Exhibit 10.5
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such omitted information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.
CONFIDENTIAL
September 15, 2015
SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (the “Agreement”), effective as of September 15, 2015 (the “Effective Date”), is made and entered into by and between Seres Therapeutics, Inc. (formerly Seres Health, Inc.), a corporation organized and existing under the laws of Delaware, having its principal place of business at 215 First Street, Cambridge MA 02142, USA (“Seres”); and GenIbet BioPharmaceuticals, SA, a corporation organized and existing under the laws of Portugal, having its principal place of business at Edifício da Unidade Piloto do IBET, Estação Agronómica Nacional, Avenida da República, 2780-157 Oeiras, Portugal (“GenIbet”). Seres and GenIbet may be referred to herein individually as a “Party” or collectively as the “Parties.”
WHEREAS, Seres desires to have SER-109, SER-262, SER-287 and other products (each a “Product” and collectively, the “Products”) manufactured by a third party for purposes of conducting clinical trials and commercial supply;
WHEREAS, GenIbet has expertise and cGMP-compliant facilities for the manufacture of products similar to the Products at its manufacturing facility located at Edifício da Unidade Piloto do IBET, Estação Agronómica Nacional, Avenida da República, 2780-157 Oeiras, Portugal (the “Facility”);
WHEREAS, GenIbet desires to modify a manufacturing suite for the manufacture of the Products and to supply such Products to Seres, all in accordance with the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants and obligations set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
Capitalized terms used but not defined in this Agreement shall have the meaning given in Exhibit 1.
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GenIbet shall not subcontract its obligations under this Agreement (other than with respect to the construction of Seres Dedicated Area) without the prior written consent of Seres, which consent shall not be unreasonably withheld or delayed. [***]. GenIbet shall cause its subcontractors to execute agreements with provisions substantially similar to the provisions in Sections 7, 11, and 12.2. Seres may revoke its approval of a subcontractor if the subcontractor breaches Section 7, 11, and 12.2 in any material respect.
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(Current Exchange Rate - Baseline Exchange Rate) / Baseline Exchange Rate, where
"Baseline Exchange Rate" means the Euro to Dollar exchange rate, as quoated in the Wall Street Journal published [***].
“Current Exchange Rate” means the Euro to Dollar exchange rate, as quoted in the Wall Street Journal published [***].
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Each Party may disclose the other Party’s Confidential Information to the extent such disclosure is reasonably necessary for prosecuting or defending litigation, advising investors and the investment community of the results of activities hereunder (subject to the prior written consent of the other Party, which consent will not be unreasonably withheld), complying with applicable governmental regulations, granting a permitted sublicense of its rights hereunder or otherwise in performing its obligations or exercising its rights hereunder. If a Party is required to make any such disclosure of the other Party’s Confidential Information, it will give reasonable advance notice to that other Party of such disclosure requirement, will cooperate with the other Party in its efforts to secure confidential treatment of such Confidential Information prior to its disclosure, and, except to the extent inappropriate in the case of patent applications, will use all reasonable efforts to secure confidential treatment of such information prior to its disclosure (whether through protective orders or confidentiality agreements or otherwise).
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If to Seres, addressed to:
Seres Therapeutics, Inc.
215 First St., Suite 100
Cambridge, MA 02142, USA
Attention: [***]
Fax:+16179450268
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If to GenIbet, addressed to:
GenIbet Biopharmaceuticals
Estação Agronómica Nacional
Avenida da Rebública, 2780-157 Oeiras,Portugal
Attention: [***]
Fax:+351214469480
[Signature page follows]
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In Witness Whereof, the Parties have caused this Agreement to be executed by their respective duly authorized officers as of the Effective Date, each copy of which will for all purposes be deemed to be an original.
Seres Therapeutics, Inc.
By: /s/ Roger Pomerantz
Name: Roger Pomerantz, M.D.
Title: President and Chief Executive Officer
GenIbet BioPharmaceuticals
By: /s/ [***]
Name: [***]
Title: [***]
By: /s/ [***]
Name: [***]
Title: [***]
Exhibit 1
Definitions
As used in the Agreement, the following terms are defined as indicated:
“Active Pharmaceutical Ingredient” or “API” means the active pharmaceutical or biological ingredient as further set forth in the applicable Product Manufacturing Plan.
