definiens: means, with respect to any Licensed Product for which Regulatory Approval has been granted, any pharmaceutical product that ( i ) is sold by a Third Party that is not a licensee or sublicensee of [COMPANY] or its Affiliates, orany of their licensees or sublicensees under a Regulatory Approval for an indication in the Field granted by a RegulatoryAuthority to such Third Party, and ( ii ) * * * ( x ) for purposes of the United States, is approved in reliance on the prior approvalof a Licensed Product, as determined by the FDA, or ( y ) for purposes of a country outside the United States, is approved inreliance on the prior approval of a Licensed Product as determined by the applicable Regulatory Authority, in either casethrough an abbreviated regulatory process that does not require the submission of full safety and efficacy data by reason ofreference ( other than by permission or licensee or sublicensee of [COMPANY] or its Affiliates, or any of their licensees orsublicensees ) to regulatory filings with respect to the such Licensed Product . A product that is approved in a country primarilybased upon the prior regulatory approval of such product in another country ( the ) will qualify as a GenericProduct for purposes of this Agreement with respect to the applicable country if at the time of such approval such productqualifies as a Generic Product under this Agreement with respect to the Prior Country