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Exclusive License Agreement

License Agreement

Exclusive License Agreement | Document Parties: NITROMED INC | Archemix Corp | Ribomic, Inc You are currently viewing:
This License Agreement involves

NITROMED INC | Archemix Corp | Ribomic, Inc

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Title: Exclusive License Agreement
Governing Law: New York     Date: 12/19/2008
Industry: Biotechnology and Drugs     Law Firm: Mintz Levin     Sector: Healthcare

Exclusive License Agreement, Parties: nitromed inc , archemix corp , ribomic  inc
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Exhibit 10.48 Execution Copy EXCLUSIVE LICENSE AGREEMENT      This Exclusive License Agreement (this " Agreement ") is made effective as of December 10, 2007 (the " Effective Date "), by and between Archemix Corp, a Delaware corporation with offices at 300 Third Street, Cambridge, MA 02142 (" Archemix "), and Ribomic, Inc., a corporation organized under the laws of Japan with offices at 3-15-5-601 Shirokanedai, Minato-Ku, Tokyo 108-007 Japan (" Ribomic "). Archemix and Ribomic are each sometimes hereinafter referred to individually as a "Party" and collectively as the "Parties."      WHEREAS, Archemix is the owner of or otherwise controls, certain patents and proprietary technology;      WHEREAS, Ribomic desires to obtain an exclusive license from Archemix under such patents and technology to develop and commercialize certain products; and      WHEREAS, Archemix desires to grant such license to Ribomic on the terms and subject to the conditions of this Agreement.      NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows: 1. DEFINITIONS      Whenever used in the Agreement with an initial capital letter, the terms defined in this Article 1 shall have the meanings specified.      1.1 " Acceptance "means (a) with respect to the United States, [***] days from the date an NDA is received by the FDA if no refuse-to-file order is issued by the FDA or, to the extent issued, such later date on which the deficiencies referred in such refuse-to-file notice are corrected or the NDA is otherwise deemed "filed" by the FDA; and (b) with respect to an E5 Country or Japan, the equivalent of the above or any other action or non-action that allows a party to proceed with a product launch.      1.2 " Adverse Event " means any untoward, undesired or unplanned medical occurrence in a human clinical trial subject or patient, which occurrence has a temporal relationship to administration of a Licensed Product, whether or not considered related to the Licensed Product, including, without limitation, any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease that may be associated with the use of such Licensed Product.      1.3 " Affiliate " means, with respect to any Person, any other Person that, directly or indirectly, controls or is controlled by or is under common control with, such Person. For purposes of this definition, "control" means (a) ownership of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors in the case of a corporation or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, (b) status as a general partner in any partnership, or (c) any other arrangement whereby a Person controls or has the right to control the board of directors of a corporation or equivalent governing body of an entity other than a corporation. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 




 

     1.4 " Annual Net Sales " means, with respect to any Calendar Year, the aggregate amount of the Net Sales for such Calendar Year.      1.5 " Applicable Laws " means federal, state, local, national and supra-national laws, statutes, rules and regulations, including any rules, regulations, guidance, guidelines or requirements of regulatory authorities, national securities exchanges or securities listing organizations, that may be in effect from time to time during the Term and are applicable to a particular activity hereunder.      1.6 " Applicable Sublicense Income Rate "means (a) with respect to any Early Stage Sublicense Agreement, [***] percent ([***]%) and (b) with respect to any Late Stage Sublicense Agreement, [***] percent ([***]%).      1.7 " Aptamer " means (a) any naturally or non-naturally occurring oligonucleotide identified through the SELEX Process that binds with high specificity and affinity to a Target, and (b) any oligonucleotide Derived from an oligonucleotide of clause (a) that has such high specificity and affinity to a Target.      1.8 " Archemix-Gilead License Agreement " means the License Agreement between Gilead Sciences, Inc. and Archemix dated October 21, 2001, as amended.      1.9 " Calendar Quarter " means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31.      1.10 " Calendar Year " means the period beginning on the Effective Date and ending on December 31 of the year in which the Effective Date falls and thereafter each successive period of twelve (12) months commencing on January 1 and ending on December 31.      1.11 " Challenge " means any challenge to the validity or enforceability of any Licensed Patent Right in the absence of a breach of this Agreement including, without limitation, by (a) filing a declaratory judgment action in which any Licensed Patent Right is alleged to be invalid or unenforceable; (b) citing prior art pursuant to [***], filing a request for re-examination of any Licensed Patent Right pursuant to [***] and/or [***] or provoking or becoming party to an interference with an application for any Licensed Patent Right pursuant to [***]; or (c) filing or commencing any reexamination, opposition, cancellation, nullity or similar proceedings against any Licensed Patent Right in any country.      1.12 " Commercially Reasonable Efforts " means, with respect to activities of Ribomic under this Agreement, the efforts and resources customarily used by similarly sized biotechnology companies in the performance of such activities for other products owned by such companies which are of similar market potential and at a similar stage of development, taking into account the competitiveness of the market place, the regulatory structure involved and other relevant and material factors.      1.13 " Commercialization Regulatory Approval " means, with respect to any Product, the Regulatory Approval required by Applicable Laws to sell such Licensed Product for use in the Field in a country or region in the Territory. "Commercialization Regulatory Approval" shall include, without limitation, the approval of any Drug Approval Application. For purposes of clarity, "Commercialization Regulatory Approval" in the United States shall mean final approval Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

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of an NDA for the first Indication in the United States, "Commercialization Regulatory Approval" in the European Union shall mean marketing authorization for the applicable Product pursuant to Council Directive 2001/83/EC, as amended, or Council Regulation 2309/93/EEC, as amended and "Commercialization Regulatory Approval" in Japan shall mean final approval of an application submitted to the Ministry of Health, Labor and Welfare and the publication of a New Drug Approval Information Package permitting marketing of the applicable Product in Japan, as any of the foregoing may be amended from time to time.      1.14 " Commercialization Regulatory Filing "means, with respect to any Licensed Product, the filing required to obtain Commercialization Regulatory Approval for use in the Field in a country or region in the Territory.      1.15 " Completion " means, with respect to a clinical trial, the closing of the database with respect to the applicable clinical trial.      1.16 " Confidential Information " means all information and Technology disclosed or provided by, or on behalf of a Party (the " Disclosing Party ") to the other Party (the " Receiving Party ") or to any of the Receiving Party’s employees, consultants, Affiliates or sublicensees pursuant to or in connection with this Agreement; provided, that, none of the foregoing shall be Confidential Information if: (a) as of the date of disclosure, it is known to the Receiving Party or its Affiliates, as demonstrated by credible written documentation, other than by virtue of a prior confidential disclosure to such Receiving Party; (b) as of the date of disclosure it is in the public domain or it subsequently enters the public domain other than through a breach by the Receiving Party or its Affiliates of a contractual obligation; (c) it is obtained by the Receiving Party from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party or its Affiliates; or (d) it is independently developed by or for the Receiving Party or its Affiliates without reference to or use of any Confidential Information of the Disclosing Party or its Affiliates as demonstrated by credible written documentation. For purposes of clarity, unless excluded from Confidential Information pursuant to the provisos of the preceding sentence, any scientific, technical or financial information Controlled by a Disclosing Party and disclosed at any meeting of the Parties or disclosed through an audit report shall constitute Confidential Information of the Disclosing Party.      1.17 " Control " or " Controlled " means with respect to Technology or Patent Rights, the possession by a Party of the right to grant a license or sublicense to such Technology or Patent Rights as provided herein without the payment of additional consideration to, and without violating the terms of any agreement or arrangement with, any Third Party and without violating any Applicable Laws.      1.18 " Defined Territory " means, collectively, the United States, any E5 Country and Japan.      1.19 " Derived " means identified, developed, created, synthesized, designed, resulting or generated from, conjugated to, or complexed with (whether directly or indirectly or in whole or in part).      1.20 " Development " and " Develop " means, with respect to any Licensed Product, all activities with respect to such Licensed Product relating to the development in connection with Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

