definiens: means, on a country - by - country basis, any pharmac eutical product sold by a Third Party which ( a ) contains a compound which is the same active pharmaceutical ingredient ( or any s alt, free acid, free base, clathrate, solvate, hydrate, hemih ydrate, anhydride, ester, chelate, conformer, conge ner, crystal form, crystal habit, polymorph, amorphous solid, ho molog, isomer, stereoisomer, enantiomer, racemate, prodrug, isotopic or radiolabeled equivalent, metabolite, co njugate, complex or mixture of any of the foregoing ) as an approved Product of OV, its sublicensee and their r espective Affiliates and ( b ) is approved under an A NDA or under 505(b)(2 ) of the FD&C Act or any similar abbr eviated route of approval in any country in the Ter ritory