definiens: shall mean, with respect to a Collaboration Product, any pharmaceuti cal product in such Tier One Ex- U.S. Country that : ( i ) contains the same active pharmaceutical i ngredient ( irrespective of its solvate, hydrate, salt, pro - drug or polymorphic form ) as the Collabor ation Product ; ( ii ) is approved by the applicable Governmental or Regulatory Authority in such jurisdiction in reliance, in whole or in part, on the prior Drug Approval of such Collaborat ion Product ; ( iii ) is bioequivalent to such Collaboration Product ; and ( iv ) is sold in such jur isdiction by a Third Party that ( a ) is not a licensee or sublicensee of [COMPANY] or its Affiliates or any of their licensees or sublicensees, ( b ) has not obtained such product from a chain of distribut ion including [COMPANY], its Affiliates or any of their licensees or sublicensees, and ( c ) is not oth erwise authorized by [COMPANY] or any of its Affiliates, licensees, sublicensees or distributors to sell such product ( provided that a licensee or sublicensee of [COMPANY] or its Affiliates or any of th eir licensees or sublicensees who is granted such license or sublicense as a result of a settlement b y [COMPANY] of any action taken in a court or Governmental or Regulatory Authority, a compulsory license grant ed pursuant to Applicable Law or any action taken by a court or Governmental or R egulatory Authority shall not be considered as having been authorized by [COMPANY] or any of its Affil iates, licensees, sublicensees or distributors to sell such product for the purposes of this Paragrap h 2.a . ) . Notwithstanding the foregoing, on a country - by country basis, from and after the calend ar quarter in which Loss of Exclusivity ( as defined below ) occurs in any country, possession or territory of the Ex - U.S. Territory other than the Tier One Ex - U.S. Countries, then royalties paya ble to Onyx with respect to Net Sales of the applicable Collaboration Product in such country, p ossession or territory of the Ex - U.S. Territory sha ll be reduced to sixteen percent ( 16 % )