Collaboration and License Agreement between Avalon Pharmaceuticals, Inc. and MedImmune, Inc. (June 17, 2005)
Avalon Pharmaceuticals, Inc. and MedImmune, Inc. have entered into an agreement to collaborate on the discovery and development of compounds for treating inflammatory and autoimmune disorders. Avalon will provide access to its proprietary chemical genomics technology, while MedImmune will use this technology to identify and develop potential drug candidates. The agreement outlines each party's rights to intellectual property, obligations in the research program, and terms for licensing and commercialization. Confidentiality and indemnification provisions are included, and certain terms are subject to conditions and time limits specified in the contract.
EXECUTION COPY | CONFIDENTIAL |
1. | DEFINITIONS. | |
1.1 | Affiliate(s) means any Person that, directly or indirectly, owns, is owned by, or is under common ownership with a Party to this Agreement or any Person actually controlled by, controlling, or under common control with a Party to this Agreement. For the purposes of this definition, ownership or control means a Person owns or controls at least (a) fifty percent (50%) of the voting stock of a corporation, or (b) in the absence of the ownership of at least fifty percent (50%) of the voting stock of a corporation or in the case of non-corporate entity, has the power to direct or cause the direction of the management and polices of such corporation or non-corporate entity, as applicable. | |
1.2 | Analog of a given Compound means a chemical compound derived by addition to or manipulation of the structure of such Compound. | |
1.3 | Avalon Chemical Library means the set of Compounds that Avalon owns or controls that are employed during Stage II of the Research Program and from which a Compound Hit is selected. | |
1.4 | Avalon Compound Know-How means any Avalon Know-How covering the Lead Compounds, Optimized Lead Compounds and Compound Families. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
1.5 | Avalon Compound Patent Rights means any Avalon Patent Rights covering the Lead Compounds, Optimized Lead Compounds and Compound Families. | |
1.6 | Avalon Core Technology means all proprietary apparatuses, materials, methods, processes, information, data, databases and analyses Controlled by either Avalon or its Affiliates as of the Effective Date or coming into the Control of Avalon or its Affiliates during the Term relating to the use of HITS, METS, RACETraCK and/or TSAR and all related screening methods and processes, including methods and processes useful or helpful to induce a desired profile across a gene signature set and its correlation with the inhibition or activation of a target. | |
1.7 | Avalon Indemnified Party shall have the meaning set forth in Section 11.1. | |
1.8 | Avalon Target Know-How means * and any analyses thereof obtained from the activities conducted by Avalon under Sections A.2 or A.3 of the Research Program; * the* designed by Avalon and any Know-How developed by Avalon relating to the use of * for inhibiting expression of a Target in a Reference Cell or MedImmune Cell under * of the Research Program (other than Avalon Core Technology); * (as defined in * and any Avalon Know-How developed by Avalon under the Research Program related thereto; and (d) any protein, peptide, biological agent (including but not limited to an antibody), Selected Compound Hit, Lead Compound, Analog of a Lead Compound, Optimized Lead Compound or Clinical Candidate that would have the substantially equivalent * as determined by Avalon Core Technology obtained from the activities conducted by Avalon under the Research Program. | |
1.9 | Avalon Know-How means all apparatuses, materials (including the Avalon Chemical Library), processes, information, data, databases and analyses controlled by either Avalon or its Affiliates as of the Effective Date or coming into the control of Avalon or its Affiliates during the Term relating to the Research Program, including Joint Inventions that are also Avalon Core Technology and including information, analyses and material (including RNA) derived from HITS, METS, RACETraCK and TSAR or relating to any Compound, Compound Families and/or Compound Hits, Avalon Target Know-How, or information relating to cell signaling pathways involving a Target, that is at any time identified or developed under the Research Program, or to any Analogs of any such Compounds. | |
1.10 | Avalon Patent Rights means Patent Rights that Avalon owns or Controls as of the Effective Date or that come into the Control of Avalon during the Term relating to the Research Program, including Avalons interest in the Joint Inventions that are also Avalon Core Technology and including information, analyses and material (including RNA) derived from HITS, METS, RACETraCK and TSAR or relating to any Compound, Compound Families and/or Compound Hits, Avalon Target Know-How, or information relating to cell signaling pathways involving a Target, that is at any time identified or developed under the Research Program, or to any Analogs of any such |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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Compounds including those patents and/or patent applications set forth on Exhibit C attached hereto and incorporated by reference. |
1.11 | Avalon Technology means the Avalon Patent Rights, Avalon Know-How, the Avalon Target Know-How and any and all intellectual property rights in data, information, materials and inventions created and/or invented solely by employees of Avalon or persons obligated to assign such data, information, materials and inventions to Avalon. | |
1.12 | Breaching Party has the meaning defined in Section 10.3.1(a). | |
1.13 | Calendar Quarter means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect. | |
1.14 | Change of Control means any of the following: (a) the sale or disposition of all or substantially all of the assets of a Party to a Third Party, (b) the acquisition by a Third Party, other than an employee benefit plan (or related trust) sponsored or maintained by a Party or any of its Affiliates, of more than 50% of such Partys outstanding shares of voting capital stock, or (c) the merger or consolidation of a Party with or into another corporation, other than a merger or consolidation of a Party in which holders of shares of such Partys voting capital stock immediately prior to the merger or consolidation will have at least 50% of the ownership of voting capital stock of the surviving corporation immediately after the merger or consolidation. | |
1.15 | Clinical Candidate means an (a) Optimized Lead Compound or any Analog thereof or (b) any other Compound that MedImmune selects or otherwise designates in writing to Avalon for participation in a Development and Commercialization Program as a candidate for clinical study in humans. | |
1.16 | Collaboration Technology has the meaning defined in Section 7.2.1(c). | |
1.17 | Commercially Reasonable Efforts means with respect to efforts and resources that would be at least commensurate with the efforts used by a Party, as applicable, to identify, discover, develop, market or sell products having similar market and profit potential as the Product, provided that such efforts shall be at least commensurate with the efforts reasonably used in the biotechnology industry for products having similar market and profit potential exercising prudent scientific and business judgment. | |
1.18 | Compound means (a) a chemical compound or substance, identified using Avalon Core Technology, together less than two kilodaltons (kD), with all complexes, mixtures and other combinations, prodrugs, metabolites, enantiomers, polymorphs, salt forms, racemates, and isomers thereof (b) that is not a nucleic acid, polypeptide, protein, vaccine or antibody and fragments of an antibody, any of which is either of natural origin, expressed by recombinant methodology or chemically synthesized or which may be a chemical structure derived therefrom, an analog, derivative, congener or the like. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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1.19 | Compound Family means a group of Compounds that shares a similar gene expression profile generated by METS analysis and a common chemical scaffold. | |
1.20 | Compound Hit means a Compound identified from HITS screening that induces a desired profile across a gene Signature Set that correlates with the inhibition or activation of a Target. Upon achievement of the milestone for Selection of a Compound Family and MedImmunes payment of the first milestone payment set forth in Section 5.2.2, MedImmune shall have the right to select, through written notice to Avalon, * provided, however, that MedImmune shall have the right, by delivering written notice to Avalon during the term of the Research Program, to delete any previously selected Compound Families and replace them with additional Compound Families so long as the total number of Compound Families so selected does not exceed *. | |
1.21 | Confidential Information means with respect to each Party, non-public proprietary data or information that belongs, in whole or in part, to such Party or its Affiliates and/or information designated as Confidential Information of such Party hereunder, including, but not limited to, information relating to a Partys research programs, development, marketing and other business practices and finances. | |
