definiens: shall mean December 18, 2008, or such other date as ONCOTHYREON and MERCK mayagree upon in writing ; 1.1.17 shall mean, with respect to PRODUCT, any person at arm ’s length with MERCK and its AFFILIATESthat acquires PRODUCT in final form for end use, including physicians and hospitals but excludingDISTRIBUTORS and other agents ; 1.1.18 shall mean the use of BLP25 for the prevention and/or treatment of cancers in humans ; 1.1.19 means that certain amended and restated license agreement dated November 14, 2000 withImperial Cancer Research Technology Limited + DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FORCONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION 4 ( now Cancer Research Technology Limited ), together with all schedules thereto and any amendments to orrestatements of such license agreement ; 1.1.20 means international financial reporting standards, consistently applied ; 1.1.21 means, collectively, all inventions, discoveries, improvements or other technology in theFIELD and all processes or uses relating thereto, whether or not patentable, that arise after the ORIGINALEFFECTIVE DATE as a result of conduct under this AGREEMENT and relate directly to BLP25 . For clarity, IMPROVEMENTS shall not include any inventions, discoveries, improvements or other technology thatONCOTHYREON, develops or acquires to the extent covering any active compound that is separate and clearlydistinct from BLP25, notwithstanding the fact that such active compound may be useful as part of a combinationtherapy with BLP25 . For further clarity, BGLP40 shall be deemed not to be an IMPROVEMENT ; 1.1.22 means a specific health care indication ( e.g., non - small cell lung cancer ) for which PRODUCT is, asindicated on the label for the PRODUCT, specified for the treatment and/or prevention thereof ; 1.1.23 has the meaning attributed to that term in section 10.1.1 of thisAGREEMENT ; 1.1.24 has the meaning attributed to that term in section 9.1 of this AGREEMENT ; 1.1.25 shall mean, with respect to PRODUCT in a particular country in the TERRITORY, the date of the firstarms ’ length sale of PRODUCT in such country after receipt of MARKET APPROVAL for PRODUCT in suchcountry ; 1.1.26 shall mean any one of Germany, France, United Kingdom, Italy, Spain or Japan, and shall mean all of such countries ; 1.1.27 shall mean, with respect to PRODUCT in a particular country in the TERRITORY, thedate upon which the last of all governmental or regulatory approvals required for the sale of PRODUCT in thatcountry has been granted, including price approval for the PRODUCT ( if required ) ; 1.1.28 shall mean the marketing plans contemplated in section 3.1 of this AGREEMENT ; 1.1.29 includes, but is not limited to, with respect to PRODUCT in the TERRITORY, reasonable direct material, labour and subcontracted costs incurred by or on behalf of MERCK in connection withthe procurement of raw materials, manufacture, vialing, testing, stability, releasing and shipment of PRODUCT, aswell as the reasonable indirect costs of administration, salary, support, depreciation, facility rental, facility repairand + DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FORCONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION 5 maintenance, facility utilities, insurance and facility property taxes attributable to PRODUCT ; 1.1.30 has the meaning attributed to that term in section 9.3 of this AGREEMENT ; 1.1.31 has the meaning attributed to that term in section 9.10 of thisAGREEMENT ; 1.1.32 has the meaning attributed to that term in section 2.7.2 of this AGREEMENT ; 1.1.33 means cancer associated mucin-1 ; 1.1.34 shall mean, collectively, Canada ( including Quebec ) and its territories and the United States ofAmerica and its territories ; 1.1.35 has the meaning attributed to that term in section 2.7.2 of this AGREEMENT ; 1.1.36 shall mean, with respect to PRODUCT in a particular country, the sum of the gross amountsinvoiced for all SALES ( directly or indirectly ) by MERCK, its AFFILIATES and their respective sublicensees, DISTRIBUTORS, assignees and transferees of PRODUCT to END USERS, less the following deductions from suchinvoiced amounts which are actually incurred in accordance with IFRS : 1.1.36.1 credits or allowances actually granted for spoiled or damaged PRODUCT or with respect to returned orrejected PRODUCT, and for retroactive price adjustments ; 1.1.36.2 normal and customary trade, cash and quantity discounts, allowances, rebates and credits actuallyallowed, including allowances, adjustments, reimbursements, discounts, chargebacks and rebates given tohealthcare organizations and any governmental or quasi - governmental body or agency, whether duringthe actual SALES / royalty period or not ; 1.1.36.3 sales, value added or similar taxes measured by the billing amount, when included in billing ; 1.1.36.4 freight, postage, shipping, and insurance charges related to delivery of PRODUCT from the applicableMERCK / distributor warehouse measured by the billing amount, when included in billing ; and 1.1.36.5 import and export duties actually paid