definiens: shall mean, with respect to Product that has rece ived Regulatory Approval in a country and is being marketed and sold by Purchas er or any of its Affiliates or Licensees in such co untry, any pharmaceutical product that : ( a ) is sold in such ju risdiction by a Third Party that is not a Licensee of Purchaser or its Affiliates and did not purchase or acquire such product in a chain of distribution that included P urchaser or any of its Affiliates or Licensees ; and ( b ) has receive d Regulatory Approval in such jurisdiction, for at least one of the same indications as such Product, as a or similar designation of interchangeability by the applicable Regulatory Authority in such jurisdiction, pursuan t to an expedited or abbreviated approval process in accord ance with the then - current rules and regulations in such jurisdiction, where ( i ) such Product is the or similar designation in such jurisdiction, and ( ii ) such app roval referred to or relied on ( x ) the approved NDA for such Product held by Purchaser, its Affiliate or a Licen see in such jurisdiction or ( y ) the data contained or incorporated by reference in such approved NDA for such Product in such jurisdiction