definiens: shall have the meaning set out in Subsection 6.1(b ) ; ( i ) shall have the meaning set out in Section 2.1 ; ( 1 ' ) shall mean the United States Food and Drug Administration or any successor agency thereof ; ( It ) shall mean the use of a Licensed Compound or a Licensed Product for — ( 1 ) shall mean the ﬁrst sale of a Licensed Product by [COMPANY] or an Affiliate or a sublicensee of [COMPANY] in a country in the Territory following the receipt or issuance of Regulatory 21 8268 90242W3 9.RAC 020404/1143/[397 Approval for the Licensed Product in that country or, if no such Regulatory Approval or similar marketing approval is required, the date upon which the Licensed Product is ﬁrst commercially launched in such country . For the purposes of the deﬁnition of in the deﬁnition of Afﬁliate shall mean direct or indirect beneﬁcial ownership of 35 % or greater interest in the income of a Person or such other relationship as, in fact, constitutes actual control ; ( 111 ) or shall mean the conventions, rules and procedures that deﬁne accounting practices as established, and revised or amended, by ﬁle‘Financial Accounting Standards Board ; ( n ) shall mean The Institute of Cancer Research : Royal Cancer Hospital, London, United Kingdom ; ( 0 ) means the Collaboration Agreement between ICR and Johnson Matthey PLC dated November 15th, 1989, as amended by Letter Agreement dated February 25th ; 2 % and by Amendment dated March 24, 1998 ; I ( p ) shall mean an lnvestigational New Drug Exemption under 21 CPR . 355(i ) pursuant to the rules and policies of the FDA and such equivalent regulations or standards of countries outside the United States as may 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, trademark applications and trade secrets ; - ( r ) shall mean any and all data, results, instructions, processes, formulae, trade secrets, expert opinions, regulatory submissions and other information ( in written or other tangible form ) including, without limitation, any chemical, pharmacological, toxicological, pre - clinical, clinical, assay, control and manufacturing data, biological materials, manufacturing or related technology, analytical methodology, chemical and quality control procedures, protocols, techniques, improvements, results and reports of experimentation and testing ; the making, having made, using, sel mg, 0 enng or sa e or importing of which would, but or e rcense 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 in dosage form in any formulation that containsa Licensed Compound as an active ingredient and that are packaged 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 all documents, data, and other information concerning a Licensed Product which are necessary for, or included in, FDA approval to market such Licensed Product as more fully deﬁned in 21 C.F.R. § 314.5 et seq and such equivalent regulations or standards of countries outside the United States as may be applicable to activities anticipated hereunder ; ( v ) shall mean the gross invoiced sales price for Licensed Product sold or otherwise transferred to end 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 otherwise unacceptable product ( voluntarily made or requested or made by quantity, trade, an appropriate governmental agency, subdivision or department ) on account of or in relation to the invoiced sales price 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, 21 826B 90242\V39.RAC 020404 ” 143/ 1397 ( W ) ( X ) ( y ) ( Z ) ( 33 ) ( bb ) ( iii ) any duty, tax, excise or governmental charge upon or measured by the production, sale, tIaDSportation, delivery or use of Licensed Products related to or based upon sales of Licensed Products ( including value added taxes but excluding taxes on netainggme ), 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