Examples of End of Phase 1 in a sentence
A joint research committee (the “JRC”) shall monitor the progress of the research program for Potential Licensed Compounds, and permit collaboration, wherever possible, during compound discovery through GLP Tox Completion or End of Phase 1, as applicable, for any given Potential Licensed Compound.
For the avoidance of doubt, with respect to a given Program, during the period from the end of the End of Phase 1 Date until the end of the Phase 1 Option Period for such Program, no further activities shall be conducted by or on behalf of Prothena with respect to such Program (including the Collaboration Target, Collaboration Candidates or Collaboration Product thereunder), unless agreed to by Celgene in writing (such agreement not to be unreasonably withheld).
Celgene shall have the right to exercise its Phase 1 Option with respect to such Program as set forth in Article 3 (including entering into a Global License Agreement for such Program with Prothena), with the date that Prothena so delivers the complete Phase 1 Data Package for such Program being deemed be the End of Phase 1 Date for such Program, and the provisions of Article 3 shall apply in connection therewith, mutatis mutandis.
EXHIBIT 3 Buyer shall transition the sale and support of the Products from Seller’s sites to Buyer’s designated sites by the End of Phase 1.
Please revise the Summary to disclose your plan to conduct an End of Phase 1 meeting with the FDA.
Establishment and completion of its own product distribution chain (which shall be completed by no later than the End of Phase 1).
Schedule 1.320 Triple Combination End of Phase 1 Success Criteria [...***...] * Confidential information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission.
End of Phase 1: [****] Interim analysis of [****] [****] The JDC will assess the possibility and desirability of [****] for testing [****].
Maximum Term: Commencing on the Closing Date and for a period ending on the later of (a) ninety (90) days or (b) the End of Phase 1.
For clarity, AbbVie may elect to, but shall not be required to, proceed with the Development of a Triple Combination Product if such Triple Combination Product does not satisfy the Triple Combination End of Phase 1 Success Criteria, in which case, such failure to satisfy the Triple Combination End of Phase 1 Success Criteria shall not be a Combination POC Development Failure.