Provision Language
5. STATUTORY AND NIH REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
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5.4
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(b) In exceptional circumstances, and in the event that the Licensed Patent Rights are Subject Inventions made under a CRADA, the Government, pursuant to 15 U.S.C. §3710a(b)(1)(B), retains the right to require the Licensee to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the Licensed Patent Rights in the Licensed Field of Use on terms that are reasonable under the circumstances, or if the Licensee fails to grant this license, the Government retains the right to grant the license itself. The exercise of these rights by the Government shall only be in exceptional circumstances and only if the Government determines:
(i) the action is necessary to meet health or safety needs that are not reasonably satisfied by the Licensee;
(ii) the action is necessary to meet requirements for public use specified by Federal regulations, and these requirements are not reasonably satisfied by the Licensee; or
(iii) the Licensee has failed to comply with an agreement containing provisions described in 15 U.S.C. §3710a(c)(4)(B); and
(c) the determination made by the Government under this Paragraph 5.4 is subject to administrative appeal and judicial review under 35 U.S.C. §203(b).
9. REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
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9.10 In the event PHS receives a license application from a Third Party Applicant for commercial development of one or more Licensed Products or Licensed Processes in the exclusive Licensed Fields of Use, as they pertain to Licensed Patent Rights for which the proposed commercial development is not specifically addressed in Licensee’s then-current Commercial Development Plan (“Third Party Applications”), PHS shall notify Licensee , in writing, of the existence of the Third Party Applicant ’s license application. Upon receipt of the written notice, Licensee shall respond in writing by either:
(a) amending its Commercial Development Plan within one hundred and twenty (120) days in a manner acceptable to PHS to include a clinical research and development program for the proposed commercial development of the Third Party Applications including revised Benchmarks to be incorporated into Appendix E, and acceptance of the amendment to the Commercial Development Plan by PHS shall take into account if Licensee has already carried out work in respect of such Third Party Applications prior to notification by PHS; or
(b) amending its Commercial Development Plan within one-hundred eighty (180) days (or such longer period agreed by Licensee and such Third Party Applicant) in a manner acceptable to PHS to include a joint pre-clinical research and development program with the Third Party Applicant for the proposed commercial development of the Third Party Applications; or
(c) granting an exclusive or non-exclusive sublicense under commercially reasonable terms to the Third Party Applicant under Licensed Patent Rights in respect of the Third Party Applications within one-hundred eighty (180) days (or such longer period agreed by Licensee and such Third Party Applicant);
or both (b) and (c).
If Licensee does not respond to the written notice as described in this Paragraph 9.10, and after thirty (30) days of final notice being sent to Licensee, PHS may remove the Licensed Products or Licensed Processes in respect of the Third Party Applications from the exclusive Licensed Field of Use in this Agreement, and PHS shall be free to grant a license to the Third Party Applicant under the Licensed Patent Rights in respect of the Third Party Applications.
13. TERM, TERMINATION, AND MODIFICATION OF RIGHTS
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13.7 When the public health and safety so require, and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, PHS shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless the 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 shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.