1.22 | Contract Year means, during the Term, the twelve-month time period from the Effective Date to the anniversary of the Effective Date. | |
1.23 | Control or Controlled means, with respect to any (a) material, technology, item of information, method, data or other know-how, or (b) intellectual property right, either ownership thereof or possession (other than by ownership) of the ability by Avalon or MedImmune, as the case may be, to grant the other party access and/or a license as provided herein without breaching the terms of an agreement or other arrangement with a Third Party. | |
1.24 | Development and Commercialization Program means all activities performed by MedImmune to develop a Clinical Candidate into a Product, obtain Regulatory Approval of such Product and commercialize such Product, including marketing and selling. | |
1.25 | Disclosing Party has the meaning defined in Section 8.1. | |
1.26 | Effective Date has the meaning set forth in the preamble. | |
1.27 | FDA means the United States Food and Drug Administration, and any successor agency(ies) thereto. | |
1.28 | Field means the use by MedImmune of the Avalon Target Know-How * including but not limited to *. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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1.29 | First Commercial Sale means, with respect to any Product and any country of the world, the first sale of such Product under this Agreement to a Third Party in such country, after such Product has been granted Regulatory Approval by the competent Regulatory Authorities in such country. | |
1.30 | FTE or Full Time Equivalent means a full time equivalent scientific person year consisting of a total of * of scientific work on or directly related to the Research Program. Work on or directly related to the Research Program can include, but is not limited to, experimental preclinical and clinical laboratory and research work, recording and writing up results, reviewing literature and references, holding scientific discussions, managing and leading scientific staff, and carrying out management duties related to the Research Program. The portion of an FTE year devoted by any one employee under this Agreement shall be determined by dividing the number of hours during any twelve-month period devoted by such employee *. | |
1.31 | FTE Rate means *. The FTE Rate is limited to salary, fringe benefits, overhead and routine lab supplies (other than those taken into account under Project Reagent Costs on Exhibit B). | |
1.32 | High Throughput Integrated Transcriptional Screening or HITS means that portion of the Avalon Patent Rights and/or Avalon Know-How that encompasses a highly modified quantitative polymerase chain reaction platform used to screen large numbers of compounds by determining the compounds effect on the expression of a given set of genes. | |
1.33 | Indemnifying Party has the meaning defined in Section 11.3. | |
1.34 | IND means an Investigational New Drug Application, as defined in the United States Food Drug & Cosmetics Act, that is required to be filed with the FDA before beginning clinical testing of a Product in human subjects, or an equivalent foreign filing. | |
1.35 | Joint Inventions has the meaning set forth in Section 7.1.3. | |
1.36 | Know-How means information and data, including, but not limited to, materials, formulae, procedures, processes, protocols, techniques and results of experimentation and testing. | |
1.37 | Lead Compound means a Compound Hit that has been selected for Lead Compound Optimization, based upon data obtained through secondary screening in various assays performed by the Parties as outlined in the Research Program. | |
1.38 | Lead Compound Optimization means the chemical modification of a Lead Compound, undertaken by or on behalf of either Party, in order to enhance the Lead |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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Compounds properties, including potency, in vivo efficacy, pharmacokinetic profile, solubility and other physical chemical characteristics, and/or decreased toxicity. | ||
1.39 | Management Committee or MC shall have the meaning set forth in Section 3.1. | |
1.40 | MedImmune Antibodies means any polyclonal or monoclonal antibody provided by MedImmune to Avalon that specifically binds to * including, but not limited to, variants, chimeric antibodies, humanized antibodies, human antibodies, recombinant antibodies, grafted antibodies, single chain antibodies and fragments or derivatives of any of the foregoing. | |
1.41 | MedImmune Cells *. | |
1.42 | MedImmune Indemnified Party shall have the meaning set forth in Section 11.2. | |
1.43 | MedImmune Know-How means all materials, processes, information, data, databases and analyses controlled by either MedImmune or its Affiliates as of the Effective Date, or coming into the control of MedImmune or its Affiliates during the Term, relating to the MedImmune Antibodies, and MedImmune Cells, including any information relating to cell signaling pathways involving a Target, and, in all instances, not encompassing any Avalon Patent Rights and/or Avalon Know-How. | |
1.44 | MedImmune Patent Rights means Patent Rights that MedImmune owns or controls as of the Effective Date or that come into the control of MedImmune during the term of this Agreement, which Patent Rights claim any MedImmune Invention relating to the MedImmune Antibodies and MedImmune Cells and not encompassing any Avalon Patent Rights and/or Avalon Know-How. | |
1.45 | MedImmune Technology means the MedImmune Antibodies, MedImmune Cells, MedImmune Patent Rights, MedImmune Know-How and any and all intellectual property rights in data, information, materials and inventions created and/or invented solely by employees of MedImmune or any Third Party obligated to assign such data, information, materials and inventions to MedImmune. | |
1.46 | MedImmune Termination Notice shall have the meaning set forth in Section 10.3.2. | |
1.47 | Microarray-based Expanded Transcriptional Screening or METS means that portion of the Avalon Patent Rights and/or Avalon Know-How encompassing the production and use of gene microarray platforms used for the in-depth characterization of cell treatments. | |
1.48 | NDA means a New Drug Application, as defined in the Food Drug & Cosmetic Act, that is required to be approved by the FDA before marketing a Product, or an equivalent foreign filing. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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1.49 | Net Sales means the gross invoice price for sales of Products as to each Calendar Quarter by MedImmune, its Affiliates, or sublicensees, as appropriate, to Third Parties during such Calendar Quarter, less, if not previously deducted from the amount invoiced or received, reasonable and customary amounts for: (i) trade, cash and quantity discounts or rebates (other than price discounts granted at the time of sale), service allowances and brokers or agents commissions, if any, actually allowed or paid, (ii) refunds, credits or allowances actually given or made for rejection or return of, previously sold Products or for retroactive price reductions (including Medicaid, managed care and similar types of rebates); (iii) taxes, duties or other governmental charges imposed and paid by MedImmune on the production, sale delivery or use of a Product, (excluding income and franchise taxes), as adjusted for rebates and refunds; (iv) any administrative fees paid to group purchasing organizations or managed care entities necessary for the sale of the Product; * provided that MedImmune shall perform a reconciliation relating to this allowance, as consistent with other MedImmune products and practices, and provide to Avalon reasonable documentation supporting the reconciliation. A sale of a Product is deemed to occur upon the invoicing, or if no invoice is issued, upon the earlier of shipment or transfer of title in the Product to a Third Party. | |
All of the foregoing deductions from the gross invoiced sales prices of Licensed Products shall be determined in accordance with GAAP. In the event that MedImmune, its Affiliates or Sublicensees make any adjustments to such deductions after the associated Net Sales have been reported pursuant to this Agreement, the adjustments shall be reported and reconciled in the next report and payment of any royalties due. | ||
In the case of any sale or other disposal of a Product between or among MedImmune, its Affiliates or sublicensees, for resale, Net Sales shall be calculated as above only on the gross invoice price of the first arms length sale thereafter to an independent Third Party. | ||
No royalties shall accrue on the disposition of Product in reasonable quantities by MedImmune, its Affiliates or sublicensees as samples (promotion or otherwise) or as donations (for example, to non-profit institutions or government agencies for a non-commercial or humanitarian purpose). | ||
Proceeds from any Product used in a clinical trial will only be included in Net Sales to the extent MedImmune receives cash compensation for such Product. | ||
1.50 | Notifying Party has the meaning set forth in Section 7.2.4. | |
1.51 | Optimized Lead Compound means a Lead Compound that has undergone Lead Compound Optimization. | |
1.52 | Options has the meaning set forth in Section 5.3. | |
