AMENDED AND RESTATED LICENSE AGREEMENT

Exhibit 10.1

AMENDED AND RESTATED LICENSE AGREEMENT (2008)

This amended and restated agreement is between Biomira Management Inc., a Delaware corporation with offices located at Seattle, Washington (“ONCOTHYREON”), and Merck KGaA, a German corporation with offices located at Darmstadt, Germany (“MERCK”) and is effective as of December 18, 2008.

WHEREAS Biomira B.V. 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 International Inc. and MERCK entered into an amended and restated supply agreement effective as of May 7, 2001 (the “2001 SUPPLY AGREEMENT”) in relation to, inter alia, the manufacture and supply by Biomira International Inc. to MERCK of BLP25;

AND WHEREAS the 2001 COLLABORATION AGREEMENT was further amended and restated by the parties thereto by agreement effective as of March 1, 2006 (the “2006 COLLABORATION AGREEMENT”);

AND WHEREAS the 2001 SUPPLY AGREEMENT was further amended and restated by the parties thereto by agreement effective as of March 1, 2006 (the “2006 SUPPLY AGREEMENT”);

AND WHEREAS on December 7, 2007, the respective rights and obligations of Biomira B.V. and Biomira International Inc. under the 2006 COLLABORATION AGREEMENT and the 2006 SUPPLY AGREEMENT were transferred and assigned to ONCOTHYREON;

AND WHEREAS ONCOTHYREON and MERCK now wish to combine and amend and restate the 2006 COLLABORATION AGREEMENT and the 2006 SUPPLY AGREEMENT as a single amended and restated license agreement, all upon the terms and subject to the conditions set forth in this AGREEMENT;

AND WHEREAS, ONCOTHYREON (and certain AFFILIATES of ONCOTHYREON) and EMD Serono Canada, Inc. (an AFFILIATE of MERCK), in conjunction with entering into this AGREEMENT, have entered into an asset purchase agreement (the “ASSET PURCHASE AGREEMENT”) pursuant to which ONCOTHYREON and the specified AFFILIATES of ONCOTHYREON have sold certain assets relating to BLP25 to EMD Serono Canada, Inc.;

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:

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 1.1.36), “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;

ARTICLE 2
LICENSE GRANT

Section 2.1 ONCOTHYREON 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, ONCOTHYREON hereby grants to MERCK a license (or in the case of ONCOTHYREON TECHNOLOGY that ONCOTHYREON has licensed from a third party, a sublicense) under the ONCOTHYREON TECHNOLOGY to make, use, import, develop, market and SELL and have made, 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 ONCOTHYREON under this AGREEMENT.

MERCK shall have the right to grant sublicenses (including the right to appoint DISTRIBUTORS of PRODUCT in the TERRITORY, including AFFILIATES of MERCK) under the licenses obtained under this AGREEMENT without the prior written consent of ONCOTHYREON provided however, that MERCK, when doing so, complies with the provisions of the THIRD PARTY LICENSES. MERCK shall be responsible for the acts and omissions of its DISTRIBUTORS, AFFILIATES, sublicensees and contract manufacturers and such acts and omissions shall be regarded for purposes of this AGREEMENT as the acts and omissions of MERCK. ONCOTHYREON agrees not to, and shall cause its wholly owned AFFILIATES not to assert against MERCK or its sublicensees any patent not included in the ONCOTHYREON PATENT RIGHTS that is or might be infringed by reason of MERCK or its sublicensees exercise of the licenses granted to MERCK under this section 2.1. Further, ONCOTHYREON covenants and agrees that for so long as MERCK has exclusive rights to all

of the ONCOTHYREON TECHNOLOGY under this AGREEMENT, ONCOTHYREON shall not grant to any third party rights to the ONCOTHYREON 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) the expiration or termination of the last to expire or terminate of VALID CLAIMS that cover PRODUCT in such country, and (b) the date which is the fifteenth (15 ^th ) anniversary of the LAUNCH of PRODUCT in any country in the TERRITORY. Upon the expiration of any such license grant as aforesaid, MERCK shall thereafter, subject to complying 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 ONCOTHYREON TECHNOLOGY to make, use, import, develop, market and SELL, and have made, used, imported, developed, marketed and SOLD PRODUCT in such country in the FIELD.

Section 2.3 Third Party Licenses

With respect to the THIRD PARTY LICENSES to the extent not waived in writing by the licensor under such THIRD PARTY LICENSES, ONCOTHYREON 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 ONCOTHYREON to MERCK. MERCK also agrees to cooperate with ONCOTHYREON and its AFFILIATES in fully complying in a timely manner with the terms of such THIRD PARTY LICENSES and, without limiting the generality of the foregoing, MERCK shall provide to ONCOTHYREON or its designated AFFILIATE in a timely manner or assist ONCOTHYREON 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 ONCOTHYREON or its designated AFFILIATE in connection therewith. ONCOTHYREON shall provide MERCK with examples of applicable reports previously utilized by ONCOTHYREON 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 Combination Products

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

Section 2.6 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 ONCOTHYREON TECHNOLOGY including, without limitation, the ONCOTHYREON PATENT RIGHTS.

