definiens: AffiliateAgreementAmerican Depository Shares " Has the meaning set out in the Oty Code on Takeovers and Mergers current at the date of this Agreement ; Means with respect to a party, a person, corporation, partnership or other entity which Controls, is Controlled by or is under Control of such a party ; Means this patent and know - how licence agreement ; Means American depository shares issued by Citibank N.A., each such American depository share representing ten ordlnary shares of 10 pence each in the capital of the Licensee or as may otherwise be provided 147961v2 -1 -4 5 Means the use of the Licensed Product for the treatment and prevention of HD ; Spino­cerebellar atrophy ; Progressive supranuclear palsy ; Fragile X ; and Friedreich 's ataxia ; Means the aggregate at the Effective Date of ( i ) the entire issued share capital of Licensee ; and ( ii ) all unissued share capital of Licensee which Licensee is or may be under an obligation to issue ( whether by way of option, contract, encumbrance, conversion, pre - emption or otherwise howsoever and whether exercisable now or in the future and whether actual or contingent ) ; Means an agreement between the parties which sets out the commercial terms including but not limited to up - front payments, milestones, IIUIU.m.um performance targets, royalties and/or profit sharing arrangements for the licence, manufacture and sale of Potential Product ; Means any improvement, enhancement or modification to the Licensed Know - how or Licensed Patent which is relevant to the development, Manufacture or use of any Licensed Product in the Field of Use ; Means the date of first Sale of Licensed Product in the Territory by Licensee ; Means all and any information, data and know - how provided by Licensor to Licensee under this Agreement including but not limited to, Development Work, the New Drug Application, Results and any and all pre - clinical components in relation to the Results ; Means the patent application number US 09.492,741 filed in January 2000 based on GB 9901809.5 and, in the event of any amendment of or division of the same such amended or divided applications or any of them and any patent granted pursuant to such applications and ( in the event the grant of patents is finally refused ) all rights which Licensor has in the inventions and subject 147961v2 -3 -,,, I matter ef such applications and the Orphan Drug Status ; Means any product Manufactured fer Sale by Licensee in the Field ef Use which contains any cempound er fermUlatien ef a compeund which falls within the claims ef the Licensed Patent er the Orphan Drug Status er is derived or Manuiactured using Licensed Knew - hew ; Means the Licensee and its majerity - owned subsidiaries ; Means the impertatien, encapsulatien and packaging of Licensed Product and '' Manufacturing, '' ' ' Manufactured '' and derivatiens therefrem shall be censtrued accordingly ; Means these criteria set eut at Schedule 2 ; Means a dessier containing the infermatien required to obtain regulatery approval ef the Licensed Product by the FDA in the Field ef Use in the Territery ; Means the orphan designatien ef Ethyl EPA in the Field of Use issued by the Office ef Orphan Products Develepment under authority of the FDA on 6th April 2000 ; Means large scale human clinical trials conducted in patients and designed to ' establish Licensed Preduct efficacy in the Field ef Use tested and required to ' ebtain regulatory appreval ef Licensed Preduct by the FDA ; Means any new product Licenser devises in the fields of schizophrenia, depressien, dementia, bipolar diserder, Parkinsen 's disease and attention deficit hyperactivity disorder which is derived frem the Licensed Patent ; 147961v2 -4 -2 3 4 5 /, . 12