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Exhibit 10.19    
    

***Text Omitted and Filed Separately

Pursuant to a Confidential Treatment Request

Under C.F.R. §§ 200.80(b)(4) and Rule 406

of the Securities Act of 1933, as amended.

DSM PHARMA CHEMICALS, INC.

and

NOVACARDIA, INC.  

 DEVELOPMENT, TECHNOLOGY TRANSFER AND PRE-COMMERCIAL MANUFACTURING AGREEMENT  

        THIS DEVELOPMENT, TECHNOLOGY TRANSFER AND PRE-COMMERCIAL MANUFACTURING AGREEMENT (the "Agreement") is executed as of this 5th day of  June, 2006 (the "Effective Date"), by and between DSM Pharma Chemicals North America, Inc., a
corporation organized under the laws of the State of Delaware, having a place of business at 45 Waterview Blvd., Parsippany, NJ 07054, and its affiliate, DSM Fine Chemicals
Austria Nfg GmbH Co KG, an Austrian corporation, having a place of business at St. Peter Strasse 25, 4021 Linz, Austria (collectively, both DSM parties hereinafter referred to
as "DPC"); and NovaCardia, Inc.("NovaCardia"), a corporation organized under the laws of Delaware, having its principal place of business at
12230 El Camino Real, Suite 300, San Diego, California 92130. 

WITNESSETH:  

        WHEREAS, DPC is in the business of providing contract manufacturing services to the pharmaceutical industry and desires to provide such services to NovaCardia;
and 

        WHEREAS,
NovaCardia desires to engage DPC to provide certain of such services; and 

        WHEREAS,
DPC and NovaCardia have agreed upon a contract pursuant to which DPC would provide pre-commercial manufacturing for the Active Pharmaceutical Ingredient (as
hereinafter defined) for NovaCardia pursuant to the terms and conditions set forth below; 

        NOW,
THEREFORE, in consideration of the foregoing premises, which are hereby incorporated as a substantive part of this Agreement, and in consideration of the performance of the mutual
covenants and promises herein contained, DPC and NovaCardia intending to be legally bound, agree as follows: 

ARTICLE 1: DEFINITIONS  

        The following terms have the following respective meanings: 

        1.1   "AAA" shall have the meaning provided in Section 15.2. 

        1.2   "Act" shall mean the United States Federal Food, Drug and Cosmetic Act,
as amended. 

        1.3   "Active Pharmaceutical Ingredient" or
"API" shall mean the substance having the name of KW-3902. 

        1.4   "Affiliate" shall mean, with respect to either party, all corporations or
other business entities that, directly or indirectly, are controlled by, control or are under the common 

 

control
with that party. For this purpose, the meaning of the word "control" shall mean having the power to direct or cause the direction of the management and policies of an entity including, but not
limited to, ownership of more than fifty percent (50%) of the voting shares or interest of such corporation or other business entity. 

        1.5   "Batch Records" shall mean the executed manufacturing instructions, the
executed packaging order, the analytical testing results and any other manufacturing related document, such as deviation or investigation reports. 

        1.6   "Certificate of Analysis" shall mean the documented test results that
demonstrate compliance to the Specifications. 

        1.7   "cGMPs" shall mean the then current and applicable good manufacturing
practice regulations established in 21 C.F.R. Parts 210 and 211, as amended and in effect from time to time and other applicable FDA policies relating thereto in effect at any time during the term of
this Agreement. 

        1.8   "Claims" shall have the meaning provided in Section 8.1. 

        1.9   "Clinical Lot" shall mean a Pre-Commercial Lot manufactured for the purpose of
conducting human clinical studies. 

        1.10 "Commercial Manufacturing Agreement" shall have the meaning provided in Article 6. 

        1.11 "Compliance Papers" shall have the meaning provided in Section 3.5. 

        1.12 "Confidential Information" shall have the meaning provided in Section 7.1. 

        1.13 "Development and Technology Transfer Phase" shall mean the activities described in Schedules B
and D. 

        1.14 "Disclosing Party" shall have the meaning provided in Section 7.1. 

        1.15 "DPC Facilities" shall mean the DSM Pharma Chemicals facilities located in Linz, Austria. 

        1.16 "FDA" shall mean the United States Food and Drug Administration. 

        1.17 "Inventions" shall have the meaning provided in Section 11.1. 

        1.18 "Laboratory" shall have the meaning provided in Section 3.6. 

        1.19 "Lead Party" shall have the meaning provided in Section 11.2. 

        1.20 "Loss" or "Losses" shall have the meaning
provided in Section 8.1. 

        1.21 "Materials" shall mean all materials necessary for the manufacture of the API. 

2

 

        1.22 "NDA" shall mean the New Drug Application(s) for the API submitted to the FDA by NovaCardia,
including any amendments and supplements thereto. 

        1.23 "Notice" shall have the meaning provided in Article 17. 

        1.24 "Phase III Clinical Trials" shall mean the human clinical trials on sufficient numbers of
patients that are designed to establish the safety and biological activity of a drug for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug
in the dosage range to be prescribed, as more fully defined in 21 C.F.R. 312.21(b). 

        1.25 "Pre-Commercial Lots" shall mean the API as manufactured for the purpose of
conducting human clinical studies as well as for pre-commercial work such as experimental, demonstration and stability lots. 

        1.26 "Receiving Party" shall have the meaning provided in Section 7.1. 

        1.27 "Specifications" shall mean the bulk drug specifications that are set forth in  Schedule A hereto for API manufacturing and
testing, and any revisions thereto which are mutually agreed upon by the parties. Specifications
shall also include any specifications added to this Agreement by mutual agreement of the parties during the term of this Agreement. 

        1.28 "U.S." shall mean the United States of America. 

ARTICLE 2: PRE-COMMERCIAL MANUFACTURING OF PRODUCT  

        2.1    Development and Technology Transfer Phase.    The Development
and Technology Transfer Phase shall be performed at the DPC Facilities as described in Schedules B and  D. During such Development and Technology Transfer
Phase, DPC will assist NovaCardia in obtaining approval for commercial manufacturing for the API in
DPC's Facilities in order to facilitate the commercial supply of API by DPC, in the event the parties enter into a Commercial Manufacturing Agreement as
described in Article 6. To such effect, DPC shall perform testing of the API and USP/NF monograph testing of Materials. 

        2.2    Manufacture of API.    DPC will manufacture API in accordance
with cGMPs and other applicable rules and regulations of the FDA. If NovaCardia requires API for distribution of product outside the U.S., then NovaCardia shall so notify DPC, and the parties shall
agree on any additional costs and activities required to comply with such foreign governmental or regulatory agencies with jurisdiction over the manufacture, use or sale of such API, as then in
effect. In accordance with cGMPs and during the term of this Agreement, DPC shall (i) take all steps necessary to ensure that any API that may be produced by it pursuant to this Agreement shall
be free of cross-contamination from any other manufacturing or similar activities and (ii) be responsible for validated cleaning and changeover procedures prior to manufacturing any API for
NovaCardia. Both parties shall promptly notify each other of any new instructions or specifications required by the FDA or the Act, and of other applicable domestic or foreign rules and regulations,
and shall confer with each other with respect to the best means to comply with such requirements and shall allocate any costs of implementing such 

3

 

changes
on an equitable basis. DPC and NovaCardia shall agree on the schedule for manufacture and delivery of API and Pre-Commercial Lots. Unless otherwise agreed by DPC, NovaCardia shall
provide at least [. . .***. . .] notice prior to the required shipment date for delivery of product hereunder, or
[. . .***. . .]. 

