BiTE Research Collaboration Agreement

Exhibit 10.41

***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

BiTE Research Collaboration Agreement

     This BiTE Research Collaboration Agreement (“ Agreement ”) is made and entered into effective as of June 6, 2003 (the “ Effective Date ”), by and between Micromet AG, having its principal place of business at Staffelseestrasse 2, 81477, Munich, Germany (“ Micromet ”), and MedImmune, Inc., having its principal place of business at 35 W. Watkins Mill Road, Gaithersburg, MD 20878 (“ MedImmune ”). Micromet and MedImmune each may be referred to herein individually as a “ Party ,” or collectively as the “ Parties .”

Recitals

      A.  Micromet is a biotechnology company that has developed the BiTE product platform, which is useful for the development of antibody-based pharmaceutical products.

      B.  MedImmune is a biotechnology company with experience in the development and commercialization of pharmaceutical products.

      C.  MedImmune desires to develop pharmaceutical products that target certain antigens using Micromet’s BiTE product platform.

      D.  Micromet and MedImmune desire to collaborate on the development and commercialization of BiTE products binding to antigens designated by MedImmune that are proprietary to MedImmune or in the public domain.

     In consideration of the foregoing premises and the mutual promises and covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

Agreement

1. Definitions

     When used in this Agreement, capitalized terms will have the meanings as defined below and throughout this Agreement.

      1.1 “ Affiliate ” means a legal entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with a Party. For purposes of this definition only, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means (a) the possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a legal entity; provided, however, that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests.

      1.2 “Applicable Law” means the laws, rules, and regulations, including any statutes, rules, regulations, or other requirements, that may be in effect from time to time and that apply to the development, manufacture, registration, and marketing of Collaboration Product in the United States and the European Union and its member states, including any such statutes, rules, regulations, or other requirements of the FDA and the EMEA. If MedImmune is manufacturing Collaboration Product for sale in Japan, the term “Applicable Law” will be deemed to include the laws, rules, and regulations, including any rules, regulations, or other requirements of the Ministry of Health, Labor and Welfare and any other Japanese regulatory authorities, that may be in effect from time to time and apply to the development, manufacture, registration, and marketing of Collaboration Product in Japan.

      1.3 “ Approved Collaboration Product ” means a Collaboration Product selected by the JDC pursuant to Section 4.1.1 for further development in a pre-clinical development program.

      1.4 “ BiTE Molecule ” means a polypeptide comprising a bi-specific Single Chain Antibody binding to T-cells.

      1.5 “ BiTE Product ” means any composition or formulation containing a BiTE Molecule.

      1.6 “ BLA ” means a Biologics License Application filed with the FDA in conformance with applicable laws and regulations.

      1.7 “ cGMP ” means current Good Manufacturing Practices as contained in 21 CFR Parts 210 and 211 as amended from time to time, and the equivalent Applicable Laws in jurisdictions outside the United States.

      1.8 “ Clinical Trial Materials ” means Collaboration Product formulated in accordance with applicable specifications, and placebo of such formulations, for administration to patients in clinical trials.

      1.9 “ Collaboration Product ” means any composition or formulation containing a BiTE Molecule binding to a Collaboration Target.

      1.10 “ Collaboration Target ” means any Target selected by MedImmune pursuant to Section 2 that becomes a Collaboration Target pursuant to Section 2.2.2.

      1.11 “ Collaboration Technology ” means Joint Collaboration Technology, MedImmune Collaboration Technology and Micromet Collaboration Technology.

      1.12 “ Commercial Process ” means a commercial scale manufacturing process for a Collaboration Product that is compliant with all Applicable Laws.

      1.13 “ Commercialization ” means the marketing, promotion, advertising, selling or distribution of a pharmaceutical product in a country after Marketing Approval has been obtained in such country for such product. The term “ Commercialize ” has a correlative meaning.

      1.14 “ Commercially Reasonable Efforts ” means those efforts consistent with the exercise of prudent scientific and business judgment, as applied by a Party to the development of its own research or development projects at a similar stage of development or Commercialization of pharmaceutical products of similar market potential and market size, at a similar stage in the product life cycle, taking into account the

risk of development or Commercialization of the product, the cost-effectiveness of efforts or resources, the competitiveness of alternative products that are or are expected to be in the marketplace, the scope and duration of patent rights or other proprietary rights related to the product, the profitability of the product and alternative products and other relevant commercial factors.

      1.15 “ Control ” and, with correlative meaning, the term “Controlled , ” means, with respect to any Patent, Know-How, or other intellectual property right of a Party, the ability to grant the other Party access, a license or a sublicense (as applicable) or right to use such Patent, Know-How, or intellectual property right as provided in this Agreement without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required under this Agreement to grant the other Party such access, license, sublicense or right of use.

      1.16 “ Co-Promotion Option ” has the meaning set forth in Section 5.1.

      1.17 “ Development Activities ” means any activities to be performed in connection with the development of Collaboration Product pursuant to a Development Plan, including any in vitro or in vivo studies, clinical studies in humans, and the preparation and filing of BLAs and MAAs.

      1.18 “ Development Cost ” means the aggregate amount of costs incurred by MedImmune in research and development of a Collaboration Product, including Commercial Process development and regulatory filing costs as determined in a reasonable manner consistent with MedImmune’s normal internal cost accounting practices and in accordance with generally accepted accounting principles, consisting of: (i) [***], (ii) [***], (iii) [***], and [***], (iv) [***].

      1.19 “ Development Plan ” has the meaning set forth in Section 3.2.4.

      1.20 “ EMEA ” means the European Medicines Evaluation Agency and any successor agency thereof.

      1.21 “ Europe ” means the countries located in Europe and including the Russian Federation and Turkey.

      1.22 “ Excluded Target ” has the meaning set forth in Section 2.2.1.

      1.23 “ FDA ” means the United States Food and Drug Administration, and any successor agency thereof.

      1.24 “ FTE ” means the equivalent of a total of [***] per year of scientific or technical work on or directly related to the execution or implementation of a Research Plan or a Development Plan or other tasks to be performed under this Agreement, carried out by a qualified employee of a Party, except to the extent included in [***]. Scientific or technical work includes performing research, experimental laboratory work, developing manufacturing processes for Collaboration Products, conducting pre-clinical and clinical development of Collaboration Products, recording and writing up results, reviewing literature and references, holding scientific discussions, and attending conferences in the relevant field.

      1.25 “ FTE Rate ” means US$[***] per FTE per annum for MedImmune, and € [***] per FTE per annum for Micromet, which amount includes, for each FTE, [***]), [***], [***] and [***].

      1.26 “ Fully-Burdened Manufacturing Cost ” means the consolidated fully burdened cost incurred by MedImmune in the manufacture of Collaboration Product, consisting of: (i) [***]; (ii) [***]; (iii) [***], excluding any [***]; (iv) a charge for [***]; (v) [***] costs; (vi) a charge for [***]; and (vii) charges for [***]; and (viii) [***] that are paid to a [***] with respect to [***]; in each of the above cases to the extent reasonably allocable to the manufacture of Collaboration Product as determined in accordance with United States generally accepted accounting principles as applied by MedImmune consistently for all its products. To the extent that manufacturing of Collaboration Product or any component thereof is performed for MedImmune by a Third Party, amounts paid by MedImmune to such Third Party in connection with the manufacturing of Collaboration Product or any component thereof, excluding any process development amortization costs paid to such Third Party, will be added to the aggregate amount of the foregoing items (i) through (viii).

      1.27 “ IND ” means an Investigational New Drug Application filed with the FDA.

