CO-DEVELOPMENT AND LICENSE AGREEMENT

Exhibit 10.33

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934, AS AMENDED

CO-DEVELOPMENT AND LICENSE AGREEMENT

This Co-Development and License Agreement (the “Agreement” ) is made and entered into effective as of December 19, 2005 (the “Effective Date” ) by and between GPC Biotech AG, a German corporation, having its place of business at Fraunhoferstrasse 20, 82152 Martinsried/Munich, Germany ( “GPC Biotech” ); and Pharmion GmbH, a Swiss limited liability company and wholly-owned subsidiary of Pharmion Corporation, a Delaware corporation, having a place of business at Aeschenvorstadt 71, 4051 Basel, Switzerland ( “Licensee” ). GPC Biotech and Licensee are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

RECITALS

      WHEREAS , GPC Biotech has rights with respect to the platinum complex known as “Satraplatin” and has commenced a Phase III registrational trial for the use of the same for the second-line treatment of hormone-refractory prostate cancer;

      WHEREAS , Licensee and its Affiliates have specialized experience in, among other things, the development and commercialization of pharmaceutical compounds for the treatment of cancer in the Licensee Territory (as defined below); and

      WHEREAS , GPC Biotech desires to grant a license to Licensee, and Licensee desires to obtain a license, to Develop and Commercialize (each as defined below) the above-mentioned pharmaceutical compound in accordance with the terms and conditions set forth below.

      NOW, THEREFORE , in consideration of the foregoing premises, the mutual promises and covenants of the Parties contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:

ARTICLE 1

DEFINITIONS

     Unless otherwise specifically provided herein, the following terms shall have the following meanings:

      1.1 “Additional Indication(s)” shall mean each indication, other than the Initial Indication.

      1.2 “Adverse Event Experience” shall have the meaning set forth in Section 9.2.

      1.3 “Affiliate” shall mean, with respect to a Party, any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” shall mean (a) the

possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise, or (b) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).

      1.4 “Agreement” shall have the meaning set forth in the preamble to this Agreement.

      1.5 “Alliance Manager” shall have the meaning set forth in Section 4.4.7.

      1.6 “ANDA Act” shall have the meaning set forth in Section 8.3.2.

      1.7 “ANZ Territory” shall mean the Commonwealth of Australia and New Zealand.

      1.8 “Applicable Law” shall mean applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the Regulatory Authorities, that may be in effect from time to time.

      1.9 “Arbitration Matter” shall have the meaning set forth in Section 15.7.4.

      1.10 “Arbitration Rules” shall have the meaning set forth in Section 15.7.4.

      1.11 “Arbitrator” shall have the meaning set forth in Section 7.12.

      1.12 “Breaching Party” shall have the meaning set forth in Section 14.2.

      1.13 “Business Day” shall mean a day other than a Saturday or Sunday on which banking institutions in Munich, Germany are open for business.

      1.14 “Calendar Quarter” shall mean each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1.

      1.15 “Calendar Year” shall mean each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31.

      1.16 “Change of Control” means, with respect to Licensee, its ultimate parent corporation or any successor to the foregoing, (a) a merger, consolidation, share exchange or other similar transaction involving such party and any Third Party which results in the holders of the outstanding voting securities of such party immediately prior to such merger, consolidation, share exchange or other similar transaction ceasing to hold more than fifty percent (50%) of the combined voting power of the surviving, purchasing or continuing entity immediately after such merger, consolidation, share exchange or other similar transaction, (b) any transaction or series of related transactions in which any “person”, as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), together with any of such person’s “affiliates” or “associates”, as such terms are used in the Exchange Act, becomes the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such party, or (c) the sale or other transfer to a Third Party of all or substantially all of such party’s assets which relate to this Agreement.

      1.17 “Clinical Data” shall mean all information with respect to the Licensed Product and the Licensed Compound, made, collected or otherwise generated in the performance of or in connection with Clinical Studies or Post Approval Studies for the Licensed Product, including any data, reports and results with respect thereto.

      1.18 “Clinical Studies” shall mean Phase I, Phase II, Phase III and such other tests and studies in patients that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals, but excluding Post Approval Studies.

      1.19 “Collaboration Costs” shall mean the FTE Costs (charged in accordance with Sections 6.1.2, 6.1.3, 6.1.4 and 6.1.6) incurred, and the direct out-of-pocket costs recorded as an expense in accordance with GAAP, by or on behalf of: a Party or any of its Affiliates on or after October 1, 2005 or during the term of and pursuant to this Agreement, in connection with (i) tasks that are specifically identified in or reasonably allocable to the Development Plan and Budget or (ii) Joint Commercialization Activities specifically identified in the applicable Commercialization Plan and Budget. Except in the case of Collaboration Costs incurred in accordance with Section 1.19.5, Collaboration Costs incurred on or after the Effective Date with respect to Development activities or Joint Commercialization Activities shall be included in “Collaboration Costs” for the Licensed Product only to the extent less than or equal to the amounts set forth in the applicable Development Budget or Commercialization Budget for such activities (subject to permitted overruns pursuant to Sections 2.3.2 and 3.10.2). Subject to the foregoing, Collaboration Costs shall include such costs incurred in connection with the following activities:

           1.19.1 pre-clinical and non-clinical activities such as toxicology and formulation development, test method development, stability testing, quality assurance, quality control development and statistical analysis;

           1.19.2 Clinical Studies and Post Approval Studies for the Licensed Product, including (a) the preparation for and conduct of clinical trials; (b) data collection and analysis and report writing; (c) clinical laboratory work; and (d) regulatory activities in connection with such studies, including adverse event recordation and reporting;

           1.19.3 the preparation of a regulatory dossier reasonably necessary to obtain Initial Regulatory Approval for the Licensed Product in both the GPC Biotech Territory and the European Union;

           1.19.4 Manufacturing Costs for (a) the Licensed Product for use in Clinical Studies, Post Approval Studies or other Development activities for the Licensed Product and (b) the manufacture, purchase or packaging of comparators or placebo for use in Clinical Studies or Post Approval Studies for the Licensed Product (with the manufacturing costs for comparators or placebo to be determined in the same manner as Manufacturing Costs are determined for any Licensed Product) and (c) costs and expenses of disposal of drugs and other supplies used in such Clinical Studies, Post Approval Studies or other Development activities;

           1.19.5 Losses incurred in connection with Third Party Claims described in Section 13.3 to the extent such losses are to be included in Collaboration Costs pursuant to Section 13.3; and

           1.19.6 Costs for the development of the Manufacturing Process for the Licensed Product, scale-up, Manufacturing Process validation, including validation batches, manufacturing improvements and qualification and validation of Third Party contract manufacturers; provided, however, as set forth in Section 3.1.3 of the Supply Agreement, Licensee’s share pursuant to Section 6.1.1 of any such costs allocable to the Manufacture of any validation batch (or part thereof) that is subsequently sold commercially by or on behalf of Licensee or any of its Affiliates, Sublicensees or Distributors, shall be credited against the Supply Price for such supply.

For the avoidance of doubt and notwithstanding the foregoing, Collaboration Costs shall not include any (a) FTE costs or other costs and expenses that are specifically identifiable or reasonably allocable to Unilateral Activities of either Party during the applicable Opt-Out Period, (b) filing fees in connection with the filing of applications for Regulatory Approvals (c) Third Party Payments or (d) intercompany payments or charges of a Party or its Affiliates (or between such Affiliates).

      1.20 “Combination Product” shall mean a Licensed Product that contains the Licensed Compound as an active ingredient together with one or more other active ingredients that are sold either as a fixed dose or as separate doses in a single package.

      1.21 “Commercialization” shall mean any and all activities (whether before or after Regulatory Approval) directed to the marketing, Detailing and promotion of the Licensed Product and shall include pre-launch and post-launch marketing, promoting, Detailing, marketing research, distributing, offering to commercially sell and commercially selling the Licensed Product, importing, exporting or transporting the Licensed Product for commercial sale and regulatory affairs with respect to the foregoing, but shall not include Post Approval Studies or Manufacturing. When used as a verb, “Commercializing” means to engage in Commercialization and “Commercialize” and “Commercialized” shall have corresponding meanings.

      1.22 “Commercialization Budget” shall mean the budget for the Joint Commercialization Activities set forth in the Commercialization Plan, as provided in Section 3.2.1.

      1.23 “Commercialization Plan” shall mean the plan for the Commercialization of the Licensed Product in the Field in the Licensee Territory and for the Joint Commercialization Activities in support of the Commercialization of the Licensed Product in the Field in the Territory to be developed and amended as provided in Section 3.2.1.

      1.24 “Commercialization Plan and Budget” shall mean the Commercialization Plan and the Commercialization Budget.

      1.25 “Commercially Reasonable Efforts” shall mean, with respect to the Development or Commercialization of the Licensed Product, as the case may be, efforts and

resources commonly used in the research-based pharmaceutical industry by companies similarly situated to the applicable Party, but in no event less than those efforts and resources commonly used by companies similarly situated to the applicable Party as of the Effective Date, for an internally-developed product of similar commercial potential at a similar stage in its lifecycle. Commercially Reasonable Efforts shall be determined on a market-by-market basis for the Licensed Product without regard to the particular circumstances of a Party, including any other product opportunities of such Party and, with respect to Licensee, without regard to any payments owed to GPC Biotech under Articles 6 and 7. When used as an adjective, “ Commercially Reasonable ” shall mean using Commercially Reasonable Efforts.

      1.26 “Committee” shall mean any one of the JEC, the JDC or the JCC and “Committees” shall mean two or more of the JEC, the JDC or the JCC.

      1.27 “Competitive Program” means a clinical development program in a Phase II or Phase III stage or later anywhere in the Territory in support of commercialization activities in the Licensee Territory or commercialization activity (including marketing or promotion) in the Licensee Territory that involves a compound or product (other than the Licensed Product) [...***...] .

      1.28 “Complaining Party” shall have the meaning set forth in Section 14.2.

      1.29 “Complaint” shall have the meaning set forth in Section 9.1.

      1.30 “Completion Notice” shall have the meaning set forth in Section 2.5.6(b).

      1.31 “Compound Option Notice” shall have the meaning set forth in Section 5.4.

      1.32 “Confidential Information” shall have the meaning set forth in Section 11.1.

      1.33 “Control” shall mean, with respect to any item of Information, Drug Master File, Regulatory Documentation, Patent or Intellectual Property Right, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise (other than by

     operation of the assignments, license and other grants in Article 5 and Sections 8.1.3 and 8.1.4 of this Agreement), to assign or grant a license, sublicense or other right to or under, such Information, Drug Master File, Regulatory Documentation, Patent or Intellectual Property Right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

      1.34 “Corporate Names” shall mean (a) in the case of GPC Biotech, the Trademark “ GPC BIOTECH ” and the GPC Biotech corporate logo or such other names and logos as GPC Biotech may designate in writing from time to time and (b) in the case of Licensee, the Trademark “ PHARMION” and the Licensee corporate logo or such other names and logos as Licensee may designate in writing from time to time, in each case ((a) and (b)) together with any variations and derivatives thereof.

      1.35 “Country Commercialization Plan” shall have the meaning set forth in Section 3.2.3.

      1.36 “Derivative Compound ” means an analog or derivative of the Licensed Compound. For clarity, a Derivative Compound is not an Improvement.

      1.37 “Detail” shall mean an interactive face-to-face contact of a sales representative, who is fully equipped with, and knowledgeable of, applicable Promotional Materials and Product Labeling for the Licensed Product, with a physician or other medical professional licensed to prescribe drugs or other healthcare professional that has a significant impact or influence on prescribing decisions, in which relevant characteristics of the Licensed Product are described by the sales representative in a fair and balanced manner consistent with the requirements of this Agreement and Applicable Law, and in a manner that is customary in the industry for the purpose of promoting a prescription pharmaceutical product. When used as a verb, “ Detail” means to engage in a Detail.

      1.38 “Developing Party” shall have the meaning set forth in Section 2.5.2(a).

      1.39 “Development” shall mean all activities related to research, preclinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control related to the foregoing manufacturing activities, Clinical Studies and Post Approval Studies, including manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “Develop” shall mean to engage in Development.

