EXHIBIT 10.23 AMENDED AND RESTATED COLLABORATION AGREEMENT (2006)

EXHIBIT 10.23

AMENDED AND RESTATED COLLABORATION AGREEMENT (2006)

        This amended and restated agreement is between Biomira B.V. (formerly Biomira Europe B.V.), a Netherlands corporation with offices located at Amsterdam, The Netherlands ("BIOMIRA"), and Merck KGaA, a German corporation with offices located at Darmstadt, Germany ("MERCK") and is effective as of March 1, 2006.

        WHEREAS BIOMIRA and MERCK entered into an amended and restated collaboration agreement effective as of May 7, 2001 (the "2001 COLLABORATION AGREEMENT") in relation to, inter alia, the development of BLP25;

        AND WHEREAS BIOMIRA, Biomira International Inc. and MERCK entered into a letter of intent effective as of January 26, 2006 to amend, inter alia, certain provisions of the 2001 COLLABORATION AGREEMENT;

        AND WHEREAS BIOMIRA and MERCK now wish to amend and restate the 2001 COLLABORATION AGREEMENT in accordance with, inter alia, such letter of intent, all upon the terms and subject to the conditions set forth in this AGREEMENT;

        NOW, THEREFORE, in consideration of the premises and covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby agreed to by the parties, and intending to be legally bound hereby, the parties hereto agree as follows:

ARTICLE 1
DEFINITIONS

Section 1.1 Meaning

        Whenever a term is written in this AGREEMENT with all capital letters it shall have the following meaning:

• 1.1.1

  "ADVERSE EVENT" 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

  "AFFILIATES" 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 "control" 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

  "AGREEMENT" 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;
  
  

  1.1.4

  "BIOMIRA COST OF GOODS" includes, but is not limited to, with respect to PRODUCT in relation to a particular country in the TERRITORY, [+]

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• 1.1.5

  "BIOMIRA IMPROVEMENTS" has the meaning attributed to that term in section 9.2 of this AGREEMENT;
  
  

  1.1.6

  "BIOMIRA KNOW-HOW" 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

  "BIOMIRA PATENT RIGHTS" 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. BIOMIRA PATENT RIGHTS also includes 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 foreign patents which correspond to those described in the preceding sentence and in any patents that claim BIOMIRA IMPROVEMENTS, JOINT IMPROVEMENTS and/or IMPROVEMENTS. Notwithstanding the foregoing, BIOMIRA PATENT RIGHTS shall not include any subsequently developed or acquired BIOMIRA PATENT RIGHTS 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;
  
  

  1.1.8

  "BIOMIRA TECHNOLOGY" means all BIOMIRA PATENT RIGHTS and/or BIOMIRA KNOW-HOW in the FIELD;
  
  

  1.1.9

  "BLP25" 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

  "CLINICAL DEVELOPMENT" means all activities required for MARKET APPROVAL 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 IIIb and Phase IV

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• • studies). This term does not include any activities necessary for manufacture and/or supply of PRODUCT;

  1.1.11

  "COMMERCIAL MANUFACTURING PLAN" shall mean the manufacturing plans reviewed by the STEERING COMMITTEE pursuant to section 3.2.2 of this AGREEMENT;
  
  

  1.1.12

  "COMPETITIVE PRODUCT" [+]
  
  

  1.1.13

  "CONFIDENTIAL INFORMATION" has the meaning attributed to that term in section 8.1 of this AGREEMENT;
  
  

  1.1.14

  "CORIXA LICENSE" means that certain adjuvant license agreement dated as of October 20, 2004 with Corixa Corporation, together with all schedules thereto and any amendments to or restatements of such adjuvant license agreement;
  
  

  1.1.15

  "DANA-FARBER LICENSE" means that certain license agreement dated November 22, 1996 with the Dana-Farber Cancer Institute, Inc., together with all schedules thereto and any amendments to or restatements of such license agreement;
  
  

  1.1.16

  "DEVELOPMENT PLAN" shall mean the development plans reviewed by the STEERING COMMITTEE pursuant to section 3.2.1 of this AGREEMENT;
  
  

  1.1.17

  "DISTRIBUTOR" means, with respect to PRODUCT in a particular country in the TERRITORY, a third party retained to market, promote and/or sell PRODUCT in such country, but excluding for greater certainty wholesalers and any such third party in circumstances where the laws of such country require the use of such third party to market, promote and/or sell PRODUCT in such country;
  
  

  1.1.18

  "DOMAIN NAMES" has the meaning attributed to that term in section 5.12.6 of this AGREEMENT;
  
  

  1.1.19

  "DOSE" 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 lipopeptide);
  
  

  1.1.20

  "EFFECTIVE DATE" shall mean March 1, 2006, or such other date as BIOMIRA and MERCK may agree upon in writing;
  
  

  1.1.21

  "END USER" shall mean, with respect to PRODUCT, any person at arm's length with MERCK and its AFFILIATES that acquires PRODUCT in final form for end use, including physicians and hospitals but excluding DISTRIBUTORS and other agents;
  
