Drug Product Development And Clinical Supply Agreement

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.

EXHIBIT 10.58

Drug Product Development and Clinical Supply Agreement THIS DRUG PRODUCT DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT (the " Agreement" ) is effective as of the 28th day of April 2006 (the " Effective Date" ).

BY AND BETWEEN:

NUVELO, INC. , a corporation organized and existing under the laws of the state of Delaware, with its principal offices located at 201 Industrial Road, Suite 310, San Carlos, CA 94070 (hereinafter referred to as " NUVELO" );

AND:

BAXTER PHARMACEUTICAL SOLUTIONS LLC , a Delaware limited liability company, with a place of business located at 927 South Curry Pike in Bloomington, Indiana 47403 (hereinafter referred to as " BPS" ); WHEREAS, NUVELO has rights to patents, formulations and know-how related to each Drug Product, as defined below; WHEREAS, BPS has the expertise and the manufacturing facility suitable for the Production (as defined below) and Development (as defined below) of Drug Product;

WHEREAS, NUVELO wishes to have BPS Produce and Develop Drug Product and BPS wishes to Produce and Develop Drug Product for NUVELO; NOW, THEREFORE, in consideration of the premises and the undertakings, terms, conditions and covenants set forth below, the Parties hereto agree as follows:

Article 1, DEFINITIONS.

1.1 AFFILIATE of a Party hereto shall mean any entity that controls or is controlled by such Party, or is under common control with such Party. For purposes of this definition, an entity shall be deemed to control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting equity of another entity. 1.2 BLA shall mean the FDA required Biologics License Application, or the equivalent thereof in any other jurisdiction. 1.3 APPLICABLE LAWS shall mean all applicable supranational, national or local laws, rules and regulations of the United States and the European Union that apply to the production of pharmaceutical products, including without limitation

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the sections of the FD&C Act relating to biologics manufacture, as amended from time to time, the regulations promulgated pursuant thereto, and any successor laws, rules or regulations of any of the preceding. A law that applies specifically to the Production of Drug Product, and not generally to the production of pharmaceutical products, does not become an Applicable Law under this Agreement until it is disclosed in written or Electronic form to BPS by NUVELO.

1.4 BATCH shall mean a specific quantity of a Drug Product, comprising a number of units mutually agreed upon between NUVELO and BPS, that (a) is intended to have uniform character and quality within specified limits, and (b) is Produced according to a single manufacturing order during the same cycle of manufacture.

1.5 BATCH PURCHASE PRICE (BPP) shall mean the fees and costs charged for the Production of a specific Batch, as expressly set forth in the applicable Project Plan.

1.6 BILL of MATERIALS shall mean a bill of materials which sets forth in detail the specific components, materials and excipients necessary for performance under a particular Plan or set of specifically-related Plans. Each Bill of Materials will be generated electronically by BPS and transmitted electronically to NUVELO. NUVELO shall review, approve and execute, or modify, the applicable Bill of Materials. If NUVELO modifies the Bill of Materials, the Parties will promptly commence discussions on the components, materials and excipients to be set forth in the Bill of Materials. Once the Parties have reached agreement on the content of the Bill of Materials and a new Bill of Materials has been generated and transmitted electronically to NUVELO by BPS, NUVELO shall return one (1) executed copy of the final version of the Bill of Materials to BPS. BPS is bound by any Bill of Materials electronically submitted to Nuvelo that NUVELO executes without modifying its terms.

1.7 BPS SOPs shall mean BPS' standard operating procedures, which do not include the DPS SOPs. Copies of BPS SOPs will be made available to NUVELO for auditing purposes in accordance with Section 5.8. BPS SOPs shall be deemed approved by NUVELO [ * ] , but deemed approval of BPS SOPs does not, nor shall it be deemed to result in, approval of any DPS SOP or any MBR in which any BPS SOP is referenced.

1.8 BULK DRUG SUBSTANCE (BDS) shall mean the active compound, alfimeprase, as set forth in the Development Plan and/or Project Plan, to be supplied by NUVELO for use in Production or Development of Drug Product.

