Common use of Testing; Rejection Clause in Contracts

Testing; Rejection. No later than [***] after Client’s or its designee’s receipt of a Batch (or Product samples intended for testing by Client) plus all relevant Batch Records and documents set forth in the Quality Agreement to be included with each released Batch (“Review Period”), Client shall notify Catalent whether such Batch conforms to the Specifications. Upon receipt of notice from Client that such Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, such Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch. If Client timely notifies Catalent in writing (an “Exception Notice”) that such Batch does not conform to the Specifications or otherwise does not meet the warranty set forth in Section 12.1(A) (“Defective Product”) and provides a sample of the alleged Defective Product, then Catalent shall conduct an appropriate investigation in its discretion to determine (i) whether Catalent agrees with Client that Product is Defective Product and (ii) the cause of any nonconformity. If Catalent agrees that Product is Defective Product and determines that the cause of nonconformity is attributable to Catalent’s [***] (“Catalent Defective Processing”), then Section 5.4 shall apply. For the avoidance of doubt, where the cause of any nonconformity cannot be determined or assigned, it shall not be deemed Catalent Defective Processing.

Testing; Rejection. No later than […***…] days after Client’s or its designee’s receipt of a the Batch (or Product samples intended for testing by Client) plus and all relevant Batch Records and documents set forth in the Quality Agreement to be included with each released Batch documentation as required under Section 5.1 (“Review Period”), Client or its designee shall notify Catalent whether such the Batch conforms to the Specifications. Upon receipt of notice from Client that such a Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, such the Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch. If Client or its designee timely notifies Catalent in writing (an “Exception Notice”) that such a Batch does not conform to the Specifications or otherwise does not meet the warranty set forth in Section 12.1(A) 12.1 (“Defective Product”) ), and provides a sample of the alleged Defective Product, then Catalent shall conduct an appropriate investigation in its discretion to determine (i) whether Catalent or not it agrees with Client that Product is Defective Product and (ii) to determine the cause of any nonconformity. If Catalent agrees that the Product is determined by Catalent or pursuant to Section 5.3 below to be Defective Product and determines that the cause of nonconformity is attributable to Catalent’s […***…] (“Catalent Defective Processing”), then Section 5.4 shall apply. For the avoidance of doubt, where the cause of any nonconformity cannot be determined or assigned, it shall not be deemed not Catalent Defective Processing.

Testing; Rejection. No later than […***…] after Client’s or its designee’s receipt of a the Batch (or Product samples intended for testing by Client) plus and all relevant Batch Records and documents set forth in the Quality Agreement to be included with each released Batch documentation as required under Section 5.1 (“Review Period”), Client or its designee shall notify Catalent whether such the Batch conforms to the Specifications. Upon receipt of notice from Client that such a Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, such the Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch. If Client or its designee timely notifies Catalent in writing (an “Exception Notice”) that such a Batch does not conform to the Specifications or otherwise does not meet the warranty set forth in Section 12.1(A) 12.1 (“Defective Product”) ), and provides a sample of the alleged Defective Product, then Catalent shall conduct an appropriate investigation in its discretion to determine (i) whether Catalent or not it agrees with Client that Product is Defective Product and (ii) to determine the cause of any nonconformity. If Catalent agrees that the Product is determined by Catalent or pursuant to Section 5.3 below to be Defective Product and determines that the cause of nonconformity is attributable to Catalent’s […***…] (“Catalent Defective Processing”), then Section 5.4 shall apply. For the avoidance of doubt, where the cause of any nonconformity cannot be determined or assigned, it shall not be deemed not Catalent Defective Processing.

Testing; Rejection. No later than [***] after Client’s or its designee’s redacted]after receipt of a the Batch (or Product samples intended for testing by Client) plus all relevant Batch Records and documents set forth in the Quality Agreement to be included with each released Batch (“"Review Period”"), Client or its designee shall notify Catalent whether such the Batch conforms to the Specifications. Upon receipt of notice from Client that such a Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, such the Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch. If Client or its designee timely notifies Catalent in writing (an “"Exception Notice”") that such a Batch does not conform to the Specifications or otherwise does not meet the warranty set forth in Section 12.1(A) 12.1 (“"Defective Product”) "), and provides a sample of the alleged Defective Product, then Catalent shall conduct an appropriate investigation in its discretion to determine (i) whether Catalent or not it agrees with Client that Product is Defective Product and (ii) to determine the cause of any nonconformity. If Catalent agrees that Product is Defective Product and determines that the cause of nonconformity is attributable to Catalent’s [***] 's negligence or willful misconduct (“"Catalent Defective Processing”"), then Section 5.4 shall apply. For the avoidance of doubt, where the cause of any nonconformity cannot be determined or assigned, it shall not be deemed not Catalent Defective Processing.

Testing; Rejection. No later than [***] after Client’s or its designee’s receipt of a Batch (or Product samples intended for testing by Client) plus all relevant Batch Records and documents set forth in the Quality Agreement to be included with each released Batch (“Review Period”), Client shall notify Catalent whether such the Batch conforms to the Specifications. Upon receipt of notice from Client that such a Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, such subject to Section 5.7 (Latent Defects), the Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch. If Client timely notifies Catalent in writing (an “Exception Notice”) that such a Batch does not conform to the Specifications or otherwise does not meet the warranty set forth in Section 12.1(A) (“Defective Product”) ), and provides a sample of the alleged Defective Product, then Catalent shall in good faith conduct an appropriate investigation in its discretion to determine (i) whether Catalent agrees with Client that the Product is Defective Product and (ii) to determine the cause of any nonconformity. If If, upon its good faith efforts, Catalent agrees that Product is Defective Product and determines that the cause of nonconformity is attributable to Catalent’s [***] negligence or willful misconduct (“Catalent Defective Processing”), then Section 5.4 shall apply. For the avoidance of doubtIf, where upon its good faith efforts, Catalent agrees that Product is Defective Product and determines that the cause of any nonconformity is shared between the parties or cannot be determined or assignedassigned (“Shared/Unassigned Defect”), it then Section 5.5 shall not be deemed Catalent Defective Processingapply.