definiens: means, with respect to an Initial Licensed Product, a biologicalproduct : ( a ) that contains ( i ) an identical active ingredient(s ) as the Licensed Compound in such LicensedProduct, or ( ii ) a active ingredient(s ) to the Licensed Compound in such Initial LicensedProduct, as the phrase is used in 42 U.S.C. § 262(i)(2 ), and subject to the factors set forthin FDA ’s Guidance for Industry, ( February 2012 ), at Section VI, or any successor FDA guidance thereto ; ( b ) for whichRegulatory Approval is obtained by referencing Regulatory Materials of such Initial Licensed Product ; ( c)2is approved for use in such country ( or region ) pursuant to a Regulatory Approval process governingapproval of interchangeable or biosimilar biologics as described in 42 U.S.C. § 262, or a similar processfor Regulatory Approval in any country ( or region ) outside the United States, or any other similar provisionthat comes into force, or is the subject of a notice with respect to such Initial Licensed Product under 42U.S.C. § 262(l)(2 ) or any other similar provision that comes into force in such country ( or region ) ; and ( d)is sold in the same country as such Initial Licensed Product by any Third Party that is not a Sublicenseeof [COMPANY] or its Affiliates with respect to the Jounce IP and Joint IP and did not purchase such product ina chain of distribution that included any Selling Party