definiens: means the FDA, EMA or any other foreign regulatory agenciescompetent to grant marketing approvals for pharmaceutical products including the Products in theTerritory ; means the file, for each Product, which is provided by Customer to [COMPANY] inaccordance with the procedures listed in Schedule A hereto and which contains documentsrelating to such Product, including, without limitation : ( a ) specifications for Active Materials andComponents ; ( b ) manufacturing specifications, directions and processes ; ( c ) storagerequirements ; ( d ) all environmental, health and safety information relating to the Productincluding material safety data sheets ; and ( e ) the finished Product specifications, packagingspecifications and shipping requirements for each Product ; all as updated, amended and revisedfrom time to time by Customer in accordance with the terms of this Agreement ; means the [COMPANY] ’ Affiliate, [COMPANY] Italia S.p . A ; means the technology transfer Agreement dated 2 February2009 between [COMPANY] International AG and Customer ( and assigned to [COMPANY] UK Limited on22 September 2011 ) containing, inter alia, details of the technology transfer services and capitalexpenditure requirements for the Product ; means in the World each market being subject to assessment of additional technicalrequirements ( if applicable ) means the Intellectual Property of any third party ; means in the first year of this Agreement the period from the Effective Date up to andincluding December 31 of the same calendar year, and thereafter shall mean a calendar year