Manufacturing Processes. CATALYTICA has furnished CEPHALON with a copy of its production procedures and has identified to CEPHALON the equipment to be used to produce the Product, all as set forth in Schedule G hereto. CATALYTICA agrees that it will not modify these procedures, nor modify any method of formulating, packaging, labeling or testing the Product (including analytical procedures, components, process, Specifications, controls, storage, stability protocols), without notifying CEPHALON or obtaining CEPHALON's prior written consent as required in Schedule C hereto, which consent shall not be unreasonably withheld or delayed. Costs incurred by CATALYTICA as a result of any such changes or modifications requested by the FDA or by CEPHALON and relating primarily to the production of the Product will be borne by CEPHALON; costs for other changes affecting CATALYTICA's cGMP compliance or affecting products generally will be borne by CATALYTICA.
Appears in 2 contracts
Sources: Toll Manufacturing and Packaging Agreement (Cephalon Inc), Toll Manufacturing and Packaging Agreement (Cephalon Inc)