      1.28 “ Independent MedImmune Technology ” means any Patent or Know-How, other than Collaboration Technology, that (a) is Controlled by MedImmune or its Affiliates at any time during the Term, and (b) claims or covers the composition, use, or manufacture of Collaboration Product, or compounds or materials used or employed in the manufacture or use thereof or, in the case of Know-How, is useful with respect to any of the foregoing.

      1.29 “Independent Micromet Technology” means: (a) any Know-How (i) that, as of the Effective Date, has been used or is being used by Micromet with respect to research, development, or production of Collaboration Products, or (ii) that is Controlled by Micromet at any time during the Term, in each case to the extent that such Know-How is useful with respect to the research, development, or production of Collaboration Products; and (b) any Patent (i) that is owned by or licensed to Micromet as of the Effective Date, (ii) that becomes owned by Micromet at any time during the Term, except to the extent that such Patent is acquired from a Third Party under terms that prevent Micromet from granting the licenses contemplated herein, or (iii) that is licensed to Micromet by a Third Party under an agreement entered into after the Effective Date and as to which Micromet has the right to grant the sublicenses contemplated herein, and in each of the foregoing cases only to the extent that such Patent claims or covers a Collaboration Product or the manufacture or use thereof or compounds or compositions used or employed in the manufacture or use of a Collaboration Product. Independent Micromet Technology includes the Patents listed in Exhibits A-1 and A-2.

      1.30 “ JDC ” has the meaning set forth in Section 3.1.1.

      1.31 “ Joint Collaboration Technology ” means any Patents and Know-How made or generated jointly by employees, Third Party agents or independent contractors of both Parties or their Affiliates during the course of, in furtherance of, and as a direct result of such employees, agents or independent contractors performing an activity pursuant to this Agreement.

      1.32 “ JPT ” has the meaning set forth in Section 3.2.1.

      1.33 “ JPT Leader ” has the meaning set forth in Section 3.2.1.

      1.34 “ Know-How ” means (a) any scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data, and (b) any biological, chemical, or physical materials.

      1.35 “ Licensed Technology ” means the Independent Micromet Technology, the Micromet Collaboration Technology, and Micromet’s rights and interest in Joint Collaboration Technology.

      1.36 “ MAA ” means a marketing approval application filed with the EMEA, and any corresponding applications in countries or territories other than the European Union and the United States.

      1.37 “ Major European Markets ” means [***] and [***].

      1.38 “ Marketing Approval ” means the approval of a BLA or MAA, and any pricing and reimbursement approvals to the extent required by Applicable Law prior to the marketing and sale of pharmaceutical products in a country.

      1.39 “ MedImmune Collaboration Technology ” means any Patents and Know-How, other than MedImmune Process Technology, made or generated solely by employees, or Third Party agents or independent contractors of MedImmune or its Affiliates during the course of, in furtherance of, and as a direct result of such employees, agents or independent contractors performing an activity pursuant to this Agreement.

      1.40 “ MedImmune Process Technology ” means any Patents and Know-How made or generated solely by employees, Third Party agents or independent contractors of MedImmune or its Affiliates during the course of, in furtherance of, and as a direct result of such employees, agents or independent contractors performing an activity pursuant to this Agreement, in each case that is useful for the manufacture of a Collaboration Product.

      1.41 “ Micromet Collaboration Technology ” means any Patents and Know-How made or generated solely by employees, Third Party agents or independent contractors of Micromet or its Affiliates during the course of, in furtherance of, and as a direct result of such employees, agents or independent contractors performing an activity pursuant to this Agreement.

      1.42 “ Net Profits ” has the meaning as defined in Exhibit B.

      1.43 “ Net Sales ” means the gross amount invoiced to Third Parties or received from Third Parties without prior invoice by a Party, its Affiliates, or any of their sublicensees for the sale of a Collaboration

Product, less: (a) trade, quantity and cash discounts allowed; (b) commissions, discounts, refunds, rebates (including federal, state or local government rebates), chargebacks, retroactive price adjustments, all to the extent allowed; (c) refunds or credits for actual returns of a Collaboration Product; (d) any tax imposed on the production, sale, delivery or use of a Collaboration Product, including, without limitation, sales, use, excise or value added taxes, other than income taxes; (e) freight and insurance costs included in the gross amount invoiced; (f) a reasonable allowance for distribution expenses; and (g) actual write-offs of uncollectible accounts receivable. Such amounts will be determined from the books and records of the applicable Party, Affiliate, or sublicensee in accordance with United States generally accepted accounting principles as applied by such entity consistently across its products. “Net Sales” excludes any amounts invoiced or received in connection with any transfers of a Collaboration Product between a Party and its Affiliates or their sublicensees who have the right to Commercialize a Collaboration Product.

      1.44 “ Non-Proprietary Target ” means a Target that is not a Proprietary Target.

      1.45 “ Patents ” means (a) all patents and patent applications in any country or supranational jurisdiction, and (b) any provisionals, substitutions, divisions, continuations, continuations in part, reissues, renewals, registrations, confirmations, reexaminations, extensions, supplementary protection certificates and the like, of any such patents or patent applications.

      1.46 “ Phase I Clinical Trial ” means, as to a specific Collaboration Product, the first controlled and lawful study in humans of the safety of such Collaboration Product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase II Clinical Trial of such Collaboration Product, as further defined in Federal Regulation 21 C.F.R. 312.21, or corresponding Applicable Laws outside the United States.

      1.47 “ Phase II Clinical Trial ” means, as to a specific Collaboration Product, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Collaboration Product, which is prospectively designed to generate sufficient data (if successful) to commence a Pivotal Trial of such Collaboration Product, as further defined in Federal Regulation 21 C.F.R. 312.21, or corresponding Applicable Laws outside the United States.

      1.48 “ Pivotal Trial ” means a clinical trial that is of size and design agreed to by the FDA that is appropriate to establish that a pharmaceutical product is safe and effective for its intended use, to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Marketing Approval of such pharmaceutical product or label expansion of such pharmaceutical product.

      1.49 “ Proprietary Target ” means any Target (a) that is set forth on Exhibit C, or (b) as to which, at the time of receipt of a Selection Notice for such Target, a BiTE Molecule binding to such Target, or use of such a BiTE Molecule, is subject to issued Patents or patent applications that: (i) are owned or exclusively licensed by MedImmune, (ii) in the case of patent applications, have been submitted to the European Patent office or filed under the Patent Cooperation Treaty designating Europe, (iii) in the case of issued Patents, have at least [***] of patent protection remaining on one or more claims of such Patents, and (iv) would reasonably be expected to exclude Micromet from developing and Commercializing a BiTE Product against such Target in Europe.

      1.50 “ Qualified Sales Force ” means, with respect to a Collaboration Product in a country, a sales organization for such Collaboration Product capable of covering the target audience for such Collaboration Product in such country to the lesser of: (a) [***]% of such target audience, and (b) the percentage of the [***] that is [***] of such Collaboration Product in such country.

      1.51 “ Research Plan ” has the meaning as defined in Section 3.2.3.

      1.52 “ Single Chain Antibody ” means a single chain polypeptide having a binding affinity for one or more Targets, and comprising: (a) a first polypeptide segment having a light chain variable region, (b) a second polypeptide segment having a heavy chain variable region, and (c) at least one peptide linker linking the first and second polypeptide segments into a single chain polypeptide.

      1.53 “ Target ” means a cell-surface antigen.

