AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT

Exhibit 10.59

AMENDED AND RESTATED

COLLABORATION AND LICENSE AGREEMENT

T HIS A MENDED AND R ESTATED C OLLABORATION AND L ICENSE A GREEMENT (the “Agreement” ) is entered into and made effective as of July 31, 2006 (the “Effective Date” ), by and between N UVELO , I NC ., a Delaware corporation having its principal place of business at 201 Industrial Road, Suite 310, San Carlos, CA 94070 ( “Nuvelo” ), and A RCHEMIX C ORP ., a Delaware corporation having its principal place of business at 300 Third Street, Cambridge, MA 02142 ( “Archemix” ). Nuvelo and Archemix are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

R ECITALS

W HEREAS , the Parties entered into a Collaboration Agreement as of January 12, 2004 (the “Original Agreement” ), for the purpose of identifying aptamers with anti-thrombin activity (the terms and conditions contained therein, the “Original Terms”); and

W HEREAS , the particular aptamer that was the original Development Compound (as defined in the Original Agreement), ARC 183, has been withdrawn from Development; and

W HEREAS , on March 4, 2006, Archemix initiated arbitration proceedings with Judicial Arbitration and Mediation Services, Inc., New York ( “JAMS” ), Case No. 1425000626 (the “Arbitration”), and Nuvelo submitted counterclaims on May 17, 2006; and

W HEREAS , the Parties wish to revise their collaboration so that Archemix will be responsible for the discovery of short-acting aptamers which bind to specifically defined protein targets causing an anti-coagulation effect, and Nuvelo will have the exclusive right to develop and commercialize aptamers so identified by Archemix; and

W HEREAS , the Parties have by mutual agreement, agreed to supersede the terms of the Original Agreement, with those set forth in this Agreement as of the Effective Date.

N OW , T HEREFORE , the Parties agree as follows:

1. D EFINITIONS

The following terms and those set forth in Exhibit A have the meanings set forth below or in Exhibit A, as the case may be, as used in this Agreement:

1.1 “Affiliate” means a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with a Party. For the purposes of this Section 1.1, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with” ) means the actual power, either directly or indirectly through one or more intermediaries, to direct the management and policies of such entity, whether by the ownership of at least fifty percent (50%) of the voting stock of such entity, or by contract or otherwise.

1.2 “Allowable Commercialization Expenses” means those expenses incurred during the term of this Agreement which are specifically attributable to the actual or contemplated Commercialization of a specific Licensed Product(s), and shall consist of: (a) Costs of Goods; (b) Marketing, Sales and Distribution Costs; (c) out of pocket costs to identify potential partners and to negotiate Partnering Agreements; (d) all patent prosecution, maintenance and litigation expenses incurred under Article 9 of this Agreement; (e) Post Launch Research and Development Expenses; (f) Allocated Administrative Expenses; (g) the costs of engaging Third Parties to assist with Commercialization; and (h) Currency Gains or Losses. “Allowable Commercialization Expenses” shall exclude Development Costs.

1.3 “Aptamer” means any oligonucleotide that binds to a target through means other than Watson-Crick base-pairing.

1.4 “ARC 2172” means the Aptamer having the nucleotide sequence set forth in Exhibit D.

1.5 “Archemix Background Technology” means any Technology used by Archemix, or provided by Archemix for use hereunder and/or which is otherwise necessary or useful for the Research, Development, Commercialization, manufacture, importation or use of any Candidate Compound, Development Compound or Licensed Product and that is (a) Controlled by Archemix as of the Effective Date, (b) conceived or first reduced to practice by employees of, or consultants to, Archemix after the Effective Date other than in the conduct of Research, Development or Commercialization, (c) conceived or first reduced to practice in the conduct of Research, Development or Commercialization and that constitutes SELEX Inventions or SELEX Technology, or (d) Archemix’s interest in all Program Technology to the extent it is not Compound Technology.

1.6 “Archemix Patent Rights” means Patent Rights Controlled by Archemix claiming or disclosing Archemix Technology. For clarity, Archemix Patent Rights include all Licensed Patent Rights.

1.7 “Archemix Product” has the meaning assigned in Section 12.2(a)(ii).

1.8 “Archemix Program Technology” means any Program Technology that is conceived or first reduced to practice by or through employees of, or consultants to, Archemix, alone or with any Third Party, in the conduct of the Research, Development or Commercialization of Candidate Compounds, Development Compounds or Licensed Products.

1.9 “Archemix Technology” means, collectively, Archemix Background Technology, Archemix’s interest in all Joint Technology, and Archemix Program Technology. “Archemix Technology” includes the Compound Technology.

1.10 “Bankrupt Party” has the meaning assigned in Section 16.2(a).

1.11 “Candidate Compound” means an Aptamer that is a Short Acting Coagulation Cascade Aptamer that is identified by Archemix in the course of its Research under this Agreement pursuant to an approved Research Plain.

 

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1.12 “Coagulation Cascade Protein” means a protein that is included on the list set forth in Exhibit B.

1.13 “Collaboration” means all activities performed by or on behalf of Nuvelo or Archemix in the course of performing the activities described in, or fulfilling of their obligations pursuant to, this Agreement.

1.14 “Commercialization” or “Commercialized” means all activities that are undertaken prior to, during or after completion of an NDA filing for a particular Licensed Product and that relate to the commercial manufacture, marketing and sale of such Licensed Product including but not limited to pre-commercialization, advertising, education, planning, marketing, promotion, distribution, market and product support studies, and Phase 4 Trials.

1.15 “Compound Patent Rights” means Patent Rights to the extent claiming (a) Compound Technology or (b) ARC 2172.

1.16 “Compound Technology” means any Program Technology developed solely by Archemix or which is Joint Technology and in either case to the extent specifically disclosing the composition of matter, formulation or use in the Field of a Short Acting Coagulation Cascade Aptamer that is or was discovered or made by Archemix under this Agreement or the Original Agreement, including any Candidate Compound, Development Compound or Licensed Product.

1.17 “Confidential Information” has the meaning assigned to it is Section 10.1.

1.18 “Contract Year” means (a) the period beginning on the Effective Date and ending on the first anniversary of the last day of the calendar month in which the Effective Date falls and (b) each succeeding twelve (12) month period thereafter.

1.19 “Control” means, with respect to an item of Technology, a molecule or an intellectual property right, that a Party owns or has a license to such item, to a Patent Right claiming such molecule, or to such right and has the ability to disclose and grant a license or sublicense as provided for in this Agreement under such item, Patent Right, or right without the payment of additional consideration to, and without violating the terms of any agreement or other arrangement with, any Third Party.

1.20 “Derived” means identified, obtained, developed, created, synthesized, designed, derived or resulting from based, upon, containing, incorporating or otherwise generated from, conjugated to or complexed with (whether directly or indirectly, or in whole or in part).

1.21 “Develop” or “Development” means all activities with respect to a Development Compound or Licensed Product relating to: (a) the preparation for and conducting of Phase 1 Trails, Phase 2 Trials, and Phase 3 Trials; (b) the filing and obtaining of Regulatory Approval for a Licensed Product; and (c) all activities relating to developing the ability to manufacture Development Compounds or Licensed Products. This includes, but is not limited to: (i) preclinical testing, toxicology, formulation development, clinical studies, regulatory affairs and outside counsel regulatory legal services; and (ii) manufacturing process development and scale up for bulk and final forms or Development Compounds and Licensed Products, validation documentation, all documentation generated in connection with the manufacturing or processing activities and manufacturing and quality assurance technical support activities for such Development Compounds or Licensed Products prior to first commercial sale.

 

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1.22 “Development Compound:”

(a) means any Candidate Compound that is discovered or made by Archemix under the Original Agreement or this Agreement and selected by Nuvelo for IND-enabling studies and designated by Nuvelo as Development Compound pursuant to Section 2.2 and 2.3 of this Agreement;

(b) any compound Derived from a Development Compound, as defined in subsection (a) above, under the Original Agreement or this Agreement that is a Short Acting Coagulation Cascade Aptamer (for clarity, any such compound defined in this subsection (b) shall be designated as a separate Development Compound under this Agreement); and

(c) ARC 2172.

1.23 “Development Costs:”

(a) means the expenses incurred by Nuvelo or Archemix or for its account after the Effective Date, and which are specifically attributable to the Development of Development Compounds and Licensed Products, including, without limitation:

(i) costs of preclinical design and evaluation of Candidate Compounds, Development Compounds and Licensed Products, and costs of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of Candidate Compounds, Development Compounds and Licensed Products (such costs include the costs of any consultants or other Third Parties engaged by Nuvelo to conduct such design or evaluation);

(ii) costs of pre-IND studies including the manufacturing cost of preclinical supplies of Candidate Compounds, Development Compounds and Licensed Products, including GMP materials;

(iii) costs of conducting clinical trails on Development Compounds and Licensed Products including the manufacturing cost of clinical supplies of the Development Compounds and Licensed Products;

(iv) costs of preparing, submitting, reviewing or developing data or information for the purpose of submission to a Regulatory Authority to obtain approval to Commence Phase 1 Trails or to obtain Regulatory Approval for Development Compounds and Licensed Products;

(v) fees, including FDA user fees, associated with U.S. and foreign regulatory filings or other U.S. and foreign governmental requirements related to Development Compounds and Licensed Products;

 

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(vi) costs of Third Party licenses under Patents or other intellectual property rights reasonably necessary to develop Development Compounds or Licensed Products or to commercialize Licensed Products;

(vii) external and internal costs of process development, manufacturing, quality assurance, release testing, and clinical materials relating to Development Compounds or Licensed Products; and

(viii) such other costs directly incurred in Development of Development Compounds or Licensed Products.

