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EX-10.42 25 w31794exv10w42.htm EX-10.42 exv10w42
Exhibit 10.42
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
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.
1.14 Development 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 Micromets 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.
1.29 Lead 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.
1.30 Lead 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 Micromets 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.
1.39 MT103 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 Partys Patents that claim the composition, use, or manufacture of Licensed Product, or (b) any of such Third Partys 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 Micromets 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 Partys 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 Micromets 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 Micromets 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 MedImmunes 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 Micromets 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 MedImmunes 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 JDCs 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 Partys 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 MedImmunes Affiliates and sublicensees, together with any efforts of Micromet performed under a Development Plan (to the extent applicable to MedImmunes development efforts for the United States), will be considered efforts of MedImmune for the purpose of determining MedImmunes 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 MedImmunes Affiliates and sublicensees will be considered efforts of MedImmune for the purpose of determining MedImmunes 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 MedImmunes 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 MedImmunes conclusion of such adverse effects are based. Promptly after receipt of such notice and materials from MedImmune, the Parties will meet to discuss MedImmunes 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 MedImmunes 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 MedImmunes 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 Micromets 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 MedImmunes 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 Micromets 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 Micromets 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 Partys 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 Micromets 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, MedImmunes 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 Micromets 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 Micromets 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 Micromets 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) MedImmunes 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 MedImmunes 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 arbitrators 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 into a supply agreement setting forth the terms and conditions of the manufacture and supply (the Commercial Supply Agreement).
4.11.2 Supply Price; Royalty.
(a) Each Commercial Supply Agreement will provide that the supply price of Licensed Product intended for commercial sale outside the Territory will be [***]% of the [***] so long as such amount exceeds [***]% of [***] of Micromet or its licensees outside the Territory. If [***]% of [***] is less than or equal to [***]% of [***], then the supply price will be the lesser of [***]% of [***] or [***]% of [***] of Micromet or its licensees outside the Territory.
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(b) If MedImmune has transferred a Commercial Process pursuant to Section 5 below and Micromet obtains Licensed Product for commercial sale either by manufacturing Licensed Product itself or by engaging a Third Party for the manufacture and supply of Licensed Product for commercial sale using the Commercial Process transferred by MedImmune, without material changes thereto, then Micromet will pay MedImmune a royalty of [***]% of Net Sales of such Licensed Product by Micromet, its Affiliates or licensees. At the time when the total royalty payments by Micromet to MedImmune under this Section 4.11.2(b) equal [***], plus an interest charge of [***]% per annum on the unpaid principal, the royalty rate will be adjusted as set forth in Exhibit F.
(c) Notwithstanding the provisions of Section 4.11.2(b) above, Micromet will have no obligation to pay royalties on Net Sales in Japan if the Commercial Process transferred to Micromet by MedImmune, at the time of such transfer, is not compliant with Japanese cGMP and Applicable Law.
5. Transfer of Manufacturing Process
5.1 Transfer Triggers. In accordance with Section 5.2 and upon 60 days advance written notice to MedImmune, MedImmune will transfer to Micromet the then-current Commercial Process: (1) if MedImmune does not desire to supply Licensed Product to Micromet; or (2) upon request of Micromet. In each case, the Party whose decision triggers the transfer will provide the other Party with written notice at least 60 days before such transfer. MedImmune cannot provide notice under this Section 5.1 until such time as it has completed the development of the applicable Commercial Process. Except upon termination of all the licenses granted to MedImmune, Micromet cannot provide notice under this Section 5.1 before MedImmune has completed the development of the applicable Commercial Process if and for so long as MedImmune is developing such Commercial Process as set forth in the applicable Development Plan unanimously approved by the JDC. Micromet will pay MedImmune: (a) upon process transfer at Micromets request, a technology transfer fee equal to the amount of any reasonable and documented expenses at the FTE Rate as well as any reasonable and documented out-of-pocket expenses incurred by MedImmune in the course of effecting such process transfer, or (b) upon process transfer for any other reason under this Section 5.1, a technology transfer fee equal to the amount of any reasonable and documented out-of-pocket expenses incurred by MedImmune in the course of effecting such process transfer. For the avoidance of doubt, no payment shall be due under the preceding sentence if the transfer results from a termination of the licenses granted to MedImmune in the entirety pursuant to Section 15.2.
5.2 Manufacture During Process Transfer. During any transfer of Commercial Process made pursuant to Section 5.1 above and until such time as Micromet or a contract manufacturer designated by Micromet has established and validated such Commercial Process and is approved to manufacture commercial supplies of the applicable Licensed Product (but in no event longer than [***] after the applicable triggering event described in Section 5.1 above), MedImmune will continue to supply such Licensed Product to Micromet at [***] for Clinical Trial Materials, and at the supply price set forth in Section 4.11.2 pursuant to the Commercial
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Supply Agreement. Except as provided in this Section 5.2, upon receipt of the written notice pursuant to Section 5.1, MedImmune will no longer have an obligation to manufacture such Licensed Product for Micromet.
5.3 Technology Transfer. As part of any Commercial Process transfer made pursuant to this Section 5, MedImmune will provide Micromet with technical reports and materials for process development activities completed at the time of such transfer that are relevant to and would be required to perform such Commercial Process as performed by MedImmune at such time and for regulatory filings (including but not limited to any master cell banks, working cell banks, fermentation processes, recovery steps established, process validation, product identity assays, in-process-control assays, relevant standard operating procedures, blueprints of facilities, information regarding equipment and the layout thereof, etc.), as well as samples of the working cell bank prepared at MedImmune, and technical methods for assays required for the applicable process. At the option of MedImmune in lieu of providing Micromet with recipes for the cell culture media and nutrient feeds used in the applicable process, MedImmune itself or though a Third Party may provide Micromet at cost with such cell culture media and nutrient feeds. Micromet will not, directly or indirectly, take any steps to ascertain the recipe of any such cell culture media or nutrient feeds provided by MedImmune. MedImmune will provide to Micromet, or at the discretion of MedImmune to the applicable regulatory agencies, all necessary CMC documentation relating to such cell culture media and nutrient feeds required for regulatory filings for the applicable Licensed Product.
5.4 Subsequent Process Transfer by Micromet. To the extent that Micromet has rights under this Agreement to use a Commercial Process, Micromet will have the right to use a Third Party to manufacture Licensed Product by means of a Commercial Process transferred to Micromet pursuant to this Section 5 and to transfer to such Third Party the Know-How transferred to Micromet by MedImmune in connection with the transfer of such Commercial Process; provided, however, that such Third Party enters into a confidentiality agreement with MedImmune containing confidentiality and non-use obligations substantially similar to those set forth in this Agreement with respect to Confidential Information of MedImmune. Except as provided in this Section 5.4, Micromet will not transfer such Know-How to any Third Party.
6. Commercialization
6.1 Principles of Commercialization. As between the Parties, MedImmune has the sole right to Commercialize Licensed Product in the Territory during the Term, except as otherwise expressly set forth in Section 3.6. As between the Parties, Micromet has the sole right to Commercialize Licensed Product outside the Territory during the Term.
6.2 Regulatory Obligations. MedImmune will be solely responsible for all activities in connection with maintaining Marketing Approvals and other regulatory approvals for the marketing and manufacture of Licensed Product in the Territory, including communicating and preparing and filing all reports (including without limitation adverse drug experience reports) with the FDA. Micromet will have the sole right to conduct activities in connection with maintaining Marketing Approvals and other regulatory approvals for the manufacture of Licensed Product outside the Territory, including communicating and preparing and filing all
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reports (including without limitation adverse drug experience reports) with the applicable regulatory authorities.
6.3 Diligence.
6.3.1 MedImmune will use Commercially Reasonable Efforts to Commercialize Licensed Product in each country of the Territory in which MedImmune receives Marketing Approval therefor.
6.3.2 If Micromet determines that MedImmune is not Commercializing Licensed Product as required under Section 6.3.1 in a particular country in the Territory, then, as the sole and exclusive remedy for such failure, Micromet will have the right to terminate all the licenses granted to MedImmune under this Agreement with respect to such Licensed Product in such country pursuant to Section 15.2.
6.4 Adverse Drug Experiences. To the extent either Party receives any information regarding adverse drug experiences related to the use of Licensed Product, such Party will promptly provide the other Party with such information as is required under Applicable Laws. Prior to the first commercial launch of Licensed Product by either Party, the Parties will agree on standard operating procedures implementing the requirements under Applicable Laws regarding adverse event reporting, which procedures, as may be amended from time to time upon mutual agreement of the Parties, will be incorporated in this Agreement by reference.
6.5 Branding, Trademarks, Trade Dress, and Logos.
6.5.1 MedImmune will have sole responsibility for all trademarks, trade dress, logos, slogans, and designs used on and in connection with Licensed Product in the Territory. MedImmune will be the sole owner of all trademarks, trade dress, logos, slogans, designs and copyrights developed for or used on or in connection with the marketing and sale of Licensed Product in the Territory. MedImmune will select the trademark used to identify Licensed Product that will be sold in the Territory pursuant to this Agreement. MedImmune will oversee the filing, prosecution and maintenance of all trademark registrations for Licensed Product in the Territory. MedImmune will be responsible for the payment of any and all costs relating to filing, prosecution, and maintenance of the trademarks for Licensed Product in the Territory.
6.5.2 Micromet will have sole responsibility for all trademarks, trade dress, logos, slogans, and designs used on and in connection with Licensed Product outside the Territory. Micromet will be the sole owner of all trademarks, trade dress, logos, slogans, designs and copyrights developed for or used on or in connection with the marketing and sale of Licensed Product outside the Territory. Micromet will select the trademark used to identify Licensed Product that will be sold outside the Territory pursuant to this Agreement. Micromet will oversee the filing, prosecution and maintenance of all trademark registrations for Licensed Product outside the Territory. Micromet will be responsible for the payment of any and all costs relating to filing, prosecution, and maintenance of the trademarks for Licensed Product outside the Territory.