  

  1.1.22

  "EXECUTION DATE" 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 terminated, or such other date as BIOMIRA and MERCK may agree upon in writing;
  
  

  1.1.23

  "FIELD" shall mean the use of BLP25 for the prevention and/or treatment of cancers in humans;
  
  

  1.1.24

  "ICRT LICENSE" means that certain amended and restated license agreement dated November 14, 2000 with Imperial Cancer Research Technology Limited (now Cancer Research

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• • Technology Limited), together with all schedules thereto and any amendments to or restatements of such license agreement;

  1.1.25

  "IFRS" means international financial reporting standards, consistently applied;
  
  

  1.1.26

  "IMPROVEMENTS" has the meaning attributed to that term in section 9.1 of this AGREEMENT;
  
  

  1.1.27

  "INDICATION" 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;
  
  

  1.1.28

  "JOINT IMPROVEMENT PATENT RIGHTS" has the meaning attributed to that term in section 10.1.1 of this AGREEMENT;
  
  

  1.1.29

  "JOINT IMPROVEMENTS" has the meaning attributed to that term in section 9.1 of this AGREEMENT;
  
  

  1.1.30

  "LAUNCH" shall mean, with respect to PRODUCT in a particular country in the TERRITORY, the date of the first arms' length sale of PRODUCT in such country after receipt of MARKET APPROVAL for PRODUCT in such country;
  
  

  1.1.31

  "MAJOR MARKET" shall mean any one of Germany, France, United Kingdom, Italy, Spain or Japan, and "MAJOR MARKETS" shall mean all of such countries;
  
  

  1.1.32

  "MANUFACTURING/CMC PROJECT TEAM" has the meaning attributed to that term in section 3.2.4 of this AGREEMENT;
  
  

  1.1.33

  "MARKET APPROVAL" 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

  "MARKETING PLAN" shall mean the marketing plans reviewed by the STEERING COMMITTEE pursuant to section 3.2.3 of this AGREEMENT;
  
  

  1.1.35

  "MERCK IMPROVEMENTS" has the meaning attributed to that term in section 9.3 of this AGREEMENT;
  
  

  1.1.36

  "MUC1" means cancer associated mucin-1;
  
  

  1.1.37

  "NA TERRITORY" shall mean, collectively, Canada (including Quebec) and its territories and the United States of America and its territories;
  
  

  1.1.38

  "NET SALES" 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;
  
  

  1.1.38.2

  normal and customary trade, cash and quantity discounts, allowances, rebates and credits actually allowed, including allowances, adjustments, reimbursements, discounts, chargebacks and rebates given to healthcare organizations and any governmental or quasi-governmental body or agency, whether during the actual SALES/royalty period or not;

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• • 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.

• • Any refund or reimbursement of any of the foregoing amounts previously deducted from NET SALES shall be appropriately credited upon receipt thereof.

    If PRODUCT is SOLD in combination with another product or products (for greater certainty the use of adjuvant or other such PRODUCT enhancer stipulated to be mixed with PRODUCT shall not be considered to be "another product" for purposes of this section 1.1.38), "NET SALES" under such circumstances shall be calculated by multiplying the "NET SALES" of the combination by the fraction A/(A + B), in which A is the amount invoiced for PRODUCT when SOLD separately, and B is the total amount invoiced for any other product or products in combination when SOLD separately;

  1.1.39

  "ORIGINAL EFFECTIVE DATE" means May 7, 2001;
  
  

  1.1.40

  "PRODRUG" means a chemical precursor of PRODUCT which is to be cleaved in a human being directly into PRODUCT and/or a metabolic intermediate thereof, but excluding for greater certainty, antigen processing;
  
  

  1.1.41

  "PRODUCT" shall mean BLP25;
  
  

  1.1.42

  "ROW TERRITORY" shall mean all countries in the world except the NA TERRITORY;
  
  

  1.1.43

  "SALE" includes, with respect to PRODUCT, the sale thereof to an END USER, and "SOLD" and "SELL" have a corresponding meaning;
  
  

  1.1.44

  "SALES REPORT" has the meaning attributed to that term in section 7.2 of this AGREEMENT;
  
  

  1.1.45

  "STEERING COMMITTEE" has the meaning attributed to that term in section 3.1.1 of this AGREEMENT;
  
  

  1.1.46

  "STOCK PURCHASE AGREEMENT" means that certain agreement dated May 2, 2001 between Biomira Inc., Biomira International Inc. and MERCK relating to the purchase of Biomira Inc. common shares, together with all schedules thereto and any amendments to or restatements of such agreement;
  
  

  1.1.47

  "SUPPLY AGREEMENT" means that certain amended and restated supply agreement of even date herewith between MERCK and Biomira International Inc. relating to the supply of PRODUCT by Biomira International Inc. to MERCK, together with all schedules thereto and any amendments to or restatements of such amended and restated supply agreement;
  
  

  1.1.48

  "TERRITORY" shall mean, collectively, the NA TERRITORY and the ROW TERRITORY;
  
