Common use of Testing; Rejection Clause in Contracts

Testing; Rejection. No later than [***] after Client’s or its designee’s receipt of the Batch (“Review Period”), Client shall notify Catalent whether the Batch conforms to the Specifications. Upon receipt of notice from Client that a Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, 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 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 to determine whether the Product is Defective Product and to determine the cause of any nonconformity. 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. If, upon its good faith efforts, Catalent agrees that Product is Defective Product and determines that the cause of nonconformity is shared between the parties or cannot be determined or assigned (“Shared/Unassigned Defect”), then Section 5.5 shall apply.

Appears in 1 contract

Sources: Manufacturing Preparation and Commercial Supply Agreement (Avadel Pharmaceuticals PLC)

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 the such Batch conforms to the Specifications. Upon receipt of notice from Client that a such Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, subject to Section 5.7 (Latent Defects), the 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 a 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 in good faith conduct an appropriate investigation in its discretion to determine (i) whether the Catalent agrees with Client that Product is Defective Product and to determine (ii) the cause of any nonconformity. If, upon its good faith efforts, If 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. IfFor the avoidance of doubt, upon its good faith efforts, Catalent agrees that Product is Defective Product and determines that where the cause of any nonconformity is shared between the parties or cannot be determined or assigned (“Shared/Unassigned Defect”)assigned, then Section 5.5 it shall applynot be deemed Catalent Defective Processing.

Appears in 1 contract

Sources: Commercial Supply Agreement (Precigen, Inc.)

Testing; Rejection. No later than […***…] days after Client’s or its designee’s receipt of the Batch and all relevant Batch documentation as required under Section 5.1 (“Review Period”), Client or its designee shall notify Catalent whether the Batch conforms to the Specifications. Upon receipt of notice from Client that a Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, 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 or its designee timely notifies Catalent in writing (an “Exception Notice”) that 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 in good faith conduct an appropriate investigation to determine whether the or not it agrees with Client that Product is Defective Product and to determine the cause of any nonconformity. If, upon its good faith efforts, Catalent agrees that If 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 negligence or willful misconduct […***…] (“Catalent Defective Processing”), then Section 5.4 shall apply. IfFor avoidance of doubt, upon its good faith efforts, Catalent agrees that Product is Defective Product and determines that where the cause of nonconformity is shared between the parties or cannot be determined or assigned (“Shared/Unassigned Defect”)assigned, then Section 5.5 it shall applybe deemed not Catalent Defective Processing.

Appears in 1 contract

Sources: Commercial Supply Agreement (Omthera Pharmaceuticals, Inc.)

Testing; Rejection. No later than [***] after Client’s or its designee’s redacted]after receipt of the Batch (“"Review Period”"), Client or its designee shall notify Catalent whether the Batch conforms to the Specifications. Upon receipt of notice from Client that a Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, 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 or its designee timely notifies Catalent in writing (an “"Exception Notice”") that 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 in good faith conduct an appropriate investigation in its discretion to determine whether the or not it agrees with Client that Product is Defective Product and to determine the cause of any nonconformity. If, upon its good faith efforts, 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. IfFor avoidance of doubt, upon its good faith efforts, Catalent agrees that Product is Defective Product and determines that where the cause of nonconformity is shared between the parties or cannot be determined or assigned (“Shared/Unassigned Defect”)assigned, then Section 5.5 it shall applybe deemed not Catalent Defective Processing.

Appears in 1 contract

Sources: Softgel Commercial Supply Agreement (Aurinia Pharmaceuticals Inc.)

Testing; Rejection. No later than […***…] after Client’s or its designee’s receipt of the Batch and all relevant Batch documentation as required under Section 5.1 (“Review Period”), Client or its designee shall notify Catalent whether the Batch conforms to the Specifications. Upon receipt of notice from Client that a Batch meets the Specifications, or upon failure of Client to respond by the end of the Review Period, 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 or its designee timely notifies Catalent in writing (an “Exception Notice”) that 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 in good faith conduct an appropriate investigation to determine whether the or not it agrees with Client that Product is Defective Product and to determine the cause of any nonconformity. If, upon its good faith efforts, Catalent agrees that If 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 negligence or willful misconduct […***…] (“Catalent Defective Processing”), then Section 5.4 shall apply. IfFor avoidance of doubt, upon its good faith efforts, Catalent agrees that Product is Defective Product and determines that where the cause of nonconformity is shared between the parties or cannot be determined or assigned (“Shared/Unassigned Defect”)assigned, then Section 5.5 it shall applybe deemed not Catalent Defective Processing.

Appears in 1 contract

Sources: Commercial Supply Agreement (Omthera Pharmaceuticals, Inc.)