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COLLABORATION AND LICENSE AGREEMENT

License Agreement

COLLABORATION AND LICENSE AGREEMENT | Document Parties: MedImmune, Inc | Micromet AG You are currently viewing:
This License Agreement involves

MedImmune, Inc | Micromet AG

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Title: COLLABORATION AND LICENSE AGREEMENT
Governing Law: New York     Date: 3/16/2007
Industry: Biotechnology and Drugs     Law Firm: Cooley Godward     Sector: Healthcare

COLLABORATION AND LICENSE AGREEMENT, Parties: medimmune  inc , micromet ag
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Exhibit 10.42
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
COLLABORATION AND LICENSE AGREEMENT
     This Collaboration and License Agreement (the “ 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 developing MT103 (as defined below).
     B. MedImmune is a biotechnology company with experience in the development and commercialization of pharmaceutical products.
     C. Micromet and MedImmune desire to collaborate on the development of Licensed Products to obtain marketing approval of such products for various indications in the countries of North America, and thereafter to have MedImmune commercialize Licensed Product in these countries.
     D. Micromet and MedImmune desire to have MedImmune develop a commercial scale manufacturing process for Licensed Products developed under this Agreement, and thereafter to have MedImmune produce Licensed Product for the Parties.
     E. Micromet desires to have MedImmune grant a loan in the amount of 10,000,000 secured by a note convertible into Micromet preferred stock, and MedImmune desires to make such loan.
     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 the 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 Licensed 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 Licensed 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 Licensed Product in Japan.
      1.3 “BiTE Molecule” means a polypeptide comprising a bi-specific Single Chain Antibody binding to T-cells.
      1.4 “BiTE Product” means any composition or formulation containing a BiTE Molecule.
      1.5 “BLA” means a Biologics License Application filed with the FDA in conformance with applicable laws and regulations.
      1.6 “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.
      1.7 “Clinical Trial Materials” means Licensed Product formulated in accordance with applicable specifications, and placebo of such formulations, for administration to patients in clinical trials.
      1.8 “Collaboration Technology” means Joint Collaboration Technology, MedImmune Collaboration Technology and Micromet Collaboration Technology.
      1.9 “Commercial Process” means a commercial scale manufacturing process for a Licensed Product that is compliant with all Applicable Laws.
      1.10 “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.
      1.11 “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

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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.
      1.12 “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.
      1.13 “Development Activities ” means any activities to be performed in connection with the development of Licensed 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.
      1.14Development Cost ” means the aggregate amount of costs incurred by Micromet in development of MT103, including Commercial Process development and regulatory filing costs, as determined in a reasonable manner consistent with Micromet’s normal internal cost accounting practices and in accordance with generally accepted accounting principles, consisting of: (i) [***], (ii) [***], (iii) [***] including [***] and [***], [***], and [***] and [***], (iv) [***].
      1.15 “Development Plan” means the development plan for a Licensed Product, as approved pursuant to Section 2 and as may be amended pursuant to the terms of this Agreement.
      1.16 “EMEA” means the European Medicines Evaluation Agency and any successor agency thereof.
      1.17 “FDA” means the United States Food and Drug Administration and any successor agency thereof.
      1.18 “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 [***] Costs. Scientific or technical work includes performing research, experimental laboratory work, developing manufacturing processes for Licensed Product, conducting pre-clinical and clinical development of Licensed Product, recording and writing up results, reviewing literature and references, holding scientific discussions, and attending conferences in the relevant field.
 
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      1.19 “FTE Rate” means US$[***], for [***], and #eu#[***] for [***], which amount includes, for each FTE, [***] [***] and [***] (excluding items provided for separately in the Development Plan), [***], [***], [***], and a [***] plus [***].
      1.20 “Fully-Burdened Manufacturing Cost” means the consolidated fully burdened cost incurred by MedImmune in the manufacture of Licensed Product, consisting of: (i) [***]; (ii) [***]; (iii) [***] of [***] and [***], excluding any [***] or [***]; (iv) a charge for [***] and [***] of [***] and [***]; (v) [***] and [***]; (vi) a charge for [***] for [***] and [***]and [***]and [***]and [***]and [***]; and (vii) charges for [***] or [***]; and (viii) [***] that are paid to [***] with respect to [***]; in each of the above cases to the extent reasonably allocable to the manufacture of Licensed 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 Licensed 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 Licensed Product or any component thereof, excluding any process development amortization costs paid to such Third Party as a result of such Third Party performing development work on a Commercial Process for MedImmune, will be added to the aggregate amount of the foregoing items (i) through (viii).
      1.21 “IND” means an Investigational New Drug Application filed with the FDA.
      1.22 “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 a Licensed 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.
      1.23 “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 Licensed 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 Licensed 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 Licensed Product or the manufacture or use thereof or compounds or compositions used or employed in the manufacture or use of a Licensed Product. Independent Micromet Technology includes the Patents listed in Exhibits A-1, A-2 and A-3.
      1.24 “JDC” has the meaning set forth in Section 2.1.1.
 
