definiens: means, with respect to PRODUCT and for purposes of section 6.3 of this AGREEMENT, the amount of PRODUCT currently ( i.e., as at the date of this AGREEMENT ) specified to be taken at one time ( being four vials each containing 250 micrograms of Ii po peptide ) ; 1.1.20 shall mean March 1, 2006, or such other date as BIOMIRA and MERCK may agree upon in writing ; 1.1.21 shall mean, with respect to PRODUCT, any person at ann 's length with MERCK and its AFFILIATES that acquires PRODUCT in final fonn for end use, including physicians and hospitals but excluding DISTRIBUTORS and other agents ; 1.1.22 shall mean the first day on which the waiting period under the Hart - Scott - Rodino Antitrust Improvements Act of 1976, as amended, in relation to the notification and report of the parties with respect to this AGREEMENT has expired or been tenninated, or such other date as BIOMIRA and MERCK may agree upon in writing ; 1.1.23 shall mean the use of BLP25 for the prevention and/or treatment of cancers in humans ; 1.1.24 means that certain amended and restated license agreement dated November 14, 2000 with Imperial Cancer Research Technology Limited ( now Cancer Research Technology Limited ), together with all schedules thereto and any amendments to or restatements of such license agreement ; 1.1.25 means international financial reporting standards, consistently applied ; 11 17215.12 Execution Copy 1117215.12 Confidential Treatment Requested by [COMPANY] Corporation, File No . 333 - 145995, Exhibit 10.23 5 1.1.26 has the meaning attributed to that tenn in section 9.1 of this AGREEMENT ; 1.1.27 means a specific health care indication ( e.g., non - small cell lung cancer ) for which PRODUCT is, as indicated on the label for the PRODUCT, specified for the treatment and/or prevention thereof ; Execution Copy Confidential Treatment Requested by [COMPANY] Corporation, File No . 333 - 145995, Exhibit 10.23 6 1.1.28 has the meaning attributed to that tenn in section 10.1.1 of this AGREEMENT ; 1.1.29 has the meaning attributed to that tenn in section 9.1 of this AGREEMENT ; 1.1.30 shall mean, with respect to PRODUCT in a particular country in the TERRITORY, the date of the first anns ' length sale of PRODUCT in such country after receipt of MARKET APPROVAL for PRODUCT in such country ; 1.1.31 shall mean anyone of Gennany, France, United Kingdom, Italy, Spain or Japan, and shall mean all of such countries ; 1.1.32 has the meaning attributed to that tenn in section 3.2.4 of this AGREEMENT ; 1.1.33 shall mean, with respect to PRODUCT in a particular country in the TERRITORY, the date upon which the last of all governmental or regulatory approvals required for the sale of PRODUCT in that country has been granted, including price approval for the PRODUCT ( if required ) ; 1.1.34 shall mean the marketing plans reviewed by the STEERING COMMITTEE pursuant to section 3.2.3 of this AGREEMENT ; 1.1.35 has the meaning attributed to that tenn in section 9.3 of this AGREEMENT ; 1.1.36 means cancer associated mucin - I ; 1.1.37 shall mean, collectively, Canada ( including Quebec ) and its territories and the United States of America and its territories ; 1.1.38 shall mean, with respect to PRODUCT in a particular country, the sum of the gross amounts invoiced 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 such invoiced amounts which are actually incurred in accordance with IFRS : 1.1.38.1 credits or allowances actually granted for spoiled or damaged PRODUCT or with respect to returned or rejected PRODUCT, and for retroactive price adjustments ; 1117215.12 1.1.38.2 nonnal and customary trade, cash and quantity discounts, allowances, rebates and credits actually allowed, including allowances, adjustments, reimbursements, discounts, chargebacks and rebates given to healthcare Execution Copy Confidential Treatment Requested by [COMPANY] Corporation, File No . 333 - 145995, Exhibit 10.23 7 organizations and any governmental or quasi - governmental body or agency, whether during the actual SALES / royalty period or not ; 1.1.38.3 sales, value added or similar taxes measured by the billing amount, when included in billing ; 1.1.38.4 freight, postage, shipping, and insurance charges related to delivery of PRODUCT from the applicable MERCK / distributor warehouse measured by the billing amount, when included in billing ; and 1.1.38.5 import and export duties actually paid