definiens: means any business entity which controls, is controlled by, or is under common control with either the Supplier or Company . For the purpose of this definition shall mean either ownership of more than 50 per cent . of the issued capital of the company ( or other business entity ) or a right to direct the business and/or policies ( including dividend policies ) and/or affairs of such company whether by law, contract, governmental decree or regulation, ownership of voting power or otherwise and if one or more persons fits any of the categories set out in this paragraph ( whether or not they are acting in concert ) each such person shall be treated as in control of such company ; means the standard costs of Raw Materials and packaging materials required in connection with the manufacture, packaging and labelling ( as applicable ) of each [COMPANY] Product, Dynamin and Isodur ; means Monday to Friday, 9.00 am to 5.00 p.m. excluding public holidays and bank holidays in Northern Ireland ; - 1 -<PAGE > means the business purchase agreement between [COMPANY] Limited and Pharmaceutical Development and Manufacturing Services Limited dated 2 December 2003 ; means current Good Manufacturing Practice of the pharmaceutical industry standards as required by the EMEA in the European Union ( and as more particularly described in Directive 91/356 / EEC of 13 June 1991 or as amended by Directive 2001/83 / EC ) and the similar guidelines and requirements of any other recognised and applicable national regulatory body, including ( without limitation ) the MHRA in the United Kingdom, including all standards, guidelines and requirements in relation to product description, manufacturing processes, quality control, packaging instructions, specifications and guidelines relating to the manufacture, testing, analysis, QP release and packaging of medicinal products ; is defined at clause 5.2 ; is defined at clause 13.7 ; is defined at clause 6.1 ; means those pharmaceutical products supplied and delivered to the Supplier during the Term by the Company or third party suppliers of the Company, as set out in schedule 1 or such other products as agreed by the Parties from time to time, which shall be tested for release - to - market, QP released, stored and despatched by the Supplier in accordance with the terms of this agreement ; means bulk capsules of Isodur pharmaceutical product, which are supplied by the Company to the Supplier ( in finished dosage form ) from time to time in accordance with clause 3.1(b ), and which the Supplier shall package, label, test for release - to - market, QP release, store and despatch for the Company in accordance with the terms of this agreement ; means the date of the Business Purchase Agreement ; means the European Agency for the Evaluation of Medicinal Products ; means those pharmaceutical products listed in schedule 1 together with any other such products which may be added from time to time by agreement of the Parties, which the Supplier shall manufacture, package, label, test for release - to - market, QP release, store and despatch for the Company in accordance with the terms of this agreement . For the avoidance of doubt references to [COMPANY] Products in this agreement shall not include Dynamin, Isodur or Distribution Products ; is defined at clause 5.7 ; means any and all patents, trade marks, service marks, logos, rights in designs, get - up, trade, business or domain names and copyrights, ( 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 secrets and other confidential information, rights in databases and all other intellectual property rights of a similar or corresponding character which may now or in the future subsist in any part of the world ; - 2 -<PAGE > means bulk capsules of Isodur pharmaceutical product, which are supplied by the Company to the Supplier ( in finished dosage form ) from time to time in accordance with clause 3.1(b ), and which the Supplier shall package, label, test for release - to - market, QP release, store and despatch for the Company in accordance with the terms of this agreement ; means any and all damages, costs ( including, without limitation, reasonable legal and other professional fees reasonably incurred ), claims, ( including third party claims ) liabilities, expenses, losses and demands ; means all relevant and current ( as at the date of this agreement ) descriptions and instructions concerning the processes, formulae and quality standards to be observed by the Supplier in relation to the manufacture, packaging and labelling of [COMPANY] Products and packaging and labelling of Dynamin and Isodur as provided by the Company . The Manufacturing and Packaging Instructions may be varied from time to time by written agreement of the Parties ; means, in respect of a Product, the relevant and current ( as at the date of this agreement ) Marketing Authorisation issued by the EMEA ( or such other regulatory body that replaces the EMEA from time to time ) in respect of the manufacture and supply of that Product in the European Union and such other Marketing Authorisations issued by any other applicable regulatory body in any jurisdiction where the manufacture and supply of that Product may occur from time to time in accordance within the terms of this agreement, including ( without limitation ) the MHRA, as shall be deemed attached to the Technical Agreement ; means all Raw Materials ( excluding bulk capsules of Dynamin and Isodur ) and packaging materials used in connection with the manufacture, packaging, labelling, testing for release - to - market and QP release of [COMPANY] Products, Dynamin and Isodur by the Supplier in accordance with the terms of this agreement ; means the Medicines and Healthcare products Regulatory Agency ; means the minimum order quantity, which shall be in batch sizes or multiples of batch sizes ( or as otherwise agreed by the Parties from time to time ), for each particular [COMPANY] Product or Dynamin or Isodur, which may be included in a Confirmed Order as detailed in schedule 2 ; is defined at clause 8.1 ; shall mean the respective Head of Quality ( or as otherwise agreed by the Parties ) for each of the Parties from time to time ( as confirmed to each other in writing ) ; shall mean a party to this agreement ; means the shelf life of each Product as set out in the relevant Marketing Authorisation ; means the [COMPANY] Products, Dynamin, Isodur and the Distribution Products ; - 3 -<PAGE > is defined at clause 11.1 and shall have the corresponding meaning ; has the meaning ascribed to it under Article 21 of Directive 75/319 / EEC ( or as amended by Directive 2001/83 / EC ) ; means active pharmaceutical ingredients and excipients ; is defined at clause 11.1 ; means all relevant and current ( as at the date of this agreement ) manufacturing, packaging, labelling and testing specifications for the Products ( as applicable ) as provided by the Company . The Specifications may be amended by the Parties from time to time in accordance with clause 4 ; means a situation where the Supplier can not comply with its despatch obligations hereunder due to the Company having insufficient stock of a particular [COMPANY] Product Dynamin or Isodur available in the Supplier storage facilities at the Supplier Premises at any time 30 days after the due date for completion and delivery into storage of a relevant Confirmed Order . In the case of the full range of Kapake products ( ) and the full range of Ursogal products ( ) the Stock Out period would be at any time 60 days after the due date for completion and delivery into storage of a relevant Confirmed Order