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      1.25 “Joint Collaboration Technology” means any Patents and Know-How made or generated jointly by employees, or 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.
      1.26 “JPT” has the meaning set forth in Section 2.2.1.
      1.27 “JPT Leader” has the meaning set forth in Section 2.2.1.
      1.28 “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.
      1.29Lead Product ” means MT103 or any Replacement Product selected by the JDC pursuant to Section 3.5 as a successor to the then-current Lead Product.
      1.30Lead Product Process ” means a Commercial Process for the Lead Product.
      1.31 “Licensed Product” means MT103 and any Replacement Product, in each case, alone or as part of a composition or formulation.
      1.32 “Licensed Technology” means the Independent Micromet Technology, the Micromet Collaboration Technology, and Micromet’s rights and interest in Joint Collaboration Technology.
      1.33 “MAA” means a marketing approval application filed with the EMEA, and any corresponding applications in countries or territories other than the European Union and other than the United States.
      1.34 “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.
      1.35 “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.
      1.36 “MedImmune Process Technology” means any Patents and Know-How 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, in each case that is useful for the manufacture of a Licensed Product.

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      1.37 “Micromet Collaboration Technology” means any Patents and Know-How, made or generated solely by employees, or 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.
      1.38 “MT103” means the BiTE Product containing the BiTE Molecule with the amino acid sequence set forth in Exhibit B.
      1.39MT103 Patents ” means (a) patent applications [***] entered as national phases of [***]; and (b) any related Patents.
      1.40 “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 Licensed 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 Licensed Product; (d) any tax imposed on the production, sale, delivery or use of a Licensed 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 Licensed Product between a Party and its Affiliates or their sublicensees who have the right to Commercialize a Licensed Product.
      1.41 “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.
      1.42 “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.
      1.43 “Replacement Product” means any BiTE Molecule, other than MT103, that binds to [***], alone or as part of a composition or formulation.
      1.44 “Research Plan” has the meaning set forth in Section 3.5.3.
      1.45 “Royalty Term” has the meaning set forth in Section 10.4.2.
 
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      1.46 “Single Chain Antibody ” means a single chain polypeptide having a binding affinity for a cell surface antigen, 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.
      1.47 “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 Licensed 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 Licensed Product. The Technology Acquisition Agreements of Micromet that exist as of the Effective Date are listed in Exhibit C.
      1.48 “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 Licensed Product.
      1.49 “Territory” means the United States of America, Canada, and Mexico, and any territories or possessions of the foregoing countries.
      1.50 “Third Party” means any entity other than Micromet, MedImmune or their respective Affiliates.
      1.51 “Upstream Licensor” means Micromet’s licensor of the [***] Patent.
      1.52 “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.
      1.53 “[***] Patent” means the patent listed in Exhibit D.
2. Collaboration Governance
2.1 Joint Development Committee.
      2.1.1 Establishment of the JDC . The Parties will establish a joint development committee (the “ JDC ”), which will oversee the development of Licensed Products under this Agreement. Each Party will appoint two employees to serve as their 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 2, the JDC will establish its own procedural rules for its operation.
 
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           2.1.2 Tasks of the JDC . The JDC will: (a) determine indications to be pursued in the development of each Licensed Product in addition to the indications set forth in the applicable Development Plan; (b) review and approve any updates or amendments to each Research Plan and Development Plan proposed by the JPT; (c) review the product lifecycle plans of the Parties for Licensed Products, including indication and label expansions, new dosage forms, and new formulations or delivery systems; and (d) take such other actions as are expressly delegated to the JDC in this Agreement.
           2.1.3 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 12) to attend any meeting of the JDC. Each meeting of the JDC will include at least one representative from each Party.
           2.1.4 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.
           2.1.5 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 of the Parties who will use good faith efforts to resolve such matter. If such officers fail to resolve such matter, then: (a) if such matter is primarily related to the development of Licensed Product in the Territory or the development of a Commercial Process, the Chief Executive Officer of [***] will finally decide the issue; and (b) if such matter is primarily related to the development of Licensed Product outside the Territory, the Chief Executive Officer of [***] will finally decide the issue.
                (c)  Notwithstanding the provisions in this Section 2.1.5 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 20.4.
 
