneal pursuant to this Agreement other than the Supply Price for Products delivered (including with respect to R&D Support Fee and earn-out payments) may be invoiced and paid separately from any invoice for the Supply Price for Products delivered. Subject to Section 9.5, any undisputed invoice issued pursuant to this Section 9.4 shall be payable within [***] following receipt by Metsera.

9.5 Late Payments. If Metsera fails to pay any undisputed payment under this Agreement by the date when such payment is due, then, without limiting any other right or remedy of Amneal, such late payment shall be paid together with interest thereon at [***]. If Metsera or its designee disputes in good faith any portion of an invoice that is presented by Amneal in accordance with this Agreement, Metsera or its designee shall pay the undisputed portion of such invoice and provide Amneal with written notice of the disputed portion and its reasons therefor, and Metsera or its designee will not be obligated to pay such disputed portion unless and until such dispute is resolved in favor of Amneal.

9.6 All payments hereunder shall be calculated in accordance with the Accounting Standard.

10.1 Quality Agreement. Amneal and Metsera shall enter into a Quality Agreement within [***] and attach it hereto as Schedule D, which shall govern matters relating to quality assurance, quality control and change control with respect to the Manufacturing and supply of Products, as more particularly set out therein. Any changes or variations to the Product (including Drug Substance, Drug Product, packaging, or any Component(s)), the Manufacturing process or any Facilities involved in the Manufacture of the Product (including the Drug Substance, Drug Product and Components) shall only be made in accordance with this Agreement and the Quality Agreement. If required under Applicable Laws in a particular country, ▇▇▇▇▇▇ agrees to use [***] to enter into a quality agreement directly with one or more CMOs of Metsera, which agreement may or may not include Metsera as a party. Amneal and Metsera shall perform their respective obligations and comply with all provisions of the Quality Agreement.

10.2 Conflict with Agreement. In the event of any conflict or inconsistency between the provisions of this Agreement and the provisions of the Quality Agreement, the Quality Agreement shall govern in respect to quality matters, and the provisions of this Agreement shall govern with respect to all other matters, including, for clarity, all financial matters.

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11.1 Relationship Manager. Promptly after the Effective Date, each Party shall appoint a relationship manager with responsibility for managing operational matters between the Parties under this Agreement (each, a “Relationship Manager”). The Relationship Manager shall participate as a member of the Joint Manufacturing Team and Joint Supply Team described below.

11.2 Establishment of Joint Manufacturing Team. Promptly after the Effective Date, the Parties shall establish a joint manufacturing team (the “Joint Manufacturing Team” or “JMT”). The Joint Manufacturing Team shall consist of [***] representatives appointed by each Party, one (1) of whom shall be the Relationship Manager appointed by the applicable Party pursuant to Section 11.1 and at least [***] of whom must be a senior manager with decision-making capacity on Product Manufacturing development. The JMT will meet at least once per Calendar Quarter or as otherwise agreed by the Parties.

11.3 Specific Responsibilities of Joint Manufacturing Team. In addition to the JMT’s general discussion, review and coordination regarding the Manufacturing development of Product, the JMT shall:

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11.4 Establishment of Joint Supply Team. Promptly after the Effective Date, the Parties shall establish a joint supply team (the “Joint Supply Team” or “JST”). The Joint Supply Team shall consist of [***] representatives appointed by each Party, one (1) of whom shall be the Relationship Manager appointed by the applicable Party pursuant to Section 11.1 and at least [***] of whom must be a senior manager with decision-making capacity on clinical and commercial Product supply and Manufacturing. The JST will meet at least once per Calendar Quarter, or as otherwise agreed by the Parties.

11.5 Specific Responsibilities of Joint Supply Team. In addition to the JST’s general discussion, review and coordination regarding the Manufacture and supply of Product, the JST shall:

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11.6 General Provisions Regarding Membership; Meetings; Minutes; Decision Making; Term.

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11.7 Escalation of Team Disputes. For matters that cannot be settled within a Team pursuant to Section 11.6(C), the matter may be escalated by either Party to the Designated Officers. In the event that the Designated Officers are unable to resolve any such dispute referred to them within [***] after the date such dispute was referred to the Designated Officers (or such longer period as the Designated Officers may agree upon), the matter may be escalated by either Party to the Executive Officers. In the event that the Executive Officers are unable to resolve any such dispute referred to them within [***] after the date such dispute was referred to the Executive Officers (or such longer period as the Executive Officers may agree upon), then, subject to Section 11.8, Metsera shall have the final decision-making authority with respect to all matters pertaining to the Product (including specifications therefore) and the determination of when and at which Facility Products shall be developed or Manufactured.

11.8 Limitations. The Teams are not empowered to amend, or waive compliance with, the terms of this Agreement.

12.1 Notice of Defects. Promptly following delivery, Metsera or its designee shall inspect (without having to open the packaging of) Product delivered under this Agreement. Notice of all claims arising out of or relating to Obvious Defects shall be given by Metsera or its designee in writing to Amneal within [***] after the date of receipt of both the Product and the Release Documentation or such other documentation agreed upon by the Parties in writing. Notice of all claims arising out of or relating to Latent Defects shall be given by Metsera or its designee in writing to Amneal at any time prior to [***], provided, however, that such written notification shall be given promptly after Metsera’s or its designee’s determination of any such Latent Defect.