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7. | Ownership of Intellectual Property; Acquisition of Third Party Intellectual Property |
7.1 Ownership by Micromet. Micromet will own all right, title, and interest in and to the Independent Micromet Technology and Micromet Collaboration Technology, subject only to the licenses granted to MedImmune in this Agreement. Micromet will promptly disclose to MedImmune in writing, and will cause its Affiliates, agents and independent contractors to so disclose to Micromet, the development, making, conception or reduction to practice of any Patents within Micromet Collaboration Technology.
7.2 Ownership by MedImmune. MedImmune will own all right, title, and interest in and to any Independent MedImmune Technology, MedImmune Process Technology and MedImmune Collaboration Technology, subject only to the licenses granted to Micromet in this Agreement. MedImmune will promptly disclose to Micromet in writing, and will cause its Affiliates, agents and independent contractors to disclose to MedImmune, the development, making, conception or reduction to practice of any Patents within MedImmune Collaboration Technology.
7.3 Joint Ownership. Micromet and MedImmune will each own an undivided 50% interest in any Joint Collaboration Technology, without obligation to account to the other for the exploitation thereof or to seek consent of the other for the grant of any licenses under or the enforcement of Joint Collaboration Technology, in each case subject to the licenses granted in this Agreement. Each Party will promptly disclose to the other Party in writing, and will cause its Affiliates, agents and independent contractors to so disclose to it, the development, making, conception or reduction to practice of any Joint Collaboration Technology.
7.4 Further Acts. Each Party will take all necessary and proper acts, and will cause its employees, Affiliates, contractors, and consultants to take such necessary and proper acts, to effectuate the ownership provisions provided in this Section 7.
7.5 Third Party Technology.
7.5.1 Consent.
(a) After the Effective Date, if a Party intends to negotiate a Technology Acquisition Agreement that would be applicable to Licensed Product, such Party will keep the other Party advised of such negotiation. It is expressly understood that the Party negotiating the Technology Acquisition Agreement will make the final determination as to the terms thereof and whether or not to enter into such Technology Acquisition Agreement, and the other Party will not interfere with such negotiation or the ability of the Party to enter into such Technology Acquisition Agreement.
(b) Subject to Section 7.5.1(c) below, the Party negotiating the Technology Acquisition Agreement will use reasonable efforts to secure a license that is sublicensable to the other Party on the same terms and conditions applicable to the negotiating Party.
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(c) Notwithstanding the provisions of Section 7.5.1(b), any Technology Acquisition Agreement entered into by MedImmune with respect to any Commercial Process for a Lead Product will include the right of MedImmune to grant Micromet a sublicense to MedImmunes rights and licenses under such Technology Acquisition Agreement.
(d) Promptly upon execution by a Party of any Technology Acquisition Agreement under which the other Party receives a sublicense under this Agreement, the Party that executed such Technology Acquisition Agreement will provide to the other Party a complete copy of such Technology Acquisition Agreement.
7.5.2 Terms and Maintenance. Each Party hereby covenants and agrees that: (i) it will not consent to any amendment or modification or termination of any Technology Acquisition Agreement that would adversely affect the licenses granted to the other Party hereunder without the written permission of such other Party; (ii) it will perform its contractual obligations to keep any Technology Acquisition Agreement in full force and effect during the respective terms thereof; (iii) it will not assign any Technology Acquisition Agreement without the written consent of the other Party (which consent will not be unreasonably withheld), except that such consent will not be required for assignment in connection with the transfer or sale of all or substantially all of its business, or in the event of its merger, consolidation, change in control or similar transaction, (x) provided that such assignment is subject to this Agreement and (y) such assignment does not adversely affect the Technology Acquisition Agreement or either Partys rights thereunder; and (iv) it will promptly advise the other Party of any notice of a breach or intent to terminate any Technology Acquisition Agreement that is received, and to the extent permitted under the Technology Acquisition Agreement, such other Party will have the right but not the obligation to cure any such breach. Notwithstanding the foregoing, MedImmunes obligations under this Section 7.5.2 only apply to Technology Acquisition Agreements that affect the Lead Product or the Lead Product Process.
7.5.3 Technology Acquisition Payments.
(a) MedImmune will be responsible for and will make any Technology Acquisition Payments arising in connection with the development or Commercialization of Licensed Product in the Territory under its own Technology Acquisition Agreements and under any Technology Acquisition Agreements of Micromet existing as of the Effective Date pursuant to which Licensed Technology is licensed to MedImmune under this Agreement; provided, however, that MedImmune may deduct a portion of these Technology Acquisition Payments paid by MedImmune from royalties payable to Micromet under this Agreement, as set forth in Section 10.4.3(b). Each such Technology Acquisition Payment under a Micromet Technology Acquisition Agreement will be due and payable as set forth in the applicable Technology Acquisition Agreement and shall be paid by MedImmune to Micromet.
(b) Micromet will be responsible for and will make any Technology Acquisition Payments arising in connection with the development or Commercialization of Licensed Product outside the Territory under its own Technology Acquisition Agreements and under any Technology Acquisition Agreements of MedImmune under which Micromet holds a license under this Agreement. Each such Technology Acquisition Payment under a MedImmune
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Technology Acquisition Agreement will be due and payable as set forth in the applicable Technology Acquisition Agreement and shall be paid by Micromet to MedImmune.
(c) Each Party has the right to notify the other Party that such Party terminates such Partys license under one or more of the other Partys Technology Acquisition Agreements, in which case such license will be terminated thereunder and the notifying Party will no longer be obligated to make payments thereunder.
8. License Grants
8.1 Licenses granted by Micromet.
8.1.1 Subject to the terms and conditions set forth in this Agreement, Micromet hereby grants to MedImmune an exclusive (exclusive even as to Micromet), royalty-bearing right and license under the Licensed Technology, to make, have made, use, offer for sale, sell, and import Licensed Product in the Territory for any use in humans.
8.1.2 MedImmune hereby covenants and agrees not to use any confidential Know-How that is Independent Micromet Technology or Micromet Collaboration Technology, nor grant any Third Party any license or right under confidential Know-How that is Independent Micromet Technology or Micromet Collaboration Technology, to develop or Commercialize any product other than Licensed Product in the Territory without Micromets written consent, and not otherwise to use or practice the confidential Know-How that is Independent Micromet Technology or Micromet Collaboration Technology except as expressly permitted by this Agreement.
8.1.3 MedImmune will have the right to grant sublicenses under the licenses granted in Section 8.1.1, provided that each such sublicense grant will be made subject to the terms of this Agreement. If a sublicensee of MedImmune commits any act or omission relating to (a) Micromets Confidential Information disclosed by MedImmune to such sublicensee, (b) the practice of the sublicense granted by MedImmune under the licenses granted to it in this Agreement to such sublicensee outside the limited geographic and product-related scope thereof, or (d) the misappropriation of Micromets confidential Know-How, which act or omission, if committed by MedImmune, would constitute a material breach of this Agreement, then MedImmune will, upon request of Micromet, terminate the sublicense agreement with such sublicensee. Promptly upon execution of each agreement under which MedImmune grants a sublicense under the licenses granted by Micromet to MedImmune under this Agreement, MedImmune will provide to Micromet a complete copy of such sublicense agreement, except that financial terms may be redacted.
8.2 Licenses granted by MedImmune.
8.2.1 Subject to the terms and conditions set forth in this Agreement and subject to the payment obligations of Section 7.5.3, MedImmune hereby grants to Micromet an exclusive (even as to MedImmune), royalty-free, right and license, with the right to grant and authorize the grant of sublicenses, under the Independent MedImmune Technology, MedImmunes rights and interest in the Joint Collaboration Technology, and the MedImmune Collaboration Technology to use, offer for sale, sell, and import outside the Territory Licensed Products developed by
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MedImmune pursuant to any Development Plan for any use in humans. MedImmune understands and agrees that, under the license set forth in this Section 8.2.1, Micromet may use, offer for sale, sell, and import outside the Territory Licensed Product purchased from MedImmune hereunder for any use in humans.
8.2.2 Subject to the terms and conditions set forth in this Agreement, MedImmune hereby grants to Micromet a worldwide, co-exclusive (with MedImmune), royalty-free right and license, with the right to grant and authorize the grant of sublicenses, under MedImmunes rights and interest in the Joint Collaboration Technology and the MedImmune Collaboration Technology to make, have made, use, offer for sale, sell, and import any BiTE Product (other than Licensed Product or any BiTE Product as to which MedImmune is exclusively licensed under an agreement with Micromet) for any use in humans. The license set forth in this Section 8.2.2 is exclusive except as to MedImmune and its permitted licensees under Section 8.3 below.
8.2.3 Upon transfer of a Commercial Process to Micromet in accordance with Sections 5.1 and 5.2 of this Agreement and subject to the payment obligations of Section 4.11.2 and Section 7.5.3, MedImmune hereby grants to Micromet an exclusive (even as to MedImmune, but not as to sublicensees of Micromet that receive a direct license from MedImmune upon Micromets request pursuant to Section 8.2.5), royalty-bearing right and license, without the right to grant sublicenses, under Independent MedImmune Technology, MedImmunes rights and interest in the Joint Collaboration Technology, and the MedImmune Collaboration Technology to use such Commercial Process to make and have made the applicable Licensed Product for sale and use outside of the Territory.
8.2.4 Upon transfer of a Commercial Process to Micromet in accordance with Section 5 of this Agreement and subject to the payment obligations of Section 4.11.2 and Section 7.5.3, MedImmune hereby grants to Micromet an exclusive (even as to MedImmune but not as to sublicensees of Micromet that receive a direct license from MedImmune upon Micromets request pursuant to Section 8.2.5), royalty-bearing right and license, without the right to grant sublicenses, under MedImmune Process Technology to use such Commercial Process to make and have made the applicable Licensed Product for sale and use outside of the Territory.
8.2.5 In the event that Micromet grants a license outside the Territory to a Third Party for a Licensed Product, and Micromet has a license under this Section 8.2 to the applicable Commercial Process for such Licensed Product, then, upon request by Micromet, MedImmune will grant such Third Party a license under Independent MedImmune Technology, MedImmune Process Technology, MedImmunes right and interest in the Joint Technology, and the MedImmune Collaboration Technology to use such Commercial Process to make and have made the applicable Licensed Product for sale and use outside of the Territory. The commercial terms of each such license will be the same as the terms set forth in Sections 4.11.2 and 5, as applicable, and the remaining terms will be negotiated in good faith between MedImmune and such Third Party. In addition, MedImmune will transfer the Commercial Process to such Third Party pursuant to the terms, mutatis mutandis, of Section 5.