      1.54 “ Technology Acquisition Agreement ” means any agreement entered into before or after the Effective Date between a Party and a Third Party under which such Party is granted a license to or is assigned (a) any of such Third Party’s Patents that claim the composition, use, or manufacture of Collaboration Product, or (b) any of such Third Party’s Know-How that covers or is useful with respect to the composition, use, or manufacture of Collaboration Product. The Technology Acquisition Agreements of Micromet that exist as of the Effective Date are listed in Exhibit D.

      1.55 “ Technology Acquisition Payments ” means license fees, milestone payments, or royalties payable by a Party to a Third Party under any Technology Acquisition Agreement in connection with the development or Commercialization of a Collaboration Product.

      1.56 “ Territory ” means all countries of the world, except that with respect to Collaboration Products that bind to a Non-Proprietary Target, the Territory means all countries of the world except the countries in Europe.

      1.57 “ Third Party ” means any entity other than Micromet, MedImmune or their respective Affiliates.

      1.58 “ Upstream Licensor ” means Micromet’s licensor of the [***] Patent.

      1.59 “ Valid Claim ” means an issued claim of an issued patent that has not (a) expired or been canceled, (b) been declared invalid by a decision of a court or other appropriate body of competent jurisdiction that has not been appealed or that is not appealable, (c) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (d) been abandoned or disclaimed.

      1.60 “ [***] Patent ” means the patent listed in Exhibit E.

2. Selection of Collaboration Targets

      2.1 Identification of Targets by MedImmune.

           2.1.1 Selection Notice . During the period beginning on the Effective Date and ending [***] after Micromet initiates work under Section 4.1.1 with respect to the first Collaboration Target (the “ Selection Period ”), MedImmune has the right to provide Micromet written notice of specific Targets with respect to which MedImmune wishes to commence the development of a BiTE Molecule. Each such notice (a “ Selection Notice ”) will set forth a detailed description of the Target, including any Patents of MedImmune or Patents of Third Parties known to MedImmune that may claim such Target or the use thereof or antibodies against such Target, as well as a description of whether such Target, in MedImmune’s estimation, is a Proprietary Target or a Non-Proprietary Target. The Selection Period may be extended by successive [***] periods upon mutual agreement of the Parties no later than 30 days prior to the expiration of the original Selection Period or any extension thereof. MedImmune agrees to provide a Selection Notice within [***] from the Effective Date and, if MedImmune fails to do so, as the sole and exclusive remedy for such failure, Micromet may terminate this Agreement.

           2.1.2 Target Limitation . MedImmune may provide a Selection Notice for Proprietary Targets until [***] such Proprietary Targets have become Collaboration Targets as provided for in Section 2.2. Except with the prior written consent of Micromet, MedImmune’s right under Section 2.1.1 to provide Selection Notices for Targets will expire at the time when a total of [***] Targets have become Collaboration Targets pursuant to Section 2.2. In the event that there is a change in Target status under Section 2.2.3, MedImmune will have the right to select such Target even if MedImmune has selected the maximum number of Targets under this Section 2.1.2.

      2.2 Gatekeeping Process .

           2.2.1 Exclusion Criteria . Upon receipt of a Selection Notice, Micromet will within [***] days determine whether the Target described in such Selection Notice is the same as: (a) any Target set forth on Exhibit F; (b) any Target that, at such time, is part of a development program conducted at Micromet that has been approved by Micromet’s Project Monitoring Committee; (c) any Target for which at such time Micromet has granted a Third Party the exclusive right to develop or Commercialize a BiTE Product that binds to such Target; or (d) any Target for which Micromet at such time is in good faith discussions with a Third Party respecting an agreement to grant such Third Party an exclusive right to develop, co-develop with Micromet, or Commercialize a BiTE Product that binds to such Target (each such Target described in (a), (b), (c), and (d) above an “ Excluded Target ”).

           2.2.2 Notification by Micromet . If a Target described in a Selection Notice is an Excluded Target, then Micromet will notify MedImmune in writing of the grounds for the exclusion during the [***] period described above. If a Target described in a Selection Notice is not an Excluded Target, then Micromet will notify MedImmune in writing thereof during the [***] period described above, and such Target will become a Collaboration Target upon dispatch of such notice to MedImmune or upon the failure of Micromet to provide any notice during such [***] period. For each Target that becomes a Collaboration Target under this Section 2.2.2, Micromet will provide notice to MedImmune of Micromet’s determination as to whether such Collaboration Target is a Proprietary Target. Each such notice will include reasonable documentation supporting Micromet’s determination. If the Parties fail to agree as to whether a Collaboration Target is a Proprietary Target (including, without limitation, due to a disagreement as to whether one or more claims in a patent application would reasonably be expected to be granted),

MedImmune will have the right to submit such issue to arbitration under Section 22.4. If a Target described in a Selection Notice as a Proprietary Target is, as the result of arbitration, judged not to be a Proprietary Target, then MedImmune may withdraw such Target from selection and such Target will be treated for the purposes of the limits set forth in Section 2.1.2 as if MedImmune had not submitted a Selection Notice for such Target.

           2.2.3 Change of Target Status .

                (a)  If a Target designated an Excluded Target pursuant to Section 2.2.1 becomes available for selection as a Collaboration Target in that the circumstance of Section 2.2.1 that caused the Target to become an Excluded Target no longer exists, then as of such date, such Target will no longer be deemed an Excluded Target under Section 2.2.1, Micromet will promptly notify MedImmune of such availability, and MedImmune may thereafter tender a Selection Notice with respect to such Target as provided in Section 2.1.1.

                (b)  If with respect to a Target designated an Excluded Target pursuant to Section 2.2.1(d) Micromet does not execute an agreement under which a Third Party is granted an exclusive right to develop, co-develop with Micromet, or Commercialize a BiTE Product that binds to such Excluded Target within [***]s following such designation, then, as of the expiration of such [***] period, such Target will no longer be deemed an Excluded Target under Section 2.2.1(d), Micromet will promptly notify MedImmune thereof, and MedImmune may thereafter tender a Selection Notice with respect to such Target as provided in Section 2.1.1.

3. Collaboration Governance for Collaboration Products

      3.1 Joint Development Committee .

           3.1.1 Establishment of the JDC . Promptly after the first Target becomes a Collaboration Target pursuant to Section 2, the Parties will establish a joint development committee (the “ JDC ”), which will oversee the research and development of Collaboration Products under this Agreement. Each Party will appoint two employees to serve as its representatives on the JDC. From time to time, Micromet and MedImmune each may substitute any of its representatives on the JDC. The JDC will meet in person not less than once every calendar semester. Each Party will bear its own costs associated with holding and attending such meetings. Subject to the provisions of this Section 3, the JDC will establish its own procedural rules for its operation.

           3.1.2 Tasks of the JDC . The JDC will: (a) select Approved Collaboration Products for preclinical development from BiTE Molecules constructed by Micromet pursuant to Section 4.1.1; (b) review and approve the Research Plan for each Approved Collaboration Product and any updates or amendments thereto proposed by the JPT; (c) prior to the filing of the first IND for any Approved Collaboration Product, determine the indications to be pursued in the clinical development of such products; (d) review and approve the Development Plan for each Approved Collaboration Product and any updates or amendments thereto proposed by the JPT; (e) review the product lifecycle plans for Approved Collaboration Products, including indication and label expansions, new dosage forms, and new formulations or delivery systems; and (f) take such other actions as are expressly delegated to the JDC in this Agreement.

           3.1.3 JDC Meetings . Each Party will designate one of its representatives on the JDC as a co-chairperson. The co-chairpersons will be responsible for organizing the meetings of the JDC and for setting the agenda of the meetings. An agenda will be agreed upon by the co-chairpersons and be distributed to the Parties no less than one week before any JDC meeting. Upon prior written notice to the other Party, a Party may, in its discretion, invite non-voting employees, consultants or advisors (which consultants and advisors will be under an obligation of confidentiality no less stringent than the terms set forth in Section 15) to attend any meeting of the JDC. Each meeting of the JDC will include at least one representative from each Party.