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12.2 Determination of Defect. In the event Metsera or its designee rejects any Product as Defective, Amneal or its Permitted Subcontractor shall have the right to sample and retest such Product, which shall be done as soon as reasonably practicable and in accordance with the Quality Agreement, and Metsera or its designee shall make Product alleged to be Defective available for inspection by Amneal or its Permitted Subcontractor in accordance with the Quality Agreement. In the event of a discrepancy between, on the one hand, Metsera’s or its designee’s and, on the other hand, Amneal’s or its Permitted Subcontractor’s opinion on test results such that one Party (i.e., either Metsera or Amneal) is of the opinion that the Product is Defective and the other Party (i.e., either Metsera or Amneal, as applicable) is of the opinion that the Product is not Defective, including a dispute over whether the alleged Defect results from acts or omissions of Metsera or its designee or any Third Party after delivery and loading onto the carrier’s vehicle, which disagreement is not resolved through good faith negotiations for up to [***] following identification of the discrepancy, the Parties shall cooperate to submit the matter to an Independent Expert for evaluation. The findings of the Independent Expert shall be binding on the Parties, absent manifest error. The expenses of the Independent Expert shall be borne by the Party against whom the finding is given. Notwithstanding anything to the contrary in this Section 12.2, nothing in this Section 12.2 is intended to (and shall not) impact the Parties’ respective rights (and the exercise of such rights) and obligations under this Agreement until such time that retesting or any disagreement is resolved hereunder. For clarity, any Product Actions resulting from any notifications made pursuant to this Article 12 shall be addressed in accordance with Article 17.

12.3 Product Replacement. Notwithstanding the foregoing, Metsera shall be entitled to require Amneal to promptly replace or procure the replacement of any allegedly Defective Product that Metsera rejects pursuant to this Agreement or the Quality Agreement at no additional charge to Metsera, irrespective of whether it has been finally settled that the Product was Defective; provided that if such Product is later found not to be Defective pursuant to Section 12.2, Metsera shall pay Amneal an additional amount equal to [***] of the then-current (as of the time of replacement) Supply Price of the replacement Product delivered to Metsera in accordance with this Section 12.3. Without prejudice to the right of Metsera to require replacement of Defective Product in the immediately preceding sentence, if Product is found to be Defective pursuant to Section 12.2, Amneal or its Permitted Subcontractor shall promptly (a) unless the Defective Products have previously been replaced pursuant to the immediately preceding sentence, supply Metsera with the applicable quantity of Product free of Defects, at Amneal’s or its Permitted Subcontractor’s expense, and (b) either collect, at the expense of Amneal, any damaged or Defective Product from Metsera or its designee or reimburse Metsera for any direct costs reasonably and actually incurred in its disposal of such Product following invoice from Metsera; provided, however, that in the event the Defect was, or was determined by the Independent Expert to have been, caused by Metsera, Metsera or its designee shall be responsible for all expenses and direct costs reasonably and actually incurred pursuant to subclause (a) or (b). WITHOUT LIMITING THE PARTIES’ RIGHTS AND OBLIGATIONS UNDER SECTIONS 3.3, 6.2, 13, 17, 24 OR 27 (solely with resect to Metsera’s right to terminate), THIS SECTION 12.3 STATES METSERA’S AND ITS AFFILIATE’S SOLE AND EXCLUSIVE RIGHT AND REMEDY FOR REPLACEMENT OF DEFECTIVE PRODUCT. Notwithstanding the foregoing, nothing in this 12.3 is intended to or shall limit or restrict any rights or remedies of Metsera or its Affiliates resulting from Amneal’s or its Affiliate’s gross negligence, willful misconduct or fraud. The limitations of liability in Section 24.4(B) shall not apply to this Section 13.

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13.1 Notice of Delay. If at any time during the Term of the Agreement, Amneal is or expects that it may be unable, in full or in part, to materially satisfy Metsera’s Forecast Schedule or Firm Orders for any reason (including, without limitation, regulatory challenges, rejections, shortages, notifications related to nonconformance with cGMP, or Force Majeure event), Amneal shall immediately notify Metsera, detailing the extent to which it expects it will not meet such requirements and provide Metsera with the expected date of shipment for the affected Product. The Parties shall work together in good faith to agree on a reasonable plan consistent with Amneal’s obligations in Section 13.3 that ensures the delivery takes place as close as possible to the requested delivery date, and Amneal shall implement such plan.

13.2 Supply Failure. If for any reason, including for an Event of Loss, Amneal fails to supply [***] (each [***], a “Supply Failure”), Metsera may meet the shortfall from any alternate source(s) and shall, to the extent that the amount of the actual supply price paid by Metsera in meeting such shortfall by procuring from alternate source(s) is greater than the Supply Price for the equivalent amount and type of Product, be entitled to credit such greater amount against future orders for Product from Amneal up to an amount equal to [***]. In addition, Metsera shall receive the Construction Rebate against the Supply Price for the amount of such shortfall purchased by Metsera from the alternate source(s) in accordance with Section 7.5, even if Metsera purchases the shortfall from alternate sources for longer than [***]. Moreover, in Metsera’s sole discretion, Metsera may elect to reduce Metsera’s annual Minimum Order Quantity purchase obligation and/or the Supply Threshold by the total shortfall amounts of any Product that is the subject of a Supply Failure. Notwithstanding the foregoing, in the event that any shortfall or failure to supply as described in subclauses (a) or (b) above was attributable to [***], such shortfall or failure to supply shall not be deemed a Supply Failure, provided that with respect to subclause (ii), Amneal is in compliance with its obligations to maintain safety stock in accordance with Section 18. WITHOUT LIMITING THE PARTIES’ RIGHTS AND OBLIGATIONS UNDER SECTIONS 3.3, 6.2, 12.3, 24 OR 27 (solely with resect to Metsera’s right to terminate), THIS SECTION 13.2 STATES METSERA’S AND ITS AFFILIATE’S SOLE AND EXCLUSIVE RIGHT AND REMEDY FOR ANY SUPPLY FAILURE. Notwithstanding the foregoing, nothing in this 12.3 is intended to or shall limit or restrict any rights or remedies of Metsera or its Affiliates resulting from Amneal’s or its Affiliate’s gross negligence, willful misconduct or fraud. The limitations of liability in Section 24.4(B) shall not apply to this Section 13.2.

