definiens: means all applicable Good Manufacturing Practices including, as applicable, ( a ) the principles detailed inthe U.S. Current Good Manufacturing Practices, Title 21, Parts 210, 211, 601 and 610 of the CFR, ( b ) the applicable part ofquality assurance to ensure that products are consistently produced and controlled in accordance with the quality standardsappropriate for their intended use, as defined in European Commission Directive 2003/94 / EC laying down the principals andguidelines of good manufacturing practice, ( c ) the principles detailed in the ICH Q7A guidelines, ( d ) the Rules GoverningMedicinal Products in the 6Confidential Treatment Requested by [COMPANY] Sciences International, Inc.,Confidential treatment requested with respect to certain portions hereof denoted with European Community, Volume IV Good Manufacturing Practice for Medicinal Products, and ( e ) the equivalent ApplicableLaws in any relevant country, each as may be amended and applicable from time to time