definiens: means direct or indirect beneficial ownership of at least fifty per cent ( 50 % ) of the issued share capital w ith voting rights in such company or business entity ; shall mean [COMPANY] ’s facility situated at Seagoe Ind ustrial Estate, Craigavon, Northern Ireland BT63 5UA, or, to the extent approv ed in advance by Client, such other place at which [COMPANY] or its sub - contractors ( if applicable and as agreed between [COMPANY] and Client ), may from time to time provide the Services ; shall mean the proforma quotation, proposal or pro forma invoice attached hereto at Schedule 1 ; shall mean all applicable rules, regulations and la ws of the United States and European Union including, where relevant to the Ser vices performed pursuant to an Applicable Appendix, cGMP means 9.00 am to 5.00 pm GMT on any Monday to Frid ay, excluding public holidays and bank holidays in the United Kingdom, Northern I reland, and United States of America ( and/or Pennsylvania ) ; means documentation providing a record of analytica l testing data, provided and properly certified by a Qualified Person, stati ng and confirming that the Product to be provided b y [COMPANY] or Free Issue Material to be provided by Clie nt to which such documentation refers has been tested to, and complies with the relevant release s pecification for the Product or Free Issue Material ( as appropriate ) ; means documentation signed by a Qualified Person, which will include a statement that the Product has been manufactured, packaged, tested, and stored according to the terms of cGMP, and the Specifications ; means current Good Manufacturing Practice of the p harmaceutical industry standards for the EMA in the European Union ( more particularly descri bed in directive 2003/94 / EC of 8 Oct 2003 ) and the FDA in the United States of America ( more parti cularly described in the Code of Federal Regulations 21 CFR Parts 210 and 211 cGMPs ) relatin g to product description, manufacturing processes, quality control, packaging instructions, specifications, and guidelines relating to the manufacture, testing, analysis, packaging, and stor age of medicinal products and any subsequent updates to such directives, regulations or guidelin es ; means any and all claims, demands, suits, Losses ( as hereinafter defined ), liability, damage, fines, expenses and costs ( including without limita tion attorney ’s fees and expenses and settlement costs ) arising from any cause of action brought by any party ( including without limitation either Part y and/or a Third Party or Third Parties ), whether in contract, tort ( including, without limitation, negligence ) warranty, strict liability, product lia bility, statutory duty or otherwise ; means any local or national agency, authority, depa rtment, inspectorate, minister, ministry official or public or statutory person ( whether autonomous or not ) of any government or any country in the agreed Territory, including, but not limited to, the FDA, the EMA, the European Commission and the European Court of J ustice ; means all information whether commercial, financia l, technical, operational or otherwise in any format, disclosed b y one Party to the other Party in connection with t his Agreement that is either marked or designated as co nfidential or proprietary or would be readily recognized as such by a reasonable person working i n the area of pharmaceutical manufacturing, in each case whether disclosed orally in documentary f orm, by documentation or otherwise ( including information obtained visually during site visits to either party ) and including the terms of this Agreement ; means the date of this Agreement or the commenceme nt date of the Services whichever is earlier ; means the European Union ; means the European Medicines Agency and any succes sor entity thereto ; shall mean, as that term is defined in INCOTERMS 2010, in ac cordance with Section 4 of this Agreement ; means the United States ’ Food and Drug Administrat ion and any successor entity thereto ; means the intermediate products or materials, manu factured to cGMP, to be supplied by the Client to [COMPANY] free of charge for the purposes of this Agreement and as described in the Applicable Appendix ( as may be amended by th e mutual agreement of the Parties ) together with the respective Certificate of Analysis for each bat ch ; means any and all trade marks, rights in designs, get - up, trade, business or domain names, copyrights, future copyri ghts, patents, rights in databases ( whether registered or not and any applications to register or rights to apply for registration of any of the foregoing ), rights in inventions, know how, trade s ecrets and other confidential information and all other intellectual property rights of a similar or corresponding nature which m ay now or in the future subsist in any part of the world ; means the full descriptions and instructions relat ing to the processes, formulae and quality standards to be observed by [COMPANY] in the manufacture, testing, packaging, release, and storage of the Products, as provided by the Client and as set out in the Technical Agreement ; means the licence granted by a Competent Authority relating to each country of the Territory permitting manufacture, su pply, importation, distribution, marketing and sale of the Products in the Territory ; means the minimum annual spend ( excluding material s and pass through costs ) by Client on Services relating to th e manufactured Products ( at any scale including any process validation batches ) which are to be sold in any given Year of this Agreement ( as detailed in Schedule 2, as may be amended from time to time by written agreement of the Parties ) ; means those printed and unprinted materials used i n the packaging of the Products, the specification for which is set out in the Manufacturing and Packaging Instructions, whic h in the case of printed materials shall bear the Cli ent ’s and/or Product ’s text, trademark and livery, to be obtained by [COMPANY] and the cost of which shall be in cluded in the prices set out in the Applicable Appendix as may be amended from time to time by wri tten agreement of the Parties ; means a party to this Agreement ; means the products described in the Applicable App endix, which are the subject of the Services to be supplied by [COMPANY] to the Client on t he terms of this Agreement and in accordance with the Technical Agreement ; means a formal document in written form issued by the Client to [COMPANY] containing a firm instruction to manufacture, packa ge, test, store, and/or release the Products giving the following :  purchase order number ;  Product identity ;  quantity required ;  contract price ;  delivery date required ;  delivery address required ; and  invoice address