  

  1.1.49

  "THIRD PARTY LICENSES" means, collectively, the ICRT LICENSE, the DANA-FARBER LICENSE, the U of A LICENSE and any other third party license or sublicense of any technology included as part of the BIOMIRA TECHNOLOGY and/or the BIOMIRA MANUFACTURING KNOW-HOW (as such term is defined in the SUPPLY AGREEMENT);
  
  

  1.1.50

  "TRADEMARK" means the trademarks and logos selected for BLP25 pursuant to section 5.12 of this AGREEMENT, being the trademarks [+]

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• • [+] as well as any alternate trademarks for BLP25 agreed to in writing by BIOMIRA and MERCK, acting reasonably;

  1.1.51

  "U of A LICENSE" means that certain license dated December 1, 2001 with the University of Alberta in relation to the Samuels MUC1 liposomal formulation patents, together with all schedules thereto and any amendments to or restatements of such license agreement; and
  
  

  1.1.52

  "VALID CLAIM" means, with respect to PRODUCT in a particular country in the TERRITORY, a claim of an issued and unexpired patent included within the BIOMIRA PATENT RIGHTS which has not been held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

ARTICLE 2
LICENSE GRANT

Section 2.1    BIOMIRA License Grant

        Subject to the terms and conditions of this AGREEMENT and only for the purpose of MERCK fulfilling its obligations and exercising its rights under this AGREEMENT, BIOMIRA hereby grants to MERCK a license (or in the case of BIOMIRA TECHNOLOGY that BIOMIRA has licensed from a third party, a sublicense) under the BIOMIRA TECHNOLOGY to use, import, develop, market and SELL and have used, imported, developed, marketed and SOLD PRODUCT in the FIELD in the NA TERRITORY and the ROW TERRITORY. Such license shall, except to the extent otherwise provided in this AGREEMENT or otherwise required by applicable law or regulation (as, for example, in the European Union under applicable competition law), be exclusive for the FIELD in the NA TERRITORY and in the ROW TERRITORY, subject to the rights of BIOMIRA under this AGREEMENT.

        MERCK shall have no right to grant sublicenses under such licenses without the prior written consent of BIOMIRA (such consent not to be unreasonably withheld) and, to the extent applicable, complying with the provisions of the THIRD PARTY LICENSES, except only for purposes of exercising its right to appoint DISTRIBUTORS of PRODUCT in the TERRITORY including AFFILIATES of MERCK (but again always subject to and in compliance with the provisions of the THIRD PARTY LICENSES). MERCK shall be responsible for the acts and omissions of its DISTRIBUTORS, AFFILIATES and permitted sublicensees and such acts and omissions shall be regarded for purposes of this AGREEMENT as the acts and omissions of MERCK. BIOMIRA agrees not to, and shall cause its wholly owned AFFILIATES not to assert against MERCK or its permitted sublicensees any patent not included in the BIOMIRA PATENT RIGHTS that is or might be infringed by reason of MERCK or its permitted sublicensees exercise of the licenses granted to MERCK under this section 2.1. Further, BIOMIRA covenants and agrees that for so long as MERCK has exclusive rights to all of the BIOMIRA TECHNOLOGY under this AGREEMENT, BIOMIRA shall not grant to any third party rights to the BIOMIRA TECHNOLOGY which would permit such third party to make, use, import, develop, market or SELL or have made, have used, imported, developed, marketed or SOLD PRODUCT for the treatment of disease in humans.

Section 2.2    Term of Grant

        The licenses granted in section 2.1 of this AGREEMENT shall remain in force and effect on a country-by-country basis until the later of (a) [+] (b) [+]. Upon the expiration of any such license grant as aforesaid, MERCK shall thereafter, subject to complying

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• with any applicable provisions of the THIRD PARTY LICENSES (including the payment of any and all royalties and other amounts required to be paid thereunder), have a paid up, royalty free, non-exclusive license under the BIOMIRA TECHNOLOGY to use, import, develop, market and SELL, and have used, imported, developed, marketed and SOLD PRODUCT in such country in the FIELD.

Section 2.3    Third Party Licenses and Corixa License

        With respect to the THIRD PARTY LICENSES to the extent not waived in writing by the licensor under such THIRD PARTY LICENSES, BIOMIRA and MERCK hereby incorporate by reference in this AGREEMENT any provisions specified in such THIRD PARTY LICENSES to be included in sublicenses of the subject matter of such THIRD PARTY LICENSES and to make such other amendments to this AGREEMENT as may be required in connection with the sublicensing of such THIRD PARTY LICENSES by BIOMIRA to MERCK. MERCK also agrees to cooperate with BIOMIRA and its AFFILIATES in fully complying in a timely manner with the terms of such THIRD PARTY LICENSES and the CORIXA LICENSE and, without limiting the generality of the foregoing, MERCK shall provide to BIOMIRA or its designated AFFILIATE in a timely manner or assist BIOMIRA or its designated AFFILIATE in preparing in a timely manner any and all reports, data, confirmations, approvals and other information that may be required by BIOMIRA or its designated AFFILIATE in connection therewith. BIOMIRA shall provide MERCK with examples of applicable reports previously utilized by BIOMIRA and/or its AFFILIATES for such purposes in order to assist MERCK in preparing the necessary reports.