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                (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 Licensed Product .
      2.2 Joint Project Team .
           2.2.1 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.
           2.2.2 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.
           2.2.3 Development Plan . The initial Development Plan for MT103 is attached as Exhibit E. The JPT will prepare and update each Development Plan for approval by the JDC from time to time, but in any case at least semi-annually.
           2.2.4 Reporting . Within 30 days 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 each Development Plan 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. Development of Licensed Products
      3.1 Technology Transfer .
           3.1.1 As further specified in the applicable Development Plan, Micromet will transfer to MedImmune: (a) the manufacturing process for MT103 as it exists on the Effective Date in [***] scale, including the analytical methods relating to MT103; and (b) certain material information relating to MT103, including preclinical and clinical analytical assays, preclinical and clinical data, and copies of any regulatory filings. MedImmune will reimburse Micromet for any reasonable and documented out-of-pocket expenses (including payments made to Micromet’s consultants and independent contractors) incurred by Micromet to a Third Party in connection with the technology transfer described in this Section 3.1.1 to the extent that Micromet is requested by MedImmune in writing to incur such expenses.
           3.1.2 During the Term on a periodic basis, Micromet will transfer to MedImmune Know-How that is Licensed Technology known to Micromet and that is useful with
 
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respect to the research, development, or production of a Licensed Product or Commercial Process being developed by MedImmune pursuant to a Development Plan. Micromet will effect the above technology transfer in accordance with procedures agreed upon by the JDC. MedImmune will reimburse Micromet for any reasonable and documented out-of-pocket expenses (including payments made to Micromet’s consultants and independent contractors) incurred by Micromet to a Third Party in connection with the technology transfer described in this Section 3.1.2 to the extent that Micromet is requested by MedImmune in writing to incur such expenses.
           3.1.3 For the avoidance of doubt, Micromet will not have any obligation under this Agreement to disclose or transfer any Know-How relating to the creation or characterization of BiTE Molecules, including protein engineering, the selection or determination of the amino acid sequence of proteins relevant for the function of BiTE Molecules, except as necessary to perform development of a Licensed Product under a Development Plan or Research Plan.
           3.1.4 During the Term on a periodic basis, MedImmune will transfer to Micromet Know-How that is MedImmune Collaboration Technology or Joint Collaboration Technology known to MedImmune and that is useful with respect to the research, development, or production of a Licensed Product being developed by Micromet pursuant to a Development Plan. MedImmune will effect the above technology transfer in accordance with procedures agreed upon by the JDC. Micromet will reimburse MedImmune for any reasonable and documented out-of-pocket expenses (including payments made to MedImmune’s consultants and independent contractors) incurred by MedImmune to a Third Party in connection with the technology transfer described in this Section 3.1.4 to the extent that MedImmune is requested by Micromet in writing to incur such expenses.
      3.2 Clinical Development Responsibilities; Development Costs .
           3.2.1 Responsibilities of MedImmune . As set forth in greater detail in each Development Plan, MedImmune will have the responsibility for (a) performing any Development Activities necessary to enable the filing of a BLA and, if applicable, the MAAs in the indications set forth in such Development Plan in the Territory, and (b) filing and prosecuting such BLA and, if applicable, MAAs through the grant of Marketing Approval for Licensed Products in the Territory. MedImmune will not conduct any clinical trial for Licensed Products outside the Territory without Micromet’s express prior written consent.
           3.2.2 Responsibilities of Micromet . As set forth in greater detail in each Development Plan, Micromet or its designees may perform in its discretion and at its own cost any Development Activities in addition to those performed by MedImmune pursuant to Section 3.2.1 above as may be necessary to obtain Marketing Approval for Licensed Product in the European Union or any other countries or territories outside the Territory. Micromet will not conduct any clinical trial for Licensed Product in the Territory without MedImmune’s express prior written consent, or as otherwise expressly permitted under this Agreement.
           3.2.3 Approval of Clinical Trials . Each Party will submit to the JDC the details of each proposed clinical study conducted for Licensed Product at least 60 days prior to the proposed initiation date of such study. Neither Party will initiate any clinical trial for

