definiens: means, in a particular country with respect to a Productregulated as a82 biological product, any biological product that : ( I ) has received all necessary approvals and licensuresby the applicable Regulatory Authorities in such country to market and sell such product as abiosimilar product ; ( II ) is marketed or sold by a Third Party that is not a Sublicensee, other than aSublicensee who is a Sublicensee as a result of settlement of any litigation ; and ( III ) is approved as a(1 ) ( 1 ) with respect to which such Product is the or ( 2 ) if not in the European Union, as the foreign equivalent of a or of such Product ; in each case ( ( 1)-(2 ) ), for use in such countrypursuant to an abbreviated regulatory approval process governing approval of biosimilars based onthe then - current standards for regulatory approval in such country ( and where such regulatoryapproval was based in part upon ﬁndings by the Regulatory Authority of clinical safety and eﬃcacybased on clinical data generated by Sobi ( or its Aﬃliate or Sublicensee ) or Apellis ( or its Aﬃliate orsublicensee ) with respect to such Product