Section 2.4    Bankruptcy or Insolvency

        All rights and licenses granted to MERCK under this article 2 are, and shall be deemed to be, for purposes of applicable bankruptcy law (including section 365(n) of the United States Bankruptcy Code), licenses of rights to "intellectual property" (including as such term is defined under section 101(35A) of the United States Bankruptcy Code). The parties agree that MERCK, as a licensee of such rights under this AGREEMENT, shall retain and may fully exercise all of its rights and elections under such applicable bankruptcy law, including but not limited to MERCK's rights to continue to exercise all rights licensed hereunder.

Section 2.5    BIOMIRA and MERCK Rights

        Notwithstanding any provision to the contrary in this AGREEMENT, each of BIOMIRA and its AFFILIATES and MERCK shall have the right at their own cost to carry out research and clinical trials (up to but not including Phase III) in the FIELD with respect to IMPROVEMENTS to PRODUCT.

Section 2.6    Combination Products

        BIOMIRA shall not prohibit MERCK from combining for use in the FIELD PRODUCT licensed under this AGREEMENT with any other product.

Section 2.7    Covenant Not to Sue or Challenge

        MERCK (on behalf of itself and its AFFILIATES and their respective sublicensees) agrees not to in any way challenge or contest (including by way of an allegation of misuse or non-infringement), nor assist any other person to challenge or contest, the validity or enforceability of any of the BIOMIRA TECHNOLOGY including, without limitation, the BIOMIRA PATENT RIGHTS.

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ARTICLE 3
DEVELOPMENT OVERSIGHT

Section 3.1    Steering Committee

• 3.1.1

  Formation.     Within thirty (30) days after the EXECUTION DATE, the parties shall re-constitute a steering committee (the "STEERING COMMITTEE") for the purpose of overseeing and exchanging information with respect to the development, (including CLINICAL DEVELOPMENT), manufacturing, marketing and SALE of PRODUCT in the TERRITORY, all as hereinafter specified in this article 3.
  
  

  3.1.2

  Membership.     The STEERING COMMITTEE shall be composed of three (3) representatives of BIOMIRA and its AFFILIATES and three (3) representatives of MERCK and its AFFILIATES, unless otherwise agreed to in writing by BIOMIRA and MERCK (but the number of representatives of BIOMIRA and its AFFILIATES and the number of representatives of MERCK and its AFFILIATES shall always be equal). The initial chair of the STEERING COMMITTEE shall be a representative of BIOMIRA, and thereafter the chair of the STEERING COMMITTEE shall alternate on the anniversary of the EXECUTION DATE between a representative of BIOMIRA and a representative of MERCK (i.e., the second chair shall be a representative of MERCK, the third a representative of BIOMIRA, and so on). The initial members of the re-constituted STEERING COMMITTEE shall be:

  • for BIOMIRA:

    • member: [+]
      member: [+]
      member: [+]

    for MERCK:

    • member: [+]
      member: [+]
      member: [+]

  3.1.3

  Member Changes.     Each party shall notify the other party in writing of any changes in its representatives to the STEERING COMMITTEE.
  
  

  3.1.4

  Meetings.     The STEERING COMMITTEE shall meet not less than once per calendar quarter during the period of CLINICAL DEVELOPMENT of PRODUCT and during the period of SALE of PRODUCT, on such dates and at such times and places as are agreed to by the members of the STEERING COMMITTEE, acting reasonably. Responsibility for arranging such meetings, including, at a minimum, providing notice and an agenda and providing minutes of the meeting, shall alternate between the parties. The first meeting will take place as soon as practicable after the EXECUTION DATE, but in no event later than forty-five (45) days after the EXECUTION DATE, and will be organized by MERCK. Meetings may be conducted in person or by telephone or video conference, and the STEERING COMMITTEE may act without a meeting if, prior to such action, a written consent thereto is signed by each member of the STEERING COMMITTEE. The STEERING COMMITTEE may amend or expand upon the foregoing procedures for its internal operation by written agreement of BIOMIRA and MERCK.
  
  

  3.1.5

  Expenses.     Each party shall be responsible for the costs and expenses (including travel, lodging and other such costs and expenses) associated with the participation of its representatives on the STEERING COMMITTEE.

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• 3.1.6

  Minutes.     The party responsible for arranging a meeting of the STEERING COMMITTEE as provided for in section 3.1.4 of this AGREEMENT shall promptly prepare and deliver to the other party within thirty (30) days after the date of each meeting, minutes of such meeting setting forth a summary of all matters addressed at such meeting of the STEERING COMMITTEE in form and content reasonably acceptable to both parties. Such minutes shall become official only upon written approval by the STEERING COMMITTEE.