1.9 cGMP shall mean current Good Manufacturing Practices as defined and established in 21 CFR Parts 210-211 and in Eudralex - Volume 4 - Medicinal Products for Human and Veterinary Use - Good Manufacturing Practice, and any successor laws, rules or regulations of any of the preceding.

1.10 CANCELLATION FEES shall mean the fees set forth in Section 3.4.

[*] 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.

NUVELO Page 2 of 36 CONFIDENTIAL 1.11 CERTIFICATE OF ANALYSIS shall mean a section of the QCMD containing a compilation of the analytical tests methods applied, specifications for each test and test results for a particular Batch of Drug Product.

1.12 COMPONENTS shall mean all components, including without limitation vials, stoppers, seals, raw materials and excipients, used by BPS in Production of Drug Product under this Agreement, including components provided by BPS and components provided by NUVELO, but specifically excluding Capital Equipment. All Components are identified as either components supplied by NUVELO (the " NUVELO Supplied Components" ) or components supplied by BPS (the " BPS Supplied Components" ). All BPS Supplied Components necessary for the performance of a particular Plan are listed in the Bill of Materials applicable to that particular Plan. All NUVELO Supplied Components applicable to a particular Plan are set forth in the applicable Plan. Any and all NUVELO Supplied Components that need to be stored in an environmentally-controlled location to avoid loss or damage are referred to herein as " NUVELO EC Components" .

1.13 CONFIDENTIAL INFORMATION shall mean all Information disclosed by one Party (the " Disclosing Party" ), its officers, directors, employees, consultants, contractors or agents and those of its Affiliates to the other Party (the " Receiving Party" ) that is marked " Confidential" at the time of disclosure if disclosed in written or tangible form; or is disclosed orally or disclosed by visual observation during a tour, site visit, or audit of either Party or any of their Affiliates' laboratories, manufacturing plants or other facilities. Notwithstanding the preceding, if a Party fails to mark written or tangibly disclosed Information as " Confidential," but notifies the other Party in writing of the confidential nature of the Information within ten (10) business days after the date of disclosure, the Information shall become " Confidential Information" as set forth herein. Confidential Information shall not include Information which: (i) is known to the Receiving Party as evidenced by its written records before receipt thereof from the Disclosing Party; (ii) is disclosed to the Receiving Party by a third person who has the right to make such disclosure; (iii) is or becomes part of the public domain through no breach of this Agreement by the Receiving Party; or (iv) the recipient can reasonably establish by competent evidence is independently developed by an employee, consultant or agent of the Receiving Party without reference to or use of the Confidential Information disclosed by the Disclosing Party. 1.14 DEVELOPMENT shall mean studies conducted by BPS to develop a process to Produce Drug Product, in accordance with the Specifications, cGMP and Applicable Laws. Development activities agreed upon by the Parties shall be expressly set forth in a Development Plan.

1.15 DEVELOPMENT PLAN shall mean a document containing the parameters for the Development of Drug Product which shall be developed by BPS in conjunction with NUVELO and agreed to in writing by the Parties for each Drug Product under this Agreement.

NUVELO Page 3 of 36 CONFIDENTIAL 1.16 DELIVERABLES shall mean: (a) all Drug Product, all unused BDS and NUVELO Components (" Material Deliverables" ); and (b) any and all information, data, materials, reports and documentation to be delivered to NUVELO by BPS in accordance with an applicable Plan, this Agreement or the Quality Agreement (" Information Deliverables" ), except that Information Deliverables shall not include [ * ], any [ * ] or [ * ] or [ * ], or the formatting of any documentation generated by BPS, [ * ] or [ * ] information, data, materials, reports or documentation provided to NUVELO by BPS in accordance with an applicable Plan, this Agreement or the Quality Agreement.

1.17 DOCUMENT REVIEW PERIOD has the meaning assigned to it in Section 6.1.

1.18 DRUG PRODUCT shall mean pharmaceutical product (or placebo, if applicable) Developed or Produced by BPS in final liquid or lyophilized dosage form, capped, packaged and labeled for shipment for development and/or clinical use only, as specified in this Agreement and the applicable Plan.

