definiens: means the file, for each Dru g Substance, containing information provided by Zog enix to Supplier and which contains documents relating to such Drug Substance, including, without limitation : ( a ) Written specifications for the Drug Substance, including the list of tests, references to any anal ytical procedures and appropriate acceptance criteria which are numer ical limits, ranges or other criteria for tests des cribed in order to establish a set of criteria to which Drug Substance at any stage of Manufacture should confor m to be considered acceptable for its intended use that are agreed upon by [COMPANY] and Supplier ; ( b ) Manufacturing and packaging process specificati ons ; ( c ) Shipping and storage requirements ; ( d ) All environmental, health and safety informatio n relating to the Drug Substance including material date safety sheets ; and ( e ) Any other technical information necessary to ca rry out the contracted operations correctly in acco rdance with any legal requirements, all as updated, amended and revised from time to ti me by the Parties in accordance with the terms of t he Agreement