8.2.6 If a sublicensee of Micromet commits any act or omission relating to (a) MedImmunes Confidential Information disclosed by Micromet to such sublicensee, (b) the
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practice of the sublicense granted by Micromet under the licenses granted to it in this Agreement to such sublicensee outside the limited geographic and product-related scope thereof, or (c) the misappropriation of MedImmunes confidential Know-How, which act or omission, if committed by Micromet, would constitute a material breach of this Agreement, then Micromet will, upon request of MedImmune, terminate the sublicense agreement with such sublicensee. Promptly upon execution of each agreement under which Micromet grants a sublicense under the licenses granted by MedImmune to Micromet under this Agreement, Micromet will provide to MedImmune a complete copy of such sublicense agreement, except that financial terms may be redacted.
8.2.7 Micromet hereby covenants and agrees not to use any confidential Know-How that is Independent MedImmune Technology or MedImmune Collaboration Technology, nor grant any Third Party any license or right under confidential Know-How that Independent MedImmune Technology or MedImmune Collaboration Technology, to develop or Commercialize any product other than Licensed Product outside the Territory without MedImmunes written consent, and not otherwise to use or practice the confidential Know-How that is Independent MedImmune Technology or MedImmune Collaboration Technology except as expressly permitted by this Agreement.
8.3 Limitations On MedImmunes Ability to License. MedImmune hereby covenants and agrees that it will not license, assign or otherwise transfer to any Third Party any of its right and interest in and to the Joint Collaboration Technology or the MedImmune Collaboration Technology for research, development, manufacture, use or Commercialization of any BiTE Product, except in connection with co-developing a BiTE Product(s) with such Third Party or with respect to Licensed Product in the Territory. This limitation is not applicable to any BiTE Product as to which MedImmune holds a license under this Agreement or under any other agreement with Micromet or its Affiliates.
8.4 Option for Exclusive License to [***] Patent.
8.4.1 Grant of Option. Micromet hereby grants MedImmune an exclusive option to obtain an exclusive, royalty-bearing right and license under the [***] Patent, to make, have made, use, offer for sale, sell, and import Licensed Products in the United States of America for any use in humans. MedImmune may exercise the option at any time during the term of this Agreement by providing written notice to Micromet.
8.4.2 Financial Terms. MedImmune will make any payments due by Micromet to Upstream Licensor; provided, however, that Micromet will remain solely responsible for the payment of any annual license maintenance fees, and provided further, that any payments due from Micromet to the Upstream Licensor as a result of receiving royalties on Net Sales from MedImmune may be off-set against royalties due to Micromet under this Agreement as provided in Section 10.4.3(b).
8.5 Bankruptcy Provision under German Law.
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8.5.1 In the event that Micromet becomes insolvent, has to file for insolvency or is adjudicated insolvent, Micromet, its legal successor or the insolvency administrator shall, to the extent legally possible, use its commercially reasonable endeavors to ensure that MedImmune retains the licensing rights based on Licensed Technology owned by Micromet granted to MedImmune under this Agreement. Except for any mandatory law, in such event MedImmune shall continue to use the licensing rights in accordance with the terms set out in this Agreement.
8.5.2 In relation to licensing rights granted to MedImmune which are based on Licensed Technology that Micromet licenses from Third Parties, Micromet or its legal successor or the insolvency administrator shall, to the extent legally possible, use its commercially reasonable endeavors to secure the retention of the licensing rights granted to MedImmune. Except for any mandatory law, depending on the terms of the license agreement between Micromet and the relevant Third Party Micromet, its legal successor or the insolvency administrator shall use its commercially reasonable endeavors to assign or transfer all its rights or obligations under the relevant licensing agreement between Micromet and the relevant Third Party to MedImmune. Alternatively, Micromet or its legal successor or the insolvency administrator shall use its commercially reasonable endeavors to convince the relevant Third Party to enter into negotiations with MedImmune in order to cause the conclusion of the appropriate license agreements between the relevant Third Party and MedImmune.
8.6 Bankruptcy Provision under US Law. All rights and licenses granted under or pursuant to this Agreement, including amendments hereto, by MedImmune to Micromet are, for all purposes of Section 365(n) of Title 11 of the U.S. Code (Title 11), licenses of rights to intellectual property as defined in Title 11. All rights, powers and remedies of Micromet provided in this Section 8.6 are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation Title 11) in the event of the commencement of a Title 11 case by or against MedImmune. In such event, Micromet will be entitled to exercise all other such rights and powers and resort to all other such remedies as may now or hereafter exist at law or in equity (including, without limitation, under Title 11).
8.7 First Offer. In the event that Micromet decides to transfer ownership of Micromet Collaboration Technology to any Third Party, Micromet will first offer ownership in and to such Micromet Collaboration Technology to MedImmune by written notice to MedImmune and if, within [***] after such written notice, MedImmune notifies Micromet that MedImmune has an interest in acquiring the Micromet Collaboration Technology, then for a period of [***] thereafter, the Parties will negotiate in good faith the terms and conditions of such acquisition. If the Parties do not reach agreement on such terms and conditions within a period of [***] after such written notice from MedImmune, then for a period of [***] thereafter Micromet will have the right to transfer ownership to the Micromet Collaboration Technology to a Third Party without re-offering such rights to MedImmune; provided, however, that, during such [***] period, Micromet will not transfer the applicable rights to a Third Party on financial terms and conditions that, in the aggregate, are more favorable to the Third Party or equal to MedImmunes final offer to Micromet. This clause does not apply to any assignment of this
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Agreement by Micromet or any sale by Micromet of substantially all of Micromets assets pertaining to a Collaboration Product, each as set forth in Section 20.2.
9. Prosecution, Enforcement and Defense of Patents
9.1 Prosecution and Maintenance of Patents.
9.1.1 Micromet will have the sole right to file, prosecute and maintain Patents in the Licensed Technology (including Patents within Joint Collaboration Technology). MedImmune will reimburse Micromet for [***]% of Micromets reasonable and documented out-of-pocket costs incurred in connection with the filing and prosecution of Patents included in the Joint Collaboration Technology inside or outside the Territory. MedImmune will cooperate with Micromet to file, prosecute and maintain such Patents inside or outside the Territory, and will have the right to review and provide comments to Micromet relating to such patent applications and patents. For all other Patents, the person or entity owning the Patent will pay the costs and expenses thereof.
9.1.2 With respect to Patents in the Licensed Technology or Patents in MedImmune Collaboration Technology, each Party will provide to the other Party all documents that relate to patent filing, prosecution and maintenance, including, but not limited to, each patent application, office action, response to office action, request for terminal disclaimer, and request for reissue or reexamination or extension of any patent issuing from such application sufficiently prior to the filing of such application, response or request to allow for review and comment by such other Party, except to the extent that the filing Party is prohibited from doing so under a Technology Acquisition Agreement. The filing Party agrees to consider and take into account all comments received from the other Party.
9.1.3 Micromet will not withdraw or abandon any Patent in the Licensed Technology in the Territory, without MedImmunes prior written consent, and at the request of MedImmune, Micromet will file continuation and divisional applications, except to the extent that Micromet is prohibited from doing so under a Technology Acquisition Agreement.
9.2 Enforcement of Patents.
9.2.1 Notice. If either Party learns that a Third Party is infringing or allegedly infringing any Patent within the Micromet Independent Technology, MedImmune Independent Technology, or Collaboration Technology, it will promptly notify the other Party thereof including available evidence of infringement. The Parties will cooperate and use reasonable efforts to stop such alleged infringement without litigation.
9.2.2 Enforcement Actions for Micromet Technology.
(a) Outside the Territory, Micromet will have the sole right (but not the obligation) to take the appropriate steps to remove the infringement or alleged infringement of Licensed Technology, including, by initiation, prosecution and control at its own expense of
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any suit, proceeding or other legal action by counsel of its own choice. MedImmune will have the right, at its own expense, to be represented in any such action by counsel of its own choice.
(b) Within the Territory, with respect to the alleged infringement by a Third Party of Licensed Technology by making, using, selling, importing or offering for sale a Licensed Product, subject to the rights of any licensor of Licensed Technology under agreements with Micromet, MedImmune will have the first right (but not the obligation) to bring any infringement action or proceeding within the Territory, at the cost and expense of MedImmune, by counsel of its own choice. Micromet will have the right, at its own cost and expense, to be represented in any such action by counsel of its own choice. If MedImmune fails to bring such an action in the Territory within 180 days of written notice thereof from Micromet to MedImmune, then Micromet will have the right to bring such action at the cost and expense of Micromet with counsel selected by Micromet. MedImmune, at its cost and expense, will have the right to be represented by counsel in any such action brought by Micromet.
9.2.3 Enforcement Actions for MedImmune Technology. MedImmune will have the first right (but not the obligation) to take the appropriate steps to remove the infringement or alleged infringement of Independent MedImmune Technology and MedImmune Collaboration Technology, including by initiation, prosecution and control at its own expense of any suit, proceeding or other legal action by counsel of its own choice. Micromet will have the right, at its own expense, to be represented in any such action by counsel of its own choice. If MedImmune fails to bring such an action in the Territory under MedImmune Collaboration Technology with respect to a Third Party making, using, selling, offering for sale or importing Licensed Product within 180 days of written notice thereof from Micromet to MedImmune, then Micromet will have the right to bring such action at the cost and expense of Micromet with counsel selected by Micromet. MedImmune, at its cost and expense, will have the right to be represented by counsel in any such action brought by Micromet.
