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 ( or issold by any [ * * * ], even if such [ * * * ] is an Affiliate of a Sublicensee ) and such Third Party product ( a ) has been [ * * * ] ( i ) as [ * * * ] or [ * * * ] by FDA pursuant to [ * * * ] of the [ * * * ] or any subsequent or superseding law, statute or regulation, or(ii ) under [ * * * ] or [ * * * ] of the [ * * * ] or any subsequent or superseding law, statute or regulation, ( b ) has been [ * * * ] as a [ * * * ] or [ * * * ] by the [ * * * ] pursuant to [ * * * ], as may be amended, [ * * * ], as may be amended, or any subsequent orsuperseding law, statute or regulation, or ( c ) has otherwise [ * * * ] or is otherwise [ * * * ] or [ * * * ] in reliance on the [ * * * ] ofthe [ * * * ] from another applicable [ * * * ] where in the case of each of clauses ( a ), ( b ) or ( c ) above, the [ * * * ] is the [ * * * ] forpurposes of determining [ * * * ] or [ * * * ] of the Third Party product