        2.3    Facilities and Equipment.    DPC shall provide its facilities,
personnel and equipment for the manufacturing, testing and validation, where required, of the Pre-Commercial Lots. Except with respect to Pre-Commercial Lots, NovaCardia will
reimburse DPC for the first set only of all API specific change parts, including, but not limited to, equipment required for the manufacturing and testing of the API. Reimbursement by NovaCardia shall
be made in accordance with Section 5.1 and Schedule C of this Agreement. 

        2.4    Supply of Materials and Supplies.    DPC shall provide the
Materials for the manufacture of the Pre-Commercial Lots. DPC shall use and rotate all stock of Materials on a first-in, first-out basis. 

        2.5    Processing and Testing.    As set forth in  Schedule B, DPC shall be responsible
for performance of the manufacturing process of the Pre-Commercial Lots. DPC shall be
responsible for the testing and release of the Pre-Commercial Lots. As such, DPC shall be responsible for obtaining, and shall store at no cost to NovaCardia, the Materials required for
such testing. 

        2.6    Rework.    DPC shall not rework any batch of the API without
NovaCardia's prior written consent. 

        2.7    Analytical Methods.    DPC shall be responsible for providing
the API standards for the assay and impurities for analytical methods validation, subject to written approval in advance by NovaCardia. DPC shall perform: (i) development and validation of all
API analytical methods set forth on Schedule A hereto, (ii) Materials USP/NF monograph testing, and (iii) all analytical and
microbiological testing for API and for release of Pre-Commercial Lots. All Materials supplied by DPC shall comply with USP/NF requirements. DPC shall conduct the stability work for the
experimental and clinical batches of API as established in the stability protocol set forth in Schedule B. 

ARTICLE 3: DELIVERY AND ACCEPTANCE  

        3.1    Purchase and Supply Agreement.    During the term of this
Agreement, NovaCardia agrees to buy, and DPC agrees to sell, such quantities of the API as set forth on Section A.7 of Schedule B at the
prices set forth on Schedule C. 

        3.2    Delivery.    Unless otherwise agreed by the parties in writing,
DPC shall deliver all shipments of the API, F.C.A. DPC's Facilities in Linz, Austria (Incoterms 2000) for shipment by common carrier to the
destination(s) specified by NovaCardia in the applicable purchase order and at NovaCardia's expense. DPC shall ship the API under conditions consistent
with the 

***Confidential Treatment Requested

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Specifications
and the type of transport chosen by NovaCardia. The API shall be packaged for shipment as described in Schedule B. 

        3.3    Title.    Title and risk of loss to API and to each
Pre-Commercial Lot shall pass to NovaCardia at the F.C.A. point pursuant to Section 3.2. 

        3.4    Timely Delivery.    DPC agrees to use its reasonable commercial
efforts to ensure that APIs ordered by NovaCardia hereunder shall be delivered at the times set forth in Schedule D. 

        3.5    Acceptance and Rejection.    Prior to delivery to NovaCardia of
each Pre-Commercial Lot supplied pursuant to this Agreement, DPC shall send to NovaCardia (a) confirmation in writing that such Pre-Commercial Lot was manufactured in
accordance with the applicable Batch Records and (b) if such Pre-Commercial Lot is a Clinical Lot, a Certificate of Analysis with respect to such Clinical Lot (the "Compliance
Papers"). Upon receipt of such Compliance Papers, NovaCardia shall have such Compliance Papers reviewed by a quality consultant chosen by NovaCardia in order to determine whether such
Pre-Commercial Lot conforms to the Specifications. Unless NovaCardia notifies DPC within [. . .***. . .] of
receipt of the Compliance Papers that it rejects a Pre-Commercial Lot, NovaCardia shall be deemed to have accepted such Pre-Commercial Lot. If NovaCardia rejects a
Pre-Commercial Lot, DPC will deliver a new Pre-Commercial Lot to NovaCardia at [. . .***. . .]
expense and upon NovaCardia's request, within a mutually agreeable time frame after receiving notice of such rejection from NovaCardia;  provided, however,
that if it is determined either by the Laboratory, as such term is defined in Section 3.6 below, or by DPC that the failure of
any Pre-Commercial Lot to meet Specifications is due to [. . .***. . .] shall be responsible, at its own
expense, for the replacement of the new Pre-Commercial Lot. Subject to Section 8.2, [. . .***. . .]. In
the event that the Laboratory, as such term is defined in Section 3.6 below, or DPC determines (and such determination does not conflict with
Laboratory's determination) that the failure of any API to meet Specifications is due to causes other than
[. . .***. . .] the fees set forth in Section 2 of Schedule C
with respect to (i) such finished API, and (ii) the costs of the testing methods employed by DPC to determine the cause for rejection. 

        3.6    Disputes.    Notwithstanding anything in this Agreement to the
contrary, if either party disputes the determinations with respect to the quality of any API pursuant to the provisions of Section 3.5 hereof, and such dispute is not resolved by mutual
agreement of the parties within sixty (60) days, such dispute shall be resolved by the determination of either (a) an independent laboratory approved by both DPC and NovaCardia that is
compliant with FDA guidelines and regulations or (b) an independent expert of recognized repute within the United States pharmaceutical industry approved by both DPC and NovaCardia (in either
case, a "Laboratory"), the appointment of which shall not be unreasonably withheld or delayed by either party. The determination of the Laboratory shall be final and binding upon the parties. The
party against whom the determination is made shall pay the fees and expenses of the Laboratory making the determination as well as all costs relating to the supply of defective API. 

***Confidential Treatment Requested

5

 
ARTICLE 4: QUALITY  

        DPC shall ensure that all API supplied to NovaCardia complies with the Specifications and has been manufactured in accordance with cGMPs. Conformance to the
Specifications will be verified in accordance with the testing standards and procedures specified therein. The parties agree that within thirty (30) days after execution of this Agreement they
will execute a pharmaceutical quality agreement containing terms mutually agreed to by the parties, such agreement to be attached hereto as  Schedule E. Such pharmaceutical quality agreement shall
include, but not be limited to, provisions regarding test reports and certificates of
analysis, access to DPC Facilities by NovaCardia representatives, records, change in manufacturing process, failed batches, samples and complaints and adverse reactions. The parties agree that, should
NovaCardia wish to implement any amendment to the Specifications or Schedule E, NovaCardia shall provide to DPC such proposed amendment in
writing for DPC's review and approval, which approval shall not be unreasonably withheld. The parties acknowledge that the Specifications may need to be
refined and modified as the parties gain experience with the manufacture, testing and use of the API. Accordingly, NovaCardia and DPC agree to negotiate in good faith to modify the Specifications
and/or Schedule E, as applicable, from time to time as the parties'experience with the
manufacture, testing and use of the API warrants; and DPC further agrees that it will facilitate changes to the Specifications and/or Schedule E,
as applicable, that are necessary or appropriate in light of FDA or other regulatory requirements. The parties agree to allocate on an equitable basis any special costs of developing and implementing
revised procedures. 

