Discrepant Results. If the parties disagree as to whether Product is Defective Product and/or whether the cause of the nonconformity is Catalent Defective Processing, and this is not resolved within [**] days of the Exception Notice date, the parties shall cause a mutually 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 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.
Discrepant Results. In the event of a disagreement between the parties regarding whether Packaging is Defective Packaging and/or whether the cause of the nonconformity is PCI Fault, which disagreement cannot be resolved by the parties within […***…] days of the date of the completion of PCI’s investigation, 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 Packaging and its components, including Client-supplied Materials. The independent party’s determination as to whether or not Packaging is Defective Packaging 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 PCI if Packaging is Defective Packaging attributable to PCI Fault, and by Client in all other circumstances.
Discrepant Results. If the parties disagree as to whether Product is Defective Product and/or whether the cause of the nonconformity is Catalent Defective Processing, and this is not resolved within 30 days of the Exception Notice date, the parties shall cause a mutually 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 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. Client will be apprised in writing of all Defective Product investigations executed by Catalent on Client’s materials/products, including Product and Client-supplied Materials, as well as final investigation outcome and conclusion(s).
Discrepant Results. If the parties disagree as to whether Product is Defective Product and/or whether the cause of the nonconformity is Catalent Defective Processing, without regard to whether Catalent conducts an appropriate investigation as provided in Clause 5.2, and this is not resolved within [***] of the Exception Notice date, the parties shall cause a mutually 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 Palatin-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 Palatin in all other circumstances. For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall be deemed not Catalent Defective Processing.
Discrepant Results. In the event of a disagreement between the parties regarding whether Product is Defective Product, 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 [*]. In the event the cause of nonconformity cannot be determined or assigned, the costs associated with the Defective Product and the replacement of the same shall be shared equally between the parties.
Discrepant Results. In the event of a disagreement between the parties regarding whether Drug Substance or Drug Product is Defective Drug Product and/or the cause of the nonconformity, which disagreement cannot be resolved by the parties within [***] 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 Drug Product and its components, including Vaccinex-supplied Materials. The independent party’s results as to whether or not Drug Substance or Drug Product is Defective Drug 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 the party proven incorrect regarding either the existence of Defective Drug Product or the cause of the nonconformity. For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, the parties shall share the cost associated with testing and review.
Discrepant Results. If the parties disagree as to whether Product is Defective Product and/or whether the cause of the nonconformity is Catalent Defective Processing, the parties shall use commercially reasonable efforts to resolve such disagreement as promptly as possible. If the parties are unable to resolve such disagreement within [**] of the Exception Notice date, the parties shall cause a mutually 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 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.
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.
Discrepant Results. As more specifically addressed in the Quality Agreement, in the event of a disagreement between the parties regarding whether a Product is non-conforming due to a failure to meet to Specifications or cGMP (“Defective Product”) and/or whether the cause of the nonconformity is attributable to Catalent (“Catalent Defective Processing”), which disagreement cannot be resolved by the parties, the parties shall cause a mutually agreeable [ * ] = Certain information on this document has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 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 in fact 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 [ * ], and by [ * ]. For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, [ * ]; provided, however, that, notwithstanding anything to the contrary contained in this Agreement, where nonconformity cannot be determined or assigned, [ * ] and [ * ].
Discrepant Results. If the Parties disagree as to whether a Batch is Defective Product or whether the cause of the nonconformity is Catalent Defective Processing, and this disagreement is not resolved within 30 days of the Exception Notice date, then the Parties shall cause a mutually acceptable independent Third-Party laboratory to review records, test data, and perform comparative tests or analyses on samples of the alleged Defective Product and its components, including Client-supplied Materials. The independent Third-Party laboratory’s results as to whether or not the Batch is Defective Product and the cause of any nonconformity shall be final and binding. Unless otherwise agreed 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. For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall be deemed not to be Catalent Defective Processing and the failed Batch shall constitute a No-Fault Supply Failure.
