definiens: means, as relevant to the Product, the current principles and guidelines of good manufacturing practice and general biologics products standards as contained in US Federal Food Drug and Cosmetic Act at 21CFR ( Chapters 210, 211, 600 and 610 ) and any comparable laws, rules or regulations of any foreign jurisdiction, as each may be amended from time to time ; 1.1.20 means all documents relating to the Manufacture of a Batch of Product, including but not limited to Manufacturing Instructions, deviations, Raw Materials, in - Process and Bulk Product test results, Specifications and out of Specification results ; 1.1.21 means reasonable, diligent, good faith efforts to accomplish a party 's objective or obligation as such party would normally use to accomplish a similar objective or obligation under similar circumstances taking into account relevant commercial factors ; 1.1.22 means any compound, including without limitation PEG, which is capable of being conjugated to an antibody fragment ; 1.1.23 means a clinical trials application made to a Regulatory Authority, other than the FDA, including a clinical trials application, a clinical trials exemption or a clinical trials certificate ; 1.1.24 means the date agreed by the parties pursuant to Clause 9 for the delivery of Product