9.2.4 Cooperation; Damages. If one Party brings any enforcement action or proceeding under this Section 9 with respect to Licensed Product, the other Party agrees to be joined as party plaintiff if necessary to prosecute the action or proceeding and to give the first Party reasonable assistance and authority to file and prosecute the suit; provided, however, that neither Party will be required to transfer any right, title or interest in or to any property to the other Party or any other party to confer standing on a Party hereunder. The Party bringing the action will have the right to control such action, including the settlement thereof, provided, however, that no settlement will be made that adversely affects the validity, enforceability or scope of a Patent included in Licensed Technology unless agreed to in writing by both Parties. Any damages or other monetary awards recovered pursuant to any suit, proceeding or other legal action taken under this Section 9.2 will be allocated first to the costs and expenses of the Party bringing suit, and second to the costs and expenses (if any) of the other Party that were authorized by the Party bringing the suit, with any remaining amounts (if any) to be allocated to the Party bringing suit and if the amount is allocated to MedImmune, such amount will be Net Sales subject to royalty under this Agreement.
9.3 Third Party Patents. If any notice of infringement is received by, or a suit is initiated against, either Party with respect to Licensed Product, the Parties will consult in good faith regarding the best response. In each case, the Party that is sued will have the sole right to
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defend such action. If MedImmune is required to make any payments to any Third Party with respect to the development, manufacture, use or sale of Licensed Product as a result of such action, MedImmune will be entitled to offset such payments against the royalties otherwise due and payable by MedImmune under this Agreement to Micromet as provided in Section 10.4.3.
10. Fees and Payments
10.1 Technology Access Fee. MedImmune will pay to Micromet a non-refundable, non-creditable annual technology access fee of [***] in equal quarterly installments, each payable within 30 days after the end of the applicable calendar quarter during the first 2 years following the Effective Date. The Parties will negotiate the amount of the annual technology access fee, if any, payable during each year thereafter.
10.2 Development Milestones. MedImmune will make the following non-refundable, non-creditable payments to Micromet in the amounts set forth below within 30 days of the occurrence of the following events with respect to each Licensed Product in the Territory:
Milestone Event | Milestone Payment | |||
1. | Upon filing of the first IND or equivalent filing in any country of the Territory | US$[***] | ||
2. | First patient enrolled in first Pivotal Trial for any country of the Territory | US$[***] | ||
3. | Filing of the first BLA for such Licensed Product | US$[***] | ||
4. | Filing of the second BLA for such Licensed Product | US$[***] | ||
5. | Approval of the first BLA for such Licensed Product | US$[***] | ||
6. | Approval of the second BLA for such Licensed Product | US$[***] |
Notwithstanding the foregoing, if the Lead Product is not MT103, then MedImmune will not be required to make any milestone payment that MedImmune has earlier paid in connection with the development of a predecessor of the then-current Lead Product.
10.3 Commercialization Milestones. MedImmune will make the following non-refundable one-time payments to Micromet in the amounts set forth below within 30 days of the occurrence of the following events with respect to Licensed Product sold in the Territory by MedImmune, its Affiliates or sublicensees:
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Milestone Event | Milestone Payment | |
The first time that Net Sales of Licensed Product in the Territory reaches US$[***] in a calendar year | US$[***] | |
The first time that Net Sales of Licensed Product in the Territory reaches US$[***] in a calendar year | US$[***] |
[***]% of the milestone payments made pursuant to this Section 10.3 are creditable against the royalties due to Micromet pursuant to Section 10.4 below; provided, however, that MedImmune may take such credit only to the extent that each such royalty payment due to Micromet is not reduced by more than [***]% of the payment that would be due without such credit.
10.4 Royalties.
10.4.1 Royalty Rates.
(a) Subject to the adjustments provided for in Section 10.4.3 MedImmune will pay to Micromet a royalty equal to:
(i) [***]% of Net Sales of Licensed Product in the Territory for that portion of the total amount of aggregate Net Sales of Licensed Product in the Territory during a calendar year that is less than or equal to US$[***];
(ii) [***]% of Net Sales of Licensed Product in the Territory for that portion of the total amount of aggregate Net Sales of all Licensed Product in the Territory during a calendar year that is greater than US$[***] but less than or equal to US$[***]; and
(iii) [***]% of Net Sales of Licensed Product in the Territory for that portion of the total amount of aggregate Net Sales of all Licensed Product in the Territory during a calendar year that is greater than US$[***].
(b) In the event that a Licensed Product is sold in combination with a therapeutically active component that is not a Licensed Product (Combination Product), then net sales (calculated as Net Sales) of such Combination Product upon which a royalty is paid will be subject to the following adjustment. If the Licensed Product and the other therapeutically active component of the Combination Product are sold separately in a country, then net sales of such Combination Product in such country upon which a royalty is paid will be multiplied by the fraction A/A+B, where A equals the average sales price of such Licensed Product sold separately in such country, and B equals the average sales price of the other therapeutically active component sold separately in such country. Otherwise, the parties will enter into good faith negotiations and attempt to reach mutual agreement to determine an appropriate adjustment to
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the net sales of such Combination Product in a country to reflect the relative contributions of the Licensed Product and the other therapeutically active component to the value of the Combination Product in such country. If such mutual agreement is not reached within ninety (90) days after commencement of such negotiations, then the determination will be submitted to binding arbitration under Section 20.4.3.
(c) Only one royalty will be due and payable for the manufacture, use and sale of Licensed Product irrespective of the number of Valid Claims within the Licensed Technology that cover the manufacture, use and sale of Licensed Product. Upon payment of a royalty under this Agreement with respect to a unit of Licensed Product, no further royalty will be due with respect to such unit of Licensed Product.
10.4.2 Royalty Term. Royalties due under the preceding Section 10.4.1 for Licensed Product will continue until the later of: (i) the expiration of the last-to-expire Patent within the Licensed Technology containing a Valid Claim claiming or covering Licensed Product in the country of the Territory where sold, or (ii) [***] from the first commercial sale of such Licensed Product in the Territory (the Royalty Term).
10.4.3 Royalty Adjustments.
(a) In the event that one or more Third Parties sell a Licensed Product in a country of the Territory that does not infringe a Valid Claim of a Patent that is Licensed Technology and the sales of such Licensed Product by such Third Parties amounts to [***] percent ([***]%) of MedImmunes sales of Licensed Product in such country in a calendar year, then the royalty payable by MedImmune pursuant to Section 10.4.1 on Licensed Product in such country for such calendar year will be reduced to [***]%. If sales by such Third Parties are only for a portion of a calendar year, the [***]% of MedImmunes sales will be determined over such portion of the calendar year.
(b) MedImmune may credit up to [***]% of any Technology Acquisition Payments that may become due as a result of the development or Commercialization of Licensed Product by MedImmune against the amount of any royalties due and payable by MedImmune pursuant to Section 10.4.1; provided, however, that in no event will such credit reduce the amount of royalties due and payable by MedImmune to Micromet to less than [***]% of Net Sales of Licensed Product.
(c) The royalty rate adjustments set forth in Sections 10.4.3 (a) and (b) are not cumulative and in no event will the application of one or both of such adjustments reduce the royalty payable by MedImmune pursuant to Section 10.4.1 on Licensed Product to less than [***]% of Net Sales of Licensed Product.
11. Payment Terms
11.1 Payment Method. All amounts due to Micromet will be paid in EURO and those due to MedImmune will be paid in United States Dollars, in each case by wire transfer in
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immediately available funds to an account designated by the Party that is the payee. The conversion for royalties will be made at the exchange rate reported in the Wall Street Journal, Eastern Edition on the last business day of the calendar quarter for which royalties are payable, and in all other cases at such exchange rate on the date that the payment is due. Any payments or portions thereof due hereunder which are not paid on the date such payments are due under this Agreement will bear interest at the lower of (i) [***]% over the overnight LIBOR rate in effect on the due date, or (ii) the maximum rate permitted by law, calculated on the number of days such payment is delinquent, compounded monthly.
11.2 Payment Schedules; Reports. Royalty payments due pursuant to Sections 4.11.2 and 10.4 are due and payable within [***] of the end of each calendar quarter during the Term during which there were Net Sales of the applicable product in the Territory. A Party will accompany each payment of royalties under this Agreement with a report containing a detailed account of Net Sales of each product for which royalties are due during the preceding calendar quarter.
11.3 Records Retention; Audit.
11.3.1 Record Retention. Each Party will maintain complete and accurate books, records and accounts used for the determination of expenses incurred in connection with the performance of the Development Plan and Net Sales, in sufficient detail to confirm the accuracy of any payments required under this Agreement, which books, records and accounts will be retained by such Party until [***] years after the end of the period to which such books, records and accounts pertain.
11.3.2 Audit. Each Party will have the right to have an independent certified public accounting firm of internationally recognized standing, reasonably acceptable to the other Party, have access during normal business hours, and upon reasonable prior written notice, to such of the records of the other Party as may be reasonably necessary to verify the accuracy of any payments made to or received from the other Party for any calendar quarter ending not more than [***] prior to the date of such request; provided, however, that no Party will have the right to conduct [***]. The accounting firm will disclose to the Parties only whether the development expenses or Net Sales reported by the audited Party are correct or incorrect and the specific details concerning any discrepancies. The auditing Party will bear all costs of such audit, unless the audit reveals a discrepancy in the audited Partys favor of more than [***]%, in which case the audited Party will bear the cost of the audit. The results of such accounting firm will be final, absent manifest error.
11.3.3 Payment of Additional Amounts. If, based on the results of any audit, additional payments are owed to a Party under this Agreement, the amount of such payments will be credited against future amounts payable by such Party to the other Party under this Agreement; provided, however, that if such additional payments are not fully credited within [***] months after the receipt of the applicable audit results, the Party owing such additional payments will at such time pay the other Party any uncredited amounts thereof.
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11.3.4 Confidentiality. Each party will treat all information subject to review under this Section 11.3 in accordance with the provisions of Section 12 and will cause its accounting firm to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such firm to maintain all such financial information in confidence pursuant to such confidentiality agreement.
12. Confidentiality
12.1 Definition. Confidential Information means (a) any Know-How, and (b) any scientific, manufacturing, marketing and business plans, and financial and personnel matters relating to a Party or its present or future products, sales, suppliers, customers, employees, investors or business; in either case, that has been disclosed by or on behalf of such Party to the other Party either in connection with the discussions and negotiations pertaining to this Agreement or in the course of performing this Agreement (including any information disclosed under the Confidentiality Agreement between the Parties dated December 11, 2002).
