definiens: First Development PlanFirst IndicationForce MajenreGroupIndicationsIndications CommitteeIntellectnal Property " means the member states from time to time of the European Union and Switzerland and Norway ; means the average cost per patient in respect of patients in the EU in a Phase ill Study effected in respect of a Product under a Development Plan ; means in respect of each Product, the date upon which a Dossier for such Product shall first be submitted by [COMPANY] in support of an application for Marketing Authorisation to the EMEA under the Centralized Procedure ; means the Development Plan relating to the First Indication Product ; means recurrent and/or progressive malignant brain neoplasms ; means in relation to either party any circumstances beyond the reasonable control of that party and caused by factors external to that party, including without limitation any strike, lock - out, or other fOIln of industrial action, act of God, war, riot, accident, fire, flood, explosion or government action ; means in relation to either party that party and all of its Affiliates for the time being and a of a party 's Group shall mean such party and any such Affiliate ; means the First Indication, the Second Indication and any Agreed Indications ; means a committee composed of an equal number of representatives of each Party, for the purposes of Clause 16 and otherwise in respect of any Market Research ; means all Patents, claims in Patents, trademarks and trade names, service marks, registered designs, applications for any of the foregoing and the right to apply for any of the foregoing in any part of the world, copyright, design right, inventions, confidential infollnation ( including Know - how ) and any other 4 ..... DeltaView comparison of iManageDeskSite : IINYDMSO I INYDOCS / I 156748/1 and iManageDeskSite : IINYDMSOIINYDOCS / I156748/2 . PerfoIlned on 6/14/2004 . • ••, f, • •,, •, similar right situated in any country in the world ; means all infounation not in the public domain of whatsoever nature, including ideas, discoveries, inventions, data, fonnulae, techniques, procedures for experiments and tests, designs, sketches, records, biological materials and confidential analyses and interpretations of infounation which is in the public domain ; means the trademark which as at the Effective Date is the subject of an application for a Community Trademark under application number 002544492 and registered as a trademark in the United Kingdom and Switzerland, in connection with the Product ; means whichever is the earlier of either the date of Commercial Launch by [COMPANY] of a Product in a Major EU or at least two EU Countries after all necessary Marketing Authorisations shall have been obtained and for this purpose shall mean a launch supported by such marketing expense and support and in such Product quantities as may reasonably be appropriate to establish the Product in such Major EU Country or in at least two EU countries ; and for the purposes of this definition, shall mean Geunany, United Kingdom or France ; means the rate per armum ( rounded upwards if necessary to the next higher 1I100th of 1 % ) which is the average of the interbank offered rates for EURO and US Dollar deposits in the London interbank Euro Dollar Market for a period of one week as reported in the Financial Times newspaper in its column on the relevant date or if the Financial Times does not publish such rate for any reason, such rate as is quoted by Reuters at 10.00 am ( London time ) on such date or ( if the relevant date is not a Business Day ) on the first Business Day following the relevant date ; means an estimation by an independent market 5 " DeltaView comparison of iManageDeskSite : IINYDMSOIINYDOCSII 156748/1 and iManageDeskSite:/INYDMSOIINYDOCSII 156748/2 . Perfouned on 6114/2004 . ! t, t,,,, Market ResearchMarketing AuthorisationMode of ActionNet Sales " research organisation based on its Market Research of the commercial potential for a Product in the Territory taking into consideration number of patients suffering from a disease relevant to such indication and who would be likely to be treated with the Product for that disease, including issues such as hospital policies, concurrent symptoms and typical overall health condition of a patient suffering from the relevant disease, availability of alternative treatments, ethical considerations, surgeons perception of the effect and relevance of the Product on the disease of the specific patient and the probable local price of the Product ; means market research conducted by an independent market research organisation ( in connection with the Third Indication, identified and agreed by the Indications Committee ) and based on interviews with an adequate number of neurosurgeons or other experts deemed of relevance in various countries ; means approval / license for a Product issued by the competent authorities in the Territory or part of the Territory, being a national or supra national ( EMEA for the EU ) as