definiens: means, ( a ) with respect to a Monotherapy Licensed Product, ( i ) any Phase I Clinical Trials, and ( ii ) any pre - clinical bioequivalence studies or similar studies conducted prior to a Phase I Clinical Trial that in each case ( 1 ) are conducted for such Licensed Product in the Field in any juris diction and ( 2 ) are not, in whole or in part, an expansion study Phase II Clinical Trials, Phase III Clinical Trials, a Pivotal Trial or Clinical Trials conducted after Regulatory Approval of such Licensed Product, or ( b ) with respect to a Licensed Product that is being st udied in combination with a chemotherapy product, whether or not in fixed dosage form, any pharmacokinetic studies o r bioequivalence studies or dose escalation studies of the Licensed Product from a P hase I Clinical Trial that is not in whole or in pa rt an expansion study, Phase II Clinical Trial, Phase III Clinical Tri al, Pivotal Trial, or Clinical Trial conducted after Regulatory Approval of such Licensed Product