definiens: means the first to occur for a particular [COMPANY] Product of ( i ) the meetingof the primary endpoint by or on behalf of [COMPANY], or an Affiliate or permitted sublicensee of [COMPANY], in a phaseIIb clinical trial ( as such is defined by relevant FDA guidelines wherein the subject clinical trial endpoints are designedto be sufficient for regulatory approval of the clinical product without a subsequent clinical phase III trial ) for a givenOragenics Product, irrespective of whether such occurs in the United States of America under the jurisdiction of theFDA or elsewhere under the jurisdiction of a foreign regulatory agency, or ( ii ) the meeting of the primary endpoint by oron behalf of [COMPANY], or an Affiliate or permitted sublicensee of [COMPANY], in a phase III clinical trial ( as such isdefined by relevant FDA guidelines ) for a given [COMPANY] Product, irrespective of whether such occurs in the UnitedStates of America under the jurisdiction of the FDA or elsewhere under the jurisdiction of a foreign regulatory agency