ARTICLE 5: CONSIDERATION  

        5.1    Billing.    NovaCardia will compensate DPC for services
rendered for development of the API and for the manufacture of the API, at the prices set forth in Schedule C. With respect to prices related to
the manufacture of API, the prices per lot are based on the Specifications. Development activities will be charged to NovaCardia
[. . .***. . .] according to the information and requirements supplied by NovaCardia and
[. . .***. . .] the prices set forth on Schedule C
[. . .***. . .]. DPC shall not undertake additional development activity
(i.e. activity beyond the scope of work set forth on Schedule B) without
NovaCardia's prior written agreement as to the scope of work and the costs thereof. DPC shall submit invoices for amounts due under this Agreement
pursuant to the timing schedules set forth in Schedule C. In the event that DPC is required to obtain any special permit for API, (a) DPC
shall obtain NovaCardia's prior written consent with regard to obtaining such special permit, and (b) if the acquisition of such special permit
is approved by NovaCardia, NovaCardia shall reimburse DPC for all expenses associated with obtaining such special permit. 

        5.2    Method of Payment.    NovaCardia shall pay all amounts due
hereunder to DPC in Euros not later than thirty (30) days following the receipt of the applicable invoice, unless, with 

***Confidential Treatment Requested

6

 

respect
to payments for a specific shipment of API, such shipment of API is rejected in accordance with the provisions of Section 3.5. 

        5.3    Taxes.    NovaCardia shall reimburse DPC for all taxes, customs
duties, excises, or other charges hereafter imposed or increased which DPC may be required to pay to any government (federal, state, or local) and which are levied directly upon, or measured directly
by, the sale, production or transportation (a) of API supplied hereunder or (b) of raw materials utilized by DPC's supplier(s) in the
production of API supplied hereunder. 

        5.4    Late Payments.    Any payment due pursuant to this
Section 5 which is not made by the date it is due will accrue simple interest from that date to the date of the actual payment at a rate of one and one half percent (1.5%) per month, or such
lesser maximum permissible rate of interest. DPC may, at any time during the term of this Agreement, seek further assurances from NovaCardia regarding
NovaCardia's ability to continue to perform its obligations under this Agreement. If such assurances are not forthcoming from NovaCardia, DPC may
suspend its performance hereunder or, at its sole option, may terminate this Agreement upon due notice to NovaCardia. 

ARTICLE 6: RIGHT OF FIRST NEGOTIATION REGARDING COMMERCIAL MANUFACTURING  

        The parties hereto have entered into this Agreement with the expectation that DPC will be NovaCardia's designated
commercial manufacturer of API. On this basis, NovaCardia hereby grants DPC the first right to negotiate the terms of an agreement for the commercial manufacture of API (the "Commercial Manufacturing
Agreement"). The parties agree to use commercially reasonable efforts to negotiate in good faith a definitive commercial manufacturing agreement within
[. . .***. . .]. If no agreement is reached by the parties within such
[. . .***. . .] period, NovaCardia shall be free to enter into a commercial manufacturing agreement with a third party so
long as the terms of such agreement are no less favorable to NovaCardia than the terms last offered by DPC during such
[. . .***. . .] period. 

ARTICLE 7: CONFIDENTIAL INFORMATION  

        7.1    Confidentiality.    Any information or data, tangible or
intangible, whether in written, graphic or electronic form, including, but not limited to, information or data related to formulations, plans, programs, plants, process, technical materials, products,
production requirements, standard specifications, costs, equipment, operations, procedures, instructions or customers (all of which is herein referred to as "Confidential Information") disclosed by
one party (the "Disclosing Party") to the other party (the "Receiving Party") under this Agreement is the sole property of the Disclosing Party. For clarification, all records, data, plans and other
information pertaining to API, including API developed or generated by DPC under this Agreement, shall be Confidential Information of NovaCardia. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing by the parties, the parties agree that, during the term of this Agreement, and for a period of five (5) years thereafter, the Receiving 

***Confidential Treatment Requested

7

 

Party
will maintain in confidence all Confidential Information disclosed by Disclosing Party. The Receiving Party may use the Confidential Information of the Disclosing Party only to the extent
required to accomplish the purposes of this Agreement. The Receiving Party shall use at least the same standard of care as it uses to protect proprietary or confidential information of its own (but at
least reasonable care) to ensure that its employees, agents, consultants and other representatives do not disclose or make any unauthorized use of the Disclosing
Party's Confidential Information. Each party
will promptly notify the other upon discovery of any unauthorized use or disclosure of the other party's Confidential Information. 

        7.2    Limitations.    The Receiving Party shall not be obligated to
treat information as Confidential Information if the Receiving Party can show by competent written evidence that such information: 

        (a)   was already known to the Receiving Party without any obligations of confidentiality prior to receipt from the Disclosing
Party; 

        (b)   was in the public domain or otherwise generally available to the public at the time of its disclosure to the Receiving
Party; 

        (c)   became part of the public domain or otherwise generally available to the public after its disclosure other than through
any act or omission of the Receiving Party in breach of any obligation of confidentiality; 

        (d)   was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a third party who had no
obligation not to disclose such information to others; or 

        (e)   was independently discovered or developed by the Receiving Party without use of the Disclosing
Party's Confidential Information. 

        7.3    Authorized Disclosure.    Each party may disclose the
Confidential Information to the extent such disclosure is reasonably necessary in the following circumstances: 

        (a)   with respect to NovaCardia, conducting clinical trials; 

        (b)   with respect to NovaCardia, as required pursuant to certain disclosure obligations to third parties with respect to the
manufacture of the API; 

        (c)   prosecuting or defending litigation or complying with applicable court orders or governmental laws, rules or regulations
including, but not limited to, disclosures required by the FDA or the Securities and Exchange Commission; or 

        (d)   disclosure to Affiliates, sublicensees, employees, consultants, agents or other third parties who have a need to know
such information for purposes of this Agreement or in connection with due diligence or similar investigations, and disclosure to potential third party investors in confidential financing documents,
provided, in each case, that any such Affiliate, sublicensee, employee, consultant, agent or third party are subject to obligations of confidentiality and non-use comparable to those set
forth in this Article 7. 

