definiens: means . I Party 's use of lhose efforts and resources, comistent lO'ith the uen::ise of prudenl ... : : ientlf'lth its Affiliates . would Ipply with rupect to its own products at I SImilar stage of ~Iopmcnt orC(lmmer<:ia li7.J1tion, with .illlilar commen::ial ~t ial, 1.26 me,,(~ llW : ans I common informalion format for regulalory submi5.5ion in the European Union, Ihc United Stales, and Japan . as defined by the Internalional Conference on lIarmonil .. alioo, 1.27 ~Comple(/o " of ' h _ Ir OCCUR for I LICeI\$Cd Product in an IndlC.ltion with the first adrninistrllioo of luch Licensed f'mdllCt to a potient in a Phase HI Chnoeal Tnal of such • Licensed Product for such Indication