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seeking, obtaining and/or maintaining Commercialization Regulatory Approval for such Licensed Product in the Field in the Territory, including, without limitation, all pre-clinical research and development activities, all human clinical studies, all activities relating to developing the ability to manufacture any Licensed Product or any component thereof (including, without limitation, process development work), and all other activities relating to seeking, obtaining and/or maintaining any Regulatory Approvals from the FDA and/or any Foreign Regulatory Authority.      1.21 " Diagnosis " means (a) the determination or monitoring of (i) the presence or absence of a disease, (ii) the stage, progression or severity of a disease or (iii) the effect on a disease of a particular treatment; and/or (b) the selection of patients for a particular treatment with respect to a disease.      1.22 " Diagnostics " means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.      1.23 " Early Stage Sublicense Agreement "means any Sublicense Agreement that is not a Late Stage Sublicense Agreement.      1.24 " E5 Country " means each of the United Kingdom, Germany, France, Italy and Spain.      1.25 " Existing License Agreement "means the Non-Exclusive IgG Antibody Purification License Agreement dated as of October 31, 2006, by and between Ribomic and Archemix.      1.26 " Field " means the prevention, treatment or cure of any Indication in animals and humans, but excluding, without limitation, Diagnostic Products, In Vivo Imaging Applications and all non-therapeutic uses.      1.27 " First Commercial Sale " means, on a country-by-country basis, the date of the first arm’s length transaction, transfer or disposition for value to a Third Party of a Licensed Product by or on behalf of, Ribomic, its Affiliate(s) or Sublicensee(s) in such country after obtaining the Commercialization Regulatory Approval for the Licensed Product. For purposes of clarity, the use of any Licensed Product in clinical trials, pre-clinical studies or other research or development activities or the disposal or transfer of a Licensed Product for a bona fide charitable purpose or for purposes of a commercially reasonable sampling program shall not be deemed to be an arm’s length transaction, transfer or disposition for value for purposes of this definition.      1.28 " FDA " means the United States Food and Drug Administration and any successor agency or authority thereto.      1.29 " Full Royalty Net Sales "means Net Sales in any country in which the Full Royalty Term has not expired.      1.30 " Full Royalty Term "means, with respect to each Licensed Product in each country in the Territory, the period beginning on the date of First Commercial Sale of such Licensed Product in such country and ending on the expiration of the last to expire Valid Claim Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

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of the Licensed Patent Rights in such country.      1.31 " IND " means an investigational new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed or to be filed with the FDA with regard to any Licensed Product and any counterpart of an investigational new drug application that is required in any other country or region in the Territory before beginning clinical testing of a Licensed Product in humans in such country or region.      1.32 " Indication " means any indication, disease, disorder or condition in the Field, which can be treated, controlled, prevented, cured or the progression of which can be delayed.      1.33 " Initiation " means, with respect to a human clinical trial, the first date that a subject or patient is dosed in such clinical trial.      1.34 " In Vitro Diagnostics " means the use of the SELEX Process or Aptamers in the assay, testing or determination, outside of a living organism, of a substance in a test material. In Vitro Diagnostics shall include, among other things, the use of the SELEX Process or Aptamers in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples); and (c) any other in vitro diagnostic use of the SELEX Process or Aptamers in drug development processes, including target identification, pre-clinical and clinical testing, and the following more specific examples of uses of Aptamer technology: (i) to observe, through protein profiling, protein levels moving up or down in diseases or models of diseases, and to evaluate whether such proteins are sensible targets for the development of therapeutic agents; (ii) to observe coordinated expression of protein pathways in a variety of biological states in various systems; (iii) to study protein or metabolite levels during pre-clinical drug candidate evaluation in response to putative therapeutic agents during clinical trials ( e.g. , as markers of efficacy or response); and (iv) to study human protein or metabolite levels in response to putative therapeutic agents during clinical trials ( e.g. , as markers of efficacy or response). Notwithstanding the above, In Vitro Diagnostics shall exclude any of the above-described uses in this Section 1.34(c) conducted in the Development of Program Aptamers under this Agreement.      1.35 " In Vivo Diagnostics " means the use of any product containing one or more Aptamers for any human in vivo diagnostic purpose related to ( inter alia ) the identification, quantification or monitoring of the propensity toward, or actual existence of, any disease state.      1.36 " Joint Patent Rights " means Patent Rights that contain one or more claims that cover Joint Technology.      1.37 " Joint Technology " means any Technology (including, without limitation, any new and useful process, method of manufacture or composition of matter) that is jointly conceived or first reduced to practice (actively or constructively) by employees of or consultants Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

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to Ribomic and employees of or consultants to Archemix at any meeting of the DC.      1.38 " Knowledge " means, with respect to Archemix, the actual knowledge of the chief executive officer, any vice president or the chief legal officer of Archemix.      1.39 " Late Stage Sublicense Agreement "means any Sublicense Agreement involving a Licensed Product that is executed on or after the Initiation of a Phase II Clinical Trial with respect to such Licensed Product.      1.40 " Licensed Patent Rights " means all Patent Rights Controlled by Archemix or any of its Affiliates during the Term that cover or claim Licensed Products in the Field including, without limitation, the Development, manufacture, use, offer for sale, sale or importation thereof. For purposes of clarity, the Licensed Patent Rights, as of the Effective Date, include without limitation the Patent Rights listed on Exhibit A attached hereto.      1.41 " Licensed Product " means any pharmaceutical product containing, incorporating, comprised of, identified through the material use of or Derived from, in whole or in part, any Program Aptamer.      1.42 " Licensed Technology " means any Technology Controlled by Archemix or any of its Affiliates during the Term that is necessary or useful for the Development, manufacture, use, offer for sale, sale or importation of Licensed Products in the Field.      1.43 " Major Market Country "means each of the United States, the United Kingdom, Germany, Spain, France, Italy, Canada and Japan.      1.44 " Net Sales " means the gross amount billed or invoiced by Ribomic or any of its Affiliates or Sublicensees to Third Parties throughout the Territory for sales or other dispositions or transfers for value of Licensed Products less (i) allowances for normal and customary trade, quantity and cash discounts actually allowed and taken, and inventory management fees paid to wholesalers and distributors; (ii) transportation, insurance and postage charges, if paid by Ribomic or any Affiliate or Sublicensee and included on any such Person’s bill or invoice as a separate item; (iii) credits, chargebacks, retroactive price reductions, rebates and returns, to the extent actually allowed; (iv) negotiated payments made to private sector and government Third Party payors (e.g., PBMs, HMOs and PPOs) and purchasers/providers (e.g., staff model HMOs, hospitals and clinics), regardless of the payment mechanism, including, without limitation, off-invoice, rebate, chargeback and credit mechanisms, including, without limitation, with respect to any Net Sales in Japan, any sales-based contribution for "Drug Induced Suffering" and any sales-based contribution for "Contribution for Measure for Drug Safety," in each case as required by Applicable Laws or any regulatory authority, in the amount determined by and payable to the Pharmaceuticals and Medical Devices Agency (so-called "KIKO"); (v) discounts paid under discount prescription drug programs and reductions for coupon and voucher programs; and (vi) any tax, tariff, customs duty, excise or other duty or other governmental charge (other than a tax on income) levied on the sale, transportation or delivery of Licensed Product and actually paid by Ribomic or any of its Affiliates or Sublicensees. In addition, Net Sales are subject to the following:           (a) If Ribomic or any of its Affiliates or Sublicensees effects a sale, Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

