definiens: means, with respect to ( a ) an IND submitted by [COMPANY], its Aﬃliates, orits or their Sublicensees to a Regulatory Authority or ( b ) an IND submitted by [COMPANY] orits Aﬃliates to a Regulatory Authority for the purposes of Section 10.3.2(a ) ( ResearchMilestone Payments ), in each case ( ( a ) and ( b ) ) the earlier of ( i ) receipt by such Party or itsAﬃliate, or in the case of ( a ), a Sublicensee of [COMPANY] or [COMPANY] ’s Aﬃliate, of written conﬁrmationfrom such Regulatory Authority that Clinical Trials may proceed under such IND, and ( ii)expiration of the applicable waiting period after which Clinical Trials may proceed under suchIND