Common use of Testing; Rejection Clause in Contracts

Testing; Rejection. No later than [***] days after receipt of the Batch (“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 other than for defects which existed at the time of delivery and were not discovered or discoverable in the exercise of reasonable care (“Latent Defects”). For the avoidance of doubt, (i) Batches failing to meet Specifications at the time of delivery due to Latent Defects may be rejected, if at all, only upon notice to Catalent within [***] days following the date on which such Latent Defect was discovered or should have been discovered in the exercise of reasonable care and (ii) in no event may Client reject Product after such Product’s expiration date. 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), whether due to a Latent Defect or otherwise (“Defective Product”), and provides a sample of the alleged Defective Product, 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 failure to perform the Processing in accordance with the Specifications (“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. No later than 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 [***] days after Client’s receipt of the a Batch (“Review Period”), Client or its designee shall notify notifies Catalent whether in writing (an “Exception Notice”) that such Batch does not meet the Batch conforms to Specifications. Upon receipt of notice from Client that warranty set forth in Section 12.1 (“Defective Product”), and provides a Batch meets Specifications, or upon failure of Client to respond by the end sample of the Review Periodalleged Defective Product, the Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch other than for defects which existed at the time of delivery and were not discovered or discoverable Batch, except in the exercise case of reasonable care (“a Latent Defects”). For the avoidance of doubt, (i) Batches failing to meet Specifications at the time of delivery due to Latent Defects may be rejected, if at all, only upon notice to Catalent Defect detected within [***] days following after Client’s receipt of a Batch. In the date on which event of any Latent Defect in a Batch, Client shall provide an Exception Notice notifying Catalent of such Latent Defect was discovered or should have been discovered in the exercise promptly following Client’s discovery of reasonable care and (ii) in no event may Client reject Product after such Product’s expiration date. 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), whether due to a Latent Defect or otherwise (“Defective Product”), and provides 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 nonconformitynonconformity 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 failure negligence, willful misconduct or breach of its obligations with respect to perform the Processing in accordance with the Specifications 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 not Catalent Defective Processing[**].

Testing; Rejection. No later than [***] days after receipt A. Following Catalent’s release of the Batch (“Review Period”)a Batch, Client or its Client’s designee shall notify Catalent whether may test samples of such Batch to confirm that the Batch conforms to SpecificationsSpecifications have been met. 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 A Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch other than for defects which existed at the time of delivery and were not discovered or discoverable in the exercise of reasonable care (“Latent Defects”). For the avoidance of doubtsuch Batch shall be deemed accepted by Client , (i) Batches failing to meet Specifications at the time of delivery due to Latent Defects may be rejectedunless, if at all, only upon notice to Catalent within [***] days following the date on which such Latent Defect was discovered or should have been discovered in the exercise after Catalent’s release of reasonable care and a Batch (ii) in no event may Client reject Product after such Product’s expiration date. If “Review Period”), Client or its designee 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), whether due to a Latent Defect or otherwise 12.1 (“Defective Product”), ) and provides a sample of the alleged Defective Product. However, if Client thereafter discovers a Latent Defect (for example, of the printing of the Package Insert or Carton, or Serialization of the Batch), it shall notify Catalent in writing with an Exception Notice of such Latent Defect within [***] of the discovery of the Latent Defect, but in no event later than [***] after tender of delivery of such Batch, and upon delivery of such Exception Notice the Batch alleged to have a Latent Defect will be hereafter referred to as Defective Product. B. 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 such Batch of Client Product is Defective Product and to determine the cause of any nonconformity. If Catalent agrees that such Batch of Client Product is Defective Product and determines that the cause of nonconformity is attributable to Catalent’s failure to perform the Processing in accordance with the Specifications negligence or willful misconduct (“Catalent Defective Processing”), then Section 5.4 5.2 (D) shall apply. For avoidance of doubt, where the cause of nonconformity cannot be determined or assignedassigned after resort to Section 5.2 (C), it shall be deemed not Catalent Defective ProcessingProcessing and Client shall be responsible to pay for the Batch or Batches at issue. Any nonconformity solely caused by the Client Equipment shall not be deemed Catalent Defective Processing unless such nonconformity was caused by Catalent's negligence or willful misconduct in the use of the Client Equipment.

