definiens: . First Opt - Out Milestone means the earlier of : ( a ) each of the following conditions having been met : ( i ) [ a determination by the JSC that the pre - defined primary endpoints of the pediatric Phase II Clinical Study designed to complete development of a sufficient data set for an end of phase II meeting with the FDA have been achieved within reasonable safety parameters, ( ii ) the occurrence of the end of phase II meeting with the FDA with respect to a pediatric indication, and ( iii ) after the occurrence of the end of phase II meeting, the JSC determines to continue with plans for conducting a pediatric Phase III Clinical Study ] *, in each case with respect to Licensed Product in the Field and with respect to the Profit - Share Territory ; or ( b ) [ commencement of a pediatric Phase III Clinical Study ] * with respect to Licensed Product in the Field and with respect to the Profit - Share Territory . For purposes of clause ( a)(iii ) above, the JSC shall make the determination whether to continue with plans for [ conducting a first pediatric Phase III Clinical Study based on a reasonable assessment that the data to be generated in all then - contemplated pediatric Phase III Clinical Study(ies ), if such data satisfy the pre - defined primary endpoints of all such Clinical Study(ies ), will be sufficient to obtain Regulatory Approval ] *