8

 

        Notwithstanding
the foregoing, in the event a party is required to make a disclosure of the other party's Confidential Information
pursuant to Section 7.3(c), it will, except where impracticable, give reasonable advance notice to the other party of such disclosure and use efforts to secure confidential treatment of such
information at least as diligent as such party would use to protect its own Confidential Information, but in no event less than reasonable efforts. In any event, the parties agree to take all
reasonable action to avoid disclosure of Confidential Information hereunder. The parties will consult with each other on the provisions of this Agreement to be redacted in any filings made by the
parties with the Securities and Exchange Commission or as otherwise required by law. 

        7.4    Access Restriction.    Each party shall restrict access to the
other party's Confidential Information to only those employees, consultants, agents and other representatives who are directly connected with the
performance of the services hereunder. 

        7.5    Obligations Upon Termination.    Upon termination of this
Agreement, if requested, the Receiving Party shall deliver to the Disclosing Party all notes, drawings, blueprints, manuals, letters, notebooks, reports of or pertaining to the Confidential
Information of the Disclosing Party, including all copies thereof, and all other Confidential Information of the Disclosing Party that is in the possession of or under the control of the Receiving
Party. 

ARTICLE 8: INDEMNIFICATION  

        8.1    Indemnification by NovaCardia.    NovaCardia shall indemnify,
defend and hold DPC, its Affiliates and their respective directors, officers, employees, consultants and agents harmless from and against any and all claims, causes of action or suits ("Claims")
resulting in any losses, liabilities, costs or expenses (including reasonable attorney's fees) of any kind ("Losses") asserted by any third party that
arise out of or are attributable to (a) the negligence or willful misconduct of NovaCardia, its Affiliates or their respective employees, consultants, agents or representatives relating to
NovaCardia's performance
hereunder, (b) any material breach of any representation, warranty, covenant or other provision of this Agreement by NovaCardia, or (c) the research, development, manufacture, use, sale,
offer for sale, storage, importation or transport of API by NovaCardia or its sublicensees, except to the extent such Losses are attributable to the negligence or willful misconduct of DPC, its
Affiliates or their directors, officers, employees, consultants or agents, or any material breach of any representation, warranty, covenant or other provision of this Agreement by DPC or any breach of
Section 13.2. 

        8.2    Indemnification by DPC.    DPC shall indemnify, defend and hold
NovaCardia, its Affiliates and their respective directors, officers, employees, consultants and agents harmless from and against any and all Claims resulting in any Losses asserted by any third party
that arise out of or are attributable to (a) the negligence or willful misconduct of DPC, its Affiliates, or their respective employees, consultants, agents or representatives, relating to
DPC's performance hereunder, or (b) any material breach of any representation, warranty, covenant or other provision of this Agreement by DPC or
any breach of Section 13.2, except where such Losses are attributable to the negligence or willful misconduct of NovaCardia, its Affiliates or their respective directors, officers, employees,
consultants or agents (in any case excluding DPC), or 

9

 

any
material breach of any representation, warranty, covenant or other provision of this Agreement by NovaCardia, provided that in no event shall DPC be
liable for any third party claims or damages solely resulting from late or cancelled deliveries hereunder. 

        8.3    Indemnification Procedures.    Each party shall notify the
other promptly of any threatened or pending claim or proceeding covered by this Article 8 and shall include sufficient information to enable the other party to assess the basis for such claim.
Each party shall cooperate fully with the other party in the defense of all such claims. No settlement or compromise shall be binding on a party hereto without its prior written consent, such consent
not be unreasonably withheld. 

        8.4    Insurance.    During the term of this Agreement, each party
shall maintain adequate product liability insurance. During the term of this Agreement, DPC shall maintain comprehensive general liability insurance, including product liability. The insurance
afforded by the parties shall be primary insurance with minimum limits of Five Million U.S. Dollars (U.S.$5,000,000) per occurrence and an annual aggregate amount of Ten Million U.S. Dollars
(U.S.$10,000,000). Such insurance shall not be cancelled or modified without providing the other party at least thirty (30) days prior written notice. The parties shall name the other party as
an additional insured. 

ARTICLE 9: TERM AND TERMINATION  

        9.1    Term.    This Agreement shall commence on the Effective Date
and shall continue until the date of FDA approval of the API or December 31, 2008 whichever is earlier, unless terminated earlier in accordance with Section 9.2. 

        9.2    Termination.    This Agreement may be terminated under the
conditions stated herein: 

        (a)   by NovaCardia upon ninety (90) days' prior written notice to DPC
in the event that NovaCardia in its sole discretion decides to terminate development and commercialization of the API; 

        (b)   by a party upon or after the breach of any material provision of this Agreement by the other party if the breaching party
has not cured such breach within the sixty (60) day period following written notice of termination by the non-breaching party. If reasonable efforts to cure are being made within
such period by the breaching party and the breach is capable of cure within ninety (120) days, such period shall be extended for an additional thirty (60) days; or 

        (c)   by a party if (i) the other party is declared insolvent or bankrupt by a court of competent jurisdiction,
(ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by the other party, (iii) the other party makes or executes any assignment for the benefit of
creditors, or (iv) any dissolution or winding up of the other party (other than a dissolution or winding up for the purpose of reconstruction or amalgamation). 

10

 

        9.3    Effect of Termination.    Upon termination of this Agreement
for any reason, DPC shall furnish to NovaCardia a complete inventory of all remaining Materials and API. Unless otherwise agreed to between the parties, all such remaining Materials and API shall be
dealt with promptly as follows: 

        (a)   DPC shall complete work on all Pre-Commercial Lots ordered prior to the effective date of such termination in
accordance with the terms of this Agreement. Upon delivery of such Pre-Commercial Lots, NovaCardia shall pay DPC for such Pre-Commercial Lots accordance with the terms of this
Agreement; 

        (b)   All API, Materials and documents relating to this Agreement that are in
DPC's possession upon termination of this Agreement shall be delivered to NovaCardia; or 

        (c)   NovaCardia shall pay DPC for Materials purchased by DPC in accordance with  Schedule B. 

        9.4    No Discharge of Obligations.    Termination of this Agreement
for any reason shall not discharge either party's liability for obligations incurred hereunder and amounts unpaid at the time of such termination. 

        9.5    Tooling.    Upon any termination, DPC shall, after consultation
with and upon request by NovaCardia, deliver to NovaCardia or a third party designated by NovaCardia all tooling and equipment purchased by NovaCardia. Such delivery costs shall be borne by
NovaCardia. 

ARTICLE 10: REGULATORY MATTERS  

        10.1    Regulatory Filings.    NovaCardia shall be responsible for
preparing and submitting all documents necessary for obtaining approval of its NDA. DPC agrees to comply with all reasonable commitments made in the NDA regarding
DPC's manufacturing responsibilities as directed herein, provided that DPC is notified of such responsibilities and given an opportunity to review such
commitments with sufficient time prior to their being included in the submitted document by NovaCardia and provided they are not inconsistent with the then applicable Specifications. DPC further
agrees to use its best efforts to assist NovaCardia in obtaining FDA approval of its NDA with respect to such API, as well as approvals from any other government or agency which may be required for
the marketing of such API in any other country. NovaCardia shall have the right to make reference in any documents necessary for obtaining approval of its NDA to the drug master files established by
DPC in connection with the manufacture of the API. 