Testing; Rejection. No later than […***…] days after Client’s or its designee’s receipt of the Batch and the certificate of conformance/analysis (“Review Period”), Client or its designee shall notify Catalent whether the Batch conforms to the Specifications and meets cGMP (for purposes of this Article 5, “conformity/conform(s) to Specifications”). Upon receipt of notice from Client that a Batch meets conforms to the Specifications, or upon failure of Client to respond provide any written notice to Catalent by the end of the Review PeriodPeriod subject to Section 5.2, the Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch other than for defects which existed at the time of delivery and were not discovered or discoverable Batch, except in the exercise case of reasonable care (“Latent Defects”). For the avoidance of doubt, (i) Batches failing to meet Specifications at the time of delivery due to Latent Defects may be rejected, if at all, only upon notice to Catalent within [***] days following the date on which such a Latent Defect was discovered or should have been discovered in that causes a Batch to fail to conform to the exercise of reasonable care and (ii) in no event may Client reject Product after such Product’s expiration dateSpecifications. If Client or its designee timely notifies Catalent in writing by the end of the Review Period or the later period set forth in the definition of Latent Defect with respect to any Latent Defect (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), whether due to a Latent Defect or otherwise (“Defective Product”), and provides a sample of the alleged Defective Product, then Catalent shall promptly conduct an appropriate investigation in its discretion to determine whether or not it Catalent agrees with Client that Product is Defective Product and to determine the cause of any nonconformity. Catalent shall provide written notice to Client as promptly as reasonably possible, but in any event within […***…] days after completing its internal investigation, and in any event no later than […***…] days after date of the Exception Notice, whether Catalent agrees that Product is Defective Product. If Catalent agrees that Product is Defective Product and determines […***…], or if Catalent fails to timely provide written notice to Client that the cause of nonconformity (a) it disagrees with Client’s position that Product is attributable to CatalentDefective Product or (b) it disagrees with Client’s failure to perform the Processing in accordance with the Specifications (“Catalent Defective Processing”)position that […***…], then Section 5.4 shall apply. For avoidance of doubt, where Catalent will work in good faith with Client to identify the cause of nonconformity cannot be determined in the case that Client provides notice of Defective Product after the Review Period (or assigned, it shall be deemed not Catalent Defective Processingafter the period in the definition of Latent Defect with respect to any Latent Defect).