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Licensed Product without the JDC’s express prior written authorization, which authorization will not be withheld unreasonably or delayed unreasonably.
           3.2.4 Development Costs .
                (a)  With respect to the costs and expenses incurred by [***] in the performance of Development Activities relating to any [***] and [***] that are ongoing as of the Effective Date and that are necessary to support [***] for [***] (as determined by the JDC), [***] will bear [***]% of such costs and expenses incurred after the Effective Date for any such Development Activities pursuant to the Development Plan for MT103.
                (b)  [***] will bear [***]% of the costs and expenses of any [***] that are necessary to support [***] for [***] (as determined by the JDC) and that are initiated after the Effective Date pursuant to the Development Plan for MT103.
                (c)  With respect to the costs and expenses incurred by [***] after the Effective Date, but prior to [***] for [***], in the performance of Development Activities relating to any clinical studies for MT103, [***] will bear [***]% of such costs and expenses up to a maximum reimbursement of US$[***]; provided, however, that any amounts paid to [***] under this Section 3.2.4(c) will be [***] upon [***] of an [***] for a Licensed Product in the Territory.
                (d)  After the [***] for a Licensed Product, [***] will bear any costs incurred by [***] in connection with its performance of Development Activities provided for in the applicable Development Plan; provided, however, that any costs and expenses incurred by the Parties in connection with a clinical trial for Licensed Product that, pursuant to a Development Plan, is conducted jointly by both Parties will be shared by the Parties as follows: [***]% by MedImmune and [***]% by Micromet.
                (e)  Each Party will make any payments due to the other Party under this Section 3.2.4 [***] based on an invoice and supporting documentation submitted by such other Party.
           3.2.5 Progress Reports and Exchange of Information .
                (a)  The Parties will continuously inform each other of their Development Activities through their interactions in the JPT and through progress reports submitted to the JDC. Upon request of a Party, the other Party will provide the requesting Party copies of clinical trial protocols, preliminary reports and final reports of any clinical studies performed by it, and any other information or data reasonably requested by the other Party.
                (b)  Each Party hereby grants to the other Party (the “ Passive Party ”) the right to use and reference any non-clinical and clinical data (including raw data, safety data, and efficacy data), clinical trial protocols, INDs, BLAs, MAAs and other regulatory filings, any Marketing Approvals for Licensed Product, and any correspondence with any regulatory
 
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authorities relating to any Licensed Product, generated, developed or received by or on behalf of the granting Party in the course of the performance of this Agreement, in each case, for the development of Licensed Product and the filing and prosecution of any INDs, BLAs, and MAAs, and the maintenance of any Marketing Approvals and other regulatory approvals of Licensed Product by the Passive Party in the Territory (if MedImmune is the Passive Party) or outside the Territory (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 Licensed Product, then such Party will notify the Passive Party of such meeting or visit and such Passive Party will have the right to have two representatives of such Passive Party present at such meeting or visit, provided that such representatives remain silent observers 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 3.2.5(b).
                (c)  Prior to the compilation of a final report for any clinical trial performed pursuant to any Development Plan, the Party conducting such clinical trial will provide the Passive Party with any data (including raw data, safety data, and efficacy data) resulting from such trial. The Passive Party may review such data and make recommendations to the other Party regarding such data (including, by way of example, the accuracy, presentation, or interpretation thereof). The Party compiling the final report will reasonably consider and incorporate the comments provided by a Passive Party under this Section 3.2.5(c).
           3.2.6 Diligence in the United States .
                (a)  MedImmune, itself or through one or more Third Parties, will use its Commercially Reasonable Efforts to develop the Lead Product for approval and sale in the United States, and to develop the Lead Product Process. 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 United States), will be considered efforts of MedImmune for the purpose of determining MedImmune’s compliance with its obligations under this Section 3.2.6.
                (b)  MedImmune will be deemed to have met its obligations under Section 3.2.6(a) with respect to the Lead Product during such time as MedImmune is performing the Development Activities with respect to the development of the Lead Product and Lead Product Process for approval and sale in the United States set forth in the initial Development Plan for such Lead Product, as may be amended by unanimous consent of the JDC.
                (c)  MedImmune will be deemed to have met its obligations under Section 3.2.6(a):

