Common use of Specifications Quality Clause in Contracts

Specifications Quality. 3.12.1. Company shall cause the Product Manufacturer to Manufacture the Products in strict conformity with the Specifications. Further, Company represents that, as of the Effective Date and during the Term, the Product Manufacturer holds the required manufacturing authorization pursuant to Applicable Laws for the Manufacture of the Products. 3.12.2. Within [***], USWM and Company (and/or the Product Manufacturer, as applicable) shall enter into a mutually agreeable Quality Agreement relating to the Products. Company shall maintain a current Quality Agreement and quality control system compliant with the Regulatory Authority for the Products to be delivered hereunder. Such a system shall include [***]. Each Batch of Product to be supplied to USWM hereunder shall be subject to a quality control inspection by Company in accordance with Company’s then current quality assurance standards and the approved Regulatory Filings. In the event a conflict arises between the Quality Agreement and this Agreement, the term contained in the Quality Agreement shall control with respect to quality-related matters relating to the Products. 3.12.3. [***] modifications, changes, additions or deletions to the (1) [***]; (2) [***]; (3) [***]; (4) [***]; (5) [***]; (6) [***]; (7) [***]; or (8) [***], which Company intends to carry out (hereinafter, “Product Changes”), must be evaluated and documented by [***]. Prior to implementation of any material Product Change, and in any event, within [***] from [***], Company agrees to provide reasonable notice to USWM in writing of such change and Company shall consider in good faith any input timely provided by USWM regarding any Product Changes. Reasonable notice applies in (1) circumstances in which [***], and (2) circumstances where [***]. In such circumstances, following reasonable notice, USWM shall be informed of [***]. If appropriate and upon considering in good faith timely input provided by USWM, Company shall [***]. 3.12.4. Company is responsible for storing and maintaining retention samples of each Batch of Product produced for USWM for [***] in accordance with Good Manufacturing Practices and the terms of the Quality Agreement. Company will take measures to ensure that the quantity of retention samples shall be of sufficient quantity [***]. 3.12.5. Company shall be responsible for the testing and generation of stability data for the Products in accordance with the cGMP and ICH guidelines. 3.12.6. Company shall be responsible for confirming that all facilities (including the Manufacturing Facility), utilities, equipment and the processes utilized to Manufacture the Products are satisfactorily validated according to the guidelines of all applicable Regulatory Authorities, Applicable Laws, and cGMP. 3.12.7. Records which include the information relating to the Manufacturing, packaging and quality operations for each Batch of Product shall be prepared by Company for each lot at the time such operations occur. Such records shall be prepared in accordance with Applicable Laws and Company’s standard operating procedures. Company shall keep Batch Records, and all associated batch documentation (i.e., deviations, testing data, testing results, Batch release documentation, etc.), for each Batch of Product until the later of (i) the period of time required by Applicable Law, or (ii) [***].

Specifications Quality. 3.12.13.13.1. The Company shall cause the Product Manufacturer to Manufacture the Products Product in strict conformity with the Specifications. Further, the Company represents that, as of the Effective Date and during the Term, the Product Manufacturer holds the required manufacturing authorization pursuant to Applicable Laws for the Manufacture of the ProductsProduct. 3.12.23.13.2. Within [***], USWM Sandoz and the Company (and/or the Product Manufacturer, as applicable) shall enter into a mutually agreeable Quality Agreement relating to the ProductsProduct. The Company shall maintain a current Quality Agreement and quality control system compliant with the Regulatory Authority for the Products Product to be delivered hereunder. Such a system shall include [***]. Each Batch of Product to be supplied to USWM Sandoz hereunder shall be subject to a quality control inspection by the Company in accordance with the Company’s then current quality assurance standards and the approved Regulatory Filingsstandards. In the event a conflict arises between the Quality Agreement and this Agreement, the term contained in the Quality Agreement shall control with respect to quality-related matters relating to the ProductsProduct. 3.12.33.13.3. [***] modifications, changes, additions or deletions to the the: (1a) [***]; (2b) [***]; (3c) [***]; (4d) [***]; (5e) [***]; (6f) [***]; (7g) [***]; or (8) h) [***], which the Company intends to carry out (hereinafter, “Product Changes”), must be evaluated and documented by [***]. Prior to implementation of any material Product Changesuch change, and in any event, within [***] from [***], the Company agrees to provide reasonable notice to USWM Sandoz in writing of such change and Company to obtain Sandoz’s prior written consent to do so, which consent shall consider in good faith any input timely provided by USWM regarding any Product Changesnot be unreasonably withheld or delayed. Reasonable notice applies in (1) circumstances where a change is required as a result of changes to Applicable Law or the order of any Regulatory Authority, in which [***], and (2) circumstances where [***]. In such circumstances, following reasonable notice, USWM case the Parties shall be informed of [***]. If appropriate and upon considering cooperate in good faith timely input provided to implement the applicable change as soon as reasonably practicable following provision of notice by USWMthe Company. Upon receiving Sandoz’s written consent, the Company shall [***]amend its NDA through the appropriate notification to the applicable Regulatory Authorities. 3.12.43.13.4. The Company is responsible for storing and maintaining retention samples of each Batch of Product produced for USWM shipped to Sandoz for [***] ], in accordance with Good Manufacturing Practices and the terms of the Quality Agreement. Company will take measures to ensure that the The quantity of retention samples shall be of sufficient quantity [***]required to perform all required testing. 3.12.53.13.5. The Company shall be responsible for the testing and generation of stability data for the Products Product in accordance with the cGMP and ICH guidelines. 3.12.63.13.6. The Company shall be responsible for confirming that all facilities (including the Manufacturing Facility), utilities, equipment and the processes utilized to Manufacture the Products Product are satisfactorily validated according to the guidelines of all applicable Regulatory Authorities, Authorities and Applicable Laws, and cGMP. 3.12.73.13.7. Records which include the information relating to the Manufacturing, packaging and quality operations for each Batch of Product shall be prepared by the Company for each lot at the time such operations occur. Such records shall be prepared in accordance with Applicable Laws and the Company’s standard operating procedures. The Company shall keep Batch Records, and all associated batch documentation (i.e., deviations, testing data, testing results, Batch release documentation, etc.), Records for each Batch of Product until the later of (i) for the period of time required by Applicable Law, or (ii) . [***]] designates portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. Confidential treatment has been required with respect to this omitted information.