13.3 Prevention and Mitigation of Supply Failure; Priority. If and to the extent a Supply Failure under this Agreement can be prevented or mitigated by Amneal, by waiving, delaying, or modifying manufacturing, supply or delivery of any product, including Product, to itself or any product to any Third Party, to the extent permissible under any contract with a Third Party; provided, for clarity, Amneal is under no obligation to amend any agreement with a Third Party, or include in any future agreement with a Third Party, any right or obligation to deprioritize or otherwise alter Amneal’s supply obligations to such Third Parties, either at the New Facility, any other Facility or at any CMO facility, Amneal shall so waive, delay or otherwise modify such manufacturing, supply or delivery of such product and use [***] to Manufacture and deliver the Product(s) that are the subject of the potential Supply Failure in accordance with the Firm Order.

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13.4 No Restriction on Rights. In no event shall any Amneal obligation or Metsera right in this Section 13 restrict any of Amneal’s obligations or Metsera’s rights in Section 4.3, and in no event shall any Amneal obligation or Metsera rights in Section 4.3 restrict any of Amneal’s obligations or Metsera’s rights in this Section 13.

14.1 Permits. Each Party shall ensure that it, at its own cost, obtains and maintains throughout the Term all Regulatory Authority certificates, permits, licenses or approvals that it (or the relevant Affiliate) respectively requires for the purposes of this Agreement, or with, respect to Metsera, with respect to the Products, and for the performance of its obligations (or the obligations of its Affiliates) under this Agreement. Amneal covenants that it will use [***] to ensure that its Affiliates’, Permitted Subcontractors’ and suppliers’ comply with the requirements set forth in the immediately preceding sentence.

14.2 Manufacturing Licenses. Without prejudice to Section 14.1, Amneal shall, or shall procure that its Affiliate or Permitted Subcontractor shall, at its or their own cost, obtain and maintain throughout the Term, and until the expiry of the last Batch delivered, any Manufacturing Licenses required in connection with the Manufacture and supply of the Products.

14.3 Governmental Authority Inspections. Amneal shall notify Metsera of any Governmental Authority visit or inspection of Facilities in respect of a matter relating to the Manufacture of the Products in accordance with the Quality Agreement. Amneal will (i) respond to all inquiries directed to it by any Governmental Authority that may impact the quality or timely delivery of Product and shall promptly notify Metsera of same, (ii) reasonably assist Metsera in responding to inquiries related to Product Manufactured and supplied by Amneal directed to Metsera by any Governmental Authority, and (iii) provide any Governmental Authority with such information and data in Amneal’s possession and control as is reasonably requested by such Governmental Authority with respect to the Manufacture, use, route of synthesis and testing of the Product. Amneal shall make its and its Affiliates’ Facilities reasonably available for inspection by representatives of any Governmental Authority in compliance with Applicable Law. Amneal shall notify and, if applicable, provide copies of any material notices or communications to, Metsera of any Governmental Authority inspection, investigation or other inquiry or material communication relating to the Manufacture of the Product by Amneal or to any Facility at which the Product is Manufactured that may impact the quality of Product, including any form, warning letter or observation required by Applicable Law, promptly and not more than [***] after Amneal becomes aware of such inspection, investigation or other inquiry or communication. Amneal shall also discuss with Metsera any response to observations and notifications received in connection with any inspection, investigation, communication or other inquiry concerning Product.

15.1 Recordkeeping. Amneal shall, or shall procure that any Affiliate or Permitted Subcontractor (as applicable) shall:

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Amneal and Metsera (or each of their applicable Affiliate(s)) shall discuss and execute a Safety Data Exchange Agreement (the “SDEA”), which will set forth the responsibilities of each Party with respect to clinical safety and pharmacovigilance matters relating to each Drug Product and Licensed Product (as defined in the License Agreement), as applicable, in connection with this Agreement and the License Agreement. The Parties shall update the SDEA from time to time as needed to properly reflect the status of the marketing and sale of each Drug Product and the relevant regulations in each country. In the SDEA, the Parties shall define how clinical safety and pharmacovigilance will be managed by both Parties, how the safety database for the Drug Products will be set up and how safety information will be exchanged, and in particular shall: (a) set forth how cases will be processed in the global safety database; (b) provide for submitting expedited reports in an agreed format to health authorities, in accordance with the requirements of Regulatory Authorities; (c) include provisions regarding producing outputs (tables, line listings) for aggregate reports such as periodic safety update reports and development safety update reports; (d) include provisions regarding evaluation of safety and benefit-risk; (e) include provisions regarding performing ongoing safety signal detection and assessment; and (f) include provisions governing safety statements in aggregate reports, in each case ((a)-(f)) in a manner consistent across countries to the extent reasonably practicable. Additionally, any other safety-relevant information (beyond adverse events) shall be exchanged as outlined in the SDEA.