Section 2.7 Exclusivity

ARTICLE 3
REPORTING AND PLANS

Section 3.1 Reporting

On or before March 31, 2009 for the 2009 calendar year, and on or before January 1 for each subsequent calendar year during the TERM until first commercial SALE of PRODUCT has been made, MERCK shall provide ONCOTHYREON with a written development plan (the “DEVELOPMENT PLAN”) for PRODUCT which plan shall outline the CLINICAL DEVELOPMENT activities that MERCK plans to perform in such calendar year, as well as its manufacturing activities. Upon request of ONCOTHYREON, but no more than once per calendar quarter, MERCK shall provide ONCOTHYREON with a succinct written update (i.e. one or two pages) of any material change to the DEVELOPMENT PLAN as well as the progress made with respect to the CLINICAL DEVELOPMENT, including updates on the status of each ongoing clinical trial (including the number of patients) and regulatory filings. Upon first commercial SALE of PRODUCT, the DEVELOPMENT PLAN shall no longer be provided to ONCOTHYREON. In lieu of the DEVELOPMENT PLAN, MERCK shall provide ONCOTHYREON with a marketing plan (the “MARKETING PLAN”) which plan shall outline the marketing activities that MERCK plans to perform in the then current calendar year, as well as its manufacturing activities. Upon request of ONCOTHYREON, but no more than once per calendar quarter, MERCK shall provide ONCOTHYREON with a succinct written update (i.e. one or two pages) of any material change to the MARKETING PLAN as well as the progress made with respect to the marketing of PRODUCT, including updates on the status of each ongoing clinical trial (including the number of patients) and regulatory filings. Notwithstanding the foregoing, MERCK shall promptly following any change or event which may be material to ONCOTHYREON in relation to the subject matter of this AGREEMENT advise ONCOTHYREON together with full particulars thereof. Such reports and information shall be received by ONCOTHYREON subject to the obligations of Article 8.

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

Section 4.1 CLINICAL DEVELOPMENT Studies and Costs

MERCK will be responsible, and have sole decision making authority, 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 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 4. 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 PRODUCT, all in a prudent and skilful manner in accordance with all applicable laws and regulations. To the extent not already assigned to MERCK, ONCOTHYREON shall promptly assign to MERCK all applications and filings held by ONCOTHYREON with any regulatory authority relating to the development, manufacture and commercialization of PRODUCT. MERCK shall keep ONCOTHYREON informed in respect of the matters which are the subject of this section 4.2 in the manner specified in Section 3, 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. Upon the written request of MERCK, ONCOTHYREON, shall, or shall direct its AFFILIATE to, either withdraw or transfer to MERCK any drug master file submitted by ONCOTHYREON or any of its AFFILIATES in relation to the PRODUCT to any regulatory authority in the TERRITORY. For clarity, any contact to regulatory authorities anywhere in the TERRITORY that relate to the PRODUCT shall be MERCK’s or its AFFILIATES’ or sublicensees’ responsibility, and any contact made by any such authority to ONCOTHYREON or any of its AFFILIATES in relation to the PRODUCT shall be referred promptly by ONCOTHYREON or its AFFILIATE to MERCK.

Section 4.3 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 ONCOTHYREON 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.

Section 4.4 Know-How Documentation

In an effort to support the transfer by ONCOTHYREON to MERCK of the ONCOTHYREON KNOW-HOW, ONCOTHYREON agrees (to the extent legally permitted to do so) to make available to MERCK and its designated AFFILIATE (with the right to print or photocopy documents at MERCK’s cost) for a period of two (2) years following the EFFECTIVE DATE, (a) all ONCOTHYREON KNOW-HOW, including (to the extent falling within the definition of ONCOTHYREON KNOW-HOW) any preclinical data, clinical data, assays and associated materials, protocols, plans, reports, procedures (including standard operating procedures), and any other similar information, that is necessary or useful (acting reasonably) to develop, manufacture, test, release, seek regulatory approval for, or commercialize BLP25, all to the extent in ONCOTHYREON’s possession or control, (b) copies of all material communications specifically in relation to BLP25 with regulatory authorities in the possession or control of ONCOTHYREON, (c) copies of all material communications with third parties related specifically to the development and manufacture of BLP25 (e.g. communication with contract manufacturing organizations, vendors, contractors) in the possession or control of ONCOTHYREON, and (d) copies of all material documents that ONCOTHYREON or its AFFILIATES received from third parties related specifically to the development and manufacture of BLP25 (e.g. standard operating procedures, regulatory filing documents, batch records, certificates received from contract manufacturing organizations, vendors, contractors), in the possession or control of ONCOTHYREON.

