Certificates of Analysis and Manufacturing Compliance. 5.1 Quality and Safety Data Exchange Agreement Not less than [***] before the [***], the parties shall enter into a mutually agreeable Quality Agreement (the “Quality Agreement”), in accordance with RENAISSANCE’ SOP’s and in conformity with any Regulatory Authority requirements and Applicable Law setting forth the parties’ obligations with regard to quality matters and Product complaints and adverse drug experiences. Until a Quality Agreement is entered into between the parties, this Agreement, in conjunction with all applicable Regulatory Authority requirements and Applicable Law, shall govern the parties’ responsibilities with respect to procedures impacting the identity, strength, quality, purity and all other aspects of the Product.
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Samples: Manufacturing Agreement (Silverback Therapeutics, Inc.)