Section 3.2    Functions and Authority

• 3.2.1

  Development Plans.     The parties acknowledge that MERCK will be responsible for the development (including CLINICAL DEVELOPMENT) of PRODUCT to be SOLD in the NA TERRITORY and the ROW TERRITORY. Notwithstanding the foregoing, MERCK shall present to the STEERING COMMITTEE semi-annually for its review and consultation a DEVELOPMENT PLAN, and will not make any material revisions to a previously reviewed DEVELOPMENT PLAN without prior consultation with the STEERING COMMITTEE. MERCK will consider seriously and in good faith any comments that BIOMIRA representatives to the STEERING COMMITTEE may have with respect to any such DEVELOPMENT PLAN or material revision thereto, provided, however , that the final decision on any such matter shall be made by MERCK.
  
  

  3.2.2

  Manufacturing.     The parties acknowledge that, except in the circumstances specified in section 2.12 of the SUPPLY AGREEMENT, Biomira International Inc. or its designated AFFILIATE will be responsible for the manufacture and supply of PRODUCT for sale in the NA TERRITORY and the ROW TERRITORY, all as specified in the SUPPLY AGREEMENT. Notwithstanding the foregoing, Biomira International Inc. or its designated AFFILIATE shall within six (6) months of the EXECUTION DATE provide a succinct (i.e., one or two pages) status report in relation to manufacturing to MERCK and meet with the appropriate manufacturing personnel of MERCK to discuss the timing and content of a COMMERCIAL MANUFACTURING PLAN. Commencing on the date agreed to in writing by Biomira International Inc. or its designated AFFILIATE and MERCK during or following such discussions, Biomira International Inc. or its designated AFFILIATE shall thereafter present to the STEERING COMMITTEE semi-annually for its review and consultation a COMMERCIAL MANUFACTURING PLAN, and will not make any material revisions to a previously reviewed COMMERCIAL MANUFACTURING PLAN without prior consultation with the STEERING COMMITTEE. Biomira International Inc. or its designated AFFILIATE will consider seriously and in good faith any comments that MERCK representatives to the STEERING COMMITTEE may have with respect to any such COMMERCIAL MANUFACTURING PLAN or material revision thereto, provided, however , that the final decision on any such matter shall be made by Biomira International Inc. or its designated AFFILIATE.
  
  

  3.2.3

  Marketing.     The parties acknowledge that, with respect to the NA TERRITORY and the ROW TERRITORY, MERCK will be responsible for the SALES and marketing of PRODUCT. Notwithstanding the foregoing, MERCK shall present to the STEERING COMMITTEE semi-annually for its review and consultation, beginning a reasonable period of time prior to LAUNCH of PRODUCT in the NA TERRITORY and/or the ROW TERRITORY, a MARKETING PLAN, and will not make any material revisions to a previously reviewed MARKETING PLAN without providing prior written notification (including particulars) to the STEERING COMMITTEE. MERCK will consider seriously and in good faith any comments that BIOMIRA representatives to the STEERING COMMITTEE may have with respect to any such MARKETING PLAN or material revision thereto, provided, however , that the final decision on any such matter shall be made by MERCK.

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• 3.2.4

  Manufacturing/CMC Project Team :    The STEERING COMMITTEE will establish a MANUFACTURING/CMC PROJECT TEAM. The STEERING COMMITTEE will approve the members of the MANUFACTURING/CMC PROJECT TEAM comprising an equal number of individuals from BIOMIRA and its AFFILIATES and from MERCK and its AFFILIATES. The chairperson of the MANUFACTURING/CMC COMMITTEE shall be a member from BIOMIRA and its AFFILIATES designated by BIOMIRA. The MANUFACTURING/CMC PROJECT TEAM shall, subject to the final decision with respect to any manufacturing matter residing with Biomira International Inc. or its designated AFFILIATE as provided for in section 3.2.2, be responsible for (i) assuring the security of supply of PRODUCT, (ii) reviewing specifications, (iii) identifying and resolving quality issues, (iv) reviewing potential changes to the production processes for PRODUCT, and (v) overseeing the implementation of the COMMERCIAL MANUFACTURING PLAN.

ARTICLE 4
DEVELOPMENT AND MARKET APPROVAL
—NA TERRITORY AND ROW TERRITORY

Section 4.1    CLINICAL DEVELOPMENT Studies and Costs

        Unless otherwise agreed to in writing by BIOMIRA and MERCK, MERCK will be responsible for conducting, or having conducted, all development (including CLINICAL DEVELOPMENT) and MARKET APPROVAL (including the preparation, submission and prosecution of all regulatory authority filings and applications required to obtain all necessary MARKET APPROVALS to SELL PRODUCT in, among others, the NA TERRITORY and the MAJOR MARKETS in the ROW TERRITORY) tasks (including all studies) necessary and/or desirable for CLINICAL DEVELOPMENT of PRODUCT in the NA TERRITORY and the ROW TERRITORY. Without limiting the generality of the foregoing, MERCK agrees to undertake the Phase III clinical trial of BLP25 in Stage III a/b non-small cell lung cancer described in the protocol set forth in appendix 3. MERCK will bear all costs in relation to all of the foregoing.