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                     (i)  for [***], if MedImmune has spent US$[***] in such year on Development Activities with respect to the development of the Lead Product and Lead Product Process;
                     (ii)  for each of [***], if MedImmune has spent US$[***] during each such calendar year on Development Activities with respect to the development of the Lead Product and Lead Product Process;
                     (iii)  for each [***], if MedImmune has spent US$[***] in such calendar year on Development Activities with respect to the development of the Lead Product and Lead Product Process;
                     (iv)  even if MedImmune has not met its minimum spending obligations set forth in subsections (i) through (iii) above in a particular calendar year:
                          (1)  if [***] it has spent US$[***] in [***] on Development Activities with respect to the development of the Lead Product and Lead Product Process;
                          (2)  if [***] it has spent US$[***] in [***] on Development Activities with respect to the development of the Lead Product and Lead Product Process;
                          (3)  if [***] it has spent US$[***] in [***] on Development Activities with respect to the development of the Lead Product and Lead Product Process;
                          (4)  if at the [***] year thereafter up to the calendar year of the first Marketing Approval for the Lead Product in the US, it has spent US$[***] in [***] and the [***] on Development Activities with respect to the development of the Lead Product and Lead Product Process.
                (d)  If Micromet determines that MedImmune has failed to meet its obligations under Section 3.2.6(a) with respect to the Lead Product and, in addition, MedImmune is not deemed to have met such obligations pursuant to Section 3.2.6(b) or 3.2.6(c), then, as the sole and exclusive remedy for such failure, Micromet will have the right to terminate in the entirety the licenses granted to MedImmune under this Agreement pursuant to Section 15.2.1.
           3.2.7 Diligence in [***].
                (a)  After a Licensed Product receives Marketing Approval in [***], MedImmune will submit to the JDC a Development Plan for developing such Licensed Product for sale in [***]. Following approval of such Development Plan by the JDC pursuant to Section 2.1.2 above, MedImmune will use its Commercially Reasonable Efforts to perform the Development Activities set forth in each such Development Plan and to file for Marketing
 
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Approval with respect to such Licensed Product in [***]. All efforts of MedImmune’s Affiliates and sublicensees will be considered efforts of MedImmune for the purpose of determining MedImmune’s compliance with its obligations under this Section 3.2.7. If MedImmune fails to submit such a plan for [***] or, if such a plan is submitted and approved, and MedImmune fails to undertake such activities and file for Marketing Approval as provided in the preceding sentence, then, as its sole and exclusive remedy for such failure, Micromet may terminate MedImmune’s licenses as provided in Section 15.2 with respect to each such country with respect to which a plan is not submitted or not executed, as applicable.
                (b)  Notwithstanding Section 3.2.7(a) above, MedImmune may at any time after first commercial sale of Licensed Product in [***] provide written notice to Micromet that Commercialization of Licensed Product in either or both of [***] will have a material adverse effect on [***] that can be generated with Licensed Product [***]. Any such notice will include copies of marketing studies and other materials on which MedImmune’s conclusion of such adverse effects are based. Promptly after receipt of such notice and materials from MedImmune, the Parties will meet to discuss MedImmune’s conclusion.
                (c)  If the Parties agree that MedImmune should not [***], then MedImmune will be under no obligation under this Agreement to develop, obtain Marketing Approval for, or sell Licensed Product [***]. MedImmune will provide Micromet with an annual update, in writing, on the reasons for continuing the delay of the launch of such Licensed Product [***].
                (d)  If Micromet disagrees with MedImmune’s initial assessment or any annual update thereof that the sale of Licensed Product [***] will have a material adverse effect on [***] that can be generated with such Licensed Product [***], Micromet will have the right to submit such dispute to arbitration in accordance with the provisions of Section 20.4. Micromet will not have the right to terminate MedImmune’s license [***] until there is a determination in an arbitration proceeding pursuant to Section 20.4 that the sale of Licensed Product [***], as the case may be, will not adversely affect [***] in the Territory as a whole.
      3.3 Process Development .
           3.3.1 Performance of Development Plan .
                (a)  As set forth in greater detail in the applicable Development Plan, MedImmune will develop the Lead Product Process. MedImmune will use the manufacturing process transferred to it by Micromet pursuant to Section 3.1 as the basis for the Lead Product Process. MedImmune will bear all costs and expenses associated with the development of the Lead Product Process.
                (b)  Micromet will assist MedImmune in the development of each Commercial Process being developed by MedImmune through Micromet’s participation in the JPT and by providing any other assistance reasonably requested by MedImmune. MedImmune will reimburse Micromet for any reasonable and documented out-of-pocket expenses and, based
 
