definiens: shall have the meaning set out in Subsection 6.1(b ) ; ( i ) shall have the meaning set out in Section 2.1 ; ( j ) shall mean the United States Food and Drug Administration or any successor agency thereof ; ( k ) shall mean the use of a Licensed Compound or a Licensed Product for the diagnosis, preventionand / or treatment of any human disease ; - 2 - ( l ) shall mean the first sale of a Licensed Product by [COMPANY] or an Affiliate or asublicensee of [COMPANY] in a country in the Territory following the receipt or issuance of Regulatory Approval forthe Licensed Product in that country or, if no such Regulatory Approval or similar marketing approval isrequired, the date upon which the Licensed Product is first commercially launched in such country . For thepurposes of the definition of, in the definition of Affiliate shall mean director indirect beneficial ownership of 35 % or greater interest in the income of a Person or such other relationshipas, in fact, constitutes actual control ; ( m ) or shall mean the conventions, rules and proceduresthat define accounting practices as established, and revised or amended, by the Financial AccountingStandards Board ; ( n ) shall mean The Institute of Cancer Research : Royal Cancer Hospital, London, United Kingdom ; ( o ) means the Collaboration Agreement between ICR and Johnson Matthey PLC datedNovember 15th, 1989, as amended by Letter Agreement dated February 25th, 1998 and by Amendment datedMarch 24, 1998 ; ( p ) shall mean an Investigational New Drug Exemption under 21 C.F.R. 355(i ) pursuant to the rules andpolicies of the FDA and such equivalent regulations or standards of countries outside the United States asmay be applicable to the activities conducted hereunder ; ( q ) shall mean any discoveries, improvements, patents, patent applications, copyrights, copyright applications, industrial designs, industrial design applications, mask works, trademarks, trademarkapplications and trade secrets ; ( r ) shall mean any and all data, results, instructions, processes, formulae, trade secrets, expertopinions, regulatory submissions and other information ( in written or other tangible form ) including, withoutlimitation, any chemical, pharmacological, toxicological, pre - clinical, clinical, assay, control andmanufacturing data, biological materials, manufacturing or related technology, analytical methodology, chemical and quality control procedures, protocols, techniques, improvements, results and reports ofexperimentation and testing ; ( s ) shall mean AMD473, and any analogues or derivatives or backup compounds ofAMD473, the making, having made, using, selling, offering for sale or importing of which would, but for thelicense granted herein, infringe a Valid Claim of one or more of the AnorMED Patents ; ( t ) shall mean any pharmaceutical compositions approved as a drug in the Territory indosage form in any formulation that contains a Licensed Compound as an active ingredient and that arepackaged and labelled for sale to the ultimate customer for use in the Field ; ( u ) means a complete New Drug Application and all supplements thereto filed with the FDA including alldocuments, data, and other information concerning a Licensed Product which are necessary for, or includedin, FDA approval to market such Licensed Product as more fully defined in 21 C.F.R. § 314.5 et seq and suchequivalent regulations or standards of countries outside the United States as may be applicable to activitiesanticipated hereunder ; ( v ) shall mean the gross invoiced sales price for Licensed Product sold or otherwise transferred toend users of the Licensed Product, less : ( i)credits or allowances, if any, given or made for purchase charge backs, price reductions, returns, rebates, rejections, recall or destruction of spoiled, damaged, out - dated, returned or otherwiseunacceptable product ( voluntarily made or requested or made by quantity, trade, an appropriategovernmental agency, subdivision or department ) on account of or in relation to the invoiced salesprice of Licensed Products, ( ii)if actually allowed or given ( A)allowances and/or incentives, ( B)price reductions, and ( C)rebates, on account of or in relation to the invoiced sales price of Licensed Products, - 3 - ( iii)any duty, tax, excise or governmental charge upon or measured by the production, sale, transportation, delivery or use of Licensed Products related to or based upon sales of LicensedProducts ( including value added taxes but excluding taxes on net income ), and ( iv)transportation and handling charges or allowances ( freight, postage, shipping and insurance ), if any, incurred on account of or in relation to the invoiced sales price of Licensed Products