        10.2    Ownership of Regulatory Approvals and Documentation.    The
parties agree that NovaCardia shall be the sole and exclusive owner of all right, title and interest in and to the NDA and any other drug approval application or regulatory approval related to the
API. DPC shall assist NovaCardia in the preparation of all documents necessary to effectuate NovaCardia's rights in any drug approval application or
regulatory approval related to the API and agrees to transfer, effect, confirm, perfect, record, preserve, protect and enforce all rights, title and interests transferred hereunder, at the reasonable
request and expense of NovaCardia. 

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        10.3    Pre—Approval Inspections.    DPC shall provide
support to NovaCardia with respect to pre-approval inspections. DPC shall provide the FDA with (i) the necessary information related to its activities in respect of the API; and
(ii) any information reasonably requested by the FDA. 

        10.4    Cooperation.    The parties expect that NovaCardia will submit
any information concerning the API required by the FDA. If DPC is required to submit to the FDA any information concerning the API as part of a FDA inspection or audit in connection with the
manufacture of the API, NovaCardia will provide to DPC such documentation, data and other information as DPC may require for submission to the FDA. 

        10.5    Compliance Audits.    DPC shall permit representatives of
NovaCardia to conduct audits to confirm DPC's compliance with cGMPs and the Specifications upon reasonable advance notice and subject to the provisions
of Article 7. DPC shall notify NovaCardia within twenty-four (24) hours after it receives notice of an FDA audit involving the API or any component thereof and shall provide
to NovaCardia copies of any resulting document of action resulting from these audits within two (2) business days after receipt. Should either DPC or NovaCardia receive any such document of
action, it shall so notify the other within two (2) business days after receipt and shall provide to the other an opportunity to the extent feasible under the circumstances, to provide input to
any response to any such document of action. 

ARTICLE 11: INTELLECTUAL PROPERTY  

        11.1    Ownership and Rights.    Inventorship of inventions shall be
determined in accordance with U.S. patent law. Inventions, discoveries, know-how and information developed, discovered or invented in the course of performance under this Agreement, and
intellectual property arising therefrom ("Inventions") shall be solely owned by a party if solely invented by personnel of such party. Inventions shall be jointly owned by both parties if jointly
invented by personnel of both parties, except that DPC shall solely own any such Inventions having utility with respect to the manufacture of products other than the API. Each party hereby assigns to
the other party such of the assigning party's right, title and interest in and to Inventions as is necessary to achieve ownership of Inventions as
provided in this Section 11.1. [. . .***. . .] solely to make, have made, use, import, offer for sale, sell and
otherwise develop and commercialize the API. [. . .***. . .] for all uses. Inventions shall be deemed to be the Confidential
Information of the party owning them. Each party shall have the sole right to file and prosecute patent applications and to maintain and enforce patents covering Inventions that it solely owns.
Responsibility
for filing, prosecution, maintenance, and enforcement of jointly owned Inventions shall be determined on a case-by-case basis. 

        11.2    Defense and Settlement of Third Party Claims.    If a third
party asserts that a patent or other right owned by it is infringed by the manufacture of Pre-Commercial Lots by 

***Confidential Treatment Requested

12

 

DPC
pursuant to 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. DPC shall
be deemed to be the "Lead Party" with respect to any such alleged infringement that directly results from the manufacture, use or sale of Inventions solely owned by DPC, and NovaCardia shall be deemed
to be the "Lead Party" with respect to any other alleged infringement. The Lead Party shall investigate the situation thoroughly with reasonable cooperation by the other party, and the parties shall
discuss in good faith the defense of any such claim. The Lead Party shall have the right, but not the obligation, to control such defense at its sole expense. The other party shall have the right to
be represented separately by counsel of its own choice at its own expense. 

        11.3    Trademarks and Labeling.    DPC shall affix labeling to the
API as specified in the Specifications. That labeling shall bear one or more trademarks to be designated by NovaCardia, and any patent marking designated by NovaCardia. Nothing contained herein shall
give DPC any right to use any NovaCardia trademark except on API for NovaCardia, and DPC shall not obtain any right, title or interest in any
NovaCardia's trademark by virtue of this Agreement or its performance of services hereunder. 

        11.4    No Other Ownership Rights Granted.    No right or license is
granted under this Agreement by either party to the other, either expressly or by implication, except those specifically set forth herein. 

ARTICLE 12: RELATIONSHIP OF PARTIES  

        12.1    Independent Contractors.    It is not the intent of the
parties hereto to form any partnership or joint venture. Each party shall, in relation to its obligations hereunder, act as an independent contractor, and
nothing in this Agreement shall be construed to give such party the power or authority to act for, bind or commit the other party in any way whatsoever. DPC will be solely responsible for all tax
returns and payments required to be filed with or made to any federal, state or local tax authority with respect to DPC's performance of services and
receipt of fees under this Agreement. 

        12.2    Public Statements.    DPC and NovaCardia each agree not to
disclose the terms of this Agreement in any public statements, whether oral or written, including, but not limited to, shareholder reports, communications with stock market analysts, statements to
customers or prospective customers, press releases or other communications with the media, or prospectuses, without the other party's prior written
consent, which shall not be unreasonably withheld, except as required by federal, state or local laws, rules or regulations. If possible, each party shall give the other at least five
(5) business days advance written notice of a disclosure required by applicable law and will cooperate with the other party to minimize the scope and content of such disclosure. 

13

   ARTICLE 13: REPRESENTATIONS AND WARRANTIES  

        13.1    Mutual Representations and Warranties.    Each party
represents and warrants as follows: 

        (a)   that the terms of this Agreement are not inconsistent with its other contractual arrangements or obligations; 

        (b)   it has full power and authority to enter into this Agreement; and 

        (c)   this Agreement has been duly authorized and is binding upon it. 

        13.2    DPC's Warranty.    DPC hereby represents and warrants as
follows: 

        (a)   DPC shall provide good and enforceable title to all items provided by DPC to NovaCardia hereunder; 

        (b)   As of the date of delivery, all items provided to NovaCardia shall conform to the quality requirements stated herein and
the Specifications; 

        (c)   DPC shall comply with NovaCardia's written instructions provided under
this Agreement and DPC's internal written procedures in connection with activities performed by DPC under this Agreement; 

        (d)   DPC shall comply in all material respects with any law, regulation, ordinance, order, injunction, decree or requirement
applicable to the manufacture of the API (including cGMPs); 

        (e)   DPC shall use its commercially reasonable efforts to perform the services contemplated hereunder in accordance with the
terms described herein with respect to the Development and Technology Transfer Phase and the schedules agreed hereunder. It is recognized and agreed by and between DPC and NovaCardia, however, that
since the services are of a developmental or research nature, there can be no guarantee that the Development and Technology Transfer Phase will be successfully completed, or successfully completed
within the contemplated time period, despite DPC's commercially reasonable efforts to do so. DPC shall produce the API and Pre-Commercial
Lots in accordance with the Specifications. 