(b) Development Costs excludes Nuvelo’s and Archemix’s overhead expenses and FTE expenses, and any FTE payments to Archemix hereunder, notwithstanding anything else in this Section 1.23.

(c) Development Costs will be calculated on an accrual basis consistent with GAAP except for the expenses incurred by Nuvelo in manufacturing clinical supplies of each Development Compound or Licensed Compound, which will be calculated on a cash basis prior to the Commercialization of the Development Compound or Licensed Compound.

1.24 “Diligent Efforts” means the carrying out of obligations or tasks in a reasonable, good faith, and diligent manner consistent with efforts and resources as commonly used in the research-based biotechnology industry for a company of a similar size and a similar market capitalization, for a therapeutic product at a similar stage of research, development or commercialization, and having similar market potential, taking into account issues of safety, efficacy, product profile, the costs to develop, the competitiveness of alternative products that are or are expected to be in the relevant marketplace, the proprietary position of the product, the regulatory structure and the likelihood of regulatory approval and product reimbursement, the profitability of the product, and all other commercial factors.

1.25 “Drug Approval Application” means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction.

1.26 “EMEA” means the European Medicines Agency, or any successor thereof.

1.27 “EMEA and Pricing Approval” means approval by the EMEA to sell a Licensed Product together with pricing approval in at least one of France, Germany, Italy, Spain or United Kingdom.

1.28 “FDA” means the United States Food and Drug Administration, or any successor federal agency thereto.

1.29 “Field” means the use of Short Acting Coagulation Cascade Aptamers to Modulate blood clotting times in acute therapeutic applications, including but not limited to coronary artery bypass graft surgery and percutaneous coronary intervention. [        *

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[*]

Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.[*] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

 

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*

                     *                       ] For clarity, if any Short Acting Coagulation Cascade Aptamers Developed under this Agreement for use in the “Field” , as described in the previous sentences, have additional therapeutic uses, those additional therapeutic uses will also be considered part of the “Field.”

1.30 “FTE” means the equivalent of one person working full time for one 12-month period in a Research, Development, Commercialization, regulatory or other relevant capacity, for [     *     ] hours per year. For clarity, a single individual who works more than [     *     ] hours in a single year shall be treated as one FTE regardless of the number of hours worked.

1.31 “FTE Reimbursement Rate” means the rate at which Nuvelo shall reimburse Archemix for costs related to FTEs under this Agreement. Such costs shall cover all salary and benefits, and facilities and infrastructure costs, travel expenses, laboratory supplies and materials used internally by Archemix in fulfilling its obligations under this Agreement and all overhead charges which are allocable to company departments based on space occupied or headcount or another activity-based costing method and related to FTE obligations necessary for performance under this Agreement. Such FTE Reimbursement Rate shall be [     *     ] per FTE. For clarity, each Party shall be responsible, at its sole cost and expense, for paying the salaries and benefits of its employees.

1.32 “Generic IP” has the meaning assigned in Section 5.7.

1.33 “Gilead” means Gilead Sciences, Inc., a Delaware corporation with its principal offices located at 333 Lakeside Drive, Foster City, California 94404.

1.34 “Gilead-Archemix Agreement” means the License Agreement entered into by and between Gilead and Archemix dated October 23, 2001, as amended September 4, 2003.

1.35 “IND” means: (a) an Investigational New Drug Application as defined in the Federal Food, Drug and Cosmetic Act (“FDCA”) and regulations promulgated thereunder or any successor application or procedure required to initiate clinical testing of a Development Compound and/or Licensed Product in humans in the United States; (b) a 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 Development Compound and/or Licensed Product in humans in such country or region; and (c) all supplements and amendments to any of the foregoing.

1.36 “In Vitro Diagnostics” means the use of the SELEX Process or Aptamers or PhotoAptamers identified through the use of the SELEX Process in the assay, testing or determination, outside of a living organism, of a substance in a test material. [        *

*

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

 

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*

 

 

]

1.37 “Indemnitees” has the meaning assigned in Section 14.1.

1.38 “Internal FTE” means an FTE performing activities related to the Collaboration by Archemix or its Affiliate(s).

1.39 “IPO Price” means the price per share paid by investors participating in the Qualified IPO.

1.40 “Joint Management Committee” or “JMC” means the committee described in Section 3.2.

1.41 “Joint Patent Rights” means Patent Rights claiming Joint Technology.

1.42 “Joint Technology” means any Program Technology jointly conceived or reduced to practice by employees of or consultants to Nuvelo and employees of or consultants to Archemix under this Agreement. For clarity, any jointly developed Technology that is SELEX Technology or SELEX Inventions shall not be considered Joint Technology regardless of which Party conceived or reduced to practice such Technology or Inventions.

1.43 “Licensed Patent Rights” means any Archemix Patent Rights (a) to the extent claiming any Compound Technology, Candidate Compound, Development Compound or Licensed Product or the manufacture thereof or the use thereof in the Field, or (b) that are necessary or useful for Nuvelo to exercise the relevant licenses granted to it pursuant to Article 5. For clarity, the Licensed Patent Rights shall exclude any Patent Rights that relate to the SELEX Inventions or the SELEX Technology and shall include, without limitation, the following United States Patents and their counterparts throughout the world to the extent not SELEX Inventions or SELEX Technology: 6,334,318 B1; 5,476,766; 5,543,293; 5,582,981; 5,688,291; 5,817,785; 5,840,867; and 6,331,398 B1.

1.44 “Licensed Product” means a product that comprises, consists of, or which incorporates a Development Compound regardless of its formulation or mode of administration;

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

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provided, that, any Aptamer contained therein is a Short Acting Coagulation Cascade Aptamer, and provided, further, that such Short Acting Coagulation Cascade Aptamer is not formulated, modified or administered such that the Short Acting Coagulation Cascade Aptamer or the Licensed Product does not demonstrate the short acting characteristics set forth in Exhibit C. For clarity, and without limitation, a Licensed Product shall not include any pegylated Aptamer.

1.45 “Licensed Technology” means any Archemix Technology that (a) specifically relates to any Candidate Compound, Development Compound or Licensed Product relevant to the license grant, or (b) is necessary or useful for Nuvelo to exercise the relevant licenses granted to it pursuant to Article 5.

1.46 “Licensing Revenue” means any and all forms of consideration that Nuvelo or any Nuvelo Affiliate receives directly or indirectly from a Third Party Partner in connection with a Partnering Agreement, which may include upfront license fees, annual license or maintenance payments, milestone payments, royalties, imputed income on interest-free loans received from such Third Party Partner, the portion of an equity investment in Nuvelo or a Nuvelo Affiliate that is greater than the fair market value of Nuvelo’s or its Affiliate stock sold in such investment at the time of sale and other similar payments; but Licensing Revenue shall exclude any of the following amounts received by Nuvelo or its Affiliates under a Partnering Agreement: (a) an equity investment by such Third Party (but solely to the extent that such investment is at a price equal to or less than the fair market value of Nuvelo’s or its Affiliate’s stock sold in such investment at the time of sale); (b) a loan at reasonable interest rates for work required to be performed by Nuvelo and directed to the Development or Commercialization of Licensed Products subject to the Agreement; (c) research and development support (at a reasonable FTE value); (d) reimbursement of patent prosecution, maintenance, enforcement or defense expenses; or (e) payments directly attributable to supplying goods (at no more than one hundred twenty-five percent (125%) of actual manufacturing cost) or services to such Third Party Partner to enable the commercialization of the Licensed Product that is subject to the Partnering Agreement.

1.47 “Losses” has the meaning assigned in Section 14.1.

1.48 “MHLW” means the Ministry of Health, Labor and Welfare, otherwise referred to as “Korosho” or any successor thereto, which governs the scientific review of human pharmaceutical products in Japan.

1.49 “Minimum FTE Funding Requirement” has the meaning assigned to it in Section 2.4.

1.50 “Modulate” or “Modulation” means the inhibition or activation of a Coagulation Cascade Protein using a Short Acting Coagulation Cascade Aptamer. As used in this definition, “inhibition” means either (a) inhibition at a therapeutically useful level of a Short Acting Coagulation Cascade Aptamer by binding of a Short Acting Coagulation Cascade Aptamer to a pre-selected Coagulation Cascade Protein or (b) inhibition at a therapeutically useful level of a Short Acting Coagulation Cascade Aptamer of a second pre-selected Coagulation Cascade Protein by binding at a therapeutically useful level of a Short Acting Coagulation Cascade Aptamer to a first pre-selected Coagulation Cascade Protein. As used in

 

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this definition, “activation” means either (a) activation at a therapeutically useful level of a Short Acting Coagulation Cascade Aptamer by binding of a Short Acting Coagulation Cascade Aptamer to a pre-selected Coagulation Cascade Protein or (b) activation at a therapeutically useful level of a Short Acting Coagulation Cascade Aptamer of a second pre-selected Coagulation Cascade Protein by binding at a therapeutically useful level of a Short Acting Coagulation Cascade Aptamer to a first pre-selected Coagulation Cascade Protein.