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disposition or transfer of a Licensed Product to a customer in a particular country as part of a package of Licensed Products and services (but not in a Combination Product), the Net Sales of such Licensed Product to such customer shall be deemed to be "the fair market value" of such Licensed Product less applicable discounts pursuant to this definition of Net Sales. For purposes of this subsection (a), "fair market value" shall mean the fraction (A/A+B), where A equals the value that would have been derived had such Licensed Product been sold as a separate Licensed Product to another customer in the country concerned on customary commercial terms, during the applicable Calendar Quarter in the country concerned, and B equals the aggregate value that would have been derived had the other components of such package been sold as separate products to another customer in the country concerned on customary commercial terms, during the applicable Calendar Quarter in the country concerned.           (b) In the case of pharmacy incentive programs, hospital performance incentive program chargebacks, disease management programs, similar programs or discounts on "bundles" of Licensed Products, all discounts and the like shall be allocated among Licensed Products on the basis of which such discounts and the like were actually granted or, if such basis cannot be determined, in proportion to the respective list prices of such Licensed Products.           (c) For clarity, use of any Licensed Product in clinical trials, pre-clinical studies or other research or development activities or disposal or transfer of Licensed Products for a bona fide charitable purpose or purposes of a commercially reasonable sampling program shall not give rise to any Net Sales.           (d) Sales or transfers of Licensed Product among Ribomic, its Affiliates and Sublicensees for the purpose of subsequent resale to Third Parties shall not be included in Net Sales; with respect to such sales or transfers, the gross amounts billed or invoiced in connection with the subsequent resale to Third Parties will be included in the calculation of Net Sales.      In the event that a Licensed Product under this Agreement is sold in combination (" Combination Product ") with another ingredient or component having independent, supplementary or enabling therapeutic effect (e.g., as a catalyst or adjuvant) or diagnostic utility or that has independent function as a medical device or means of administration (a " Supplemental Component "), then "Net Sales," for purposes of determining royalty payments on the Combination Product, shall be calculated using one of the following methods:           (y) By multiplying the Net Sales of the Combination Product (calculated prior to the application of this formula) by the fraction C/C+D, where C is the average gross selling price, during the applicable Calendar Quarter in the country concerned, of the Licensed Product when sold separately, and D is the average gross selling price, during the applicable Calendar Quarter in the country concerned, of the Supplemental Component(s) when sold separately; or           (z) In the event that no such separate sales are made of the Licensed Product or any of the Supplemental Components in such Combination Product during the applicable Calendar Quarter in the country concerned, Net Sales, for the purposes of determining royalty payments, shall be calculated using the above formula where C is the reasonably estimated commercial value of the Licensed Product sold separately, during the applicable Calendar Quarter in the country concerned, and D is the reasonably estimated commercial value of the Supplemental Components sold separately, during the applicable Calendar Quarter in the country Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

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concerned,. Any such estimates shall be determined using criteria to be mutually agreed upon by the Parties. Such estimates shall be reported to Archemix in the reports to be provided pursuant to Section 4.5.1 hereof. If the Parties are unable to agree on the criteria for determining such estimates, either Party may submit such dispute for resolution pursuant to the provisions of Section 10.2.2.      1.45 " Non-Royalty Term " means, with respect to each Licensed Product that has been sublicensed under a Sublicense Agreement, the period commencing on the Effective Date and continuing on a Licensed Product-by-Licensed Product and country-by-country basis until the date on which no further payments of Sublicense Income are received by Ribomic.      1.46 " Partial Royalty Net Sales "means Net Sales in any country in which the Full Royalty Term has expired but the Partial Royalty Term has not expired.      1.47 " Partial Royalty Term "means, with respect to each Licensed Product in each country in the Territory, the period commencing on the day after the last day of the Full Royalty Term for such Licensed Product in such country and expiring ten (10) years from the date of the First Commercial Sale of such Licensed Product in such country.      1.48 " Patent Rights " means all rights and interests in and to issued patents and pending patent applications including, without limitation, non-provisional patent applications, and all divisions, continuations and continuations-in-part thereof, patents issuing on any of the foregoing, all reissues, reexaminations, renewals and extensions thereof, and supplementary protection certificates therefor, as well as any certificates of invention or applications therefor, and all foreign equivalents of any of the foregoing.      1.49 " Permitted Archemix Activities "means (a) with respect to any Program Target, any screening activities conducted by Archemix with respect to such Program Target for itself and/or for any Third Party for the purpose of identifying aptamers that bind to a Target other than a Program Target; and (b) any grant by Archemix to any Third Party of rights to discover, develop and/or commercialize aptamers that bind to Targets (including Program Targets) outside of the Field.      1.50 " Permitted Ribomic Activities "means, on a country-by-country and Valid Claim-by-Valid Claim basis, any activity conducted by Ribomic or any of its Affiliates or Sublicensees (a) involving the discovery, research, development and commercialization of aptamers in a country for use in the Field against any Target other than the Program Target at any time on and after the expiration of the last to expire applicable Valid Claim of the Licensed Patent Rights in such country or (b) pursuant to the terms of the Existing License Agreement, for so long as the Existing License Agreement continues in full force and effect.      1.51 " Person " means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

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     1.52 " Phase I Clinical Trial " means a clinical trial conducted in healthy humans, which clinical trial is designed to initially explore the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.      1.53 " Phase II Clinical Trial " means a clinical trial conducted in patients with a particular disease or condition, which clinical trial is designed to establish the safety, appropriate dosage and pharmacological activity of an investigational drug given its intended use, and to initially explore its efficacy for such disease or condition.      1.54 " Phase IIa Clinical Trial "means, as to a particular Licensed Product, the portion of a Phase II Clinical Trial which contains a sufficient number of subjects to generate sufficient data (if successful) to commence a Phase IIb or a Phase III Clinical Trial of such Licensed Product or otherwise satisfies the proof of concept applicable to such Licensed Product.      1.55 " Phase IIb Clinical Trial "means, as to a particular Licensed Product, the portion of a Phase II Clinical Trial which contains a sufficient number of subjects to generate sufficient data (if successful) to commence a Phase III Clinical Trial of such Licensed Product or act as a basis for obtaining Commercialization Regulatory Approval of such Licensed Product.      1.56 " Phase III Clinical Trial " means a pivotal clinical trial conducted in patients with a particular disease or condition, which clinical trial is designed to ascertain efficacy and safety of an investigational drug for its intended use and to define warnings, precautions and Adverse Events that are associated with the investigational drug in the dosage range intended to be prescribed, with the purpose of preparing and submitting applications for Regulatory Approval or label expansion to the FDA in the United States or pertinent Foreign Regulatory Authority in a country outside the United States.      1.57 " Program Aptamer " means any Aptamer that binds to a Program Target and any Aptamer(s) Derived therefrom that binds to a Program Target.      1.58 " Program Target " means the protein [***], as more fully described on Schedule 1 attached hereto.      1.59 " Radio Therapeutics " means any product for human therapeutic use that contains one or more Aptamers that targets specifically any diseased tissue, cells or disease-specific molecules or any tissue or cells which are affected by a disease or located in the close neighborhood of a disease process and is linked to or incorporates (a) radionucleotides or (b) any structure or elements which develop therapeutic effects similar to the effect of linking or incorporating radionucleotides after submission of any kind of radiation.      1.60 " Regulatory Approval " means any and all approvals (including pricing and reimbursement approvals), product and establishment licenses, registrations or authorizations of any kind of the FDA or any Foreign Regulatory Authority necessary for the development, pre-clinical and/or human clinical testing, manufacture, quality testing, supply, use, storage, importation, export, transport, marketing and sale of a Licensed Product (or any component Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