      1.40 “Development Budget” shall mean the budget for the Development of the Licensed Product agreed to by the Parties as of the Effective Date, as it may be amended from time to time in accordance with Section 2.3.1. For clarity, the Development Budget shall not include budgets for Unilateral Activities.

      1.41 “Development Lead” shall mean, with respect to a Development activity, the Party that (a) is assigned primary responsibility for the day-to-day implementation of such

Development activity as provided in the Development Plan or (b) is the Developing Party for a Unilateral Activity.

      1.42 “Development Plan” shall mean the plan for the Development of the Licensed Product in the Field agreed to by the Parties as of the Effective Date, as it may be amended from time to time in accordance with Sections 2.2.1 and 2.5.1. For clarity, the Development Plan shall not include any Development plans for Unilateral Activities.

      1.43 “Development Plan and Budget” shall mean the Development Plan and the Development Budget.

      1.44 “Dispute” shall have the meaning set forth in Section 15.7.

      1.45 “Distributor” shall mean a Person, other than a Sublicensee or an Affiliate, in one or more countries in the Licensee Territory that (a) purchases the Licensed Product in finished form or in bulk capsule form (to be packaged or labeled by such Person in accordance with Applicable Law) from the Licensee, its Affiliate or Sublicensee for such country(ies), (b) assumes responsibility from the Licensee for all or a portion of the Commercialization of the Licensed Product in such country(ies) and (c) sells Licensed Product in such country(ies).

      1.46 “Drug Approval Application” shall mean a New Drug Application (an “ NDA ”) as defined in the FFDCA and the regulations promulgated thereunder, or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (a “ MAA ”) filed with the EMEA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure.

      1.47 “Drug Master File” shall mean any drug master files filed with the FDA with respect to the Licensed Product and any equivalent filing in other countries or regulatory jurisdictions.

      1.48 “Effective Date” shall mean the effective date of this Agreement as set forth in the preamble to this Agreement.

      1.49 “EMEA” shall mean the European Medicines Agency and any successor agency thereto.

      1.50 “Europe” shall mean the countries comprising the European Economic Area as it may be constituted from time to time, which as of the date hereof, consists of the member countries of the European Union, Iceland, Norway, Lichtenstein and Switzerland.

      1.51 “European Union” shall mean the economic, scientific and political organization of member states as it may be constituted from time to time, which, as of the date hereof, consists of Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and the United Kingdom of Great Britain and Northern Ireland and that certain portion of Cyprus included in such organization.

      1.52 “ Exchange Act ” shall have the meaning set forth in Section 1.16.

      1.53 “Expert” shall have the meaning set forth in Section 15.7.4(b)(i).

      1.54 “Exploit” shall mean to make, have made, import, use, sell or offer for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of.

      1.55 “Exploitation” shall mean the act of Exploiting a product or process.

      1.56 “Exploratory Study” shall mean a Clinical Study other than any Registrational Study.

      1.57 “FDA” shall mean the United States Food and Drug Administration and any successor agency thereto.

      1.58 “FFDCA” shall mean the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time.

      1.59 “Field” shall have the meaning set forth in the Spectrum Agreement, as it may be amended from time to time.

      1.60 “Follow Up Registrational Study” shall mean the first Registrational Study, if any, conducted by the Parties pursuant to the Development Plan to obtain Initial Regulatory Approval for the Licensed Product in the United States and Europe with respect to an Additional Indication.

      1.61 “FTE” shall mean the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of eighteen hundred (1800) hours per Calendar Year, or such other number as may be agreed by the JDC) of work directly related to the Development of the Licensed Product or any other activities contemplated under this Agreement. No additional payment shall be made with respect to any person who works more than eighteen hundred (1800) hours per Calendar Year (or such other number as may be agreed by the JDC) and any person who devotes less than eighteen hundred (1800) hours per Calendar Year (or such other number as may be agreed by the JDC) shall be treated as an FTE on a pro-rata basis based upon the actual number of hours worked divided by eighteen hundred (1800) (or such other number as may be agreed by the JDC).

      1.62 “FTE Cost” shall mean the FTE rate for employees who shall be performing services under this Agreement which, as of the Effective Date, is equal to [...***...] . Such rate shall be adjusted subsequently in accordance with Section 6.1.4.

      1.63 “GAAP” shall mean United States generally accepted accounting principles consistently applied.

      1.64 “Generic Product” shall mean, with respect to a Licensed Product in a country, any product (a) that contains the Licensed Compound, (b) in the case of any country in the European Union, is approved for sale in the Field pursuant to an application approved by the applicable Regulatory Authorities in the European Union under Article 10.1 of Directive 2001/83/EC, and for which the applicant is not required under Article 8.3(i) of Directive 2001/83/EC to have submitted any preclinical and clinical data other than data from bioequivalence studies comparing such product to such Licensed Product required under Article 10.1 of that Directive, and in the case of any other country in the Licensee Territory, is approved for sale pursuant to any corresponding application in such country, and (c) is sold for use or consumption in the Field by the general public in such country by a Third Party, other than any Third Party that is a Sublicensee or Distributor or otherwise sells such product pursuant to a (sub)license, distributorship or other arrangement with Licensee, or pursuant to or in reliance on any right of reference granted to such Third Party or any of its Affiliates by or on behalf of Licensee .

      1.65 “Global Strategy” shall have the meaning set forth in Section 3.1.3(a).

      1.66 “GPC Biotech” shall have the meaning set forth in the preamble to this Agreement.

      1.67 “GPC Biotech Activities” shall have the meanings set forth in Section 2.2.2(b).

      1.68 “GPC Biotech Counter-Party” shall mean a Third Party with which GPC Biotech has entered into an agreement that includes Development and Commercialization rights or Commercialization rights for the Licensed Product.

      1.69 “GPC Biotech Improvement” shall mean any Improvement conceived or used by or on behalf of GPC Biotech or its Affiliates in connection with the Development of the Licensed Product under this Agreement but excluding any Joint Improvement.

      1.70 “GPC Biotech Know-How” shall mean all Information, including any GPC Biotech Improvements and Clinical Data, that is Controlled by GPC Biotech or its Affiliates as of the Effective Date or during the term of this Agreement that is not generally known and (a) is developed or acquired by or licensed to GPC Biotech or any of its Affiliates under or in connection with this Agreement or otherwise used by or on behalf of GPC Biotech or any of its Affiliates in the Development or Commercialization of the Licensed Product or (b) is necessary for the Development or Commercialization of the Licensed Product, but excluding any Information to the extent covered or claimed by published GPC Biotech Patents, published Joint Patents and any Joint Know-How.

      1.71 “GPC Biotech Patents” shall mean all of the Patents that GPC Biotech and its Affiliates Control as of the Effective Date or during the term of this Agreement that are necessary (or, with respect to Patent applications, would be necessary if such Patent applications were to issue as Patents) for the Development or Commercialization of the Licensed Product or any Improvement thereto, including those that claim or cover the Licensed Product or the Development or Commercialization thereof, but excluding any Joint Patents. For the avoidance

of doubt, the GPC Biotech Patents include, as of the Effective Date, the Patents set forth on Exhibit A.

      1.72 “GPC Biotech Territory” shall mean the entire world, other than the Licensee Territory and including any countries or Major Market Regions in which this Agreement is terminated pursuant to Article 14.

      1.73 “Improvement” shall mean any modification, variation or revision to a compound, product or technology or any discovery, technology, device or process or formulation related to such compound, product or technology, whether or not patented or patentable, including any enhancement in the efficiency, operation, manufacture (including any manufacturing process), ingredients, preparation, presentation, formulation, means of delivery, packaging or dosage of such compound, product or technology, any discovery or development of any new or expanded indications for such compound, product or technology or any discovery or development that improves the stability, safety or efficacy of such compound, product or technology; provided that, Improvements shall exclude any Derivative Compound.

      1.74 “Indemnification Claim Notice” shall have the meaning set forth in Section 13.4.

      1.75 “IND” shall mean an investigational new drug application filed with the FDA for authorization to commence Clinical Studies or Post Approval Studies and its equivalent in other countries or regulatory jurisdictions.

      1.76 “Indemnified Party” shall have the meaning set forth in Section 13.4.

      1.77 “Information” shall mean all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including: biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols; assays and biological methodology; (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, but excluding the Regulatory Documentation and the Drug Master File.

      1.78 “Initial Indication” shall mean the second-line treatment of hormone-refractory prostate cancer.

      1.79 “Initial Opt-Out Threshold” shall have the meaning set forth in Section 2.6.1(b).

      1.80 “Initial Regulatory Approval” of the Licensed Product for an indication means (a) with respect to the United States, the approval by FDA (whether through means of an NDA, subpart E, or subpart H filing or otherwise); or (b) with respect to a country in a regulatory jurisdiction in the Licensee Territory, the approval by the applicable Regulatory Authorities, of the Drug Approval Application with respect to the Licensed Product for such indication in the

applicable regulatory jurisdiction (including, in the European Union, the approval by the EMEA of an MAA filed pursuant to the centralized approval procedure, if applicable, or otherwise with respect to the mutual recognition approval procedure on a country-by-country basis with the applicable Regulatory Authority of a country in Europe).

      1.81 “Intellectual Property Rights” shall mean Trademarks, service marks, trade names, registered designs, design rights, copyrights (including rights in computer software), database rights, trade secrets and any rights or property similar to any of the foregoing (other than Patents) in any part of the Territory whether registered or not registered together with the right to apply for the registration of any such rights.

      1.82 “Invoiced Sales” shall have the meaning set forth in Section 1.114.

      1.83 “Joint Commercialization Activities” shall have the meaning set forth in Section 4.3.2.

      1.84 “Joint Commercialization Committee” or “JCC” shall have the meaning set forth in Section 4.3.1.

      1.85 “Joint Development Committee” or “JDC” shall have the meaning set forth in Section 4.2.1.

      1.86 “Joint Executive Committee” or “JEC” shall have the meaning set forth in Section 4.1.

      1.87 “Joint Improvement” shall mean any Improvement jointly conceived by or on behalf of GPC Biotech or its Affiliates, on the one hand, and Licensee or its Affiliates or Sublicensees, on the other hand.

      1.88 “Joint Intellectual Property Rights” shall have the meaning set forth in Section 8.1.5.

      1.89 “Joint Know-How” shall have the meaning set forth in Section 8.1.5.

      1.90 “Joint Patents” shall have the meaning set forth in Section 8.1.5.

      1.91 “Knowledge” shall mean the actual knowledge or good faith understanding of the vice presidents, senior vice presidents, president or chief executive officer of a Party of the facts and information then in their possession without any duty to conduct any investigation with respect to such facts and information and “Knowingly” shall mean, with respect to any action, to take such action with Knowledge.

      1.92 “Licensed Compound” shall mean the platinum complex af-bis(acetato)-b-ammine-cd-dichloro-e-(cyclohexylamine)platinum(IV).

      1.93 “Licensed Product” shall mean any form, mode of administration or dosage of a pharmaceutical composition or preparation that contains the Licensed Compound as an active ingredient, including any Improvements thereto.

      1.94 “Licensee” shall have the meaning set forth in the preamble to this Agreement.

      1.95 “Licensee Activities” shall have the meaning set forth in Section 2.2.2(b).

      1.96 “Licensee Change of Control Notice” shall have the meaning set forth in Section 14.5.2.

      1.97 “Licensee Improvement” shall mean any Improvement conceived or used by or on behalf of Licensee or its Affiliates in connection with the Development of the Licensed Product under this Agreement, but excluding any Joint Improvement.

      1.98 “Licensee Initial Indication Study” shall have the meaning set forth in Section 2.6.2(b).

      1.99 “Licensee Know-How” shall mean all Information, including any Licensee Improvements and Clinical Data, that is Controlled as of the Effective Date or during the term of this Agreement by Licensee or any of its Affiliates or Sublicensees that is not generally known and (a) is developed or acquired by or licensed to Licensee or any of its Affiliates or Sublicensees under or in connection with this Agreement or otherwise used by or on behalf of Licensee or any of its Affiliates or Sublicensees in the Exploitation of the Licensed Product or the Licensed Compound or (b) is necessary for the Exploitation of the Licensed Product or the Licensed Compound, but excluding any Information to the extent covered or claimed by published Licensee Patents, published Joint Patents and any Joint Know-How.