17.1 Handling of Product Actions. Product Actions shall be handled in accordance with the Quality Agreement, and the provisions of this Article 17. In compliance with the Quality Agreement, each Party shall provide prompt notice to the other Party upon receipt or discovery of any information which indicates a Product Action may be necessary.

17.2 Assistance. If a Governmental Authority requires a Product Action, or Metsera deems it necessary under Applicable Law or customary industry practice to initiate a Product Action, Amneal shall provide such reasonable assistance as Metsera reasonably requests to facilitate such Product Action. Metsera shall have final decision-making authority with respect to Product Actions and related matters, including communications with Governmental Authorities and the public.

17.3 Amneal Responsibility. Where a Product Action is necessitated by a failure by Amneal or its Affiliate or Permitted Subcontractor to comply with its responsibilities or obligations under this Agreement or the Quality Agreement, or Amneal’s or its Affiliate’s or Permitted Subcontractor’s negligence or willful misconduct, Amneal shall, at the sole discretion of Metsera, either:

within [***] of receipt of an invoice for the same, reimburse Metsera for all documented and reasonable costs incurred by Metsera and its designees in carrying out the Product Action.

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17.4 Exchange of Information. Each Party shall promptly provide to the other Party any information obtained by it suggesting that a Product Action is or may be necessary. Further, the Parties shall cooperate in obtaining any additional information that may bear upon whether to initiate a Product Action and in carrying out the Product Action, including by providing or procuring the provision of any information reasonably requested by the other Party.

17.5 Product Complaints. Metsera will be fully responsible for handling complaints in connection with the Product subject to and in accordance with the Quality Agreement.

18.1 Components. Subject to Section 11.5(L), Amneal shall be responsible for obtaining and maintaining (or shall procure that its Affiliates and Permitted Subcontractors obtain and maintain) all Components necessary for the Manufacture of Products in accordance with the Forecast Schedules, this Agreement, the Quality Agreement and Applicable Law, and shall be responsible for ensuring that the quality of Components provided by its suppliers, in each case, comply with cGMP, as applicable and the Quality Standards and the terms of any Marketing Authorization. Without limitation to the foregoing, any contract with a Third Party for the supply of any container, pen, vial, injector or other device that is incorporated into a Product shall require the prior written approval of Metsera.

18.2 Safety Stock. Amneal shall secure and maintain or cause the procurement and maintenance of, an adequate Safety Stock of Drug Product and key Components to avoid any shortfalls of Product supply for the Territory. The Parties will agree in good faith on reasonable levels of Safety Stock consistent with Metsera’s then-current forecast and taking into consideration [***]. Amneal shall notify Metsera in writing of any anticipated shortage in Drug Product that reasonably may be expected to occur notwithstanding Amneal’s maintenance of Safety Stock in accordance with this Section 18, as soon as practicable, including the reported reasons for such anticipated shortage, proposed remedial measures and the date such shortage is expected to end. All Safety Stock inventory shall be maintained on a first-product-in, first-product-out basis. Amneal shall be responsible for the cost of establishing and maintaining the Safety Stock.

19.1 Duty of Confidentiality and Nonuse. Subject to the other provisions of this Article 19:

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19.2 Exceptions. The foregoing obligations with respect to particular Confidential Information of a Disclosing Party shall not apply to the extent that the Receiving Party can demonstrate that such Confidential Information:

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.

19.3 Authorized Disclosures. Notwithstanding the obligations set forth in Section 19.1, the Receiving Party may disclose the Disclosing Party’s Confidential Information (including this Agreement and the terms herein) to the extent:

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19.4 SEC Filings and Other Disclosures. Subject to the terms of this Section 19.4, either Party may disclose the terms of this Agreement and make any other public written disclosure regarding the existence of, or performance under, this Agreement, to the extent required, in the reasonable opinion of such Party’s internal department responsible for such disclosures, to comply with: (a) Applicable Laws, including the rules and regulations promulgated by the United States Securities and Exchange Commission; or (b) any equivalent Governmental Authority, securities exchange or securities regulator in any country in the Territory. Prior to disclosing this Agreement or any of the terms hereof pursuant to this Section 19.4, to the extent practicable in light of filing and disclosure deadlines, the Parties shall consult with one another with respect to the timing, form, and content of such disclosure and shall reasonably consider in good faith comments received from the other Party relating to such filing. If so requested by the other Party, and to the extent practicable in light of disclosure and filing deadlines, the Party subject to such obligation shall use commercially reasonable efforts to obtain an order protecting to the maximum extent possible the confidentiality of such provisions of this Agreement as reasonably requested by the other Party. If the Parties are unable to agree on the form or content of any required disclosure, such disclosure shall be limited to the minimum required as reasonably determined by the disclosing Party’s internal department responsible for such disclosures.

19.5 Return of Confidential Information. Upon the expiration or earlier termination of this Agreement for any reason, each Party and its Affiliates shall immediately, at the Receiving Party’s discretion: (a) return to the other Party; or (b) destroy and provide proof of destruction, all tangible items bearing or containing any Confidential Information disclosed by the other Party or any of its Affiliates, except for one (1) copy which may be retained in its confidential files for archive or compliance purposes. Each Party and its Affiliates will also be permitted to retain such additional copies of or any computer records or files containing the other Party’s or any of its Affiliates’ Confidential Information that have been created solely by automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with the retaining Party’s standard archiving and back-up procedures, but not for any other use or purpose. All Confidential Information shall continue to be subject to the terms of this Agreement.

