definiens: means 5 - aminoimidazole -4 - carboxamide -1 - b - D - ribofuranoside, CAS number : 2627 -69 -2 ; means any business entity which, from time to time, controls, is controlled by, or is under common control of either party ; and, for the purpos es of this definition, a business entity will be de emed to another business entity if it owns, direc tly or indirectly, in excess of fifty ( 50 ) per cent . of the outstanding voting securities or capital stock of s uch business entity and has the right, directly or indirectly, to appoint more than half of the members of the boa rd of directors of such business entity, or owns, d irectly or indirectly, any other comparable equity or owner ship interest with respect to a business entity oth er than a corporation ; means any claim, counterclaim, suit, action or proc eedings ; 1 has the meaning given in clause 18.1 ; means those studies of the Product described as suc h in the Development Programme, and means any of them ; means any confidential information disclosed to a p arty by, or at the direction of, the other in connection with this agreement, regard less of form or medium ; means cost and expense of any nature whatsoever ( in cluding legal costs and disbursements ) ; means applicable trade and cash discounts and ( wher e such items are specifically shown in the relevant invoice ) purchase, applicable sales and i m port taxes, Value Added Taxes, and the costs of del ivery and insurance ; means the manufacturing, non - clinical and clinical development and studying of the Product undertaken further to this agreement, a s determined pursuant to clause 5.7(e ) or 5.13 ; has the meaning given in clause 10.1 ; means any dispute or controversy of whatever nature arising out of, or in any way relating to, this agreement or its formation or Termination, includin g any Claim ; means Product processed so as to be ready for human use ; means the date of signature this agreement by the s econd party to sign ; means any licence, mortgage, charge ( fixed or float ing ), pledge, lien, hypothecation, trust, right of set off or other third party right or inte rest ( legal or equitable ) including any right of pr e - emption, assignment by way of security, reservation of title or any other security interest of any kind however created or arising or any other agreement or arrangement ( incl uding a sale and repurchase arrangement ) having sim ilar effect, and will be construed accordingly ; means this agreement, together with any other docum ents referred to in it ; means an interest - bearing deposit account with the Escrow Account Bank ; means Barclays Bank plc or such other bank or finan cial institution as the parties may agree from time to time in writing ; has the meaning given in clause 18.1 ; has the meaning given in clause 21.13 ; means any and all areas of human use of the Product ; means the clinical study in which the Product is gi ven, for the first time, to human subjects, but not including any extensions of such study after the first set of data derived from it h ave been analysed ; means, with respect to any country or territory, th e first disposal for value of any quantity of the Product for use in the Indication a fter the grant of 2 all Health Registration Approvals and Pricing Appro vals in such country or territory, not including an y Named Patient Sale ; means those principles, and the guidelines in line with those principles, provided for in Commission Directive 2005/28 / EC, and their equiv alents anywhere in the world ; means those principles and guidelines provided for in Commission Directive 2003/94 / EC, and their equivalents anywhere in the w orld ; means the exercise of that degree of skill, diligen ce, prudence and foresight which would reasonably and ordinarily be expected from a skilled and experienced business seeking in good fa ith to comply with its contractual obligations and engaged in the same type of undertaking, and under the sam e or similar circumstances and conditions, as those envi saged by this agreement, including, as applicable, compliance with Good Clinical Practice, Good Manufacturing Pra ctice and Good Laboratory Practice ; means those rules and criteria applicable to Qualit y Assurance, as are relevant in the circumstances, concerned with the organisationa l process and the conditions under which non - clinic al health and environmental safety studies are planned, perfo rmed, monitored, recorded, reported and archived ; means any applicable supra - national, national, fede ral, regional, state, provincial or local agency, department, bureau, commission, council or other entity regulating, or otherwise exercising au thority with respect to, the development, testing, manufact ure, marketing or sale of pharmaceutical products ; means, with respect to a country or territory, any and all approvals, licences, registrations or authorisations of any Health Autho rity necessary lawfully to : ( a ) distribute, sell and market the Product for the Ind ication in such country or territory, including, wh ere applicable, post - approval marketing authorisations, labelling approvals and technical, medical and scientific licences and pricing or reimbursement ap provals ; or ( b ) undertake clinical studies ; means defend, indemnify and hold harmless ; means the treatment of chronic lymphocytic xxxxxxxx x ; means Christian Wagner of Bioscience Valuation BSV GmbH, registered in Xxxxxxx xxxx xxx xxxxx xx xxxxxxxx xx Xx Zigeunerbergl 3, 8 2491 Grainau, Germany, or such other person of comparable skill and experience as such company may designate ; means any loss which would be recoverable only unde r the seconx xxxx of the relevant test set out in Hadley -v- Baxendale ( 1854 ) 9 Ex.341, that is, such losses beyond those arising naturally, but of a type as may reasonably be supposed to have been in the cont emplation of both parties, at the time they made th e agreement, as the probable result of the breach of it ; means any and all trade marks, domain names, rights in designs, get - up, business names, database rights, copyrights, future copyrights, and patents ( whether registered or not and any applications to register or rights to apply for reg istration of any of the foregoing ), rights in inven tions, know - how, trade secrets and 3 other confidential information, and all other intel lectual property rights of a similar or correspondi ng nature, which may now or in the future subsist in any part of the world ; means the committee referred to by that name in cla use 4, constituted and having the functions and responsibilities specified therein ; means the technical information and data pertaining to