definiens: means, with respect to any Product, on a country - by - country basis, a biologicproduct ( a ) for which the licensing, approval, or marketing authorization relies in whole or in part on a prior approval, licensing or marketing authorization granted such Product ; ( b ) that is to such Product, as the term isdeﬁned in 42 U.S.C. § 262(i)(2 ) ; and ( c ) that has been licensed by the FDA or other Regulatory Authority outside of theUnited States by reference to such Product, as set forth at 42 USC 262(k)(4 ) or other analogous applicable Law outside ofthe United States . A Product licensed, marketed, sold, manufactured, or produced by or on behalf of [COMPANY] or its Aﬃliates(or any Sublicensees or Distributors in their capacity as Sublicensee or Distributor for [COMPANY] or any of its Aﬃliates ) will notconstitute a Biosimilar Product