definiens: means a drug product in oral dosage form pharmaceutical or inhalation dosage form pharmaceutical marketed by or on behalf of a Third Party other than a Sublicensee ) and that ( a ) contains or delivers ( including without limitation in the form of the active metabolite in the body the same Active Dru Substance as an Product marketed y or on . behalf of [COMPANY] or its Mfiliate or Sublicensee, and tha delivers a substantiall e uivalen dose of such Active Dru Substance or could ractically be used to do so, and/or ( b ) is, within the meaning of applicable generic drug laws and regulations, considered sufficientl uivalent to the Product that such drug roduct marketed by or on behalf of a Third Part than a Sublicensee can be a roved on the basis of the clinical data that were used to su ort Regulatory A roval of the Product marketed y or on behalf of Co Therix ( or its Mfiliate or Sublicensee ) without the need for additional clinical testing ( other than any that may ! Ibe required to show such sufficient bioequivalence ) 1