the Product, including such as arises from the Development Programme, in the possession, or un der the control, of Advancell, now or hereafter ( in cluding all biological, chemical, pharmacological, toxicolo gical, clinical, assay, control and manufacturing d ata and any other information relating to the Product useful fo r the Development Programme, in each case to the ex tent that the same is secret, substantial and identified ) ; means all ( or the highest ) statutory, common law, e quitable governmental and regulatory obligations in the relevant part of the world, including any order of a court of competent jurisdiction or government department or agency or the rules and standards of any recogni sed securities exchange ( including the Listing Rule s of the UK Listing Authority ) or the rules and requirements of any other regulatory body, including any Health Authority ; and any rules or requirements relating t o export or import ; has the meaning given in clause 13.6 ; means the rights and licences granted, or to be gra nted, to [COMPANY] by clause 7 ; has the meaning given in clause 10.2 ; means any losses or damages of any nature whatsoeve r, comprising : ( a ) Indirect Loss ; and ( b ) any loss which under English law would properly be considered as direct loss or which does not constitute Indirect Loss ; means any Health Registration Approval which is a m arketing authorisation for the purposes of Directive 2001/83 / EC of the European Pa rliament and of the Council ( as amended ), and any equivalent Health Registration Approval, including a product licence having effect as such an authoris ation and a parallel import licence ; means the lawful placing on the market, or distribu tion by way of wholesale dealing, of the Product for which no Marketing Authorisation is in force in the part of the world in which it is p laced on the market or distributed by way of wholesale dealing a t the time of such placing on the market or distrib ution ; means the gross receipts of [COMPANY], or its rele vant Sub - Licensee, as applicable, in cash or otherwise, in respect of any Royalty Event, less an y Deductions ; has the meaning given in clause 18.2 ; means those studies of the Product described as suc h in the Development Programme, and means any of them ; and have the respective meanings given to them in claus e 16.7 ; means a pharmaceutical product designated as such b y the relevant Health Authority ; 4 means the designation of the Product as an Orphan D rug for the Indication and the benefits of such designation conferred on its a pplicant ; means : ( a ) the patents and patent applications specified in sc hedule 1 and any patent which may be granted pursua nt to any such application ; ( b ) any patent or application corresponding to any such patent or application which may be granted or made ; and ( c ) any re - issue, extension or restoration of any such patent, and any division or continuation of any suc h application ; means the relevant party ’s employees, agents and su b - contractors ; “ Phase IIb Study means a study in patients designed to compare the s afety and efficacy of a range of dosing regimens of the Product, and which is not a Phase I II Study ; means a large scale, pivotal, multi - centre, human c linical study to be conducted in a number of patients estimated to be sufficient to establish efficacy of the Product at a standard suitable to obtain a Health Registration Approval, or otherwise intended to pro vide the substantial evidence of efficacy necessary to support an approvable filing for a Health Registration Appr oval ; means pricing or reimbursement approvals in the rel evant country or territory ; means any injectable formulation of Acadesine devel oped prior to the Effective Date ; xxxxs, with respect to [COMPANY], Saxxx Xxxxxxxx ; and with respect to Advancell, Clara Campàs, or such other persons as the relevant party may appoint by notice in their place ; means the sum total of the arrangements made with t he object of ensuring that products are of the quality required for their intended purp ose ; means the period ending on 31 March, 30 June, 30 Se ptember and 31 December in each year, and will be construed accordingly ; has the meaning given in clause 10.1 ; means all applications, registrations, licences, au thorisations and approvals relating to the use of the Product for the Indicati on ; has the meaning given in clause 21.13 ; means the sum for the time being standing to the cr edit of the Escrow Account, together with interest which accrues thereon, or so much thereof as remains subject to the provisions of clause 3 fr om time to time ; means any sale of the Product ( including a Named Pa tient Sale, and regardless of the location of the sale and the identity of the Purchaser ) for the Indication by or on behalf of [COMPANY], or an y of its Sub - licensees, to any third party, provided that : ( a ) if the third party is an Affiliate of [COMPANY], R oyalty Event means the first such sale of the Produ ct to a third party which is not an Affiliate of [COMPANY] ; and 5 ( b ) if, at the time of the sale by or on behalf of Prot herics, its Sub - Licensee or its Affiliate ( as the c ase may be ), the Product is not in the form of a Drug Produ ct, Royalty Event means the first such sale of the Product which ix x Xxxx Xxoduct ; xxxxx Barry Riley of [COMPANY] and Luis Ruiz - Avila of Advancell, or such other persons as the relevant party may appoint by notice in thei r place ; has the meaning given in clause 13.6 ; means the committee referred to by that name in cla use 5, constituted and having the functions and responsibilities specified therein ; means any Clinical Study or Non - clinical Study ; means a sub - licence under the Licence, and will be construed accordingly ; means the sub - licensee under any Sub - licence ; means the term of this agreement ; means termination of this agreement, by either part y, at any time on any lawful ground, as well as expiry of this agreement ; means any claim of any Patent which : ( a ) has not been h eld permanently revoked, unenforceable or invalid b y a decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal ; ( b ) has not been abandoned, disclaimed, denied or admit ted to be invalid or unenforceable through re - issue, disclaimer or otherwise ; and ( c ) with respect to a Patent which is a pending patent application, has not been abandoned or finally disallowed without the possibility of appeal or re -filing of the application ; and means value added tax or any other tax of a similar nature that may be substituted for or levied in addition to it in each case at the rate c urrent from time to time