Successful Development Batch Release Sample Clauses

Successful Development Batch Release. Pre-Validation Campaign Review. If at least one (1) of the two (2) Development Batches manufactured under Clause 2.3(a) can be Released or if rework, reprocessing or further manufacture carried out in accordance with Clause 2.3(b) results in a Development Batch which can be Released, the Project Steering Committee shall review the activities carried out to date, solely to evaluate operability of the Process and Avecia’s cGMP compliance in order to ensure that both Parties are confident of success in the Validation Campaign (“the Pre-Validation Campaign Review”). During the Pre-Validation Campaign Review, the PSC, with input from the Quality Team, shall discuss readiness to carry out the Validation Campaign, potential timing for its conduct and any other issues concerning the Process operability or cGMP compliance. This discussion will include a review and analysis of the actual performance of the Development Batches compared to the Process Assumptions, and an attempt by the PSC to reach agreement with respect to whether the Validation Campaign shall be delayed, not be delayed, or not be carried out at all. If during the Pre-Validation Campaign Review, the EC, after referral of the matter to it by the Project Steering Committee, is unable to reach a final decision in accordance with the terms of Clause 2.7(f) as to whether the Validation Campaign shall be delayed, not be delayed, or not be carried out at all—solely due to Process operability or Avecia cGMP compliance issues, or any other concerns which resulted in a Development Batch being a Defective Batch— then either Party may terminate this Agreement in accordance with and subject to the terms provided for termination set forth in this Agreement, including the possibility that the Parties may mutually agree to terminate the Agreement under Clause 8.4.