        (f)    DPC shall maintain all required governmental permits, including, without limitation, health, safety and environmental
permits, licenses, orders, applications and approvals regarding the manufacturing of the API necessary for the conduct of the actions and procedures that it undertakes pursuant to this Agreement. DPC
shall manufacture API in accordance with all such permits, licenses, orders, applications and approvals. DPC shall comply with all applicable present and future orders, regulations, requirements and
laws of any and all federal, state, provincial and local authorities and agencies, including, but not limited to, all laws and regulations of such territories applicable to the transportation,
storage, use, handling and disposal of hazardous materials; 

14

 

        (g)   API shall, at the time it is shipped to the location designated by NovaCardia (i) not be adulterated or misbranded
within the meaning of the Act, or within the meaning of any applicable state or municipal laws in which the definitions of adulteration and misbranding are substantially the same as those contained in
the Act; and (ii) not be articles that may not, under the Act or any other applicable law, statute or regulation, be introduced into interstate commerce; 

        (h)   DPC represents and warrants that it shall not employ, contract with, or retain any person directly or indirectly to
perform any services under this Agreement if such a person (a) is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to 21 U.S.C. § 335a or
its successor provisions, or (b) has a disqualification hearing pending or has been disqualified by the FDA pursuant to 21 CFR § 312.70 or its successor provisions. In addition, DPC
represents and warrants that it has not engaged in any conduct or activity that could lead to any of the above-mentioned disqualification or debarment actions. If, during the term of this Agreement,
DPC or any person employed or retained by it to perform services under this Agreement (i) comes under investigation by the FDA for a debarment action or disqualification, (ii) is
debarred or disqualified, or (iii) engages in any conduct or activity that could lead to any of the above-mentioned disqualification or debarment actions, DPC shall immediately notify
NovaCardia of same; and 

        (i)    To DPC's knowledge, as of the Effective Date, any activity performed by
or on behalf of DPC under this Agreement (including, without limitation, the practice of any of DPC's manufacturing processes or technology, but
excluding use of API in accordance with this Agreement) would not infringe any patent, trademark, trade secret or other proprietary right of any third party. 

        13.3    NovaCardia's Warranty.    NovaCardia hereby represents and
warrants as follows: To NovaCardia's knowledge, as of the Effective Date, the research, development, manufacture (other than any activity performed by
or on behalf of DPC under this Agreement including, without limitation, the practice of any of DPC's manufacturing processes or technology, but
excluding use of API in accordance with this Agreement), use, sale, offer for sale, storage, importation or transport of API by or on behalf of NovaCardia in countries other than Japan and certain
other Asian countries would not infringe any patent, trademark, trade secret or other proprietary right of any third party. 

        13.4    No Implied Warranties.    EXCEPT AS OTHERWISE EXPRESSLY SET
FORTH IN THIS AGREEMENT, DPC AND NOVACARDIA MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, ANY EXPRESS OR IMPLIED WARRANTIES OF TITLE,
NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES ARISING OUT OF
THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY, INCLUDING WITHOUT LIMITATION, DAMAGES FOR LOST BUSINESS OPPORTUNITY OR LOST PROFITS. 

15

 

        13.5    Limitation of Liability and
Claims.    Except for (i) DPC's obligations under Section 8.2 in respect of indemnification for third party claims arising out
or in connection with DPC's negligent acts or omissions, and (ii) DPC's obligations pursuant to Article 7, in no event shall the
collective, aggregate liability of DPC and its Affiliates and its and their respective directors, officers, employees and agents under this Agreement exceed
[. . .***. . .]. 

ARTICLE 14: ASSIGNMENT  

        Except as provided herein, the terms and conditions of this Agreement shall inure to the benefit of and be binding upon the successors and assigns of the parties
hereto; provided, however, that neither party shall transfer or assign this Agreement without the prior written consent of the other party, which
consent shall not be unreasonably withheld. However, a party may assign this Agreement and its rights and obligations hereunder without such consent in connection with the assignment by a party to an
Affiliate, to the successor to or the assignee of all or substantially all of the business of such party to which this Agreement relates, whether by merger, sale of stock, sale of assets or otherwise.
NovaCardia may, after written notice to DPC, assign this Agreement to any person or entity to which it has sold, licensed or otherwise transferred the rights to manufacture, the API and which has
assumed all of NovaCardia's obligations hereunder provided that such assignment shall not release NovaCardia of its obligations hereunder.
Notwithstanding the aforesaid, NovaCardia shall have no further obligations hereunder, except to the extent the same has accrued prior to assignment, provided that the assignee has in the reasonable
judgment of DPC, sufficient financial capability and regulatory status to enable it to perform the obligations of NovaCardia hereunder. DPC may not subcontract or otherwise delegate its obligations
under this Agreement without NovaCardia's prior written consent. 

ARTICLE 15: GOVERNING LAW AND DISPUTE RESOLUTION  

        15.1    Good Faith Negotiation.    Any controversy, claim or dispute
arising out of or relating to this Agreement or the breach of this Agreement shall be settled, if possible, through good faith negotiation between the parties. Such good faith negotiations shall
commence promptly upon a party's receipt of notice of any claim or dispute from the other party and continue for a period of sixty (60) days. 

        15.2    Binding Arbitration.    If such efforts are not successful,
such controversy, claim or dispute relating to, arising out of, or in any way connected with this Agreement or any term or condition hereof, or the performance by either party of its obligations
hereunder, whether before or after termination of this Agreement, except as otherwise expressly provided in this Agreement, shall be finally resolved by binding arbitration. Whenever a party shall
decide to institute arbitration proceedings, it shall give written notice to that effect to the other party. This Agreement shall be governed by and construed in accordance with the laws of the State
of Delaware, excluding its conflict of law principles. Disputes shall be resolved through arbitration 

***Confidential Treatment Requested  

16

 

before three (3) arbitrators. Such arbitration shall take place in New York, New York and shall proceed in accordance with the Commercial Arbitration Rules of the
American Arbitration Association ("AAA"). Within seven (7) calendar days of either party making a demand for arbitration (or longer if the parties so agree), NovaCardia and DPC shall each
select one (1) arbitrator. A third (3rd) arbitrator shall be selected by the arbitrators selected by the parties within thirty (30) days of the demand for arbitration. In
the event that either party shall fail to appoint its arbitrator, or the two (2) arbitrators selected by the parties fail to appoint a third (3rd) arbitrator, in either case
within the prescribed time period, then either party may apply to the AAA for the appointment of such arbitrator. The determination of a majority of the panel of arbitrators shall be the decision of
the panel and shall be binding regardless of whether one of the parties fails or refuses to participate in the arbitration. The panel shall be authorized to award compensatory damages, but shall NOT
be authorized (i) to award non-economic damages, such as for emotional distress, pain and suffering or loss of consortium, (ii) to award punitive damages, or (iii) to
reform, modify or materially change this Agreement or any other agreements contemplated hereunder; provided, however, that the damage limitations
described in subsections (i) and (ii) of this sentence will not apply if such damages are statutorily imposed. The panel also shall be authorized to grant any temporary, preliminary or
permanent equitable remedy or relief it deems just and equitable and within the scope of this Agreement, including, without limitation, an injunction or order for specific performance. The
determination of the panel shall be enforceable by any court of competent jurisdiction. Nothing herein shall limit or restrict a party's ability to seek
injunctive or other equitable relief in the event of a breach or anticipated breach of Article 7. 