“Affiliate” means with respect to either Party, any business entity controlling, controlled by, or under common control with such Party. For the purpose of this definition only, “control” means (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract or otherwise, or (b) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of a business entity; provided that, if local law requires a minimum percentage of local ownership, control will be established by direct or indirect beneficial ownership of one hundred per cent (100%) of the maximum ownership percentage that may, under such local law, be owned by foreign interests.
“Applicable Law” shall mean all international, national, federal, state, provincial and local laws, statutes, codes, guidelines, rules, regulations, ordinances, orders, decrees or other pronouncements of any governmental, administrative or judicial authority that apply to either of the Parties’ respective obligations hereunder, including cGMP.
“Batch” shall mean a specific quantity of product that (a) is intended to have uniform character and quality within specified limits, and (b) is Manufactured according to a single manufacturing order during the same cycle of manufacture as further specified in the applicable Product Manufacturing Plan.
“Certificate of Compliance” means a document signed by the designated quality manager of GenIbet in connection with the Manufacture of a Batch of Product that evidences such Batch’s compliance with cGMPs and Master Batch Record.
“Change of Control” means the occurrence of any one of the following: (a) any person (as the term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act)) is or becomes the beneficial owner (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of voting securities of GenIbet representing more than 50% of GenIbet’s outstanding voting securities or rights to acquire such securities; (b) any sale, lease, exchange or other transfer (in one transaction or a series of transactions) of the Facility or all or substantially all of the assets of GenIbet; or (c) a plan of liquidation of the Company or an agreement for the sale or liquidation of the Company is approved and completed.
“Commercially Reasonable Efforts” mean taking such steps and performing in such a manner as a well-managed company would undertake where such company was acting in a determined, prudent, and reasonable manner to achieve the particular result provided always that such steps are within the reasonable control of the Party required to exert such efforts.
“Confidential Information” means any and all non-public and proprietary information that is specifically designated as such and that is disclosed by any Party to any other Party in written or other
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similar form in connection with this Agreement; provided, however, that in the case of such information that is disclosed orally, the disclosing party shall deliver the required designation in writing to the receiving Party within 30 days after such disclosure.
“Consumables” shall mean the consumable products and packaging supplies and components, including, without limitation, all of the raw materials and packaging supplied required by GenIbet to Manufacture a Product as set forth in the applicable Product Manufacturing Plan.
“Control” means, with respect to an item or an intellectual property right, possession of the ability, whether arising by ownership or license, to grant a license or sublicense as provided for in this Agreement under such item or right without violating the terms of any written agreement with any Third Party.
“Current Good Manufacturing Practices” or “cGMP” shall mean the following to the extent having jurisdiction over the Manufacture of a Product and/or the Facility and Seres Dedicated Area: (a) the good manufacturing practices required by the FDA and set forth in the FD&C Act or FDA regulations (including without limitation 21 CFR 210 and 211); (b) the Commission Directive 2003/94/EC, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, and any amendment thereto; (c) the Commission Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products, and any amendment thereto; (d) the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001, on the Community code relating to medicinal products for human use, and any amendment thereto; (e) the Guidelines on Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, approved by the European Commission and currently provided for at Eudralex - Volume 4 and any amendment thereto; (f) any local laws, statutes, codes, guidelines, rules, regulations, ordinances, orders, decrees or other pronouncements of any governmental, administrative authority enacting and/or implementing and/or regulating the provisions of (b) to (e), and (f) the PICS guidelines to good manufacturing practices in effect at any time during the Term of this Agreement. For the avoidance of doubt, when reference is made herein to “any amendment thereto” it shall include acts which supersede and replace the ones expressly provided for.
“Drug Product” shall mean the Drug Substance in its finished dosage form that is produced in accordance with the Master Batch Record.
“Drug Substance” shall mean the substance that is produced in accordance with the Master Batch Record and intended to be used in the manufacture of a drug product.
“FDA” shall mean the United States Food and Drug Administration or any successor entity thereto.
“FD&C Act” shall mean the United States Federal Food, Drug and Cosmetic Act, as may be amended from time to time.
“Government Authority TC "Government Authority" \f C \l “5” ” means any supranational, national, regional, state or local government, court, governmental agency, authority, board, bureau, instrumentality, or regulatory body.
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“Intellectual Property” shall mean ideas, concepts, discoveries, inventions, developments, know-how, trade secrets, techniques, methodologies, modifications, innovations, improvements, writings, documentation, data and rights (whether or not protectable under state, federal or foreign patent, trademark, copyright or similar laws) or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable.
