Common use of Documentation and Recordkeeping Clause in Contracts

Documentation and Recordkeeping. 1.7.1 Regulatory compliance requires numerous documents and extensive recordkeeping. [*] Such records must cover all aspects of the production process, the product ingredients and their sourcing and testing, quality control, quality assurance and product release, and the finished DCVax® Products themselves. In addition, recordkeeping must include information about any serious adverse events related or possibly related to the DCVax® Products. The parties acknowledge and agree that special arrangements are necessary for fulfillment of such comprehensive and long-term recordkeeping obligations. NW Bio will obtain legal and regulatory advice, and determine the scope and extent of recordkeeping required for each country, and so advise Cognate. Cognate will analyze the systems, capacity and other requirements necessary to fulfill the recordkeeping specified by NW Bio, and determine whether other parties may be needed to provide such services. Both NW Bio and Cognate will have full access to all such records and information at all times, whether or not the records are being stored and managed by third parties, or third parties are otherwise involved in the long-term recordkeeping and related regulatory compliance. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. 1.7.2 In conjunction with production of DCVax® Products, Cognate will create initial sets of applicable records. Such records will include batch production records and other records required for initial regulatory compliance at the time of production and product release. Both NW Bio and Cognate will have full access to all such records and information at all times, whether or not the records are being stored and managed by third parties, or third parties are otherwise involved in this recordkeeping and related regulatory compliance.