      1.100 “Licensee Patents” shall mean all Patents Controlled by Licensee and any of its Affiliates or Sublicensees that are necessary (or with respect to Patent applications, would be necessary if such Patent applications were to issue as Patents) for the Exploitation of the Licensed Product, the Licensed Compound or any Licensee Improvement thereto, including those that claim or cover any Licensed Compound, Licensed Product, Licensee Know-How, any Licensee Improvement thereto or the Exploitation of any of the foregoing, but excluding any Joint Patents.

      1.101 “Licensee Territory” shall mean Europe, the Middle East, the ANZ Territory and any portion of Cyprus not otherwise included within Europe, and except for those countries in which this Agreement is terminated pursuant to Article 14.

      1.102 “Losses” shall have the meaning set forth in Section 13.1.

      1.103 “MAA” shall have the meaning set forth in Section 1.46.

      1.104 “Major Market Country” shall mean (a) with respect to Europe, France, Germany, Italy, Spain and the United Kingdom and (b) with respect to the ANZ Territory, the Commonwealth of Australia and (c) with respect to the Middle East, Israel and the Republic of Turkey.

      1.105 “Major Market Region” shall mean each of Europe, the Middle East, and the ANZ Territory.

      1.106 “Major Meetings” shall mean meetings (in person or otherwise) scheduled with the Regulatory Authorities in the United States or the Licensee Territory concerning the Licensed Product (including advisory committee meetings and any other meetings of experts convened by a Regulatory Authority concerning any topic relevant to the Licensed Product of which a Party has been notified) that would constitute type “A,” “B” or “C” meetings in the United States, or the equivalent thereof in the European Union, Pre-NDA meetings or meetings relating to Product Labeling.

      1.107 “Manufacture” and “Manufacturing” shall mean all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of the Licensed Product or any intermediate thereof, including process development, process qualification and validation, scale up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.

      1.108 “Manufacturing Cost” shall mean GPC Biotech’s cost to Manufacture the Licensed Product calculated in accordance with the method disclosed by GPC Biotech in its letter to Licensee dated December 13, 2005.

      1.109 “Manufacturing Process” shall mean any process or step thereof that is necessary or useful for Manufacturing the Licensed Product or any intermediate thereof.

      1.110 “Markings” shall have the meaning set forth in Section 3.4.2.

      1.111 “Merger Party” shall have the meaning set forth in Section 14.5.3.

      1.112 “Middle East” shall mean the following countries: Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Oman, the Palestinian Territories (including the West Bank and the Gaza Strip) as they may be constituted from time to time and any successor state comprising such territories, Qatar, the Republic of Turkey, Saudi Arabia, Syria, the United Arab Emirates and Yemen; and any successor state comprising the territory of any such countries.

      1.113 “NDA” shall have the meaning set forth in Section 1.46.

      1.114 “Net Sales” shall mean, for any period, (a) the gross amount invoiced by Licensee and its Affiliates or Sublicensees for the sale of Licensed Product in an arm’s length transaction exclusively for money (the “ Invoiced Sales ”), after deduction of normal trade discounts and of any credits actually given by Licensee for returned or defective products, as determined in accordance with GAAP, and excluding or making proper deductions for any costs of packing, insurance, carriage and freight and VAT or other sales tax and, in the case of export orders, any import duties or similar applicable governmental levies or export insurance costs expressly subject in all cases to the same being separately charged on customer invoices or (b) in any sale or other disposal of Licensed Product otherwise than in an arm’s length transaction exclusively for money, the fair market value (if higher) in the relevant country of disposal.

     Notwithstanding the foregoing, in the event that the Licensed Product is sold in conjunction with another proprietary component so as to be a Combination Product (whether packaged together or in the same therapeutic formulation), Net Sales shall be calculated by

multiplying the Net Sales of such Combination Product by a fraction, the numerator of which shall be the fair market value of the Licensed Product if sold separately (determined in accordance with GAAP) and the denominator of which shall be the aggregate fair market value of all the proprietary active components of such Combination Product, including the Licensed Product, if sold separately. In the event that no such separate sales are made by Licensee or its Affiliates or Sublicensees, Net Sales of the Combination Product shall be calculated in a manner to be negotiated and agreed upon by the Parties, reasonably and in good faith, prior to any sale of such Combination Product, which shall be based upon the respective estimated commercial values of the proprietary active components of such Combination Product.

     Licensee’s or any of its Affiliate’s or Sublicensee’s transfer of Licensed Product to an Affiliate or Sublicensee shall not result in any Net Sales, unless the Licensed Product is consumed by such Affiliate or Sublicensee in the course of its commercial activities.

      1.115 “Non-Approvable Study” shall mean, with respect to any Registrational Study for the Initial Indication or any Additional Indication conducted pursuant to the Development Plan, that such study was determined by the applicable Regulatory Authority, or mutually by the Parties, to be insufficient to support Initial Regulatory Approval of the Licensed Product in the designated jurisdiction in the absence of substantial additional data or investment.

      1.116 “Notice Period” shall have the meaning set forth in Section 14.2.

      1.117 “Opt-In” shall have the meaning set forth in Section 2.5.6(a).

      1.118 “Opt-In Exercise Notice” shall have the meaning set forth in Section 2.5.6(b).

      1.119 “Opt-In Exercise Period” shall have the meaning set forth in Section 2.5.6(a).

      1.120 “Opting-Out Party” shall have the meaning set forth in Section 2.5.2(a).

      1.121 “Opt-Out” shall have the meaning set forth in Section 2.5.2(a).

      1.122 “Opt-Out Period” shall mean, with respect to any Unilateral Activity, the period commencing on the date on which an activity is deemed to be a Unilateral Activity pursuant to Section 2.5.2(a) and ending on the earlier to occur of (a) the date of completion of such Unilateral Activity or (b) the date on which the Opt-In Exercise Notice is received by the Developing Party, as applicable.

      1.123 “Party” and “Parties” shall have the meaning set forth in the preamble to this Agreement.

      1.124 “Patents” shall mean (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any

and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)) and (e) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.

      1.125 “Payments” shall have the meaning set forth in Section 7.8.1.

      1.126 “Person” shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

      1.127 “Pharmacovigilance Agreement” shall have the meaning set forth in Section 9.3.

      1.128 “Phase I” shall mean a human clinical trial of the Licensed Product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities, including the trials referred to in 21 C.F.R. §312.21(a), as amended.

      1.129 “Phase II” shall mean a human clinical trial of the Licensed Product, the principal purpose of which is a determination of safety and efficacy in the target patient population or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.

      1.130 “Phase III” shall mean a human clinical trial of the Licensed Product on a sufficient number of subjects that is designated to establish that a pharmaceutical product is safe and efficacious for its intended use and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support marketing approval of the Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise.

      1.131 “Post Approval Study” shall mean any human clinical study or other test or study with respect to a product for an indication that (a) is conducted solely in support of pricing or reimbursement for such product in a country or (b) is not required to obtain or maintain Regulatory Approval for such product for such indication (for clarity, any human clinical study that is intended to expand the Product Labeling for such product shall be a Clinical Study). Subject to the foregoing, Post Approval Studies may include epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored studies and health economics studies.

      1.132 “Product Labeling” shall mean (a) the Regulatory Authority-approved full prescribing information for the Licensed Product for that country, including any required patient

information; and (b) all labels and other written, printed or graphic matter upon a container, wrapper or any package insert utilized with or for the Licensed Product.

      1.133 “Product Trademarks” shall mean (a) the Trademark(s) for the Licensed Product Controlled by GPC Biotech during the term of this Agreement and used or intended for use in connection with the Commercialization of Licensed Products, and (b) such other Trademarks designated by the JCC in accordance with Section 3.4.4 and any registrations thereof or any pending applications relating thereto.

      1.134 “Promotional Materials” shall mean all sales representative training materials with respect to the Licensed Product and all written, printed, graphic, electronic, audio or video matter, including journal advertisements, sales visual aids, direct mail, medical information/education monographs, direct-to-consumer advertising, Internet postings, broadcast advertisements and sales reminder aids (e.g., scratch pads, pens and other such items) intended for use or used by a Party, its Affiliates or, with respect to Licensee, its Sublicensees or Distributors, in connection with any promotion of the Licensed Product, except Product Labeling for the Licensed Product.

      1.135 “Proposed Unilateral Activities” shall have the meaning set forth in Section 2.5.2.

      1.136 “Registrational Study” shall mean (a) in the case of a Clinical Study with respect to which GPC Biotech is the Development Lead, a pivotal Clinical Study for the Licensed Product for the Initial Indication or any Additional Indication that is designed to be sufficient to obtain Initial Regulatory Approval by the FDA of the Licensed Product for such indication or (b) in the case of a Clinical Study with respect to which Licensee is the Development Lead, a pivotal Clinical Study for the Licensed Product for the Initial Indication or any Additional Indication that is designed to be sufficient to obtain Initial Regulatory Approval by the applicable Regulatory Authorities in a given country or countries in the Licensee Territory, or if applicable, the European Union. For the avoidance of doubt, the SPARC Study shall be deemed to constitute a Registrational Study for the Initial Indication.

      1.137 “Registrational Study Budgeted Funding Commitment” shall mean [...***...] .

      1.138 “Regulatory Approval” shall mean, with respect to a country in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market the Licensed Product in such country, including, where applicable, (a) pricing or reimbursement approval in such country, (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), (c) labeling approval and (d) technical, medical and scientific licenses.

      1.139 “Regulatory Authority” shall mean any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus,

*** Confidential Treatment Requested

commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of the Licensed Compound or the Licensed Product in the Territory.

      1.140 “Regulatory Documentation” shall mean all applications, registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, relating to the Licensed Product and all data contained in any of the foregoing, including all INDs, Drug Approval Applications, regulatory drug lists, advertising and promotion documents, Clinical Data, adverse event files and complaint files (but excluding any Drug Master File).

      1.141 “Regulatory Exclusivity Period” shall mean any period of data, market or other regulatory exclusivity, including any such periods listed in the FDA’s Orange Book or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 and all international equivalents.

      1.142 “Regulatory Lead” shall mean, with respect to a country or regulatory region, the Party that has primary responsibility for preparing, obtaining and maintaining Regulatory Approvals for, and for conducting communications with the Regulatory Authorities with respect to, the Licensed Product in such country or region as provided in Section 2.4.

      1.143 “Related Unilateral Activities” shall have the meaning set forth in Section 2.5.6(a).

      1.144 “Royalty Rate Floor” shall have the meaning set forth in Section 7.2.

      1.145 “Royalty Term” shall have the meaning set forth in Section 7.3.

      1.146 “Selected Development Activities” shall mean Development activities for the Licensed Product consisting of (a) any Exploratory Study or (b) other Development activities in each case ((a) and (b)) provided for in the Development Plan, excluding in each case ((a) and (b)) any Development activities associated with (i) the SPARC Study, (ii) any other Registrational Study and (iii) any Unilateral Activities.

      1.147 “SPARC Study” shall have the meaning set forth in Section 2.1.1.

      1.148 “Spectrum Agreement” shall mean that certain Co-Development and License Agreement between Spectrum Pharmaceuticals, Inc. (f/k/a Neotherapeutics, Inc.) and GPC Biotech AG, dated September 30, 2002, a redacted copy of which is on file with the United States Securities and Exchange Commission, as Exhibit 10.1 to GPC Biotech’s Form F-1, dated June 9, 2004.

      1.149 “Spectrum Payments” shall have the meaning set forth in Section 8.4.1(a).

      1.150 “Spectrum Royalty Term” shall have the meaning set forth in Section 7.3.

      1.151 “Statement Cut-Off Date” shall have the meaning set forth in Section 2.5.6(b).

      1.152 “Sublicensee” shall mean a Person, other than an Affiliate, that is granted a sublicense by Licensee under the grant in Section 5.1 as provided in Section 5.3.

      1.153 “Supply Agreement” shall mean the agreement for supply of Licensed Product by GPC Biotech to Licensee executed by the Parties as of the Effective Date.

      1.154 “Supply Price” shall mean one hundred and ten percent (110%) of the Manufacturing Costs.

