definiens: means, with respect to a Unilateral Product and on a country -by - country basis, a product that ( a ) is marketed for sale in such country by a Third Party ( not licensed, supplied or otherwise permitted by a Party or its Affiliates or Sublicensees ), ( b ) is approved based on a showing that it is highly similar to the corresponding Unilater al Bispecific Antibody as an active pharmaceutical ingredient in such country with no clinically meaningful differences in terms of purity, safety and efficacy, and ( c ) is approved as a under Title VII, Subtitle A Biologics Pr ice Competition and Innovation Act of 2009, 42 U.S.C. § 262, Section 351 of the PHSA, or, outside the United States, in accordance with European Directive 2001/83 / EC on the Community Code for medicinal products ( Article 10(4 ) and Section 4, Part II of Anne x I ) and European Regulation EEC/2309/93 establishing the community procedures for the authorization and evaluation of medicinal products, each as amended, and together with all associated guidance, and any counterparts thereof or equivalent process inside or outside of the United States or EU to the foregoing