Examples of GMP Batch in a sentence
Specifications and other criteria which have been mutually agreed by both parties to which cGMP Product must conform, including the test methods to be used in determining whether Product conforms thereto: at least two (2) weeks before the scheduled commencement of manufacture of the 1st GMP Batch.
DPT agrees that each GMP Batch produced hereunder shall be manufactured at the Facility, in accordance with cGMPs, at the time of delivery to Company, provided that the API intended for use in the GMP Batches conforms, at the time of delivery to DPT, to the specifications therefor.
If Alnylam accepts the terms of such GMP Batch Change Order in writing, then the relevant GMP Batch Work Order will be deemed amended to reflect those changes set forth in such Change Order.
Provider shall reduce the payment due under this Section 9.5 by a sum equal to the fee received by the third party customer (after accounting for out-of-pocket costs incurred by Provider to accomplish such mitigation) for the costs of Provider’s labor and equipment that Provider would have expended on manufacturing Synthorx’s non-cGMP or GMP Batch, as the case may be.
Tekmira shall be reasonable and use good faith in its considerations of draft GMP Batch Work Orders from Alnylam.