      1.155 “Territory” shall mean the GPC Biotech Territory and the Licensee Territory.

      1.156 “Third Party” shall mean any Person other than GPC Biotech, Licensee and their respective Affiliates.

      1.157 “Third Party Claims” shall have the meaning set forth in Section 13.1.

      1.158 “Third Party Payment” shall have the meaning set forth in Section 8.4.1(a).

      1.159 “Trademark” shall include any word, name, symbol, color, designation or device or any combination thereof, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo or business symbol, whether or not registered.

      1.160 “Unilateral Activities” shall have the meaning set forth in Section 2.5.2.

      1.161 “Unilateral Activity Cost Statement” shall have the meaning set forth in Section 2.5.6(b).

      1.162 “United States” or “U.S.” shall mean the United States of America, including its territories and possessions, the District of Columbia and Puerto Rico.

      1.163 “Valid Claim” shall mean, with respect to a particular country, (a) any claim of an issued and unexpired Patent in such country that (i) has not been held permanently revoked, unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal and (ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise in such country; or (b) a claim of a pending Patent application, which claim has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application; provided, however , that if a claim of a patent application has been pending for more than five (5) years, such claim shall not constitute a Valid Claim for the purposes of this Agreement unless and until a Patent issues with such claim.

      1.164 “VAT” shall have the meaning set forth in Section 7.8.2.

ARTICLE 2

DEVELOPMENT AND REGULATORY

      2.1 Development of the Licensed Product.

           2.1.1 Ongoing Development. As of the Effective Date, GPC Biotech is conducting a Phase III Clinical Study for the Initial Indication described more fully in the Development Plan (the “SPARC Study” ) and certain Phase I, Phase I/II and Phase II Clinical Studies for the Licensed Product in the Territory as listed in the Development Plan. The Parties acknowledge and agree that the SPARC Study is a pivotal study which is intended to be sufficient for the filing of an MAA for the Initial Indication in the European Union.

           2.1.2 Diligence.

                (a) In General . Subject to Section 2.1.2(c), each Party shall use Commercially Reasonable Efforts to perform the responsibilities assigned to it under the Development Plan and this Agreement expeditiously and efficiently and in accordance with the Development Budget. For clarity, nothing contained in this Section 2.1.2(a) shall operate to limit any right of the Parties to amend the Development Plan or Development Budget in accordance with the terms and conditions of this Agreement.

                (b) By Licensee. Without limitation to Section 2.1.2(a),

                     (i)  Licensee shall use Commercially Reasonable Efforts (1) to Develop and obtain Regulatory Approval for the Licensed Product in all Major Market Countries in the Licensee Territory, and (2) to Develop and obtain Regulatory Approval for the Licensed Product in each other country in the Licensee Territory where performing such Development and seeking such Regulatory Approval would be Commercially Reasonable;

                     (ii)  without limitation to Section 2.1.2(b)(i), Licensee shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approvals for the Licensed Product in each such country and with respect to such indications for which Clinical Data obtained from Clinical Studies performed hereunder is sufficient to support Regulatory Approval for the Licensed Product in such country; and

                     (iii)  Notwithstanding anything contained in this Section 2.1.2, in no event shall Licensee have any diligence obligations with respect to the conduct of Clinical Studies that are Unilateral Activities of Licensee, except as otherwise provided in Section 2.6.2(d).

                (c) By GPC Biotech. Notwithstanding anything contained in this Section 2.1.2 or any other term or condition of this Agreement, (i) provided that GPC Biotech shall use Commercially Reasonable Efforts to perform the responsibilities assigned to it under the Development Plan with respect to the SPARC Study, in the event that the SPARC Study is a Non-Approvable Study in the United States, GPC Biotech shall have no obligation to perform

any additional Registrational Study or part thereof and (ii) in no event shall GPC Biotech have any diligence obligations with respect to Unilateral Activities of GPC Biotech.

           2.1.3 Compliance. Each Party shall perform or cause to be performed, any and all of its Development obligations under this Agreement in good scientific manner, and in compliance with all Applicable Law, and shall endeavor to achieve the objectives of the Development Plan diligently and efficiently by allocating sufficient time, effort, equipment and skilled personnel to complete such Development activities successfully and promptly.

      2.2 Development Plan and Implementation.

           2.2.1 Development Plan.

                (a)  As of the Effective Date, the Parties have agreed to the initial Development Plan. The Joint Development Committee shall review the Development Plan within one hundred and eighty (180) days after the Effective Date and, thereafter, at least annually, and shall make amendments thereto with respect to the Development of the Licensed Product in accordance with Section 2.5.1.

                (b)  Any amendment to the Development Plan shall continue to provide for the joint Development by the Parties of the Licensed Product and shall assign responsibility for Development activities between the Parties by considering (i) the allocation of responsibility set out in the initial Development Plan, and (ii) the expertise and available resources of the Parties, including the ability to use the Parties’ respective existing facilities and infrastructure.

           2.2.2 Global Development Plan; Development Leads.

                (a)  It is contemplated that from and after the Effective Date, the Clinical Studies and Post Approval Studies for the Licensed Product, where practicable and without any obligation to amend the initial Development Plan, shall be structured so as to support the filing of Drug Approval Applications for the Licensed Product in the United States and European Union.

                (b)  Except as otherwise provided in the Development Plan, (i) Licensee shall be the Development Lead with respect any Clinical Studies, Post Approval Studies and other Development activities for the Licensed Product that are conducted solely in support of Regulatory Approvals for the Licensed Product or Commercialization of the Licensed Product in the Licensee Territory, including any Development activities that constitute Unilateral Activities of Licensee pursuant to Section 2.5.2 (collectively, the “Licensee Activities” ), and (ii) GPC Biotech shall be the Development Lead with respect to all other Clinical Studies, Post Approval Studies and other Development activities for the Licensed Product, including any Development activities that constitute Unilateral Activities of GPC Biotech pursuant to Section 2.5.2 (collectively, “ GPC Biotech Activities ”).

           2.2.3 Responsibilities of the Development Lead.

                (a)  Under the direction and supervision of the JDC, and subject to the Development Plan and Budget, each Party shall have primary responsibility for the day-to-day implementation of the Clinical Studies and Post Approval Studies for the Licensed Product for which it is the Development Lead.

                (b)  The Party that is not the Development Lead with respect to a Clinical Study or Post Approval Study for the Licensed Product shall cooperate with the Development Lead in conducting such Clinical Studies and Post Approval Studies and shall perform such activities with respect thereto as are assigned to it in the Development Plan under the direction of the Development Lead and subject to the Development Plan and Budget; provided, however , that in no event (i) shall GPC Biotech have any obligation to perform any such activities with respect to Licensee Activities without its consent, and (ii) shall either Party have any obligation (1) to cooperate with the Development Lead in conducting Unilateral Activities of such Development Lead, unless the Parties agree in writing to cooperate with respect thereto and the Development Lead agrees to reimburse the other Party for reasonable costs and expenses associated therewith, or (2) to otherwise perform any Development activities consisting of or supporting the Unilateral Activities of the other Party.

                (c)  Subject to the provisions of Section 2.5.1, each Party shall prepare and propose, for consideration by the JDC, amendments to the Development Plan and Budget that may be necessary or desirable to efficiently and expeditiously complete the Development activities, including Clinical Studies and Post Approval Studies, for which it is the Development Lead. Further, Licensee shall, subject to the provisions of Section 2.5.1, prepare and propose, for consideration by the JDC, amendments to the Development Plan and Budget that may be necessary or desirable to efficiently and expeditiously obtain and maintain Regulatory Approvals and successfully Commercialize the Licensed Product in each country in the Licensee Territory.

      2.3 Development Budget.

           2.3.1 Amendment of the Development Budget. The Parties have agreed to the initial Development Budget. The Joint Development Committee shall review the Development Budget within one hundred and eighty (180) days after the Effective Date and, thereafter, at least annually, and shall make modifications thereto to reflect any amendments to the Development Plan made pursuant to Sections 2.2.1 and 2.5.1. With respect to any proposed amendments to the Development Plan, each Party shall, in consultation with the other Party, prepare and submit to the JDC, for its review and approval, a proposed budget in a format to be agreed by the Parties for the new Clinical Studies, Post Approval Studies or other Development activities for which it is the Development Lead, which budget shall include line item estimates of Collaboration Costs broken down on a Calendar Year basis.

           2.3.2 Cost Overruns.

                (a)  In any Calendar Year, each Party shall promptly inform the other Party upon such Party determining that it is likely to overspend or underspend by more than ten percent (10%) its respective total Collaboration Costs set forth in the Development Budget for that Calendar Year.

                (b)  If in any such Calendar Year a Party exceeds its budgeted costs and expenses by more than ten percent (10%), the Party that has so exceeded its budget shall provide to the JDC and to the JEC (if the matter is escalated to the JEC because it cannot be resolved by the JDC) a full explanation for exceeding the Development Budget. If and to the extent that any such overspend (i) was outside the reasonable control of the applicable Party, or (ii) resulted from a reasonable or necessary acceleration of Development activities within a particular Calendar Year, some or all of which activities had been expected to occur in a subsequent Calendar Year; then (in each case (i) and (ii)), provided the applicable Party has promptly notified the other Party of such overspend and, in the case of overspends covered by clause (i) of this Section 2.3.2(b), used reasonable efforts to mitigate the size of such overspend, then such overspend shall be included in Collaboration Costs and shared by the Parties pursuant to Section 6.1.1.

                (c)  To the extent that any overspend is not included in Collaboration Costs as provided in this Section 2.3.2, the Party that has exceeded its budget by more than ten percent (10%) for a Calendar Year shall be solely responsible for the overspend.

      2.4 Regulatory Matters.

           2.4.1 Regulatory Lead. Licensee shall be the Regulatory Lead with respect to any Drug Approval Applications and other Regulatory Approvals for the Licensed Product (which, for clarity, does not include filings of or with respect to INDs and other filings with respect to the Development of the Licensed Product, which shall be the responsibility of the applicable Development Lead) in the Licensee Territory. GPC Biotech shall be the Regulatory Lead with respect to any Drug Approval Applications or Regulatory Approvals for the Licensed Product (which, for clarity, does not include filings of or with respect to INDs and other filings with respect to the Development of the Licensed Product, which shall be the responsibility of the applicable Development Lead) in the GPC Biotech Territory.

           2.4.2 Regulatory Responsibilities With Respect to Licensee Territory; Preparation of Regulatory Submissions. As promptly as practicable after the Effective Date, under the direction and supervision of the JDC, Licensee shall assume control of and responsibility for all regulatory submissions with respect to Regulatory Approvals, including Drug Approval Applications, for the Licensed Product in the Licensee Territory and Licensee Activities in those countries where such activities are conducted. Ownership of Regulatory Approvals and related submissions within the Licensee Territory relating to the Licensed Product shall be governed by Section 8.1.3.

           2.4.3 Clinical and Non-Clinical Data.

                     (a)  Subject to Section 2.5.5, each Party shall promptly provide to the other Party copies of all all clinical and non-clinical data, and other results and analyses with respect to any Development activities with respect to the Licensed Product, when and as such data, results and analyses become available; provided, however, in the event that GPC Biotech enters into an agreement with a GPC Biotech Counter-Party, GPC Biotech shall have no further obligation to provide Licensee with such data, results or analyses with respect to Unilateral

Activities or any Development activities in connection with such agreement for which Licensee has not funded its share as determined hereunder or for which Licensee has Opted-Out.

                     (b)  Subject to Section 2.5.5, each Party shall support the other, as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Product, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the Development Plan and Budget.

                2.4.4 Communications with Regulatory Authorities.

                     (a) Licensee Territory .

                          (i) In General . Licensee shall be responsible for any communications with the Regulatory Authorities occurring or required in connection with performing its responsibilities set forth in Section 2.4.2 and shall designate a representative to serve as the designated regulatory representative with respect to such communications.