12.2 Exclusions.
12.2.1 Notwithstanding the foregoing, any information of a Party will not be deemed Confidential Information with respect to a receiving Party for purposes of this Agreement if such information:
(a) was already known or available to the receiving Party or its Affiliates, other than under an obligation of confidentiality or non-use to the other Party, at the time of disclosure to the receiving Party;
(b) was generally available or known to parties reasonably skilled in the field to which such information pertains, or was otherwise part of the public domain, at the time of its disclosure to the receiving Party;
(c) became generally available or known to parties reasonably skilled in the field to which such information pertains, or otherwise became part of the public domain, after its disclosure to the receiving Party through no fault of or breach of its obligations under this Section 12 by the receiving Party;
(d) was disclosed to the receiving Party, other than under an obligation of confidentiality or non-use, by a Third Party who had no obligation to the Party that Controls such information not to disclose such information to others; or
(e) was independently discovered or developed by the receiving Party or its Affiliates, as evidenced by their written records, without the use of, and by personnel who had no access to, Confidential Information belonging to the Party that Controls such information.
12.3 Disclosure and Use Restriction. Except as expressly provided herein, the Parties agree that, during the Term and for [***] thereafter, each Party and its Affiliates and
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sublicensees will keep completely confidential and will not publish or otherwise disclose any Confidential Information of the other Party, its Affiliates or sublicensees. Neither Party will use any Confidential Information of the other Party without such other Partys consent, except as expressly permitted by this Agreement.
12.4 Authorized Disclosure. Each Party may use and disclose Confidential Information of the other Party to the extent that such use and disclosure is:
12.4.1 made in response to a valid order of a court of competent jurisdiction or other governmental or regulatory body of competent jurisdiction; provided, however, that such Party will first have given notice to such other Party and given such other Party a reasonable opportunity to quash such order and to obtain a protective order requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or governmental or regulatory body or, if disclosed, be used only for the purposes for which the order was issued; and provided, further, that if a disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order will be limited to that information which is legally required to be disclosed in response to such court or governmental order;
12.4.2 otherwise required by law, rule, or regulation; provided, however, that the disclosing Party will provide such other Party with notice of such disclosure in advance thereof to the extent practicable;
12.4.3 made by such Party to the regulatory authorities as required in connection with any filing of MAAs, INDs, BLAs, marketing approval applications, or similar applications or requests for regulatory approvals; provided, however, that reasonable measures will be taken to assure confidential treatment of such information;
12.4.4 made by such Party, in connection with the performance of this Agreement, to Affiliates, permitted sublicensees, research parties, employees, consultants, representatives or agents, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Section 12;
12.4.5 made by such Party to existing or potential acquirers or merger candidates; existing or potential pharmaceutical collaborators (to the extent contemplated under this Agreement); investment bankers; existing or potential investors, venture capital firms or other financial institutions or investors for purposes of obtaining financing; or Affiliates, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Section 12; provided, however, that neither Party will disclose any item of the other Partys Confidential Information to any existing or potential acquirer or merger partner that is substantially involved in the development or Commercialization of pharmaceutical products comprising or containing Single Chain Antibodies or Licensed Products without first providing such other Party with reasonable advance written notice of each such disclosure; or
12.4.6 made in a patent application filed in conformance with this Agreement.
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12.5 Terms of Agreement to be Maintained in Confidence. Subject to the provisions of this Section 12, the Parties agree that the terms of this Agreement are deemed Confidential Information of both Parties and will be subject to the restrictions on use and disclosure set forth herein.
13. Public Communications
13.1 General Provisions. The Parties will cooperate with respect to the timing and content of communications with the public regarding the development and marketing of Licensed Product, under the terms to be set forth in the Development Plan and subject to the provisions of this Section 13.
13.2 Use of Name. Neither Party will make public use of the other Partys name except (a) in connection with announcements and other permitted disclosures relating to this Agreement and the activities contemplated hereby, (b) as required by applicable law, rule, or regulation, and (c) otherwise as agreed in writing by such other Party.
13.3 Press Releases.
13.3.1 If the Parties desire to make a joint press release regarding the execution of this Agreement, the final form of such release will be subject to approval of both Parties prior to its release to the public. For subsequent press releases and other written public disclosures relating to this Agreement or the Parties relationship hereunder (each, a Proposed Disclosure), each Party will use reasonable efforts to submit to the other Party a draft of such Proposed Disclosure for review and comment by the other Party at least [***] prior to the date on which such Party plans to release such Proposed Disclosure, and in any event will submit such drafts at least [***] prior to the release of such Proposed Disclosure, and will review and consider in good faith any comments provided in response.
13.3.2 If a Party is unable to comply with the foregoing [***] notice requirement because of a legal obligation or stock exchange requirement to make more rapid disclosure, such Party will not be in breach of this Agreement but will in that case give telephone notice to a senior executive of the other Party and provide a draft disclosure with as much notice as possible prior to the release of such Proposed Disclosure.
13.3.3 A Party may publicly disclose without regard to the preceding requirements of this Section 13.3 information that was previously disclosed in a Proposed Disclosure that was in compliance with such requirements.
13.4 Publications. At least [***] prior to submission of any material related to the research or development activities hereunder for publication or presentation, the submitting Party will provide to the other Party a draft of such material for its review and comment. The receiving Party will provide any comments to the submitting Party within [***] of receipt of such materials. No publication or presentation with respect to the research or development activities hereunder will be made unless and until the other Partys comments on the proposed
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publication or presentation have been duly considered and any information determined by the other Party to be its Confidential Information has been removed. If requested in writing by the other Party, the submitting Party will withhold material from submission for publication or presentation for an additional [***] to allow for the filing of a patent application or the taking of such measures to establish and preserve proprietary rights in the information in the material being submitted for publication or presentation.
14. Convertible Note
On the Effective Date, MedImmune will execute the agreement attached as Exhibit G hereto.
15. Term and Termination
15.1 Term. The term of this Agreement (the Term) will commence on the Effective Date and will expire upon the earlier of (i) the date of expiration of all royalty and payment obligations due under this Agreement for all Licensed Products, and (ii) fifty years from the Effective Date, unless earlier terminated as provided in this Agreement.
15.2 Breach.
15.2.1 In the event that MedImmune materially breaches a material obligation under this Agreement, Micromet will have the right to send written notice to MedImmune that Micromet will terminate the licenses granted to MedImmune under this Agreement in the entirety or, as set forth in Sections 3.2.7 and 6.3, with respect to a particular Licensed Product in a particular country of the Territory unless such breach is cured in [***] ([***] for a payment breach). If such breach is not cured within the applicable period and if for a breach other than a payment breach, MedImmune does not submit the issue of breach to arbitration under Section 20.4.3, then, upon expiration of the applicable period, the licenses granted to MedImmune under this Agreement will terminate in the entirety or with respect to the applicable Licensed Product in the applicable country of the Territory and MedImmune will have no further obligations under this Agreement except those set forth in Section 16. In the event that MedImmune disputes a payment obligation for which Micromet provides notice under this Section 15.2.1 and MedImmune notifies Micromet of such dispute and makes the payment under protest, then notwithstanding such payment, MedImmune will have the right to arbitrate under Section 20.4.3 whether or not MedImmune is obligated to make such payment and to the extent MedImmune prevails in such arbitration, Micromet will return such disputed payments to MedImmune.
15.2.2 In the event that Micromet materially breaches a material obligation under this Agreement, MedImmune will have the right to send written notice to Micromet that MedImmune will terminate the licenses granted to Micromet under this Agreement in the entirety unless such breach is cured in [***] ([***] for a payment breach). If such breach is not cured within the applicable period and if, for a breach other than a payment breach, Micromet does not submit the issue of breach to arbitration under Section 20.4.3, then, upon expiration of the applicable period, the licenses granted to Micromet under this Agreement will terminate in
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the entirety and Micromet will have no further obligations under this Agreement except those set forth in Section 16. In the event that Micromet disputes a payment obligation for which MedImmune provides notice under this Section 15.2.2 and Micromet notifies MedImmune of such dispute and makes the payment under protest, then notwithstanding such payment, Micromet will have the right to arbitrate under Section 20.4.3 whether or not Micromet is obligated to make such payment and to the extent Micromet prevails in such arbitration, MedImmune will return such disputed payments to Micromet.
15.3 Voluntary Termination. MedImmune will have the right to terminate the licenses granted to MedImmune under this Agreement in the entirety or in one or more countries of the Territory by [***] prior written notice to Micromet and if the licenses granted to MedImmune are terminated in the entirety, then MedImmune will have no further obligations under this Agreement except for those set forth in Section 16 and, if the licenses granted to MedImmune are terminated in one or more countries, then MedImmune will have no further payment obligations with respect to such countries.
16. Effects of Termination
16.1 Post-Termination Activities.
16.1.1 Upon termination of the rights and licenses granted to MedImmune in its entirety, and subject to any rights retained by MedImmunes sublicensees in the Territory pursuant to Section 16.7, Micromet will have the right to continue the development of and to Commercialize Licensed Product by itself or with or through Third Parties anywhere in the world. Upon such termination, MedImmune will upon request of Micromet:
(a) continue the Development Activities set forth in the Development Plan relating to clinical trials commenced by or on behalf of MedImmune prior to the effective date of such termination, at the cost and expense of Micromet, or upon request by Micromet and subject to Applicable Law and to MedImmunes obligations to Third Parties conducting such Development Activities on behalf of MedImmune, transfer such Development Activities to Micromet;
(b) transfer the then-existing clinical scale manufacturing process for the Lead Product or, if applicable, the fully-developed Lead Product Process to Micromet or its designee under the terms set forth in Section 5;
(c) provide Micromet with Clinical Trial Materials (if, at the time of such termination, MedImmune is supplying Micromet with Clinical Material) until such time as Micromet or its designee has established and validated a manufacturing process for one or more Licensed Products and is approved to manufacture Pivotal Trial and commercial supplies of such Licensed Products (but in no event longer than [***] from completion of the transfer of the manufacturing process described in Section 5); and
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(d) transfer to Micromet all non-clinical and clinical data, information, regulatory approvals, and Know-How directly related to Licensed Product (other than that directed to a Commercial Process), and any trademarks relating to Licensed Product.