           3.1.4 Meeting Minutes . Minutes will be kept of all JDC meetings by the hosting Party and sent to all members of the JDC for review and approval within 7 days after each meeting. Minutes will be deemed approved unless any member of the JDC objects to the accuracy of such minutes by providing written notice to the other members of the JDC within 14 days of receipt of the minutes. In the event of any such objection that is not resolved by mutual agreement of both co-chairpersons, such minutes will be amended to reflect such unresolved dispute.

           3.1.5 Decision Making .

                (a)  The JDC will take action by unanimous consent of its members, with each representative having a single vote, or by a written resolution signed by all of the representatives.

                (b)  If the JDC is unable to reach unanimous consent on a particular matter, then the matter will be referred to the Chief Executive Officers the Parties who will use good faith efforts to resolve such matter. If such officers fail to resolve such matter, then the [***] of [***] will finally decide the issue, except that if such matter is primarily related to Micromet’s activities to be performed for the development in Europe of an Approved Collaboration Product that binds to a Non-Proprietary Target, the [***] of [***] will finally decide the issue.

                (c)  Notwithstanding the provisions in this Section 3.1.5 above, if the matter concerns a dispute regarding the interpretation of this Agreement, the performance or alleged nonperformance of a Party’s obligations under this Agreement, or any other alleged breach of this Agreement, such matter will be decided in accordance with the terms of Section 22.4.

                (d)  The JDC will not have any power to amend this Agreement and will have only such powers as are specifically delegated to it under this Agreement. Without limiting the preceding sentence, the Parties understand and agree that the JDC has no decision-making authority with respect to Commercialization of any Approved Collaboration Product.

      3.2 Joint Project Team .

           3.2.1 Establishment of the JPT . Promptly after the Effective Date, the JDC will establish a joint project team consisting of an adequate number of employees of both Parties that will be responsible for managing the execution of each Development Plan (the “ JPT ”). Each Party will designate one of its JPT members as the co-leader of the JPT (each, a “ JPT Leader ”). The JPT Leaders may, in their

discretion, create sub-teams of the JPT for the purpose of carrying out specific tasks provided for in a Development Plan.

           3.2.2 Decision Making . The JPT will act by unanimous consent of its members or by a written resolution signed by both JPT Leaders. If the JPT is unable to reach unanimous consent on a particular matter, either JPT Leader may refer such matter to the JDC for resolution.

           3.2.3 Research Plan . Promptly after a Target becomes a Collaboration Target pursuant to Section 2.2.2, the JPT will prepare a plan for the construction of BiTE Molecules binding to the Collaboration Target, and the pre-clinical development of Approved Collaboration Products binding to such target up to and including the filing of an IND for such products (each such plan a “ Research Plan ”). Each such Research Plan will provide for Micromet to construct the BiTE Molecules and, if applicable, to perform any re-engineering thereof, and will include a detailed set of features or specifications for such BiTE Molecules. Each Research Plan will include a budget of the costs and expenses to be incurred by the Parties and their subcontractors in the performance of the tasks and activities described in such Research Plan, as well as a description of the preclinical proof of concept criteria described in clause (1) of the table set forth in Section 13.1. Any changes to the Research Plan, including changes to the target dates included in the Research Plan or the budget, will be discussed in the JPT. The JPT will update the Research Plan for approval by the JDC from time to time, but in any case at least semi-annually.

           3.2.4 Development Plan . Promptly after the decision of the JDC to file an IND for a particular Approved Collaboration Product, the JPT will develop the clinical development strategy and prepare a plan for the clinical development through the filing of Marketing Approvals for such Approved Collaboration Product in the Major European Markets, the United States and Japan (each such plan a “ Development Plan ”). Each Development Plan will include a budget of the costs and expenses to be incurred by the Parties and their subcontractors in the performance of the tasks and activities described in such Development Plan. Any changes to a Development Plan, including changes to the target dates included in the Development Plan or the budget, will be discussed in the JPT. The JPT will update each Development Plan for approval by the JDC from time to time, but in any case at least semi-annually.

           3.2.5 Reporting . Within [***] after the end of each calendar quarter and at least one week prior to any JDC meeting, the JPT Leaders will provide to the JDC a written progress report, which will describe the progress made in the execution of the Research Plans and Development Plans since the last such report. In addition to the progress reports provided hereunder, it is contemplated that the Parties and the JPT Leaders will maintain informal communications through the JDC on their day-to-day activities under this Agreement.

           3.2.6 Agendas; Meetings; Minutes . The JPT Leaders will be responsible for organizing the meetings of the JPT and for setting the agenda of the meetings. An agenda will be agreed upon by the JPT Leaders and distributed to the Parties no less than one week before any JPT meeting. Minutes will be kept of all JPT meetings by the hosting Party and sent to all members of the JPT for review and approval within 7 days after each meeting. Minutes will be deemed approved unless any member of the JPT objects to the accuracy of such minutes by providing written notice to the other members of the JPT within 14 days

of receipt of the minutes. In the event of any such objection that is not resolved by mutual agreement of both JPT Leaders, such minutes will be amended to reflect such unresolved dispute.

4. Research and Development of Collaboration Products

           4.1.1 No later than [***] after the approval of each Research Plan by the JDC, Micromet will commence with the construction of BiTE Molecules, and will be responsible for creating BiTE Molecules that meet the specifications contained in such Research Plan. Micromet will present the JDC with any BiTE Molecules meeting the applicable criteria, and the JDC may select one or more of such BiTE Molecules as an Approved Collaboration Product for further development in a pre-clinical development program as further described in the applicable Research Plan. Micromet will not be obligated to initiate work under more than one Research Plan during any [***] period.

           4.1.2 Each Party will use Commercially Reasonable Efforts to perform the tasks assigned to it in each Research Plan with respect to the preparation of an IND filing for the applicable Approved Collaboration Product.

      4.2 Clinical Development of Collaboration Products binding to Proprietary Targets . With respect to the development of any Approved Collaboration Product binding to a Proprietary Target, and as set forth in greater detail in each applicable Development Plan, as between Micromet and MedImmune, MedImmune will have the sole right to (a) perform any Development Activities necessary to enable the filing of a BLA and MAAs in the indications set forth in the applicable Development Plan in the Territory, and (b) file and prosecute such BLA and MAAs through the grant of Marketing Approval for such Approved Collaboration Product in the Territory. Without limiting the foregoing, Micromet will not conduct any clinical trial for an Approved Collaboration Product binding to a Proprietary Target without MedImmune’s express, prior, written consent.

      4.3 Clinical Development of Collaboration Products binding to Non-Proprietary Targets .

           4.3.1 With respect to the development of any Approved Collaboration Product binding to a Non-Proprietary Target, and as set forth in greater detail in each applicable Development Plan, as between Micromet and MedImmune, MedImmune will have the sole right to: (i) perform any Development Activities necessary to enable the filing of a BLA and the MAAs in the indications set forth in the applicable Development Plan in countries outside of Europe; (ii) file and prosecute such BLA and MAAs through the grant of Marketing Approval for such Approved Collaboration Product in countries outside of Europe; and (iii) perform any Development Activities provided for in the Development Plan for the development of the applicable Approved Collaboration Product in Europe up to and including the completion of Phase I Clinical Trials, if any. MedImmune will not conduct any clinical trial in Europe for an Approved Collaboration Product binding to Non-Proprietary Targets after the completion of Phase I Clinical Trials for such Approved Collaboration Product without Micromet’s express, prior, written consent. Micromet will not conduct any clinical trial in the Territory for Approved Collaboration Products binding to Non-Proprietary Targets without MedImmune’s express prior written consent.

