definiens: means any pharmaceutical product that ( a ) is sold by a Third Party that is not a licensee or sublicensee of [COMPANY] or its Affiliates . or any of their licensees or sublicensees, under a marketing authorization granted by a Regulatory Authority to such Third Party and ( b ) contains the same Compound as an active pharmaceutical ingredient as the relevant Licensed Product and ( c ) ( j ) for purposes of the United States, is approved in reliance, in whole or in part, on the prior approval of a Licensed Product or on the safety and efficacy data generated for the prior approval of a Licensed Product, in each case as determined by the FDA, or ( ij ) for purposes of a country outside the United States . is approved in reliance, in whole or in part . on the prior approval of a Licensed Product or on the safety and efficacy data generated for the prior approval of a Licensed Product . in each case as determined by the applicable Regulatory Authority