definiens: means the price received by the Distributor for sale of the Product, excluding applicable sales taxes, customs fees, duties and freight costs ; ( 20 ) means an individual, corpo ration, company, co -operative, partnership organization or any similar entity ; ( 21 ) means DRAXIMAGEÒ Sestamibi manufactured and supplied by DRAXIMAGE or its designated subcontractors and any other product hereafter included as a Product by written agreement of the Parties, as further described in Schedule 1 ; ( 22 ) means that quality agreement to be entered into between the Parties within ninety ( 90 ) days of the date of execution of this Agreement ; ( 23 ) means the Drug Identification Number ( DIN ) or similar drug product identification, regulatory dossiers, data, results of clinical or other trials or investigations and the like, if any, submit ted as part of any application for the Marketing Authorizations and which is in the possession of DRAXIMAGE at any time during the course of this Agreement, including, without limitation, the drug master file and all information and data submitted to any p rovincial, state or federal or private insurance authorities or price control or licensing bodies ; ( 24 ) means any federal, provincial, territorial, state, local or foreign government agency, board, tribunal, court, commission or authority and includes, without limitation, the FDA, having authority over the purchase, manufacture, storage, handling, packaging, labelling, dispos al, marketing, distribution or sale of the Product ; ( 25 ) means any rules, regulations, directives, policies, guid elines and orders of any Regulatory Authority, including, without limitation, current good manufacturing practice and any Applicable Laws ; ( 26 ) shall have the meaning set out in Section 11.01(2 ) ; ( 27 ) means the specifications of the Product attached hereto as Schedule 2, as amended from ti me to time by DRAXIMAGE upon prior notice to the Distributor ; ( 28 ) means, collectively, the Initial Term and any Renewed Term, as the case may be ; ( 29 ) means the United States of America, including its territories ; ( 30 ) means the trade -marks, trade names and trade dress for the Product ( whether registered or not ), the details of which are set out in Schedule 3 ; ( 31 ) means the representations, warranties and covenants given by DRAXIMAGE to the Distributor as set out in Schedule 4 ; and ( 32 ) means US dollars