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thereof) for use in the Field in any country or other jurisdiction in the Territory.      1.61 Ribomic SELEX Patent Rights " means any Patent Rights that contain one or more claims that cover Ribomic SELEX Technology. For purposes of clarity, the Ribomic SELEX Patent Rights, as of the Effective Date, include without limitation the Patent Rights listed on Exhibit B attached hereto.      1.62 Ribomic SELEX Technology " means any Technology that is Controlled by Ribomic as of the Effective Date or during the Term relating to or constituting aptamer compositions or that is useful for the identification, generation, modification, optimization, stabilization or use of aptamers.      1.63 " ROFR Period "means the period commencing on the Effective Date and continuing until the date of execution by Ribomic of a Sublicense Agreement involving any Licensed Product and containing Minimum Acceptable Financial Terms.      1.64 " Royalty Term "means, with respect to each Licensed Product in each country in the Territory, the period beginning on the first day of the Full Royalty Term for such Licensed Product in such country and ending on the last day of the Partial Royalty Term for such Licensed Product in such country.      1.65 " SELEX Portfolio " means those Patent Rights licensed by Gilead to Archemix pursuant to the Archemix-Gilead License Agreement.      1.66 " SELEX Process " means any process used for the identification or generation of a nucleic acid that binds to a Target by means other than Watson-Crick base-pairing including, without limitation, those that are covered by the claims in (a) the SELEX Portfolio, including, without limitation, U.S. Patent Nos. [***] or [***], (b) any other Patent Rights Controlled by Archemix or (c) any continuation, divisional, continuation-in-part, substitution, renewal, reissue, re-examination or extension, or any foreign equivalent, of any of the foregoing Patent Rights.      1.67 " SELEX Technology " means any process for modifying, optimizing and/or stabilizing an Aptamer wherein such modification, optimization or stabilization includes, without limitation, minimization, truncation, conjugation, pegylation, complexation, substitution, deletion and/or incorporation of modified nucleotides.      1.68 " Sublicense Agreement "means any agreement between Ribomic and a Sublicensee.      1.69 " Sublicensee " means any Third Party to which Ribomic grants a sublicense of some or all of the rights granted to Ribomic under this Agreement.      1.70 " Sublicense Income "means [***] consideration and payments (including all upfront payments, milestone payments, and license or maintenance payments) received by Ribomic from any Sublicensees excluding (a) payments [***] a Sublicensee which are required to be used to [***] or [***] to be [***] by such Party [***] to a [***] for [***] which has been agreed to with the Sublicensee to the extent that the [***] for such [***] do not [***] the then [***] thereof, (b) payments made in consideration of the [***] of Ribomic to the extent that the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

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[***] for [***] does not [***] the then [***] thereof and (c) [***] on [***] by such Sublicensee made to Ribomic pursuant to the terms of the applicable sublicense agreement. Notwithstanding the foregoing, if a Sublicensee [***] of Ribomic and the [***] of [***] of [***] or if [***] to [***] and [***] the [***] of such [***] (such [***] being referred to as the [***]), then such [***] shall be [***] as [***]. For purposes of Section 1.70(b), the "Fair Market Value" of Ribomic’s shares on the date of sale shall be determined as follows: (i) if such shares are publicly traded on a recognized securities exchange or over the counter market, the fair market value of such shares shall be the closing price of such shares reported on the applicable date of sale; (ii) if such shares are not publicly traded on a recognized securities exchange or over the counter market, the Fair Market Value shall be the price per share of such shares paid on the date of sale or within three (3) months prior to the date of sale by a third party having no interest in Ribomic other than as a result of having purchased such shares; and (iii) if neither (i) or (ii) are applicable, the Fair Market Value shall be the price per share that a willing buyer would pay to a willing seller in an arm’s length transaction. If the Parties are unable to agree on Fair Market Value under clause (iii), the matter will be resolved in accordance with Section 10.2.2. For purposes of Section 1.70(a), the term "Fair Market Value" with respect to research and development funding shall mean the reasonable value of the applicable research and development activities based on full-time equivalent or other cost-accounting methodologies that are consistent with the approved budget and then-applicable current industry practices.      1.71 " Target " means a protein, cytokine, enzyme, receptor, transducer, transcription factor, antigen or any other non-nucleic acid molecule.      1.72 " Technology " means, collectively, inventions, discoveries, improvements, trade secrets and proprietary methods, whether or not patentable, including, without limitation: (a) methods of production or use of, and structural and functional information pertaining to, chemical compounds and (b) compositions of matter, data, formulations, processes, techniques, know-how and results (including any negative results).      1.73 " Territory " means all countries and jurisdictions of the world.      1.74 " Third Party " means any person or entity other than Ribomic, Archemix and their respective Affiliates.      1.75 " ULEHI " means University License Equity Holdings, Inc., formerly known as UTC.      1.76 " URC License Agreement " means the Restated Assignment and License Agreement, dated July 17, 1991, by and between University Research Corporation and Gilead Sciences, Inc. as successor in interest to NeXstar Pharmaceuticals, Inc.      1.77 " UTC " means University Technology Corporation, the successor to the University Research Corporation.      1.78 " Valid Claim " means any claim of a pending patent application or an issued, unexpired patent covered under the Licensed Patent Rights which, but for the license granted by Archemix hereunder, would be infringed by the discovery, research, manufacture, use, delivery, Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

11




 

import, offer for sale or sale of a Licensed Product or any component thereof, to the extent that such application or patent (a) has not been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction, (b) has not been permanently revoked, held invalid or declared unpatentable or unenforceable in a decision of a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c) has not been rendered unenforceable through disclaimer or otherwise, or (d) is not lost through an interference proceeding.       Additional Definitions . In addition, each of the following definitions shall have the respective meanings set forth in the section of this Agreement indicated below:

 

 

 

Definition

 

Section

AAA

 

10.2.1

Agreement

 

Recitals

Archemix

 

Recitals

Archemix License

 

2.1.2(a)

Archemix Indemnitees

 

8.1

Bankruptcy Action

 

9.2.4

Claims

 

8.1

Covered License Product

 

4.2.2

DC (Diligence Committee)

 

3.4

Development Plan

 

3.2

Disclosing Party

 

1.16

Dispute

 

10.2.1

Early Stage-Sublicensed Product

 

4.2.3(a)

Effective Date

 

Recitals

Expert

 

10.2.2(a)

Filing Party

 

6.4.3

Gilead Indemnitee

 

8.3

Indemnified Party

 

8.2

Indemnifying Party

 

8.2

Infringement

 

6.5.1

Infringement Notice

 

6.5.1

Minimum Acceptable Financial Terms

 

3.6

Non-Filing Party

 

6.4.3

Oncology Option

 

3.7

Oncology Option Notice

 

3.7

Oncology Option Termination Date

 

3.7

Party

 

Recitals

Parties

 

Recitals

Ribomic Patent Rights

 

6.2

Receiving Party

 

1.16

Required Jurisdictions

 

6.4.2

Ribomic

 

Recitals

ROFR Notice

 

3.6

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

12




 

 

 

 

Definition

 

Section

ROFR Response

 

