Exhibit 10.1
VONOPRAZAN COMMERCIAL SUPPLY AGREEMENT
This Vonoprazan Commercial Supply Agreement (this “Agreement”) effective as of August 1, 2022 (“Effective Date”) between Phathom Pharmaceuticals, Inc, located at 100 Campus Drive, Suite 102, Florham Park, NJ 07932, USA (“Purchaser”), and Evonik Operations GmbH, a limited liability company located at Rodenbacher Chaussee 4, 63457 Hanau (Wolfgang), Germany (“Supplier”). Purchaser and Supplier are each sometimes referred to individually as a “Party” and together as the “Parties”.
RECITALS
WHEREAS, Supplier has the expertise, resources, facilities and personnel for the manufacture and supply of Vonoprazan Fumarate (“Product”) which is also known as TAK-438, and Supplier desires to be engaged to manufacture and supply Product for Purchaser pursuant to the terms and conditions below; and
WHEREAS, Purchaser provided to Supplier the Purchaser Technology Data Package (as defined herein) containing such information, data, documents and records as reasonably necessary for Supplier to manufacture the Product,;
WHEREAS, Purchaser desires to engage Supplier to manufacture and supply Product as ordered by Purchaser, as a raw material in Purchaser’s subsequent manufacture of finished pharmaceutical products containing Product as active pharmaceutical ingredient for human use (“Final Product”),
WHEREAS, the Agreement will cover a 4 phased approach, with phase 1 being the first commercial campaign (starting after successful completion of the validation campaign, which validation campaign is not subject to this Agreement), and ending with the successful completion of the first commercial campaign (“Phase 1”), phase 2 being regular commercial supply from the Supplier Facility in [***] starting after completion of Phase 1 (“Phase 2”), phase 3 consisting of validation of the process at the Supplier Facility of [***], and ending with the successful completion of such validation (“Phase 3”) and phase 4 being commercial supply from [***] after the successful validation in [***] (“Phase 4”).
WHEREAS, in order to be able to validate the process at the Supplier’s Affiliate [***], certain equipment modifications are necessary. Supplier’s Affiliate [***] and Purchaser will enter into a separate agreement covering such equipment modification and the funding thereof.
NOW, THEREFORE, in consideration of the foregoing and the promises contained in this Agreement, Purchaser and Supplier, intending to be legally bound, hereby agree as follows:
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Supplier will use commercially reasonable efforts to supply Product earlier as stated in the Firm Commitment if desired by Purchaser.
Annual Campaign Size | Binding period before supply |
[***] | [***] |
Annual Campaign Size | Binding period before supply |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
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If Supplier produces more Product in a campaign than as agreed in the Firm Commitment, then Purchaser shall be obliged to take up to an additional [***] of the Firm Commitment at the prices set forth in the Agreement.
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For Supplier:
Evonik Operations GmbH
[***]
For Purchaser:
Phathom Pharmaceuticals, Inc.
2150 E. Lake Cook Road, Suite 800
Buffalo Grove, Illinois 60089
Attn: Vice President, Manufacturing and Supply Chain
With a copy to:
Phathom Pharmaceuticals, Inc.
100 Campus Drive, Suite 102
Florham Park, NJ 07932
Attn: General Counsel (Legal Department)
Email: [***]
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The Parties hereto have each caused this Agreement to be signed and delivered by its duly authorized officer or representative as of the Effective Date.
[Signature page to follow]
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Phathom Pharmaceuticals, Inc. | Evonik Operations GmbH | |
By: | /s/ Azmi Nabulsi | By: /s/ [***] |
Name: | Azmi Nabulsi | Name: [***] |
Title: | COO | Title: SVP Health Care |
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| By: /s/ [***] |
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| Name: [***] |
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| Title: Senior Legal Counsel |
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Exhibit A Definitions
“Affiliate” shall mean with respect to a Party, any person, corporation, company, partnership or other entity that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, "control" shall mean direct or indirect ownership of fifty percent (50%) or more 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 entity or person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity.
“Applicable Law” shall mean the applicable provisions of any national, regional, state and local laws, treaties, statutes, rules, regulations, guidance, or ordinances of or from any Governmental or Regulatory Authority of the European Union, United States, or other territory, in each instance only to the extent applicable to the performance of the Parties’ obligations hereunder including, without limitation, the manufacture or use of the Product.
“Background IP” means any and all (1) proprietary information and know-how and expertise whether patented or patentable including, without limitation, specifications, processes, formulations, procedures, instructions, technology and any other technical information which may be contained in drawings, photographs, samples, models and other documentation or communicated orally; (2) patent applications, patents and other intellectual property rights; (3) material, including without limitation, samples of products and models; and (4) software and other creation being subject to copyrights; which a Party owns or controls prior to the Effective Date, or thereafter acquires or independently develops outside the scope of this Agreement. In the case of Supplier, Supplier Background IP also includes Supplier Facility and Supplier Facility Information. In the case of Purchaser, Purchaser Background IP also includes Purchaser Technology Data Package.
