definiens: means a drug product being sold commercially by a Third Party in a country in the Licensed Territory without authorization by Bei Gene ( or its Affiliate or Sublicensee ), that ( a ) co ntains the same active ingredient as a Licensed Product, ( b ) i s determined to be bioequivalent to such Licensed P roduct in accordance with Applicable Laws, or ( c ) is approved for sale in such country under an abbreviated rout e of regulatory approval in such country similar to the Abbreviated New Drug Application, or under 505(b)(2 ) of the United States Federal Food, Drug and Cosmetic Act, in the U.S. and is sold under a Regulatory Approval granted to the selling Third Party in such country which au thorization is based substantially on clinical data pertaining to such Licensed Product . For purposes of clarity, for countries or jurisdictions in the Licensed Territo ry where no explicit generic regulations exist, the term Generi c Product also shall mean any product being sold in such country by an unauthorized Third Party that contains the sa me active ingredient as a Licensed Product