definiens: means the date that a patient is first dosed by or onbehalf of [COMPANY], its Affiliate or sublicensee with a Product in a clinical trial that isdesigned to provide a preliminary determination of safety and tolerability in healthyindividuals or patients, as described in 21 C.F.R. 312.21(a ) ( or its successor regulation ), orits foreign equivalent . means the earlier of ( a ) the date that a patient isfirst dosed by or on behalf of [COMPANY], its Affiliate or sublicensee with a Product in amultiple, ascending dose clinical trial that is designed to provide a preliminarydetermination of safety and tolerability in healthy individuals or patients and apreliminary indication of dose - ranging effects, including pharmacological effects, asdescribed in 21 C.F.R. 312.21(a ) ( or its successor regulation ), or its foreign equivalent, and(b ) one ( 1 ) year after Initiation of Phase 1 Clinical Trial for the Product unless the Product, as of such date, is not the subject of active clinical development ( e.g, if safety data from thephase 1clinical trial results in a delay or suspension of clinical development ) ; provided, however, that if there is a bona fide technical and/or scientific reason why the a clinicaltrial described in clause ( a ) is not initiated prior to one year after the Initiation of Phase 1Clinical Trial and the Product is still the subject of active clinical development, then3CONFIDENTIAL TREATMENT IS REQUESTED FOR INFORMATION IN BOLDAND BRACKETS, ..