1.51 “NDA” means a New Drug Application submitted and filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary for approval of a drug in such jurisdiction.

1.52 “Net Sales:”

(a) means the gross amount invoiced by Nuvelo or its Affiliate or a licensee or sublicensee (at any level, including a sublicensee of a sublicensee) for sales of Licensed Products to a Third Party (other than a Third Party Partner or a licensee or sublicensee) less, to the extent included within the gross amount invoiced to and paid by the customer, deductions for; (i) transportation, and customs clearance, duty charges and insurance relating to such transportation; (ii) sales and excise taxes, customs and any other governmental charges, all to the extent imposed upon the sale of the Licensed Products and paid by the selling party; (iii) distributors fees, rebates or allowances actually granted or allowed, including government and managed care rebates; (iv) quantity discounts, cash discounts or chargebacks actually granted, allowed or incurred in the ordinary course of business in connection with the sale of the Licensed Products; and (v) allowances or credits to customers, not in excess of the selling price of the Licensed Products, on account of governmental requirements, rejection, recalls or return of the Licensed Products.

(b) Solely for the purpose of calculating Net Sales of Licensed Products, if a Party or its Affiliate, or a licensee or sublicensee, sells such Licensed Products in the form of a combination product containing any such Licensed Product and one or more active ingredients or a delivery device (whether combined in a single formulation or package, as applicable, or formulated or packaged separately but sold together for a single price) (a “Combination Product” ), Net Sales of such Combination Product for the purpose of determining the royalty due to the other Party pursuant to Sections 7.4(b)(i) and/or 12.2(b) will be calculated by multiplying actual Net Sales of such Combination Product as determined in subsection (a) above by the fraction A/(A+B) where A is the invoice price of such Licensed Product if sold separately, and B is the total invoice price of the other active ingredient(s) or the delivery device in the combination if sold separately. If, on a country-by-country basis, such other active ingredient or ingredients or delivery device in the Combination Product are not sold separately in such country, but the Licensed Product component of the Combination Product is sold separately in such country, Net Sales for the purpose of determining royalties due to the other Party pursuant to Sections 7.4(b)(i) and/or 12.2(b) for the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product as determined in subsection (a) above by the fraction A/C where A is the invoice price of such Licensed Product component if sold separately, and C is the invoice price of the Combination Product. If, on a country-by-country basis, such Licensed Product component is not sold separately in such country, Net Sales for the

 

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purposes of determining royalties due to the other Party pursuant to Section 7.4(b)(i) and /or 12.2(b) for the Combination Product shall be D/(D+E) where D is the fair market value of the portion of the Combination Products that contains the Licensed Product and E is the fair market value of the portion of the Combination Products containing the other active ingredient(s) or delivery device included in such Combination Product as such fair market values are determined by mutual agreement of the Parties.

1.53 “Nuvelo Background Technology” means any Technology that is (a) Controlled by Nuvelo as of the Effective Date or (b) conceived or first reduced to practice by Nuvelo after the Effective Date other than in the conduct of Research, Development or Commercialization, and in either case is necessary or useful for the Research, Development or Commercialization, manufacture, importation, use or sale of Candidate Compounds, Development Compounds or Licensed Products under this Agreement. Nuvelo Background Technology does not include Nuvelo Program Technology or Nuvelo’s interest in Joint Technology. For clarity, any Program Technology that is SELEX Technology or SELEX Inventions shall not be considered Nuvelo Background Technology regardless of which Party conceived or reduced to practice such Technology or Inventions.

1.54 “Nuveo IPO Share Amount” means that number of shares of Archemix Common Stock equal to the lesser of (a) Ten Million Dollars ($10,000,000) divided by the IPO Price or (b) fifteen percent (15%) of the total gross offering proceeds (prior to underwriter commissions and expenses) raised by Archemix in the Qualified IPO divided by the IPO Price.

1.55 “Nuvelo Patent Rights” means Patent Rights Controlled by Nuvelo claiming or disclosing Nuvelo Technology.

1.56 “Nuvelo Product” has the meaning assigned to it in Section 12.2(a)(i).

1.57 “Nuvelo Program Technology” means any Program Technology that is conceived or first reduced to practice by or through employees of, or consultants to, Nuvelo, alone or with any Third Party, in the conduct of the Research, Development or Commercialization of Candidate Compounds, Development Compounds or Licensed Products. For clarity, any Program Technolgy that is SELEX Technology or SELEX Inventions shall not be considered Nuvelo Program Technology regardless of which Party conceived or reduced to practice such Technology or Inventions.

1.58 “Nuvelo Technology” means, collectively, Nuvelo Background Technology, Nuvelo Program Technology, and Nuvelo’s interest in all joint Technology.

1.59 “Partnered Product” means a Licensed Product that is the subject of a Partnering Agreement.

1.60 “Partnering Agreement ” means an executed and in-force written agreement between Nuvelo and a Third Party or between a Third Party Partner and another Third Party, wherein such Third Party is granted the right to Develop or Commercialize, alone or in collaboration with Nuvelo or another Third Party Partner, a Licensed Product.

 

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1.61 “Patent Rights” means the rights and interests in and to (a) a pending application for a patent anywhere in the world, including without limitation any provisional, converted provisional, continued prosecution application, substitution, continuation, divisional or continuation-in-part thereof; (b) any patent issuing on any of the foregoing, including any inventor’s certificate, that has not expired or been declared invalid by a court from which no appeal can be or has been taken; or (c) any extension, renewal, reissue or reexamination of any of the foregoing.

1.62 “Phase I Trial” means that portion of the clinical development program that generally provides for the first introduction into humans of a product with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of the product, and that is consistent with 21 CFR §312.21(a) or the applicable rules and regulations of the jurisdiction in which the clinical trial is conducted.

1.63 “Phase 2 Trail” means that portion of the clinical development program that provides for a clinical trial of a product on patients, which may include pharmacokinetic studies, the principal purpose of which is to make a preliminary determination that such product is safe for its intended use, to determine potential doses and to obtain sufficient information about such product’s efficacy to permit the design of further clinical trials, and that is consistent with 21 CFR §312.21(b) or the applicable rules and regulations of the jurisdiction in which the clinical trial is conducted.

1.64 “Phase 3 Trail” means that portion of the clinical development program that provides for a pivotal human clinical trial of a product, which trial is designed to: (a) establish that a product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed; and (c) support Regulatory Approval of such product; and which trial is consistent with 21 CFR §312.21(c) or the applicable rules and regulations of the jurisdiction in which the clinical trial is conducted.

1.65 “ Phase 4 Costs” means all expenses incurred by either Party or for its account, and specifically attributable to: (a) direct support of the performance of a Phase 4 Trail for a Licensed Product; or (b) process development for a Licensed Product in a Phase 4 Trail. All Phase 4 Costs shall be treated as Post Launch R&D Expenses in accordance with Exhibit A.

1.66 “Phase 4 Trial” means a clinical trial of a Licensed Product commenced in a particular country after receipt of Regulatory Approval in such country in order to support commercialization of the Licensed Product.

1.67 “Product Profit and Loss” means the profits or losses resulting from the Commercialization of Licensed Products and is equal to Net Sales plus Licensing Revenue less Allowable Commercialization Expenses.

1.68 “Program Target” means a Coagulation Cascade Protein identified in Exhibit B that is the subject of an approved Research Plan.

1.69 “Program Technology” means any Technology that is generated, conceived or first reduced to practice (actively or constructively) by either Party or both Parties in the conduct of the Research, Development or Commercialization of Candidate Compounds, Development Compounds or Licensed Products.

 

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1.70 “Qualified IPO” means Archemix’s firm commitment underwritten initial public offering on the [             *            ] filed under the Securities Act of 1933, as amended, covering the offer and sale of Archemix Common Stock, with total gross offering proceeds to Archemix (prior to underwriter commissions and expenses) of at least [     *    ] dollars ($ [    *    ]) exclusive of the dollar value represented by the Nuvelo IPO Share Amount.

1.71 “Radio Therapeutic Aptamer” 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.

1.72 THIS SECTION LEFT INTENTIONALLY BLANK.

1.73 “Regulatory Approval” means any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national ( e.g ., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the manufacture, distribution, use or sale of a Licensed Product in a regulatory jurisdiction.

1.74 “Regulatory Authority” means the FDA or any counterpart of the FDA outside the United States, or other national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council, or other governmental entity with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport or clinical testing or sale of a Licensed Product.

1.75 “Regulatory Documentation” means, with respect to a Licensed Product, all regulatory filings and supporting documents created, submitted to the FDA or any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) relating to such product, and all data contained therein, including, without limitation, any IND(s), NDA(s), Biologics License Application(s) (“BLA(s)”), Investigator’s Brochures, Drug Master File(s), correspondence to and from the FDA or any equivalent agency or governmental authority outside of the United States, minutes from teleconferences with Regulatory Authorities, registrations and licenses, regulatory drug lists, advertising and promotion documents shared with Regulatory Authorities, adverse event files, complaint files and manufacturing records.

