definiens: means, with respect to a Licensed Product that hasreceived Regulatory Approval in a country in the Territory and is being marketed and sold byClementia or any of its Affiliates or Sublicensees in such country, any pharmaceuticalproduct that : ( a ) is sold in such country by a Third Party that is not a Sublicensee ofClementia or its Affiliates and did not purchase or acquire such product in a chain ofdistribution that included [COMPANY] or any of its Affiliates or Sublicensees ; and ( b ) hasreceived Regulatory Approval in such country, for at least one of the same Indications assuch Licensed Product, as a or similar designation of interchangeability by theapplicable Regulatory Authority in such country, pursuant to an expedited or abbreviatedapproval process in accordance with the then - current rules and regulations in such country, where ( i ) such Licensed Product is the or similar designation in such country, and ( ii ) such approval referred to or relied on(A ) the approved MAA for such Licensed Product held by Blueprint or its Affiliate, Clementiaor its Affiliate or Sublicensee in such country or ( B ) Regulatory Data contained orincorporated by reference in such approved MAA for such Licensed Product