1.53 | Option Agreement(s) has the meaning set forth in Section 5.3. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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1.54 | Patent Rights means any and all (a) patents, (b) pending patent applications, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, and (c) all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation, supplementary protection certificates or the equivalent thereof. | |
1.55 | Phase I Clinical Trial means a human clinical trial in the United States that would satisfy the requirements of US 21 CFR 312.21(a), or in any other country that would satisfy the analogous, relevant standards in such country. | |
1.56 | Phase II Clinical Trial means a human clinical trial in the United States that would satisfy the requirements of US 21 CFR 312.21(b), or in any other country that would satisfy the analogous, relevant standards in such country. | |
1.57 | Phase III Clinical Trial means a human clinical trial in the United States that would satisfy the requirements of US 21 CFR 312.21(c), or in any other country that would satisfy the analogous, relevant standards in such country. | |
1.58 | Pivotal Registration Clinical Trial means a human clinical trial the results of which are intended to generate safety and efficacy data necessary to support Regulatory Approval in the proposed therapeutic indication, as more fully defined in 21 CFR § 312.21(c) in the United States and equivalent submissions with similar requirements in other countries. | |
1.59 | Product means (a) any pharmaceutical product containing any Compound identified by use of the Avalon Patent Rights and/or Avalon Know-How as modulating Target activity, (b) any Compound that is derived from a Compound identified by use of the Avalon Patent Rights and/or Avalon Know-How as modulating Target activity (including analogs, homologs, salts, isoforms, enantiomers, polymorphs, prodrugs and compounds with the same or similar structure), or (c) any Compound derived or identified by Avalon during the Research Program from information obtained from employing the Avalon Patent Rights and/or Avalon Know-How, including one or more Lead Compounds, Analogs or Optimized Lead Compounds as an active ingredient. | |
1.60 | Program Budget has the meaning defined in Section 5.1.1 and as more fully set forth in Exhibit B attached hereto. | |
1.61 | Project Team has the meaning defined in Section 3.1(c)(ii). | |
1.62 | Proposed Disclosure has the meaning defined in Section 8.5. | |
1.63 | Rapid Assessment of Compound Efficacy, Transcriptional Change and Kinetics or RACETraCK means those Avalon Patent Rights and/or Avalon Know-How which |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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are directed to and/or encompasses the use of HITS or METS in conjunction with animal disease models to evaluate in vivo Compound activity. | ||
1.64 | Receiving Party has the meaning defined in Section 8.1. | |
1.65 | Reference Antibodies means any non-proprietary (to either Party) * including, but not limited to, variants, chimeric antibodies, human antibodies, humanized antibodies, recombinant antibodies, grafted antibodies and single chain antibodies, whether provided by MedImmune or otherwise. | |
1.66 | Reference Cells means any non-proprietary (to either Party) *, whether provided by MedImmune or otherwise. | |
1.67 | Reference Compound means any non-proprietary (to either Party) compound that has a known chemical structure and known activity. | |
1.68 | Regulatory Approval means the technical, medical and scientific licenses, registrations, authorizations and approvals (including, without limitation, approvals of New Drug Applications (NDAs), supplements and amendments, pre- and post- approvals, pricing and Third Party reimbursement approvals, and labeling approvals) of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the commercial manufacture, distribution, marketing, promotion, offer for sale, use, import, export and sale of a Product in a regulatory jurisdiction. | |
1.69 | Regulatory Authority means any national (e.g., the United States Food and Drug Administration), supra-national (e.g., the European Commission, the Council of the European Union, or the European Agency for the Evaluation of Medicinal Products), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the world involved in the granting of Regulatory Approval for the Product. | |
1.70 | Research Program means the Research Program as approved by the MC and to be attached hereto as Exhibit A, which may be amended from time to time by the MC. | |
1.71 | SEC has the meaning defined in Section 8.3. | |
1.72 | Selected Compound Hit has the meaning set forth in Section 1.20. | |
1.73 | Signature Set means a set of genes explicitly identified by METS during the Research Program, which provides a unique profile indicative of the inhibition or activation of a Target. | |
1.74 | Stage I, Stage II and Stage III shall have the respective meanings set forth in Exhibit A. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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1.75 | Target means genes and/or proteins in the *. Should MedImmune exercise the First Option and/or the Second Option under Section 5.3, Target will be amended in such Option Agreement(s) to refer to the particular target for which the First Option and/or Second Option is being exercised throughout the Option Agreement, including, but not limited to, the definition of Avalon Target Know-How. | |
1.76 | Target Biomarkers means a set of genes identified by METS during the Research Program which may be used to identify a therapeutic or prophylactic response in a patient, or predict patient sensitivity to Reference Antibodies or MedImmune Antibodies, Compound Hits, Lead Compounds, Lead Compound Analogs, Optimized Lead Compounds, Clinical Candidates and/or Products. | |
1.77 | Technology Access Fee shall have the meaning set forth in Section 5.2.1. | |
1.78 | Term shall have the meaning set forth in Section 10.1. | |
1.79 | Territory means the world. | |
1.80 | Third Party means any person or entity other than Avalon, MedImmune or their respective Affiliates. | |
1.81 | T-SAR means transcriptional structure activity relationship. | |
1.82 | *means any natural or synthetic *. | |
1.83 | * means any molecule or molecular complex, other than an antibody, expressed by a cell that specifically binds * and exerts an effect on the cell as a result of such binding. | |
1.84 | Valid Claim means a claim (i) of any issued, unexpired United States or foreign patent that shall not have been donated to the public, disclaimed, abandoned nor held invalid or unenforceable by a court or government agency of competent jurisdiction in an unappealed or unappealable decision, or (ii) in the case of any United States or foreign patent application, that shall not have been canceled, withdrawn, or abandoned or pending for more than seven years from the earliest priority date of such application. | |
2. | LICENSES. | |
2.1 | Licenses to MedImmune. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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2.2 | Licenses to Avalon. |
2.3 | Sublicensing to Third Party Contractors. Notwithstanding any provision to the contrary in this Agreement, if pursuant to Section 3.1(c)(iii), the MC approves the use of one or more Third Parties to perform certain tasks for either Party under the Research Program, the Party entering into a contract with such Third Party for the performance of such services, may, as part of such contract, grant to such Third Party a nonexclusive, nontransferable, nonsublicensable license or sublicense, as applicable, under the Avalon Patent Rights and/or Avalon Know-How or the MedImmune Technology, as applicable, only to the extent and only for so long as such license or sublicense is necessary for such Third Party to perform such tasks under the Research Program. A Party entering into any Third Party licenses or sublicenses, as applicable, must require the Third Party to execute a confidential disclosure agreement with terms and covenants relating to the protection of confidential information and intellectual property reasonably acceptable to the other Party. Notwithstanding anything to the contrary, no rights in or to the Avalon Core Technology may be licensed or sublicensed without the express prior written consent of Avalon. Notwithstanding anything to the contrary, no rights in or to the MedImmune Technology may be licensed or sublicensed without the express prior written consent of MedImmune. | |
2.4 | No Other Licenses. The Parties expressly understand and agree that the only licenses granted under this Agreement are the licenses expressly granted under this Agreement and that there is no implied license or license by estoppel. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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3. | MANAGEMENT OF COLLABORATION. | |
