definiens: means any pharmaceutical product that ( a ) is sold by a Third Party that is not a licensee orSublicensee of [COMPANY] or its Affiliates, or any of their licensees or Sublicensees, under a marketing authorization grantedby a Regulatory Authority to such Third Party and ( b ) contains the same or a similar compound as an activepharmaceutical ingredient as the relevant Product and ( c ) ( i ) for purposes of the United States, is approved in reliance, in whole or in part, on the prior approval of a Product or on the safety and efficacy data generated for the priorapproval of a Product, in each case as determined by the FDA, or ( ii ) for purposes of a country outside the UnitedStates, is approved in reliance, in whole or in part, on the prior approval of a Product or on the safety and efficacy datagenerated for the prior approval of a Product, in each case as determined by the applicable Regulatory Authority