                          (ii) Written Communications. Licensee, in consultation with GPC Biotech, shall prepare and submit to the JDC for its review, all material submissions (including any supplements or modifications thereto) to the Regulatory Authorities in the Licensee Territory or for which Licensee is the Development Lead. The JDC shall have the right to expeditiously review and comment on the content and subject matter of, and strategy for, each Drug Approval Application and other filing for Regulatory Approval, all correspondence submitted to the Regulatory Authorities related to the design of Clinical Studies and Post Approval Studies, and all proposed Product Labeling for the Licensed Product and related communications and decisions with the Regulatory Authorities (including the final approved Product Labeling for the Licensed Product and any changes thereto); provided, however , Licensee shall not be required to delay any submission to the applicable Regulatory Authorities if the JDC does not provide its comments within a reasonable time after receipt of such proposed material submissions, taking into account any submission deadlines imposed by the Regulatory Authorities. Without limiting the foregoing, Licensee shall promptly provide GPC Biotech with (1) copies of all material written or electronic communications received by Licensee, its Affiliates, Sublicensees or Distributors, from, or forwarded by Licensee or its Affiliates, Sublicensees or Distributors to, the Regulatory Authorities with respect to obtaining or maintaining any Regulatory Approvals in the Licensee Territory or any other Licensee Activities, and (2) copies of all contact reports produced by Licensee, its Affiliates, Sublicensees or Distributors, in each case ((1) and (2)) within two (2) Business Days of receiving, forwarding or producing any of the foregoing.

                     (b) GPC Biotech Territory .

                          (i)  GPC Biotech shall be solely responsible for any communications with the Regulatory Authorities occurring or required in connection with obtaining or maintaining any Regulatory Approvals for the Licensed Product in the GPC Biotech Territory.

                          (ii)  GPC Biotech shall promptly provide Licensee with copies of all written or electronic correspondence material to the Development or Commercialization of the Licensed Product in the Licensee Territory received by GPC Biotech or its Affiliates from, or forwarded by GPC Biotech or its Affiliates to, the Regulatory Authorities with respect to obtaining or maintaining any Regulatory Approvals in the United States; provided, however, in the event that GPC Biotech enters into an agreement with a GPC Biotech Counter-Party, GPC Biotech shall have no further obligation to provide Licensee with such correspondence (to the extent GPC Biotech’s agreement with such GPC Biotech Counter-Party prohibits providing Licensee with such correspondence), except for any such correspondence that relates to matters that could reasonably be expected to have a material adverse effect on the Product Labeling in the Licensee Territory which must be provided to Licensee notwithstanding the foregoing.

                     (c) Adverse Event Experiences. Without limitation to anything contained in this Section 2.4.4, each Party shall provide to the other Party documentation concerning Adverse Event Experiences required to be reported to a Regulatory Authority pursuant to Applicable Law in accordance with Article 9.

                2.4.5 Meetings with Regulatory Authorities. Each Party shall provide the other Party with prior written notice of any Major Meeting promptly after the Party receives notice of the scheduling of such Major Meeting, when practicable, within such time period as may be necessary in order to give the other Party a reasonable opportunity to attend such Major Meeting. GPC Biotech shall be entitled to have reasonable representation present at, and subject to Section 2.4.6, to participate in at its expense, all such Major Meetings relating to the Licensed Product in the Licensee Territory; provided, however , that with respect to Major Meetings relating to Unilateral Activities of Licensee, GPC Biotech shall be entitled to attend at its expense all such Major Meetings strictly as a silent observer. Licensee shall be entitled to attend at its expense all such Major Meetings with the FDA relating to the Licensed Product in the GPC Biotech Territory strictly as a silent observer unless GPC Biotech otherwise agrees in writing to permit Licensee to participate actively in any such meeting; provided, however, that GPC Biotech shall have no obligation under this Section 2.4.5 to permit Licensee to attend any such Major Meeting to the extent it results from or otherwise relates to Unilateral Activities of GPC Biotech; provided, further, that in the event that GPC Biotech enters into an agreement with a GPC Biotech Counter-Party, GPC Biotech shall have no further obligation to permit Licensee to attend Major Meetings (to the extent GPC Biotech’s agreement with such GPC Biotech Counter-Party prohibits such attendance), except where the subject of such Major Meeting relates to matters that could reasonably be expected to have a material adverse effect on the Product Labeling in the Licensee Territory in which case Licensee shall continue to have the rights specified herein. The Parties, through the JDC, shall use reasonable efforts to agree in advance on the scheduling of such Major Meetings and, in the case of Major Meetings with respect to the Licensee Territory, on the objectives to be accomplished at, GPC Biotech’s active role with respect to, and the agenda for, such meetings. Each Party shall promptly forward to the other Party copies of all meeting minutes and summaries of all Major Meetings, as well as any significant written communications received from representatives of the Regulatory Authorities relating thereto.

                2.4.6 Pricing and Reimbursement Approvals. Licensee shall take the lead in all pricing and reimbursement approval proceedings relating to the Licensed Product in the

Licensee Territory; provided that GPC Biotech shall have the right to have one (1) representative attend all meetings with Regulatory Authorities relating to pricing and reimbursement approvals strictly as a silent observer, but only if GPC Biotech’s presence is permitted by the relevant Regulatory Authority and is not otherwise prohibited by Applicable Law. Licensee shall provide GPC Biotech with reasonable advance notice of all such meetings and advance copies of all related documents (including documents to be submitted in connection with pricing and reimbursement approvals) and other relevant information relating to such meetings.

           2.4.7 Regulatory Records . Licensee and GPC Biotech each shall maintain, or cause to be maintained, records of its respective Development activities with respect to the Licensed Product in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least three (3) years after the termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right hereunder. Licensee shall provide GPC Biotech with such additional information regarding the Licensee Activities as GPC Biotech may reasonably request from time to time.

      2.5 Plan Amendments; Unilateral Development.

           2.5.1 Criteria for Amendments to the Development Plan. Either Party, through its representatives on the JDC, may propose amendments to the Development Plan, including modifications to a Clinical Study or Post Approval Study already initiated and ongoing under the Development Plan or the addition of new Clinical Studies for Additional Indications for the Licensed Product (including for a higher line of therapy for an indication that is already under Development) and Post Approval Studies for the Licensed Product. Any material amendment proposed by a Party to the Development Plan with respect to a Clinical Study or Post Approval Study must meet the following criteria, as applicable:

                (a)  Any proposed Exploratory Study, or any material amendment thereto, whether or not contemplated in the Development Plan as of the Effective Date, shall be designed to comply with all applicable regulatory guidelines of both the FDA and the EMEA;

                (b)  Any proposed Post Approval Study, or any material amendment thereto, whether or not contemplated in the Development Plan as of the Effective Date, shall be designed to satisfy all applicable regulatory requirements of both the FDA and the EMEA;

                (c)  Any proposed Registrational Study, whether or not contemplated in the Development Plan as of the Effective Date, shall be: (i) based on a scientific rationale supported by the results of an Exploratory Study; and (ii) designed to satisfy regulatory requirements of both the FDA and the EMEA, including, where applicable, conforming to any scientific advice obtained by a Party from Regulatory Authorities in its portion of the Territory. Any proposed Registrational Study that is not contemplated in the Development Plan as of the

Effective Date must, in addition to the criteria in clause (i) and (ii) above, be for an indication having sufficient commercial potential in both the United States and Europe to justify conduct of the study taking into consideration the risks of adverse results.

                (d)  Any material amendment proposed by a Party with respect to a Registrational Study already initiated and ongoing under the Development Plan must be either suggested by Regulatory Authorities or otherwise required or reasonably necessary to obtain Regulatory Approval in the proposing Party’s portion of the Territory.

     Notwithstanding the foregoing, either Party may propose a material amendment that does not meet the foregoing criteria if both Parties agree to the proposal. The Party that is proposing any amendment to the Development Plan pursuant to this Section 2.5.1 shall provide, at the other Party’s request, reasonable documentation to the JDC demonstrating that such amendment satisfies the foregoing criteria. Any Dispute in the JDC concerning whether a proposed amendment fails to meet the applicable criteria shall be referred to the JEC for resolution pursuant to Section 4.4.4, and, failing resolution by the JEC pursuant to Section 4.4.4 or by the Parties pursuant to Section 15.7.2(a)(iv), to arbitration in accordance with Section 15.7.4(b).

           2.5.2 Unilateral Activities.

                (a)  With respect to any Clinical Study or Post Approval Study that satisfies the criteria set forth in Section 2.5.1, if either Party (the “Opting-Out Party” ), pursuant to the terms of Section 2.6, opts-out (each, an “Opt-Out” ) of: (a) any modification of a (i) Clinical Study or (ii) a Post Approval Study, in each case ((i) and (ii)) already initiated and ongoing under the Development Plan; or (b) initiation of (i) a Clinical Study (including a Registrational Study), or (ii) a Post Approval Study, in each case ((i) and (ii)) for any part of the Territory, the Party (the “ Developing Party ”) desiring to proceed with such activities ( “Proposed Unilateral Activities” ) shall prepare and provide to the JDC a proposed development plan and budget with respect thereto. Such proposed development plan and budget shall in each case be in a format and with such detail corresponding to the Development Plan in effect at such time. If the JDC determines or it is otherwise determined that any such Proposed Unilateral Activities comply and are otherwise consistent with Section 2.5.3, then such activities shall be deemed to be “Unilateral Activities” hereunder, and the Developing Party shall have the right to proceed with such Unilateral Activities in accordance with the terms and conditions of this Agreement.

                (b)  Notwithstanding the foregoing, either Party may propose to the JDC as a Unilateral Activity a Clinical Study or Post Approval Study that is scientifically reasonable but does not satisfy the requirements of Section 2.5.1. In such event, the Parties may agree to incorporate such Clinical Study in the Development Plan as a joint activity hereunder or the proposing Party may conduct such Clinical Study or Post Approval Study as a Unilateral Activity. For purposes of this Agreement, the Party that is conducting such Unilateral Activity shall be deemed the Developing Party with respect to such Unilateral Activity and the other Party shall be deemed to be the Opting-Out Party with respect to such Unilateral Activity following confirmation from the other Party that it did not wish to Opt-In.

           2.5.3 Limitations on Unilateral Activities. Notwithstanding anything contained in this Section 2.5, Licensee shall not have the right to conduct any Clinical Study or Post Approval Study with respect to the Licensed Product for its portion of the Territory where the proposed protocol of such study creates an unreasonable risk of adverse results that could reasonably be expected to have a material adverse effect on the Development or Commercialization of Licensed Product in the GPC Biotech Territory, including with respect to the ability of GPC Biotech to obtain or maintain Regulatory Approval for the Licensed Product for the Initial Indication or an Additional Indication in any country in such territory. Any Dispute in the JDC concerning whether such study could reasonably be expected to have such effect shall be referred to the JEC for resolution pursuant to Section 4.4.4, and, failing resolution by the JEC pursuant to Section 4.4.4 or by the Parties pursuant to Section 15.7.2(a)(v), to arbitration in accordance with Section 15.7.4(b).

           2.5.4 Costs of Unilateral Activities. In the case of Unilateral Activities (a) the Developing Party shall bear the sole cost and expense of such Unilateral Activities, and (b) the Opting-Out Party shall have no further financial obligation to support or otherwise fund any efforts in respect of such Unilateral Activities, unless it Opts-In pursuant to Section 2.5.6.

           2.5.5 Limitation on Rights to Clinical Data. With respect to any Unilateral Activities, the Opting-Out Party, notwithstanding the right of reference granted in Section 5.1.3 or 5.6, as applicable, shall not have the right to use or reference any Clinical Data or other information resulting from such Unilateral Activities to support an application for Regulatory Approval for the Licensed Product unless such Party Opts-In pursuant to Section 2.5.6, provided that if the inclusion of such Clinical Data or other information is required solely to comply with a requirement to report worldwide clinical studies to Regulatory Authorities in a filing seeking or maintaining a Regulatory Approval of the Licensed Product, the Opting-Out Party shall have the right to use such data and other information solely for such purpose and such use shall not trigger an Opt-In or other cost-sharing pursuant to Section 2.5.6.