3.6

Specific Diligence Obligations

 

3.1.2(b)

Sublicense Income Payments

 

4.4.1

Term

 

9.1

Third Party Negotiation Period

 

3.6

2. GRANT OF RIGHTS      2.1 Licenses .           2.1.1 Grant of Rights to Ribomic .                (a)  Grant of License . Archemix hereby grants to Ribomic an exclusive, royalty-bearing license, including the right to grant sublicenses in accordance with Section 2.1.1(c), under the Licensed Patent Rights and Licensed Technology, to Develop, have Developed, make, have made, use, have used, sell, offer for sale, distribute for sale, have sold, import, have imported, export and have exported Licensed Products in the Territory, for any and all uses within the Field, subject to the terms and conditions of this Agreement. For purposes of clarity, Ribomic shall have no rights under this Agreement to use the SELEX Process and SELEX Technology, alone or with a Third Party, except for the sole purpose of identifying and modifying Program Aptamers for use in the Field.                (b)  Negative Covenant . Ribomic is not granted the right to, and hereby covenants and agrees that neither it nor its Affiliates will (i) use the SELEX Process or SELEX Technology (A) on any Target that is not the Program Target and (B) except for the purpose of identifying or modifying Program Aptamers and/or for the conduct by Ribomic of Permitted Ribomic Activities as expressly permitted under this Agreement, (ii) research, develop, make, have made, use, have used, sell, offer for sale, have sold, distribute for sale, import, have imported, export or have exported Diagnostics or (iii) perform any research or development on Program Aptamers for any use outside of the Field. Notwithstanding the foregoing, Ribomic shall not be restricted by this Section 2.1.1(b) from engaging in any (i) Permitted Ribomic Activities or (ii) activity in which Ribomic is permitted to engage pursuant to a license, sublicense or other right granted to Ribomic in any agreement other than this Agreement (including, without limitation, the Existing License Agreement) with respect to the SELEX Portfolio, the SELEX Process, SELEX Technology or Aptamers, whether granted by Archemix, or any Third Party having the right to grant such license, sublicense or other right. To the extent Ribomic or its Affiliates engages in any activities in violation of the negative covenant set forth in this Section 2.1.1(b) during the Term and files any patent applications or obtains any Patent Rights related to or arising out of such activities then, without limiting any other remedy Archemix may have under this Agreement and without any further action of either Party, Ribomic shall be deemed to have granted to Archemix, effective as of the date of any such filing, an exclusive, fully-paid, perpetual, irrevocable, royalty-free license under all such Patent Rights for any and all uses.                (c)  Right to Sublicense . Ribomic shall have the right to grant sublicenses to all or any portion of its rights under the license granted pursuant to Section 2.1.1(a); provided, that, (i) Archemix shall be notified of the grant of each such sublicense, (ii) each such sublicense shall be subject to, and consistent with, the terms and conditions of this Agreement, (iii) each such sublicense shall include the following provisions of this Agreement Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

13




 

(with appropriate modifications to account for the identities of the parties to such sublicense): Sections 2.1.1(b) (Negative Covenant), 2.1.2(d) (Reversion of License Rights), 2.1.2(e) (Gilead-Archemix License Agreement), Section 3.5 (Notice of Certain Events), 6.6 (Effect of Challenge) and 9.2.2 (Termination for Challenge), (iv) upon termination of this Agreement, any such sublicense shall be considered a direct license from Archemix as provided in Section 9.3 hereof, and (v) Ribomic shall provide Archemix with a copy of each Sublicense Agreement within thirty (30) days of execution.                (d)  Reversion of License Rights . Ribomic acknowledges and agrees that each of the URC License Agreement and the Gilead-Archemix License Agreement provides that the Archemix rights in the SELEX Process or the SELEX Technology and the SELEX Portfolio may revert to Gilead or ULEHI if Archemix, its Affiliates and all assignees and sublicensees cease to exercise reasonable efforts to develop the commercial applications of products and services utilizing the SELEX Process or the SELEX Technology. Ribomic further acknowledges and agrees that the URC License Agreement provides that in the event of any termination of the URC License Agreement, the license to SELEX granted to Ribomic hereunder shall remain in full force and effect in accordance with Section 3.4 of the URC License Agreement; provided, that, Ribomic is not then in breach of this Agreement and Ribomic agrees to be bound to ULEHI as the licensor under the terms and conditions of this Agreement. Archemix shall inform Ribomic of such event immediately after the Archemix rights revert to Gilead or ULEHI.                (e)  Gilead-Archemix License Agreement . Ribomic acknowledges and agrees that the Gilead-Archemix License Agreement provides that in the event of any termination of the Gilead-Archemix License Agreement, the license to SELEX granted to Ribomic hereunder shall remain in full force and effect in accordance with Section 2.3 of the Gilead-Archemix License Agreement; provided, that, Ribomic agrees to be bound to Gilead as the licensor under the terms and conditions of this Agreement; provided, that, if the termination of the Gilead-Archemix License Agreement arises out of the action or inaction of Ribomic, Gilead, at its option, may terminate such license. Archemix shall inform Ribomic of such event promptly after the Gilead-Archemix License Agreement is terminated.           2.1.2 Grant of Rights to Archemix .                (a)  Grant of License . Subject to the other terms of this Agreement, Ribomic hereby grants to Archemix a non-exclusive, royalty-free, paid-up, perpetual, irrevocable, worldwide license, with the right to grant sublicenses, under Ribomic SELEX Technology and Ribomic Patent Rights (i) to research, develop, make, have made, use, have used, sell, offer for sale, have sold, import, have imported, export, have exported, and commercialize Aptamers for any and all purposes, and (ii) for any and all uses of the SELEX Process and SELEX Technology (the " Archemix License "); provided, however, that the licenses in clause (i) and (ii) shall not apply to Program Aptamers or include any specific aptamer sequences that are identified through the conduct by Ribomic of the Permitted Ribomic Activities.                (b)  Covenant . Ribomic covenants and agrees to register the non-exclusive license granted to Archemix under Section 2.1.2(a) under Japanese Patent No. 2,763,958 with the Japan Patent Office as soon as practicable after the Effective Date and to provide Archemix with prompt notice of such registration. Archemix shall reasonably cooperate Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

14




 

with Ribomic to assist in the preparation and execution of the registration and all formal documents to effect such registration, at Ribomic’s sole cost and expense, if any.      2.2 No Other Rights . Ribomic is not granted any rights to use or otherwise exploit Licensed Patent Rights or Licensed Technology except as set forth in this Agreement and Archemix is not granted any rights to use or otherwise exploit Ribomic SELEX Technology or Ribomic Patent Rights except as set forth in this Agreement.      2.3 Exclusivity; Additional Targets .           2.3.1 Exclusivity .                (a)  Archemix Restrictions . During the Term, neither Archemix nor any of its Affiliates will, alone or with a Third Party, conduct any activity, or grant any Third Party a license to conduct any activity, for the purpose of researching, developing or commercializing any Program Aptamer or Licensed Product in the Field in the Territory. Notwithstanding anything to the contrary set forth in this Agreement, the restrictions set forth in this Section 2.3.1(a) shall not apply to the conduct by Archemix or any of its Affiliates of Permitted Archemix Activities.                (b)  Ribomic Restrictions . During the period commencing on the Effective Date and continuing until the later of the termination or expiration of this Agreement and the expiration of the Full Royalty Term, neither Ribomic nor any of its Affiliates will, alone or with a Third Party, conduct any activity or grant any Third Party a license to conduct any activity, for the purpose of researching, developing or commercializing any aptamer other than a Program Aptamer for use in the Field in the Territory as contemplated by this Agreement. Notwithstanding the above, Ribomic may conduct the Permitted Ribomic Activities. 3. RESEARCH, DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS .      3.1 Research, Development and Commercialization .           3.1.1 Responsibility . From and after the Effective Date, Ribomic shall have full control and authority over the research, Development and commercialization of Licensed Products in the Field in the Territory, including, without limitation, (a) all pre-clinical research activities (including any pharmaceutical development work on formulations or process development relating to any Licensed Product), (b) all activities related to the conduct of human clinical trials relating to any Licensed Product, (c) all activities relating to manufacture and supply of Licensed Products (including all required process development and scale up work with respect thereto), (d) all marketing, promotion, sales, distribution, import and export activities relating to any Licensed Product, and (e) all activities relating to any regulatory filings, registrations, applications and Regulatory Approvals relating to any of the foregoing. Ribomic shall own all data, results and all other information arising from any such activities under this Agreement, including, without limitation, all regulatory filings, registrations, applications and Regulatory Approvals relating to Licensed Products, and all of the foregoing information, documentation and materials shall be considered Confidential Information and Technology solely owned by Ribomic. All activities relating to Development and commercialization of Licensed Products under this Agreement shall be undertaken at Ribomic’s sole cost and expense, Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