Section 4.2    Regulatory Filings

        MERCK will, at MERCK's expense, use commercially reasonable efforts to diligently pursue the preparation, submission and prosecution and maintenance of all regulatory authority filings and applications required to obtain and maintain all necessary and/or desirable MARKET APPROVALS to sell PRODUCT in each of the NA TERRITORY, the MAJOR MARKETS in the ROW TERRITORY and in such other countries in the ROW TERRITORY in which MERCK, using reasonable business judgment, determines to sell such PRODUCTS, all in a prudent and skilful manner in accordance with all applicable laws and regulations. BIOMIRA shall provide reasonable assistance to MERCK in connection with preparing and supporting the Chemistry, Manufacturing and Control sections of applicable PRODUCT market applications and in regard to post-MARKET APPROVAL requirements in respect of Chemistry, Manufacturing and Control. MERCK shall keep BIOMIRA informed in respect of the matters which are the subject of this section 4.2 and shall give due consideration to any concerns and suggestions of BIOMIRA with respect thereto, provided, however , that the final decision on the specifics of the preparation, submission and prosecution and maintenance of such regulatory filings and applications shall be made by MERCK. Subject to the terms and conditions of this AGREEMENT, BIOMIRA or its applicable AFFILIATE shall take such actions as are required to be taken by it to transfer to MERCK the then current United States IND held by BIOMIRA or such AFFILIATE in relation to BLP25 within ten (10) business days of MERCK's reasonable written request to do so.

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Section 4.3    Assistance

        BIOMIRA agrees to use reasonable commercial efforts to provide such assistance as is reasonably requested by MERCK and as is reasonably necessary to be performed by BIOMIRA in connection with the preparation and prosecution of such filings and applications as described in section 4.1. BIOMIRA shall be compensated by MERCK for such assistance on the basis set forth in appendix 4 to this AGREEMENT (as such amounts shall be adjusted annually to account for normal wage increases), except to the extent that BIOMIRA is specifically obligated under the SUPPLY AGREEMENT to provide manufacturing assistance to MERCK without remuneration.

Section 4.4    Reporting

        At least quarterly during the term of this AGREEMENT until all PRODUCT approvals hereunder are obtained with respect to the NA TERRITORY and the ROW TERRITORY, MERCK shall, with respect to the NA TERRITORY and the ROW TERRITORY, provide BIOMIRA with a succinct written summary report (i.e., one to two pages) which shall describe the progress of the following: the clinical development and testing of PRODUCT in clinical trials, all regulatory filings and submissions made and the status thereof, all approvals obtained and such other information as BIOMIRA may from time to time reasonably request with respect to the subject matter of article 4. Such reports and information shall be received by BIOMIRA subject to the obligations of article 8. Further, to the extent that any such report is provided by MERCK to BIOMIRA at a meeting of the STEERING COMMITTEE, MERCK shall not be required to again provide such report to BIOMIRA under this section 4.4.

Section 4.5    MARKET APPROVAL Owner

        MERCK shall be the record owner of all MARKET APPROVALS required for SALE of PRODUCT in the NA TERRITORY and the ROW TERRITORY. Forthwith upon the expiration or termination of this AGREEMENT with respect to PRODUCT in a particular country in the ROW TERRITORY or the NA TERRITORY, or if any of the licenses granted by BIOMIRA to MERCK in this AGREEMENT become non-exclusive, MERCK shall in a timely manner comply with section 11.6 of this AGREEMENT in relation to PRODUCT in such country.

ARTICLE 5
PRODUCT MARKETING—NA TERRITORY AND ROW TERRITORY

Section 5.1    Costs and Expenses

        MERCK shall bear all costs and expenses associated with the promoting, marketing, distributing and SALE of PRODUCT in the TERRITORY.

Section 5.2    Sales Force Training

        MERCK shall be responsible for developing or having developed (in accordance with all applicable legal and regulatory requirements) training programs and materials concerning promotion of PRODUCT in the TERRITORY. MERCK shall also be responsible for developing or having developed (in accordance with all applicable legal and regulatory requirements) training programs and materials concerning technical aspects of PRODUCT.

Section 5.3    Costs of Sales Representatives and Specialty Personnel

        MERCK shall be responsible for all costs and expenses related to its sales representatives (whether employees or contracted) in the TERRITORY. MERCK shall be responsible for all costs and expenses

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related to "specialty" personnel (including managed care representatives, professional relations, patient advocacy, reimbursement, specialty sales, and the like) in the TERRITORY.

Section 5.4    Distribution

        MERCK shall have the sole responsibility for distribution of PRODUCT in the TERRITORY. In fulfilling its obligations with respect to the distribution of PRODUCT in the TERRITORY, MERCK shall use commercially reasonable efforts consistent with accepted pharmaceutical practices. All costs incurred in relation to such distribution shall be borne by MERCK.

