definiens: means a day other than a Saturday, Sunday or a day that icGMPs " means current good manufacturing practices as described in : ( a ) Division 2 of Part C of the · Food and Drug Regulations ( Canada ) ; ( b ) Parts 210 and 211 of Title 21 of the United States ' Code of Federal Regulations ; and ( c ) EC Directi ve 9113561EEC, together with the latest TPD, FDA and EMEA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time ; means the file, for each Product, which is provided by Cephal on to [COMPANY] and which contains documents relating to such Product, including, without limitation : ( a ) a detailed description of each Product, including its physical and chemical characteristics and stability ; ( b ) manufacturing and packaging directions ; ( c ) shipping and storage requirements ; Doc # : 924418.5 -2 -(d ) protocols for validating processes or equipment to produce Products ; ( e ) quality control and quality assurance procedures for sampling, testing, documenting and releasing Active Materials, Components and in - process and finished Product ; ( f ) procedures for testing the stability of the Product ; and ( g ) all environmental, health and safety information relating to the Product including material safety data sheets, incident reports, risk analyses, health concerns, preventative measures and procedures for waste disposal, all as updated, amended and revised from time to time by [COMPANY] in accordance with the terms of the Agreement ; shall mean PROYIGIL ® as well as any other trademark owned or used by [COMPANY] in connection with the Products, including without limitation those trademarks listed in Schedule H