definiens: means, with respect to a given Licensed Product in a Jurisdiction, any pharmaceutical preparation that ( a ) contains Li censed Compound as its sole active pharmaceutical i ngredient, ( b ) is marketed for sale in such Jurisdiction by a Third Party ( other than a Licensee Entity ) that is not authorized directly or indirectly by any Licensee Entity, and ( c ) receives Regulatory Approval for sale in such J urisdiction in reliance, based in whole or in part, on the prior R egulatory Approval ( or on safety or efficacy data s ubmitted in support of such prior Regulatory Approval ) of such Licensed Product as determined by the applicable Re gulatory Authority or is approved for sale in reliance, in w hole or in part, on the existing drug standard alre ady approved by the applicable Regulatory Authority ( unless a Li censee Entity authorizes the applicable Third Party to access, use or reference, such Regulatory Approval, data or drug standard )