definiens: shall mean, with respect to Product that has received Regulatory Approval in the Territory and is being marketedand sold by Licensee or any of its Affiliates or Sublicensees in the Territory, any pharmaceutical product that : ( a ) is sold in the Territory by aThird Party that is not a Sublicensee of Licensee or its Affiliates and did not purchase or acquire such product in a chain of distribution thatincluded Licensee or any of its Affiliates or Sublicensees ; and ( b ) has received Regulatory Approval in the Territory, for at least one of thesame indications as such Product, as a or similar designation of interchangeabilityby the applicable Regulatory Authority in such jurisdiction, pursuant to an expedited or abbreviated approval process in accordance with thethen - current rules and regulations in such jurisdiction, where ( i ) such Product is the orsimilar designation in such jurisdiction, and ( ii ) such approval referred to or relied on ( x ) the approved MAA for such Product held by Licensee, its Affiliate or a Sublicensee in the Territory or ( y ) the data contained or incorporated by reference in such approved MAA for such Product inthe Territory