AMENDMENT NO. 1
Exhibit 10.25
CERTAIN INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
AMENDMENT NO. 1
THIS AMENDMENT NO. 1 (“Amendment No. 1”) is made and entered into on June 28, 2022 (the “Amendment Effective Date”), by and between Pyxis Oncology, Inc., a corporation, organized under the laws of Delaware, with its registered office at 00 Xxxxxxxxxxxxx Xxxxx, Xxxxx 000-X, Xxxxxxxxx, XX 00000 (hereinafter referred to as “Pyxis” or “Client”) and Biosion USA, Inc., a Delaware corporation, having an address at 0 Xxxxxxxxxx Xxx, Xxxxx 000, Xxxxxx, Xxxxxxxx 00000 (hereinafter referred to as “Biosion”) and amends that certain March 28, 2022 License Agreement entered into by and between Pyxis and Biosion (the “Agreement”).
WHEREAS, under the terms of the Agreement, Biosion granted certain exclusive license rights to Pyxis under certain technology, materials and other proprietary materials of Biosion;
WHEREAS, subject to the terms of the Agreement, the Parties agreed to enter into a Clinical Supply Agreement within [***] of the Effective Date; and
WHEREAS, the Parties hereto have entered into an agreement to extend the time period by which to enter into such Clinical Supply Agreement, and of which they desire to memorialize in this Amendment No. 1;
NOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions hereinafter set forth, the Parties hereto agree as follows:
Section 3.5.1 shall be deleted in its entirety and shall be replaced with the following:
“3.5.1. Upon execution of the Clinical Supply Agreement, notwithstanding the provisions of Section 2.2 and Section 2.10 (but subject to the terms of the Clinical Supply Agreement), as between the Parties, Licensee shall have the first and primary right to have Manufactured by a Third Party contract manufacturer the Compound and Products for Development in the Field within the Licensed Territory and the Retained Territory. Within [***] after the Effective Date (or such later date mutually agreed by the Parties based on timing of identification of a Third Party contract manufacturer meeting the requirements set forth in this Section 3.5.1), the Parties shall negotiate in good faith the terms and conditions of a clinical supply agreement and corresponding quality agreement on customary terms, pursuant to which Licensee would Manufacture and supply, itself or through an Affiliate or one (1) or more Third Party contract manufacturers, the Compound and Products to Licensor to support Licensor’s Development of the Compound and Products in the Field in the Retained Territory (the “Clinical Supply Agreement”). The Clinical Supply Agreement shall include terms and conditions providing that the Compound and Products supplied thereunder must meet the requirements of Regulatory Authorities in the Retained Territory, and backup Manufacturing rights (including technology transfer at Licensee’s cost and expense) for Licensor in the event that Licensee is unable or unwilling to meet its supply obligations thereunder. Any Third Party contract manufacturer engaged by Licensee or any of its Affiliates for the Manufacture of Compound or Product to be supplied under the Clinical Supply Agreement shall have the capability to Manufacture such Compound or Product in conformance with the same specifications, in both the United States and China and with world class quality, and Licensor shall have the right under the Clinical Supply Agreement to designate the site of the Third Party contract manufacturer to be used to provide supply to Licensor thereunder.”
IN WITNESS WHEREOF, the Parties hereto, each by a duly authorized representative, have executed this Amendment No. 1 as of the Amendment Effective Date.
Biosion USA, Inc. |
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By: |
/s/ Xxxx Xxxxx |
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By: |
/s/ Xxx Xxxxxxxx |
Print Name: |
Xxxx Xxxxx |
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Print Name: |
Xxx Xxxxxxxx |
Title: |
COO, Biosion Inc, & President, Biosion USA, Inc. |
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Title: |
CFO |
Date: |
June 28, 2022 |
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Date: |
June 28, 2022 |