           4.3.2 With respect to the development of any Approved Collaboration Product binding to a Non-Proprietary Target, Micromet or its designees will perform any Development Activities in addition to those performed by MedImmune pursuant to Section 4.3.1 above as may be necessary to obtain Marketing Approval for such Approved Collaboration Product in Europe. Micromet will not conduct any clinical trial for such Approved Collaboration Products in countries outside of Europe without MedImmune’s express, prior, written consent.

           4.3.3 The Parties will continuously inform each other of their Development Activities with respect to any Approved Collaboration Product binding to a Non-Proprietary Target that is developed by Micromet pursuant to Section 4.3.2 above, through their interactions in the JPT and through progress reports submitted to the JDC. Upon the reasonable request of a Party, the other Party will provide the requesting Party with copies of clinical trial protocols, preliminary reports and final reports of any clinical studies performed by such other Party, and any other information or data Controlled by such other Party relating to such product.

           4.3.4 Each Party hereby grants to the other Party (the “ Passive Party ”) the right to use and reference: (a) any non-clinical data, clinical data (including raw data, safety data, and efficacy data), and clinical trial protocols relating to any Approved Collaboration Product binding to a Non-Proprietary Target, (b) any INDs, BLAs, MAAs, other regulatory filings, and Marketing Approvals for any such Approved Collaboration Product, and (c) any correspondence with any regulatory authorities relating to any such Approved Collaboration Product; in each case, as generated, developed or received by or on behalf of the granting Party in the course of the performance of this Agreement, and in each case, for the development of Approved Collaboration Products and the filing and prosecution of any INDs, BLAs, and MAAs, and the maintenance of any Marketing Approvals and other regulatory approvals of Approved Collaboration Products by the Passive Party in countries outside of Europe (if MedImmune is the Passive Party) or in countries inside of Europe (if Micromet is the Passive Party). In addition, if a Party receives notice of a scheduled meeting or visit with a regulatory authority relating to such Party’s development, manufacture, or Commercialization of an Approved Collaboration Product binding to a Non-Proprietary Target, then such Party will notify the Passive Party of such meeting or visit and such Passive Party will have the right to have [***] representatives of such Passive Party present at such meeting or visit, provided that each such representative remains a silent observer throughout such meeting or visit. Each Party will take all necessary and proper acts, and will cause its employees, Affiliates, agents, and independent contractors to take such necessary and proper acts, to effectuate the rights of use and reference provided in this Section 4.3.4.

      4.4 Research and Development Costs.

           4.4.1 Research Plan .

                (a)  MedImmune will bear the costs and expenses incurred by MedImmune in the performance of activities under the Research Plan. MedImmune will pay any costs and expenses incurred by Micromet in the performance of any activities provided for in the Research Plan quarterly in advance within [***] after receipt of a corresponding invoice from Micromet that estimates the costs and expenses for such quarter. Micromet employees will be charged on an hourly basis at the FTE Rate. Goods and services provided by Third Parties specified and agreed upon in the Research Plan that are paid by

Micromet will be charged at [***]. In no event will MedImmune be obligated to make any payments to Micromet for research activities that are not included in the applicable Research Plan or that are in excess of [***]% of the amount included in the budget of such Research Plan for a calendar year, unless such expenses have been approved in writing by the JDC in advance. In no event will Micromet be obligated to incur costs and expenses for research activities that are not included in the applicable Research Plan or costs and expenses in excess of the amount included in the budget of such Research Plan, unless such costs and expenses have been approved in writing by the JDC in advance.

                (b)  Micromet will provide quarterly reports on its activities under each Research Plan and the costs and expenses for such activities. If such report reveals that Micromet’s actual, documented costs and expenses were lower than the amount paid by MedImmune in advance for such quarter, the overpayment will be credited to the next payment due under this Section 4.4. If such report reveals that Micromet’s actual, documented costs and expenses were higher than the amount paid by MedImmune in advance for such quarter, MedImmune will make a supplemental payment for the unpaid amount within [***] after receipt of such report.

                (c)  MedImmune will have the right to terminate research with respect to Collaboration Products against a Collaboration Target and the activities under a Research Plan with respect thereto by [***] prior written notice to Micromet, and after the expiration of such [***] period, MedImmune will no longer be obligated for costs and expenses incurred by Micromet with respect to Collaboration Products against such Collaboration Target. During such 3-month period, MedImmune will be responsible for the costs and expenses that are reasonably incurred in terminating the activities under the Research Plan, including without limitation any ongoing personnel costs for Micromet employees engaged in such activities, to the extent such employees cannot be reassigned to other projects.

           4.4.2 Development Plan . Unless expressly agreed otherwise, each Party will bear any costs and expenses incurred by such Party in the performance of Development Activities provided for in a particular Development Plan.

      4.5 Diligence .

           4.5.1 MedImmune will use Commercially Reasonable Efforts (a) to develop and to obtain Marketing Approval in [***], the [***] and [***] for an Approved Collaboration Product binding to each Proprietary Target, (b) to develop and to obtain Marketing Approval in [***] and [***] for an Approved Collaboration Product binding to each Non-Proprietary Target, and (c) to develop a Commercial Process for each Approved Collaboration Product developed by MedImmune under this Agreement. It is expressly understood that MedImmune will not be required to perform trials for or seek Marketing Approval for an Approved Collaboration Product in [***] [***] (with respect to Approved Collaboration Products binding to Proprietary Targets) until MedImmune has obtained Marketing Approval for such Approved Collaboration Product in [***]. It is further expressly understood that MedImmune will not be required to perform trials for or seek Marketing Approval for an Approved Collaboration Product in [***] until MedImmune has obtained Marketing Approval for such Approved Collaboration Product in [***] and [***] (with respect to Approved Collaboration Products binding to Proprietary Targets). All efforts of MedImmune’s Affiliates and sublicensees, together with any efforts of Micromet performed under a

Development Plan (to the extent applicable to MedImmune’s development efforts for the applicable country), will be considered efforts of MedImmune for the purpose of determining MedImmune’s compliance with its obligations under this Section 4.5.1.

           4.5.2 If Micromet determines that MedImmune has failed to meet its obligations under Section 4.5.1 with respect to an Approved Collaboration Product, then, as the sole and exclusive remedy for such failure, Micromet will have the right to terminate the licenses granted to MedImmune under this Agreement with respect to such Approved Collaboration Product pursuant to Section 17.2.

           4.5.3 Micromet will use Commercially Reasonable Efforts to construct BiTE Molecules meeting the specifications in the Research Plans and otherwise to perform the activities assigned to Micromet in each Research Plan and Development Plan.

      4.6 Exchange of CMC Documentation . Upon completion of development of each Commercial Process for an Approved Collaboration Product binding to a Non-Proprietary Target, MedImmune will provide to Micromet, or at the discretion of MedImmune to the applicable regulatory agency, all necessary CMC documentation for Europe in the possession of MedImmune, its Affiliates, contractors, or licensees and, as reasonably requested by Micromet, assistance with the presentation of such documentation to regulatory authorities in Europe, all as required for filing in Europe of an MAA relating to the manufacture of the applicable Collaboration Product by means of such Commercial Process and Micromet will reimburse MedImmune at the FTE Rate for such assistance.

