definiens: shall mean CRM I 07 conjugated to human transferrin ; means in relation to either party any person who directly or indirectly controls, is controlled by or is under common control with that party . A person shall be regarded as in control of another person if it owns directly or indirectly more than 40 % ( forty per cent ) of the voting stock or other ownership or income interest of another person or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of another person by any means whatsoever ; means -a day other than a Saturday, Sunday, Bank Holiday or other public or national holiday in England or the Territory ; means the data from any Clinical Trials and any other test data related thereto and any other documentation or correspondence relating to any Clinical Trials of the Product conducted by or on behalf of either party hereto and all Know - how in respect ofthe same ; i, •,,, !, I ! ~ l l f • ! I, I ! I • • 1.1.5 means the clinical development plan for the Product for carrying out the Clinical Trials which are necessary or desirable to obtain Marketing Authorisation of the Product in the Territory ; 1.1.6 means such clinical testing ( including toxicological, stability, pharmacological and clinical studies in human beings ) as may be required to be carried out and/or produced by or on behalf of either party hereto in connection with obtaining the Marketing Authorisation for the Product either inside or outside of the Territory ; 1.1.7 means those data required by Part 2 of the Annex to Directive 2001l83IEC including the qualitative and quantitative particulars of the constituents, the description of the manufacturing method and the controls and tests carried out at all relevant stages of the manufacturing process of the Active Ingredient and/or the Product ; 1.1.8 shall mean the first shipping by SOSEI, its Affiliate or Sub - Licensee of the Product to its wholesalers in the Territory in such commercial quantities of the Product as may reasonably be appropriate to establish the Product throughout the Territory ; 1.1.9 1.1.10 LUI 1.1.12 1.1.13 1.1.14 1.1.15 means, with respect to a particular item, material or intellectual property right, that a party or an Affiliate of such party owns or has a license under such item, material or intellectual property right and where licensed, has the ability to grant to the other party access to material or Intellectual Property right without violating the telms of such license and shall be construed accordingly ; means single point mutated diptheria toxin ; means the master regulatory dossier relating to the Product prepared by or on behalf of either party hereto in connection with obtaining the Marketing Authorisations for the Product in and outside of the Territory, including relevant Clinical Data and CMC Data ; means the execution date of this Agreement . parties hereto ; means the European Union and each of the member states from time to time of the European Union ; means the date upon which a Dossier for the Product was submitted by or on behalf of SOSEI in support of an application for the Marketing Authorisation ofthe Product in the Territory ; means in relation to either party any circumstances beyond the reasonable control of that party including without limitation any strike, 3 .. DeltaView comparison ofiManageDeskSite:/INYDMSOIINYDOCS / I1566741l and iManageDeskSite:/INYDMSOlINYDOCS / I15667412 . Perfolllled on 6/14/2004 . • • • · • • • • •,