definiens: means first dosing of a patient in atrial or the first of multiple trials, initiaied after compl etion of a Phase ] ] Clinical Tria ! and aftersuch date as the U.S. Food and Drug Administration ( or equiva lent regulatory agency in another4E X E C U T iO N C O iYjurisdiction ) f.as indicated W, t the Party conducting the m al may reasombly continue su ~ h trials, which trial illtrials shaH be on sufficient nUl)1bersof p<'ttienisto esta blish that c;pt.aTIl ~ tCf;uti ~ eJproduct is seJe e.nd efficacious for its intended use, and to define w&mings, preC1!utivT, seOldadverse reactio.fJs that are associated with the pharmaceu tical PfOO'uctin the d = ge rlmge to ~prescribed, and 10support Regulatory Approvftl of such phannoceulicftl prod uct or iabelexpansion of such pharmaceutical ' product