1.19 DRUG PRODUCT SPECIFIC SOPs (DPS SOPs) shall mean standard operating procedures that are specific to the Production of Drug Product. DPS SOPs shall be approved by both Parties by prior written or prior Electronically-documented approval.

1.20 ELECTRONIC or ELECTRONICALLY shall mean e-mail transmission, receipt of the transmission confirmed by e-mail return receipt; or facsimile transmission, receipt of the transmission confirmed by fax transmittal confirmation page.

1.21 EXPOSURE EVENT shall have the meaning set forth in the Quality Agreement.

1.22 FDA shall mean the United States Food and Drug Administration or any successor entity thereto. 1.23 FD&C ACT shall mean the United States Federal Food, Drug and Cosmetic Act, as may be amended from time to time. 1.24 FINAL RELEASE shall mean NUVELO' s acceptance of the Release Documentation provided to NUVELO by BPS for a particular Batch of Drug Product, which acceptance shall be set forth in a written notice to BPS. " Finally Released" shall mean and refer to a Batch for which Release Documentation has been accepted by NUVELO. 1.25 INFORMATION shall mean any and all scientific, technical, trade, financial, personnel or business information, whether tangible or intangible and whether or not patentable or copyrightable, including without limitation: a) inventions, discoveries, methods, know-how, processes, code, data, formulations or diagrams; b) amino acid or nucleic acid sequences, expression systems, cells, cell lines, [*] 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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organisms, antibodies, biological substances, and any constituents, progeny, mutants, derivatives or replications of them or from them, together with all reagents, chemical compounds or other material; and c) information regarding equipment or apparatus, software, clinical or regulatory reports and filings, patent prosecution status and strategy, business plans or research, financial, employment, operational or marketing developments.

1.26 INVENTION has the meaning assigned to it in Section 11.2.

1.27 LABELING shall mean all labels and other written, printed, or graphic matter upon: (i) Drug Product or any container, carton, or wrapper utilized with Drug Product; or (ii) any written material accompanying Drug Product.

1.28 MASTER BATCH RECORD (MBR) shall mean the formal set of instructions setting forth the procedure to be followed for the Production of Drug Product, including but not limited to the history of a Batch from the raw material stage up through and until completion of the Batch, a complete list of all active and inactive ingredients, components, weights and measures, descriptions of Drug Product containers, closures, packaging materials, and labeling and complete specifications for each.

1.29 NON-CONFORMITY and NON-CONFORMING have the meaning assigned to each of them in Section 6.1.2. 1.30 PARTY shall mean either NUVELO or BPS, and PARTIES shall mean both NUVELO and BPS. 1.31 PLAN shall mean any Project Plan, Development Plan or Regulatory Plan.

1.32 PRODUCTION or PRODUCE, and any conjugated forms of the preceding, shall mean, as applicable in the applicable Plan, the formulation, lyophilization, filling, packaging, inspection, labeling, or testing of Drug Product by BPS.

1.33 PRODUCT REQUIREMENTS has the meaning assigned to it in Section 6.1.

1.34 PROJECT PLAN shall mean the document containing the parameters for Production of Drug Product which shall be developed by BPS in conjunction with NUVELO and agreed to in writing by both Parties for each Drug Product under this Agreement.

1.35 PURCHASE PRICE shall mean the total amount of compensation to be paid by NUVELO to BPS under a particular Plan for, or in support of, Development or Production, as specified in the applicable Plan. The Purchase Price may consist of a Batch Purchase Price and other fees and costs for services that are not for the Production of a specific Batch, and therefore not part of the Batch Purchase Price.

1.36 QUALITY AGREEMENT shall mean the agreement with that title executed by each of the Parties that allocates responsibilities for quality in relation to Drug Product including, but not limited to: the quality standards mutually agreed upon in writing applicable for the Production of Drug Product under this Agreement in

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accordance with cGMP and the Release of Drug Product, specifically including the Release Documentation; and the roles and responsibilities of each Party' s personnel in relation to quality assurance matters under this Agreement.