3.1 | Management Committee |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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3.2 | Management Committee Disputes. Any disputes or disagreements arising from the planning or performance of the Research Program that cannot be resolved by the members of the MC shall be resolved in accordance with this Section 3.2. If the MC cannot reach consensus * after it has met and attempted to reach such consensus, the matter shall then be immediately referred to the Chief Executive Officer of Avalon, or such other person holding a similar position designated by Avalon from time to time, and a senior officer of MedImmune designated by the Chief Executive Officer of MedImmune, from time to time, for resolution. The executive/senior officers shall use |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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reasonable efforts to resolve the matter referred to them. If the executive/senior officers cannot reach a mutually acceptable decision * after the matter was referred to them, then *. The Parties acknowledge and agree that the provisions of this Section 3.2 are intended to apply to decisions regarding the purposes and powers identified * and related decisions concerning * and are not intended to apply to disputes regarding * and/or (ii) whether or not * in accordance with * under this Agreement; and/or (iii) whether or not * all of which shall be subject to the provisions of Article 13. In addition, the Parties acknowledge and agree that the provisions of this Section 3.2 shall not permit * this Agreement and/or require * to perform any action or take any measure under * has not been allowed * pursuant to this Agreement. | ||
3.3 | MedImmune Executive Committee. The MedImmune Executive Committee shall review and approve recommendations from the MC of Lead Compounds selected for Lead Optimization prior to the initiation of Stage III. | |
4. | RESEARCH AND DEVELOPMENT. | |
4.1 | General. Under the terms and conditions set forth herein, Avalon shall perform, with collaboration from MedImmune, a research program for the discovery, identification, screening, characterization and optimization of Compounds and Products active against Targets (collectively, the Research Program). The Research Program is set forth in Exhibit A attached hereto. | |
4.2 | Term of the Research Program. Unless this Agreement is earlier terminated, the Research Program shall terminate when the optimization of the final Lead Compound selected for Lead Compound Optimization has been completed. It is expected that the Research Program will take approximately * to complete, which can be extended upon the mutual written agreement of the Parties or terminated by MedImmune in accordance with Section 10.3.2. | |
4.3 | Conduct of the Research Program. Avalon and MedImmune shall each use its respective Commercially Reasonable Efforts to perform its obligations under the Research Program. All activities to be undertaken in the performance of the Research Program shall be carried out by employees of the Parties and/or their respective Affiliates, provided, however, that if either Party is able to reasonably demonstrate, and the MC agrees, that it would be in the best interests of both Parties to contract with one or more Third Parties to perform certain tasks under the Research Program, the Party responsible for such task may enter into a contract with a Third Party to perform such task, which contract shall be subject to the prior written approval of the MC and to obligations of confidentiality at least as stringent as those contained in this Agreement; provided that entering into an agreement with a Third Party shall not relieve a Party from the performance of its obligations under this Agreement. In determining whether to utilize the services of any Third Party in conducting activities under the Research Program, the Parties shall consider what would be the most efficient and cost-effective means for accomplishing the proposed activity, any relevant intellectual property issues |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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that may impede a Third Partys ability to perform the proposed activity or that may warrant limiting the performance of the proposed activity to one of the Parties, and other relevant factors. | ||
4.4 | No Liability of Avalon. Notwithstanding the foregoing or any other provision of this Agreement, MedImmune acknowledges and agrees that the Research Program is experimental in nature and that Avalon does not make any representations or warranties regarding the success of the Research Program, and Avalon shall have no liability to MedImmune as a result of any failure to achieve or delay in achieving any results under the Research Program or any Development and Commercialization Program provided that Avalon has used Commercially Reasonable Efforts. | |
5. | RESEARCH PROGRAM FUNDING, PAYMENTS AND ROYALTIES. | |
5.1 | Research Program Funding. MedImmune shall be solely responsible for funding the Research Program in accordance with the Program Budget (as defined herein). |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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5.2 | MedImmune Payments and Royalties; Option. |
Milestone Payment | Milestone Event | |
* | Selection of Compound Famil(y/ies) for Lead Compound Optimization | |
* | Proof of concept of a Compound Hit or Lead Compound in an animal model | |
* | Selection of a Clinical Candidate | |
* | First dosing in a human being in a Phase I Clinical Trial | |
* | First dosing in a human being in a Pivotal Registration Clinical Trial or the date of agreement by the FDA that a trial not originally designated as a Pivotal Registration Clinical Trial could be used for registration | |
* | Filing of an NDA for a Product | |
* | Approval of an NDA for a Product | |
* | First Commercial Sale in Europe | |
* | First Commercial Sale in Japan | |
* | Clinical validation of the first Target Biomarker |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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Milestone Payment | Milestone Event | |
(this milestone payment will not be due if achievement of this milestone event is part of a Development Program for a Product) |
Net Sales | Royalty | |
Amounts from * up to and including * | * | |
Amounts in excess of * | * |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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5.3 | Option. MedImmune and Avalon may be interested in pursuing additional collaborations. Avalon grants to MedImmune options (the First Option and the Second Option, and together, the Options) to enter into up to two additional collaboration and license |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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agreements (the Option Agreement(s)) concerning targets other than the Target; provided that: (a) MedImmune may exercise either or both of the Options by delivery of written notice to Avalon accompanied by (i) the payment of * for each Option Agreement, which amount shall constitute the Technology Access Fee for each of the Option Agreements, and (ii) a description of the proposed subject matter of the Option Agreement. Each of the Option Agreements shall be identical to this Agreement in form and substance, except concerning the Technology Access Fee, the subject matter of each Option Agreement and conforming definitional changes, the lack of this Option provision, and except as mutually agreed to by the Parties. The subject matter of each Option Agreement shall be left to the discretion of MedImmune, unless Avalon has already entered into or is in the process of entering into an agreement with a Third Party or unless Avalon is pursuing a research or development program that may preclude Avalon from entering into an Option Agreement with MedImmune concerning the proposed subject matter. In the event that Avalon notifies MedImmune of such determination, then such Option exercise shall not count against the two exercises permitted hereunder, and Avalon shall have no liability for failing to enter into an Option Agreement pursuant to such Option exercise or for failing to disclose any of the facts to MedImmune underlying Avalons determination. In the event that the Parties do not enter into an Option Agreement, any payments provided by MedImmune to Avalon shall be refunded to MedImmune within *. MedImmune shall have the right to exercise the First Option by delivery of written notice to Avalon under this Section 5.3 until * and shall have the right to exercise the Second Option by delivery of written notice to Avalon under this Section 5.3 *. | ||
6. | ACCOUNTING AND RECORDS. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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6.2 | Right to Audit. Upon the written request of Avalon and with at least * prior written notice, but not more than * and at Avalons expense, MedImmune shall permit an independent certified public accounting firm of internationally recognized standing, selected by Avalon and acceptable to MedImmune, which acceptance will not be unreasonably refused, to have access during normal business hours to those records of MedImmune as may be reasonably necessary to verify the accuracy of the milestone payments or the royalty reports furnished by MedImmune pursuant to Section 6.1 of this Agreement in respect of any year ending not more than * prior to the date of such request. The report prepared by such independent certified public accounting firm will disclose only the conclusions of the accounting firm regarding the audit and specify the amount of any underpayment or overpayment, and will not include copies of any books or records reviewed. A copy of such report will be sent or otherwise provided to MedImmune by such accounting firm at the same time it is sent or otherwise provided to Avalon. No other information obtained by the accounting firm will be shared with Avalon. If the accounting firms report shows underpayment of royalties, within * after MedImmune s receipt of such report, MedImmune shall remit to Avalon the amount of such underpayment. If the underpayment is in excess of * then MedImmune shall also remit to Avalon an amount equal to Avalons substantiated out-of-pocket costs of the audit. Any overpayment of royalties shall be refunded to MedImmune by Avalon within * of the date Avalon receives the written report of the accounting firm. Avalon shall treat all financial information subject to review under this Section 6.2 as Confidential Information of MedImmune and shall cause its accounting firm to retain all such financial information in confidence under terms at least as restrictive as those set forth in Article 8. | |
