Common use of Quality Control and Quality Assurance Clause in Contracts

Quality Control and Quality Assurance. Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement and shall, in each instance, manufacture, test, and store the Products and supply the Manufacturing Services strictly in accordance with the Specifications; the Quality Technical Agreement; cGMPs; all Applicable Laws; and the terms of this Agreement. Batch review and release to Indivior will be the responsibility of Patheon’s quality assurance group. Patheon will perform its batch review and release responsibilities in accordance with the terms of the Quality Agreement. Patheon shall be solely responsible for compliance with all Laws, rules, and regulations relating to the handling, generation, transportation, treatment, storage, and disposal or other management of waste and regulated substances, including, without limitation, solid and hazardous waste and hazardous and toxic substances and materials. In the event of any seizure or other similar government action with respect to a Product, Patheon shall cooperate with Indivior and take such other actions in connection therewith as Indivior may reasonably request. Prior to the commencement of the manufacture of the Products, Patheon shall satisfy itself that the know-how and any other information provided by Indivior to Patheon is sufficient to enable Patheon to efficiently perform its obligations under this Agreement. If Patheon concludes that further information is necessary, it shall notify Indivior and obtain such information prior to the commencement of manufacture. Each time Patheon ships Products to Indivior, it will give Indivior a certificate of analysis and certificate of compliance including a statement that the batch has been manufactured and tested in accordance with Specifications and cGMPs. Such certificates shall comply with and be in the form set out in the quality assurance requirements included in the Specifications. Patheon shall not release the Products until the certificates of analysis relating to such Products demonstrate that the Products meet the Specifications and the cGMPs. If Patheon or Indivior becomes aware that any aspect of a Specification is liable to result in the manufacture of a defective Product which may lead to a liability being incurred, it shall, as soon as reasonably practicable, notify the other party in writing. Patheon and Indivior shall promptly meet to discuss and address the risk of manufacture of a defective Product and if Patheon can reasonably demonstrate that manufacture of the Product in accordance with the Specifications would, or would likely, result in a defective Product, Patheon may, while Patheon rectifies such risk, suspend its obligation to supply Product under this Agreement, without prejudice to any right or remedy of Indivior, and provided that Patheon uses all reasonable endeavors to rectify such risk as promptly as possible. Indivior will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Patheon hereby grants Indivior an irrevocable, perpetual license to retain, access, disclose, and otherwise use the batch documents solely as necessary to fulfill the terms of this Agreement, to comply with a request from an Authority, or otherwise as required to comply with Applicable Law. Specific Product related information contained in those batch documents is Indivior Property. Indivior xxxx inform Patheon of any Product manufacturing complaints of which they become aware. Patheon shall investigate the issues promptly and provide a written report to Indivior, which will include a corrective action plan (if applicable). If Patheon becomes aware of any complaints, it will promptly notify Indivior and provide reasonable assistance in investigating such complaints.

Quality Control and Quality Assurance. (i) Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement and shall, in each instance, manufacture, test, and store the Products and supply the Manufacturing Services strictly in accordance with the Specifications; the Quality Technical Agreement; cGMPs; all Applicable Laws; and the terms of this Agreement. Batch review and release for shipment to Indivior Depomed will be the responsibility of Patheon’s quality assurance group. (Subject to Patheon’s obligations under this Agreement, Depomed will be responsible for the release of Product to the market.) Patheon will perform its batch review and release responsibilities in accordance with the terms Patheon’s standard operating procedures, which are subject to Depomed audit review. (ii) Each time Patheon releases a Batch, and prior to shipment of the Quality Agreement. Patheon shall be solely responsible for compliance with all Laws, rules, and regulations relating to the handling, generation, transportation, treatment, storage, and disposal or other management of waste and regulated substances, including, without limitation, solid and hazardous waste and hazardous and toxic substances and materials. In the event of any seizure or other similar government action with respect to a ProductBatch, Patheon shall cooperate provide Depomed with Indivior and take such other actions in connection therewith as Indivior may reasonably request. Prior to the commencement Certificate of the manufacture of the Products, Patheon shall satisfy itself that the know-how and any other information provided by Indivior to Patheon is sufficient to enable Patheon to efficiently perform its obligations under this Agreement. If Patheon concludes that further information is necessary, it shall notify Indivior and obtain such information prior to the commencement of manufacture. Each time Patheon ships Products to Indivior, it will give Indivior a certificate of analysis Analysis and certificate of compliance including for the Batch, including, but not limited, to a statement that the batch Batch has been manufactured and tested in accordance with Specifications cGMPs and cGMPs. Such certificates shall comply with Applicable Laws and be in the form set out in the quality assurance requirements included in conforms to the Specifications, and any deviation reports (collectively, the “Lot Documentation Package”). Patheon shall not release the Products until the certificates of analysis relating to such Products demonstrate that the Products meet the Specifications and the cGMPs. If Patheon or Indivior becomes aware that any aspect of a Specification is liable to result in the manufacture of a defective Product which may lead to a liability being incurred, it shall, as soon as reasonably practicable, notify the other party in writing. Patheon and Indivior shall promptly meet to discuss and address the risk of manufacture of a defective Product and if Patheon can reasonably demonstrate that manufacture retain ownership of the Product in accordance with the Specifications would, or would likely, result in a defective Product, Patheon may, while Patheon rectifies such risk, suspend its obligation to supply Product under this Agreement, without prejudice to any right or remedy of Indivior, and provided that Patheon uses all reasonable endeavors to rectify such risk as promptly as possible. Indivior will have sole responsibility for the release of Products to the market. The form and style of batch documents(A) Batch Records, including, but not limited to, batch production production, lot packaging, equipment set-up control and operating parameters records, lot packaging records, equipment set up control, operating parameters, and data printouts, and raw material data, and (B) laboratory notebooks are prepared by Patheon, shall be the exclusive property of Patheon. ; provided that Patheon hereby grants Indivior an Depomed a perpetual, fully paid-up, royalty-free, worldwide, irrevocable, perpetual unencumbered right and license to retain, access, discloseuse, and otherwise to grant to third parties the right to use, the foregoing in connection with the development, manufacture, testing, seeking of regulatory approval, and commercialization of Product. Notwithstanding anything to the contrary herein, the Parties agree that any and all specific Product related information contained in such documents (the “Product Information”) shall be the sole property of Depomed, subject only to a limited right by Patheon to use the batch documents solely as necessary Product Information to fulfill provide the Manufacturing Services in accordance with the terms and conditions herein. To the extent that any rights in the Product Information do not automatically vest in Depomed by the terms of this Agreement, Patheon hereby irrevocably and unconditionally assigns and agrees to comply with a request from an Authorityassign to Depomed all of Patheon’s rights, or otherwise as required title, and interest in and to comply with Applicable Law. Specific such Product related information contained in those batch documents is Indivior Property. Indivior xxxx inform Patheon of Information, including any Product manufacturing complaints of which they become aware. Patheon shall investigate the issues promptly and provide a written report to Indivior, which will include a corrective action plan (if applicable). If Patheon becomes aware of any complaints, it will promptly notify Indivior and provide reasonable assistance in investigating such complaintsIntellectual Property therein.