19.6 Use of Names and Trademarks. Subject to Section 19.4, neither Party shall use the name, symbol, trademark, trade name or logo of the other Party or any of its Affiliates in any press release, publication or other form of public disclosure without the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned or delayed), except for those disclosures for which consent has already been obtained.

20.1 Neither Party shall be in breach of this Agreement if there is any failure of performance (except for payment of any amounts due hereunder) occasioned by any act of God, fire, epidemics, pandemics, act of government or state, including DEA restrictions on quota, war, civil commotion, insurrection, embargo, systemic supply chain or transportation failure, prevention from or hindrance in obtaining energy or other utilities or labor disputes of whatever nature or any other reason, in each case, beyond the control of either Party (“Force Majeure”); provided, however, that the Party affected shall: (a) give prompt written notice to the other Party of the date of commencement of the Force Majeure, the nature thereof, and expected duration; (b) use commercially reasonable efforts to avoid or remove the Force Majeure to the extent it is able to do so; and (c) make up, continue on and complete performance when such cause is removed.

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21.1 Facility Audits. Amneal will permit Metsera to conduct a periodic audit (not more often than once per [***], except in the event of a for-cause audit based on Metsera’s belief that there are quality issues with respect to the applicable Facility(ies) for the Manufacturing of Product) of Amneal’s and its Affiliates’ records and the Facility(ies) at which the Product is Manufactured, in accordance with the Quality Agreement. Amneal shall use reasonable efforts to include in its agreements with its Permitted Subcontractors that are entered into following the Effective Date, that the Permitted Subcontractors shall permit audits at least annually and permit one representative of Metsera to be present as an observer at any such audits that are scheduled and conducted by Amneal with respect to Products.

21.2 Financial Audits.

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22.1 Notice of Safety Hazards. Each Party shall (or shall procure that its Affiliate or, with respect to Amneal, its Permitted Subcontractor) inform(s) and keep(s) the other Party informed of all safety hazards and changes in regulations and guidance (statutory or otherwise) which such Party, its Affiliate, or, with respect to Amneal, such Permitted Subcontractor (as applicable) knows or believes affect or may affect the use, handling, storage, labelling, transport, treatment and disposal of Product or any Components.

22.2 Storage of Product. Amneal shall ensure that all consignments of Product are safe, packaged and labelled in accordance with the applicable Specifications and terms of the applicable Marketing Authorization and to prevent any health risk to persons, property or the environment and properly marked with the appropriate internationally recognized danger symbols and that prominent hazard warnings appear in English (or any other language specified by Metsera) on all packages and documents.

23.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:

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23.2 Covenants.

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23.3 Product Warranties. Amneal hereby represents and warrants that:

23.4 Anti-Bribery and Anti-Corruption. Each Party represents, warrants and covenants that it shall neither take nor refrain from taking any action that could result in liability for the other Party under any anti-corruption or anti-bribery laws including, without limitation, the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act of 2010, plus any other anti-bribery or anti-corruption law or treaty applicable to either Party or its Affiliates. Each Party has and shall maintain in place and enforce throughout the Term policies and procedures to confirm compliance with Applicable Laws relating to anti-bribery and anti-corruption. Each Party shall promptly report to the other Party any request received by such Party for any undue financial or other advantage of any kind in connection with the performance of this Agreement, including the Construction Addendum. Neither Party shall accept, offer or make any payment or provide anything else of value, or take or fail to take any other action which is either prohibited or required by Applicable Laws in connection with this Agreement, including the Construction Addendum.

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23.5 DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED (AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY PROVIDED IN THIS AGREEMENT), INCLUDING WARRANTIES OF VALIDITY OR ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, PERFORMANCE, AND NON-INFRINGEMENT OF ANY THIRD PARTY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHT. ANY FURTHER OR ADDITIONAL WARRANTY OR REPRESENTATION OF ANY KIND, EXPRESS OR IMPLIED AND ANY WARRANTIES, REPRESENTATIONS, CONDITIONS OR OTHER TERMS THAT MAY BE IMPLIED BY STATUTE OR GENERAL LAW ARE, TO THE FULLEST EXTENT PERMITTED BY LAW, EXCLUDED FROM THIS AGREEMENT.

24.1 Metsera Indemnification. Metsera shall indemnify, defend, and hold harmless Amneal, its Affiliates, and its and their respective directors, officers, employees, agents, successors, and assigns (collectively, the “Amneal Indemnitees”) from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:

except, in each case ((A) - (D)), to the extent that Amneal has an obligation to indemnify a Metsera Indemnitee pursuant to Section 24.2 (A) - (D).

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24.2 Amneal Indemnification. Amneal shall indemnify and hold harmless Metsera, its Affiliates, and its and their respective directors, officers, employees, agents, successors, and assigns (collectively, the “Metsera Indemnitees”), from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:

except, in each case ((A) - (D)), to the extent that Metsera has an obligation to indemnify an Amneal Indemnitee pursuant to Section 24.1 (A) - (D).

24.3 Indemnification Procedure. If a party is seeking indemnification under Section 24.1 or Section 24.2, as applicable (the “Indemnitee”), it shall inform the indemnifying Party (the “Indemnitor”) of the claim giving rise to the obligation to indemnify pursuant to Section 24.1 or Section 24.2, as applicable, as soon as reasonably practicable after receiving notice of the claim (an “Indemnification Claim Notice”); provided, that, any delay or failure to provide such notice shall not constitute a waiver or release of, or otherwise limit, the Indemnitee’s rights to indemnification under Section 24.1 or Section 24.2, as applicable, except to the extent that such delay or failure materially prejudices the Indemnitor’s ability to defend against the relevant claims.