7. | PATENT PROSECUTION; ENFORCEMENT; INFRINGEMENT, OWNERSHIP OF INVENTIONS. | |
7.1 | Ownership. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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7.2 | Patent Rights. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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8. | CONFIDENTIALITY. | |
8.1 | Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that, for the term of this Agreement and for ten (10) years thereafter, each Party (the Receiving Party), receiving hereunder any Confidential Information of the other Party (the Disclosing Party) shall keep such Confidential Information confidential and shall not publish or otherwise disclose or use such Confidential Information for any purpose other than as provided for in this Agreement except for Confidential Information that the Receiving Party can establish: |
8.2 | Authorized Disclosure and Use. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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8.3 | SEC Filings. Either Party may disclose the terms of this Agreement to the extent required, in the reasonable opinion of such Partys legal counsel, to comply with applicable laws, including without limitation the rules and regulations promulgated by the United States Securities and Exchange Commission (the SEC). Notwithstanding the foregoing, before disclosing this Agreement or any of the terms hereof pursuant to this Section 8.3, the Parties will consult with one another on the terms of this Agreement to be redacted in making any such disclosure. If a Party discloses this Agreement or any of the terms hereof in accordance with this Section 8.3, such Party agrees, at its own expense, to seek confidential treatment of portions of this Agreement or such terms, as may be reasonably requested by the other Party. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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8.4 | Publications. During the term of the Research Program, each Party will submit to the other Party for review and approval all proposed academic, scientific and medical publications and public presentations relating to the Research Program, Lead Compounds, Clinical Candidates, or Products for review in connection with preservation of Patent Rights and/or to determine whether Confidential Information should be modified or deleted. Written copies of such proposed publications and presentations shall be submitted to the non-publishing Party no later than * before submission for publication or presentation and the non-publishing Party shall provide its comments with respect to such publications and presentations within * of its receipt of such written copy. The review period may be extended for an additional * in the event the non-publishing Party can demonstrate a reasonable need for such extension including, but not limited to, the preparation and filing of patent applications. By mutual agreement, this period may be further extended. Avalon and MedImmune shall each comply with standard academic practice regarding authorship of scientific publications and recognition of contribution of other parties in any publications relating to the Research Program, Lead Compounds, Clinical Candidates, or Products. In no event, however, will Avalon publish or release any information regarding the MedImmune Antibodies, MedImmune Cells and/or Avalon Target Know-How without the prior, express written consent of MedImmune. | |
8.5 | Public Announcements. On the Effective Date, the Parties shall issue a press release relating to this Agreement or activities conducted hereunder in the form attached hereto as Exhibit D. A Party may issue any subsequent press releases or other written public disclosures relating to this Agreement or activities conducted hereunder (each a Proposed Disclosure) upon prior written approval of the other Party, such approval not to be unreasonably withheld; provided, however, that each Party will use commercially reasonably 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 would like to release such Proposed Disclosure. No approval of the other Party shall be required if a subsequent press release solely discloses information that has previously been approved. Neither Party shall use the name, trademark, trade name or logo of the other Party or its employees in any publicity or news release relating to this Agreement or its subject matter, without the prior express written permission of the other Party. Neither Party shall disclose the existence or terms of this Agreement except as provided in Sections 8.2 and 8.3. | |
8.6 | No Implied Rights. Except as otherwise set forth in this Agreement, nothing herein shall be construed as giving either Party any right, title, interest in or ownership of the Confidential Information of the other Party. For the purposes of this Agreement, specific information disclosed as part of Confidential Information shall not be deemed to be in the public domain or in the prior possession of the Receiving Party merely because it is embraced by more general information in the public domain or by more general information in the prior possession of the Receiving Party. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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9. | REPRESENTATIONS AND WARRANTIES. | |
9.1 | Representations and Warranties of Avalon. Avalon, subject to this Article 9, hereby represents, warrants, and covenants to MedImmune that, as of the Effective Date: |
9.2 | Representations and Warranties of MedImmune. MedImmune, subject to this Article 9, hereby represents, warrants, and covenants to Avalon that, as of the Effective Date: |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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9.3 | No Inconsistent Agreements. Neither Party has in effect and after the Effective Date neither Party shall enter into any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement or violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it. | |
9.4 | Disclaimer. THE FOREGOING WARRANTIES OF EACH PARTY ARE IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF NONINFRINGEMENT, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE ALL OF WHICH ARE HEREBY SPECIFICALLY EXCLUDED AND DISCLAIMED. | |
9.5 | Limitation of Damages. IN NO EVENT SHALL EITHER PARTY OR THEIR AFFILIATES BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, CONSEQUENTIAL OR TREBLE DAMAGES, WHETHER BASED ON CONTRACT, TORT, OR ANY OTHER LEGAL THEORY; PROVIDED, HOWEVER, THAT THIS LIMITATION SHALL NOT LIMIT THE INDEMNIFICATION OBLIGATION OF SUCH PARTY UNDER THE PROVISIONS OF ARTICLE 11 FOR SUCH DAMAGES CLAIMED BY A THIRD PARTY. | |
10. | TERM AND TERMINATION. | |
10.1 | Term. The term of this Agreement will commence on the Effective Date and extend, unless this Agreement is terminated earlier in accordance with this Article 10 or until the earlier of (i) fifty (50) years or (ii) such time as MedImmunes obligation to pay royalties with respect to the sale of such Product in all countries expires in accordance with |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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Section 5.2.3 (the Term). For the avoidance of doubt, the Parties acknowledge and agree that certain licenses may survive the termination or expiration of this Agreement in accordance with the provisions of Sections 10.4 and 10.5. | ||
10.2 | Expiration. If, at any time after the expiration of Stage III of the Research Program, MedImmune has determined not to select a Clinical Candidate, this Agreement shall expire effective as of the date that MedImmune provides written notice that no Clinical Candidate will be selected; provided, however, that if one or more Options have been exercised in accordance with Section 5.3, then the applicable provisions of this Agreement shall survive to the extent necessary to give effect thereto. Subject to Section 10.4(d), in the event of expiration of this Agreement pursuant to this Section 10.2, all licenses granted hereunder will automatically expire, and expiration of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration. | |
10.3 | Termination. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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10.4 | Effect of Termination or Expiration. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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10.5 | Survival. Except as expressly provided herein, the following provisions shall survive expiration or termination of this Agreement: Article 6, Article 7, Article 8, Article 9, Article 10, Article 11, Article 13 and Article 14, and Section 2.2(b), Section 2.1 (in accordance with Section 10.4) and Section 5.2. | |