Quality Control and Quality Assurance. Patheon will shall perform the quality control and quality assurance testing as specified in the Quality GMP Technical Agreement and shalland, in each instanceany event, manufacture, test, and store as required by any applicable laws to ensure that Patheon has manufactured the Products and supply the Manufacturing Services strictly in accordance with the Manufacturing Requirements and Specifications; the Quality Technical Agreement; cGMPs; all Applicable Laws; and the terms of this Agreement. Batch review and release to Indivior will be the responsibility of Patheon’s quality assurance group. Patheon will perform its batch review and release responsibilities in accordance with the terms of the Quality Agreement. Patheon shall be solely responsible for compliance with all Laws, rules, and regulations relating to the handling, generation, transportation, treatment, storage, and disposal or other management of waste and regulated substances, including, without limitation, solid and hazardous waste and hazardous and toxic substances and materials. In the event of any seizure or other similar government action with respect to a Product, Patheon shall cooperate with Indivior and take such other actions in connection therewith as Indivior may reasonably request. Prior to the commencement of the manufacture of the Products, Patheon shall satisfy itself that the know-how and any other information provided by Indivior to Patheon is sufficient to enable Patheon to efficiently perform its obligations under this Agreement. If Patheon concludes that further information is necessary, it shall notify Indivior and obtain such information prior to the commencement of manufacture. Each time Patheon ships Products to IndiviorSciClone, it will give Indivior shall provide SciClone with a certificate of analysis that sets out the test results for each batch of Products and certificate of compliance including a statement that the certifies that such batch has been manufactured evaluated by Patheon's Quality Control/Quality Assurance department and tested in accordance with Specifications and cGMPs. Such certificates shall comply with and be in the form set out in the quality assurance requirements included in the Specifications. Patheon shall not release the Products until the certificates of analysis relating to such Products demonstrate that the Products meet comply with the Manufacturing Requirements and Specifications; (i) Product Specifications, Testing and Release: (A) SciClone and Patheon acknowledge that the Specifications and testing procedures set forth in Schedule A may need to be changed as the cGMPs. If Patheon or Indivior becomes aware that any aspect of a Specification is liable to result in Parties gain experience with the manufacture and testing of a defective Product which may lead to a liability being incurred, it shall, as soon as reasonably practicable, notify Product. Any such changes must be agreed by the other party Parties in writing. . (B) SciClone shall qualify Patheon for Product Release to market according to SciClone's protocol as set forth in Schedule A -(Appendix VII). (C) Any Out of Specification (OOS) results from the testing of Product must be investigated and Indivior shall promptly meet to discuss and address the risk of manufacture of a defective Product and if Patheon can reasonably demonstrate that manufacture of the Product in accordance with the Specifications would, or would likely, result in a defective Product, Patheon may, while Patheon rectifies such risk, suspend its obligation to supply Product under this Agreement, without prejudice to any right or remedy of Indivior, and provided that Patheon uses all reasonable endeavors to rectify such risk as promptly as possible. Indivior will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of documented by Patheon. Patheon hereby grants Indivior an irrevocable, perpetual license will -------------------- * Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to retain, access, disclose, the omitted portions. notify SciClone immediately of such results and otherwise use investigations and both Patheon and SciClone will confer and agree as to what is the best course of action to take. (D) For each batch documents solely as necessary to fulfill the terms of this Agreement, to comply with a request from an Authority, or otherwise as required to comply with Applicable Law. Specific Product related information contained in those batch documents is Indivior Property. Indivior xxxx inform Patheon of any Product manufacturing complaints of which they become aware. shipped Patheon shall investigate supply to SciClone a copy of the issues promptly [****]. All courier costs associated with sending of such documents shall be on the account of [****]. (E) Future modifications may be made to [****] by [****]. SciClone and provide Patheon shall negotiate the cost and or implications of implementing any such modifications. (l) Patheon shall supply to SciClone a written report to Indivior, which [****]. Such [****] shall be obtained by [****] from the normal local regulatory authorities and costs associated with obtaining and sending such documents will include a corrective action plan be at [****] expense. (if applicable)m) [****] Testing. If Patheon becomes aware of any complaints, it will promptly notify Indivior and provide reasonable assistance in investigating such complaints[****].