15




 

except as otherwise expressly provided in this Agreement.           3.1.2 Diligence .                (a)  General Diligence Obligations . Ribomic will exercise Commercially Reasonable Efforts in Developing and commercializing Licensed Products in the Field and in undertaking investigations and actions required to obtain Regulatory Approvals necessary to market such Licensed Products in the Field in each of the United States, each of the E5 Countries and in Japan, and in any other ex-United States markets, in addition to the E5 Countries and Japan, where Ribomic determines, in the exercise of Commercially Reasonable Efforts, that it is commercially reasonable to do so. In the event that Ribomic fails to use Commercially Reasonable Efforts as required hereunder then, on a Licensed Product-by-Licensed Product and country–by-country basis as to such Licensed Product in the United States or Japan and, with respect to any E5 Country, in all of the E5 Countries, (i) Archemix may, in its sole discretion (A) terminate the licenses granted under Section 2.1.1 of this Agreement for breach under Section 9.2.3 below or (B) convert the licenses granted under Section 2.1.1 of this Agreement from exclusive licenses to non-exclusive licenses, in either case only as such licenses apply to such Licensed Product in such country(ies) and, with respect to any E5 Country, in all of the E5 Countries, and (ii) to the extent Archemix exercises its rights under Section 3.1.2(a)(i)(A) or (B) with respect to a Licensed Product, Archemix’s exclusivity obligations under Section 2.3.1(a) shall terminate with respect to such Licensed Product in such country(ies).                (b)  Specific Diligence Obligations . Without limiting the generality of the provision of Section 3.1.2(a) above, Ribomic hereby agrees that it will achieve the specific milestones set forth in Schedule 2 attached hereto within the timelines set forth on such Schedule 2 (such obligations, the " Specific Diligence Obligations "). In the event that Ribomic fails to meet any of the Specific Diligence Obligations set forth in this Section 3.1.2(b) within the applicable timeline, but is otherwise in compliance with the provisions of Section 3.1.2(a) during the applicable diligence period specified above, then Archemix and Ribomic will negotiate in good faith an extension of the applicable milestone deadline for a period not to exceed [***] days from the applicable deadline date. If the Parties are unable to agree on such an extension within such negotiation period, then on a Licensed Product-by-Licensed Product and country-by-country basis as to such Licensed Product in such country and, with respect to any E5 Country, in all of the E5 Countries, (i) Archemix may, in its sole discretion (A) terminate the licenses granted under Section 2.1.1 of this Agreement for breach under Section 9.2.3 below or (B) convert the licenses granted under Section 2.1.1 of this Agreement from exclusive licenses to non-exclusive licenses, in either case only as such licenses apply to such Licensed Product in such country(ies) and, with respect to any E5 Country, in all of the E5 Countries, and (ii) to the extent Archemix exercises its rights under Section 3.1.2(b)(i)(A) or (B) with respect to a Licensed Product, Archemix’s exclusivity obligations under Section 2.3.1(a) shall terminate with respect to such Licensed Product in such country(ies). Archemix may waive any specific milestone diligence requirement on a case by base basis.      3.2 Development Plan . Ribomic shall submit to Archemix, for its review, a summary development plan (" Development Plan ") for each Licensed Product that Ribomic, its Affiliates and/or Sublicensees intend to Develop and commercialize in the Field for each Indication which shall be attached hereto as Exhibit C and shall submit an update to such Development Plan(s) on each anniversary of the Effective Date. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

16




 

     3.3 Progress Reports . Ribomic shall provide Archemix with written reports every [***] months during the Term that describes in reasonable detail its progress with respect to its SELEX efforts and Development activities which shall include, at minimum, information reasonably sufficient to enable Archemix to satisfy its reporting obligations to Gilead under the Gilead-Archemix License Agreement with respect to this Agreement and to assess the progress made by Ribomic toward meeting the diligence obligations of Section 3.1 above.      3.4 Diligence Committee . To facilitate the providing of progress reports by Ribomic with respect to the research and Development of Licensed Products contemplated by this Agreement, at Archemix’s sole option and request the Parties will establish a Diligence Committee (the " DC "), which will be comprised of equal numbers of representatives of each of the Parties. The DC will meet on dates mutually agreed to by the Parties not more than twice per Calendar Year, in person or by teleconference which, if in person, shall alternate between the offices of Cambridge, Massachusetts and Tokyo, Japan.  Intellectual property representatives of each Party may be invited to participate in DC meetings and such meetings will provide a forum to discuss any patent prosecution and enforcement issues that arise under this Agreement.   The DC may be established at any time within [***] years of the Effective Date and if established, the DC will terminate [***] years after the Effective Date, subject to extension by mutual written agreement of the Parties. Each Party will be responsible for the costs and expenses incurred by its representative in participating on the DC. Notwithstanding anything to the contrary in this Section 3.4, the DC shall have no authority to make any decisions binding on the Parties with respect to either Party’s performance under this Agreement.      3.5 Notice of Certain Events . In addition to the progress reports required pursuant to Section 3.3 above, Ribomic shall provide Archemix with written notice within [***] days of the occurrence of (a) the [***] in each country, (b) the Completion of each [***], [***] and [***] of a Licensed Product, and the final reports thereof, (c) each milestone set forth in Section 4.2 below, (d) any Regulatory Approval and Commercialization Regulatory Approval in each country, (e) any other material event other than as set forth in the foregoing clauses (a)-(d) related to the Development or commercialization of Licensed Products, and (f) any Adverse Event or product complaint information relating to Licensed Products as compiled and prepared by Ribomic in the normal course of business in connection with the Development, commercialization or sale of any Licensed Product, within time frames consistent with reporting obligations under Applicable Laws. Archemix may provide such Adverse Event information (i) to the extent reasonably necessary to licensees of Archemix that are researching, developing or commercializing Aptamers for therapeutic purposes and have agreed to maintain the confidentiality thereof and (ii) to Third Parties as required by Applicable Laws.      3.6 Right of First Refusal . In the event that Ribomic at any time during the ROFR Period determines to enter into an agreement with a Third Party to [***] and/or [***] any [***] that includes [***] and [***] that are [***] Dollars ($[***]) (the " Minimum Acceptable Financial Terms "), it shall provide written notice of same to Archemix, which notice shall include a copy of the term sheet or letter of intent or other written evidence of the proposed terms of such transaction (the " ROFR Notice "). Archemix shall have [***] days from the date of the ROFR Notice to provide a written response (the " ROFR Response ") as to whether or not it wishes to participate in the Development and commercialization of such Licensed Product on the terms set forth in the ROFR Notice. If the ROFR Response is not provided by Archemix within the [***] day response period, Ribomic shall thereafter have the right to negotiate and enter into Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