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on the FTE Rate, for any FTEs performing Development Activities relating to a Commercial Process, but only to the extent requested by MedImmune. MedImmune will make any such payments to Micromet quarterly in arrears based on an invoice and supporting documentation submitted by Micromet.
           3.3.2 Progress Reports; Access . During the development of each Commercial Process being developed by MedImmune, MedImmune will keep Micromet informed through the JPT of MedImmune’s process development activities and progress on an on-going basis. Further, MedImmune will provide to Micromet, on a regular basis, any assay data, validation data, standard operating procedures, reagents and any other materials or protocols, in each case only as necessary for conducting any release assays relating to the detection, identification, and characterization of Licensed Product, that MedImmune has generated or used during the development of each such Commercial Process.
           3.3.3 Third Party Intellectual Property . Each Party will advise the other Party of Patents owned by a Third Party that are known to a Party and that may present an infringement risk with respect to Licensed Product or any Commercial Process that is being developed by MedImmune.
           3.3.4 Exchange of CMC Documentation . Upon completion of development of each Commercial Process, MedImmune will provide to Micromet, or at the discretion of MedImmune to the applicable regulatory agency, all necessary CMC documentation in the possession of MedImmune, its Affiliates or contractors and, as reasonably requested by Micromet, assistance with the presentation of such documentation to regulatory authorities outside the Territory, all as required for filing of an MAA relating to the manufacture of the applicable Licensed Product by means of such Commercial Process and Micromet will reimburse MedImmune at the FTE Rate for such assistance.
           3.3.5 Processes for other Licensed Products . Micromet understands and agrees that MedImmune is not obligated to develop a Commercial Process for any Licensed Product other than the Lead Product, except as set forth in Section 3.5.2. However, if MedImmune develops such a Commercial Process, Micromet will have the rights and obligations set forth in this Section 3.3 (excluding Section 3.3.1(a)) with respect to such Commercial Process.
      3.4 Restrictions on Development and Commercialization of Licensed Products .
           3.4.1 During the Term, Micromet will not itself or through any Third Party (whether through the grant of a license or otherwise) develop or Commercialize in the Territory any Licensed Product, 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 a Licensed Product outside the Territory.
           3.4.2 During the period commencing on the Effective Date and ending on the earlier of (a) the [***], and (b) any [***] executed by the Parties on the Effective Date (the
 
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[ *** ] ”), 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 the BiTE Agreement or a Licensed Product under this Agreement.
      3.5 Development of Replacement Products.
           3.5.1 Commencement . Subject to the terms and conditions of this Agreement, MedImmune may elect to commence development of a Replacement Product, as a follow-on product to the Lead Product, contemporaneously with the development or Commercialization of the Lead Product, or as a substitute for the then-current Lead Product. If MedImmune intends to commence development of a Replacement Product, then MedImmune will provide Micromet with written notice of such intention. Each such notice will identify the cell surface antigen of the proposed Replacement Product (i.e. [***]) and the desired specifications of the BiTE Molecule for the proposed Replacement Product.
           3.5.2 Substitution of Lead Product . If MedImmune elects to develop a Replacement Product as a substitute for the then-current Lead Product, such Replacement Product will be deemed the new Lead Product upon approval of a Research Plan for such product by the JDC, and MedImmune may discontinue development of the replaced Lead Product; provided, however, that if MT103 is replaced in this way, MedImmune will continue with the development of the Commercial Process for MT103 under the terms of this Agreement for so long as Micromet is continuing development of MT103 outside the Territory.
           3.5.3 Research Plan . Promptly after submission of an antigen for a proposed Replacement Product pursuant to Section 3.5.1, the JPT will prepare a plan for the construction of BiTE Molecules binding to such antigen, and the pre-clinical development of Replacement 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. 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 submit each Research Plan to the JDC for approval. Promptly after the JDC approves a Research Plan developed by the JPT, the JPT will meet to prepare a Development Plan for the applicable Replacement Product, as set forth in Section 2.2.2 of this Agreement. The JPT will update each Research Plan for approval by the JDC from time to time, but in any case at least semi-annually.
           3.5.4 Creation and Selection of BiTE Molecules . No later than [***] after the approval of each Research Plan by the JDC, Micromet will commence with the construction of BiTE Molecules, and will create 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 a Replacement Product
 