16.1.2 In consideration of the performance of the obligations set forth in the preceding Section 16.1.1, Micromet will pay MedImmune:
(a) in the event of termination pursuant to Section 15.3, a technology transfer fee equal to the amount of any reasonable and documented expenses at the FTE Rate as well as any reasonable and documented out-of-pocket expenses incurred by MedImmune in the course of effecting the transfer of materials described in clause (b) of Section 16.1.1;
(b) the [***] for Clinical Trial Materials, on the terms set forth in Section 4;
(c) if, at the time of such termination, MedImmune is supplying Micromet with Licensed Product, for commercial supply of Licensed Product, under the terms set forth in the applicable supply agreement executed by the Parties pursuant to Section 4.11 or, if no such agreement has been executed, under the terms set forth in Section 4; and
(d) the royalty set forth in Section 4.11.2(b) above, and the payments of Section 7.5.3.
16.1.3 If the licenses granted to Micromet under this Agreement are terminated in the entirety pursuant to Section 15.2.2, then MedImmune will have the right to continue the development of and to Commercialize Licensed Product by itself or with or through Third Parties in the Territory. Upon such termination,
(a) Micromet will, at MedImmunes option, either continue or terminate the activities set forth in a Research Plan commenced prior to the effective date of such termination, and, if any Research Plan is terminated, transfer to MedImmune at [***] expense the BiTE Molecules and associated data generated pursuant to such Research Plan, and
(b) MedImmune will provide Micromet with Clinical Trial Materials (if, at the time of such termination, MedImmune is supplying Micromet with Clinical Material) required by Micromet to complete any clinical trials commenced by or on behalf of Micromet prior to the effective date of such termination pursuant to a Development Plan approved unanimously by the JDC.
16.2 Effect of Expiration on Intellectual Property. Upon expiration of this Agreement pursuant to Section 15.1 above, (a) the licenses and sublicensing rights granted in Sections 8.1.1 and 8.1.3 by Micromet to MedImmune will become fully paid, perpetual, and irrevocable, and (b) the licenses granted in Section 8.2 by MedImmune to Micromet will become fully paid, perpetual, and irrevocable.
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16.3 Effects of Termination on Licenses.
16.3.1 If the licenses granted to MedImmune under this Agreement are terminated in the entirety pursuant to Section 15.2.1 or Section 15.3, then the licenses granted to
Micromet under this Agreement will continue in full force and effect under the terms and conditions of this Agreement, except that the licenses granted to Micromet under Section 8.2 will be extended to include the Territory and Micromets and MedImmunes obligations under this Agreement with respect to such licenses and any Patents and Know-How covered thereunder will also remain in full force and effect; provided, however, that in each case such licenses to Micromet will be subject to any rights retained by MedImmunes sublicensees in the Territory pursuant to Section 16.7.
16.3.2 If the licenses granted to MedImmune under this Agreement are terminated with respect to any Licensed Product in one or more countries in the Territory pursuant to Section 15.2.1 or with respect to any country pursuant to Section 15.3, then the licenses granted to Micromet under this Agreement will be extended to each such Licensed Product in each such country or countries, and Micromets and MedImmunes obligations under this Agreement with respect to such licenses and any Patents and Know-How covered thereunder will also be extended thereto; provided, however, that in each case such licenses to Micromet will be subject to any rights retained by MedImmunes sublicensees in the Territory pursuant to Section 16.7.
16.3.3 If the licenses granted to Micromet under this Agreement are terminated pursuant to Section 15.2.2, then the licenses granted to MedImmune under this Agreement will remain in full force and effect under the terms and conditions of this Agreement, and Micromets and MedImmunes obligations with respect to such licenses and any Patents and Know-How covered thereunder will remain in full force and effect.
16.4 Accrued Rights. Termination of this Agreement in the entirety for any reason or termination of the rights and licenses granted to a Party under this Agreement will be without prejudice to any rights that will have accrued to the benefit of a Party prior to the effective date of such termination. Such termination will not relieve a Party from obligations that are expressly indicated to survive the termination of this Agreement or termination of the rights and licenses granted to a Party thereunder.
16.5 Survival. Sections, 3.4.2, 7.1, 7.2, 7.3, 7.4, 8.1.2, 8.2.7, 9.1.1, 11, 12, 13.2, 16, 17, 19 and 20 (except for Section 20.2.2), and the limitation on remedies set forth in Sections 3.2.6(d), 3.2.7(a) and 6.3.2, together with any definitions used or exhibits referenced therein, will survive any termination or expiration of this Agreement. In addition, the provisions set forth in Sections 4 and 5 will survive any termination or expiration of this Agreement to the extent such provisions are necessary to effect the activities described in this Section 16.
16.6 Inventory. During a period of [***] following any termination of this Agreement MedImmune will be entitled, at its option, to sell any completed inventory of Licensed Product which remains on hand as of the date of the termination under the licenses
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granted under this Agreement, so long as MedImmune pays to Micromet the royalties applicable to such subsequent sales in accordance with the same terms and conditions as set forth in this Agreement.
16.7 Sublicenses. In the event that a Partys licenses under this Agreement are terminated with respect to one or more countries, and a sublicense has been granted under this Agreement under any such licenses by such Party with respect to Licensed Product in any such country, then this Agreement will become an agreement between the Party whose licenses were not terminated and any such sublicensee with respect to Licensed Products in any such country, subject to such sublicensee agreeing to be bound to the terms and conditions of this Agreement; provided, however, that this Section 16.7 will not apply with respect to any sublicensee that is in breach of the applicable sublicense agreement or would be in breach of this Agreement upon the conversion of the applicable sublicense as contemplated herein; and provided, further, that MedImmunes obligations to supply Clinical Trial Materials and Licensed Product for commercial sale, and to develop the Lead Product Process may not be transferred to any sublicensee pursuant to this Section 16.7.
17. Indemnification and Insurance
17.1 Indemnification of Micromet. MedImmune will indemnify Micromet and its Affiliates, and their respective directors, officers, and employees (each, a Micromet Indemnitee), and defend and save each of them harmless from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys fees and expenses) in connection with any and all liability suits, investigations, claims or demands (collectively, Losses) arising from or occurring as a result of any claim or lawsuit by a Third Party against a Micromet Indemnitee, to the extent caused by or arising out of: (a) the gross negligence or willful misconduct on the part of MedImmune, its Affiliates or sublicensees in performing any activity contemplated by this Agreement, or (b) the development or Commercialization of Licensed Product in the Territory by MedImmune, its Affiliates or sublicensees (other than Licensed Product provided to Micromet or its Affiliates or licensees); in each case, excluding any Losses for which Micromet has an obligation to indemnify one or more MedImmune Indemnitees pursuant to Section 17.2.
17.2 Indemnification of MedImmune. Micromet will indemnify MedImmune, its Affiliates, and their respective directors, officers, and employees (each, a MedImmune Indemnitee), and defend and save each of them harmless from and against any and all Losses arising from or occurring as a result of any claim or lawsuit by a Third Party against a MedImmune Indemnitee, to the extent caused by or arising out of: (a) the gross negligence or willful misconduct on the part of Micromet, its Affiliates or sublicensees in performing any activity contemplated by this Agreement, (b) the development or Commercialization of Licensed Product outside the Territory by Micromet, its Affiliates or sublicensees (and countries inside the Territory in the event that Micromets license is extended to countries of the Territory under Section 16.3.1 and/or 16.3.2), or (c) the research, development, manufacture or sale of BiTE Product by Micromet, its Affiliates or sublicensees pursuant to a license granted to Micromet under this Agreement; in each case, excluding any Losses for which MedImmune has an obligation to indemnify one or more Micromet Indemnitees pursuant to Section 17.1.
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17.3 Notice of Claim. All indemnification claims in respect of any MedImmune Indemnitee or Micromet Indemnitee seeking indemnity under Sections 17.1 or 17.2 (collectively, the Indemnitees and each an Indemnitee) will be made solely by the corresponding Party (the Indemnified Party). The Indemnified Party will give the indemnifying Party (the
Indemnifying Party) prompt written notice (an Indemnification Claim Notice) of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under Section 17.1 or Section 17.2, but in no event will the Indemnifying Party be liable for any Losses that result from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss are known at such time). The Indemnified Party will furnish promptly to the Indemnifying Party copies of all papers and official documents received in respect of any Losses.
17.4 Control of Defense. At its option, the Indemnifying Party may assume the defense of any claim subject to indemnification as provided for in Sections 17.1 and 17.2 (each, a Third Party Claim) by giving written notice to the Indemnified Party within 30 days after the Indemnifying Partys receipt of an Indemnification Claim Notice. Upon assuming the defense of a Third Party Claim, the Indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the Indemnifying Party. In the event the Indemnifying Party assumes the defense of a Third Party Claim, the Indemnified Party will immediately deliver to the Indemnifying Party all original notices and documents (including court papers) received by any Indemnitee in connection with the Third Party Claim. Should the Indemnifying Party assume the defense of a Third Party Claim, the Indemnifying Party will not be liable to the Indemnified Party or any other Indemnitee for any legal expenses subsequently incurred by such Indemnified Party or other Indemnitee in connection with the analysis, defense or settlement of the Third Party Claim.
17.5 Right to Participate in Defense. Without limiting Section 17.4, any Indemnitee will be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, however, that such employment will be at the Indemnitees own expense unless (i) the employment thereof has been specifically authorized by the Indemnifying Party in writing, or (ii) the Indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 17.4 (in which case the Indemnified Party will control the defense).
17.6 Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that will not result in the Indemnitees becoming subject to injunctive or other relief or otherwise adversely affect the business of the Indemnitee in any manner other than by the payment of money damages, and as to which the Indemnifying Party will have acknowledged in writing the obligation to indemnify the Indemnitee hereunder, the Indemnifying Party will have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the Indemnifying Party, in its sole discretion, will deem appropriate, and will transfer to the Indemnified Party all amounts which said Indemnified Party will be liable to pay prior to the entry of judgment. With respect to all other Losses in connection with Third Party Claims, where the Indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 17.4, the Indemnifying Party will have authority to consent to the entry of any
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judgment, enter into any settlement or otherwise dispose of such Loss provided it obtains the prior written consent of the Indemnified Party (which consent will be at the Indemnified Partys sole and absolute discretion). The Indemnifying Party will not be liable for any settlement or other disposition of a Loss by an Indemnitee that is reached without the written consent of the Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, no Indemnitee will admit any liability with respect to, or settle, compromise or discharge, any Third Party Claim without the prior written consent of the Indemnifying Party.