           2.5.6 Opt-In Rights.

                (a) In General. The Opting-Out Party shall have the right to opt-in (“ Opt-In ”) with respect to any Unilateral Activities for which such Party Opted-Out at any time within fifty (50) days after receipt by the Opting-Out Party of a Completion Notice with respect thereto, in each case in accordance with this Section 2.5.6 (such period, the “Opt-In Exercise Period” ); provided , that in each case the Opting-Out Party shall be required at the time of Opt-In with respect to any Unilateral Activities relating to a particular indication, to Opt-In with respect to (i) such Unilateral Activities, and (ii) any other Unilateral Activities with respect to such indication that are being conducted at such time or that previously were conducted by the Developing Party ( “Related Unilateral Activities” ). For clarity, the Opting-Out Party shall be permitted to Opt-In with respect to Related Unilateral Activities described in clause (ii) of this Section 2.5.6(a), notwithstanding the fact that the Opt-In Exercise Period with respect to Related Unilateral Activities may have earlier terminated without the Opting-Out Party’s having exercised an Opt-In with respect to such Related Unilateral Activities.

                (b) Opt-In Exercise . With respect to any Unilateral Activities conducted by the Developing Party, promptly after the completion thereof the Developing Party

shall prepare a report that includes a reasonable summary of the data and top-line results with respect thereto and provide such report to the Opting-Out Party, together with a notice of completion of such Unilateral Activities (each a “Completion Notice” ). The Completion Notice shall be accompanied by a written statement of costs and expenses (the “Unilateral Activity Cost Statement” ) incurred by the Developing Party in connection with such Unilateral Activities and any Related Unilateral Activities through the last day of the Calendar Quarter immediately preceding the Calendar Quarter in which such notice is provided (such date, the “Statement Cut-Off Date” ). In the event that the Opting-Out Party has an interest in Opting-In with respect to any Unilateral Activities, it shall provide written notice thereof to the other Party within the Opt-In Exercise Period (an “ Opt-In Exercise Notice ”). Thereafter, not later than sixty (60) days after receiving the Opt-In Exercise Notice, the Developing Party shall provide to the Opting-Out Party a statement of costs and expenses incurred by the Developing Party in connection with such Unilateral Activities for the period commencing on the day after the Statement Cut-Off Date and ending on the date of receipt of the Opt-In Exercise Notice, and the Opting-Out Party shall within sixty (60) days of the receipt of such statement make a payment to the Developing Party equal to [...***...] the Opting-Out Party’s funding contribution would have been had the Developing Party’s total costs and expenses with respect to such activity (and any Related Unilateral Activities) been Collaboration Costs, up to a maximum of [...***...] of the total costs and expenses of the Unilateral Activity. From and after the Developing Party’s receipt of the Opt-In Exercise Notice from the Opting-Out Party, such Unilateral Activities shall cease to be Unilateral Activities and shall be deemed Development activities under the Development Plan, and the Parties shall share all such costs and expenses as Collaboration Costs in accordance with Section 6.1.1.

      2.6 Opt-Out Rights.

           2.6.1 Contemplated Exploratory Studies or Post Approval Studies.

                (a)  GPC Biotech shall have the right to Opt-Out for any reason with respect to the initiation of any Exploratory Study or Post Approval Study proposed by Licensee.

                (b)  Licensee shall have the right to Opt-Out with respect to the initiation of any Exploratory Study or Post Approval Study proposed by GPC Biotech only if: (i) the total amount that Licensee has paid to GPC Biotech pursuant to Section 6.1 with respect to the SPARC Study and any Selected Development Activities (including such Licensee payments for expenses incurred in connection with the Development activities under the Development Plan not allocated to a particular Clinical Study or Post Approval Study), exceeds [...***...] (the “Initial Opt-Out Threshold” ); or (ii) there is no reasonable scientific rationale for such proposed study. For clarity, except as otherwise provided in Section 2.6.3, if, with respect to any Exploratory Studies or Post Approval Studies, Licensee is not permitted to Opt-Out pursuant to this Section 2.6.1 prior to the initiation thereof, Licensee shall not have the right subsequently to Opt-Out of such Exploratory Studies or Post Approval Studies as a result of the actual amounts paid by Licensee with respect to the SPARC Study and Selected Development Activities exceeding the Initial Opt-Out Threshold as a result of any overruns included within Collaboration Costs pursuant to Section 2.3.2.

           2.6.2 Contemplated Registrational Studies.

                (a)  GPC Biotech shall have the right to Opt-Out for any reason with respect to the initiation of any Registrational Study proposed by Licensee.

                (b)  Licensee shall have the right to Opt-Out with respect to the initiation of any Registrational Study proposed by GPC Biotech only if: (i) Licensee’s share of the total estimated costs of such Registrational Study is projected to exceed the Registrational Study Budgeted Funding Commitment; (ii) in the case of a Registrational Study for an Additional Indication, the available Clinical Data from Exploratory Studies relating to such Additional Indication does not support the asserted scientific rationale for such Registrational Study; (iii) the SPARC Study is a Non-Approvable Study with respect to the European Union and Licensee elects to conduct as a Unilateral Activity of Licensee an additional Registrational Study for the Initial Indication (a “ Licensee Initial Indication Study ”); (iv) GPC Biotech has elected not to pursue any additional Registrational Studies pursuant to Section 2.1.2(c) and Licensee elects to conduct as a Unilateral Activity of Licensee an additional Registrational Study for approval of an Additional Indication in the Licensee Territory; or (v) at such time, the Parties are in agreement as to the initiation of another Registrational Study other than the SPARC Study under the Development Plan.

                (c)  Licensee shall not have the right to Opt-Out, in reliance on Section 2.6.2(b)(i), with respect to a Registrational Study proposed by GPC Biotech if GPC Biotech agrees in writing to increase the share of the Collaboration Costs that GPC Biotech otherwise would have an obligation to bear pursuant to Section 6.1.1 (i.e., sixty-five percent (65%)) with respect to such study and activities and to decrease the share of the Collaboration Costs that Licensee otherwise would have an obligation to bear with respect thereto pursuant to Section 6.1.1 (i.e., thirty-five percent (35%)), in each case by an amount sufficient to ensure that, taking account of such adjusted shares, the Collaboration Costs projected for the proposed Registrational Study would not result in Licensee’s funding obligation with respect to such budgeted Collaboration Costs exceeding the Registrational Study Budgeted Funding Commitment. Any such share adjustment shall apply with respect to the budgeted Collaboration Costs for such additional Registrational Study, and to the actual Collaboration Costs specifically identifiable or reasonably allocable to such additional Registrational Study, and the calculation of any overruns with respect to such Collaboration Costs, but for no other purpose. In the event of any Dispute between the Parties with respect to whether the Collaboration Costs projected for the proposed Registrational Study would result in Licensee’s funding obligation exceeding the Registrational Study Budgeted Funding Commitment, such Dispute shall be resolved pursuant to Section 15.7.4(b).

                (d)  If, in reliance on Section 2.6.2(b)(iii), Licensee Opts-Out of any Registrational Study proposed by GPC Biotech and Licensee fails to use Commercially Reasonable Efforts to commence, conduct and complete the Licensee Initial Indication Study within a reasonable time, GPC Biotech shall have the right, upon thirty (30) days’ written notice to Licensee, to cause Licensee to Opt-In with respect to the Registrational Study for an Additional Indication with respect to which Licensee previously Opted-Out and with respect to any Related Unilateral Activities for such indication. Such Opt-In shall be deemed to be made pursuant to Section 2.5.6(b) (regardless of any prior termination or expiration of the Opt-In

Exercise Period with respect to such study) as of the date on which Licensee receives from GPC Biotech such notice (and a statement of costs and expenses incurred to date by GPC Biotech in connection with such Registrational Study and any Related Unilateral Activities with respect to such Additional Indication). Licensee shall make a payment to GPC Biotech in the amount required pursuant to Section 2.5.6(b) no later than thirty (30) days after receiving from GPC Biotech such notice (and accompanying statement). In the event of any Dispute between the Parties with respect to whether Licensee has used Commercially Reasonable Efforts to commence, conduct and complete the Licensee Initial Indication Study within a reasonable time, such Dispute shall be resolved pursuant to Section 15.7.4(b).

                2.6.3 Material Modifications to Existing Studies. If a proposed amendment to the Development Plan and Budget materially modifies any Clinical Study or Post Approval Study being conducted under the Development Plan, each Party shall have the right to Opt-Out of such Clinical Study or Post Approval Study on a going forward basis, subject to the provisions of Sections 2.6.1(b) and 2.6.2(b). Upon and following such Opt-Out by a Party, such activity shall be deemed a Unilateral Activity of the other Party for purposes of Section 2.5.5.

                2.6.4 New Clinical Studies or Post Approval Studies. Each Party shall have the right to Opt-Out of any proposed new Clinical Study (including a Registrational Study) or Post Approval Study that is not contemplated in the Development Plan as of the Effective Date, subject to the provisions of Sections 2.6.1(b) and 2.6.2(b).

                2.6.5 Notice of Opt-Out. The Opting-Out Party shall provide the other Party with written notice of the Opting-Out Party’s intention to Opt-Out not later than thirty (30) days after the JDC receives pursuant to Section 2.5.1 a written proposal for a new Clinical Study or Post Approval Study or a material modification to a Clinical Study or Post Approval Study being conducted under the Development Plan. In such event, the provisions of Section 2.5.2 shall apply to the conduct of such study as a Unilateral Activity. With respect to a material modification to a Clinical Study or Post Approval Study for which a Party has Opted-Out, any Collaboration Costs that have been incurred prior to the beginning of an Opt-Out Period shall not be reduced or refundable to the Opting-Out Party.

           2.7 Supply of Licensed Product. Licensee shall purchase its supply of Licensed Product, and GPC Biotech agrees to supply to Licensee such quantities subject to the terms of the Supply Agreement.

ARTICLE 3

COMMERCIALIZATION

      3.1 Commercialization of the Licensed Product.

           3.1.1 In General. Except with respect to Joint Commercialization Activities, if any, Licensee shall have the sole right to Commercialize the Licensed Product in the Licensee Territory at its sole expense in accordance with the Commercialization Plan and shall do so in

compliance with this Agreement and all Applicable Law. Joint Commercialization Activities, which are agreed by the Parties, shall be conducted by the Parties, in accordance with the Commercialization Plan and Budget and in compliance with Applicable Law.

      3.1.2 Commercialization Obligations. Licensee shall use Commercially Reasonable Efforts: (a) to Commercialize the Licensed Product in each country in the Licensee Territory where conducting such activities would be Commercially Reasonable; and (b) without limitation to the foregoing, within ninety (90) days after obtaining all Regulatory Approvals necessary in such a country in the Licensee Territory for the Commercialization of the Licensed Product for the Initial Indication or any Additional Indication that is the subject of a Follow Up Registrational Study, to commence Commercialization of the Licensed Product in such country. Licensee shall allocate sufficient time, effort and skilled personnel to achieve the objectives of the Commercialization Plan and each Country Commercialization Plan.

      3.1.3 Global Strategy.

               (a)  Within six (6) months after the Effective Date, the Parties shall jointly develop the global strategy for Commercializing Licensed Product throughout the Territory which strategy shall support the goal of maximizing Product revenue and profit in both the Licensee Territory and the GPC Biotech Territory and (i) shall be consistent with any approved Product Labeling for the Licensed Product and (ii) take into account, where Commercially Reasonable, any unique market characteristics of any of the Major Market Countries in Europe and the ANZ Territory (the “Global Strategy” ). Any Dispute regarding the development of the Global Strategy shall be referred to the JEC for resolution pursuant to Section 4.4.4, and, failing resolution by the JEC pursuant to Section 4.4.4, shall be subject to resolution under Section 15.7.2(a)(ii).

               (b)  Licensee shall use Commercially Reasonable Efforts to ensure, wherever possible in keeping with its obligation to use Commercially Reasonable Efforts in the Commercialization of the Licensed Product, that the branding, positioning and messaging for the Licensed Product in the Licensee Territory is consistent with such Global Strategy for the Licensed Product; provided however, that Licensee may not act in any manner that is inconsistent with the Global Strategy with respect to the branding, positioning and messaging for the Licensed Product that could reasonably result in a material adverse effect on the Commercialization of the Licensed Product in the GPC Biotech Territory. Any Dispute in the JCC concerning whether the branding, positioning or messaging for the Licensed Product in the Licensee Territory is consistent with such Global Strategy or whether any action of the Licensee that is inconsistent with the Global Strategy with respect to the branding, positioning and messaging for the Licensed Product could reasonably result in a material adverse effect on the Commercialization of the Licensed Product in the GPC Biotech Territory shall be referred to the JEC for resolution pursuant to Section 4.4.4, and, failing resolution by the JEC pursuant to Section 4.4.4, shall be subject to resolution under Section 15.7.2(a)(vi).