1.76 “Regulatory Filing” means the NDA, BLA, IND, or any foreign counterparts thereof and any other filings required by Regulatory Authorities relating to the study, manufacture or commercialization of any Licensed Product.

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

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1.77 “Research” means: (a) the discovery and identification of Candidate Compounds for use within the Field; (b) the biological characterization (including, without limitation, preclinical activities such as in vivo analysis) of such Candidate Compounds; and (c) any other activities related to the Field specified in an approved Research Plan, in each case which are to be conducted pursuant to this Agreement.

1.78 “Research Plan” means the written plan describing the Research and any other activities to be carried out by the Parties during each Contract Year during the Term of this Agreement as such written plan may be amended, modified or updated in accordance with the terms of this Agreement. Each Research Plan shall include a budget and shall specify the number of FTEs to be utilized by Archemix.

1.79 “Research Program Term” means the period during which Archemix shall be obligated to conduct Research on Nuvelo’s behalf hereunder. The Research Program Term shall begin on the Effective Date and end on the last day of the third Contract Year or such later date as the Parties may mutually agree in writing; provided, that, if this Agreement is terminated prior to the end of the Research Program Term, the effective date of termination shall be the last day of the Research Program Term.

1.80 “Royalty Period” has the meaning assigned to it in Section 7.4(b)(iii).

1.81 “SELEX Inventions” means any and all inventions, including any improvements, made solely by employees or independent contractors of one Party, or jointly by employees or independent contractors of each Party, in the course of the Party’s or Parties’ performance under this Agreement, specifically relating to the SELEX Technology.

1.82 “SELEX Portfolio” means those Patent Rights licensed by Gilead to Archemix pursuant to the Gilead-Archemix Agreement.

1.83 “SELEX Technology” means any Technology or process for identifying, modifying, optimizing and/or stabilizing an Aptamer, whether (i) existing as of the Effective Date or invented thereafter. For clarity for the purposes of this Section 1.83: (i) the process of “identifying” includes, without limitation, any process which is disclosed in or falls within the claimed scope of U.S. Patent Nos. 5,270,163 or 5,843,653” ); and (ii) the processes of “modifying”, “optimizing” and “stabilizing” include, without limitation, minimization, truncation, conjugation, pegylation, complexation, substitution, and deletion and/or incorporation of modified nucleotides. “SELEX Technology” and “SELEX Inventions” does not include any Compound Technology.

1.84 “Short Acting Coagulation Cascade Aptamer” means ARC 2172 and any other Aptamer that: (a) binds to a pre-selected Coagulation Cascade Protein identified on Exhibit B; (b) Modulates the blood coagulant function of any Coagulation Cascade Protein identified on Exhibit B; and (c) demonstrates the short-acting characteristics and limitations that are set forth in Exhibit C. For clarity, Short Acting Coagulation Cascade Aptamers do not include [

*

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

13.

*                     ] Nothing in this Section 1.84 will be interpreted to exclude an Aptamer from the definition of “ Short Acting Coagulation Cascade Aptamer ” if it Modulates functions other than the blood coagulant function of a Coagulation Cascade Protein; provided, that, it Modulates the blood coagulant function of a Coagulation Cascade Protein.

1.85 “SomaLogic Agreements” means [

*

]

1.86 “Technology” means, collectively, inventions, discoveries, improvements, trade secrets, proprietary materials 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; (b) compositions of matter, data, formulations, processes, techniques, know-how and results (including any negative results); and (c) any proprietary data, instructions, processes, methods, formulae, materials, expert opinions and information including, without limitation, biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality control data and information in the Control of a Party either prior to or during this Agreement that relates in any way to Research or Development activities.

1.87 “Term” has the meaning assigned to it in Section 11.

1.88 “Third Party” means any entity other than: (a) Nuvelo; (b) Archemix; or (c) an Affiliate of either of them.

1.89 “Third Party Partner” means a Third Party that has entered into a Partnering Agreement.

1.90 “Third Party Royalty” has the meaning assigned to it in Section 7.4(b)(ii).

1.91 “Title 11” has the meaning assigned to it in Section 16.2(a).

1.92 “ULEHI Agreement” means [

*

                            ]

1.93 “URC License Agreement” means [          *          ]

1.94 “UTC” means [                                                                          *

                                ]

1.95 “Valid Claim” means (a) any claim of a pending patent application which has been pending for a period of less than five (5) years from the date of issuance of a first patent office communication during examination of the first application related thereto, and shall not have been earlier cancelled, withdrawn or abandoned on a country-by-country basis, or (b) an

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

14.

issued unexpired patent that (i) has not been finally cancelled, withdrawn, abandoned or rejected by any administration agency or other body of competent jurisdiction, (ii) 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, (iii) has not been rendered unenforceable through disclaimer or otherwise, and (iv) is not lost through an interference proceeding.

2. R ESEARCH

2.1 Research Overview . Archemix will conduct Research in the Field in accordance with an approved Research Plan to generate Candidate Compounds during the Research Program Term. The Parties will prepare a Research Plan for Nuvelo’s approval for the initial twelve (12) months of the Research Program Term within sixty (60) days of the Effective Date. For the second and third years of the Research Program Term the Parties shall prepare an updated Research Plan for discussion by the JMC and approval by Nuvelo at least ninety (90) days prior to the first and second anniversaries of the Effective Date. Each Research Plan will include, without limitation, (a) a prioritized list of the Coagulation Cascade Protein targets for which Archemix will generate Aptamers; (b) a target product profile for Short Acting Coagulation Cascade Aptamers to meet for each Coagulation Cascade Protein pursued so that such Aptamers can be considered as Candidate Compounds; and (c) a proposed work plan and resource allocation plan.

2.2 Diligence . The Parties will use Diligent Efforts to conduct their respective tasks throughout the Term, and will conduct all Research, Development and Commercialization activities in good scientific manner, and in compliance in all material respects with the requirements of applicable laws, rules and regulations, to attempt to achieve their objectives efficiently and expeditiously. Without limiting the generality of the foregoing:

(a) Nuvelo will: (i) determine whether any Candidate Compounds should be designated as Development Compounds, and (ii) use Diligent Efforts to Develop, manufacture and Commercialize at least one (1) Development Compound and related Licensed Product for use in the Field.

(b) Archemix will use Diligent Efforts to conduct Research and Nuvelo will use Diligent Efforts to evaluate in good faith and decide in a timely manner whether to designate Candidate Compounds as Development Compounds following receipt of all data requested by Nuvelo with regard to Candidate Compounds and to Develop and Commercialize any Development Compound or Licensed Product.

2.3 Designation of Candidate Compounds and Development Compounds . Nuvelo will have the sole right to designate a Candidate Compound as a Development Compound based on whether the Candidate Compound meets the relevant target product profile established by Nuvelo and set forth in the Research Plan or as subsequently modified by Nuvelo in good faith and communicated in writing to Archemix.

2.4 FTE Funding . Nuvelo shall pay Archemix a minimum of One Million Seven Hundred Fifty Thousand Dollars ($1,750,000) per Contract Year (the “Minimum FTE Funding

 

15.

Requirement ”) for Archemix Internal FTEs dedicated to conducting Research or any Development activities in accordance with Research Plans approved by Nuvelo, and any other activities conducted in accordance with an approved Research Plan or in conducting Development activities approved in writing by Nuvelo. For clarity, the Minimum FTE Funding shall be paid to Archemix regardless of whether or not (a) a Research Plan has been approved by Nuvelo or (b) the number of FTEs contemplated by the Minimum FTE Funding Requirement are utilized in any Contract Year, provided, that, to the extent that Nuvelo provides Archemix with a Research Plan that calls for Archemix Internal FTEs up to the Minimum FTE Funding Requirement for the purpose of conducting Research or Development in the Field, Archemix shall be required to provide the services of such FTEs as a condition to its entitlement to the Minimum FTE Funding Requirement. To the extent that Nuvelo requires Archemix Internal FTEs above the amount contemplated by the Minimum FTE Funding Requirement such obligation to provide these additional FTE’s shall come only with (i) Archemix’s prior written consent and (ii) as part of an approved Research Plan. Unless otherwise stated herein, Nuvelo will have no other obligation to reimburse Archemix for any expenses Archemix incurs in connection with Archemix’s performance of Research under this Agreement. Notwithstanding any other provision hereof: (y) Archemix will have no obligation to engage any Third Party in its performance of the Research hereunder, and Nuvelo will have no obligation to reimburse Archemix for any such Third Party engagement, unless Nuvelo agrees in writing to reimburse Archemix for the costs associated with such Third Party contracts, and (z) Archemix shall have no obligation to perform any activities not identified in an agreed Research Plan, and Nuvelo will have no obligation to reimburse Archemix for any such activities. Nuvelo will have no ongoing obligation to fund any Research by Archemix after the expiration of the Research Program Term.

3. M ANAGEMENT O F THE C OLLABORATION

3.1 Overall Management Structure . The Joint Management Committee (“JMC”) will be established as set forth below and will be responsible for reviewing the Research Plan, and all amendments thereto, under this Agreement as further described below. If Archemix exercises its Profit Share Option (as defined below), then the responsibility of the JMC will expand to include Nuvelo’s sharing of information relating to its Commercialization activities with respect to a particular Development Compound, and the Licensed Products relating thereto, pursuant to Section 6.2.

