definiens: has the meaning ascribed to it under Article 48 of Directive 2001/83 / EC, in relation to the production of human medicines, and Article 52 of Directive 2001/82 / EC, in relation to the production of veterinary medicines ; means the materials, including the Packaging Mater ials but excluding the Free Issue Materials, used in the manufacture of the Products, the specifications for which are set out in the Specification, to be obtained by [COMPANY] and the cost of which shall be included in the prices set out i n the Applicable Appendix as may be amended from time to time by written agreement of the Parties ; means the General Index of Retail Pric es in the United Kingdom published by the Office for National Statistics or any successor min istry or department ; means the manufacturing, packaging, storage, analy sis, and/or release services that [COMPANY] agrees to perform pursuant to Section 2.1 her eof in connection with the Products ; means the written specifications for the manufactu re, testing, packaging, release, and storage of the Products as prepared and delivered b y the Client, as set out in the Technical Agreement from time to time ; means the separate agreement to be entered into be tween the Parties which describes the quality assurance requirements for Se rvices under this Agreement and which shall form part of this Agreement, as may be amended by the Pa rties from time to time ; means the United States of America and Europe or s uch other territory as may be agreed by the Parties in writing from time to time, such a greement not to be unreasonably withheld ; Third Party ” shall mean a party other than [COMPANY], Client, or t heir respective Affiliates, officers, directors, employees, agents and representatives ; means the United States of America ; means the period of twelve ( 12 ) calendar months fr om and including the Effective Date, and each subsequent period of ( 12 ) calendar months duri ng the continuance of this Agreement ; 1.2 A reference to the singular includes the plural and vice - versa