Common use of Testing; Rejection Clause in Contracts

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 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 No later than [***] days after Client’s receipt of a the Batch (“Review Period”), Client or its designee notifies shall notify Catalent in writing (an “Exception Notice”) whether the Batch conforms to Specifications. Upon receipt of notice from Client that such a Batch does not meet meets Specifications, or upon failure of Client to respond by the warranty set forth in Section 12.1 (“Defective Product”), and provides a sample end of the alleged Defective ProductReview Period, the Batch shall be deemed accepted by Client and Client shall have no right to reject such Batch, except Batch other than for defects which existed at the time of delivery and were not discovered or discoverable in the case exercise of a reasonable care (“Latent Defect detected 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 [***] after Client’s receipt of a Batch. In days following the event of any Latent Defect in a Batch, Client shall provide an Exception Notice notifying Catalent of date on which such Latent Defect promptly following Clientwas 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 discovery of such 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 provide provides 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 Defectnonconformity. 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 failure to perform the Processing in accordance with respect to Processing hereunder 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. 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 No later than [***] business days after Client’s receipt of a the Batch and the certificate of analysis (“Review Period”), Client or its designee notifies Catalent in writing shall notify CoreRx whether the Batch conforms to the Specifications and meets cGMP (an for purposes of this Article 5, “Exception Notice”conformity/conform(s) that such Batch does not meet the warranty set forth in Section 12.1 (“Defective Productto Specifications”); provided, and provides a sample however, that in the case of Latent Defects in the Batch such Review Period shall be no later [***] months after delivery of the alleged Defective Product. Upon receipt of notice from Client that a Batch conforms to the Specifications, or upon failure of Client to provide any written notice to CoreRx 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 notifies CoreRx in writing by the end of the Review Period (an “Exception Notice”) that a Batch does not conform to the Specifications (“Defective Product”), 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 provides a sample of the alleged Defective Product. Upon timely receipt of an Exception Notice from Client, including with respect to a Latent Defect, 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 or Latent Defectnonconformity. 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 or Latent Defect is attributable to CatalentCoreRx’s negligence, negligence or willful misconduct or breach of its obligations with respect to Processing hereunder (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 [**].

Testing; Rejection. Following No later than […***…] days after Client’s or its designee’s receipt of a shipment the Batch and the certificate 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 conformance/analysis (“Review Period”), Client or its designee notifies shall notify Catalent in writing whether the Batch conforms to the Specifications and meets cGMP (an for purposes of this Article 5, “Exception Notice”conformity/conform(s) that such Batch does not meet the warranty set forth in Section 12.1 (“Defective Productto Specifications”). Upon receipt of notice from Client that a Batch conforms to the Specifications, and provides a sample or upon failure of Client to provide any written notice to Catalent by the end of the alleged Defective ProductReview Period subject to Section 5.2, 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 that causes a Batch to fail to conform to the Specifications. If Client timely notifies Catalent in writing by the end of a Batch. In the event Review Period or the later period set forth in the definition of Latent Defect with respect to any Latent Defect in (an “Exception Notice”) that a BatchBatch does not conform to the Specifications (“Defective Product”), Client shall provide an Exception Notice notifying Catalent of such Latent Defect promptly following Client’s discovery of such Latent Defect and provide provides a sample of the alleged Defective Product. Upon timely receipt of an Exception Notice from Client, including with respect to a Latent Defect, 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 or Latent Defectnonconformity. 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 Defective Product or Latent Defect is attributable to Catalent(b) it disagrees with Client’s negligence, willful misconduct or breach of its obligations with respect to Processing hereunder (“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 [**]after the period in the definition of Latent Defect with respect to any Latent Defect).

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)met. Unless within [**] after Client’s receipt of a Batch and all documents listed in the Specifications (“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 as set forth 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 ProductSection 5.6. 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 Defectnonconformity. If Catalent agrees (or if the independent party determines pursuant to Section 5.3) that Product is Defective Product and determines that the cause of nonconformity or Latent Defect 13 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONFIDENTIAL is attributable to Catalent’s negligence, negligence or 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 [**].5.3

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 No later than [***] after Client’s receipt of a 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, provided, however, Client may revoke its acceptance after the 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 provides an Exception Notice to Catalent within [***] of Client’s discovery of such Defective Product. 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 (“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 Defectnonconformity. If Catalent agrees that Product is Defective Product and determines that the cause of nonconformity or Latent Defect is attributable to Catalent’s negligence, material breach of this Agreement or negligence or 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 [**]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. 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 No later than [***] days after Client’s receipt of a the Batch (“Review Period”), Client TXMD or its designee shall notify QPharma whether the Batch conforms to Specifications. Upon receipt of notice from TXMD that a Batch meets Specifications, or upon failure of TXMD to respond by the end of the Review Period, the Batch shall be deemed accepted by TXMD and 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 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 TXMD reject Product after such Product’s expiration date. If TXMD or its designee timely notifies Catalent QPharma 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 12.1(A), whether due to a Latent Defect or otherwise (“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 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 or Latent Defectnonconformity. If Catalent QPharma agrees that Product is Defective Product and determines that the cause of nonconformity or Latent Defect is attributable to CatalentQPharma’s negligence, willful misconduct or breach of its obligations failure to perform the Processing in accordance with respect to Processing hereunder 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 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.

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)met. Unless within [**] after Client’s receipt of a Batch and all documents listed in the Specifications (“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 as set forth 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 ProductSection 5.6. 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 Defectnonconformity. If Catalent agrees (or if the independent party determines pursuant to Section 5.3) that Product is Defective Product and determines that the cause of nonconformity or Latent Defect [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. is attributable to Catalent’s negligence, negligence or 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 [**].