Discrepant Results. In the event of a disagreement between the Parties regarding whether Product is Defective Product and/or whether the cause of the nonconformity is Catalent Defective Processing, which disagreement cannot be resolved by the Parties within [**] days of the date of the Exception Notice, the Parties shall cause a mutually agreeable independent third party to review records, test data and to perform comparative tests and/or analyses on samples of the alleged Defective Product and its components, including API and other Client-supplied Materials. The independent party’s results as to whether or not Product is Defective Product and the cause of any nonconformity shall be final and binding. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by Catalent if Product is Defective Product attributable to Catalent Defective Processing, and by Client in all other circumstances.
Appears in 1 contract
Sources: Build Out and Commercial Supply Agreement (Pharmacyclics Inc)
Discrepant Results. In the event of a disagreement between If the Parties regarding disagree as to whether the Batch of Client Product is Defective Product and/or whether the cause of the nonconformity is Catalent Defective Processing, which and this disagreement canis not be resolved by the Parties within [***] days of the date receipt of the Client’s Exception Notice, the Parties shall cause a mutually agreeable acceptable independent third party to review records, test data and to perform comparative tests and/or analyses on samples of the alleged Defective Product and its components, including API and other Client-supplied Materials. The independent party’s results as to whether or not the Batch of Client Product is Defective Product and the cause of any nonconformity shall be final and binding. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by Catalent if the Batch of Client Product is Defective Product attributable to Catalent Defective Processing, and by Client in all other circumstances.
Appears in 1 contract
Sources: Commercial Supply Agreement (Acelrx Pharmaceuticals Inc)