definiens: means, with respect to any Licensed Product, a version of such Licensed Product ( or a productcontaining the same or highly similar active pharmaceutical ingredient as such Licensed Product in a comparable dosage formand formulation as such 7 * * * = Portions of this exhibit have been omitted pursuant to a request for confidential treatment . An unredactedversion of this exhibit has been filed separately with the Commission . Licensed Product ( e.g., adult - to - adult and pediatric - to - pediatric ) ) that has received, under applicable Law in any country inthe Access Territory, any required Regulatory Approval analogous to being licensed as a biosimilar or interchangeablebiological product by the FDA pursuant to Section 351(k ) of the Public Health Service Act ( 42 U.S.C. § 262(k ) ), as may beamended, or any subsequent or superseding law, statute or regulations