NIH – UniQure, AAV5 Gene Therapies Exclusive and Non-Exclusive License Agreement

Business model | Governance

Structural Questions

Do the parties govern the project through a joint steering committee (“JSC”)? If so, what are the parties expressly designated roles and responsibilities with respect to the JSC?
Are there other committees, important governance bodies, or designated individual positions? What are the parties’ roles and responsibilities with respect to them?
Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
What are the resolution mechanisms for disputes related to the agreement?
Are there any requirements for policies or procedures to manage potential conflicts of interest?

Annotations

This agreement is between the United States Public Health Service (“PHS” or “Government”) and uniQure B.V., which previously operated as Amsterdam Molecular Therapeutics B.V. (“uniQure” or “Licensee”). The agreement was entered into in November 2011, and amended in May 2013 (“Amendment 1”) and November 2013 (“Amendment 2”). According to an SEC filing by uniQure, the agreement was also amended in 2016, but this amendment does not appear to be publicly available. The amendments were agreed between uniQure and the National Institutes of Health (“NIH”), one of the components of PHS.

Under the agreement, uniQure receives a license to make, use and sell Licensed Products and Licensed Processes using PHS’ AAV5 patents. The license is for: (a) therapeutic products to be delivered to the brain or liver for the treatment of diseases originating in the brain or liver, excluding arthritis (“Exclusive Licensed Field of Use”); (b) treatment of any human disease in any manner (“Non-Exclusive Licensed Field of Use”). The license grants apply worldwide (“Licensed Territory”).

UniQure must make payments to PHS including an initial license issue fee, minimum annual royalties, earned royalties, benchmark royalties and patent prosecution expenses. However, benchmark and earned royalties do not have to be paid in relation to pre-clinical or clinical development collaborations for Ultra-Orphan indications with a non-profit organization or academic institution (“Exempt Collaborator”). Under Amendment 1, uniQure and NIH agreed to a reduction in the payments required for sublicensing in order to expedite the development of therapeutics for rare diseases.

Provision Language

14. GENERAL PROVISIONS

[…]

14.12 The parties agree to attempt to settle amicably any controversy or claim arising under this Agreement or a breach of this Agreement, except for appeals of modifications or termination decisions provided for in Article 13. Licensee agrees first to appeal any unsettled claims or controversies to the designated PHS official, or designee, whose decision shall be considered the final agency decision. Thereafter, Licensee may exercise any administrative or judicial remedies that may be available.

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Master Alliance Provisions Guide (MAPGuide)

NIH – UniQure, AAV5 Gene Therapies Exclusive and Non-Exclusive License Agreement

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Master Alliance Provisions Guide (MAPGuide)

NIH – UniQure, AAV5 Gene Therapies Exclusive and Non-Exclusive License Agreement

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