      3.1.4 Product Trademarks. Except with respect to the Corporate Names as provided in Section 3.4.2, Licensee and its Affiliates, Sublicensees and Distributors shall Commercialize the Licensed Product solely under the Product Trademarks designated by the JCC pursuant to Section 3.4.4.

      3.2 Commercialization Plan and Implementation.

              3.2.1 Commercialization Plan.

     The Commercialization of the Licensed Product in the Licensee Territory and any Joint Commercialization Activities shall be conducted pursuant to a comprehensive multi-year plan and budget to be prepared by Licensee pursuant to Section 3.2.2 with respect to the Licensee Territory, and by the JCC pursuant to Section 4.3.2(d) with respect to any Joint Commercialization Activities, and approved by the JCC pursuant to Section 4.3.2(c) (the “Commercialization Plan” ), which plan and budget shall be consistent with the Global Strategy and the Parties’ respective obligations set forth in Section 3.1. The Commercialization Plan shall include: for each Major Market Region and each Major Market Country in the Licensee Territory (i) general strategies for the promoting, Detailing, marketing and distribution of the Licensed Product, (ii) pre-launch commercialization activities and the expected date of launch, (iii) sales force size and allocation throughout the Licensee Territory, (iv) the expected frequency and position of Details to be carried out, (v) the nature of promotional activities and Licensed Product sampling activities, if any, (vi) market and sales forecasts for the Licensed Product, (vii) advertising, public relations and other promotional programs, including medical education programs such as professional symposia and speaker and peer-to-peer activity programs to be used in the Commercialization the Licensed Product, (viii) proposals for any Additional Indications or Post Approval Studies, (ix) projected Net Sales for Licensed Product, (x) reimbursement and pricing information, and (xi) plans regarding distribution and supply chain management; and (y) any Joint Commercialization Activities. The Parties agree that any forecasts provided by Licensee as part of the Commercialization Plan are Licensee’s good faith estimates based upon conditions then existing and shall not be binding upon Licensee.

              3.2.2 Review and Approval. No later than twelve (12) months prior to the expected date of the first Regulatory Approval of the Licensed Product, Licensee shall prepare for review and approval by the JCC a proposed Commercialization Plan for the Licensed Product from the date of launch through the third anniversary of December 31 of the Calendar Year in which the first Drug Approval Application for the Licensed Product is expected to be approved in the Licensee Territory. The Joint Commercialization Committee shall review such proposed plan within sixty (60) days after receipt thereof and amend such plan to include any Joint Commercialization Activities, as provided in Section 4.3.2. Thereafter, Licensee shall, on or before September 30 of each Calendar Year, provide the JCC with proposed amendments to the Commercialization Plan, which, after the first anniversary of December 31 of the Calendar Year in which the first Drug Approval Application for the Licensed Product is approved in the Licensee Territory, shall include the Commercialization Plan for the Calendar Year commencing on the third anniversary of January 1 of the then-current Calendar Year. The Commercialization Plan may not be amended in any manner that materially reduces Licensee’s Commercialization efforts to be made in the next two (2) full Calendar Years following such amendment unless such reduction in efforts is justified by circumstances or events beyond Licensee’s control that have had or would reasonably be expected to have a material adverse impact on the market for or the commercial potential of the Licensed Product in the Licensee Territory or any relevant portion of the Licensee Territory. The JCC, or if there is a dispute in the JCC, the JEC, shall endeavor to obtain approval for any amendment or addition to the Commercialization Plan by no later than

November 30 of the Calendar Year in which it was proposed. Any Disputes resulting from review or approval of the Commercialization Plan or a Country Commercialization Plan shall be settled in accordance with Section 4.4.4 below, except with respect to disputes regarding Joint Commercialization Activities, for which the Parties must reach a mutually acceptable resolution (or otherwise discontinue such activities). Subject to the foregoing, the JCC may from time to time amend the Commercialization Plan with respect to the Joint Commercialization Activities. The Commercialization Plan and any amendment thereto shall be consistent with the Global Strategy.

              3.2.3 Other Country Commercialization Plans. In addition to the Country Commercialization Plan with respect to the Major Market Countries, Licensee shall provide to the JCC for its review and comment copies of the commercialization plans prepared by Licensee in the regular course of its business with respect to any other countries in the Licensee Territory (each such plan a “ Country Commercialization Plan ”).

        3.3 [...***...]. [...***...] .

        3.4 Promotional Materials and Activities.

              3.4.1 In General. Except with respect to Promotional Materials that are jointly developed by the Parties pursuant to a Joint Commercialization Activity, Licensee shall be responsible for preparing all Promotional Materials used to support the Commercialization of the Licensed Product in the Licensee Territory, in consultation with the JCC. All such Promotional Materials shall be submitted to the JCC prior to use by Licensee; provided that the content of Promotional Materials, once submitted, need not be submitted again prior to re-use unless the Product Labeling for the Licensed Product applicable to such Promotional Materials has been changed since such prior submission date. All Promotional Materials shall be consistent with the Global Strategy, the Commercialization Plan, the applicable Country Commercialization Plan(s), Applicable Law and with the approved Product Labeling for the Licensed Product. Licensee shall be responsible for obtaining any approvals from the Regulatory Authorities in a country within the Licensee Territory required for the use of any Promotional Materials and shall submit all applicable Promotional Materials to the Regulatory Authorities in such country as required by Applicable Law.

              3.4.2 Markings. All Promotional Materials, packaging and Product Labeling for the Licensed Product used by Licensee, its Affiliates, Sublicensees or Distributors in connection with the Licensed Product in any country in the Licensee Territory shall (a) comply with the requirements of Section 8.1(c) of the Spectrum Agreement and (b) contain (i) the Product Trademarks, (ii) Corporate Names of Licensee and (to the extent permitted by Applicable Law) GPC Biotech where practical with equal prominence, and (iii) if required by Applicable Law, the logo and corporate name of the manufacturer (collectively, the

*** Confidential Treatment Requested

“ Markings ”). The manner in which the Markings are to be presented on Promotional Materials, packaging and Product Labeling for the Licensed Product shall be subject to (y) prior review and approval by the JCC and (z) Sections 5.1.5, 5.5, 5.6 and 8.1.6.

              3.4.3 Audit. Upon request of GPC Biotech at reasonable intervals, Licensee shall provide to GPC Biotech copies or samples of any Promotional Materials, packaging and Product Labeling for the Licensed Product that have not been previously reviewed by GPC Biotech.

              3.4.4 Product Trademarks. The JCC shall discuss the Parties’ use of the Product Trademarks with respect to Commercialization and may, from time to time, recommend and approve additional Trademarks, packaging designs and other trade dress in connection with the foregoing for use in the Licensee Territory. The JCC shall have the right to designate additional Product Trademarks as may be reasonably required to address requirements under Applicable Law or to avoid adverse effects on the Commercialization of the Licensed Product in a particular country in the Licensee Territory resulting from local customs, language and other country-specific circumstances. For the avoidance of doubt, each such Trademark shall be treated as Product Trademark under the terms of this Agreement.

      3.5 Statements and Compliance with Applicable Law.

              3.5.1 Public Statements Regarding Licensed Product. Licensee shall be responsible for disseminating accurate information regarding the Licensed Product based on Product Labeling and Promotional Materials for the Licensed Product (and for causing its Affiliates, Sublicensees and Distributors to so disseminate such accurate information). In exercising its rights pursuant to this Article 3, Licensee shall seek to prevent claims or representations in respect of the Licensed Product or the characteristics of the Licensed Product (e.g., safety or efficacy) being made by or on behalf of it or its Affiliates, Sublicensees or Distributors (by members of its or their sales force or otherwise) that do not represent an accurate or fairly balanced summary or explanation of the Product Labeling for the Licensed Product in the country in question.

              3.5.2 Sales Force Compliance. Licensee shall instruct its sales representatives to and shall use Commercially Reasonable Efforts to train and monitor its sales representatives so that such sales representatives, (i) use only Promotional Materials (without any addition, deletion or other modification) approved for use under Section 3.4.1 for the promotion of the Licensed Product in the Licensee Territory, (ii) limit claims of efficacy and safety for the Licensed Product to those that are consistent with Applicable Law and with approved (by the appropriate Regulatory Authority) promotional claims in Product Labeling and Promotional Materials for the Licensed Product, and not add, delete or otherwise modify claims of efficacy and safety in the promotion of the Licensed Product in any respect from those claims of efficacy and safety that are contained in such approved Product Labeling and Promotional Materials and (iii) Commercialize the Licensed Product in accordance in all material respects with Applicable Law.

              3.5.3 Medical and Other Inquiries. The Licensee shall be responsible for responding to all medical questions or inquiries from customers or others in the Licensee Territory relating to the Licensed Product sold in Licensee Territory. The Licensee shall keep such records and make such reports as are reasonably necessary to document such communications in compliance with all Applicable Law.

              3.5.4 Compliance with Laws. Licensee shall comply with all Applicable Law with respect to the Commercialization of Licensed Product. Neither Party shall be required to undertake any activity relating to the Commercialization of the Licensed Product that it believes, in good faith, may violate Applicable Law. Licensee shall in all material respects conform its practices and procedures relating to educating the medical community in the Licensee Territory with respect to the Licensed Product to any applicable industry association regulations, policies and guidelines, as the same may be amended from time to time and shall comply with Applicable Law with respect thereto.

      3.6 Use of Distributors. Notwithstanding any other term or condition of this Agreement to the contrary, Licensee shall not use Distributors to Commercialize the Licensed Product in any country in the Licensee Territory, except in the countries listed in Exhibit B hereto, which may be amended from time to time, upon mutual written agreement of the Parties.

      3.7 Sales and Distribution in Licensee Territory. Licensee shall be solely responsible for invoicing and booking sales, establishing all terms of sale (including pricing and discounts) and warehousing and distributing the Licensed Product in the Licensee Territory and shall perform all related services, in each case in a manner consistent with the terms and conditions of this Agreement. Licensee shall also be solely responsible for handling all returns, recalls or withdrawals in accordance with Article 10, order processing, invoicing and collection, distribution and inventory and receivables in the Licensee Territory.

      3.8 Unauthorized Sales. Licensee with respect to the Licensee Territory, and GPC Biotech with respect to the GPC Biotech Territory (a) shall, and shall cause its Affiliates, sublicensees and distributors to, distribute, market, promote, offer for sale and sell the Licensed Product only in its respective part of the Territory, and (b) shall not, and shall not permit its Affiliates, sublicensees or distributors to, distribute, market, promote, offer for sale or sell the Licensed Product directly or indirectly (i) to any Person outside its part of the Territory or (ii) to any Person inside its part of the Territory that (1) is reasonably likely to directly or indirectly distribute, market, promote, offer for sale or sell the Licensed Product outside its part of the Territory or assist another Person to do so or (2) has directly or indirectly distributed, marketed, promoted, offered for sale or sold the Licensed Product outside its part of the Territory or assisted another Person to do so. If Licensee, its Affiliates or any Sublicensees or Distributors receives any orders for the Licensed Product for the GPC Biotech Territory, such Person shall refer such orders to GPC Biotech. If GPC Biotech, its Affiliates or any sublicensees or distributors receives any orders for the Licensed Product for the Licensee Territory, such Person shall refer such orders to Licensee. Notwithstanding the foregoing, if any part of the European Union becomes part of the GPC Biotech Territory during the term of this Agreement, the foregoing obligations of this Section 3.8 shall not apply in

relation to such territory and shall be replaced by the following: Licensee shall not actively solicit orders from customers based in such territory unless the rights to such territory are no longer held exclusively by GPC Biotech or one of its licensees. For the purposes of the preceding sentence, “actively solicit” includes, but is not limited to, the use of direct mail, calling on customers, placing advertisements or making other promotions specifically targeted at customers in such territory, or establishing warehouses or distribution outlets in such territory.