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24.4 LIMITATION OF LIABILITY.

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24.5 Insurance. Each Party shall procure and maintain insurance, including product liability insurance, adequate to cover its obligations hereunder and consistent with normal business practices of prudent companies similarly situated at all times during which the Products are being clinically tested in human subjects or commercially distributed or sold by such Party pursuant to this Agreement, and the insurance coverage shall in no event be less than (a) [***] It is understood that such insurance will not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 24. Each Party shall provide the other Party with written evidence of such insurance upon request.

24.6 CMO Insurance. Each Party shall use reasonable efforts to ensure that its respective Affiliates and CMOs (including Permitted Subcontractors) shall, hold and maintain such types and amounts of insurance related to its activities under this Agreement as are normal and customary in the pharmaceutical industry generally for Persons similarly situated. Subject to any confidentiality obligations and the CMO’s agreement to obtain such insurance, each Party shall provide the other Party with written evidence of such insurance upon request. Such insurance coverage shall, if and to the extent obtained, remain in effect throughout the term of the applicable agreement with the CMO.

24.7 New Facility Insurance. Amneal shall procure and maintain insurance in amounts sufficient to cover casualties, including the cost of replacement of the New Facility. In furtherance of this Section 24.7, Amneal shall purchase from and maintain (or shall cause its subcontractors and sub-subcontractors to purchase from and maintain) with insurance companies satisfactory to Metsera, such insurance as will protect Amneal, subcontractors, and Metsera, and all of their respective officers, directors, agents, servants, and employees, from claims which may arise out of or result from operations under this Agreement, including the Construction Addendum, by Amneal, a subcontractor, or by anyone directly or indirectly employed by Amneal or Amneal’s subcontractors, or by anyone for whose acts any of Amneal or its subcontractors may be liable.

25.1 Background Technology. As between the Parties, each of Amneal and Metsera solely owns all right, title and interest in and to its Background Technology.

25.2 License Grants.

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25.3 Improvements.

25.4 Assignment. Amneal agrees to assign and hereby does assign all its right, title and interest in and to all Metsera Improvements to Metsera. Metsera agrees to assign and hereby does assign all its right, title and interest in and to all Amneal Manufacturing Improvements to Amneal. Each Party will execute and record assignments and other necessary documents consistent with the ownership set forth in this Article 25 and shall cause all Persons who perform any activity under this Agreement to assign its right in any Improvements as set forth in this Section 25.4.

25.5 Disclosure. Each Party shall promptly disclose to the other Party all Improvements, including all invention disclosures or other similar documents submitted to such Party or its Affiliates, or its or their licensees, or sublicensees, together with employees, agents, or contractors of such Party or its Affiliates, or its or their licensees, or sublicensees relating to such Improvements, and shall also respond promptly to reasonable requests from the other Party for additional information relating to such Improvements.

Metsera may at any time during the Term request a technology transfer of the process(es) for Manufacturing of the Drug Substance(s) and Drug Product(s) as conducted by or on behalf of Amneal at the time of such request to Metsera or its Affiliates or its or their designees (the “Manufacturing TT”). Upon Metsera’s request, such request to be made not less than [***] prior to the date on which Metsera wishes to commence the Manufacturing TT, Amneal and Metsera shall meet to discuss and cooperate in good faith to agree as soon as reasonably practicable upon the terms and conditions of a written technology transfer plan pursuant to which Amneal and Metsera shall use commercially reasonable efforts to carry out the Manufacturing TT. Metsera shall pay Amneal for Amneal’s reasonable costs and expenses incurred in the performance of its Manufacturing TT activities under this Article 26.

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27.1 Term. This Agreement shall commence on the Effective Date and, unless terminated earlier in accordance with this Article 27, continue in full force and effect until the seventh (7^th) anniversary of First Commercial Sale of the first Product (the “Initial Term”). Metsera shall have the right, in its sole discretion, to extend the Agreement for an additional five (5)-year period (the “Initial Renewal Term”) upon written notice to Amneal at least twelve (12) months prior to the expiration of the Initial Term. Following the Initial Renewal Term, the Agreement may only be renewed upon mutual written agreement of the Parties, as agreed by the Parties no later than twelve (12) months prior to the expiration of the then-current Term (each, a “Renewal Term”) (any Initial Renewal Term and any Renewal Term(s) together with the Initial Term, the “Term”). Following the Initial Term, the JST shall discuss and determine whether the Supply Thresholds should be amended with respect to Drug Product and/or with respect to Drug Substance.

27.2 Termination.

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28.1 Expiry or Termination for any Reason.

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29.1 Performance through Affiliates. Amneal may discharge any obligations and exercise any right under this Agreement, including the right to receive payment for performance rendered, or performance hereunder or thereunder, through any of its Affiliates. Amneal shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance and shall be fully responsible for the acts or omissions of its Affiliates. Notwithstanding the foregoing, no Affiliate of a Party shall have any right of recourse directly against the other Party or any of such other Party’s Affiliates, it being understood and agreed that all rights and remedies under this Agreement shall be exercised, if at all, solely by or through the Parties signatory hereto or thereto, as the case may be.

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29.2 Severability. Should one or more of the provisions of this Agreement become invalid, void or unenforceable as a matter of law, then this Agreement shall be construed as if such provision were not contained herein and the remainder of this Agreement shall be in full force and effect, and the Parties will use commercially reasonable efforts to substitute for the invalid, void or unenforceable provision a valid and enforceable provision which conforms as nearly as possible with the original intent of the Parties.

