Regulatory Reason definition

Regulatory Reason means any delay by CymaBay to submit for filing an NDA for the Product for the Indication in the U.S. within [***] of the date of achievement of the Phase 3 Success Criteria for the Product, to the extent such delay results from a new or changed requirement imposed by the FDA with respect to the prerequisites for the submission of a filing of such NDA.
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Regulatory Reason has the meaning specified in Section 2.4(a).
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Regulatory Reason has the meaning set forth in Section 18.4(a).
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Examples of Regulatory Reason in a sentence

  • If some terms of the Agreement are terminated for any Regulatory Reason (e.g., Article 4 Anti-Dilution Rights), the Parties shall resolve the performance of the other terms of the Agreement through separate negotiations.

  • In the event that CymaBay fails to use Commercially Reasonable Efforts to so obtain Regulatory Approval for the Product, including a failure to submit for filing an NDA for the Product for the Indication in the U.S. within [***] of the date of achievement of the Phase 3 Success Criteria for the Product for any reason other than a Regulatory Reason, and this failure is not cured as set forth in Section 13.3.1, Abingworth may terminate this Agreement pursuant to Section 13.3.1.

  • If some terms of the Agreement are terminated for any Regulatory Reason (e.g., Article 3 Anti-Dilution Rights), the Parties shall resolve with respect to the other terms of the Agreement through separate negotiation.