17




 

an agreement with such Third Party with respect to the [***] and/or[***] of such [***] on the terms set forth in the ROFR Notice for a period of up to [***] days (the " Third Party Negotiation Period "); provided, that, if Ribomic and such Third Party do not enter into such agreement on or before the expiration of the Third Party Negotiation Period, the [***] shall once again be subject to this Section 3.6. If the ROFR Response states that Archemix wishes to enter into negotiations with Ribomic, the Parties shall negotiate in good faith for, and complete such negotiations within, a period of up to [***] days from the date of the ROFR Response with respect to the terms and conditions applicable to the [***] and/or [***] by Archemix of such Licensed Product on the terms set forth in the ROFR Notice. In the event the Parties fail to execute and deliver the agreement within the [***] day period, the Parties shall (a) use reasonable efforts to complete such negotiations and to execute and deliver the agreement or amendment as soon as possible after such [***] day period and (b) without limiting the generality of the foregoing, after the expiration of such [***] day period, each produce a list of issues on which they have failed to reach agreement and submit its list to be resolved in accordance with Section 10.2.2. Notwithstanding the foregoing, the Parties hereby acknowledge and agree that once Ribomic has successfully concluded an agreement with a Third Party for any or all Indications of a Licensed Product meeting the Minimum Acceptable Financial Terms, the ROFR Period shall automatically terminate and, thereafter, Archemix will cease to have the Right of First Refusal set forth herein above for subsequent agreements for [***] involving the [***] of any Licensed Product.      3.7 Oncology Opt-In Right . Archemix shall have the option (the " Oncology Option "), in its sole discretion, to jointly Develop and commercialize any Licensed Product for oncology Indications on a Major Market Country-by-Major Market Country basis by providing written notice (the " Oncology Option Notice ") at any time during the period commencing on the Effective Date and continuing until the earlier of the Initiation of the first Phase IIa Clinical Trial with respect to that Licensed Product and the execution by Ribomic of a Sublicense Agreement which includes the grant to a Third Party of the right to Develop and commercialize any Licensed Product in a Major Market Country (the " Oncology Option Termination Date "), which notice shall identify the Licensed Product which Archemix elects to jointly Develop and commercialize. In connection therewith, Ribomic shall provide Archemix with written notice not less than [***] days prior to the expected occurrence of any Oncology Option Termination Date. If Archemix exercises the Oncology Option with respect to any Licensed Product, the Parties shall negotiate an agreement and/or an amendment to this Agreement and the terms applicable thereto in good faith and with sufficient diligence as is required to execute and deliver the agreement or amendment within [***] days after Archemix provides the Oncology Option Notice. In the event the Parties fail to execute and deliver the agreement or amendment within the [***] day period, the Parties shall (a) use reasonable efforts to complete such negotiations and to execute and deliver the agreement or amendment as soon as possible after such [***] day period and (b) without limiting the generality of the foregoing, after the expiration of such [***] day period, each produce a list of issues on which they have failed to reach agreement and submit its list to be resolved in accordance with Section 10.2.2. The Parties hereby acknowledge and agree that in the event Ribomic is in compliance with the notice provisions of this Section 3.7 and enters into a Sublicense Agreement with a Third Party which includes the grant to such Third Party of the right to Develop and commercialize any Licensed Product in the applicable Major Market Country(ies), the Oncology Option will automatically terminate and thereafter be void in the applicable Major Market Country(ies). Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

18




 

4. PAYMENTS AND ROYALTIES      4.1 Technology Access and License Fee . In consideration for the rights granted to Ribomic hereunder, Ribomic hereby agrees to pay Archemix an upfront technology access and license fee in the amount of One Million Dollars (U.S. $1,000,000), payable within thirty (30) days of the Effective Date by wire transfer of immediately available funds, which payment shall be non-refundable and non-creditable.      4.2 Milestone Payments .           4.2.1 All Licensed Products . Ribomic shall make the corresponding non-refundable, non-creditable payments to Archemix by wire transfer according to instructions that Archemix shall provide within [***] days of the occurrence of the following milestone events for a Licensed Product Developed by Ribomic or any Affiliate or Sublicensee of Ribomic:

 

 

 

 

 

Milestone Event

 

Milestone Payment

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

          4.2.2 Licensed Products That Are Not Early-Stage Sublicensed Products . In addition to the milestone payments described in Section 4.2.1 above, Ribomic shall make the corresponding non-refundable, non-creditable payments to Archemix by wire transfer according to instructions that Archemix shall provide within [***] days of the occurrence of the following milestone events for any Licensed Product that is not an Early-Stage Sublicensed Product (including, without limitation, any Licensed Product that is Developed under a Late Stage Sublicense Agreement) (a " Covered Licensed Product "):

 

 

 

 

 

Milestone Event

 

Milestone Payment

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

19




 

 

 

 

 

 

Milestone Event

 

Milestone Payment

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

     For purposes of clarity, (i) any Sublicense Agreement that includes a Covered Licensed Product shall be considered a Late Stage Sublicense Agreement regardless of whether other Licensed Products that are not Covered Licensed Products are included in such Sublicense Agreement and (ii) all Licensed Products included in such Late Stage Sublicense Agreement shall be subject to Section 4.2.2 and not Section 4.2.3.           4.2.3 Early Stage-Sublicensed Products .                (a) In the event Ribomic enters into an Early-Stage Sublicense Agreement, then, in addition to the milestone payments contemplated by Section 4.2.1, but in lieu of making any milestone payments for the milestone events contemplated by Section 4.2.2, Ribomic shall make the corresponding non-refundable, non-creditable payments to Archemix by wire transfer according to instructions that Archemix shall provide within [***] days of the occurrence of the following milestone events for any Licensed Product that is Developed under such Early-Stage Sublicense Agreement (an " Early Stage-Sublicensed Product "):

 

 

 

 

 

Milestone Event

 

Milestone Payment

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

               (b)  Adjustment to Milestone Payments . In the event that any Early Stage Sublicense Agreement provides for the payment to Ribomic of aggregate Sublicense Income in an amount in excess of [***] Dollars (US $[***]), the aggregate milestone payments included in Section 4.2.3(a) shall be increased by [***] percent ([***]%) of the amount by which such aggregate Sublicense Income exceeds [***] Dollars (US $[***]), which increase shall be apportioned equally across each of the Milestone Events set forth in Section 4.2.3(a). By way of example, if Ribomic enters into an Early Stage Sublicense Agreement that provides for the payment of, and/or otherwise receives, aggregate Sublicense Income in the amount of [***] Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

20




 