      4.7 Restrictions on Development and Commercialization of Licensed Products

           4.7.1 During the period commencing on the Effective Date and ending on the earlier of (a) the date 4 years after the Effective Date, and (b) any termination of this Agreement, MedImmune hereby covenants not to engage, directly or indirectly, in the research, development, or Commercialization of any BiTE Product that is not an Approved Collaboration Product under this Agreement or a “Licensed Product” under that certain Collaboration and License Agreement executed by the Parties on the Effective Date.

           4.7.2 During the Term, Micromet will not itself or through any Third Party (whether through the grant of a license or otherwise) develop or Commercialize outside of Europe any Collaboration Product binding to Non-Proprietary Targets, except as expressly permitted under the terms of this Agreement. During the Term, MedImmune will not itself or through a Third Party, whether through the grant of a license or otherwise, develop or Commercialize in Europe any Collaboration Product binding to Non-Proprietary Targets.

           4.7.3 During the period that MedImmune has licenses under this Agreement to a Collaboration Product, neither Party shall develop or perform clinical trials or obtain marketing approval for such Collaboration Product, other than for an Approved Collaboration Product as permitted by this Agreement.

5. Co-Promotion Option

      5.1 Grant and Exercise . MedImmune hereby grants Micromet an option with respect to any Approved Collaboration Product binding to a Proprietary Target to obtain the right to co-promote such Approved Collaboration Product in Europe (the “ Co-Promotion Option ”). Micromet may exercise such option with respect to each such Approved Collaboration Product by written notice to MedImmune at any

time prior to the [***] with such Approved Collaboration Product. Such exercise will be effective on the date of receipt of such written notice by MedImmune (the “ Exercise Date ”). Upon such exercise, Micromet will have the right to participate in the Commercialization of such Approved Collaboration Product in Europe by sharing [***]% of the Net Profits generated by MedImmune with such Approved Collaboration Product, as provided in Section 13.3.

      5.2 Development Following Option Exercise . The development of an Approved Collaboration Product with respect to which Micromet has exercised the Co-Promotion Option will continue pursuant to the terms of Sections 2, 3 and 4. MedImmune will file and prosecute an MAA, and maintain any Marketing Approval granted on such MAA, in all Major European Markets and any other countries in Europe reasonably designated by Micromet prior to the filing of the first MAA in Europe.

      5.3 Development Costs . If Micromet has exercised the Co-Promotion Option with respect to an Approved Collaboration Product, then Micromet will bear [***]% of MedImmune’s Development Cost incurred in connection with the worldwide development of such Approved Collaboration Product [***] for such Approved Collaboration Product in accordance with the applicable Development Plan. Micromet will pay Micromet’s share of such Development Costs for Development Activities provided for in the Development Plan quarterly in arrears within 30 days after receipt of a corresponding invoice from MedImmune. With each invoice, MedImmune will provide a detailed accounting of the costs and expenses invoiced.

      5.4 Co-Promotion Agreement .

           5.4.1 Within [***] after completion of the Pivotal Trials required for obtaining Marketing Approval in the Major European Markets for an Approved Collaboration Product for which Micromet has exercised the Co-Promotion Option, the Parties will negotiate in good faith a co-promotion agreement governing the co-promotion of such Approved Collaboration Product by the Parties in Europe. The co-promotion agreement will provide for a role of the Parties in the marketing and promotion of the applicable Approved Collaboration Product in Europe commensurate with the Parties’ respective sales force capabilities; provided, however, that MedImmune will set the sales price, book all sales revenue, and have control over the marketing and sales programs in Europe.

           5.4.2 Dispute Resolution for Co-Promotion Terms .

           (a) If the Parties are unable to agree on all terms of the co-promotion agreement with respect to a particular Collaboration Product prior to the expiration of the [***] period referred to in Section 5.4.1, the Parties may select a mutually agreeable arbitrator who has significant relevant experience in the pharmaceutical industry and the promotion of pharmaceutical products in Europe and no affiliation or pre-existing relationship with either Micromet or MedImmune. If the Parties cannot agree on an arbitrator within [***] after the termination of the [***] period described in Section 5.4.1, either Party may request the Judicial Arbitration Mediation Services (“ JAMS ”) in Washington, D.C. to appoint an arbitrator with such experience on behalf of the Parties in accordance with the commercial arbitration rules of JAMS. The date on which such arbitrator is selected will be the “Arbitration Commencement Date.”

                (b)  Within [***] after the Arbitration Commencement Date, each Party will prepare and deliver to both the arbitrator and the other Party its proposed co-promotion agreement and a memorandum (the “ Support Memorandum ”) in support thereof. The arbitrator will also be provided with a copy of this Agreement. Within [***] after receipt of the other Party’s Support Memorandum, each Party may submit to the arbitrator (with a copy to the other Party) a rebuttal to the other Party’s Support Memorandum (a “ Rebuttal ”), which may include a revision, marked to show changes, of either Party’s proposed co-promotion agreement. Neither Party may have communications (either written or oral) with the arbitrator other than for the sole purpose of engaging the arbitrator or as expressly permitted in this Section 5.4.2.

                (c)  Within [***] after the Arbitration Commencement Date, the arbitrator will select from the two co-promotion agreements provided by the Parties the co-promotion agreement that he or she believes most accurately reflects the intention of the Parties to this Agreement and the industry customs regarding the co-promotion of pharmaceutical biopharmaceutical products (the “ Selected Agreement ”). The Selected Agreement will become a binding and enforceable agreement between Micromet and MedImmune.

                (d)  The arbitrator will have reasonable discretion to request additional information, hold a hearing, and extend the time frame for reaching his or her decision regarding the dispute at issue. To the extent any further arbitration rules or procedures are necessary for resolution of the dispute at issue, the arbitration rules of JAMS will apply. Notwithstanding the foregoing, the Parties are not required to select an arbitrator from JAMS’s panel of arbitrators. The arbitrator’s fees and expenses will be paid by the Party whose form of co-promotion agreement is not selected by the arbitrator. Each Party will bear and pay its own expenses incurred in connection with any contract resolution under this Section 5.4.2.

           5.4.3 Buy-Out of Co-Promotion Option . At any time prior to or after the exercise of the Co-Promotion Option by Micromet, but in any event before the Parties refer a co-promotion agreement to arbitration pursuant to Section 5.4.2, MedImmune will have the right to terminate such option or the co-promotion right by providing written notice of such termination to Micromet. Upon such termination, MedImmune will pay Micromet a royalty of [***]% of all Net Sales of such Approved Collaboration Product in [***] sold by MedImmune, its Affiliates or their sublicensees for the royalty term of Section 13.2.2(a), and will assume any Technology Acquisition Payments that may become due as a result of the development or Commercialization of such Approved Collaboration Product in Europe. In such event, Section 13.2.3 will apply with respect to such payments; provided, however, that in no event will the credit set forth in Section 13.2.3(b) reduce the amount of royalties due and payable by MedImmune to Micromet under this Section 5.4.3 to less than [***]% of Net Sales of such Approved Collaboration Product in Europe. For the avoidance of doubt, the royalties set forth in this Section 5.4.3 are in lieu of, and not in addition to, the royalties set forth in Section 13.2.1.

