definiens: means : ( i ) with respect to a LicensedProduct comprising a Compound sold in a country and approved for a particularindication, an AB - rated Generic Product that : ( A ) is owned by a Third Party thathas not obtained the rights to such product as a sublicensee or distributor of GSKor any of its Affiliates ; ( B ) contains as an active ingredient the same LicensedProduct ( or salt, metabolite, prodrug or other physical form thereof, or equivalentas determined by the relevant regulatory authority ) as contained in such LicensedProduct ; and ( C ) is approved for use in the same country as such LicensedProduct pursuant to 21 U.S.C. 355(b)(2 ), an abbreviated new drug application, aseparate NDA ( excluding any NDA owned by [COMPANY] or any of its Affiliates),compendia listing, or other drug approval application ( excluding any NDAowned by [COMPANY] or any of its Affiliates ), including any and all foreign equivalentsof the foregoing ; and ( ii ) with respect to a Licensed Product comprising aBiologic, a biologic product that : ( A ) is owned by a Third Party that has notobtained the rights to such product as a sublicensee or distributor of [COMPANY] or anyof its Affiliates ; and either ( B ) for countries in which an abbreviated reviewprocess has been enacted to allow a biologic product to be approved for use inthe same country by relying on clinical data of the Licensed Product, such ThirdParty product has been approved for use in the same county as such LicensedProduct pursuant to such abbreviated review process ; or ( C ) for any othercountry, such Third Party product contains as an active ingredient the samebiologic ( i.e., identical relevant amino acid sequence ) as contained in suchLicensed Product and has been approved for use in the same country as suchLicensed Product