17.7 Cooperation. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party will, and will cause each other Indemnitee to, cooperate in the defense or prosecution thereof and will furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection with such Third Party Claim. Such cooperation will include access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim, and making Indemnitees and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its reasonable and documented out-of-pocket expenses in connection with such cooperation.
17.8 Insurance. During the Term, each Party will have and maintain such types and amounts of liability insurance as is normal and customary in the industry generally for parties similarly situated, and will upon request provide the other Party with a complete copy of its policies of insurance in that regard, along with any amendments and revisions thereto.
18. Representations and Warranties
18.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party that, as of the Effective Date:
18.1.1 Such Party (a) has the power and authority to enter into this Agreement and perform its obligations hereunder, and (b) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
18.1.2 This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity;
18.1.3 The execution and delivery of this Agreement and the performance of such Partys obligations hereunder (a) do not conflict with or violate any requirement of applicable law or any provision of the articles of incorporation, bylaws or any similar instrument
48
of such Party in any material way, and (b) do not conflict with, violate, or breach or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such Party is bound.
18.2 Additional Representations and Warranties of Micromet. Micromet hereby represents and warrants to MedImmune that:
(a) Micromet is a corporation duly organized, validly existing and in good standing under the laws of Germany, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement;
(b) Micromet owns all right, title and interest in and to the Patents of Exhibit A-1;
(c) The Patents of Exhibit A-2 are licensed to Micromet under the Technology Acquisition Agreements of Exhibit C and that the Patents of Exhibit A-2 have been sublicensed to MedImmune in the Territory under this Agreement;
(d) Micromet (i) owns all right, title and interest in and to the MT103 Patents with respect to [***] and [***], (ii) believes that it owns all right, title and interest in and to the MT103 Patents with respect to [***], and (iii) will use commercially reasonable efforts to resolve the [***] with respect to [***] interest in the MT103 Patents;
(e) Micromet has not previously granted and, prior to expiration or termination of this Agreement, will not grant any rights in the Licensed Technology that conflict with the rights and licenses granted to MedImmune herein;
(f) prior to the Effective Date, it has provided to MedImmune access to all material information and data in Micromets possession and control regarding the safety and efficacy of Licensed Product and has disclosed to MedImmune all such information that, to Micromets knowledge, is material to the activities contemplated hereunder and that, to Micromets knowledge, such information and data is correct in all material respects;
(g) as of the Effective Date, it has neither received from nor delivered any written claim to a Third Party (nor has a Third Party to the knowledge of Micromets officers expressly threatened such a claim) asserting the invalidity, unenforceability or misuse of any Patent included in Licensed Technology;
(h) to the knowledge of Micromets officers as of the Effective Date, other than Patents licensed or optioned to MedImmune under this Agreement, no Patent owned or controlled by a Third Party would be infringed by manufacture, use or sale of Licensed Product in the Territory; and
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
49
(i) as of the Effective Date, (i) all the Technology Acquisition Agreements as to which Micromet is a party with respect to Know-How and Patents that relate to Licensed Product or manufacture or use thereof are listed in Exhibit C, (ii) such Technology Acquisition Agreements are in full force and effect and that valid and effective sublicenses thereunder have been granted to MedImmune pursuant to this Agreement, (iii) to the knowledge of Micromet, no Party to any such Technology Acquisition Agreement is in breach thereof, and (iv) to the knowledge of Micromet, no Party to any such Technology Acquisition Agreement has notified any other party thereto of any breach thereof.
18.3 Additional Representations and Warranties of MedImmune. MedImmune hereby represents and warrants to Micromet that MedImmune is a corporation duly organized, validly existing and in good standing under the laws of Delaware, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement.
19. Disclaimer; Limitation of Liability
19.1 Disclaimer of Warranty. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, MEDIMMUNE AND MICROMET MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND MEDIMMUNE AND MICROMET EACH SPECIFICALLY DISCLAIM ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
19.2 Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR LOST PROFITS, LOSS OF DATA, OR FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION AND ARISING IN ANY WAY OUT OF THIS AGREEMENT. THE FOREGOING LIMITATIONS WILL NOT APPLY TO AN AWARD OF ENHANCED DAMAGES AVAILABLE UNDER THE PATENT LAWS FOR WILLFUL PATENT INFRINGEMENT AND WILL NOT LIMIT EITHER PARTYS LIABILITY AND OBLIGATIONS TO THE OTHER PARTY UNDER SECTIONS 12 AND 17.
20. Miscellaneous
20.1 Force Majeure. Neither Party will be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not),
50
insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority. The non-performing Party will notify the other Party of such force majeure within 10 days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance will be of no greater scope and no longer duration than is necessary and the non-performing Party will use commercially reasonable efforts to remedy its inability to perform; provided, however, that in the event the suspension of performance continues for [***] after the date of the occurrence, the Party not affected by such force majeure may terminate this Agreement immediately upon written notice to the other Party.
20.2 Assignment.
20.2.1 Neither Party will sell, transfer, assign, delegate, pledge or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties under this Agreement without the prior written consent of the other Party, which consent will not be withheld or delayed unreasonably; provided, however, that either Party may assign or transfer this Agreement or any of its rights or obligations under this Agreement without the consent of the other Party (a) to any Affiliate of such Party, or (b) to any Third Party with which it merges or consolidates, or to which it transfers all or substantially all of its assets to which this Agreement relates. The assigning Party (unless it is not the surviving entity) will remain jointly and severally liable with the relevant Affiliate or Third Party assignee under this Agreement, and the relevant Affiliate assignee, Third Party assignee or surviving entity will assume in writing all of the assigning Partys obligations under this Agreement. Any purported assignment or transfer in violation of this section will be void ab initio and of no force or effect.
20.2.2 Neither Party will assign or otherwise transfer ownership (in whole or in part), in the case of Micromet, in and to Licensed Technology and, in the case of MedImmune, in and to MedImmune Collaboration Technology and/or MedImmune Independent Technology, in each case only as to MedImmune, with respect to any Licensed Product or Commercial Process without the prior written consent of the other Party; provided, however, that a Party may assign such interest in whole without such consent (a) to an Affiliate of such Party, (b) in connection with the transfer or sale of all or substantially all of its business, or (c) to any Third Party with which it merges or consolidates; provided, however, that such assignment is in connection with a permitted assignment of this Agreement and to the same assignee as to which this Agreement is assigned, that such assignment is subject to this Agreement, and that the assignee assumes in writing the assigning Partys obligations under this Agreement.
20.3 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision will be fully severable, (b) this Agreement will be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part of this Agreement, (c) the
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
51
remaining provisions of this Agreement will remain in full force and effect and will not be affected by the illegal, invalid or unenforceable provision or by its severance from this Agreement, and (d) in lieu of such illegal, invalid or unenforceable provision, there will be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.
20.4 Governing Law; Dispute Resolution.
20.4.1 This Agreement, and any claim, dispute, or controversy of whatever nature arising out of or relating to this Agreement will be governed by and construed in accordance with the laws of the State of New York, U.S.A., without giving effect to any principles of choice of law that would require the application of the laws of a different state or country.
20.4.2 The Parties will try to settle their differences amicably between themselves. If any claim, dispute, or controversy of whatever nature arising out of or relating to this Agreement, including the performance or alleged non-performance of a Party of its obligations under this Agreement arises between the Parties (each a Dispute), a Party may notify the other Party in writing of such Dispute. If the Parties are unable to resolve the Dispute within 20 days of receipt of the written notice by the other Party, such dispute will be referred to the Chief Executive Officers of each of the Parties who will use their good faith efforts to resolve the Dispute within [***] after such referral.
20.4.3 If a Dispute is not resolved as provided in the preceding Section 20.4.2, whether before or after termination of this Agreement, the Parties hereby agree to resolve such Dispute by final and binding arbitration administered under the rules of arbitration of JAMS by one arbitrator appointed in accordance with the said Rules, provided that upon request of either Party, three arbitrators will be appointed. If the Parties are unable to mutually select such panel, the panel will be selected in accordance with the procedures of JAMS. The decision and award rendered by the panel will be final and binding. In any such arbitration, the arbitrators will not have the right to modify the terms and conditions of this Agreement. As a result, the rights and obligations of the Parties will be determined in accordance with the terms and conditions of this Agreement and any decision or award will be only in accordance with the terms and conditions of this Agreement. The Parties will exert best efforts to have the decision and award rendered within [***] after the first to occur of (i) notice of breach of this Agreement, which breach is a subject of the arbitration, and (ii) a notice invoking this arbitration provision. Judgment upon the award may be entered in any court having jurisdiction thereof. Any arbitration pursuant to this section will be held in Washington, D.C. or such other place as may be mutually agreed upon in writing by the Parties. With respect to any disputes arising in connection with an alleged breach of a Partys rights and obligations with respect to confidential Know-How or Confidential Information received from the other Party, the arbitrator will apply the discovery provisions of the Federal Rules of Civil Procedure. This means that depositions may be taken and full
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
52
discovery may be obtained in any arbitration commenced under this Section 20.4 with respect to such disputes.
20.4.4 Notwithstanding the provisions of this Section 20.4, either Party will have the right to seek temporary or permanent injunctive relief in any court of competent jurisdiction as may be available to such Party under the laws and rules applicable in such jurisdiction. Further, the provisions of this Section 20.4 will not apply with respect to any claim of a Party that the other Party is infringing any of its patents.
20.5 Notices. All notices or other communications that are required or permitted hereunder will be in writing and delivered personally, sent by facsimile (and promptly confirmed by personal delivery or overnight courier as provided in this Agreement), or sent by internationally-recognized overnight courier addressed as follows:
If to MedImmune, to:
Before January 1, 2004
MedImmune, Inc.
