definiens: means, with respect to any Licensed Product in a given country, anybiopharmaceutical product that is sold by a Third Party that is not a Sublicensee of [COMPANY] or its Affiliates and such Third Partyproduct ( a ) contains the same [ * * * ] and [ * * * ] and the same [ * * * ] as the relevant Licensed Product, or ( b ) ( i ) has been [ * * * ] as a [ * * * ] or [ * * * ] by FDA pursuant to [ * * * ] of [ * * * ] ), as may be amended, or any subsequent or superseding law, statute orregulation, ( ii ) has been [ * * * ] as a [ * * * ] by the European Medicines Agency pursuant to [ * * * ], as may be amended, or anysubsequent or superseding law, statute or regulation, or ( iii ) has otherwise achieved [ * * * ] in reliance on the [ * * * ] of a [ * * * ] from another applicable Regulatory Authority where in the case of each of clauses ( i ), ( ii ) or ( iii ) above, the [ * * * ] is the [ * * * ] for purposes of determining [ * * * ] or [ * * * ] of the Third Party product