definiens: means all BIOMIRA PATENT RIGHTS and/or BIOMIRA KNOW - HOW in the FIELD ; 1.1.9 means BIOMIRA 's immunotherapeutic vaccine composed of a 25 - amino acid sequence of the MUC1 cancer mucin, which vaccine is combined with the adjuvant Lipid A and is encapsulated in 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 by BIOMIRA or licensed in by BIOMIRA with the right to sublicense in the manner contemplated by this AGREEMENT and which BIOMIRA and MERCK agree in writing to implement and ( ii ) any PRODRUG thereof ; 1.1.10 means all actIVIties required for MARKET APPROV AL of PRODUCT in the TERRITORY ( including without limitation non - clinical and clinical trials, including but not limited to, toxicology and absorption, distribution, metabolism and elimination studies ), as well as all clinical activities desirable for optimized marketing of PRODUCT in the TERRITORY ( including without limitation Phase lIIb and Phase IV studies )