definiens: means a course of treatment of a patient with Licensed Product that consists of two treatmen ts, each of not more than 27 micrograms of API ; 1.1.8 means single point mutated diphtheria toxin ; 1.1.9 means a plan for t he undertaking of all appropriate activities for the develo pment of Licensed Product in the Territory, to be prepared in acco rdance with Clause 4.3, and which shall include detailed plans co vering the activities summarised in Schedule 2 ; 1.1.10 means, in respect of each c ountry, the master regulatory dossier relating to the Licensed Prod uct prepared by or on behalf of either Party in connection with ob taining the Marketing Authorisations for the Licensed Produ ct in and outside of the Territory, including relevant Program me Data ; 1.1.11 means 12th April 200 5 ; 1.1.12 means the European Union and eac h of the member states from time to time of the European Union ; 1.1.13 means the date upon whi ch a Dossier for the Licensed Product is submitted by or on behalf of [COMPANY] in support of an application for the Marketing Auth orisation of the Licensed Product in any part of the Territory ; 1.1.14 means in relation to either Party any circumstances beyond the reasonable c ontrol of that Party including without limitation any stri ke, lock - out or other form of industrial action, act of God, war, r iot, accident, fire, flood, earthquake, explosion or government a ction ; 1.1.15 means glioblastoma multiforme ; 2 Final Version 12 April 2005 Confidential 1.1.16 means the guidelines established from time to time by the International Conference on Harmonization of Technical Requirements for Registration of Phar maceuticals for Human Use ; 1.1.17 means the Initial Indic ations and any Other Indications ; 1.1.18 means each indi cation within the general area of the treatment of brain tumour s in humans including the following indications : ( a ) recurrent, non - resectable GBM in adult humans ; ( b ) newly diagnosed GBM in adult h umans ; ( c ) metastatic GBM in adult humans ; and ( d ) each of the indications referr ed to in paragraphs ( a ) to ( c ) above in humans under the age of 18 years ; 1.1.19 means all pat ents, claims in patents, registered designs, applications for any of the foregoing and the right to apply for any of the foregoi ng in any part of the world, copyright, design right, inventions, confidential information ( including Know how ) and any other si milar right ( but excluding any Trademarks ) situated in any count ry of the world ; 1.1.20 means a Joint Development and Commercialisation Committee to be formed in accordance with Claus e 4.2 ; 1.1.21 means all information rela ting to the API and/or the Licensed Product not in the public do main of whatsoever nature, including any such information contai ned in the Dossier and including any pre - clinical and clinic al data ; 1.1.22 means each date of Comm ercial Launch by [COMPANY] of the Licensed Product in each count ry of the Territory after all necessary Marketing Authorisations ha ve been obtained by [COMPANY] ; 1.1.23 means the rate per annum ( rou nded upwards if necessary to the next higher 1/100th of 1 % ) which is the average of the inter bank offered rates for US Dollar depo sits in the London inter bank Euro Dollar Market for a period of fi ve consecutive Business Days as reported in the Financial Times ne wspaper in its column on the relevant date or if the Financial Times does not publish such rate for any reason, suc h 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 fi rst Business Day following the relevant date ; 1.1.24 means any pharmace utical product in finished dosage or in finished dosage package form ready for sale to third parties which consists of or contains the API for human use 1.1.25 means such formal approvals from the State Food and 3 Final Version 12 April 2005 Confidential Drug Administration ( People 's Republi c of China ), Korean Food and Drug Administration ( Republic of Kore a ) or Department of Health ( Taiwan ), as applicable, as are neces sary for the commercial marketing, sale and use of the Licens ed Product in the Territory ; 1.1.26 means an application for Marketing Authorisation in any countr y of the Territory ; 1.1.27 means a plan for the undertaking of all appropriate activities for commercial isation of Licensed Product in the Territory, including pre - launc h and post - launch marketing and sales activities, to be prepared in accordance with Clause 4.3 ; 1.1.28 means perso ns appointed by [COMPANY] and [COMPANY] to communicate with each other with regard to information to be exchanged pursuant to Clause 7.1 ; 1.1.29 means all monies invoiced to the ultimate purchaser by [COMPANY] or its Affiliates or any Sub - Licensees or their respective agents or distributors, in respect of the sale of the Licensed Product less the following i tems to the extent that they are actually paid or allowed and spec ified on any documents related to such sale : ( a ) normal discounts actually gran ted ; ( b ) credit actually allowed for an y Licensed Product returned or not accepted by customers o n quality grounds ; ( c ) packaging, transportation and prepaid insurance charges on shipments or deliveries to cus tomers ; ( d ) cost of samples for regulatory testing, promotional and hospital listing purposes as s et out in the Marketing Plan from time to time ; and ( e ) sales or value added taxes act ually incurred and paid by [COMPANY], its Affiliates o r any Sub - licensees in connection with the sale or de livery of the Licensed Products to customers ; Provided that the total, aggregate am ount of deductions under paragraphs ( a ), ( b ) and ( c ) above wit h respect to any unit of Licensed Product shall not exceed 10 % of the sale price