11. | INDEMNIFICATION AND INSURANCE. | |
11.1 | Indemnification by MedImmune. MedImmune shall defend, indemnify and hold harmless Avalon and its Affiliates and their respective directors, officers, employees, shareholders and agents (each, an Avalon Indemnified Party) from and against any and all Third Party claims, suits or demands for liabilities, damages, losses, costs and expenses (including the reasonable fees of attorneys and other professionals) arising out of or resulting from (i) the development, manufacture, use, distribution or sale of any Product by MedImmune, its Affiliates, distributors, co-marketers or sublicensees, their agents or any person or entity that prepares or manufactures Product for or on behalf of any of the foregoing or any person or entity who receives or obtains Product from any source; (ii) Development and Commercialization Program work performed by or on behalf of MedImmune other than by Avalon or a Third Party mutually agreed upon by Avalon and MedImmune; (iii) the performance by MedImmune of any of MedImmunes obligations under the Research Program and/or (iv) any MedImmune representation or warranty set forth herein being untrue in any material respect when made, or the failure of MedImmune to perform any covenant hereunder, except in each case of (i) (iii) above, to the extent caused by the negligence or willful misconduct of Avalon or any Avalon Indemnified Party. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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11.2 | Indemnification by Avalon. Avalon shall defend, indemnify and hold harmless MedImmune, and its Affiliates and their respective directors, officers, employees, shareholders, sublicensees and agents (each, a MedImmune Indemnified Party) from and against any and all Third Party claims, suits or demands for liabilities, damages, losses, costs and expenses (including the reasonable fees of attorneys and other professionals) arising out of or resulting from (i) the performance of Avalons obligations under the Research Program, or (ii) any Avalon representation or warranty set forth herein being untrue in any material respect when made, including, but not limited to, Third Party claims of infringement, or the failure of Avalon to perform any covenant hereunder, except in the case of (i) above, to the extent caused by the negligence or willful misconduct of MedImmune or any MedImmune Indemnified Party. | |
11.3 | Procedure. Each Party will promptly notify the other in the event it becomes aware of a claim for which indemnification may be sought hereunder. In case any proceeding (including any governmental investigation) shall be instituted involving any Party in respect of which indemnity may be sought pursuant to this Article 11, such Party (the Indemnified Party) shall promptly notify the other Party (the Indemnifying Party) in writing and the Indemnifying Party and Indemnified Party shall meet to discuss how to respond to any claims that are the subject matter of such proceeding. The Indemnifying Party shall retain counsel reasonably satisfactory to the Indemnified Party and shall pay the fees and expenses of such counsel related to such proceeding. The Indemnifying Party shall have the sole right to control the defense of any such claim or action. In any such proceeding, the Indemnified Party shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at the expense of the Indemnified Party unless the Indemnifying Party and the Indemnified Party shall have mutually agree in writing to the retention of such counsel. The Indemnifying Party shall not be liable for any settlement of any proceeding effected by the Indemnified Party without its written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the Indemnifying Party agrees to indemnify the Indemnified Party from and against any loss or liability by reason of such settlement or judgment. The Indemnifying Party may settle any such claim, demand, action or other proceeding or otherwise consent to an adverse judgment (a) with prior written notice to the Indemnified Party but without the consent of the Indemnified Party where the only liability is the payment of money and the Indemnifying Party makes such payment or (b) with the prior written consent of the Indemnified Party, which will not be unreasonably withheld or delayed. | |
11.4 | Insurance. Prior to the first sale or use in humans, whichever is earlier, of a Product, MedImmune shall maintain and carry in full force and effect product liability insurance (including contractual liability coverage on MedImmunes indemnification obligations under this Agreement), which shall provide coverage with minimum limits of * per occurrence and * in the aggregate. Such insurance shall be maintained with an insurance company or companies having an A.M. Best rating of A- or better. MedImmune shall promptly provide Avalon with Certificates of Insurance evidencing the same upon the written request of Avalon. MedImmune may satisfy the insurance requirements set forth in this Agreement under MedImmunes existing product liability policies; MedImmune |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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will not be required to procure a new or separate insurance policy for the purposes of this Agreement. MedImmune reserves the right to self-insure with respect to all or part of its obligations under this Agreement. | ||
12. | DILIGENCE OBLIGATIONS. | |
12.1 | Annual Development and Commercialization Program Plan. Upon initiation of a Development and Commercialization Program, MedImmune shall submit to Avalon a Development and Commercialization Program plan setting forth in reasonable detail the activities to be pursued in that Development and Commercialization Program during the first twelve (12) months. Thereafter, annual updates of the Development and Commercialization Program plan for each Contract Year in which there is expected to be Development and Commercialization Program activity shall be submitted to Avalon by no later than three months prior to the end of the previous Contract Year. MedImmune shall have sole discretion for making all decisions relating to the Development and Commercialization of Products, provided that actions or omissions undertaken by MedImmune in its sole discretion shall not relieve it of its obligations under this Agreement, including its obligations to use Commercially Reasonable Efforts in connection with the Development and Commercialization Program as set forth in Section 12.3. | |
12.2. Development and Commercialization Program Reports. During performance of any Development and Commercialization Program, MedImmune shall submit to Avalon semi-annual reports setting forth in reasonable detail the past half calendar years activities, and the prospective activities for the next half calendar year. | ||
12.3 | MedImmunes Commercially Reasonable Efforts. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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12.4 | Avalons Commercially Reasonable Efforts. During the Term, Avalon agrees to use Commercially Reasonable Efforts to perform research in accordance with the Research Program. | |
13. | DISPUTE RESOLUTION. | |
13.1 | Good Faith Negotiations. In the event of any dispute, disagreement or claim between the Parties as to the interpretation of any provision of this Agreement or the performance of obligations hereunder other than Management Committee disputes under Section 3.2, the matter, upon written request of either Party, shall first be referred to the Chief Executive Officer of Avalon, or such other person holding a similar position designated by Avalon from time to time, and the Chief Executive Officer of MedImmune, or such other person holding a similar position designated by MedImmune from time to time, for resolution. These individuals shall, within * of when the matter is referred to them, attempt in good faith to resolve the dispute. These individuals may obtain the advice of other employees as they deem necessary or advisable in order to make the decision. | |
