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Exhibit 10.12
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Master Services Agreement for
Drug Product Development and Manufacturing
(the “Agreement”)
by and between
Lonza Ltd
Münchensteinerstrasse 38
CH-4002 Basel
Switzerland
- hereinafter “Lonza” -
and
Vaxcyte, Inc.
825 Industrial Road
Suite 300
San Carlos, CA 94070
United States of America
- hereinafter “Customer” -
Effective as of March 22, 2022 (the “Effective Date”)
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Table of Contents
Page
1 Definitions and Interpretation 1
2 Performance of Services 6
3 Project Management / Steering Committee 8
4 Quality 8
5 Insurance 9
6 Forecasting, Ordering and Cancellation 9
7 Delivery and Acceptance 11
8 Price and Payment 12
9 Capital Equipment 13
10 Intellectual Property 13
11 Warranties 15
12 Indemnification and Liability 16
13 Confidentiality 17
14 Term and Termination 19
15 Force Majeure 20
16 Miscellaneous 20
Appendix A
Recitals
WHEREAS, Customer is engaged in the development and research of certain products and requires assistance in the development and manufacture of product;
WHEREAS, Lonza and its Affiliates have expertise in the evaluation, development and manufacture of products;
WHEREAS, the Parties have entered into a development and manufacturing services agreement, dated 29 October 2018, for manufacturing services related to the drug product VAX-24, under which Customer was originally named SutroVax, Inc. (the “Original Agreement”);
WHEREAS, Customer wishes to engage Lonza for Services relating to the development and manufacture of the Product as described in this Agreement; and
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WHEREAS, Lonza, or its Affiliate, is prepared to perform such Services for Customer on the terms and subject to the conditions set out herein
NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the Parties intending to be legally bound, agree as follows:
“Affiliate” means any company, partnership or other entity which directly or indirectly Controls, is Controlled by or is under common Control with the relevant Party. “Control” means the ownership of more than fifty percent (50%) of the issued share capital or the legal power to direct or cause the direction of the general management and policies of the relevant Party.
“Agreement” means this agreement incorporating all Appendices, as amended from time to time by written agreement of the Parties.
“Applicable Laws” means all relevant U.S. and European Union federal, state and local laws, statutes, rules, and regulations which are applicable to a Party’s activities hereunder, including, without limitation, the applicable regulations and guidelines of any Governmental Authority and all applicable cGMP together with amendments thereto.
“Approval” means the first marketing approval by the FDA or EMA of Product from the Facility for commercial supply.
“Background Intellectual Property” means any Intellectual Property either (i) owned, licensed or controlled by a Party prior to the Effective Date or (ii) developed or acquired by a Party independently from the performance of the Services hereunder during the Term of this Agreement.
“Batch” means the Product derived from a single run of the Manufacturing Process at a scale to be mutually agreed by the Parties.
“Batch Price” means the Price of each Batch.
“Campaign” means a series of no less than [***] cGMP Batches manufactured consecutively.
“Cancellation Fee” has the meaning given in Clause 6.4.
“Capital Equipment“ means those certain pieces of equipment described in the Project Plan: (i) that are specific to the production of the Product and (ii) that are purchased by Customer or for which Customer
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reimburses Lonza, including, without limitation, the related documentation regarding the design, validation, operation, calibration and maintenance of such equipment.
“Certificate of Analysis” means a document prepared by Lonza listing tests performed by Lonza or approved External Laboratories, the Specifications and test results.
“cGMP” means those laws and regulations applicable in the U.S. and Europe, relating to the manufacture of medicinal products for human use, including, without limitation, current good manufacturing practices as specified in the ICH guidelines, including without limitation, ICH Q7A “ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, US Federal Food Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600, 610, and 820) and the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC. For the avoidance of doubt, Lonza’s operational quality standards are defined in internal cGMP policy documents.
“cGMP Batches” means any Batches which are required under the Project Plan to be manufactured in accordance with cGMP.
“Change” means any change to the Services or pricing incorporated into a written amendment to the Agreement in accordance with clause 17.2 or effected in accordance with the Quality Agreement.
