definiens: means, with respect to a ProdUCl in the Territory . another piutnuaceutical produCl that is : ( a ) B Prod""t ; ( b ) is bioequivaienl to ) such I'mduct with respect to phamtacol!.inetie propcnies ; and ( e ) is either ( i ) approved for USC in the Territory b ) ' the Governmenllll or Regularory Autboril ) ', or(ii ) launcl > od by a Third P.n ), in ! be Territory purwanl to ParaJ'lph IV of the Drug Price Competition and Patenl Tenn Restoration Act or 1984, 15 amended, or an ) ' successor tegul8I.ionI ( or its wmparablc : regulalion in a ju.risdiction within ! be Territory )