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for further development under the terms and conditions set forth in this Section 3. Micromet will not be obligated to initiate work under more than one Research Plan during any [***] period.
           3.5.5 Research and Development Costs .
                (a)  If MedImmune elects to develop a Replacement Product (i) as a substitute for the then-current Lead Product and Micromet is continuing development of a Licensed Product outside the Territory, or (ii) contemporaneously with the development or Commercialization of the Lead Product, then this Section 3.5.5(a) will govern the allocation of costs incurred by the Parties in connection with the performance of the Research Plan for such Replacement Product. MedImmune will bear the costs and expenses incurred by MedImmune in the performance of activities under such Research Plan. MedImmune will reimburse Micromet for any costs and expenses incurred by Micromet in the performance of any activities provided for in such Research Plan. 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. MedImmune will pay any costs and expenses incurred by Micromet in the performance of any activities provided for in the Research Plan [***] within [***] after receipt of a corresponding invoice from Micromet that estimates the costs and expenses for such quarter. Micromet will provide quarterly reports on its activities under such 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 to Micromet under this Section 3.5.5(a). 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 [***] days after receipt of such report. In any event, Sections 3.2.4(d) and (e) will govern the allocation of costs incurred by the Parties in connection with any Development Activities for Replacement Products.
                (b)  If MedImmune elects to develop a Replacement Product as a substitute for the then-current Lead Product and Micromet (i) has discontinued development of Licensed Product outside the Territory, and (ii) elects to participate in such development, then this Section 3.5.5(b) will govern the allocation of costs incurred by the Parties in connection with the performance of the Research Plan for such Replacement Product. The Parties will share the costs and expenses incurred by the Parties in the performance of activities under such Research Plan as follows: [***]% by MedImmune and [***]% by Micromet; provided, however, that if Micromet discontinues development of MT103 during the performance of a Research Plan for a
 
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new Lead Product, Micromet will only be obligated to share the costs and expenses incurred by the Parties after the date of such discontinuation. Each Party’s 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 a Party will be charged at [***]. In no event will a Party be obligated to make any payments to the other Party 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 a Party 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. Each Party will provide quarterly reports on its activities under such Research Plan and the costs and expenses for such activities and the Parties will make any payments due under this Section 3.5.5(b) in arrears based on such quarterly reports. In any event, Sections 3.2.4(d) and (e) will govern the allocation of costs incurred by the Parties in connection with any Development Activities for Replacement Products. If Micromet does not elect to participate in the development of a Replacement Product under this Section 3.5.5(b), then Micromet will not itself or through any Third Party (through a license or otherwise) develop or Commercialize such Replacement Product outside the Territory, except pursuant to Section 3.5.5(d).
                (c)  If Micromet has constructed a BiTE Molecule as a Replacement Product and selected such BiTE Molecule for further development in a pre-clinical development program, and such selection is contemporaneous with the development or Commercialization of the Lead Product under this Agreement, then Micromet will provide MedImmune with written notice of such selection.
                     (i)  If MedImmune elects to participate in the development of such Replacement Product and MedImmune informs Micromet in writing of such election within [***] after receipt by MedImmune of Micromet’s notice of selection, then (a) the provisions of Section 3.5.5(b) will govern the allocation of costs incurred by the Parties in connection with the performance of the Research Plan for such Replacement Product, and (b) Sections 3.2.4(d) and (e) will govern the allocation of further costs.
                     (ii)  If MedImmune does not elect to participate in the development of such Replacement Product within such [***] period, or if MedImmune informs Micromet that it declines to participate in such development, then (a) notwithstanding anything in this Agreement, MedImmune will not itself or through any Third Party (through a license or otherwise) develop or Commercialize such Replacement Product inside the Territory, except pursuant to Section 3.5.5(d), (b) Micromet may continue development of such product [***], (c) MedImmune will have no obligations whatsoever with respect to the development or Commercialization of such product, and (d) during the Term, Micromet will not develop or Commercialize such product in the Territory.
 