Dollars (US $[***]), (i) the aggregate Milestone Payments in Section 4.2.3(a) will by increased by [***] Dollars (US $[***]) ([***] percent ([***]%) of [***] Dollars (US $[***])), (ii) the Milestone Payments due and payable in Japan pursuant to Section 4.2.3(a) shall be increased in the aggregate by [***] Dollars (US $[***]), (iii) the Milestone Payments due and payable in the United States shall be increased in the aggregate by [***] Dollars (US $[***]) and (iv) the Milestone Payments due and payable in the E5 Countries shall be increased in the aggregate by [***] Dollars (US $[***]).           4.2.4 Skipped Milestones; Crediting of Certain Milestone Payments .                (a)  Skipped Milestones . If at the time any given milestone payment set forth in Section 4.2 is due and one or more preceding milestone payments for logically antecedent milestones have not been paid, then such unpaid antecedent milestone payments shall be paid at such time as well. For example, if at the time an [***] milestone payment is due for a Licensed Product, an [***] milestone payment has not been paid for a Licensed Product, then such [***] milestone payment shall be paid at such time as well.                (b)  Crediting of Certain Milestone Payments . In the event that Ribomic enters into one or more Sublicense Agreements covering a Licensed Product, all Milestone Payments for Milestone Events achieved by Ribomic and/or the Sublicensee with respect to that Licensed Product on and after the effective date of the Sublicense Agreement shall be fully creditable against Sublicense Income Payments payable by Ribomic with respect to that Sublicense Agreement.                (c)  Payable Once Per Program Target. All of the milestone payments set forth in Section 4.2 shall be payable only once per Program Target, regardless of how many Licensed Products achieve such milestones and no milestone payment already made for a Licensed Product shall be paid for any subsequent Licensed Product or any subsequent Indication for the same Licensed Product with respect to said particular milestone.           4.2.5 Determination that Payments are Due . In the event that Archemix believes any milestone payment is due pursuant to Section 4.2.1, 4.2.2 and/or 4.2.3, it shall so notify Ribomic and shall provide to Ribomic the data and information supporting its belief that the conditions for payment have been achieved. If Ribomic disputes that such milestone payment is due, either Party may submit such dispute for resolution pursuant to the provisions of Section 10.2.2.      4.3 Payment of Royalties; Royalty Rates.           4.3.1 Royalty Rates in Defined Territory . For each Licensed Product, Ribomic shall pay Archemix a royalty based on Annual Net Sales of such Licensed Product in each Calendar Year (or partial Calendar Year) in any country in the Defined Territory commencing with the First Commercial Sale of such Licensed Product in any country in the Defined Territory and ending upon the last day of the last Royalty Term for such Licensed Product, at the following rates: Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

21




 

 

 

 

 

 

 

 

 

 

 

 

Full Royalty Net

 

Partial Royalty

 

 

Sales

 

Net Sales

Annual Net Sales

 

Royalty Rate (%)

Up to $[***]

 

 

[***]

%

 

 

[***]

%

Above $[***] and up to $[***]

 

 

[***]

%

 

 

[***]

%

Above $[***] and up to $[***]

 

 

[***]

%

 

 

[***]

%

Above $[***]

 

 

[***]

%

 

 

[***]

%

          4.3.2 Royalty Rates Outside Defined Territory . For each Licensed Product, Ribomic shall pay Archemix a royalty based on Annual Net Sales of such Licensed Product in each Calendar Year (or partial Calendar Year) in any country outside the Defined Territory commencing with the First Commercial Sale of such Licensed Product in any country outside the Defined Territory and ending upon the last day of the last Royalty Term for such Licensed Product, at a royalty rate equal to [***] percent ([***]%) for Full Royalty Net Sales and [***] percent ([***]%) for Partial Royalty Net Sales.           4.3.3 Acknowledgements . Ribomic recognizes and acknowledges that each of the following, separately and together, has substantial economic benefit to Ribomic: (a) the licenses granted to Ribomic hereunder with respect to Licensed Technology that are not within the claims of any Patent Rights Controlled by Archemix; (b) the licenses granted to Ribomic under Patent Rights Controlled by Archemix; (c) the restrictions on Archemix pursuant to Section 2.3.1(a); and (d) the "head start" afforded to Ribomic by each of the foregoing. The Parties agree that the royalty rates set forth in Sections 4.3.1 and 4.3.2 reflect an efficient and reasonable blended allocation of the royalty amounts to be paid by Ribomic to Archemix in its totality.           4.3.4 Royalty Reductions . In the event that a Third Party sells an aptamer product that binds to the Program Target (a " Third Party Product ") in a country in which a Program Aptamer or Licensed Product is then being sold by Ribomic and such Third Party Product is not covered by a Valid Claim under the Licensed Patent Rights in such country, then, during the period in which sales of the Third Party Product are equal to at least [***] percent ([***]%) of Ribomic’s volume-based market share of the Program Aptamer or Licensed Product in such country (as measured by prescriptions or other similar information available in such country) all applicable royalties in effect with respect to such Program Aptamer or Licensed Product in such country as specified in Section 4.3.1 shall be reduced by [***] percent ([***]%). Notwithstanding the foregoing, Ribomic’s obligation to pay royalties at the full royalty rates shall be reinstated on the first day of the Calendar Quarter immediately following the Calendar Quarter in which sales of such Third Party Product account for less than [***] percent ([***]%) of Ribomic’s volume-based market share in such country.      4.4 Sublicense Income .           4.4.1 Sublicense Income Payments . In consideration for the rights granted to Ribomic hereunder, Ribomic shall pay Archemix a percentage of all Sublicense Income received by Ribomic under Sublicense Agreements with respect to Licensed Products equal to the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

22




 

Applicable Sublicense Income Rate (" Sublicense Income Payments ").           4.4.2 Crediting of Milestones . Notwithstanding anything to the contrary in this Agreement, Ribomic shall have the right to credit any Milestone Payment it makes with respect to a Licensed Product on and after the date of execution of any Sublicense Agreement against Sublicense Income Payments due and payable to Archemix with respect to that Licensed Product under that Sublicense Agreement.      4.5 Payment Terms .           4.5.1 Payment of Royalties and Sublicense Income Payments . Unless otherwise expressly provided, Ribomic shall make any royalty and Sublicense Income payments owed to Archemix hereunder in arrears, within [***] days from the end of the Calendar Quarter in which such payment accrues. For purposes of determining when a sale of any Licensed Product occurs under this Agreement, the sale shall be deemed to occur on the date the invoice is provided by Ribomic, its Affiliates or Sublicensees. Each royalty payment shall be accompanied by a report for each country in the Territory in which sales of Licensed Products occurred in the Calendar Quarter covered by such statement, specifying: (a) the gross sales (if available) and Net Sales in each country’s currency; (b) the applicable royalty rate under this Agreement; (c) an accounting of deductions taken in the calculation of Net Sales made in the United States and in any other country in which such accounting is reasonably available; (d) the applicable exchange rate to convert from each currency other than United States dollars to United States dollars under this Section 4.5; and (e) the royalties payable in United States dollars. Each Sublicense Income Payment will be accompanied by a report for each country in the Territory in which Sublicense Income is received in the Calendar Quarter covered by such statement, specifying: (a) all consideration and payments received by Archemix under such Sublicense Agreement; (b) the Applicable Sublicense Income Rate; and (c) an accounting of any deductions taken in the calculation of the amount of the Sublicense Income.           4.5.2 Overdue Payments . Subject to the other terms of this Agreement, any payments not paid within the time period set forth in this Article 4 shall bear interest at a rate of [***] percent ([***]%) per month from the due date until paid in full; provided, that, in no event shall said annual rate exceed the maximum interest rate permitted by law in regard to such payments. Any such overdue royalty or milestone payment shall, when made, be accompanied by, and credited first to, all interest so accrued. Said interest and the payment and acceptance thereof shall not negate or waive the right of Archemix to any other remedy, legal or equitable, to which it may be entitled because of the delinquency of the payment.           4.5.3 Accounting . All payments hereunder shall be made in the United States in United States dollars. Conversion of foreign currency to United States dollars shall be made at the conversion rate existing in the United States (as


 
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