“Inventions” shall mean any inventions, discoveries, innovations, methods, improvements, processes, techniques or other valuable developments, whether patentable or copyrightable or not, relating to Product, the API or their manufacture, arising out of the performance of services under this Agreement by GenIbet and/or any use of either Seres Intellectual Property and/or the API. For the avoidance of doubt, Inventions include Process Inventions, as defined below.
“Licensed Know-How TC "Government Authority" \f C \l “5” ” shall mean any and all technology, information, expertise, know-how, and/or trade secrets Controlled by GenIbet that is necessary or useful for the manufacture of the Product and/or the manufacture, use, sale, offer for sale, and importation of the Products.
“Manufacture,” “Manufacturing,” and “Manufactured” shall mean all operations of GenIbet in the scheduling, production, manufacturing, processing, packaging, labeling, testing, storage, quality control testing (including in-process, release, and stability testing when applicable) and release of Product.
“Master Batch Record” or “MBR” shall mean, with respect to each Product to be Manufactured hereunder, a formal set of instructions given by Seres for the Manufacture of each such Product. The MBR shall be developed and maintained in GenIbet’s standard format by GenIbet, as per Seres’ instructions and using master formulation and technical support.
“Materials” as used in this Agreement shall collectively mean all materials required for Manufacture of Product, including the API, Consumables, and Raw Materials.
“Process Inventions” shall mean any Inventions that are new manufacturing technologies, methods, processes or techniques, or are improvements to existing manufacturing technologies, methods, processes or techniques, and that are generally applicable to pharmaceutical products. For purposes of clarity, Process Inventions shall not include such Inventions that (i) are only applicable to Product, Seres Technology, the intellectual property of a collaborator and/or the API and/or (ii) require the use of Product, Seres Technology, the intellectual property of a collaborator and/or the API.
“Product Manufacturing Plan” shall mean an addendum to this Agreement for each Product Manufactured hereunder, which may include, without limitation, the Product, Product Specifications, Materials, Materials Specifications, Regulatory Authorities, the countries where such Product will be used in clinical trials, and pricing for such Product Manufactured under this Agreement.
“Purchase Order” shall mean written orders from Seres to GenIbet which shall specify (a) the quantity of Product ordered, (b) the minimum number of employees and their status (e.g., full-time dedicated or part-time dedicated) to be engaged, (c) shipping instructions (e.g. choice of container, temperature requirements), (d) requested delivery dates, and (e) delivery destinations.
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“Quality Agreement” shall mean individually, either the Clinical Quality Agreement or Commercial Quality Agreement and “Quality Agreements” shall mean the Clinical Quality Agreement and Commercial Quality Agreement collectively, both of which are addenda to this Agreement under which the Parties allocate the pharmaceutical responsibilities, as further set forth in Section 8.2.
“Raw Materials” shall mean all excipients, inactive ingredients and other substances used by GenIbet in the Manufacture of a Product, with the exception of API and Consumables, as specified in the applicable Product Manufacturing Plan.
“Regulatory Authority” shall mean those agencies or authorities responsible for regulation of the Product in the country where the Product is Manufactured and/or used in clinical trials.
“Site Master File” shall mean a document prepared by GenIbet containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the Facility and any closely integrated operations at adjacent and nearby buildings.
“SOP” means GenIbet’s standard operating procedures applicable to the Manufacture of the Product.
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Exhibit 2
Seres Dedicated Area Project Plan
[***]
Attachment 2-1
Dedicated Area
[***]
Attachment 3
Product Manufacturing Plan for SER-109
[***]
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Exhibit 4
Charges
[***]
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200 Sidney Street
Cambridge, MA 02139
Tel: 617-945-9626
www.serestherapeutics.com
September 14, 2020
GenIbet Biopharmaceuticals SA Via Email: [***]
Estação Acronómica Nacional
Avenida da República ACKNOWLEDGEMENT REQUESTED
2780-157 Oeiras, PORTUGAL
Attention: [***]
Re: Supply Agreement effective September 15, 2015, as subsequently amended and extended (the "Agreement") by and between Seres Therapeutics, Inc. ("Seres") and Genlbet BioPharmaceuticals SA ("Genlbet").
Dear [***]:
Pursuant to Section 15.1 of the Agreement, this letter serves as notice that Seres will extend the Term of the Agreement for an additional [***] on the now-current terms and conditions.
Please confirm receipt of this letter via email to [***]
Regards,
/s/John G. Aunins
John Auniņš, Ph.D.