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                     (d)  If a Party that has not elected to participate in the development of a Replacement Product pursuant to Section 3.5.5(b) (in the case of Micromet) or Section 3.5.5(c)(ii) (in the case of MedImmune), and such Party desires to commence such participation, such Party may provide written notice of such desire to the other Party at any time. Upon receipt of such notice, the Parties will meet to discuss and negotiate in good faith the commercial terms upon which the non-participating Party will commence such participation.
           3.5.6 Discontinuation . MedImmune will have the right to terminate research with respect to Replacement Products and the activities under a Research Plan with respect thereto by 3 months prior written notice to Micromet, and after the expiration of such 3-month period, MedImmune will no longer be obligated for costs and expenses incurred by Micromet with respect to such Replacement Products. 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.
      3.6 Consequences of Substitution of MT103.
           3.6.1 If MedImmune elects to discontinue development of MT103 and develop a Replacement Product as the new Lead Product, and if Micromet obtains Marketing Approval for MT103 in Europe prior to the [***], Micromet will have the right, notwithstanding anything in this Agreement to the contrary (including, without limitation, MedImmune’s exclusive right to market Licensed Products in the Territory), to develop MT103, file a BLA and MAAs, and obtain Marketing Approval for MT103 in the Territory.
           3.6.2 MedImmune will have the right to reacquire the license to Commercialize MT103 in the Territory by providing written notice thereof to Micromet within [***] after receiving written notice from Micromet that it has obtained Marketing Approval of MT103 in the US, and by paying with such notice any milestone payments set forth in Section 10.2 that have not already been paid with respect to a new Lead Product. Within [***] after exercising such right, MedImmune will pay to Micromet [***]% of the amount corresponding to [***]% of any [***] with respect to MT103 after the date that MedImmune has discontinued the development of MT103. MedImmune will pay the remaining [***]% of such [***] either (a) as a lump sum payment on the first anniversary of the date on which MedImmune has provided notice under this Section 3.6.2, or (b) in the form of a royalty of [***]% on Net Sales of MT103 in the Territory by MedImmune, its Affiliates or their sublicensees in addition to the royalties payable pursuant to Section 10.4.1; provided, however, that any remaining amounts due to Micromet will bear interest of [***]% per annum compounded annually until the payment has been made in full; and provided, further, that any amounts remaining unpaid will be due and payable with the last royalty payment due for MT103 under this Agreement.
           3.6.3 If MedImmune does not provide any notice within the [***] period set forth in Section 3.6.1, or provides notice that it declines to exercise its right to reacquire the
 
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license to Commercialize MT103 in the Territory, Micromet will be free to Commercialize MT103 in the Territory alone or with or through a Third Party.
4. Supply of Licensed Product
      4.1 Clinical Supply of Licensed Product . As provided in this Section 4, 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 clinical trials to be performed pursuant to each Development Plan.
      4.2 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 [***] for such Clinical Trial Materials. If Micromet orders such Clinical Trial Material for use in Pivotal Trials, then MedImmune will manufacture any such Clinical Trial Material 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 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 Licensed Product with its respective requirements of such Clinical Trial Materials at [***] for such Clinical Trial Material, 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.
      4.3 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 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,
 
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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.
      4.4 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.
      4.5 Invoice and Payment . MedImmune will enclose an invoice with each shipment of Clinical Trial Materials made pursuant to this Section 4 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 4, 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.
      4.6 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 4.3 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 (the “ Product Warranties” ).
      4.7 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
 
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(including, but not limited to, quality control tests) relating to the production of the Clinical Trial Materials in question or the Rejection Notice.
      4.8 Disputes Regarding Clinical Trial Materials .
           4.8.1 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 4.8.
           4.8.2 If the Clinical Trial Materials are alleged not to conform with the Product Warranties set forth in Section 4.6(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.
           4.8.3 If the Clinical Trial Materials are alleged not to conform with the Product Warranties set forth in Section 4.6(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 the Judicial Arbitration and Mediation Services (“ JAMS ”), will determine whether the Clinical Trial Materials were non-conforming with the Product Warranties set forth in Section 4.6(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.
      4.9 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 4.8, 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.
      4.10 Audits and Inspections .
           4.10.1 A delegation consisting of representatives of Micromet and its licensees that are to be supplied Licensed Product 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

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Commercial Process is implemented, and the documentation generated in connection with the manufacture and testing of Licensed Product; 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 Licensed Product are manufactured fail to comply with Applicable Law in such a manner as may affect the supply of Licensed Product hereunder. Such inspections will take place during regular business hours 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.
           4.10.2 A representative of Micromet and its licensees that are to be supplied Licensed Product by MedImmune under this Agreement will have the right to be present as a silent observer at any announced visits to MedImmune by any regulatory authority relating to the manufacture of Licensed Product. 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 Licensed Product. 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 4.10 in accordance with the provisions of Section 12 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.
      4.11 Commercial Supply of Licensed Product .
           4.11.1 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 Licensed Product in bulk form (i.e. filled vials, unlabelled and unpackaged) for use and sale outside the Territory. If MedImmune elects to undertake the supply of Licensed Product to Micromet or its licensees, then the Parties will enter in

 
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