Commencing on August 1, 2023, Collaborator shall have the right to terminate the Agreement without cause upon [ * ] prior written notice to Exelixis if the PMDA has not granted approval of the MAA for the Product in any cancer indication in the Collaborator Territory.
The Development Plan shall be amended only upon mutual written agreement by the Parties, provided that Zosano may amend the Development Plan without such agreement by Lilly (but with a copy provided to Lilly within three (3) days) with respect to any amendments addressing discussions with and guidance by the FDA or PMDA.
An Alternative Method for Disposition of U.S. Excess Weapons-Grade Plutonium: Addressing the Challenges of the PMDA.
At any time prior to August 1, 2023, the Parties may mutually agree that the PMDA is unlikely to grant approval of the MAA for the Product in any cancer indication in the Collaborator Territory.
Kissei shall provide ObsEva with an English summary of all formal correspondences for the Compound or the Product with the PMDA in a timely manner.