1.37 QUALITY CONTROL MASTER DOCUMENT (QCMD) shall mean a document, agreed upon in writing or prior Electronically-documented approval by the Parties, that lists for each individual Batch, the analytical testing to be performed on, and corresponding Specifications for, the Bulk Drug Substance, raw materials, consumables and in-process materials and Drug Product, and includes the Certificate of Analysis for the Batch.

1.38 REGULATORY AUTHORITY shall mean those agencies or authorities responsible for regulation of Drug Product in the United States, the European Union and in the other territories of the world. BPS shall have no obligation to Produce Drug Product in compliance with the requirements of a Regulatory Authority, [ * ], unless the Regulatory Authority is specified in the applicable Plan. Each Plan generated by BPS under this Agreement and delivered to NUVELO is required to include a list of Regulatory Authorities, [ * ] NUVELO may, in its sole discretion, agree to limit the Regulatory Authorities applicable to a particular Plan by agreeing to an express statement in the applicable Plan that [ * ] are not applicable to Production under the applicable Plan. 1.39 REGULATORY PLAN shall mean a document containing regulatory services and support for the development and maintenance of regulatory submissions and supporting documentation mutually developed by the Parties and agreed to in writing by the Parties.

1.40 RELEASE, or with correlative meaning, RELEASED , shall mean the process by which, in respect of each Batch, BPS' quality assurance team:

1.40.1 reviews and approves completed Batch records;

1.40.2 closes out all exceptions;

1.40.3 issues a QCMD; and

1.40.4 reviews and approves any additional documents as identified in the Quality Agreement.

1.41 RELEASE DOCUMENTATION shall mean the following documentation prepared by BPS and provided to NUVELO by BPS after Release: 1.41.1 Released Executed Batch Record, which includes the QCMD;

1.41.2 Batch-related manufacturing documentation, as set forth in the Quality Agreement;

[*] 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.

NUVELO Page 6 of 36 CONFIDENTIAL 1.41.3 The QC Batch-related analyses, as set forth in the Quality Agreement; and

1.41.4 Certificate of Analysis (located in the QCMD).

1.42 RELEASED EXECUTED BATCH RECORD shall mean, for each Batch of Drug Product that has been Released: a written record that includes: (i) the completed Batch record, to include the items set forth in the Quality Agreement, and associated exception reports; (ii) the statement of conformance, if requested by NUVELO pursuant to, or if it is otherwise incorporated into, the relevant MBR; and (iii) the associated QCMD.

1.43 SPECIFICATIONS shall mean the specifications, including without limitation the specifications for raw materials, consumables, in-process testing and in-process materials: (i) for Drug Product set forth in the Master Batch Record or QCMD; (ii) for Drug Product provided to BPS by NUVELO and included in the product specification section of the QCMD for a particular Batch; and (iii) to the extent that BPS is required to test the Bulk Drug Substance (i.e., formulated BDS or sterile-filtered BDS), for the Bulk Drug Substance, as further set forth in the Quality Agreement.

Article 2, DEVELOPMENT AND PRODUCTION OF DRUG PRODUCT.

2.1 Initiation: Upon execution of this Agreement and a corresponding Development Plan for each Drug Product, BPS will use good faith, diligent efforts to develop Drug Product pursuant to the Development Plan for that Drug Product, including any timelines established in that Development Plan. Upon execution of this Agreement and a corresponding Project Plan for each Drug Product, BPS will use good faith, diligent efforts to Produce Drug Product pursuant to the Project Plan, including any timelines established in that Project Plan.