“Commencement Date” means the date of commencement of manufacturing activities for a Batch hereunder.
“Confidential Information” means Customer Information and/or Lonza Information, as the context requires.
“Corruption Laws” means all applicable anti-bribery and anti-corruption laws and regulations, including but not limited to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act 2010, and the Organization for Economic Co-operation and Development (OECD) Convention on Combating Bribery and Foreign Public Officials in International Business Transactions.
“Customer Information” means all technical and other information which at the time of disclosure by Customer was not known to Lonza or in the public domain relating to the Manufacturing Process and the Product, from time to time supplied by the Customer to
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Lonza, including any materials supplied by Customer to Lonza in accordance with the Project Plan.
“Customer Materials” means any Raw Materials or other materials of any nature (e.g., antibodies used in product-specific assays), proprietary to Customer, provided by Customer to Lonza under or in connection with this Agreement, and previously not possessed by or not available to Lonza. For the avoidance of doubt, Drug Substance shall be considered Customer Material.
“Drug Product” means the formulation of the Drug Substance(s) filled into its final containers (e.g., vials).
“Drug Substance” means any proprietary molecule(s) identified in the Project Plan that are to be included in the Drug Product. For clarity, the term Drug Substance may be used interchangeably with Active Pharmaceutical Ingredient (API).
“EMA” means the European Medicines Agency or any successor agency thereto.
“External Laboratories” means any Third Party analytical service provider contracted directly by Customer.
“Facility” means Lonza’s manufacturing facilities in Visp and/or Basel Switzerland, or such other facility, including [***], as may be agreed upon by the Parties.
“FDA” means the United States Food and Drug Administration, or any successor agency thereto.
“GDPR” means any applicable data protection or privacy laws, rules and regulations, including but not limited to, the European Union e-Privacy Directive 2002/58/EC, the European Union General Data Protection Regulation 2016/679, the UK Data Protection Act 2018, and any other laws equivalent thereto.
“Governmental Authority” means any Regulatory Authority and any national, multi-national, regional, state or local regulatory agency, department, bureau, or other governmental entity in the U.S., Switzerland or the European Union.
“Intellectual Property” means (i) inventions (whether or not patentable), patents, trade secrets, copyrights, trademarks, trade names and domain names, rights in designs, rights in computer software, database rights, rights in confidential information (including
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know-how) and any other intellectual property rights, in each case whether registered or unregistered, (ii) all applications (or rights to apply) for, and renewals or extensions of, any of the rights described in the foregoing clause (i) and (iii) and all rights and applications that are similar or equivalent to the rights and application described in the foregoing clauses (i) and (ii), which exist now, or which come to exist in the future, in any part of the world.
“International Trade Restrictions” means any export control requirements and trade, financial and economic sanctions which apply to this Agreement and the Services under the laws, regulations and rules of the United Nations, the European Union, the United Kingdom, Switzerland and any other relevant jurisdiction; and all necessary export and re-export written consents, permits, and authorizations required by International Trade Restrictions.
“Lonza Information” means all information that is proprietary to Lonza or any Affiliate of Lonza and that is maintained in confidence by Lonza or any Affiliate of Lonza and that is disclosed by Lonza or any Affiliate of Lonza to Customer under or in connection with this Agreement, including without limitation, any and all Lonza know-how and trade secrets.
“Manufacturing Instructions” means the document compiled by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.
“Manufacturing Process” means the production process for the manufacture of Product to be developed by Lonza and approved by Customer, as described in the Project Plan.
“New Customer Intellectual Property” has the meaning given in Clause 10.2.
“New General Application Intellectual
Property” has the meaning given in Clause 10.3.
“Non-Clinical Batches” means a Batch manufactured under the Project Plan that is not intended as a cGMP Batch, which shall include “Technical Batches”, “Toxicology Batches”, “Proof-of-Concept Batches” and any other non-cGMP Batches in the Project Plan.
“Party” means each of Lonza and Customer and, together, the “Parties”.