      3.9 Reporting. Licensee shall prepare and maintain complete and accurate records regarding Commercialization of the Licensed Product in the Licensee Territory and shall provide to GPC Biotech and the JCC a detailed report regarding such Commercialization at least twice per Calendar Year. Such report shall contain sufficient detail to enable GPC Biotech to assess Licensee’s compliance with the Global Strategy, the Commercialization Plan and the applicable Country Commercialization Plan(s) including: (i) Licensee’s activities with respect to achieving its general strategies for the promoting, detailing and marketing of the Licensed Product in such country(ies); (ii) pre-launch Commercialization activities; (iii) sales force size and allocation; (iv) the nature of promotional activities and Licensed Product sampling activities conducted, if any; (v) market and sales reports for the Licensed Product; (vi) an approximate number and position of Details carried out in the applicable period; (vii) the conduct of advertising, public relations and other promotional programs, including professional symposia and speaker and peer to peer activity programs used in the Commercialization of the Licensed Product; (viii) Net Sales of Licensed Product in the Licensee Territory; and (ix) actual expenditures with respect to the budgets set forth in the Commercialization Plan and Country Commercialization Plan, including the Commercialization Budget. Licensee shall provide GPC Biotech with such additional information regarding the Commercialization of the Licensed Product as GPC Biotech may reasonably request from time to time.

      3.10 Commercialization Budget. Except for Joint Commercialization Activities, Licensee shall be responsible for Commercialization in the Licensee Territory at its own cost and expense. The budget for Joint Commercialization Activities shall be set forth in the Commercialization Plan, as provided in Section 3.2.1.

              3.10.1 Amendment of the Commercialization Budget . The Joint Commercialization Committee shall review the Commercialization Budget at least annually, and shall make modifications thereto to reflect any changes to ongoing Joint Commercialization Activities or any unforeseen events. With respect to any such changes or unforeseen events, each Party shall, in consultation with the other Party, prepare and submit to the JCC a proposed budget in a format to be agreed by the Parties for the new or changed Joint Commercialization Activities, which budget shall include line item estimates of Collaboration Costs broken down on a Calendar Year basis.

              3.10.2 Cost Overruns .

                         (a)  In any Calendar Year, each Party shall promptly inform the other Party upon such Party determining that it is likely to overspend or underspend by more than ten

percent (10%) its respective total Collaboration Costs set forth in the Commercialization Budget for that Calendar Year.

                         (b)  If in any such Calendar Year a Party exceeds its budgeted costs and expenses by more than ten percent (10%), the Party that has so exceeded its budget shall provide to the JCC and to the JEC (if the matter is escalated to the JEC because it cannot be resolved by the JCC) a full explanation for exceeding the Commercialization Budget. If and to the extent that any such overspend (i) was outside the reasonable control of the applicable Party, or (ii) resulted from a reasonable or necessary acceleration of Joint Commercialization Activities within a particular Calendar Year, some or all of which activities had been expected to occur in a subsequent Calendar Year; then (in each case (i) and (ii)), provided the applicable Party has promptly notified the other Party of such overspend and, in the case of overspends covered by clause (i) of this Section 3.10.2(b), used reasonable efforts to mitigate the size of such overspend, such overspend shall be included in Collaboration Costs and shared by the Parties pursuant to Section 6.1.1.

                         (c)  To the extent that any overspend is not included in Collaboration Costs as provided in this Section 3.10.2, the Party that has exceeded its budget by more than ten percent (10%) for a Calendar Year shall be solely responsible for the overspend.

      3.11 GPC Biotech Territory. Licensee acknowledges and agrees that (a) GPC Biotech retains all rights to Exploit the Licensed Product in the GPC Biotech Territory and to Develop and Manufacture the Licensed Product in the Territory in connection therewith, and (b) GPC Biotech has and retains the right to enter into agreements or other arrangements with one or more Third Parties with respect to such Exploitation, Development and Manufacture, including license agreements, co-promotion agreements and supply agreements. GPC Biotech shall have the right to delegate one or more of its obligations with respect to activities conducted pursuant to this Agreement, in whole or in part, to any such Third Party and Licensee shall cooperate with such Third Party. GPC Biotech hereby guarantees the performance in accordance with the terms of this Agreement of any such Third Party to which GPC Biotech delegates obligations under this Agreement, and any such delegation shall not relieve GPC Biotech of its obligations under this Agreement, except to the extent they are satisfactorily performed by such Third Party.

ARTICLE 4

COLLABORATION MANAGEMENT

      4.1 Joint Executive Committee (JEC). Within thirty (30) days after the Effective Date, the Parties shall establish a joint executive committee (the “ Joint Executive Committee ” or “ JEC ”), which shall: (a) oversee the Development of the Licensed Product in the Territory, the Commercialization of the Licensed Product in the Licensee Territory and the Joint Commercialization Activities; (b) resolve Disputes that may arise in the JDC or the JCC; (c) coordinate the Parties’ activities under this Agreement, including oversight of the JDC and JCC; (d) review and approve decisions

regarding Development and Commercialization of the Licensed Product as set forth in this Agreement, including Sections 6.1.5, 8.2.5, 8.4.1 and 11.6; (e) create such other committees with such responsibilities as the Parties may mutually agree to from time to time, such as, by way of example, a joint patent committee or joint manufacturing committee; and (f) perform such other functions as are set forth herein with respect to the JEC, or as the Parties may mutually agree in writing. The JEC shall have the membership and shall operate by the procedures set forth in Section 4.4.1. Each Party shall designate its initial members of the JEC within thirty (30) days after the Effective Date by written notice to the other Party.

      4.2 Joint Development Committee (JDC).

              4.2.1 Formation and Purpose. Within thirty (30) days after the Effective Date, the Parties shall form a joint development committee (the “Joint Development Committee” or “JDC” ) to oversee, coordinate and expedite the Development of, and the filing of Drug Approval Applications and other regulatory filings for, the Licensed Product in the Territory in order to obtain and maintain Regulatory Approvals in the Licensee Territory. The JDC shall also facilitate the flow of information with respect to Development activities being conducted for the Licensed Product and direct and supervise all Clinical Studies and Post Approval Studies for the Licensed Product conducted under the Development Plan. The JDC shall have the membership and shall operate by the procedures set forth in Section 4.4.1. Each Party shall designate its initial members of the JDC within thirty (30) days after the Effective Date by written notice to the other Party.

              4.2.2 Specific Responsibilities of the JDC. In support of its responsibility for overseeing, coordinating and expediting the Development of, and regulatory filings for, the Licensed Product, the JDC shall: (a) review and, if necessary, amend the Development Plan and Development Budget from time to time, but no less frequently than once per Calendar Year; (b) establish a worldwide strategy for the Development and Regulatory Approval of the Licensed Product, consistent with the applicable Development Plan and Budget; (c) direct and supervise the implementation of the Development Plan for the Licensed Product; (d) review and approve the statistical analysis plans and protocols for all Clinical Studies for the Licensed Product conducted under the Development Plan and, in consultation with the JCC, Post Approval Studies for the Licensed Product conducted under the Development Plan, and any revisions thereto (in each case other than with respect to Unilateral Activities); (e) review and discuss the development plan for and execution of any Unilateral Activities; (f) review all proposed Product Labeling; (g) review all proposed Drug Approval Applications and other filings with the Regulatory Authorities with respect to Regulatory Approvals in the Licensee Territory; (h) monitor the progress of all Clinical Studies and Post Approval Studies for the Licensed Product, including reviewing costs and activities against the Development Plan and Budget; (i) facilitate the exchange of all information and data relating to all Clinical Studies, Post Approval Studies and other Development activities for the Licensed Product; (j) consult and coordinate with the JCC to assure a smooth transition from Development to Commercialization of the Licensed Product for each indication and with respect to Post Approval Studies or the proposed Development of Additional Indications and lines of therapy for the Licensed Product; (k) consult with the JCC with respect to such other matters as may have an effect on the Commercialization of the Licensed Product; (l) provide updates on JDC’s activities and achievements to the JEC no

less often than each Calendar Quarter during the term of this Agreement; and (m) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

      4.3 Joint Commercialization Committee (JCC).

              4.3.1 Formation and Purpose. GPC Biotech and Licensee shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC” ) and hold the initial meeting of the JCC, as provided in Section 4.4.2, within ninety (90) days after the Effective Date, which Committee shall coordinate and oversee the Commercialization of the Licensed Product in the Licensee Territory to ensure consistent branding, messaging and positioning of the Licensed Product on a worldwide basis in accordance with the Global Strategy and direct any Joint Commercialization Activities undertaken by the Parties in accordance with Article 3. The JCC shall have the membership and shall operate by the procedures set forth in Section 4.4.1. Each Party shall designate its initial members of the JCC within thirty (30) days after the Effective Date by written notice to the other Party.

              4.3.2 Specific Responsibilities of the JCC. In support of its responsibility for coordinating and overseeing the Commercialization of the Licensed Product in the Licensee Territory and directing any Joint Commercialization Activities, the JCC shall: (a) review and provide a forum for the Parties to discuss the Global Strategy; (b) oversee the implementation of the Global Strategy by Licensee in the Licensee Territory; (c) review and approve the Commercialization Plan and Budget and determine conformance of the foregoing with the Global Strategy; (d) identify any activities that will be jointly performed by mutual written agreement of the Parties in support of Commercialization of the Licensed Product in the Territory (the “ Joint Commercialization Activities ”) and prepare and approve such portions of the Commercialization Plan and Budget with respect thereto; (e) review advertising materials and strategies and Promotional Materials to be used in the Licensee Territory, and Markings and Trademark usage with respect to the Licensed Product in the Licensee Territory and determine conformance with the Global Strategy; (f) facilitate the flow of information with respect to the Commercialization of the Licensed Product between the Parties; (g) review the periodic reports provided by Licensee pursuant to Section 3.9 and otherwise monitor Licensee’s activities under, and compliance with, the Commercialization Plan and Budget and each Country Commercialization Plan; (h) consult with the JDC with respect to all proposed Product Labeling for the Licensed Product; (i) consult with the JDC with respect to Commercialization issues that may arise with respect to the Development of the Licensed Product; (j) review all (i) Drug Approval Applications and other filings with the Regulatory Authorities with respect to Regulatory Approvals for the Licensed Product in the Licensee Territory, (ii) Post Approval Studies for the Licensed Product and Additional Indications and lines of therapy with respect to the Licensed Product and (iii) otherwise work to assure a smooth transition from Development to Commercialization of the Licensed Product for each indication; (k) provide updates on the JCC’s activities and achievements to the JEC no less frequently than each Calendar Quarter during the term of this Agreement; and (l) perform such other functions as are set forth herein or as the Parties may mutually agree in writing.

      4.4 General Provisions Governing Committees. The following general provisions shall govern the conduct of the JEC, JDC, JCC and such other committees as the JEC may establish from time to time under this Agreement (each, a “ Committee ”), except as otherwise expressly provided elsewhere in this Agreement or as agreed to by the Parties in writing:

              4.4.1 Membership. Each Committee shall include an equal number of representatives from each of the Parties, each with the requisite experience and seniority to enable them to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of such Committee. From time to time, each Party may substitute one or more of its representatives to a Committee on written notice to the other Party. GPC Biotech shall designate one of its representatives on the JEC and JDC to serve as chairperson of such Committees and Licensee shall designate one of its representatives to serve as chairperson of the JCC, which designation such Party may change from time to time by written notice to the other Party. GPC Biotech shall have the right to designate as its representatives on a Committee one or more representatives of Spectrum Pharmaceuticals, Inc. or any GPC Biotech Counter-Party.

              4.4.2 Meetings and Minutes. Each Committee shall meet quarterly, or as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by GPC Biotech and locations designated by Licensee, provided that each Committee may meet by teleconference if in-person meetings are not feasible. The chairperson of the Committee shall be responsible for calling meetings, provided that the chairperson shall call a meeting of the Committee promptly upon the reasonable request of Licensee, in the case of the JEC or JDC, or GPC Biotech, in the case of the JCC. The Parties shall provide to the other Party proposed agenda items along with appropriate information at least ten (10) Business Days in advance of each meeting of the applicable Committee; provided that under exigent circumstances requiring Committee input, a Party may