29.3 Notices. Any notice required or permitted to be given by this Agreement shall be in writing and in English and shall be: (a) delivered by hand or by overnight courier with tracking capabilities; (b) mailed postage prepaid by first class, registered, or certified mail; or (c) delivered by electronic mail followed by delivery via either of the methods set forth in clauses (a) and (b) above, in each case, addressed as set forth below unless changed by notice so given:

If to Amneal:

Amneal Pharmaceuticals LLC

[***]

[***]

Attn: [***]

With a copy to:

[***]

[***]

[***]

Attn: [***]

Email: [***]

If to Metsera:

Metsera, Inc.

[***]

[***]

Attn: [***]

[***]

[***]

[***]

Attn: [***]

Email: [***]

Any such notice shall be deemed given on the date received, except any notice received after 5:30 p.m. (in the time zone of the receiving Party) on a Business Day or received on a non-Business Day shall be deemed to have been received on the next Business Day. A Party may add, delete, or change the person or address to which notices should be sent at any time upon written notice delivered to the other Parties in accordance with this Article 29.4.

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29.5 Change of Control of Metsera. In the event of a Change of Control of Metsera, Metsera shall provide Amneal with written notice thereof within [***] following the consummation of such Change of Control, which notice shall identify the acquirer (the “Change of Control Date”). Within [***] following the Change of Control Date, Metsera (or its acquirer) shall have the right to terminate this agreement upon written notice to Amneal, which termination shall be effective upon the [***]; provided, however, that the following shall apply in the event of such election to terminate:

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29.6 Change of Control of Amneal. Subject to this Section 29.6 and Sections 29.4(D) - 29.4(E), Amneal may assign or transfer this Agreement, or any rights or obligations hereunder, in the event of a Change of Control or to a successor to all of its business or assets to which this Agreement relates[***]. In the event of a Change of Control of [***]:

29.7 Parent Guaranty. Amneal Pharmaceuticals LLC, and a parent company of Amneal, (the “Guarantor”), (a) hereby unconditionally guarantees the performance of all of Amneal’s obligations and commitments under this Agreement, and (b) without limiting the foregoing or being limited thereby, hereby further covenants to procure and cause Amneal and its Affiliates to take such actions that may be necessary or useful to support and duly complete the performance of Amneal’s obligations and commitments under this Agreement (collectively, (a) and (b) the “Parent Guaranty”). This Parent Guaranty is an irrevocable guaranty of performance and shall continue in effect notwithstanding any extension or modification of the terms of this Agreement, any assumption of any such guaranteed obligations by any other party or any other act or event that might otherwise operate as a legal or equitable discharge of Guarantor; provided, the total liability of the Guarantor shall not exceed the liability of Amneal under this Agreement.

29.8 Waiver. No provision of this Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving Party. The waiver by either Party of any right hereunder, or of any failure of the other Party to perform, or of any breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach by or failure of such other Party whether of a similar nature or otherwise.

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29.9 Dispute Resolution. If the Parties are unable to resolve any dispute under this Agreement, including the Construction Addendum, that is not subject of resolution by reference to the Designated Officers and Executive Officers pursuant to Section 11.7 or an Independent Expert pursuant to Article 12, within [***] after such dispute is first identified by either Party in writing to the other, then either Party may refer the dispute first to the Relationship Managers for discussion and resolution. If the Relationship Managers are unable to resolve the dispute within [***] of the dispute being referred to them, either Party may require that the Parties forward the matter to the Executive Officers, who shall attempt in good faith to resolve such dispute. If the Executive Officers cannot resolve such dispute within [***] of the matter being referred to them, then either Party shall be free to commence arbitration proceedings in accordance with Section 29.10.

29.10 Arbitration. Subject to Sections 29.9 and 29.11, any dispute arising out of this Agreement, shall be resolved solely and exclusively by final and binding arbitration conducted as set forth in this Section 29.10. Whenever a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party. The arbitration will be conducted by a panel of three (3) arbitrators in accordance with the Rules of Arbitration (“ICC Rules”) of the International Chamber of Commerce (“ICC”). The claimant shall nominate an arbitrator in its request for arbitration. The respondent shall nominate an arbitrator within [***] of the receipt of the request for arbitration. The two (2) arbitrators nominated by the Parties shall together, within [***] of the appointment of the later-nominated arbitrator, select a third arbitrator as the chairperson of the arbitration panel. If any of the three (3) arbitrators are not nominated within the time prescribed above, then the ICC shall appoint the arbitrator(s) in accordance with the ICC Rules. The Parties will mutually agree on the rules to govern discovery and the rules of evidence for the arbitration within [***] after the request for arbitration. If the Parties fail to timely agree to such rules, the United States Federal Rules of Civil Procedure will govern discovery and the United States Federal Rules of Evidence will govern evidence for the arbitration. The arbitrators shall have significant experience in the pharmaceutical industry and shall not include any current or former employee, consultant, officer or director of Amneal or Metsera (or their respective Affiliates), or otherwise have any current or previous relationship with Amneal or Metsera or their respective Affiliates. The seat of the arbitration shall be New York City, New York, and the language of the arbitration shall be English. The arbitrators shall be instructed to render their opinion within [***] of the close of the proceedings. No arbitrator (nor the panel of arbitrators) shall have the power to award punitive damages under this Agreement and such award is expressly prohibited. Decisions of the panel of arbitrators shall be final and binding on the Parties. Judgment on the award so rendered may be entered in any court of competent jurisdiction. Nothing in this Section 29.10 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a dispute, in each case, if necessary to protect the interests of such Party without the necessity of posting bond. The existence of the arbitration, any non-public information provided in the arbitration, and any submissions, orders or awards made in the arbitration shall not be disclosed to any non-party except the tribunal, the ICC, the Parties, their counsel, experts, witnesses, accountants, auditors, insurers, reinsurers, and any other person necessary to the conduct of the arbitration, except to the extent that disclosure may be required to fulfill a legal duty, protect or pursue a legal right, or enforce or challenge an award in bona fide legal proceedings, including as required to comply with Applicable Law or securities exchange disclosure requirements.

