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

Liability | Insurance

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This document outlines the standard terms and conditions for an exclusive patent license 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.

Although the license is exclusive, the IC retains: (a) a right to grant licenses to third parties for research use; and (b) a royalty-free, worldwide license to practice licensed inventions “for or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory.”

Provision Language

12. NEGATION OF WARRANTIES AND INDEMNIFICATION

[…]

12.6 The Licensee agrees to maintain a liability insurance program consistent with sound business practice.

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

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

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