definiens: --means : ( a ) all reasonable costs and expenses ( priced on a competitive basis ) paid by either of the Parties 10 third parties in connection with the Second Development Program ( including . for the avoidance of doubt, the preparation of the CTD ) conducted externally ( whether through a direct relation ship with a consultant or a clinical inve stigator or through a contract research organisation ) and in all cases including the costs and expenses incurred to such third party for data managemelll, statistical designs and studies, reJXll1 preparation and other administrative expenses of such third party associated with the Second Development Program : ( b ) all costs and expenses paid by either of the Partie s to third parties including to outside patent attorneys, legal counsel and experts for the preparation, filing, prosecution and maintenance of Joint Program Patent Right s including costs of patent interference, opposition, re - examination, reissue, and revocation proceedings or requests for patent tenn or SPC extensions relating thereto to the extent the same occurs during the peliod of the Development Program : and ( c ) the Fully Burdened Manufacturing Costs incurred in cormection with supply ofCTM for the Second Development Program