CHANGES IN SPECIFICATIONS. In the event that an amendment to the Specifications, the Manufacturing process, or the test methods for the Crofelemer Animal API is (i) required in writing by any Regulatory Authority, or (ii) requested by Jaguar, Jaguar promptly shall provide Glenmark with appropriate documentation relating to any such changes to the Specifications or Manufacturing process to the extent that such changes affect Glenmark’s Manufacturing of the Crofelemer Animal API hereunder. If the requested changes can be made without modification to the existing process capability, Glenmark shall implement such changes in accordance with the change control procedures applicable under GMP and per agreement between the Parties regarding the timing of the changes. It shall be within Glenmark’s sole discretion to determine whether or not the requested change can be made without modification to the existing process capability. In the event that Glenmark determines that the requested change cannot be made without modification to the existing process capability, then Glenmark, in its sole discretion, shall have the right to reject any request for changes to the Specifications or Manufacturing process. Glenmark shall not, in any respect, amend, modify or supplement the Specifications, the Manufacturing process, or the test methods for the Crofelemer Animal API or any Jaguar-Supplied CPL or sources of Jaguar-Supplied CPL used in connection with Manufacturing the Crofelemer Animal API without the prior written consent of Jaguar.
Appears in 2 contracts
Sources: Manufacture and Supply Agreement, Manufacture and Supply Agreement (Jaguar Animal Health, Inc.)