13.2 | Arbitration. Any dispute, disagreement or claim (other than a dispute that involves the validity, scope or enforceability of patents that arise under the patent laws of a country or a dispute under Article 3) that cannot be resolved by the respective officers of the Parties under Section 13.1 above within * after its submission, shall be settled by binding arbitration held in Washington, DC in accordance with the Commercial Arbitration Rules of the American Arbitration Association, except that (a) there shall be three U.S.-licensed attorneys acting as arbitrators, (b) the arbitration proceedings shall be subject to the confidentiality provisions of Article 8 of this Agreement and (c) the Parties will bear their own costs in preparing for the arbitration. Whenever a Party decides to institute arbitration proceedings, it shall give written notice to that effect to the other. The demand for arbitration may be filed by either Party within a reasonable time after the controversy or claim has arisen; provided, however, in no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based upon such claim, dispute or other matter in question would be barred by the applicable statute of limitations or the provisions of this Agreement. Each Party shall select one arbitrator. The Party initiating recourse to arbitration shall include in its notice of arbitration its appointment of an arbitrator, and the other Party shall select the second arbitrator within * of the date it receives such notice. The two arbitrators selected by the Parties shall select the third arbitrator. At least one of the arbitrators shall be a licensed attorney who has represented pharmaceutical companies for at least ten (10) years and is knowledgeable concerning the type of subject matter at issue in the dispute. Discovery in any arbitration proceeding under this Section 13.2 shall be permitted with respect to the performance by the Parties of their obligations under this Agreement and such other matters as the arbitrators may determine (it being the intent of the Parties that full discovery occur with respect to the salient facts). The arbitrators shall render a decision within * of the completion of the arbitration. The arbitrators shall award costs and expenses, including reasonable attorneys fees, to the Party in whose favor the arbitral |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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award has been granted. The award of the arbitrators shall be in writing and shall be binding on the Parties, and judgment upon the award rendered by the arbitrators may be entered in any federal court having jurisdiction. Any decision or award made by the arbitrators shall be in accordance with the terms and conditions of this Agreement and shall not be inconsistent with the rights and obligations of the Parties as set forth in this Agreement. Nothing in this Agreement bars the right of either Party to obtain preliminary or permanent injunctive relief against threatened conduct that will cause it loss or damage, in accordance with the rules for obtaining injunctive relief in any jurisdiction, including the applicable rules for obtaining restraining orders and preliminary injunctions. The Parties hereby waive their right to a jury trial in connection with any matter submitted for resolution by arbitration hereunder, except as provided in the last sentence hereof. Notwithstanding the foregoing, disputes regarding the validity, inventorship, scope or enforceability of patents shall be submitted to a court of competent jurisdiction in the country where such patent has issued or such patent application is filed. | ||
14. | MISCELLANEOUS. | |
14.1 | Assignment. Neither this Agreement nor any interest hereunder shall be assignable by either Party without the prior written consent of the other Party, except for assignment in connection with a Change of Control of a Party or in connection with a transfer by MedImmune of all or substantially all of the assets to which this Agreement is related. This Agreement shall be binding upon the successors and permitted assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of such Partys successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with this Section 14.1 shall be void. | |
14.2 | Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or reasonably appropriate in order to carry out the purposes and intent of the Agreement or to better assure and confirm unto such other Party its rights and remedies under this Agreement. | |
14.3 | Force Majeure. Neither Party shall be liable to the other for delay or failure in the performance of the obligations on its part contained in this Agreement if and to the extent that such failure or delay is due to circumstances beyond its control which it could not have avoided by the exercise of reasonable diligence. It shall notify the other Party promptly should such circumstances arise, giving an indication of the likely extent and duration thereof, and shall use all commercially reasonable efforts to resume performance of its obligations as soon as practicable, provided, however, that neither Party shall be required to settle any labor dispute or disturbance. Actions taken by a Party to resume performance of its obligations with respect to the Research Program shall be taken in consultation with the MC. | |
14.4 | Correspondence and Notices. Correspondence, reports, documentation, notices and any other communication in writing between the Parties pursuant to this Agreement shall be delivered by hand, sent by registered mail, return receipt requested, postage prepaid or |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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sent by facsimile transmission (receipt verified) to the employee or representative of the other Party who is designated by such other Party to receive such written communication. Notices shall be deemed effective given and received upon personal delivery, the fifth day following mailing sent by registered or certified mail, or upon transmission of facsimile (with telephonic notice). | ||
All correspondence to Avalon shall be addressed as follows: |
20358 Seneca Meadows Parkway
Germantown, MD 20876
Attn: Chief Executive Officer
Telephone: (301)  ###-###-####
Fax: (301)  ###-###-####
20358 Seneca Meadows Parkway
Germantown, MD 20876
Attn: General Counsel
Telephone: (301)  ###-###-####
Fax: (301)  ###-###-####
All correspondence to MedImmune shall be addressed as follows: |
One MedImmune Way
Gaithersburg, MD 20878
Attn: Senior Vice President, Corporate Development
Telephone: (301)  ###-###-####
Fax: (301)  ###-###-####
Attn: General Counsel
Telephone: (301)  ###-###-####
Fax: (301)  ###-###-####
14.5 | Amendment. No amendment, modification or supplement of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party. | |
14.6 | Waiver. No provision of the Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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Party. Such waiver shall not be deemed a waiver of any other right hereunder or of any other breach or failure by a Party whether of similar nature or otherwise. | ||
14.7 | Severability. Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall be, as to such jurisdiction and to the extent practicable, modified so as to make it valid, legal and enforceable and to maintain as nearly as practicable the intent of the Parties without invalidating the remaining provisions hereof or affecting the validity or enforceability of such provision in any other jurisdiction. | |
14.8 | Descriptive Headings; Interpretation. The section headings contained in this Agreement are for convenience of reference only, do not form a part of this Agreement and shall not affect in any way the meaning or interpretation of this Agreement. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words include, includes and including shall be deemed to be followed by the phrase but not limited to. All references herein to Articles, Sections and Exhibits shall be deemed references to Articles and Sections of, and Exhibits to, this Agreement unless the context shall otherwise require. All Exhibits attached to this Agreement shall be deemed incorporated herein by reference as if fully set forth herein. Words such as herein, hereof, hereto, hereby and hereunder refer to this Agreement and to the Exhibits, taken as a whole. Except as otherwise expressly provided herein: any reference in this Agreement to any law shall include corresponding provisions of any successor law and any regulations and rules promulgated pursuant to such law or such successor law. | |
14.9 | Governing Law. This Agreement shall be governed by and interpreted in accordance with the substantive laws of the State of New York, without regard to conflict of law principles thereof. | |
14.10 | Entire Agreement. This Agreement and the Exhibits thereto, constitute the full and entire understanding and agreement among the Parties with regard to the subject matter hereof and no Party shall be liable or bound to any other Party in any manner by any representations, warranties, covenants, or agreements except as specifically set forth herein or therein. Nothing in this Agreement, express or implied, is intended to confer upon any Party, other than the Parties hereto and their respective successors and assigns, any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided herein. | |
14.11 | Independent Contractors. It is expressly agreed that the Parties are independent contractors under this Agreement. Nothing herein contained shall be deemed to create an employment, agency, joint venture or partnership relationship between the Parties hereto or any of their agents or employees, or any other legal arrangement that would impose liability upon one Party for the act or failure to act of the other Party. Neither Party shall have any express or implied power to enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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14.12 | Debarment. Each Party agrees that it will not use, in any capacity, in connection with any of its obligations to be performed under this Agreement any individual who has been debarred under the FD&C Act or the Generic Drug Enforcement Act. | |
14.13 | Counterparts. This Agreement may be executed in any number of counterparts, by facsimile or otherwise, each of which need not contain the signature of more than one Party but all such counterparts taken together shall constitute one and the same agreement and shall be deemed an original. | |
14.14 | Cumulative Remedies. Except as set forth in Section 12.3.3, no remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law. | |
14.15 | Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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this Agreement to be effective as of the Effective Date.
