Common use of Master Production Record Clause in Contracts

Master Production Record. Subject to the terms and conditions of this Agreement, CBL agrees to process the Product in accordance with a Master Production and Control Record approved in writing by TKT. CBL further agrees that any substantive changes to the Master Production and Control Record and the process must receive written approval of TKT prior to implementation, provided, however, that any approvals to be delivered by TKT shall not be unreasonably withheld and the parties shall cooperate and act reasonably and in good faith in connection with their respective activities under this Section. CBL will permit TKT to review all information in Master Production Records pertaining to individual product lots as well as, raw material test results and the results of environmental monitoring prior to product release by CBL but after CBL’s completion of its internal review of the batch record. CBL will release the batch record within [**] of receiving TKT’s comments and proposed changes.

Appears in 2 contracts

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