definiens: means, with respect to PRODUCT in a particular country in the TERRITORY, the occurrenceof 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 commoncontrol with either party to this AGREEMENT . A business entity shall be deemed to another businessentity if it owns, directly or indirectly, more than fifty ( 50 % ) percent of the outstanding voting securities, capitalstock, or other comparable equity or ownership interest of such business entity . If the laws of the jurisdiction inwhich such business entity operates prohibit ownership by a party of more than fifty percent ( 50 % ), control shall bedeemed to exist at the maximum level of ownership allowed by such jurisdiction ; 1.1.3 means this amended and restated license agreement, together with all schedules and appendiceshereto and any amendments to or restatements of this amended and restated license agreement ; 1.1.4 has the meaning attributed to that term in the seventh recital to thisAGREEMENT ; 1.1.5 means ONCOTHYREON ’s immunotherapeutic vaccine composed of a 25 - amino acid sequence of theMUC1 cancer mucin, which vaccine is combined with the adjuvant monophosphoryl Lipid A and is encapsulatedin a liposomal delivery system, together with ( i ) any IMPROVEMENTS thereto ( such as liposomal IL-2 in a kit, synthetic Lipid A, or new delivery formats such as unit dose liquid formulations and unit dose syringes ) owned byONCOTHYREON or licensed in by ONCOTHYREON during the term of this AGREEMENT with the right tosublicense in the manner contemplated by this AGREEMENT and ( ii ) any PRODRUG thereof ; 1.1.6 means any variant of ONCOTHYREON ’s ( or its AFFILIATES ’ ) immunotherapeutic vaccine composedof two tandem repeats of the MUC1 cancer mucin, whether or not glycosylated, and whether or not lapidated, which vaccine is combined with an adjuvant and is encapsulated / incorporated in a liposomal delivery system, together with any improvements thereto owned by ONCOTHYREON ( or its AFFILIATES ) or licensed in byONCOTHYREON ( or its AFFILIATES ) ; 1.1.7 means all activities required for MARKET APPROVAL of PRODUCT in theTERRITORY ( including without limitation non - clinical and clinical trials, including but not limited to, toxicologyand absorption, distribution, metabolism and elimination studies ), as well as all clinical activities desirable foroptimized marketing of PRODUCT in the TERRITORY ( including without limitation Phase IIIb and Phase IVstudies ) ; + DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FORCONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION 3 1.1.8 means, with respect to PRODUCT in a particular country in the ROW TERRITORY, a cancer vaccine developed, marketed and SOLD by a third party ( which, for greater certainty, shall exclude anAFFILIATE of a party to this AGREEMENT ) for the treatment and/or prevention of cancer that elicits a MUC1specific immune response ( but excluding for greater certainty gene therapy products ) and which has an adverseimpact on SALES of PRODUCT in such country ; 1.1.9 has the meaning attributed to that term in section 8.1 of this AGREEMENT ; 1.1.10 shall mean the countries listed in appendix 1 ; 1.1.11 means that certain adjuvant license agreement dated as of October 20, 2004 with CorixaCorporation, together with all schedules thereto and any amendments to or restatements of such adjuvant licenseagreement ; 1.1.12 means that certain license agreement dated November 22, 1996 with the Dana - FarberCancer Institute, Inc., together with all schedules thereto and any amendments to or restatements of such licenseagreement ; 1.1.13 shall mean the development plans contemplated in section 3.1 of this AGREEMENT ; 1.1.14 means, with respect to PRODUCT in a particular country in the TERRITORY, a third partyretained to market, promote and/or sell PRODUCT in such country, but excluding for greater certainty wholesalersand any such third party in circumstances where the laws of such country require the use of such third party tomarket, promote and/or sell PRODUCT in such country ; 1.1.15 has the meaning attributed to that term in section 5.12.6 of this AGREEMENT