definiens: means, on a country - by - country basis, any pharmaceutical product sold by a Third Party which(a ) contains a Compound which is the same active ingredient ( or any salt, free acid, free base, clathrate, solvate, hydrate, hemihydrate, anhydride, ester, chelate, conformer, congener, crystal form, crystal habit, polymorph, amorphous solid, homolog, isomer, stereoisomer, enantiomer, racemate, prodrug, isotopic or radiolabeled equivalent, metabolite, conjugate, complex or mixture of any of the foregoing ) as an approved Product of Spectrum, its sublicensee and their respectiveAffiliates and ( b ) is approved under an ANDA or under 505(b)(2 ) of the FD&C Act or any similar abbreviated route ofapproval in any country in the Territory