Master Alliance Provisions Guide (MAPGuide)

PHS – Biosyn, HIV Prophylactic Exclusive License Agreement

  • Equitable Access | Ensuring continuity



13.06 When the public health and safety so require, and after written notice to Licensee providing Licensee a ninety (90) day opportunity to respond, PHS shall have the right to require Licensee to grant sublicenses to responsible applicants, on reasonable terms, in the Licensed Field of Use under the Licensed Patent Rights , unless Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights . PHS will not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with Licensee . If Licensee is required to grant sublicense(s) under this Paragraph 13.06, Licensee agrees to provide PHS and said sublicensee(s) with all data, documents and materials generated or produced by or on behalf of Licensee that would be or could be used in regulatory filings with the Food and Drug Administration (or foreign equivalent regulatory agency). Licensee agrees that such data, documents and/or materials can be used by PHS or said sublicensee(s) to prepare regulatory filings with the Food and Drug Administration (or equivalent foreign regulatory agencies). Licensee may charge a fee to said sublicensee(s) that is equal to its direct costs only (i.e., no overhead shall be compensated) for producing said data, documents and materials that said sublicensee(s) actually use in their regulatory filings.