           5.4.4 Loss of Co-Promotion Rights . If, at the time of an MAA filing in Europe for an Approved Collaboration Product as to which Micromet has exercised Micromet’s co-promotion rights in accordance with this Agreement, Micromet does not have a Qualified Sales Force for co-promoting such Collaboration Product in one or more countries in Europe, MedImmune will have the right to terminate

Micromet’s co-promotion rights for such Collaboration Product in each such country by written notice to Micromet. Upon such written notice, Micromet’s co-promotion rights will be terminated with respect to such Collaboration Product in each such country and thereafter MedImmune will be obligated to pay royalties to Micromet with respect to Net Sales of such Collaboration Product in each such country in accordance with Section 13.2.1(c), as well as Sections 13.2.1(a) and (b). In the event that there is a dispute between the Parties as to whether or not Micromet has such a Qualified Sales Force in one or more countries, such issue will be submitted to arbitration under Section 22.4 and Micromet’s co-promotion rights will continue in each such country until there is a decision in such arbitration that Micromet does not have a Qualified Sales Force in such country at the time of the MAA filing.

6. Reversion of Collaboration Products; Expiration of Collaboration

      6.1 Reversion of Products .

           6.1.1 Reversion Triggers and Territories . If MedImmune notifies Micromet of its decision to discontinue the development or Commercialization of all Collaboration Products binding to a particular Non-Proprietary Target, Micromet will have the exclusive right to continue the development of and to Commercialize any and all Collaboration Products binding to such Non-Proprietary Target on a worldwide basis. If MedImmune notifies Micromet of its decision to discontinue development or Commercialization of all Collaboration Products binding to a particular Proprietary Target in Europe and Micromet has exercised a Co-Promotion Option and made the contribution to development costs set forth in Section 5.3 with respect to each Approved Collaboration Product, then Micromet will have the exclusive right to continue the development of and to Commercialize any and all Collaboration Products against such Proprietary Target being developed by MedImmune at such time, but only for sale and use in Europe. In each of the above cases, such rights will become effective only upon provision by Micromet of the notice described in Section 6.1.2.

           6.1.2 Continuation Notice . If Micromet decides to continue the development or Commercialization of Collaboration Products under Section 6.1.1 or Section 18.1.1, it will provide MedImmune with written notice of such decision (the “ Continuation Notice ”) within [***] after receipt of the notice from MedImmune under Section 6.1.1, or within [***] after the effective date of termination in the entirety of MedImmune’s licenses under this Agreement, as applicable. During such [***] period, MedImmune will make available to Micromet all data and information relating to such product generated by or on behalf of MedImmune in the performance of the applicable Research Plan and Development Plan, other than MedImmune Process Technology, as may be reasonably requested by Micromet to determine its interest in such Collaboration Products.

           6.1.3 Licenses and Royalties . If Micromet decides to continue the development or Commercialization of a Collaboration Product pursuant to this Section 6.1, Micromet will bear all costs and expenses incurred by it in the development and Commercialization of such Collaboration Product, including any Technology Acquisition Payments becoming due and payable after Micromet has provided the Continuation Notice. In addition, Micromet will pay to MedImmune a [***] of such Collaboration Product that is equal to [***], subject to the [***] set forth in Section [***]. Payment of said royalty to MedImmune will expire if and when the [***] has reached the [***] in connection with the development of

such Collaboration Product pursuant to the applicable Research Plan and Development Plan to the extent such [***] were not [***] under this Agreement, plus an interest charge of [***]% compounded annually on [***]. For the avoidance of doubt, notwithstanding the termination of royalty payments, Micromet will continue to pay all Technology Acquisition Payments under Technology Acquisition Agreements of MedImmune and Micromet that become due as a result of Micromet’s development and Commercialization of such Collaboration Products.

           6.1.4 Any continuation of development or Commercialization of a Collaboration Product pursuant to this Section 6.1 will be subject to the terms and conditions set forth in Section 18.1.

      6.2 Expiration of Collaboration .

           6.2.1 The decision-making powers of the JDC and the JPT will cease to apply to the development of any Approved Collaboration Product for which Micromet fails to exercise the Co-Promotion Option or for which Micromet’s Co-Promotion Option or co-promotion rights have been terminated. MedImmune will assume full control over the development of such Approved Collaboration Products, except that MedImmune will update Micromet at the meetings of the JDC regarding the progress of the development, and will provide Micromet with the Development Plan and any updates thereof prepared by MedImmune in accordance with its normal business practices.

           6.2.2 The decision-making powers of the JDC and the JPT will cease to apply to the development of Collaboration Products that are developed by Micromet after MedImmune has discontinued its development thereof. Micromet will assume full control over the development of such Collaboration Products as to which Micromet has provided MedImmune with a Continuation Notice, except that Micromet will update MedImmune at the meetings of the JDC regarding the progress of the development, and will provide MedImmune with the Development Plan and any updates thereof prepared by Micromet in accordance with its normal business practices.

7. Supply of Collaboration Product

      7.1 Clinical Supply of Collaboration Products . Upon establishing a manufacturing process suitable for producing Clinical Trial Materials, MedImmune itself or through a Third Party will manufacture and supply Clinical Trial Materials in accordance with Applicable Law and cGMP for all clinical trials for such Collaboration Products conducted by the Parties pursuant to a Development Plan. For clinical trials of Collaboration Product conducted by Micromet pursuant to this Agreement, MedImmune will supply Micromet with such Clinical Trial Materials on the terms and conditions set forth in this Section 7.

      7.2 Supply Price, Forecasting and Purchase Orders . Upon establishing a manufacturing process suitable for producing Clinical Trial Materials, MedImmune will supply Micromet with Micromet’s requirements of such Clinical Trial Materials at MedImmune’s [***] for such Clinical Trial Materials for use in Europe. If Micromet orders such Clinical Trial Material for use in Pivotal Trials, then MedImmune will manufacture any such Clinical Trial Materials using the applicable Commercial Process or a clinical scale process, as unanimously determined by the JDC. Micromet will provide to MedImmune rolling forecasts of its requirements of such Clinical Trial Materials. The frequency and forward-looking time period of such forecasts will be determined by the JDC. Micromet will place purchase orders for such

Clinical Trial Material as needed for the performance of clinical trials by Micromet in accordance with the applicable Development Plan. Each purchase order will specify the delivery dates for the quantities ordered; provided, however, that MedImmune will not be required to supply such Clinical Trial Materials earlier than a certain number of days after receipt of a purchase order from Micromet. The number of days for the lead time will be determined by the JDC. Should MedImmune at any time during the term of this Agreement have reason to believe that it will be unable to meet an agreed upon delivery date of a shipment after submission of the relevant purchase order, then MedImmune will promptly notify Micromet of the cause for such delay and the steps to be undertaken by MedImmune to make up lost time. MedImmune will supply each of Micromet’s licensees of Collaboration Product with such licensee’s requirements of Clinical Trial Materials at [***] for such Clinical Trial Materials, and each such licensee will be entitled to the rights and privileges set forth in this Agreement with respect to such Clinical Trial Material; provided, however, that such licensee agrees to comply with the terms and conditions applicable to Micromet’s purchase of such Clinical Trial Material hereunder from MedImmune and MedImmune is made a third party beneficiary thereof with the right of enforcement.

      7.3 Packaging, Shipping and Delivery . MedImmune will fill, release, package and label Clinical Trial Materials for shipment using due care and in accordance with Applicable Laws and the specifications set forth in the applicable Development Plan. Any packaging and labeling material for such Clinical Trial Materials to be used in countries outside the Territory will be provided by Micromet, at the cost and expense of Micromet. MedImmune will ship such Clinical Trial Materials [***] (Incoterms 2000) MedImmune’s facility by a common carrier designated by Micromet in the applicable purchase order. Each shipment will be made according to the delivery schedule and in the amounts specified in the applicable purchase order, and under the terms and conditions set forth in this Agreement. Each shipment will include a certificate of analysis and such other documentation as may be requested on the applicable purchase order.

