definiens: means the date of this Agreement ; means the field of the diagnosis, treatment or prevention of disease in humans ; means fully formulated, in final form packed for ultimate consumer use and suitable for purchase by a purchaser or distributor who is not undertaking substantial product support or marketing, ( e.g. a d rug wholesaler, a pharmacist or a group of pharmacists, a chain of drug retailers or a hospital or central purchasing department for a group of hospitals ) ; the date of the last to occur of : the date of the f irst commercial sale by or on behalf of the Licensee or any Sub - licensee of Licensed Product ( excluding License d Product utilised under clinical trials ) in any coun try of the Major Territory or Japan ; means the General Index of Retail Prices ( All 5 Items ) of the United Kingdom Central Statistical Office or, if that Index shall cease to be publishe d, the nearest index having like effect ; means the technical information and data specified in Schedule 2 and any other information and/or data disclosed to the Licensee by [COMPANY] pursuant to this Agreement, which in either case at the time of thei r disclosure to the Licensee are not in the public do main other than by any default of the Licensee or person s acquiring the same from the Licensee and are proprietary to [COMPANY] or are owned or controlled by [COMPANY] . For the avoidance of doubt it is declared and agreed that : ( i ) the know - how set out in Schedule 2 shall not be excluded from the definition of due to the fact that [COMPANY] only has a sole licen se of the same from CRC or due to the fact that such know - how has be en disclosed to Licensee indirectly by or on behalf of KuDOS under the terms of the Novace a Licence ; and ( ii ) know how may be added to the list set out in Schedule 2 according to the provisions of Cl ause 11.9 ; means : ( a ) AQ4N ; or ( b ) any product made or sold or otherwise dispos ed of, in any country by, or on behalf of, the Licensee or a Sub - licensee or their Affiliates, and which : ( i ) falls within the scope of, or utilises any method or process which falls within the scope of Valid Claims of any of the Patents ; or ( ii ) embodies or utilises any of the Know How ; means any and all discoveries and inventions which are owned or controlled by or licensed to the Licensee or any Sub - licensee and which directly relate to the inventions which are the subject of the Patents and which arise from any evaluation, trial, research an d / or development, by or on behalf of the Licensee or Sub -licensee of Licensed Products ; 6 means any and all technical data, know - how, softwar e, notes, chemical compounds, biological material, reports, pre - clinical and clinical data, documentat ion relating to regulatory submissions and marketing authorisations, and all other material owned or controlled by or licensed to the Licensee or any Su b - licensee which arise from any evaluation, trial, research and/or development by or on behalf of the Licensee or Sub -licensee of Licensed Products ; means any of the United States of America, France, Germany or the United Kingdom ( or the European Union as a whole in any case where the relevant application for Marketing Authorisation was a singl e application in respect of the European Union as a whole ) ; means regulatory approval granted to the Licensee, any Sub - licensee or any of their respective Affiliates from the body or bodies having responsibility for the regulation of medicinal products in a particular ma rket for Lic ensed Products to be marketed and sold ; means the price of Licensed Products which are the subject of a Chargeable Transaction calculated as follows : ( i ) in the case of an arm ’s length sale or othe r disposal, the gross price as charged or invoiced, less any Deductions ; ( ii ) in the case of a sale or other disposal which is no t at an open market price or which is for non - cash consideration the open market price in the country where the transaction was effected less any Deductions ; ( iii ) With respect to sale of a Combination Produc t, the for the purposes of calculating royalties hereunder on Licensed Products in such Combination Product will be calculated by multiplying the gross price as charge or invoiced for such Combination Product less any Deductions by the fraction A/(A+B ) where A is the gross price as charged or invoiced 7 for the Licensed Product when sold in a product in which Licensed Product is the sole Active Ingredient and B is the aggregate of the gross prices charged or invoiced for any other Active Ingredient(s ) in the Combination Product when sold in a product in which it is or they are the sole Active Ingredient(s ) in such product . If the Active Ingredient(s ) in the Combination Product other than Licensed Product is / are not sold separately, for purposes of calculating royalties payable hereunder shall be the greater of : ( i ) A ( as defined above ) less any Deductions ; or ( ii ) the result of multiplying the actual price charged or invoiced for such Combination Product less any Deductions by the fraction A / C in which A is defined as above and C is defined as the gross price charged or invoiced for the Combination Product . If the Licensed Product in a Combination Products is not sold separately, then for the Licensed Product in a Combination Product shall be the greater of : ( i ) the amount calculated by deducting from the gross price charged or invoiced for such Combination Product, the Deductions and an amount equal to B as defined above ; and ( ii ) 50 % of the gross price charged or invoiced for the Combination Product less any Deductions . If neither the Licensed Product nor the Active Ingredient(s ) in the Combination Product are sold separately, of the Licensed Product shall be determined by a reputable independent auditor appointed by agreement between the Parties ( or failing which the Chairman for the time being of the Institute of Chartered Accountants of England and Wales ) with a decision of such auditor being final and binding on the parties and with the auditor acting as an expert and not as an arbitrator . If the price determined by the auditor is equal to or lower than that proposed by the Licensee, then [COMPANY] should be responsible for the costs of the appointment of the auditor . If the price determined by the auditor is greater than that 8 proposed by the Licensee then the Licensee should be responsible for the costs of such appointment