Section 5.5    Label Content

        MERCK shall be responsible for ensuring that the label and product insert for any PRODUCT SOLD in the TERRITORY shall comply with all legal, governmental and regulatory requirements. Insofar as it is not contrary to law or regulation in any particular country in the TERRITORY, the box and package insert, and the label to the extent that space permits, shall include prominent reference to MERCK (or, if applicable, any AFFILIATE of MERCK designated by MERCK) as marketer and to Biomira International Inc. as manufacturer of the PRODUCT. Any trademark or other content as may be from time to time required pursuant to the CORIXA LICENSE shall be marked on every PRODUCT label and/or insert in the manner required under the CORIXA LICENSE.

Section 5.6    Product Price

        MERCK shall determine the SALES price for PRODUCT SOLD in the TERRITORY.

Section 5.7    Booking Sales

        MERCK shall book all SALES of PRODUCT in the TERRITORY.

Section 5.8    Advertising and Promotion

        MERCK shall be responsible for determining the sales strategy for SALE of PRODUCT in the TERRITORY, and shall create, or have created all materials for advertising and promotion of PRODUCT in the TERRITORY. All costs and expenses incurred in relation to such advertising and promotion shall be borne by MERCK.

Section 5.9    Customer Complaints and Medical Inquiries

        MERCK (or its designated AFFILIATE) shall be responsible for handling all customer complaints and inquiries regarding PRODUCT in the TERRITORY. All complaints and inquiries received by BIOMIRA or its agents shall be promptly referred to MERCK for response according to applicable law. MERCK shall use commercially reasonable efforts to handle such matters in a timely, prudent and skilful manner, in compliance with applicable laws, regulations, rules, policies and regulatory requirements and in accord with MERCK's standard operating procedures. MERCK shall keep BIOMIRA informed in a timely manner with respect to MERCK's activities in regard to customer complaints and inquiries for PRODUCT. All customer complaints specifically relating to the manufacture of PRODUCT shall be referred to BIOMIRA and handled in accordance with the terms of the SUPPLY AGREEMENT. All costs incurred in responding to customer complaints and inquiries (other than those specifically relating to the manufacture of PRODUCT by BIOMIRA and handled in accordance with the terms of the SUPPLY AGREEMENT) shall be borne by MERCK.

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Section 5.10    Adverse Event Reporting

        MERCK (or its designated AFFILIATE) shall be responsible for reporting all ADVERSE EVENTS regarding PRODUCT to the appropriate regulatory authorities in the TERRITORY. All information received by BIOMIRA or its agents shall be promptly transferred according to applicable law to MERCK for handling. MERCK shall handle such matter in a timely, prudent and skilful manner, in compliance with all applicable laws, rules, policies, regulations and regulatory requirements, and in accord with MERCK's standard operating procedures. MERCK shall keep BIOMIRA informed in a timely manner with respect to MERCK's activities with respect to ADVERSE EVENT reporting for PRODUCT. All costs incurred in responding to and reporting ADVERSE EVENTS regarding PRODUCT in the TERRITORY shall be borne by MERCK. In the event that the parties determine its necessity, then further details shall be set forth in a pharmacovigilance data exchange agreement to be entered into by the parties in due course.

Section 5.11    PRODUCT Recall

        MERCK (or its designated AFFILIATE) shall be responsible for initiating and implementing all PRODUCT recalls required by controlling regulatory agencies and for all voluntary PRODUCT market withdrawals in the TERRITORY. MERCK shall handle such matters in a timely, prudent and skilful manner, in compliance with all applicable laws, rules, policies, regulations and regulatory requirements, and in accord with MERCK's standard operating procedures. MERCK shall keep BIOMIRA informed in a timely manner with respect to MERCK's activities in regard to recalls and market withdrawals. All costs incurred in responding to recalls and market withdrawals shall be borne by MERCK, except for a recall or voluntary withdrawal which is attributable to the actions or omissions of BIOMIRA or its AFFILIATES, in which case BIOMIRA shall be solely responsible for the costs of such recall or market withdrawal.

Section 5.12    Trademarks and Branding

• 5.12.1

  Ownership and Filing.     PRODUCT shall be marketed and sold in the TERRITORY under the applicable TRADEMARK. BIOMIRA acknowledges that MERCK shall be the owner of the TRADEMARKS in the TERRITORY. BIOMIRA shall not knowingly do or cause to be done any act or thing contesting, challenging or, in any way, impairing or intending to impair any part of MERCK's right, title or interest in the TRADEMARKS for the duration of this AGREEMENT. Further, BIOMIRA shall not use or register in the TERRITORY any trademark which is similar or identical to any of the TRADEMARKS on similar or identical goods or services to those which are the subject of this AGREEMENT for the duration of this AGREEMENT. MERCK shall diligently pursue the filing, maintenance and defence of the TRADEMARKS in the TERRITORY. All trademark-related costs (including, without limitation, legal, third party, branding, filing, maintenance and other such costs) of developing, prosecuting, registering, maintaining and defending the TRADEMARKS shall be borne by MERCK as of the EFFECTIVE DATE.
  