appropriate ; means the mechanism by which a Product is understood to work using a biologic targeting mechanism to deliver toxin to diseased cells ; means all monies invoiced by [COMPANY] or its Affiliates or any Sub - licensee in respect of the sale by [COMPANY], its Affiliate or any Sub - licensee of Products to an independent third party on anns length terms less the following items to the extent that they are actually paid or allowed and specified on the invoice or actually included in the invoice price : ( i ) normal discounts actually granted ( including for the avoidance of doubt reimbursement to a customer of promotional costs ) ; ( ii ) credit actually allowed for Products returned or not accepted by customers ; ( iii ) packaging, transportation and prepaid insurance charges on shipments or deliveries to customers ; 6 . DeltaView comparison ofiManageDeskSite:/INYDMSOIINYDOCS/115674811 and iManageDeskSite:/INYDMSOIINYDOCSII 156748/2 . Perfonued on 6114/2004 ., • • and ( iv ) sales or value added taxes actually incurred and paid by [COMPANY], its Affiliates or any Sub­licensee in connection with the sale or delivery of Products to customers ; Provided That : ( a ) there shall be substituted for the price calculated as above in the calculation of Net Sales where Products are sold otherwise than on ann 's length tenns, but are subsequently sold on ann 's length terms, the price charged under the first such ann 's length sale, calculated as above ; ( b ) Products reasonably supplied as samples shall not be treated as being disposed of on a commercial basis and shall be ignored for the purpose of calculating Net Sales ; means such Phase III Clinical Trials in respect of a Product as may be effected by [COMPANY] in the Territory at the request of KSB, prior to grant of a Marketing Authorisation in respect of such Product, upon the telms of Clause 4.3.3 ; means any trademark or name or logo proprietary to [COMPANY] used on products marketed by [COMPANY] ( in addition to any mark, logo or name specifically identifYing the Product ) to identifY [COMPANY] as the holder of a Marketing Authorisation for such product ; means the designation number EMEA - H - MC-3433 - 02, dated 19th March 2002 of the Product as an orphan medicine by the Committee for Orphan Medicinal Products in accordance with Article 5 of Regulation ( EC ) No 14112000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products ; means any indication for a Product in the field of the therapy of brain cancer excluding only the First Indication, the Second Indication and the Third Indication ; 7 DeltaView comparison ofiManageDeskSite : IINYDMSOIINYDOCS / I156748/1 and iManageDeskSite : IINYDMSOIINYDOCS/115674812 . Performed on 6/14/2004 . ! Part Trial Review DatePatentsPharmacovigilancePhase III StudyPrice & Reimbursement ApprovalsProductProduct Data " means the date of completion of the Part Trial Review, being an analysis of the relevant number of patients in the first Phase III Study effected by the independent safety and monitoring board established under the First Development Plan, such analysis and such number of patients to be such as may be necessary to give an indication of the likely success of the first Phase III Study, as agreed in the First Development Plan ·, means all patents or letters patent, claims in any patent and applications for the same and the right to apply for the same in any part of the world including, all reissues, extensions, substitutions, confinnations, registrations, revalidations, additions, continuations in part and divisions thereof and any SPCs ; means the establishment and maintenance of a system to ensure ( i ) that infonnation about all suspected adverse reactions regarding the Product is collected, evaluated and collated so that it may be accessed at one single point within the ED ; ( ii ) the preparation for submission to the Agency and competent authorities of the Member States of the reports referred to in Council Regulation ( EEC ) No.2309/93 ; and ( iii ) that any request from the Agency and competent authorities for the provision of any necessary additional information is answered fully and promptly ; therapeutic confirmatory Clinical Trials effected for the purpose of obtaining Marketing Authorisation in the ED for a Product in an Indication ; means approval or listing on official price lists, reimbursement schedules or hospital recommendation lists as appropriate for the individual markets ; means any product developed from single point mutated diphtheria toxin linked to human transferrin and any improvements or line extensions of any such products developed by KSB or any KSB Affiliate for use in ( i ) the First Indication ; or ( ii ) the Second Indication ; or ( iii ) an Agreed Indication ; means all data ( single data, reports, analyses etc . ), documentation or correspondence obtained in the use 8 ... DeltaView comparison ofiManageDeskSite:/INYDMSOIINYDOCS / I156748/1 and iManageDeskSite:/INYDMSOIINYDOCSIl156748/2 . Performed on 6/14/2004