definiens: means a product suppan human dinicnl trial of a Licensed Product commenced afler receipl of Initial Approval in the country for which such trial is beinS conducted and that is conducted within Ihe pantmctcrs of the RegulalOry Approval for the Licensed Product, other than I'ltase 1118 Clinical Trials nnd clinical trials required or requested by P Regulatory Authority lIS a condition of or in connection with an Approval . Phase II.C '' ' ..........., • nUll '' ..... Meke .... ', " m .. u 13 IV Clinical Trills mIIy indude, withOlit limitation . [ epKlemiologM : aJ studies, modehng Ind phal"ll'Gcocconorrue STUdIeS. InyestJplOr sponsoml climcal tnlls of Licensed Product and poSt­markcuns s.urvelilancc studiesl