        15.3    Payment of Costs.    Each party shall pay for the arbitrator
it selects with the cost of the third (3rd) arbitrator being split equally between the parties. All other costs shall also be split equally between the parties. Either party may enter
any arbitration award in any court having jurisdiction or may make application to any such court for a judicial acceptance of the award and order of enforcement, as the case may be. The
parties' agreement to submit to arbitration referred to herein shall in no way prevent either party from exercising its right to terminate this
Agreement consistent with the terms herein. 

        15.4    Equitable Remedies From A Court of Law.    Each party has the
right before or during the arbitration to seek and obtain from the appropriate court provisional remedies, such as attachment, preliminary injunction or replevin, to avoid irreparable harm, maintain
the status quo, or preserve the subject matter of the arbitration. 

        15.5    Intellectual Property and Anti-Trust.    This
Article 15 shall not apply to any dispute, controversy or claim that concerns (i) the validity or infringement of a patent, trademark or copyright; or (ii) any antitrust,
anti-monopoly or competition law or regulation, whether or not statutory. 

        15.6    Waiver and Acknowledgement.    By agreeing to this binding
arbitration provision, the parties understand that they are waiving certain rights and protections which may otherwise be available to such party in court, including, without limitation, the right to
seek or obtain certain types of damages precluded by this provision, the right to a jury trial, certain rights of appeal, and a right to invoke formal rules of procedure and evidence. 

17

 
ARTICLE 16: FORCE MAJEURE  

        Neither party shall be liable to the other for default or delay in the performance of its obligations under this Agreement, if such default or delay shall be
caused directly or indirectly by accident, fire, flood, riot, act of terrorism, war, weather, act
of God, embargo, strike, failure or delay of usual sources of supply of materials, or delay of carriers or complete or partial shutdown of plant by any of the foregoing causes or other causes beyond
its reasonable control, provided the same are not due to the fault or neglect of such party and provided further that any such default, delay or failure shall be remedied by such party as soon as
possible after the removal of the cause of such default, failure or delay. 

ARTICLE 17: NOTICES  

        Unless otherwise provided herein, any notice required or permitted to be given hereunder or any proposal for any modification of this Agreement (hereinafter
collectively referred to as the "Notice") shall be faxed, mailed by overnight mail, mailed by certified mail, postage prepaid, or delivered by hand to the party or the individual to whom such Notice
is required or permitted to be given hereunder. If mailed, any such Notice shall be deemed to have been given five (5) business days from the date mailed, as evidenced by the postmark at the
point of mailing. If delivered by hand or fax, any such Notice shall be deemed to have been given when received by the party to whom such Notice is given, as evidenced by written and dated receipt of
the receiving party. 

All
correspondence to DPC shall be addressed as follows: 

DSM
Pharma Chemicals North America, Inc.

45 Waterview Blvd.

Parsippany, NJ 07054

        Attention: [. . .***. . .], V. P. Marketing

        E-mail: [. . .***. . .] 

All
correspondence to NovaCardia shall be addressed as follows: 

NovaCardia, Inc.

12230 El Camino Real, Suite 300

San Diego, CA 92130

Attn: Chief Executive Officer 

        with
a copy to: 

Cooley
Godward LLP

4401 Eastgate Mall

San Diego, CA 92121

Attention: L. Kay Chandler, Esq. 

        Either
party may change the address to which any correspondence to it is to be addressed by notification to the other party as provided herein. 

***Confidential Treatment Requested  

18

 
 ARTICLE 18: CAPTIONS  

        The captions in this Agreement are solely for convenience of reference and shall not be used for purposes of interpreting or construing the provisions hereof. 

ARTICLE 19: SEVERABILITY  

        Should any part or provision of this Agreement be held unenforceable or in conflict with the applicable laws or regulations of any jurisdiction, the invalid or
unenforceable part or provision shall be replaced with a provision that accomplishes, to the extent possible, the original business purpose of such part or provision in a valid and enforceable manner,
and the remainder of this Agreement shall remain binding upon the parties hereto. 

ARTICLE 20: WAIVER  

        No failure on the part of either party hereto to exercise, and no delay in exercising, any right, privilege or power hereunder shall operate as a waiver or
relinquishment of the provision giving rise thereto; nor shall any single or partial exercise by either party hereto of any right, privilege or power hereunder preclude any other further exercise
thereof, or the exercise of any other right, privilege or power. 

ARTICLE 21: SURVIVAL  

        The provisions of Articles 7, 12, 14, 15, 16, 17, 21, 22 and 23 and Sections 8.1, 8.2, 8.3, 9.3, 9.4, 9.5, 11.1, 13.4 and 13.5 shall survive the termination or
expiration of this Agreement. 

ARTICLE 22: ENTIRE AGREEMENT  

        This Agreement, together with the Schedules hereto (which are hereby incorporated by reference) constitute the complete and exclusive Agreement between the
parties hereto with reference to the subject matter hereof, and no statement or agreements, oral or written, made prior to or at the signing hereof shall vary or modify the written terms hereof, and
neither party shall claim any modification or rescission from any provision hereof unless such modification or rescission is in writing, signed by the other party. No modification shall be effected by
the acknowledgement or acceptance of purchase orders, invoices, shipping documents, order confirmations or other forms or documents containing terms or conditions at variance with or in addition to
those set forth herein. 

ARTICLE 23: LANGUAGE  

        The parties hereto confirm their agreement that this Agreement, as well as any amendment hereto and all other documents related hereto (including legal notices)
and all information disclosed hereunder shall be in the English language only. 

19

 
ARTICLE 24: COUNTERPARTS; FACSIMILE  

        This Agreement may be executed in multiple counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same
instrument. This Agreement may be executed and delivered by facsimile and upon such delivery the facsimile signature will be deemed to have the same effect as if the original signature had been
delivered to the other party. 

ARTICLE 25: EXPORT  

        This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States of America or other countries
and territories that may be imposed upon or related to DPC or NovaCardia from time to time. Each party agrees that it will not export, directly or indirectly, any technical information acquired from
the other party under this Agreement to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to
do so from the appropriate agency or other governmental entity. 

[Signatures
on following page] 

20

 

        IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their respective duly authorized representatives as of the
Effective Date. 

	DSM Pharma Chemicals North America, Inc.
	

