definiens: or shall mean the regulatory requirements for current goodmanufacturing practices with respect to the Processing, storage and Release Testing ofBulk Product under this Agreement, including ( as applicable ): the United States currentGood Manufacturing Practices pursuant to the FDCA and pursuant to the relevantregulations found in Title 21 of the U.S. Code of Federal Regulations ( including Parts 11,210, 211, 610 and 611 ), the European Union ’s current Good Manufacturing Practicespursuant to EC Directive 2003/94 / EC of 8 October 2003, and the International Conferenceon Harmonisation Guidance for Industry, as applicable, including Q7 Good ManufacturingPractice Guidance for Active Pharmaceutical Ingredients, in the case of Q7 as applicableto the activities carried out by [COMPANY] under this Agreement, and any comparableregulatory requirements designated by the Parties in a Purchase Order, as suchregulatory requirements may be amended from time to time