3.2 Joint Management Committee .

(a) Membership . The JMC shall be composed of six (6) members, with an equal number of members appointed by each Party. Immediately following the Effective Date, each Party shall appoint its initial representatives to the JMC. Each Party may replace its JMC representatives at any time upon written notice to the other Party. Nuvelo will designate one of its representatives as the Chairperson of the JMC. The Chairperson shall be responsible for scheduling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each meeting within thirty (30) days thereafter. Minutes of a JMC meeting shall be final only when approved by the JMC.

 

16.

(b) Power and Responsibilities. During the Research Program Term of this Agreement, the JMC shall meet a minimum two (2) times per year as provided in Section 3.3. The JMC is responsible for: (i) reviewing the annual Research Plan; and (ii) receiving updates on Nuvelo’s Development activities hereunder with regard to any Development Compounds or Licensed Products then under Development. If Archemix exercises its Profit Share Option, then the responsibility of the JMC will expand to include receiving updates on Nuvelo’s Commercialization activities with respect to Licensed Products. The JMC shall have no power to amend this Agreement. Any amendments that alter the terms of this Agreement shall be implemented pursuant to Section 16.1 below.

3.3 Meetings. The Parties shall endeavor to schedule meetings of the JMC at least thirty (30) days in advance. Committee meetings held in person will alternate between sites designated by each Party, unless otherwise agreed by the Parties. With the consent, not to be unreasonably withheld, of the representatives of each Party serving on the JMC, other representatives of each Party may attend meetings of the JMC as nonvoting observers. A meeting of the JMC may be held by audio or video teleconference. Each Party shall be responsible for all of its own expenses of participating in the meetings of the JMC, and such expenses shall not be included in the Development Costs or Allowable Commercialization Expenses if Archemix exercises its Profit Share Option pursuant to Article 6.

3.4 Decision Making. If the JMC is unable to reach a unanimous agreement on any matter that the JMC is responsible for, then Nuvelo shall have the final decision; provided, however, that, to the extent that a Research Plan contemplates Archemix Research or Development activities in excess of the minimum commitment described in Section 2.4, Archemix shall not be required to perform any Research or Development activities as part of a Research Plan without its prior written consent. Nuvelo will have the sole right to designate a Candidate Compound as a Development Compound based on whether the Candidate Compound meets a target product profile acceptable to Nuvelo and set forth in an approved Research Plan or subsequently modified by Nuvelo in good faith and communicated in writing to Archemix.

3.5 Access to Information. Archemix shall provide Nuvelo and its authorized representatives with reasonable access during regular business hours to records, documents, and other information relating to the Candidate Compounds that Nuvelo may reasonably require in order to evaluate their potential as Development Compounds or, following their designation as Development Compounds, to Develop such Development Compounds pursuant to the exclusive licenses granted hereunder.

3.6 Research Expenses. Nuvelo will reimburse Archemix for the Minimum FTE Funding Requirement per year during each Contract Year during the Research Program Term of this Agreement. Nuvelo shall pay twenty five percent (25%) of the annual Minimum FTE Funding Requirement for each Contract Year quarterly in advance; provided that, in the event that an approved Research Plan sets forth a number of FTE’s higher than those indicated in the Minimum FTE Funding Requirement, then Nuvelo shall pay quarterly in advance twenty five percent (25%) of the annual FTE funding requirement based on the number of FTEs set forth in the Research Plan.

 

17.

3.7 Independence. Subject to the terms of this Agreement, each Party shall manage its own activities and resources, acting independently and in its individual capacity. The relationship between Nuvelo and Archemix is that of independent contractors and neither Party shall have the power to bind or obligate the other Party in any manner, other than as is expressly set forth in this Agreement.

4. D EVELOPMENT , M ANUFACTURE AND C OMMERCIALIZATION

4.1 Designation of ARC 2172. Nuvelo hereby designates ARC 2172 as a Development Compound.

4.2 Development and Commercialization. Nuvelo has sole and full control, authority and responsibility for conducting, funding (subject to Sections 6.1 and 7.5) and pursuing all aspects of the designation, Development and Commercialization of Development Compounds and Licensed Products throughout the world, so long as Nuvelo uses Diligent Efforts with respect thereto. Nuvelo may, at its discretion, contract with or grant sublicenses to Third Parties in connection with the exercise of its rights with regard to the Development and Commercialization of Development Compounds and Licensed Products.

4.3 Abandonment of Development Compounds. Any time after a Candidate Compound has been designated as a Development Compound, Nuvelo may determine that Development of such Development Compound should be abandoned. If Nuvelo decides to abandon Development of particular Development Compound, and is not pursuing another Candidate Compound or Development Compound for the same therapeutic indication for which the first Development Compound was in Development, or against the same Target to which such abandoned Development Compound binds, then Archemix will have the right to continue such Development within the Field either by itself or with a Third Party only with Nuvelo’s prior, written consent and upon the terms and conditions, if any, on which the Parties may agree in writing based on good faith negotiations. In addition, Archemix shall have the right to continue Development within the Field either by itself or with a Third Party of ARC 183 (as defined in the Original Agreement), whose joint Development the Parties have previously agreed to abandon, with Nuvelo’s prior, written consent and on terms and conditions, if any, on which the Parties may agree in writing based on good faith negotiations.

4.4 Regulatory Affairs. With respect to each Development Compound, at its discretion Nuvelo will prepare, file and own all right, title and interest in Regulatory Filings and Regulatory Approvals relating to each such Development Compound.

4.5 Manufacturing. Nuvelo will be responsible for manufacturing and supplying Development Compounds and Licensed Products for Development and Commercialization and for making all decisions with respect thereto in its sole discretion including, without limitation, decisions relating to process development work to support quality assurance, improving manufacturing/cost efficiency and commercial scale-up manufacturing. For clarity, Nuvelo shall have final decision making authority to fulfill its regulatory responsibilities over all steps of the manufacturing process (including bulk, finish and fill, labeling and packaging, lot release and management of contractors and subcontractors). The Parties recognize the Nuvelo may use Third Parties to conduct some or all of Nuvelo’s manufacturing responsibilities hereunder, and Nuvelo will have sole decision making authority for contracting with any such Third Parties.

 

18.

5. LICENSES AND RELATED RIGHTS

5.1 Research Licenses.

(a) Subject to the other terms of this Agreement, Archemix hereby grants to Nuvelo a worldwide, non-exclusive license, without the right to grant sublicenses, under the Licensed Technology and Licensed Patent Rights, for the sole purpose of conducting Research on Short Acting Coagulation Cascade Aptamers identified by Archemix in the course of performance of Research.

(b) Subject to the other terms of this Agreement, Nuvelo hereby grants to Archemix a worldwide, non-exclusive license during the Research Program Term, without the right to grant sublicenses, under Nuvelo Technology and Nuvelo patent Rights, for the sole purpose of conducting Research or Development.

5.2 Commercialization License. Archemix hereby grants to Nuvelo an exclusive (even as to Archemix), worldwide, sublicensable license under the Licensed Technology and Licensed Patent Rights, to Develop, Commercialize, make, have made, use, have used, sell, have sold, lease, offer for sale or lease, import and export Development Compounds and Licensed Products within the Field.

5.3 License Grant upon Termination of the Collaboration. Upon termination the license grants between the Parties of this Agreement shall be governed under Section 12.2 of this Agreement.

5.4 License Limitations. Notwithstanding any provision hereof to the contrary, (a) Archemix does not grant to Nuvelo a license to the SELEX Technology or SELEX Inventions and Nuvelo hereby covenants that it will not practice any SELEX Technology or SELEX Inventions Controlled by Archemix and (b) Nuvelo hereby covenants that it will not practice any of the rights granted hereunder to any of the Licensed Patent Rights or Licensed Technology or use, make, have made, import, sell, have sold, or offer for sale any Short Acting Coagulation Cascade Aptamer, Development Compound or Licensed Product for a purpose other than that expressly permitted in Sections 5.1 and 5.2 hereof.

5.5 Exclusivity. During the Term of this Agreement, and for a period of one (1) year thereafter, unless otherwise provided in Section 4.3 or Section 12.2, neither Party not its Affiliates shall, except with respect to the Parties’ activities under this Agreement [

*

                                                                                                                                                                                                            ] or (c) license or otherwise enable any Third Party to perform any of the activities set forth in subsections (a) through (c) above. For clarity, nothing herein shall be deemed to prohibit Archemix from identifying, discovering, researching, developing, making, using or selling Aptamers that are not Short Acting Coagulation Cascade Aptamers, so long as such actions are

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

19.

consistent with Sections 5.1, 5.2 and Article 10 hereof. In addition, neither Party may independently or with a Third Party [

*

]

5.6 Sharing of Data.

(a) During the Term of this Agreement, Nuvelo will have reasonable access to all Program Technology (including, without limitation, all raw data) as it is generated.

(b) The Parties’ access to Program Technology and Nuvelo Technology after the termination of the Agreement shall be governed by Section 12.2(a) and Section 9.1.

