Common use of Product and Process Failure Clause in Contracts

Product and Process Failure. 3.9.1. Product shall be Manufactured in accordance with cGMP and the Manufacturing Process approved mutually by Customer and BVL. Customer acknowledges that it is aware that in May 2011 and November 2011, BVL’s manufacturing facility was inspected by the United States Food and Drug Administration and by the European Medicines Agency in March 2011 and November 2011. Customer further acknowledges that each of these inspections resulted in observations from the regulatory authority citing deviations from current Good Manufacturing Practices. Customer acknowledges The European Medicines Agency and the Therapeutic Goods Administration have issued BVL short-dated, restricted GMP licenses. Customer further acknowledges that it is aware BVL voluntarily suspended manufacturing at its site as of November 2011. Customer has reviewed the records of inspection from the above mentioned regulatory authorities as well as BVL’s corrective action responses to the regulatory agencies and is satisfied that the corrective actions set forth in BVL’s corrective action plan should rectify the cGMP issues at the manufacturing facility that directly or indirectly affect Customer’s Products. Each Batch of Product will be sampled and tested by BVL against the Specification. The Quality Assurance Department of BVL will review the Records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP and the Manufacturing Process.

Product and Process Failure. 3.9.1. Product shall be Manufactured in accordance with cGMP and the Manufacturing Process approved mutually by Customer and BVL. Customer acknowledges that it is aware that in May 2011 and November 2011, BVL’s manufacturing facility was inspected by the United States Food and Drug Administration and by the European Medicines Agency in March 2011 and November 2011. Customer further acknowledges that each of these inspections resulted in observations from the regulatory authority citing deviations from current Good Manufacturing Practices. Customer acknowledges The European Medicines Agency and the Therapeutic Goods Administration have issued BVL short-dated, restricted GMP licenses. Customer further acknowledges that it is aware BVL voluntarily suspended manufacturing at its site as of November 2011. Customer has reviewed the records of inspection from the above mentioned regulatory authorities as well as BVL’s corrective action responses to the regulatory agencies and is satisfied that the corrective actions set forth in BVL’s corrective action plan should rectify the cGMP issues at the manufacturing facility that directly or indirectly affect Customer’s ProductsProduct. Each Batch of Product will be sampled and tested by BVL against the Specification. The Quality Assurance Department of BVL will review the Records relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP and the Manufacturing Process.