  

  5.12.2

  Trademark License.     MERCK hereby grants to BIOMIRA and its designated AFFILIATES a royalty free, non-exclusive license to use, display, reproduce and publish the TRADEMARKS in connection with the (i) manufacture, and (ii) in the circumstances expressly described in this AGREEMENT, use, marketing, promotion, distribution and SALE of PRODUCT in any countries in the TERRITORY where BIOMIRA or an AFFILIATE of BIOMIRA has the right to SELL PRODUCT under this AGREEMENT for so long as such right to SELL exists under this AGREEMENT. BIOMIRA and its designated AFFILIATES shall have no right to grant sublicenses under such license without the prior written consent of MERCK (such consent not to be unreasonably withheld). Any goodwill arising from the use of the TRADEMARKS by BIOMIRA or its designated AFFILIATES shall inure to the benefit of

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• • MERCK. Further, such use shall be in accordance with the applicable laws in the relevant jurisdiction, as well as with any reasonable requirements of any brand guide that may be provided by MERCK from time to time. When using any of the TRADEMARKS under license, BIOMIRA and its designated AFFILIATES shall use the identifiers ™ or ®, as appropriate.

  5.12.3

  Alternative Trademarks.     In the event that STIMUVAX, [+] cannot be used for the PRODUCT in any country of the TERRITORY due to legal or regulatory or other valid reasons, MERCK shall at its discretion and cost develop and file one or several alternative trademarks in the relevant country, which will (once agreed to in writing by BIOMIRA, in a timely manner acting reasonably, as specified in section 1.1.50 of this AGREEMENT) be considered TRADEMARKS under this AGREEMENT.
  
  

  5.12.4

  [+] such third party. Further, BIOMIRA represents and warrants that, to the knowledge of BIOMIRA, there is no action, suit, proceeding, alternative dispute resolution, mediation or investigation pending or threatened against BIOMIRA relating to the trademarks [+]. Within forty-five (45) days of the EXECUTION DATE, MERCK shall pay to and reimburse BIOMIRA or its designated AFFILIATE for all reasonable costs and expenses (other than internal costs and expenses) incurred from the EFFECTIVE DATE up to and including the EXECUTION DATE by BIOMIRA and its AFFILIATES in connection with the TRADEMARKS, including, without limitation, [+] paid by BIOMIRA or its AFFILIATE to MERCK in respect of STIMUVAX (MERCK also confirms that BIOMIRA and its AFFILIATES are released from all other obligations under the STIMUVAX letter agreement dated December 21, 2004 including, without limitation, [+]).
  
  

  5.12.5

  Trademark Infringement.     For countries in which the TRADEMARKS are used under license by BIOMIRA and/or its AFFILIATES, BIOMIRA shall promptly report to MERCK particulars of any use by any other party of a trademark, trade name or mode of advertising which comes to BIOMIRA's or its designated AFFILIATES' attention and which might qualify

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• • as an infringement of the TRADEMARKS or as unfair competition. In the event that it comes to the attention of BIOMIRA or its designated AFFILIATES that any party alleges that the TRADEMARKS are invalid or that they infringe any rights of a third party, or that the TRADEMARKS are open to any other form of attack, BIOMIRA or its designated AFFILIATES shall promptly report the matter to MERCK. In any event described in this section BIOMIRA shall not take any action, either amicably or legally, and shall let MERCK or a nominee of MERCK take any action which MERCK, acting reasonably, deems necessary, provided, however, that nothing herein shall prevent BIOMIRA from defending and/or protecting its own reasonable interests. BIOMIRA or its designated AFFILIATES, upon MERCK's reasonable request and at MERCK's expense, shall cooperate in any action so taken to the extent that such cooperation is not materially adverse in interest to BIOMIRA and/or its AFFILIATES.

  5.12.6

  Domain Names.     Any domain names (the "DOMAIN NAMES") related to the TRADEMARKS in the TERRITORY shall be owned by MERCK. BIOMIRA acknowledges that MERCK shall be the owner of the DOMAIN NAMES in the TERRITORY. BIOMIRA shall not knowingly do or cause to be done any act or thing contesting, challenging or, in any way, impairing or intending to impair any part of MERCK's right, title or interest in the DOMAIN NAMES in the TERRITORY for the duration of this AGREEMENT. Further, BIOMIRA shall not use or register in the TERRITORY any domain name which is similar or identical to any of the DOMAIN NAMES on similar or identical goods or services which are the subject of this AGREEMENT for the duration of this AGREEMENT. MERCK shall diligently pursue the filing, maintenance and defence of the DOMAIN NAMES in the TERRITORY. All domain name-related costs (including, without limitation, legal, third party, filing, maintenance and other such costs) of prosecuting, registering, maintaining and defending the DOMAIN NAMES or any alternate or additional domain names shall be borne by MERCK.
  
  

  5.12.7

  Domain License.     To the extent required, MERCK hereby grants to BIOMIRA and its de