FIRST AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
DocuSign Envelope ID: C23403EF-A3D5-465F-8315-7AD59052E3C4
Agreement #: X00000000
EXHIBIT 10.1
Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Triple asterisks denote omissions.
FIRST AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
THIS FIRST AMENDMENT (this “Amendment”) to the EXCLUSIVE LICENSE AGREEMENT effective as of January 28, 2022 (the “Agreement”) is made as of the date of last signature below (“Amendment Date”) by and between Xxxxx Therapeutics Holdings LLC, a Delaware limited liability company (“Licensee”), and the Regents of the University of Minnesota, a constitutional corporation under the laws of the state of Minnesota (“University”).
WHEREAS, the parties desire to make certain amendments to the Agreement as set forth herein.
NOW THEREFORE, in consideration of the mutual covenants and promises contained in this Amendment, the parties hereby agree as follows:
Provided that a Regulatory Authority does not recommend or require unanticipated studies or prerequisites, including, without limitation, detailed characterization of control material for clinical trial use, as part of the regulatory approval process for obtaining a Licensed Product, Licensee (directly or indirectly by way of sublicense) shall achieve the following milestones. If the Regulatory Authority does recommend or require such unanticipated studies or prerequisites, the parties will negotiate in good faith extensions to the milestones to reflect additional time that may be needed to achieve the following:
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DocuSign Envelope ID: C23403EF-A3D5-465F-8315-7AD59052E3C4
Agreement #: X00000000
[***].
“Regulatory Authority” means, with respect to a Licensed Product, any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in the Territory, with authority over (a) the distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing or sale of the Licensed Product, including the United States Food and Drug Administration (“FDA”), European Medicines Agency, Therapeutic Goods Administration (Australia), Health Canada, and National Medical Products Administration (China), or (b) setting the price and/or reimbursement for the Licensed Product.
10.1 (University’s Right to Terminate for Breach) of the General Terms of the Agreement is hereby amended to replace “FDA” with “Regulatory Authority”.
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DocuSign Envelope ID: C23403EF-A3D5-465F-8315-7AD59052E3C4
Agreement #: X00000000
THE PARTIES HEREBY EXECUTE THIS AMENDMENT
Regents of the University of Minnesota |
Xxxxx Therapeutics Holdings LLC
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By: |
/s/ Xxxx Xxxxxxx |
By: |
/s/ Xxxx Xxxxx |
Name: |
Xxxx Xxxxxxx |
Name: |
Xxxx Xxxxx |
Title: |
Executive Director |
Title: |
CEO |
Date: |
April 11, 2023
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Date: |
April 12, 2023 |
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