definiens: means applicable current Good Manufacturing Pract ices, including, as applicable, ( a ) the principles detailed in the U.S. Current Good Manufa cturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, ( b ) European Directive 2003/94 / EC and Eudralex 4, ( c ) the principles detailed in the Internationa l Conference on Harmonization 's Q7 guidelines, and ( d ) the Appli cable Laws in any relevant country or region corres ponding to ( a ) through ( c ) above, each as may be amended an d applicable from time to time . 1.13 means any and all data ( together with all clinica l trial reports and the results of analyses thereof ) derived or generated in any Clini cal Trial conducted by or on behalf of a Party