definiens: shall mean this Supply Agreement of which the Exhibits attached hereto form an integral and substantive part ; ( b ) shall mean the date first written above ; ( c ) shall mean medical grade paclitaxel conforming to the specifications set forth on Exhibit 1 attached hereto ( the ) and Supplier 's DMF filed with FDA ; ( d ) shall mean the new pharmaceutical product containing the Product to be manufactured, marketed and sold by Purchaser in the Territory ; 1 < PAGE > ( e ) shall mean any country of the world ; ( f ) shall mean the United States Food and Drug Administration ; ( g ) shall mean approval by the FDA of the NDA relating to the Finished Product and of Supplier as supplier of Product ; ( h ) shall mean the New Drug Application required to manufacture, market and sell the Finished Product in the United States ; ( i ) shall mean Supplier 's Drug Master File required to manufacture, market and sell the Product in the Territory ; ( j ) shall mean current good manufacturing practices as the same are or shall from time to time be established by governmental authority in the Territory ; ( k ) of a party hereto shall mean any company or other entity directly or indirectly controlling, or controlled by, such party or under common control as such party, the term meaning ownership of the majority of shares carrying the right to vote at General Meetings or the power to direct the policies and management of a company or entity ; and ( l ) shall mean the United States Pharmacopoeia, current edition