definiens: means the price specified in Appendix 2 ; 2 < PAGE > means the Product listed in Appendix 1, which may be amended by prior written agreement of the parties from time to time ; means the specification for a Product contained in the relevant Regulatory Approval and such additional amended specification as may be agreed by the parties in writing ; shall have the meaning specified in section 3.2 ; means the substances required to be incorporated into the Product and specified in the Technical Agreement ; means the final approval to market the Products in any country of the Territory, including without limitation, pricing and reimbursement approval and any other approval which is required to market the Products in the normal course of business ; means any governmental or regulatory bodies, agencies, departments or entities ( whether national or supra - national ) which regulate, direct or control commercial and other related activities in the Territory ; means the agreement between NovaDel and INyX, which is attached as Appendix 3 and which is incorporated into this Agreement ; means the countries specified in Appendix 4 ; means : ( a ) any tax imposed in compliance with the Sixth Directive of the Council of the European Communities ( 77/388 / EEC ) ; and ( b ) any other tax of a similar fiscal nature, whether imposed in a member state of the European Union in substitution for or in addition to such tax, or imposed elsewhere ; and1.2 In this Agreement, a reference to a month is to a calendar month