definiens: means, as to a Product that has received Regulatory Approval in a particular countryin the Territory and is marketed and sold by a Party in such country, a non - innovator product that : ( A ) ( i ) has obtainedRegulatory Approval by means of an abbreviated NDA filed pursuant to Section 505(j ) of the Act which refers to the specificProduct at issue as the Reference Listed Drug ( as defined in 21 C.F.R. 314.3(b ) ( as amended ) ) in the United States, or anapplication similar to an abbreviated NDA filed pursuant to Section 505(j ) of the Act for any jurisdiction outside the UnitedStates, in each case, without the requirement of any human clinical efficacy trials ; or ( ii ) has obtained Regulatory Approval bymeans of a BLA or an NDA or a comparable procedure for establishing bioequivalence or biosimilarity to orinterchangeability with such Product, in each case, without the requirement of any human clinical efficacy trials other than toestablish biosimilarity or interchangeability ; and ( B ) is bioequivalent or bio - similar to, or interchangeable with, such Product;and ( C ) is legally marketed in such country by an entity other than such Party, its Affiliates or Sublicensees