      7.4 Risk of Loss . Risk of loss of Clinical Trial Materials will be transferred to Micromet upon delivery to the carrier, and thereafter with respect to any loss thereof, Micromet will be responsible for payment to MedImmune for such Clinical Trial Materials.

      7.5 Invoice and Payment . MedImmune will enclose an invoice with each shipment of Clinical Trial Materials made pursuant to this Section 7 setting forth a detailed account of the quantities of such Clinical Trial Materials included in such shipment and a good faith estimate of the [***] for such Clinical Trial Materials. Within [***] of acceptance by Micromet of a shipment of such Clinical Trial Materials, Micromet will pay the full amount of the estimated [***] set forth in the relevant invoice. Within [***] after each shipment of Clinical Trial Materials provided to Micromet under this Section 7, MedImmune will calculate the actual [***] for such shipment and will provide Micromet with written notice of such [***] and, within [***] of receipt of such notice, Micromet will pay the difference between the actual [***] for such Clinical Trial Materials and the amounts paid by Micromet based on MedImmune’s estimate of the [***] for such Clinical Trial Materials, or MedImmune will reimburse any amount of overpayment, as the case may be.

      7.6 Warranties . MedImmune hereby warrants that any Clinical Trial Materials provided by MedImmune to Micromet under this Agreement, at the time of delivery pursuant to Section 7.3 above: (a) will conform to the specifications for such Clinical Trial Materials set forth in the Development Plan (the

“ Specifications ”), and (b) will have been manufactured and shipped to Micromet in accordance with cGMP and other Applicable Laws in Europe (the “ Product Warranties ”).

      7.7 Acceptance of Clinical Trial Materials . Micromet will have 60 days after receipt of each shipment of Clinical Trial Materials (such period, the “ Acceptance Period ”) to review such shipment and test the Clinical Trial Materials therein. If Micromet believes that the Clinical Trial Materials do not comply with the Product Warranties, then Micromet will deliver to MedImmune written notice of rejection (the “ Rejection Notice ”) of such Clinical Trial Materials, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. Any Clinical Trial Materials not rejected within such 60 day period will be deemed to be accepted by Micromet; provided, however, that Micromet thereafter may send a Rejection Notice for Clinical Trial Material promptly following the discovery of any failure to comply with the Product Warranties if (a) such non-compliance was not reasonably discoverable within such 60-day period (each such non-compliance a “ Latent Defect ”), and (b) such non-compliance is discovered within 12 months following receipt by Micromet of the applicable shipment of Clinical Trial Materials. If a Rejection Notice is received by MedImmune during the Acceptance Period, or thereafter as permitted with respect to Latent Defects, then MedImmune and Micromet will provide one another with all related paperwork and records (including, but not limited to, quality control tests) relating to the production of the Clinical Trial Materials in question or the Rejection Notice.

      7.8 Disputes Regarding Clinical Trial Materials .

           7.8.1 MedImmune and Micromet will attempt to resolve any dispute regarding the conformity of a shipment of Clinical Trial Materials with the Product Warranties. If such dispute cannot be settled within 30 days of the submission by each Party of such related paperwork and records to the other Party, then such dispute will be resolved as set forth in this Section 7.8.

           7.8.2 If the Clinical Trial Materials are alleged not to conform with the Product Warranties set forth in Section 7.6(a), then Micromet will submit a sample of the batch of the disputed shipment to an independent testing laboratory of recognized repute selected by Micromet and approved by MedImmune (such approval not to be unreasonably withheld) for analysis, under Quality Assurance approved procedures, of the conformity of such shipment of Clinical Trial Materials with the applicable Specifications. The costs associated with such analysis by such independent testing laboratory will be paid by the Party whose assessment of the conformity of the shipment of Clinical Trial Materials with the Specifications was mistaken. The determination by the independent testing laboratory, will be final and binding.

           7.8.3 If the Clinical Trial Materials are alleged not to conform with the Product Warranties set forth in Section 7.6(b), then such dispute will be submitted to an arbitrator located in the state where the Clinical Trial Materials are manufactured. Such arbitrator will have adequate scientific background and training and will be selected jointly by Micromet and MedImmune. Such arbitrator, in accordance with the commercial arbitration rules of JAMS, will determine whether the Clinical Trial Materials were non-conforming with the Product Warranties set forth in Section 7.6(b), and such arbitrator’s findings, will be final and binding. The costs and expenses associated with the retention of such arbitrator will be paid by the Party whose assessment of the conformity of the shipment of Clinical Trial Materials with the Product Warranties was mistaken.

      7.9 Remedies for Non-Conforming Clinical Trial Materials . In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.8, that all or a portion of a shipment of Clinical Trial Materials materially fails to conform to the Product Warranties, then, as the sole and exclusive remedy for such failure, Micromet will not be obligated to make any payment for such non-conforming Clinical Trial Materials and MedImmune will reimburse any payments for such materials previously received from Micromet. Further, MedImmune will produce for Micromet sufficient quantities of Clinical Trial Materials to replace the non-conforming portion of such shipment of Clinical Trial Materials, in accordance with the provisions of this Agreement.

      7.10 Audits and Inspections .

           7.10.1 A delegation consisting of representatives of Micromet and its licensees that are to be supplied Clinical Trial Materials by MedImmune under this Agreement, no more than once per calendar year, will have the right to inspect and audit any MedImmune facility where a manufacturing process is implemented for such Clinical Trial Materials, and the documentation generated in connection with the manufacture and testing of such Clinical Trial Materials; provided, however, that Micromet will be entitled to perform an additional audit in the event that an inspection by a regulatory authority results in a determination that the facilities in which Clinical Trial Materials are manufactured fail to comply with Applicable Law in such a manner as may affect the supply of Clinical Trial Materials hereunder. Such inspections will take place during regular business hours and with at least 60 days prior notice to MedImmune. Micromet will discuss the results of any inspection with MedImmune. Any inspection by Micromet, if it occurs, does not relieve MedImmune of its obligation to comply with all Applicable Laws and does not constitute a waiver of any right otherwise available to Micromet.

           7.10.2 Up to two representatives of Micromet and its licensees that are to be supplied Clinical Trial Materials by MedImmune under this Agreement will have the right to be present as silent observers at any announced visits to MedImmune by any regulatory authority relating to the manufacture of Clinical Trial Materials. Furthermore, MedImmune will inform Micromet of the results of any inspection by a regulatory authority that does or could reasonably be expected to affect the manufacture of such Clinical Trial Materials. MedImmune will promptly provide Micromet with copies of notifications from any regulatory authority (including, without limitation, any Form No. 483 notification, Enforcement Inspection Reports, Notice of Adverse Finding, etc.). Micromet will treat all information subject to review under this Section 7.10.2 in accordance with the provisions of Section 15 and will cause any Third Party auditor retained by Micromet (and reasonably acceptable to MedImmune) to enter into a reasonably acceptable confidentiality agreement with MedImmune obligating such auditor to maintain all such information in confidence pursuant to such confidentiality agreement.

      7.11 Commercial Supply of Collaboration Product .

           7.11.1 Commercial Supply Agreement . MedImmune will inform Micromet of the completion of development of each Commercial Process. At such time, Micromet may request that MedImmune supply Micromet or its licensees with Approved Collaboration Product manufactured using such Commercial Process in bulk form (i.e. filled vials, unlabelled and unpackaged) for use and sale in Europe if such Approved Collaboration Product is developed or Commercialized by Micromet or its licensees in Europe pursuant to this Agreement. If MedImmune elects to undertake the supply of such Approved Collaboration Product to Micromet or its licensees, then the Parties will enter into a supply

agreement setting forth the terms a