2.2 Documentation; Plans:

2.2.1 Development Plan. Prior to commencing Development hereunder for any Drug Product, BPS shall deliver two (2) signed originals of the mutually developed Development Plan to NUVELO. If NUVELO approves of the Development Plan, NUVELO shall sign both originals of the Development Plan and return one (1) fully executed original to BPS. Each fully executed Development Plan is incorporated herein by reference and made a part of this Agreement. Neither Party shall have any obligation with respect to the commencement of Development for a Drug Product until the Parties have executed a Development Plan for such Drug Product. In the event of a conflict between any of the provisions of this Agreement and a Development Plan, the provisions of this Agreement govern.

2.2.2 Project Plan. Prior to commencing Production of any Drug Product, BPS shall deliver two (2) signed originals of the mutually developed Project Plan to NUVELO. If the Project Plan is acceptable to NUVELO,

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NUVELO shall sign both originals of the Project Plan and return one (1) fully executed original to BPS. Each fully executed Project Plan is incorporated herein by reference and made a part of this Agreement. Neither Party shall have any obligation with respect to the Production of a Drug Product until both Parties have executed a Project Plan for such Drag Product. In the event of a conflict between any of the provisions of this Agreement and a Project Plan, the provisions of this Agreement govern.

2.2.3 Regulatory Plan. BPS shall execute any mutually agreed upon Regulatory Plan and deliver two (2) originals of the Regulatory Plan to NUVELO. If a Regulatory Plan is acceptable to NUVELO, NUVELO shall sign both originals of the Regulatory Plan and return one (1) fully executed original to BPS. Upon full execution, the Regulatory Plan is incorporated herein by reference and made a part of this Agreement. Neither Party shall have any obligation with respect to the performance of regulatory services or the provision of regulatory support for a Drug Product until the Parties have executed a Regulatory Plan in writing for such Drag Product. For the avoidance of doubt, any and all obligations set forth in the Quality Agreement are not and shall not be deemed to be regulatory services or regulatory support requiring the execution of a Regulatory Plan. In the event of a conflict between any of the provisions of this Agreement and the Regulatory Plan, the provisions of this Agreement govern.

2.2.4 Master Batch Records; Changes to MBRs. Master Batch Records shall be reviewed and approved by BPS and by NUVELO prior to commencement of Production. The MBR for Drug Product may be amended, supplemented or restated from time to time by mutual written agreement of the Parties. No changes to the content, specifically including written, graphic, tabular or pictorial content, of an MBR, other than the correction of typographical or formatting errors, or the inclusion of documentation in a Batch-Specific MBR regarding the occurrence of an exception or deviation from the manufacturing process established in the then-current MBR, as discussed in more detail below, will be made without NUVELO' s prior written or prior Electronically- documented approval. Each Batch of Drug Product shall be Produced by using a copy of the then-current Master Batch Record. Each copy of the then-current Master Batch Record for a particular Batch of Drag Product (" Batch-Specific MBR" ) shall be assigned a unique Batch number. Any deviation or exception from the manufacturing process specified in the then-current Master Batch Record must be documented in the Batch-Specific MBR. For clarity, BPS' inclusion of documentation in a Batch-Specific MBR regarding the occurrence of a deviation or exception from the manufacturing process specified in the then-current MBR is not considered a change to an MBR requiring NUVELO approval as set forth above in this Section 2.2.4; however, any change to the manufacturing process specified in the then-current MBR that is proposed as a result of the occurrence of the exception or deviation that is documented in the Batch-Specific MBR would be a change requiring both Parties approval, as discussed above. BPS also shall provide NUVELO with copies of the Released Executed Batch Record for each Batch, as part of the Release Documentation. BPS shall provide NUVELO with

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any required supporting Development and Production documentation in a form reasonably suitable for NUVELO' s submission to the FDA.

2.2.5 Quality Agreement. If the Quality Agreement has not been executed as of the Effective Date, then once the terms of the Quality Agreement have been mutually agreed upon by the Parties, BPS shall execute the mutually agreed upon Quality Agreement and deliver two (2) originals of the Quality Agreement to NUVELO for NUVELO' s execution. If the Quality Agreement is acceptable to NUVELO, NUVELO shall sign both originals of the Quality Agreement and return one (1) fully executed original to BPS. Upon full execution, the Quality Agreement is incorporated herein by reference and made a part of this Agreement. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement, [ * ].