5.7 Grantback. Notwithstanding anything in this Agreement to the contrary, Nuvelo hereby grants to Archemix a non-exclusive, paid-up, royalty-free license to any Nuvelo Technology and Nuvelo Patent Rights that generically relates to and covers the manufacturing, formulation, methods of use and/or processing of Aptamers (such Patent Rights hereinafter referred to as “ Generic IP ”). Archemix shall have the right to practice the Generic IP and to grant sublicenses to the Generic IP to Third Parties who have a license from Archemix to Archemix technology and/or intellectual property solely in order to permit Archemix or such Third Party to research, discover, make, have made, keep, use, sell and/or have sold, import or export Aptamers which are not subject to Nuvelo’s exclusive rights hereunder, and to the extent such actions are consistent with Section 5.5 hereof and for no other purpose. For clarity, the rights granted to Archemix by Nuvelo under this Section 5.7 are limited to the claims to Generic IP and no rights are granted under other claims in any patent or patent application of Nuvelo that contains the claims(s) which is (are) Generic IP.

5.8 Sublicenses. Nuvelo has the right to subcontract its Development and Commercialization responsibilities under this Agreement (and grant any necessary sublicenses in connection therewith) without obtaining the written consent of Archemix; provided, that, Nuvelo shall at all times remain primarily responsible and liable for all such activities.

With respect to each sublicense granted hereunder: (a) such sublicense shall be subject to all the material terms and conditions of the Agreement as applicable; (b) the scope of such sublicense shall be limited to performing Development or Commercialization activities hereunder; (c) Nuvelo shall be liable to Archemix as if Nuvelo is exercising such sublicensed rights itself under this Agreement; and (d) Nuvelo shall provide, upon written request by Archemix, reasonable assurance that its sublicensees are bound by confidentiality, indemnity, reporting, audit rights, access to data, and information and inventions assignment obligations substantially the same as those set forth in this Agreement. Nuvelo shall promptly provide notice to Archemix of any sublicense granted pursuant to this Section 5.8.

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

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5.9 No Other Rights. No licenses other than as expressly provided herein are granted by either Party to such Party’s Technology or Patent Rights.

6. O PTION

6.1 Option Exercise.

(a) With respect to each Development Compound, Archemix shall have the right, but not obligation, to elect to share in the expenses incurred and profits obtained in connection with the Development and Commercialization of such Development Compound and all Licensed Products comprising such Development Compound (the “Profit Share Option” ) by providing Nuvelo a written notification of such election within forty-five (45) days after receipt from Nuvelo of written notification of the closing of the first patient in the first Phase 3 Trial for a Licensed Product comprising, consisting of or incorporating such Development Compound. For clarity, such Profit Share Option with respect to a particular Development Compound shall expire after such forty-five (45) day period.

(b) Within thirty (30) days after Nuvelo receives notice that Archemix elects to exercise its Profit Share Option pursuant to (a) above, Nuvelo shall provide Archemix with an invoice for a payment that equals the sum of twenty-five percent (25%) of (i) the sum of all costs incurred by Nuvelo in the Research and all Development Costs incurred by Nuvelo, both as of the date of invoice, with respect to such Development Compound and Licensed Product; and (ii) the total for all milestone payments paid by Nuvelo to Archemix as of the date of the invoice to Archemix with respect so such Development Compound and Licensed Product. Archemix shall pay such invoice within ten (10) days after its receipt in order to effect its exercise of such Profit Share Option.

6.2 Consequence of Option Exercise.

(a) Upon Archemix exercising its Profit Share Option with respect to a particular Development Compound, Archemix shall be responsible for twenty-five percent (25%) of all subsequent Development and Commercialization Costs with respect to such Development Compound and all of its related Licensed Products, and Archemix shall share in the Product Profit and Loss with respect to such Licensed Products pursuant to Section 7.5 below. Nuvelo shall have no payment obligations to Archemix for milestone events pursuant to Section 7.4 which are not yet due as of the date of exercise of the Profit Share Option with respect to such Development Compounds or Licensed Products.

(b) Upon Archemix exercising its Profit Share Option with respect to a particular Development Compound and its related Licensed Products, Nuvelo will share all Nuvelo Information reasonably requested by Archemix regarding its Commercialization activities of any such Licensed Products in connection with the JMC meetings.

6.3 Option Exercise and Third Party License. Archemix’s rights to its Profit Share Option hereunder shall survive and remain in full force and effect relative to any Development Compound that becomes subject to a Partnering Agreement for so long as such Partnering Agreement remains in effect. Further, Archemix shall be entitled to twenty-five percent (25%) of all Licensing Revenue associated with such Partnering Agreement regardless of whether such Licensing Revenue is received before or after Archemix’s exercise of its Profit Share Option.

 

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7. C OMPENSATION

7.1 Obligations Prior to the Effective Date. Within sixty (60) days of the Effective Date, each Party will fulfill any and all of its payment obligations accrued and due under the Original Agreement.

7.2 Upfront Payment . Nuvelo shall pay to Archemix Four Million Dollars ($4,000,000) within ten (10) days of the Effective Date by wire transfer of immediately available funds.

7.3 Stock Purchase and Sale.

(a) Stock Purchase . Contingent upon and subject to the execution and delivery of, and compliance with the terms and conditions of, this Agreement and the agreements contemplated herein, and provided that this Agreement is still in effect, Archemix shall instruct its underwriters to the Qualified IPO to offer to Nuvelo, subject to the determination by Archemix or the underwriters, with the advice of counsel, that such offer does not violate applicable state or federal securities laws or regulations or any rule, policy or limit imposed by the U.S. Securities and Exchange Commission, the National Association of Securities Dealers, any securities exchange or any other applicable regulatory body (together, the “Applicable Regulations” ), the opportunity to purchase the Nuvelo IPO Share Amount as an allotment in any Qualified IPO that closes within five (5) years of the Effective Date at the IPO Price; provided, however, that if the underwriters determine in good faith that an allotment of shares in such manner would be materially detrimental to the success of the Qualified IPO, then the underwriters may limit all or a portion of the Nuvelo IPO Share Amount. Should Nuvelo not be offered or elect not to accept the opportunity to purchase the full Nuvelo IPO Share Amount as an allotment in any such Qualified IPO, then Nuvelo shall instead purchase from Archemix, and Archemix shall sell to Nuvelo in a private placement (the “Private Placement” ), concurrently with a Qualified IPO that closes within five (5) years of the Effective Date, the portion of the Nuvelo IPO Share Amount that is not included in the Qualified IPO at the IPO Price. The purchase of shares of Archemix Common Stock in the Private Placement shall be subject to compliance with Applicable Regulations, including but not limited to compliance with the U.S. Securities and Exchange Commission’s integration doctrine. For clarity, if the Qualified IPO occurs prior to the first anniversary of this Agreement then Nuvelo shall consummate the stock purchase set forth in this Section 7.3 as a Private Placement pursuant to Section 7.3(c) below.

(b) Purchase Mechanics.

(i) Notice of Qualified IPO. At least ten (10) days prior to the anticipated effective date of the registration statement for the Qualified IPO, Archemix shall deliver to Nuvelo written notice (the “Qualified IPO Notice” ) specifying:

(1) that Archemix has filed a registration statement for a Qualified IPO;

 

22.

(2) the anticipated effective date of the registration statement for the Qualified IPO;

(3) the anticipated total gross offering proceeds (prior to underwriter commissions and expenses) expected to be raised by Archemix in the Qualified IPO;

(4) the anticipated range of the IPO Price; and

(5) the anticipated number of shares of Archemix Common Stock to be purchased and sold in the Qualified IPO (appropriately adjusted to reflect stock splits, stock dividends, combinations of shares and the like).

(ii) Nuvelo Notice of Participation. Nuvelo shall inform Archemix in writing within eight (8) days of the date of the Qualified IPO Notice whether Nuvelo wishes to purchase shares of Archemix Common Stock in the Qualified IPO and the portion of the Nuvelo IPO Share Amount it wishes to purchase.

(iii) Purchase Notice. Following the pricing of the Qualified IPO (the “IPO Effective Date” ), Archemix shall deliver to Nuvelo written notice within one (1) business day (the “Purchase Notice” ) specifying:

(1) that the registration statement for the Qualified IPO has been declared effective;

(2) the total gross offering proceeds (prior to underwriter commissions and expenses) to be raised by Archemix in the Qualified IPO;

(3) the IPO Price;

(4) the number of shares of Archemix Common Stock comprising the Nuvelo IPO Share Amount;

(5) if applicable, details for the purchase and settlement of the portion of the Nuvelo IPO Share Amount to be purchased by Nuvelo in the Qualified IPO, as specified by the underwriter(s) to the qualified IPO, and the aggregate purchase price for such shares (the “Qualified IPO Purchase Price” );

(6) if applicable, the place and time at which the Private Placement Closing will occur, the portion of the Nuvelo IPO Share Amount to be purchased by Nuvelo in the Private Placement, the aggregate purchase price of such shares (the “Private Placement Purchase Price” ) and wire transfer instructions for the payment of the Private Placement Purchase Price.

