AMENDMENT 1 TO THE COMMERCIAL SUPPLY AGREEMENT
Exhibit 10.22
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. THE OMISSIONS HAVE BEEN INDICATED BY “[***].”
AMENDMENT 1 TO THE COMMERCIAL SUPPLY AGREEMENT
This amendment 1 (this “Amendment 1”) is made on December 1, 2020, to the commercial supply agreement effective on April 30, 2020 by and between Takeda Pharmaceutical Company Limited, a company incorporated under the laws of Japan having its principal place of business at 1-1, Xxxxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx 000-0000, Xxxxx (“Takeda”) and Phathom Pharmaceuticals, Inc., a company incorporated under the laws of Delaware having its principal place of business at 0000 X. Xxxx Xxxx Xxxx, Xxxxx 000, Xxxxxxx Xxxxx, Xxxxxxxx 60089, U.S.A. (“Company”). Takeda and Company are referred to herein individually as a “Party” and collectively as the “Parties.”
WHEREAS, the Parties have also entered into a Commercial Supply Agreement effective on April 30, 2020 (the “Agreement”) pursuant to which Takeda has agreed to supply to Company, and Company has agreed to purchase from Takeda, certain quantities of Bulk Drug Product to Commercialize the Product in the Territory;
1.DEFINITIONS
1.1 |
Unless otherwise defined herein, capitalized words in this Amendment 1, including in its preamble, shall have the same meaning as defined in the Agreement or in the License Agreement. |
2.AMENDMENT
2.1 |
The Parties have agreed that the Company has the option to order API instead of Bulk Drug Product, up to the amount of API required to produce the corresponding maximum order quantities of Bulk Drug Product agreed by the Parties in Exhibit 2 of the Agreement. For the sake of clarity, it is acknowledged that (i) any order of API shall be made by the Company in accordance with the agreed delivery forecast specified in Exhibit 3 (minus the 2 months period to allow for conversion of the API to bulk tablets in case of bulk tablets production), and (ii) the price for such API that the Company may order under the Agreement, as amended by this Amendment 1 is the price specified in paragraph 4. Stage 2 Process Qualification in Exhibit 3 for supply of API for scale-up and validation processes purposes. |
2.2 |
Takeda has two manufacturing sites qualified to produce API [***] which Takeda may use to supply the Company with API. Takeda will decide at its discretion on the best feasible allocation between both sites, taking into consideration its available capacity and quality and regulatory status of those sites. |
2.3 |
The Parties agree to amend Exhibit 3 of the Agreement to add the “PSPA Reference Standard” to the list of Additional Materials to Support Tech Transfer, under section 1. Analytical Method Transfer Reference Materials. |
3.MISCELLANEOUS
3.1 |
This Amendment 1 shall enter into force on the Effective Date for the term of the Agreement. |
3.2 |
All provisions of the Agreement, that do not contradict the terms set forth in this Amendment 1, shall continue in full force and effect. |
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TAKEDA PHARMACEUTICAL COMPANY LIMITED |
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/s/ Xxxx Xxxxxxx
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/s/ Xxxx Xxxxxxx |
Name : Xxxx Xxxxxxx |
Name : Xxxx Xxxxxxx |
Title :Chief Operating Officer |
Title : Senior Vice President, Head of Global Manufacturing & Supply, Japan
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Date: November 30, 2020 |
Date : December 01, 2020 |
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