35 W. Watkins Mill Road
Gaithersburg, MD 20878
USA
Attention: Legal Department
Facsimile: (301 ###-###-####
35 W. Watkins Mill Road
Gaithersburg, MD 20878
USA
Attention: Legal Department
Facsimile: (301 ###-###-####
After January 1, 2004
MedImmune, Inc.
One MedImmune Way
Gaithersburg, MD 20878, USA
Attention: Legal Department
Facsimile: (301)  ###-###-####
One MedImmune Way
Gaithersburg, MD 20878, USA
Attention: Legal Department
Facsimile: (301)  ###-###-####
If to Micromet, to:
Micromet AG
Staffelseestrasse 2
81477 Munich
Germany
Attention: Chief Business Officer
Facsimile: ++49 89 895 277 205
Micromet AG
Staffelseestrasse 2
81477 Munich
Germany
Attention: Chief Business Officer
Facsimile: ++49 89 895 277 205
53
with a copy to:
Cooley Godward, LLP
One Freedom Square
Reston Town Center
11951 Freedom Drive
Reston, Virginia 20190-5656
Attention: Matthias Alder
Facsimile: (703)  ###-###-####
One Freedom Square
Reston Town Center
11951 Freedom Drive
Reston, Virginia 20190-5656
Attention: Matthias Alder
Facsimile: (703)  ###-###-####
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance with this Agreement. Any such communication will be deemed to have been given (i) when delivered, if personally delivered or sent by facsimile on a business day, and (ii) on the second business day after dispatch, if sent by internationally-recognized overnight courier. It is understood and agreed that this Section 20.5 is not intended to govern the day-to-day business communications necessary between the Parties in performing their duties, in due course, under the terms of this Agreement.
20.6 Entire Agreement; Modifications. This Agreement (including any Exhibits, Schedules, or other attachments hereto, each of which is hereby incorporated by reference herein) sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter of this Agreement and all prior agreements, understanding, promises and representations, whether written or oral, with respect thereto are superseded by this Agreement, including the Confidentiality Agreement between the Parties dated December 11, 2002; provided, however, that no agreement between the Parties executed contemporaneously with this Agreement will be so superseded by this Agreement. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment or modification of this Agreement will be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.
20.7 Relationship of the Parties. It is expressly agreed that the relationship between the Parties is and will be that of independent contractors, and that the relationship between the Parties will not constitute a partnership, joint venture or agency. Neither Party will have the authority to make any statements, representations or commitments of any kind, or to take any action, which will be binding on the other, without the prior written consent of the other to do so. All persons employed by a Party will be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment will be for the account and expense of such Party.
20.8 Waiver. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit of such term or condition, but no such waiver will be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party of any right under this Agreement or of claims based on the failure to perform or a breach by the other Party will not be deemed a waiver of any other right under this Agreement or of any other breach or failure by said other Party whether of a similar nature or otherwise.
54
20.9 Counterparts. This Agreement may be executed in counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.
20.10 No Benefit to Third Parties. The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they will not be construed as conferring any rights on any other parties.
20.11 Further Assurance. Each Party will duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
20.12 English Language. This Agreement has been written and executed in the English language. Any translation into any other language will not be an official version hereof, and in the event of any conflict in interpretation between the English version and such translation, the English version will control.
20.13 Construction. Except where the context otherwise requires, wherever used, the singular will include the plural, the plural the singular, the use of any gender will be applicable to all genders, and the word or is used in the inclusive sense (and/or). The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term including as used herein means including, without limiting the generality of any description preceding such term. References to Section or Sections are references to the numbered sections of this Agreement, unless expressly stated otherwise.
[Remainder of this page is left blank intentionally]
55
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the date first above written.
Micromet AG | MedImmune, Inc. | |||||
By: | /s/ Christian Itin | By: | /s/ David M. Mott | |||
Name: | Christian Itin | Name: | David M. Mott | |||
Title: | Chief Business Officer | Title: | CEO | |||
By: | /s/ G.K. Mirow | |||||
Name: | G.K. Mirow | |||||
Title: | Chief Financial Officer |
[Signature Page to the Collaboration and License Agreement]
56
Exhibit A-1
Issued Patents and Published Patent Applications of Micromet
(as of the Effective Date)
(as of the Effective Date)
Patent / | ||||||
Application | ||||||
Country | Title of Application | Number | Comment/Status | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Exhibit A-2
Issued Patents and Published Patent Applications
licensed by Micromet
(as of the Effective Date)
licensed by Micromet
(as of the Effective Date)
Application | Application | Patent | Date of | |||||||||
Number | Filing Date | Country | Title of Application | Status | Number | Grant | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Application | Application | Patent | Date of | |||||||||
Number | Filing Date | Country | Title of Application | Status | Number | Grant | ||||||
[***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] |
Licensed by Micromet from [***]
As per Licensing Agreement of September 2000
As per Licensing Agreement of September 2000
I. Patents based on Swiss Patent Application [***]
Country | Appln.-No. | Patent-No. | Expiry Date | Status | Type | |||||
[***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] |
II. Patents based on Swiss Patent Application [***]
Country | Appln.-No. | Patent-No. | Expiry Date | Status | Type | |||||
[***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | ||||||
[***] | [***] | [***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
2
Patents and patent applications licensed to Micromet by [***] include, in addition to those rights indicated above, the patents and patent applications based on Swiss Patent Application [***] and any and all patents that may issue from said patent applications, including any and all divisions, continuations, continuations-in-part, extensions in any form whatsoever, substitutions, renewals, registrations, revalidations, reissues or additions of or to any of the aforesaid patents and patent applications.
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
3
Exhibit A-3
Published Patent Applications of Micromet
(subject to challenge as of the Effective Date)
(subject to challenge as of the Effective Date)
Patent / | ||||||
Application | ||||||
Country | Title of Application | Number | Comment/Status | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] | |||
[***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Exhibit B
MT103 Sequence
MT103 Amino Acid Sequence
[***]
[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Exhibit C
Micromet Technology Acquisition Agreements
[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Exhibit D
[***] Patent
Country | Appln.-No. | Patent-No. | Expiry Date | Status | Type | |||||
[***] | [***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Exhibit E
Development Plan for MT103
[Exhibit begins on following page.]
ARTICLE 1 MT103 Clinical Development Plan
General assumptions:
[***]
[***]
ARTICLE 2 Phase I/II studies
Terminated studies:
1. | MT103/I-01-2001; [***] [***] |
Currently ongoing studies:
2. | MT103/I-01-2002; [***] [***] | ||
3. | MT103/I-02-2002; [***]. [***] |
Currently planned studies:
[***]
[***]
a. | [***] |
[***]
Additional studies
[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Different routes of administration
[***]
Non-invasive patient studies
[***]
Proof of efficacy
[***]
End of Phase II decision points
[***]
Phase III studies/other studies for BLA filing
[***]
CLL
[***]
Safety population
[***]
Timelines
[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
2
2003 | 2004 | |||||||||||||||||||||||||||||||
1Q | 2Q | 3Q | 4Q | 1Q | 2Q | 3Q | 4Q | |||||||||||||||||||||||||
Process related | ||||||||||||||||||||||||||||||||
Transfer @ 100L | ||||||||||||||||||||||||||||||||
Trial runs & evaluation @ MEDI | ||||||||||||||||||||||||||||||||
Process optimization | ||||||||||||||||||||||||||||||||
Stability of representative material | ||||||||||||||||||||||||||||||||
Viral clearance (1) | ||||||||||||||||||||||||||||||||
Cell line | ||||||||||||||||||||||||||||||||
Bulk harvest testing inkl. VLP (2) | ||||||||||||||||||||||||||||||||
End of production cell bank | ||||||||||||||||||||||||||||||||
MCB Characterization (3) | ||||||||||||||||||||||||||||||||
Analytical methods | ||||||||||||||||||||||||||||||||
Validation potency assay | ||||||||||||||||||||||||||||||||
Two-sided binding assay (4) | ||||||||||||||||||||||||||||||||
Removal of contaminants (5) | ||||||||||||||||||||||||||||||||
MT103 PK assay (6) | ||||||||||||||||||||||||||||||||
Assay for anti-MT103 Abs (Immunogenicity) | ||||||||||||||||||||||||||||||||
Multimer characterization | ||||||||||||||||||||||||||||||||
Degradation pathways | ||||||||||||||||||||||||||||||||
Formulation | ||||||||||||||||||||||||||||||||
Lyophilization cycle opt. | ||||||||||||||||||||||||||||||||
In vitro pharmacology | ||||||||||||||||||||||||||||||||
Toxicity studies | ||||||||||||||||||||||||||||||||
Tissue Cross Reactivity w/ MT103(7) | ||||||||||||||||||||||||||||||||
General tox at high dose (8) | ||||||||||||||||||||||||||||||||
IND Filing |
NOTES: | (1 | ) | Studies to validate viral clearance; additional viruses and process steps to be evaluated. | |||
(2 | ) | Additional EOP testing (retroviral quantitation) may be needed on the unpurified bulk; next CTM production (either CMO or MEDI) | ||||
(3 | ) | MCB testing doesnt fulfill the safety requirements in FDA PTC for mfg of mAbs (XC assay, RT assay, and in vivo adventicious agents) | ||||
(4 | ) | Develop a two-sided binding assay; Biacore for CD3 and CD19. | ||||
(5 | ) | Additional assays needed to quantify removal of process and product-related contaminants. | ||||
(6 | ) | Develop a robust assay; consider generating an anti-idotype antibody assay. | ||||
(7 | ) | Conduct TCR studies with MT103 compound to show binding to tissues known to be positive and negative for CD3 and CD19. | ||||
(8 | ) | Conduct general toxicity study in non-relevant species at high MT103 dose level. |
[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
3
Exhibit F
Process Royalties Upon [***]
Royalty Rate upon | ||
[***] | repayment of costs | |
[***] | [***]% | |
[***] | [***]% | |
[***] | [***]% |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Exhibit G
Convertible Note
[see Second Amended and Restated Note, dated December 27, 2006, incorporated by reference to Micromets Current Report on Form 8-K filed with the Securities and Exchange Commission on January 4, 2007]