Avalon Pharmaceuticals, Inc. | MedImmune, Inc. | |||||
By | /s/ | By | /s/ | |||
Name: Kenneth C. Carter | Name: Edward T. Mathers | |||||
Title: President and CEO | Title: SVP, Corporate Development |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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A.1. | General. The purpose of the Research Program is to apply Avalon Technology to the goal of discovering and optimizing Small Molecules that can block the activity of the *. In addition, the Research Program will apply Avalon Technology to the goal of defining Target Biomarkers that can characterize the activity of MedImmune Antibodies or other pharmaceutical agents, which block *. | |
The Research Program shall consist of three stages that are characterized by specific research activities. During Stage I, Avalon will conduct METS profiling *. During Stage II, Avalon will conduct HITS screening of the Avalon Chemical Library on * in order to identify Compound Hits that produce the desired response profile across the gene Signature Set. Such Compound Hits will be organized into Compound Families. Avalon and MedImmune shall further characterize Compound Hits and/or Compound Families in relevant secondary assays, and Avalon and MedImmune shall select Lead Compounds and/or Compound Families to be advanced into Stage III. During Stage III, Avalon and MedImmune will perform Lead Compound Optimization on Lead Compounds with the goal of defining and selecting Clinical Candidates. | ||
A.2 | Stage I | |
A.2.1 Collaborative Duties. Within 30 days of execution of this Agreement, the Project Team shall meet and identify the * and * for initiation of Stage I of the Research Program. The Project Team may identify further * to be used during Stage I while Stage I is being conducted. * | ||
At this time, we anticipate profiling treatments of at least one target cell line with the following kinds of reagents in Stage I: * | ||
Initially, target cells will be treated individually with each of these reagents and profiled by METS analysis. This will establish baseline expression profiles for each of these reagents treated in isolation. * | ||
A.2.2 MedImmune Duties. Within thirty (30) days after the first meeting of the Project Team, MedImmune shall provide any * to Avalon, along with any MedImmune Know-How necessary for Avalon to perform the Stage I research. MedImmune shall also provide to Avalon samples of any Reference Compounds that are in its possession, if a decision is made by the Project Team to pursue profiling of such agents. | ||
A.2.3 Avalon Duties. Upon receipt of the *, MedImmune Know-How and Reference Compounds (if any), Avalon will treat the Reference and MedImmune Cells with the * |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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and perform METS profiling of said treatments. * Avalon will conduct all relevant data analyses (including the use of bioinformatics and other analytical tools) required to establish * gene Signature Sets associated with blocking the activity of *. | ||
A.3 | Stage II | |
A.3.1. Collaborative Duties. The MC will review the data and recommendations from Avalon concerning the pilot screen of approximately * compounds selected from the Avalon Chemical Library (see below). At its discretion, based upon the analysis of screening data from the pilot screen, the MC may recommend further refinement of a gene Signature Set prior to the screening of the remaining compounds * in the Avalon Chemical Library. If the data from the pilot screen appear satisfactory to the MC, then the MC will recommend the screening of the remaining compounds in the Avalon Chemical Library. | ||
A.3.2 Avalon Duties. | ||
(a) Avalon will transfer and validate the relevant gene Signature Sets obtained from Stage I onto the HITS quantitative polymerase chain reaction platform. Avalon will then perform a pilot screen against a target cell used in Stage I. In the pilot screen, Avalon will test approximately * compounds selected from the Avalon Chemical Library. Data from the pilot screen will be analyzed by Avalon to evaluate the performance of the screen and the suitability of the selected gene Signature Sets. Following the pilot screen and upon approval by the MC, the remaining compounds in the Avalon Chemical Library (approximately * compounds) will be screened and Compound Hits will be identified by Avalon. Although Avalon estimates that approximately * Compounds from the Avalon Chemical Library may induce a gene signature similar enough to the Signature Sets obtained from Stage I to warrant further analysis, Avalon makes no warranty or representation as to how many, if any, Compounds will be identified pursuant to this Section A.3.2(a). | ||
(b) Avalon will re-screen any Compound Hits identified in Section A.3.2(a) at least once using the same HITS assay employed in Section A.3.2(a), in order to confirm the activity originally identified in the primary HITS screen. Avalon estimates, but does not warrant or represent, that approximately *. | ||
(c) Avalon will group any Compound Hits identified by the HITS assays of Sections A.3.2(a) and A.3.2(b) into Compound Families based on similarities in function and chemical scaffold. | ||
(d) Avalon will *. | ||
(e) Avalon shall choose representative, confirmed Compound Hits from each Compound Family and subject such Compound Hits to METS profiling, to generate |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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global gene expression profiles for each confirmed Compound Hit Family. The criteria used to select these Compounds from the Compound Families shall be determined by Avalon and shall include considerations of expected toxicity, expected pharmacokinetics, solubility and ability to easily modify the chemical structure. | ||
A.3.3 MedImmune Duties: MedImmune will recommend relevant secondary assays (non-METS assay) for the characterization of hits identified from screening during Stage II. MedImmune will conduct testing of compound hits in relevant (non-METS) secondary assays. When MedImmune conducts such testing, Avalon will transfer compound to MedImmune without any information on chemical structure and MedImmune will not determine or have any Third Party determine the structures of the compounds provided. Alternately, MedImmune will transfer MedImmune Know-How for the performance of such assays to Avalon, provided that resources and FTEs to conduct such assays are available at Avalon. In such cases, MedImmune will pay for the performance of such assays at Avalon. MedImmune shall participate in the selection of Lead Compounds for Lead Optimization and recommend such Lead Compounds to the MedImmune Executive Committee for approval. The MedImmune Executive Committee shall review such recommendations and approve the initiation of Stage III, in its sole discretion. | ||
A.4 | Stage III | |
A.4.1 Collaborative Duties. For each Compound Family selected by MedImmune under Section A.3.3, some or all of the Compound Hits within that Compound Family shall be designated Lead Compounds and subjected to Lead Compound Optimization. The MC shall review progress of Lead Compound Optimization and shall ultimately make the decision on selection of Clinical Candidates. | ||
A.4.2 Avalon Duties. | ||
Avalon shall use standard medicinal and combinatorial chemistry to synthesize compound Analogs during Lead Compound Optimization. Throughout the optimization process, Avalon shall employ T-SAR and METS profiling of Lead Compounds and Lead Compound Analogs to monitor and maintain activity that mimics the Signature Set generated in Stage I. The METS profiling will also be used to monitor global gene activity and identify subgroups of Analogs based upon changes in gene expression. Throughout the optimization process, Avalon shall also use RACETraCK to rapidly address in vivo activity of Lead Compounds or Compound Analogs, and identify those Lead Compounds or Lead Compound Analogs with the best activity profile. It is anticipated that MedImmune will conduct animal studies and will provide the necessary cells and/or tissues from such studies to Avalon for the isolation of RNA for use in a RACETraCK assessment; however, only Avalon shall perform the actual RACETraCK assessment of that RNA. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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Any Compound within a Compound Family undergoing optimization under this Section A.4, which is discovered to not inhibit the Target or have a modulating activity in the Target pathway shall no longer be considered part of the Avalon Technology, and shall no longer be exclusively licensed to MedImmune pursuant to Section 2.1(a). | ||
A.4.3 MedImmune Duties. MedImmune shall be responsible for * of Compounds and Analogs generated from screening or during Lead Compound Optimization. RACETraCK profiling and analysis of any cells or tissues isolated from such animal models will be performed by Avalon. MedImmune shall designate at least *, or present good reasons to the MC why no Clinical Candidate has been selected. If MedImmune selects a Clinical Candidate, then it must use Commercially Reasonable Efforts to initiate a Development and Commercialization Program and commercialize a Product. |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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1. | CERTAIN AVALON PATENT RIGHTS |
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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COLLABORATION TO DISCOVER SMALL MOLECULE THERAPEUTIC DRUGS
FOR INFLAMMATORY DISEASES
* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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* | The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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