(c) Private Placement Closing . The closing of the Private Placement, if applicable, (the “Private Placement Closing” ) shall take place on the same day as the closing of the Qualified IPO (the “Private Placement Closing Date” ) at the place specified in the Purchase Notice; provided, however , that: (A) if such purchase cannot be consummated on the Private Placement Closing Date by reason of any applicable order, judgment, decree or other legal

 

23.

impediment, then Nuvelo and/or Archemix may extend the Private Placement Closing Date to a date not more than ten (10) days after the applicable order, judgment, decree or other legal impediment has been satisfied; and (B) if prior notification to or approval of any governmental body is required, or if any waiting period must expire or be terminated, in connection with such purchase, then (1) the relevant Party shall promptly cause to be filed the required notice or application for approval and shall cause such notice or application to be processed as expeditiously as possible, (2) the other Party shall cooperate with the filing Party in the filing of any such notice or application required to be filed and in the obtaining of any such approval required to be obtained, and (3) the Private Placement Closing Date shall be extended to a date not more than ten (10) days after the latest date upon which any required notification has been made, any required approval has been obtained or any required waiting period has expired or been terminated. The Private Placement Closing shall occur as follows:

(i) On the Private Placement Closing Date, Nuvelo shall deliver to Archemix the Private Placement Purchase Price by wire transfer, in immediately available funds, to the bank account designated by Archemix in the Purchase Notice.

(ii) At the Private Placement Closing, simultaneously with the delivery of the Private Placement Purchase Price, Archemix and Nuvelo shall deliver to each other, executed counterparts of the Stock Purchase Agreement set forth as Exhibit F and the Registration Rights Agreement set forth as Exhibit G.

(d) Qualified IPO Closing. On the closing date of the Qualified IPO, Nuvelo shall deliver to the underwriters the Qualified IPO Purchase Price in accordance with the purchase and settlement instructions designated by the underwriters.

(e) “Market Stand-Off” Agreement. Nuvelo aggress that during the [                    *                    ] day period following the effective date of the registration statement for the Qualified IPO, or such other period as requested of all Archemix executive officers required to file Forms 3 and 4 and directors of Archemix by the underwriters in the Qualified IPO in order to comply with Rule 2711 of the National Association of Securities Dealers or otherwise, Nuvelo shall not, to the extent requested by the Archemix and any underwriter to the Qualified IPO, sell, pledge, lend, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any options, right or warrant to purchase, or otherwise transfer or dispose of (other than to donees who agree to be similarly bound), or enter into any swap, hedging or similar transaction with the same economic effect as a sale, any shares of Common Stock of Archemix or any securities convertible into or exercisable or exchangeable for Common Stock held by Nuvelo at any time during such period; provided, however, that all executive officers and directors of Archemix enter into similar market stand-off agreements.

7.4 Payments for Development Compounds and Licensed Products for which Archemix has not Exercised its Profit Share Option.

(a) Milestone Payments. With respect to each Development Compound, Nuvelo shall pay to Archemix the milestone payments as set forth below, which shall be due and payable within ten (10) business days of the occurrence of the event for the Development Compound for which the payment is due. For clarity, each milestone payment is due only once

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

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for each Development Compound, regardless of the number of Licensed Products Developed or Commercialized under this Agreement which comprise, consist of or incorporate such Development Compound. Each milestone payment is due only for Development Compounds for which Archemix has not exercised its Profit Share Option.

 

(b) Royalties.

(i) Nuvelo shall pay Archemix royalties on Net Sales of Licensed Products for which Archemix has not exercised its profit Share Option at the royalty rates set forth below:

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

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(ii) Third Party Royalties. Nuvelo shall be responsible for any and all royalties due to a Third Party in connection with the Development of any Development Compound and/or Commercialization of any Licensed Product (the “Third Party Royalty” ), except that Archemix shall be responsible for all royalties due to ULEHI for payments made by Nuvelo to Archemix with respect to all Licensed Products. Archemix hereby warrants that the only Third Party Royalty obligation of which Archemix is aware that exists as of the Effective Date of this Agreement is set forth in ULEHI Agreement.

(iii) Royalty Adjustment and Term. The royalty amounts set forth above shall be due on a Licensed Product-by-Licensed Product and country-by-country basis for so long as a Valid Claim of (a) Licensed Patent Rights cover the manufacture, use or sale of such Licensed Product in such country or (b) Nuvelo patent Rights that cover Nuvelo Program Technology cover the manufacture, use or sale of such Licensed Product in such country. In the event that no such Valid Claim exits, the royalty amounts set forth above, which shall be due on a country-by-country basis, shall be reduced by fifty percent (50%) on a Licensed Product-by-Licensed Product and country-by-country basis until the tenth (10 ^th ) anniversary of the first commercial sale of such Licensed Product in such country if such anniversary has not yet occurred.

(iv) Royalty Report and Payment. Commencing with the first commercial sale of a Licensed Product by Nuvelo or its licensees or sublicensees, Nuvelo or its licensees or sublicensees making such sales shall make quarterly written reports to Archemix within sixty (60) days after the end of each calendar quarter (the “Royalty Period” ), stating in each such report, by Licensed Products and by country, the number, description and aggregate Net Sales in U.S. dollars of such Licensed Products sold during such Royalty Period by Nuvelo and its licensees or sublicensees, respectively. The report shall also show: (A) the calculation of Net Sales made by Nuvelo and the royalty payments due to Archemix on such Net Sales for such Royalty Period; (B) the calculation of Net Sales made by Nuvelo’s licensees or sublicensees, the amount of sublicense revenue and royalty received from such licensees or sublicensees and the royalty payments due to Archemix on such sublicensee Net Sales for such royalty period; (C) the

 

[*]	Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

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amount of taxes, if any, withheld to comply with applicable law; and (D) the exchange rates used in calculating the payments due to the other Party, which exchange rates shall comply with Section 7.4(b)(vi) below. Simultaneously with the delivery of each such report, Nuvelo or its licensee or sublicensee making such sales shall pay to Archemix the total royalties, if any, due to Archemix for such Royalty Period. If no royalties are due, Nuvelo or its licensee or sublicensee making such sales shall so report.

(v) Blocked Currency. In each country where the local currency is blocked and cannot be removed from the country, royalties arising from sales made in that country shall be paid in the country in local currency by deposit in a local bank designated by Archemix, unless the Parties otherwise agree.

(vi) Foreign Exchange. Conversion of sales recorded in local currencies to U.S. dollars will be performed using an exchange rate for conversion of the foreign currency into U.S. dollars, at the average rate of exchange for the calendar quarter to which such payments relate, quoted for current transactions for buying U.S. dollars, as reported in The Wall Street Journal for the last business day of the week before such payment is due, except as provided in Section 7.4(b)(v).

7.5 Payments for Development Compounds and Licensed Products for which Archemix Exercises its Profit Share Option.

(a) Overview. For Licensed Products for which Archemix has exercised its Profit Share Option, the Parties shall share all Product Profit and Loss with respect to such Licensed Product so that Nuvelo shall be entitled to seventy-five percent (75%) of such Product Profit and Loss and Archemix shall be entitled to twenty-five percent (25%) of such Product Profit and Loss.

(b) Reporting and Reconciliation.

(i) Within sixty (60) days after the end of each calendar quarter following the first receipt of revenues under this Agreement (which may be either from Net Sales or Licensing Revenue), Nuvelo shall prepare and submit to Archemix a statement of quarterly Product Profit and Loss, prepared on an accrual basis in accordance with GAAP in substantially the form attached as Exhibit H, which shall include a calculation of the equalization payment which is necessary to cause the ratio of the participation of Nuvelo and Archemix in the Product Profit and Loss for such quarter on an accrual basis to be seventy-five percent/twenty-five percent (75%/25%), respectively (the “Financial Statement” ). The reports and equalization payments for the fourth quarter of the fiscal year may include reconciliations and year-end adjustments with respect to previous quarters. All payments required by this Section 7.5 shall be made concurrently with the submittal of the Financial Statement or, if a payment is due from Archemix to Nuvelo, within ten (10) days after receipt thereof by Archemix. Nuvelo will provide to Archemix such supporting information for the Financial Statement as Archemix may reasonably request. Archemix may audit, in accordance with the procedures set forth in Article 8, the accuracy of Nuvelo’s submissions pursuant to this Section 7.5(b)(i).

 

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(ii) By way of example, on an accrual basis, if during a particular quarter Nuvelo realized revenues from Licensed Products for which Archemix has exercised its Profit Share Option of One Hundred Million Dollars ($100,000,000) and incurred Allowable Commercialization Expenses of Thirty Million Dollars ($30,000,000), then the Equalization Payment for such quarter would be a payment by Nuvelo to Archemix in the amount of Seventeen Million Five Hundred Thousand Dollars ($17,500,000). For clarity, the example set forth in this Section 7.5(b)(ii) is calculated on an accrual basis of accounting.

7.6 Payment Method. All payments due under this Agreement shall be made by a bank wire transfer in immediately available funds to an account designated by the receiving Party. All payments hereunder shall be made in U.S. dollars from the United States.

7.7 Taxes. Each Party shall pay any and all taxes levied on account of all payments it receives under this Agreement. If laws or regulations require that taxes be withheld, the paying Party will: (a) deduct those taxes from the remittable payment; (b) pay the taxes to the proper taxing authority; and (c) send evidence of the obligation together with proof of tax payment to the receiving Party within thirty (30) days following that tax payment.

