definiens: means, with respect to a particular Licensed Prod uct in a country, a generic or biosimilar pharmaceutical product, that is not produced, licensed or owned by Licensee, any of its Affiliates or Sublicensees, that : ( a ) is bio equivalent or biosimilar to such Licensed Product ; and ( b ) is approved for use in such country by a Regula tory Authority by referencing the prior approval, i n whole or part, or safety and efficacy data submitte d in support of the prior approval, of the Licensed Product . Generic Product includes, but is not limit ed to, any pharmaceutical products for which Regulatory Approval is obtained via : ( i ) a bioequiv alence or bioavailability showing such as those covered by section 505(j ) of the FD&C Act or an equ ivalent outside the United States ; or ( ii ) a biosimilarity or interchangeability determination s uch as those covered by section 351(k ) of the PHS Act or an equivalent outside the United States