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 manufacturing, 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 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 manufacturer of the PRODUCT and to ONCOTHYREON or its designated AFFILIATE as licensor. 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 ONCOTHYREON 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 ONCOTHYREON informed in a timely manner with respect to MERCK’s activities in regard to customer complaints and inquiries for PRODUCT. All costs incurred in responding to customer complaints and inquiries shall be borne by MERCK.

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 ONCOTHYREON 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 ONCOTHYREON 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.

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 ONCOTHYREON 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.

Section 5.12 Trademarks and Branding

In any event described in this section ONCOTHYREON 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 ONCOTHYREON from defending and/or protecting its own reasonable interests. ONCOTHYREON 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 ONCOTHYREON and/or its AFFILIATES.

Section 5.13 General Diligence

Subject to section 14.1 and without being limited by section 5.14, MERCK shall, at MERCK’s expense, use commercially reasonable efforts to diligently pursue the development (including CLINICAL DEVELOPMENT), commercialization, manufacture (including commercial scale-up), registration, promotion, marketing and SALE of PRODUCT in a prudent and skilful manner in accordance with the DEVELOPMENT PLAN and/or the MARKETING PLAN then in effect, which plans will contain development, manufacturing and marketing activities representing commercially reasonable efforts, and in accordance with all applicable laws and regulations. MERCK will bear all costs with respect thereto.

Section 5.14 Excused Performance

In addition to the terms of section 14.1, MERCK’s performance under this AGREEMENT with respect to PRODUCT in a particular country is expressly conditioned upon the continuing absence of any safety or efficacy or regulatory event with respect to PRODUCT in such country which materially limits, reverses or restricts the development and/or marketing of such PRODUCT in such country. MERCK’s obligations to develop, promote and/or SELL such PRODUCT in such country under this AGREEMENT shall be delayed or suspended so long as any such condition exists.

Section 5.15 Japanese Market

Without derogating from section 5.13, in relation to Japan, MERCK shall, as soon as reasonable considering the Japanese market and in any event no later than [+] after positive clinical endpoint data (with no material toxicology issue) being available from a pivotal Phase II or Phase III trial with respect to PRODUCT, commence discussions with the applicable Japanese regulatory authorities with respect to initiating any required clinical trials in Japan and finalize a comprehensive CLINICAL DEVELOPMENT plan for Japan for PRODUCT (which shall include a reasonable timeframe for obtaining regulatory approval in Japan) and thereafter use commercially reasonable efforts to pursue such CLINICAL DEVELOPMENT plan within the timeframes stipulated therein. Notwithstanding any provision to the contrary in this AGREEMENT, if MERCK fails to meet the requirements of this section 5.15 with respect to Japan, then this AGREEMENT shall cease to apply to PRODUCT in relation to Japan and all rights related to PRODUCT in Japan shall revert to ONCOTHYREON.

ARTICLE 6
CONSIDERATION — NA TERRITORY AND ROW TERRITORY

Section 6.1 Consideration for Licenses Granted

In consideration for the licenses granted by ONCOTHYREON to MERCK under article 2, MERCK shall, in the event that MERCK sublicenses, assigns, transfers or otherwise relinquishes all or any of its rights and/or obligations under this AGREEMENT relating to the NA TERRITORY or any part thereof to a third party (which term for purposes of this section 6.1 shall not include an AFFILIATE of MERCK as long as all such rights and/or obligations remain with such AFFILIATE of MERCK, or a contract manufacturing organization for the development, testing, release or supply of PRODUCT selected by MERCK) and receives upfront payments, milestone payments, royalty payments or other monetary consideration, or in-kind consideration of substantive value, in respect thereof, pay ONCOTHYREON [+] within thirty (30) days of the effective date of such sublicense, assignment, transfer or relinquishment, provided that no such payment will be due in connection with the transfer or sale by MERCK of all or substantially all of its business or in the event of the merger or consolidation of MERCK with another corporation.

Section 6.2 Consideration — Milestone and Other Payments

20

For clarification, each of MERCK’s sales milestone payments identified in this section 6.2.3 shall be made only once for the stated sales milestone triggering event. However, more than one sales milestone may be achieved in a particular calendar year, in which case (if not previously paid) each such sales milestone payments shall be made by MERCK to ONCOTHYREON. Any sales milestone payments made by MERCK under this section 6.2.3 are non-refundable to MERCK.

Section 6.3 Royalty Payments