8. R ECORDS ; A UDITS

Both Parties shall keep complete, true and accurate books of accounts and records for the purpose of determining the payments to be made under this Agreement. Such books and records shall be kept for at least three (3) years following the end of the calendar quarter to which they pertain. Such records will be open for inspection during such three (3) year period by independent accountants, solely for the purpose of verifying payment statements hereunder. Such inspections shall be made no more than once each calendar year, at reasonable time and on reasonable notice. If any errors that favor the inspected Party are discovered in the course of such inspection, then within thirty (30) days after its receipt of the inspection report, the inspected Party shall pay the inspecting Party those amounts (plus interest equal to the Prime Lending Rate as published in the Wall Street Journal on the day preceding the inspection plus two hundred (200) basis points; provided, however, that in no event shall such rate exceed the maximum annual interest rate permitted under applicable law) that the inspecting Party would have received in the absence of such errors. If any errors that favor the inspecting Party are discovered in the course of such inspection, then within thirty (30) days after its receipt of the inspection report, the inspecting Party shall pay the inspected Party those amounts. Inspections conducted under this Article 8 shall be at the expense of the inspecting Party, unless a variation or error that favors the inspected Party exceeding five percent (5%) of the amount stated for any year covered by the inspection is established in the course of such inspection, whereupon all costs relating to the inspection for such period will be paid promptly by the inspected Party.

9. INFORMATION, INVENTIONS AND INTELLECTUAL PROPERTY

9.1 Ownership.

(a) Patent Rights and Technology. Subject to Section 9.1(b), all Patent Rights will be the property of the inventing Party, provided that all Joint Patent Rights will be jointly owned by the Parties with each Party having full rights to use and license same subject only to the licenses expressly granted and the terms set forth herein. In all cases, inventorship shall be determined according to United States Patent law.

 

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(b) SELEX Inventions and SELEX Technology. Notwithstanding anything to the contrary herein, the SELEX Inventions and SELEX Technology shall be the property of Archemix. Nuvelo shall and hereby does assign to Archemix all of Nuvelo’s right, title and interest in and to all SELEX Inventions and SELEX Technology.

( c) Technology. Subject to Section 9.1(b), ownership of all unpatented Technology is and will be the property of the Party who created it.

(d) Further Acts. Each Party shall perform such additional actions necessary to affect the intent of this Section 9.1, and shall reasonably cooperate with the other Party in doing so.

9.2 Patent Prosecution and Maintenance.

(a) ARC 2172 and Compound Patent Rights. Archemix will transfer all responsibility for the prosecution and maintenance of the ARC 2172 Patents to Nuvelo promptly after the Effective Date. In addition, if Archemix discovers any Short Acting Coagulation Cascade Aptamer for use within the Field or makes any new invention relating to any Short Acting Coagulation Cascade Aptamer for use within the Field in the course of its Research under this Agreement, Archemix will transfer all responsibility for the filing, prosecution and maintenance of the relevant Compound Patent Rights to Nuvelo and will provide. Nuvelo with all necessary documents and information to effect the transfer of responsibility. For so long as Nuvelo has an exclusive license hereunder to ARC 2172 or such Development Compound, Nuvelo has the right to pursue worldwide filing, prosecution and maintenance of such ARC 2172 Patents or Compound Patent Rights using mutually acceptable outside counsel. Unless Archemix exercises its Profit Share Option, in which event Section 7.5 shall apply, Nuvelo will be solely responsible for all costs incurred in this Section 9.2(a). Nuvelo will keep Archemix apprised of all prosecution matters, and will provide a copy of all official correspondence to Archemix, and Nuvelo will consider any comments in good faith from Archemix and incorporate them to the extent possible. Nuvelo shall file, prosecute and maintain the ARC 2172 Patents and Compound Patent Rights in Archemix’ name using reasonably diligent efforts including filing, prosecuting and maintaining the ARC 2172 Patents and Compound Patent Rights, at a minimum, in the countries listed on Exhibit E. If Nuvelo decides to not pursue prosecution or maintenance of any such Patent Rights, control of such Patent Rights shall be transferred to Archemix at no cost. For purposes of this Agreement, “ARC 2172 Patents” means the following United States Patent Applications and their counterparts throughout the world to the extent not SELEX Inventions or SELEX Technology: U.S. Patent Application Serial No. 60/711,768 and Serial No. 60/808,590.

(b) SELEX Technology and SELEX Inventions. Archemix shall have the sole right but not the obligation to file, prosecute and maintain Patent Rights on SELEX Technology or SELEX Inventions, at its own expense.

 

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(c) Archemix Technology. Except as set forth in Section 9.2(a), Archemix shall have the sole right but not the obligation to file, prosecute and maintain Patent Rights on Archemix Background Technology and Archemix Program Technology, at its own expense, including without limitation all Patent Rights in and to the SELEX Portfolio.

(d) Nuvelo Background Technology. Nuvelo shall have the sole right but not the obligation to file, prosecute and maintain Patent Rights claiming Nuvelo Background Technology, at its own expense.

(e) Nuvelo Program Technology. Nuvelo shall have the first right but not the obligation to file, prosecute and maintain Patent Rights claiming Nuvelo Program Technology at its own expense. If, at any time, Nuvelo elects not to pursue patent protection for, or maintenance of, any Nuvelo Program Technology, Archemix shall have the right to pursue patent protection for such technology for such Technology at Archemix’s sole expense.

(f) Joint Patent Rights. Archemix has the first right, but not the obligation, to pursue worldwide patent protection of all Joint Technology not covered by Section 9.2(a) above. The Parties will be jointly (on a fifty/fifty (50/50) basis) responsible for all costs incurred pursuant to this Section 9.2(f). If Archemix elects to pursue such patent protection, it will use outside counsel mutually acceptable to the Parties. Archemix will keep Nuvelo apprised of all prosecution matters, and will provide a copy of all official correspondence to Nuvelo. Archemix will consider in good faith any comments from Nuvelo and incorporate them to the extent possible. If, at any time, Archemix elects to not pursue patent protection for, or maintenance of, any such Joint Patent Rights, control of such Joint Patent Rights shall be transferred to Nuvelo at no cost. For clarity, Patent Rights claiming any SELEX Technology or SELEX Invention are governed by Section 9.2(b) and not this Section 9.2(f).

(g) Information and Cooperation . Each Party that has responsibility for filing and prosecuting any Patent Rights under this Section 9.2 (a “Filing Party”) shall: (a) regularly provide the other Party (the “Non-Filing Party”) with copies of all patent applications filed hereunder for Program Technology and other material submissions and correspondence with the patent offices, in sufficient time to allow for review and comment by the Non-Filing Party; and (b) to the extent practicable, provide the Non-Filing Party and its patent counsel with an opportunity to consult with the Filing Party and its patent counsel regarding the filing and contents of any such application, amendment, submission or response, and the advice and suggestions of the Non-Filing Party and its patent counsel shall be taken into consideration in good faith by such Filing Party and its patent counsel in connection with such filing. Each Filing Party shall pursue in good faith all reasonable claims and take such other reasonable actions, as may be requested by the Non-Filing Party in the prosecution of any Patent Rights under this Section 9.2; provided, however, if the Filing Party incurs any additional expense as a result of any such additional claim or taking such other activities. In addition, Nuvelo (a) agrees that if Archemix claims any action taken under Section 9.2 would be detrimental to Patent Rights covering Archemix Background Technology (including without limitation the SELEX Portfolio), Archemix shall provide written notice to Nuvelo and the Parties shall, as promptly as possible thereafter, meet to discuss and resolve such matter and, if they are unable to resolve such matter, the Parties shall refer such matter to a mutually agreeable outside patent counsel for resolution.

 

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9.3 Enforcement of Patent Rights.

(a) Notice. If a Third Party is apparently infringing any Patent Right to which exclusive licenses are granted under this Agreement, the Party first obtaining knowledge of such a claim shall immediately provide the other Party notice of such claim and the related facts in reasonable detail.

(b) Enforcement Responsibility. Nuvelo, as exclusive commercial licensee, has the first right, but not the obligation, to solely enforce all Compound Patent Rights against any actual or suspected Third Party infringer in the Field. Such enforcement will be in Nuvelo’s own name and entirely under its own direction and control, and Nuvelo may settle any such action, proceeding or dispute by license, subject to the remainder of this Section 9.3(b). Unless Archemix exercises its Profit Share Option, in which event Section 7.5 shall apply, or unless otherwise provided below, Nuvelo will be solely responsible for all costs incurred in this Section 9.3(b).

(i) Enforcement by Nuvelo . Archemix will, upon Nuvelo’s request, reasonably assist Nuvelo in any action or proceeding being prosecuted by Nuvelo under this Section 9.3(b) if so requested, and shall lend its name to such actions or proceedings if reasonably requested by Nuvelo or required by applicable law. Nuvelo shall reimburse Archemix for the documented external costs Archemix reasonably incurs in providing such assistance as specifically requested in writing by Nuvelo. Archemix shall have the right to participate and be represented in any such suit by its own counsel at its own expense; provided , that, Nuvelo shall retain overall responsibility for the prosecution of such suit or proceedings in such event. No settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of an Archemix Patent Right, or w