Common use of GMP PRODUCTION Clause in Contracts

GMP PRODUCTION. POLYPEPTIDE will manufacture the Product in phases [ * ] of the development project according to current Good Manufacturing Practice guidelines ("cGMP") as described in the Code of Federal Regulations, Title 21, Part 211 (21 CFR 211) as applicable to Bulk Pharmaceutical Chemicals. Furthermore, [ * ] will authorise the United States Food and Drug Administration ("FDA") and any other regulatory agency around the world to review the Drug Master File in support of the Product registration applications. [ * ] reserves the right to review the DMF prior to its submission to the FDA. If during the course of this contract POLYPEPTIDE is inspected by FDA, it will promptly inform INTRABIOTICS that such inspection has taken place and supply a copy of any FDA Form 483, in the form that would be available under the Freedom of Information Act, and all other documentation applicable to the manufacturing of the Product.