definiens: means, with respect to a Product in a given country of the [COMPANY] Territory, any product sold in such country by a Third Party ( other than a sublicensee of [COMPANY] or any other Third Party authorized to sell such product by, or otherwise in the chain of distribution of, [COMPANY] or a [COMPANY] Affiliate or sublicensee ) that ( a ) contains the same active ingredient(s ) as the Product, or any base form, salt form, prodrug form, isomer, crystalline polymorph, hydrate or solvate of such active ingredients ( but no additional pharmaceutically active ingredients beyond what is contained in the Product ), and ( b ) is approved or registered for use in such country pursuant to any drug approval process based on reference to a Regulatory Approval for such Product held by [COMPANY], [COMPANY] or any of their respective Affiliates or sublicensees in such country or in another country