definiens: forth III SectIOn 5.3 . 1.51 -Phase 3 Clinical Trial " mean, a pivotal Itwnan clinical trial on sufficient numben of patielltS .... hich is designed toll ( I ) cstablislt that I l > roduct is safe and efficacIOUS for its intended ~ ; ( b ) define wamill~, flT'CCautioOlIS and ad\'crse ~lICIion~ that arc associated with such l'TodllCl in the do:>agc " " ' ge to be pn : scribed ; and ( e ) suPPOI'I RCllulalOry Appro\'al of weh Product .. as further defIned in 21 C.F.R. 312.21(c ), till amcr»cd from time toO time, or the corresponding ~gulalion in jurisdictions Wilhin ! .he Cypress Territory otller than ! .he Uniled States . For clariry, a Phase 213 Clinical Trial mall be consillcred 10 be II Phase 3 Clinical Trial if il is considered by a Regulatory Authority 10 be B pivolal clinical trial rOT Ihe ProdUCI as detennincd allhe time of Accepm~ by Ihe FDA of an NOA for a Product in the United States