definiens: means, with respect to PRODUCT in a particular country in the TERRITORY, the occurrence of an adverse event with respect to PRODUCT as defined by applicable law or regulation in such country ; 1.1.2 means any business entity that directly or indirectly controls, is controlled by, or is under common control with either party to this AGREEMENT . A business entity shall be deemed to another business entity if it owns, directly or indirectly, more than fifty ( 50 % ) percent of the outstanding voting securities, capital stock, or other comparable equity or ownership interest of such business entity . If the laws of the jurisdiction in which such business entity operates prohibit ownership by a party of more than fifty percent ( 50 % ), control shall be deemed to exist at the maximum level of ownership allowed by such jurisdiction ; 1.1.3 means this amended and restated collaboration agreement, together with all schedules and appendices hereto and any amendments to or restatements of this amended and restated collaboration agreement ; 1117215.12 Execution Copy Confidential Treatment Requested by [COMPANY] Corporation, File No . 333 - 145995, Exhibit 10.23 2 1.1.4 includes, but is not limited to, with respect to PRODUCT in relation to a particular country in the TERRITORY, direct material, labour and subcontracted costs incurred by or on behalf of BIOMIRA in connection with the procurement of raw materials, manufacture, vialing, testing, stability, releasing and shipment of PRODUCT, as well as the indirect costs of administration, salary, support, depreciation, facility rental, facility repair and maintenance, facility utilities, insurance and facility property taxes attributable to PRODUCT ( which indirect costs shall not exceed forty percent ( 40 % ) of the direct costs ) ; 1.1.5 has the meanmg attributed to that term m section 9.2 of this AGREEMENT ; 1.1.6 means all proprietary information and data in the FIELD including but not limited to compounds, formulae, protocols, methods, techniques and results of experimentation and testing, which, except for published patent applications which are also included within this definition, is generally not known to the public, and which are owned by BIOMIRA or licensed in by BIOMIRA with the right to sublicense in the manner contemplated by this AGREEMENT, and which directly relate to research, CLINICAL DEVELOPMENT, use and/or sale of PRODUCT . For greater certainty, BIOMIRA KNOW - HOW shall include BIOMIRA IMPROVEMENTS and IMPROVEMENTS licensed in by BIOMIRA with the right to sublicense in the manner contemplated by this AGREEMENT, which arise or occur after the ORIGINAL EFFECTIVE DATE and which fall within the ambit of the preceding sentence . Notwithstanding the foregoing, BIOMIRA KNOW - HOW shall not include any subsequently developed or acquired BIOMIRA KNOW - HOW to the extent covering any active compound that is separate and clearly distinct from PRODUCT, notwithstanding the fact that such active compound may be useful as part of a combination therapy with PRODUCT ; 1.1.7 means all rights in the FIELD owned by BIOMIRA or licensed in by BIOMIRA with the right to sublicense in the manner contemplated by this AGREEMENT in any of the following patents : any patent issuing on any patent application identified in appendix 1, as well as any patent issuing from any continuing applications of the patents listed in appendix 2, such applications including any divisions, continuations, and continuation - in - part applications, as well as any patents issuing on any reissue and/or reexamination application, and including any patent term restoration of any such patents