Testing; Rejection. Following Client’s receipt of a shipment of a Batch, Client or Client’s designee may test samples of such Batch to confirm that the Specifications have been met (or for any other purpose). Unless within [**] after Client’s receipt of a Batch (“Review Period”), Client or its designee notifies Catalent in writing (an “Exception Notice”) that such Batch does not meet the warranty set forth in Section 12.1 (“Defective Product”), and provides a sample of the alleged Defective Product, the Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch, except in the case of a Latent Defect detected within [**] after Client’s receipt of a Batch. In the event of any Latent Defect in a Batch, Client shall provide an Exception Notice notifying Catalent of such Latent Defect promptly following Client’s discovery of such Latent Defect and provide a sample of the alleged Defective Product. Upon timely receipt of an Exception Notice from Client, including with respect to a Latent Defect, Catalent shall conduct an appropriate investigation in its discretion to determine whether or not it agrees with Client that Product is Defective Product and to determine the cause of any nonconformity or Latent Defect. If Catalent agrees that Product is Defective Product and determines that the cause of nonconformity or Latent Defect is attributable to Catalent’s negligence, willful misconduct or breach of its obligations with respect to Processing hereunder (“Catalent Defective Processing”), then Section 5.4 shall apply. For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall be deemed [**].
Testing; Rejection. Following Palatin’s receipt of a shipment of a Batch, Palatin or Palatin’s designee may test samples of such Batch to confirm that the Specifications have been met. Unless within [***] after Palatin’s receipt of a Batch (“Review Period”), Palatin or its designee notifies Catalent in writing (an “Exception Notice”) that such Batch is not in compliance with Clause 12.1A (“Defective Product”), and provides a sample of the alleged Defective Product, the Batch shall be deemed accepted by Palatin and Palatin shall have no right to reject such Batch. Upon timely receipt of an Exception Notice from Palatin, Catalent shall in its sole discretion conduct an appropriate investigation to determine whether or not it agrees with Palatin that Product is Defective Product and 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 negligence or willful misconduct (“Catalent Defective Processing”), then Clause 5.4 shall apply.
Testing; Rejection. No later than […***…] days after 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 Specifications. Upon receipt of notice from Client that a Batch meets Specifications, or upon failure of Client to respond by the end of the Review Period, 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 (“Defective Product”), and provides a sample of the alleged Defective Product, Catalent shall conduct an appropriate investigation to determine whether or not it agrees with Client that Product is Defective Product and to determine the cause of any nonconformity. If the Product is determined by Catalent or pursuant to Section 5.3 below to be Defective Product and the cause of nonconformity is attributable to […***…] (“Catalent Defective Processing”), then Section 5.4 shall apply. For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall be deemed not Catalent Defective Processing.
Testing; Rejection. Following Client’s receipt of a shipment of a Batch, Client or Client’s designee may test samples of such Batch to confirm that the Specifications have been met. Unless within 20 days after Client’s receipt of a Batch or, in the case of a latent defect within the meaning of section 377 German Commercial Code (HGB) that was not detectable through customary testing within such 20-day period, without any undue delay after discovery of such latent defect (“Review Period”), Client or its designee notifies Catalent in writing (an “Exception Notice”) that such Batch is not in compliance with Clause 12.1 (“Defective Product”), and provides a sample of the alleged Defective Product, the Batch shall be deemed accepted by Client EXECUTION VERSION and Client shall have no right to reject such Batch. Upon timely receipt of an Exception Notice from Client, Catalent shall conduct an appropriate investigation in its discretion to determine whether or not it agrees with Client that Product is Defective Product and 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 negligence or willful misconduct (“Catalent Defective Processing”), then Clause 5.4 shall apply. For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall be deemed not Catalent Defective Processing.
Testing; Rejection. Catalent will complete Catalent Internal Release and promptly provide FibroGen with copies of all relevant components of the Batch Documentation Package (including but not limited to: (i) a Certificate of Analysis; (ii) a Certificate of Compliance; (iii) TSE/BSE; (iv) Material Safety Data Sheets (MSDS); and (v) analytical test results specified in the Quality Agreement). Catalent shall also if requested by FibroGen provide Product samples, and thereafter, FibroGen will, no later than [ ] (“FibroGen Review Period”), notify Catalent whether the Batch conforms to the Specifications. Upon receipt of notice from FibroGen that a Batch meets the Specifications, or upon failure of FibroGen to respond by the end of the FibroGen Review Period, the Batch shall be deemed accepted by FibroGen and FibroGen shall have no right to reject such Batch, except as set forth in Section 4.2.4 (“FibroGen Acceptance”). If FibroGen notifies Catalent in writing (a “Complaint”) that a Batch does not conform to the Specifications or otherwise does not meet the warranty set forth in Section 11.2.6 (“Non-Conforming Product”), and [ ]then Catalent shall conduct an appropriate investigation to determine whether Catalent agrees with FibroGen that Product is Non-Conforming Product and to determine the cause of any nonconformity. If Catalent agrees that Product is Non-Conforming Product and [ ], then Section 4.2.3. shall apply. Catalent shall cooperate with FibroGen in determining the cause of any Non-Conforming Product, including quality problems involving a Product, identifying corrective/preventive action and ensuring the implementation and effectiveness thereof.
Testing; Rejection. No later than [**] days after Supernus or its designee’s receipt of the Batch (“Review Period”), Supernus shall notify Catalent whether the Batch conforms to the Specifications. Upon receipt of notice from Supernus that a Batch meets the Specifications, or upon failure of Supernus to respond by the end of the Review Period, the Batch shall be deemed accepted by the parties and Supernus shall have no right to reject such Batch. If Supernus 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 (“Defective Product”), then Catalent shall conduct an appropriate investigation to determine the cause of any nonconformity. If Catalent determines that the cause of nonconformity is attributable to Catalent’s [**], or [**] (“Catalent Defective Processing”), then Section 5.4 shall apply. Where the cause of nonconformity cannot be determined or assigned, it shall be deemed [**].
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.