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29.11 Patent and Trademark Disputes. Notwithstanding any provision to the contrary set forth in this Agreement, any and all issues regarding the scope, construction, validity, and enforceability of any Patents or Trademark relating to a Product that is the subject of this Agreement will be determined in a court or other tribunal, as the case may be, of competent jurisdiction under the applicable patent or trademark laws of the country in which such Patents or Trademark rights were granted or arose.

29.12 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, U.S. without reference to any rules of conflict of laws; provided, that the United Nations Convention on Contracts for International Sale of Goods shall not apply.

29.13 Relationship of the Parties. It is expressly agreed that Metsera and Amneal shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or legal entity of any type. Neither Metsera nor Amneal shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party. Neither Party shall report this Agreement or the relationship between the Parties as a partnership for tax purposes.

29.14 Expenses. Except as otherwise expressly provided in this Agreement, each Party shall pay the fees and expenses of its respective lawyers and other experts and all other expenses and costs incurred by such Party incurred in connection with the negotiation, preparation, execution, delivery and performance of this Agreement.

29.15 No Third Party Beneficiaries. The provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they shall not be construed as conferring any rights to any Third Party (including any third party beneficiary rights), except with respect to certain Amneal Indemnitees and certain Metsera Indemnitees who are Third Parties solely with respect to Article 24; provided, that Amneal and Metsera shall have the sole right to exercise, claim, amend, waive, or modify the terms of Article 24 with respect to such Amneal Indemnitees and such Metsera Indemnitees, respectively.

29.16 Entire Agreement; Amendments. This Agreement, together with the Exhibits and Schedules (including the Construction Addendum) hereto, contains the entire agreement and understanding of the Parties with respect to the subject matter hereof. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, with respect to the subject matter hereof are superseded by the terms of this Agreement. In the event of any conflict between a substantive provision of this Agreement and any Exhibit or Schedule hereto, the substantive provisions of this Agreement shall prevail. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representative(s) of both Parties hereto. The Parties agree that the Prior CDA is hereby terminated as of the Effective Date, but each Party’s information that was the subject of confidentiality obligations under such Prior CDA shall been deemed to be Confidential Information of such Party under this Agreement.

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29.17 Counterparties. This Agreement may be executed in two (2) or more 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 electronic mail, including Adobe^™ Portable Document Format (PDF) or any electronic signature complying with the U.S. Federal ESIGN Act of 2000, and any counterpart so delivered will be deemed to be original signatures, will be valid and binding upon the Parties, and, upon delivery, will constitute due execution of this Agreement.

29.18 Equitable Relief. Notwithstanding anything to the contrary herein, the Parties shall be entitled to seek equitable relief, including injunction and specific performance, as a remedy for any breach of this Agreement. Such remedies shall not be deemed to be the exclusive remedies for a breach of this Agreement but shall be in addition to all other remedies available at law or in equity. The Parties further agree not to raise as a defense or objection to the request or granting of such relief that any breach of this Agreement is or would be compensable by an award of money damages.

29.19 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

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29.21 English Language. This Agreement is written and executed in the English language. Any translation into any other language shall not be an official version of this Agreement and, in the event of any conflict in interpretation between the English version and such translation, the English version shall prevail.

29.22 Further Actions. Amneal and Metsera hereby covenant and agree, without the necessity of any further consideration, to execute, acknowledge and deliver any and all such other documents and take any such other action as may be reasonably necessary to carry out the intent and purposes of this Agreement.

[Signature Pages Follow]

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

As a party to this Agreement solely with respect to

the provisions of Section 29.7:

[Signature Page to Development and Supply Agreement]

SCHEDULE A

CONSTRUCTION ADDENDUM

The Parties agree that the following terms and conditions contained in this Construction Addendum (this “Addendum”) shall apply with respect to the funding and construction of the New Facility:

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For clarity, except as set forth in Section 5.2.3, the maximum cumulative aggregate amount payable by Metsera to Amneal in respect of all Construction Costs under this Addendum shall not exceed the then-effective Aggregate Cap.

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After commencement of the Construction Work and continuing until the final disbursement of the Metsera Construction Costs is made, Amneal will cause a monthly accounting statement (each a “Monthly Statement”) to be provided to Metsera through the JCC identifying all disbursements for Construction Costs during the immediately preceding month (the “Subject Month”). Each Monthly Statement will include (a) a high-level summary update on the status of design and construction (as applicable) of the New Facility and (b) a detailed calculation of the Monthly Payment Amount as of the end of the Subject Month. Within [***] days after Metsera receives a Monthly Statement, Metsera shall pay to Amneal the Monthly Payment Amount as of the end of the Subject Month.

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Exhibit A

Project Description

[***]

Exhibit B

Project Budget

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[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]