definiens: means, on a country - by - country basis, a biologic product determined by the FDA or other RegulatoryAuthority outside of the United States to be biosimilar or interchangeable with a Licensed Product under Applicable Law . A Licensed Productlicensed, marketed, sold, manufactured, or produced by [COMPANY], its Affiliates or Sublicensees will not constitute a Biosimilar Product . Forclarity, any product referencing to a Licensed Product and approved under any of the following laws shall be considered a Biosimilar Product:42 USC 262(k ) or other analogous or successor Applicable Laws inside or outside of the United States, the Drugs and Cosmetics Act ofIndia ( 1940 ), the Central Drugs Standard Control Organization ’s Guidelines on Similar Biologics : Regulatory Requirements for MarketingAuthorization ( 2016 ) with respect thereto, and the Law for Ensuring Quality, Efficacy, and Safety of Drugs and Medical Devices of Japan(2014 ), and the Ministry of Health, Labour and Welfare ’s Guideline for the Quality, Safety and Efficacy Assurance of Follow - On Biologics(2009 ) with respect thereto