Common use of Master File Clause in Contracts

Master File. CBL shall maintain one or more facility master files at the FDA and agrees to provide TKT with any requisite letters authorizing the FDA access to CBL’s facility master file in conjunction with regulatory review of CBL’s production of Product as set forth in this Agreement.

Appears in 2 contracts

Sources: Commercial Supply Agreement (Transkaryotic Therapies Inc), Commercial Supply Agreement (Transkaryotic Therapies Inc)