definiens: means, with respect to a particular Licensed Product commercialized by [COMPANY] in a particularcountry, any product ( other than Licensed Products commercialized, directly or indirectly, by [COMPANY], its Affiliates orSublicensees, or by any authorized distributors of [COMPANY], its Affiliates or Sublicensees ) that either ( a ) is a ( FOB ) or biosimilar or equivalent version to a Licensed Product, as defined by the competent Regulatory Authority, and administered in a similar dosage form as such Licensed Product or ( b ) for which a Third Party has received RegulatoryApproval ( based upon then - current applicable Laws governing approval of biological products ) whose application forapproval relies to a large extent ( but not exclusively ) on data generated for a Licensed Product, such as Regulatory Approvalunder section 505(b)(2 ) of the Federal Food Drug, and Cosmetic Act