Testing; Rejection. No later than [***] business days after Client’s receipt of the Batch and the certificate of analysis (“Review Period”), Client or its designee shall notify Catalent CoreRx whether the Batch conforms to the Specifications and meets cGMP (for purposes of this Article 5, “conformity/conform(s) to Specifications”); provided, however, that in the case of Latent Defects in the Batch such Review Period shall be no later [***] months after delivery of the Product. Upon receipt of notice from Client that a Batch meets conforms to the Specifications, or upon failure of Client to respond provide any written notice to CoreRx by the end of the Review Period, Period the Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch other than for defects which existed at the time of delivery and were not discovered or discoverable in the exercise of reasonable care (“Latent Defects”). For the avoidance of doubt, (i) Batches failing to meet Specifications at the time of delivery due to Latent Defects may be rejected, if at all, only upon notice to Catalent within [***] days following the date on which such Latent Defect was discovered or should have been discovered in the exercise of reasonable care and (ii) in no event may Client reject Product after such Product’s expiration dateBatch. If Client or its designee timely notifies Catalent CoreRx in writing by the end of the Review Period (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), whether due to a Latent Defect or otherwise (“Defective Product”), and provides a sample of the alleged Defective Product, Catalent then CoreRx shall promptly conduct an appropriate investigation in its discretion pursuant to reasonable industry standards to determine whether or not it CoreRx agrees with Client that Product is Defective Product and to determine the cause of any nonconformity. CoreRx shall provide written notice to Client as promptly as reasonably possible, but in any event within [***] business days after completing its internal investigation, and in any event no later than [***] days after date of the Exception Notice, whether CoreRx agrees that Product is Defective Product (“Response Period”). If Catalent CoreRx agrees that Product is Defective Product and determines that the cause of nonconformity is attributable to CatalentCoreRx’s failure to perform the Processing in accordance with the Specifications negligence or willful misconduct (a “Catalent Defective ProcessingCoreRx Cause”), or if CoreRx fails to respond within the Response Period, 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. No later than [***] days after receipt of the Batch and the certificate of analysis and certificate of compliance and any other documents required pursuant to the Quality Agreement, including Batch records and deviation reports, for such Batch (“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 other than for defects which existed at Batch, provided, however, Client may revoke its acceptance after the time expiration of the Review Period but before the date that is [***], if Client discovers Defective Product that could not have been reasonably discovered or detected by Client through its reasonable testing or inspection of the Product upon delivery and were not discovered or discoverable in the exercise of reasonable care (“Latent Defects”). For the avoidance of doubt, (i) Batches failing to meet Specifications at the time of delivery due to Latent Defects may be rejected, if at all, only upon notice provides an Exception Notice to Catalent within [***] days following the date on which of Client’s discovery of such Latent Defect was discovered or should have been discovered in the exercise of reasonable care and (ii) in no event may Client reject Product after such Defective Product’s expiration date. 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), whether due to a Latent Defect or otherwise 12.1 (“Defective Product”), and provides a sample of the alleged Defective Product, 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 failure to perform the Processing in accordance with the Specifications material breach of this Agreement or negligence or willful misconduct (“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. In the event a series of failures to meet Specifications or in-process requirements occurs during a production campaign, Client has the authority to request a halt in production until the root cause and a mutually agreeable resolution is found and necessary mitigation steps taken in accordance with the Quality Agreement to reasonably assure continuation will not replicate the original events or create new ones.

Testing; Rejection. No later than [***] days after receipt of the Batch (“Review Period”), Client TXMD or its designee shall notify Catalent QPharma whether the Batch conforms to Specifications. Upon receipt of notice from Client TXMD that a Batch meets Specifications, or upon failure of Client TXMD to respond by the end of the Review Period, the Batch shall be deemed accepted by Client TXMD and Client TXMD shall have no right to reject such Batch other than for defects which existed at the time of delivery and were not discovered or discoverable in the exercise of reasonable care (“Latent Defects”). For the avoidance of doubt, (i) Batches failing to meet Specifications at the time of delivery due to Latent Defects may be rejected, if at all, only upon notice to Catalent QPharma within [***] ([***]) days following the date on which such Latent Defect was discovered or should have been discovered in the exercise of reasonable care and (ii) in no event may Client TXMD reject Product after such Product’s expiration date. If Client TXMD or its designee timely notifies Catalent QPharma 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), whether due to a Latent Defect or otherwise (“Defective Product”), and provides a sample of the alleged Defective Product, Catalent QPharma shall conduct an appropriate investigation in its discretion to determine whether or not it agrees with Client TXMD that Product is Defective Product and to determine the cause of any nonconformity. If Catalent QPharma agrees that Product is Defective Product and determines that the cause of nonconformity is attributable to CatalentQPharma’s failure to perform the Processing in accordance with the Specifications (“Catalent QPharma 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 QPharma Defective Processing. For the avoidance of doubt, the Processing of any Batch that does not proceed to completion or any Batch that does not pass release testing by QPharma shall be treated as Defective Product resulting from QPharma Defective Processing. In such case, the remedies set forth in Section 5.4 shall apply.