2.2.6 Resources Necessary for and Amendments to Plans. BPS shall commit the resources and facilities necessary to perform Production and Development in accordance with the terms and conditions of this Agreement and the Plans. The Parties may amend any Plan upon commercially reasonable terms upon mutual written agreement of the Parties. The Parties recognize that the Parties will need to amend a Plan if NUVELO requires BPS to carry out additional or different work to that specified in the applicable Plan. Any amendment to a Plan that is mutually agreed upon in writing by the Parties is deemed to be incorporated into, and becomes a part of, the applicable Plan.

2.3 Bulk Drug Substance and Component Supply: NUVELO, at its sole cost and expense (including, without limitation, shipping costs), shall supply to BPS, in the manner and upon the timeline set forth in the applicable Plan, (a) all Bulk Drug Substance and (b) all other NUVELO Supplied Components. Except as may specifically be set forth otherwise in the applicable Plan or Quality Agreement, on receipt of the Bulk Drug Substance and NUVELO Supplied Components as set forth above, BPS' sole obligation with respect to evaluation of the Bulk Drug Substance and NUVELO Supplied Components shall be to review the accompanying Certificate of Analysis to confirm that the Bulk Drug Substance and any NUVELO Supplied Components conform with the specifications pursuant to BPS' receiving SOPs.

2.4 Bulk Drug Substance and Component Delivery Delays: BPS shall provide to NUVELO the vendor ordering lead times for all BPS Supplied Components prior to or contemporaneously with the Bill of Materials. BPS shall have no responsibility for delays in delivery of Drug Product caused by delays in receipt of BPS Supplied Components so long as: (i) BPS has complied with the applicable BPS Supplied Component vendor ordering lead times; (ii) the vendor ordering lead times have been disclosed to NUVELO prior to or contemporaneously with the Bill of Materials; and (iii) BPS maintains at all times at BPS' facility, at least the number of Components necessary to diligently perform BPS' obligations under all then-current Plans [ * ]. BPS [ * ] 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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shall have no responsibility for delays in delivery of Drug Product resulting from delays in receipt of Bulk Drug Substance or NUVELO-Supplied Components. In the event that BPS receives the Bulk Drug Substance for Production of Drug Product from NUVELO with less time than stated in the applicable Plan prior to the scheduled date of Production of such Drug Product, as such scheduled date is set forth in the applicable Plan, but within sufficient time to Produce such Drug Product on such scheduled date, the sufficiency of the time required to Produce such Drug Product as reasonably determined by BPS, BPS shall [ * ] Produce such Drug Product as per the original schedule. In the event that BPS receives the Bulk Drug Substance for Production of Drug Product from NUVELO with less time than stated in the applicable Plan prior to the scheduled date of Production of such Drug Product, as such scheduled date is set forth in the applicable Plan, and without sufficient time to Produce such Drug Product on the scheduled date, the insufficiency of the time required to Produce such Drug Product as reasonably determined by BPS, BPS shall reschedule Production of such Drug Product and shall charge NUVELO the applicable Cancellation Fee.

2.5 Importer of Record: In the event any material or equipment to be supplied by NUVELO, including without limitation NUVELO Supplied Components and Bulk Drug Substance, is imported into the United States for delivery to BPS (the " Imported Goods" ) , such Imported Goods shall be imported DDP Bloomington, IN (Incoterms 2000). NUVELO shall be the " Importer of Record" of such Imported Goods. As the Importer of Record, NUVELO shall be responsible for all aspects of the Imported Goods including, without limitation (a) customs and other regulatory clearance of Imported Goods, (b) payment of all tariffs, duties, customs, fees, expenses and charges payable in connection with the importation and delivery of the Imported Goods, and (c) keeping all records, documents, correspondence and tracking information required by applicable laws, rules and regulations arising out of or in connection with the importation or delivery of the Imported Goods.

2.6 Material Safety Data Sheet: NUVELO shall provide BPS a Material Safety Data Sheet for B ...