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“Price” means the price for the Services and Products as set out in Appendix A.
“Product” means the Drug Product manufactured using the Manufacturing Process by Lonza for Customer as specified in the Project Plans. .
“Project Plan” or “Project Plans” means the plans describing the Services to be performed by Lonza under this Agreement, including any update and amendment of the Project Plan to which the Parties may agree from time to time. The initial Project Plans are attached hereto as Appendix A.
“Quality Agreement” means the quality agreement entered into between the parties on May 21 and 22, 2021 by Lonza and Customer respectively.
“Raw Materials” means all ingredients, excipients as well as materials needed to perform the Services, including solvents, consumables/disposables, kits, capillaries, columns, antibody reagents, and other ‘non-standard’ reagents, filters, chromatography resins, cross flow membranes, bags, HPLC columns, specific reagents, infusion sets, pumps, and other components of the Product required to perform the Manufacturing Process or Services (including primary and secondary packaging materials, labels, filters, bags, tubings, dose administration kits and pumps, specific reagents, bioassay etc.). For the avoidance of doubt, Drug Substances are not considered to be Raw Materials.
"Raw Material Fee" means the procurement and handling fee of [***] ([***]%) of the acquisition cost of Raw Materials by Lonza that is charged to the Customer in addition to the cost of such Raw Materials. For clarity, the [***]% Raw Material Fee shall not apply to any Customer Materials or materials produced by Lonza (or any of its Affiliates), under or pursuant to any other written agreement between Lonza and Customer (such as Drug Substances).
“Regulatory Authority” means the FDA, EMA and any other similar regulatory authorities as may be agreed upon in writing by the Parties.
“Release” has the meaning given in Clause 7.1.
“Services” means all or any part of the services to be performed by Lonza under this Agreement (including, without limitation, process and analytical method transfer, process
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development, process optimization, validation, non-clinical and clinical manufacturing, as well as quality control and quality assurance activities), particulars of which are set out in a Project Plan.
“Services Data” means data generated by Lonza or any Affiliate or Subcontractor in the course of Lonza’s or such entities’ performing Services hereunder.
“Specifications” means the analytical tests and acceptance criteria of the Product as agreed between Customer and Lonza during the execution of the Services.
“Subcontractor” means a Third Party contracted directly by Lonza for the purpose of providing services to the Customer as agreed between Customer and Lonza.
“Technical Batch” means a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility.
“Term” has the meaning given in Clause 14.1.
“Third Party” means any party other than Customer, Lonza and their respective Affiliates.
In this Agreement references to the Parties are to the Parties to this Agreement, headings are used for convenience only and do not affect its interpretation, references to a statutory provision include references to the statutory provision as modified or re-enacted or both from time to time and to any subordinate legislation made under the statutory provision, references to the singular include the plural and vice versa, and references to the word “including” are to be construed without limitation.
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The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve any issues arising under this Agreement. In addition to the primary function described above, the Steering Committee shall also take on the following responsibilities:
Furthermore, unless otherwise agreed to by the Parties, if Lonza does not have suitable space at Lonza’s Services site for drug product (“Drug Product Services
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Site”), Customer shall [***]. In addition, Customer shall be permitted [***] within the Drug Product Services Site as visitor(s), for visits over periods to be determined by mutual agreement to (a) facilitate real-time (same time-zone) communications between Customer technical drug product team and the Lonza drug product team, (b) facilitate transfer of process and analytical technology between the companies; (c) facilitate master batch record review and approval process; (d) perform technical review of manufacturing batch data; and/or (e) augment program management by providing local input.
Each such Customer employee or authorized representative shall be subject to and agree to abide by confidentiality obligations to Third Parties and Lonza's customary practices, and such employee agrees to comply with all instructions of Lonza’s employees at the drug product manufacturing Facility and/or Drug Product Services Site.
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IN WITNESS WHEREOF, each of the Parties hereto has caused this Development and Manufacturing Services Agreement to be executed by its duly authorized representative effective as of the date written above.
