PHS (NIH/CDC/FDA), Model Non-Exclusive Patent 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 document outlines the standard terms and conditions for non-exclusive patent licenses from the United States Public Health Service (“PHS” or “Government”) as represented by one of the following Institutes or Centers (“IC”): the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”).

Licensee obligations include supplying the Licensed Product to the IC for research use, ensuring that products sold in the U.S. are substantially manufactured in the U.S., making the product available to patient assistance programs, and making commercially reasonable efforts to ensure that the product is reasonably accessible to the U.S. public.

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. The Licensee agrees first to appeal any unsettled claims or controversies to the designated IC official, or designee, whose decision shall be considered the final agency decision. Thereafter, the Licensee may exercise any administrative or judicial remedies that may be available.

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Master Alliance Provisions Guide (MAPGuide)

PHS (NIH/CDC/FDA), Model Non-Exclusive Patent License Agreement

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Master Alliance Provisions Guide (MAPGuide)

PHS (NIH/CDC/FDA), Model Non-Exclusive Patent License Agreement

Provision Language

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