definiens: or means all applicable good manufacturing practices including, as applicable,(a ) the applicable part of quality assurance to ensure that products areconsistently produced and controlled in accordance with the quality standardsappropriate for their intended use, as defined in the European CommissionDirective 2003/94 / EC laying down the principles and guidelines of goodmanufacturing practices ; ( b ) the principles detailed in United States CurrentGood Manufacturing Practices, 21 CFR Sections 210, 211, 601 and 610;(c ) the rules Governing Medicinal Products in the European Community, Volume IV 7nd[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT . EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [ * * * ], HAS BEENFILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION . ] Good Manufacturing Practice for Medicinal Products ; ( d ) the principlesdetailed in ICH Q7A guidelines ; and ( e ) the equivalent Applicable Laws inany relevant country or jurisdiction, each as may be amended and applicablefrom time to time