[SIGNATURES FOLLOW ON THE NEXT PAGE]
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LONZA LTD
By: /s/ Albert Pereda
Name Albert Pereda
Title
Date 13-Apr-2022
By: /s/ Bernd Stefer
Name Bernd Stefer
Title
Date 13-Apr-2022
Vaxcyte, Inc.
By: /s/ Grant Pickering
Name Grant Pickering
Title CEO
Date 4/12/2022
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APPENDIX A
Project Plan A
[***]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
FIRST AMENDMENT TO DEVELOPMENT AND MANUFACTURING
SERVICES AGREEMENT
This First Amendment (the “First Amendment”), comes into effect on May 12, 2022 (the “First Amendment Effective Date”), is made by and between Lonza Ltd (“Lonza”) and Vaxcyte, Inc. (“Vaxcyte” or “Customer”). This First Amendment is to be incorporated as part of the Development and Manufacturing Services Agreement, dated March 22, 2022, between Lonza and Vaxcyte (the “Original Agreement”). Lonza and Vaxcyte, hereafter referred to as a “Party” and collectively as the “Parties.”
Whereas:
NOW, THEREFORE, the Parties hereby agree that the following amendments are made to the Original Agreement:
IN WITNESS WHEREOF, Vaxcyte and Lonza hereby enter into this First Amendment, effective as of the Tenth Amendment Effective Date.
VAXCYTE, INC LONZA LTD
By: /s/ Grant Pickering By: /s/ Bernd Stefer
Name: Grant Pickering Name:
Title: CEO Title:
By: By: /s/ Albert Pereda
Name: Name:
Title: Title:
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APPENDIX A
Project Plan B
[***]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
SECOND AMENDMENT TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT
This Second Amendment (the “Second Amendment”), comes into effect on November 21, 2022 (the “Second Amendment Effective Date”), is made by and between Lonza Ltd (“Lonza”) and Vaxcyte, Inc. (“Vaxcyte” or “Customer”). This Second Amendment is to be incorporated as part of the Development and Manufacturing Services Agreement, dated March 22, 2022, between Lonza and Vaxcyte (the “Original Agreement”). Lonza and Vaxcyte, hereafter referred to as a “Party” and collectively as the “Parties.”
Whereas:
NOW, THEREFORE, the Parties hereby agree that the following amendments are made to the Original Agreement:
IN WITNESS WHEREOF, Vaxcyte and Lonza hereby enter into this Second Amendment, effective as of the Tenth Amendment Effective Date.
VAXCYTE, INC LONZA LTD
By: /s/ Grant Pickering By: /s/ Albert Pereda
Name: Grant Pickering Name
Title: CEO Title:
By: By: /s/ Bernd Stefer
Name: Name
Title: Title:
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Appendix A
Project Plan A
[***]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
THIRD AMENDMENT TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT
This Third Amendment (the “Third Amendment”), comes into effect on October, 31st, 2023 (the “Third Amendment Effective Date”), is made by and between Lonza Ltd (“Lonza”) and Vaxcyte, Inc. (“Vaxcyte” or “Customer”). This Third Amendment is to be incorporated as part of the Development and Manufacturing Services Agreement, dated March 22, 2022, between Lonza and Vaxcyte (the “Original Agreement”). Lonza and Vaxcyte, hereafter referred to as a “Party” and collectively as the “Parties.”
Whereas:
NOW, THEREFORE, the Parties hereby agree that the following amendments are made to the Original Agreement:
IN WITNESS WHEREOF, Vaxcyte and Lonza hereby enter into this Third Amendment, effective as of the Third Amendment Effective Date.
VAXCYTE, INC. LONZA LTD
By: /s/ Jim Wassil By: /s/ Andrea Lindemann
Name: Jim Wassil Name: Andrea Lindemann
Title: Executive VP and COO Title: Head of Commercial Development, DPS
By: By: /s/ Albert Pereda
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Name: Name: Albert Pereda
Title: Title: Assistant General Counsel
Appendix A
Project Plan C
[***]
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