Chief Technical Officer and Executive Vice President, CMC
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200 Sidney Street
Cambridge, MA 02139
Tel: 617-945-9626
www.serestherapeutics.com
September 07, 2021
GenIbet Biopharmaceuticals SA Via Email: [***]
Estação Acronómica Nacional
Avenida da República
2780-157 Oeiras, PORTUGAL
Attention: [***]
Re: Supply Agreement effective September 15, 2015, as subsequently amended and extended (the "Agreement") by and between Seres Therapeutics, Inc. ("Seres") and Genlbet BioPharmaceuticals SA ("Genlbet").
Dear [***]:
Pursuant to Section 15.1 of the Agreement, this letter serves as notice that Seres will extend the
Term of
the Agreement through [***], on the now-current terms and conditions.
Please confirm receipt of this letter by providing your e-signature below.
Best Regards,
/s/ David S. Ege
David S. Ege
EVP & Chief Technical Officer
Accepted and Agreed:
/s/[***]
[***]
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200 Sidney Street
Cambridge, MA 02139
Tel: 617-945-9626
www.serestherapeutics.com
December 6, 2021
GenIbet Biopharmaceuticals SA Via Email: [***]
Estação Acronómica Nacional
Avenida da República
2780-157 Oeiras, PORTUGAL
Attention: [***]
Re: Supply Agreement effective September 15, 2015, as subsequently amended and extended (the "Agreement") by and between Seres Therapeutics, Inc. ("Seres") and Genlbet BioPharmaceuticals SA ("Genlbet").
Dear [***]:
Pursuant to Section 15.1 of the Agreement, this letter serves as notice that Seres will extend the Term of the Agreement through [***], on the now-current terms and conditions.
Please confirm receipt of this letter by providing your e-signature below.
Best Regards,
/s/David S. Ege
David S. Ege
EVP & Chief Technical Officer
Accepted and Agreed:
/s/[***]
[***]
12/9/2021
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200 Sidney Street
Cambridge, MA 02139
Tel: 617-945-9626
www.serestherapeutics.com
March 22, 2022
Sent via email: [***]
GenIbet Biopharmaceuticals SA
Estação Acronómica Nacional
Avenida da República
2780-157 Oeiras, PORTUGAL
Attention: [***]
Re: Supply Agreement effective September 15, 2015, as subsequently amended and extended (the "Agreement") by and between Seres Therapeutics, Inc. ("Seres") and Genlbet BioPharmaceuticals SA ("Genlbet").
Dear [***]:
Pursuant to Section 15.1 of the Agreement, this letter serves as notice that Seres will extend the Term of the Agreement through June 30, 2023, on the now-current terms and conditions.
Best Regards,
/s/David S. Ege
David S. Ege
EVP & Chief Technical Officer
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200 Sidney Street
Cambridge, MA 02139
Tel: 617-945-9626
www.serestherapeutics.com
March 6, 2023
GenIbet Biopharmaceuticals SA Via Email: [***] and Federal Express
Estação Acronómica Nacional Avenida da República
2780-157 Oeiras, PORTUGAL
Attention: Raquel Fortunato
Re: Supply Agreement effective September 15, 2015, as subsequently amended and extended (the "Agreement") by and between Seres Therapeutics, Inc. ("Seres") and Genlbet BioPharmaceuticals SA ("Genlbet").
Dear [***]:
Pursuant to Section 15.1 of the Agreement, this letter serves as notice that Seres will extend the Term of the Agreement through June 30, 2024, on the now-current terms and conditions.
Best Regards,
/s/David S. Ege
David S. Ege
EVP & Chief Technical Officer
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101 Cambridge Park Drive
Cambridge, MA 02140
Tel: 617-945-9626
www.serestherapeutics.com
March 6, 2024
GenIbet Biopharmaceuticals SA Via Email: [***] and Federal Express
Estação Acronómica Nacional Avenida da República
2780-157 Oeiras, PORTUGAL
Attention: Raquel Fortunato
Re: Supply Agreement effective September 15, 2015, as subsequently amended and extended (the "Agreement") by and between Seres Therapeutics, Inc. ("Seres") and Genlbet BioPharmaceuticals SA ("Genlbet").
Dear [***]:
Pursuant to Section 15.1 of the Agreement, this letter serves as notice that Seres will extend the Term of the Agreement through June 30, 2025, on the now-current terms and conditions.
Best Regards,
/s/David S. Ege
David S. Ege
EVP & Chief Technical Officer
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