definiens: means, with respec t to a Product that has received Regulatory Approval in a Region within the Territory and is be ing marketed and sold by Apollo or any of its Affil iates or Sublicensees in such Region, any pharmaceutical / bio logic product that : ( a ) is sold in such Region by a Third Party that is not a Sublicensee of Apollo or its Affiliat es and did not purchase or acquire such product in a chain of distribution that included Apollo or any of its Aff iliates or Sublicensees ; and ( b ) has received Regul atory Approval in such Region, for at least one of the same Indica tions as such Product, as a or similar designation of interc hangeability by the applicable Regulatory Authority in such Regi on, pursuant to an expedited or abbreviated approva l process in accordance with the then - current rules and regul ations in such Region, where ( i ) such Product is th e or s imilar designation in such Region, and ( ii ) such ap proval referred - 6 - to or relied on ( x ) the approved MAA for such Produ ct held by Apollo, its Affiliate or a Sublicensee i n such Region or ( y ) the Data contained or incorporated by refere nce in such approved MAA for such Product