“Batch Record” shall have the meaning set forth in the Quality Agreement.
“Claim” shall have the meaning set forth in Article 9.1.
“Confidential Information” shall have the meaning set forth in Article 7.1.
“Disclosing Party” shall have the meaning set forth in Article 7.1.
“Current Good Manufacturing Practice" or “cGMP” means all then-current applicable laws, regulations and recognized good manufacturing practices that apply to the manufacture of any therapeutically active material that provides pharmacological activity in a pharmaceutical product, and govern the standards of manufacture of any product intended for human use, including, as applicable: (i) 21 C.F.R. Parts 210 and 211, as amended, in the United States, (ii) the EU good manufacturing practices set forth in Eudralex Volume 4: The Rules Governing Medicinal Products in the European Union Volume 4: Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use – Part II – Basic Requirements for Active Substances used as Starting Materials, (iii) the Guideline ICH Tripartite Guidance Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients and (iv) applicable guidance published by the FDA or the EMA; and; in each case as may be modified or supplemented during the Term.
“Effective Date” shall have the meaning set forth in the preamble of this Agreement.
“FDA” means the United States Food and Drug Administration, or any successor thereto, having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, drug delivery systems, and devices in the United States of America.
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“Final Product” shall have the meaning set forth in the recitals of this Agreement.
“Force Majeure” shall have the meaning set forth in Article 13.1.
“Government or Regulatory Authority” means any supranational, national, regional, state or local government, court, governmental agency, authority, board, bureau, instrumentality or regulatory body which are relevant to the development and manufacture of the Product.
“Invention” shall mean any creation, discovery and invention (whether or not patentable) conceived, created, developed or reduced to practice by Supplier in connection with its performance of the contractual obligations hereunder.
“Master Batch Record” shall have the meaning set forth in the Quality Agreement.
“Maximum Supply Obligation” shall have the meaning set forth in Article 3.2.5.
“Product” shall have the meaning set forth in the recitals, and as further described in Exhibit B.
“Product Price” shall have the meaning set forth in Article 4.1.
"Production" or "Produce" means the synthesis, manufacturing, purification, packaging, testing and release of the Product by Supplier to Purchaser.
“Project Manager” shall have the meaning set forth in Article 3.3.
“Purchaser Foreground IP” shall have the meaning as set forth in Article 6.3.
“Purchaser Technology Data Package” shall have the meaning set forth in Article 6.2.
“Purchaser Technology Data Package Improvements” shall have the meaning set forth in Article 6.3.
“Quality Agreement” means the quality agreement between Purchaser and Supplier relating to the manufacture of Product (whether executed by the Parties prior to, concurrently with, or after entry into this Agreement), as the same may be amended or modified from time to time by agreement of the Parties. The Quality Agreement describes the relationship of the Parties hereunder and the responsibilities of each Party regarding quality systems practices and activities concerning the manufacture of the Product.
"Raw Material” shall mean the chemicals, compounds, water, solvents, reagents and other materials and supplies, including disposable manufacturing materials and labeling and packaging materials, used in manufacturing the Product.
“Receiving Party” shall have the meaning set forth in Article 7.1.
"Shortfall Payment" shall have the meaning set forth in Article 3.8.
“Specification” shall have the meaning as set forth in Article 3.1.
“Supplier Facility” shall mean the specific premises of Supplier located at [***] for Phase 1, Phase 2 and Phase 4 and additionally the specific premises of Supplier’s Affiliate and subcontractor [***] for Phase 3 and Phase 4.
“Supplier Facility Information” means Supplier’s Confidential Information relating to (a) layout and design of Supplier Facility(ies); (b) equipment and other assets including information revealing the make,
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model or other identifying features of any laboratory or process equipment utilized by Supplier in the performance of this Agreement; (c) any and all nomenclature, identifiers and facility capabilities of Supplier and (d) location and address of Supplier Facilities.
“Supply Failure” means that after the second campaign following successful completion of the validation campaign of the relevant Supplier Facility Supplier has, in any given [***] period, failed to deliver at least [***] of Product ordered by Purchaser pursuant to the relevant Purchase Order(s) within [***] following the delivery date set forth in the applicable Acknowledgement and after expiry of a [***] grace period to be granted by Purchaser to Supplier to remedy such failure; for reasons solely attributable to Supplier, its Affiliates or subcontractors, and in particular other than Force Majeure.
“Supplier Foreground IP” shall have the meaning as set forth in Article 6.4.
“Term” shall have the meaning as set forth in Article 2.2.
“Third Party” shall mean any other person, company or other business entity other than Purchaser or Supplier, or an Affiliate of either of them.
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Exhibit B - Product Specification
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Exhibit C – INDICATIVE nON-BINDING Product Volumes
[***]
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Exhibit D – PrICE and PRICE ADJUSTMENTS
[***]
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Exhibit E - Purchaser Technology Data Package
[***]
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Exhibit F – PRODUCT volumes
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