By:	
 	

/s/ [. . .***. . .]
	
 	

 
	Name:	 	[. . .***. . .]	 	 
	Title:	 	V. P. Marketing	 	 
	
DSM Fine Chemicals Austria Nfg GmbH Co KG
	

By:	
 	

/s/ [. . .***. . .]
	
 	

 
	Name:	 	[. . .***. . .]	 	 
	Title:	 	Attorney-In-Fact	 	 
	
NovaCardia, Inc.
	

By:	
 	

/s/ Randall E. Woods
	
 	

 
	Name:	 	Randall E. Woods	 	 
	Title:	 	CEO	 	 

***Confidential Treatment Requested  

21

Schedule A  

Specifications  

KW-3902 Proposed Commercial Specifications  

	Tests
 
	 	Results
	 	Specification

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 	 	 	[. . .***. . .]
	

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	 	 	 
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	 	 	 
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	 	 	 
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 [. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 	[. . .***. . .]	 	 
	

***Confidential Treatment Requested  

Schedule B
  Development and Technology Transfer and Clinical Manufacturing  

 Part 1—Transfer and Process Development of KW-3902  

[. . .***. . .] 

[. . .***. . .] 

During
this part of the project, DSM will: 

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

***Confidential Treatment Requested  

   Timing and Investment for Part 1  

[. . .***. . .] 

DSM
will perform this work for €[. . .***. . .]. 

Payment
schedule: 

	•
	€ [. . .***. . .]
([. . .***. . .]%) upon initiation of the laboratory
phase—[. . .***. . .]

	•
	€ [. . .***. . .]
([. . .***. . .]%) upon completion of the laboratory
phase—[. . .***. . .] 

Terms
of payment shall be net, within thirty (30) days of the date of invoice. 

***Confidential Treatment Requested  

24

 
 Part 2—Analytical Methods Transfer to MOVA  

As
requested, DSM will transfer the analytical methods to MOVA. During this activity DSM will: 

	•
	[. . .***. . .] 

Timing and Investment for Part 2  

DSM
will transfer the methods upon NovaCardia's request as this is a stand-alone activity. 

The
cost for the transfer is € [. . .***. . .] and will be invoiced upon completion of the
activities. 

Terms
of payment shall be net, within thirty (30) days of the date of invoice. 

***Confidential Treatment Requested  

25

 
 Part 3—Stability Testing  

[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

Timing and Investment for Part 3  

[. . .***. . .]

The
cost for the stability study of one batch is € [. . .***. . .]. 

Terms
of payment shall be net, within thirty (30) days of the date of invoice. 

***Confidential Treatment Requested  

26

 
 Part 4—Production Campaign of KW-3902  

[. . .***. . .] 

[. . .***. . .] 

During
the production phase DSM will: 

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .] 

Timing and Investment for Part 4  

[. . .***. . .] 

***Confidential Treatment Requested  

27

 

DSM will perform the production of [. . .***. . .] batches of KW-3902 for an investment
of € [. . .***. . .]. 

This
investment consists of the following components which come due at different times: 

	•
	€ [. . .***. . .]
for the required amounts of
[. . .***. . .] and [. . .***. . .] for
[. . .***. . .] batches.

	•
	€ [. . .***. . .]
for the production of
[. . .***. . .] batches of KW-3902. 

Payment
schedule: 

	•
	€ [. . .***. . .]—[. . .***. . .]

	•
	€ [. . .***. . .]
([. . .***. . .]%)
[. . .***. . .]—[. . .***. . .]

	•
	€ [. . .***. . .]
([. . .***. . .]%)
[. . .***. . .]—[. . .***. . .] 

Terms
of payment shall be net, within thirty (30) days of the date of invoice. The material will be shipped FCA, Linz, Austria. 

***Confidential Treatment Requested  

28

 
 Summary of Investments  

	Part 1—[. . .***. . .]	 	€[. . .***. . .]
	Part 2—[. . .***. . .]	 	€[. . .***. . .]
	Part 3—[. . .***. . .]	 	€[. . .***. . .]
	Part 4—[. . .***. . .]	 	€[. . .***. . .]
	

	Total	 	€[. . .***. . .]

Payment
schedule: 

	•
	€ [. . .***. . .]

	•
	€ [. . .***. . .]
([. . .***. . .]%)
[. . .***. . .]—[. . .***. . .]

	•
	€ [. . .***. . .]
([. . .***. . .]%)
[. . .***. . .]—[. . .***. . .]

	•
	€ [. . .***. . .]
([. . .***. . .]%)
[. . .***. . .]—[. . .***. . .]

	•
	€ [. . .***. . .]

	•
	€ [. . .***. . .]—[. . .***. . .]

	•
	€ [. . .***. . .]
([. . .***. . .]%)
[. . .***. . .]—[. . .***. . .] 

Terms
of payment shall be net, within thirty (30) days of the date of invoice. The material will be shipped FCA, Linz, Austria. 

***Confidential Treatment Requested  

29

   Exhibit 1—Specifications  

	Tests
 
	 	Results
	 	Specification

	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]
	 	 	 	 	[. . .***. . .]
	

***Confidential Treatment Requested  

30

Exhibit 2—Schedule of Activities  

The
Gantt chart below shows the anticipated timing of the laboratory phase, followed by the production of [. . .***. . .] kg
batches. 

[. . .***. . .] 

***Confidential Treatment Requested  

Exhibit 3—The DSM Team  

Contact
information for key personnel on the NovaCardia project. In addition, we will involve others as needed. 

Project
Manager 

[. . .***. . .]

Project Manager

DSM Fine Chemicals Austria Nfg GmbH & Co KG

St.-Peter-Str. 25, A-4021 Linz, Austria

Dept.: CEL / Bldg.: 70

Phone: +[. . .***. . .]

Fax.: +[. . .***. . .]

Email: [. . .***. . .] 

Quality
Assurance and Regulatory Affairs 

[. . .***. . .]

Quality Assurance and Regulatory Affairs

DSM Pharma Chemicals

St.-Peter-Strasse 25, A-4021 Linz, Austria

PO Box 933

Phone: +[. . .***. . .]

Fax: +[. . .***. . .]

Email: [. . .***. . .] 

Commercial
Project Manager 

[. . .***. . .]

Director of Business Development

DSM Pharma Chemicals, North America Inc.

45 Waterview Boulevard

Parsippany, NJ 07054

Tel: [. . .***. . .]

Fax: [. . .***. . .]

Cell: [. . .***. . .]

Email: [. . .***. . .]
 www.dsmpharmachemicals.com

***Confidential Treatment Requested  

Schedule C
  Fee for Services—Development and Technology Transfer and Clinical Manufacturing  

DPC
shall charge NovaCardia for performing the development, technology transfer, clinical manufacturing and testing
[. . .***. . .] 

***Confidential Treatment Requested  

Schedule D
  Timeline  

[. . .***. . .] 

***Confidential Treatment Requested  

Schedule E
  Quality Agreement  

[To be provided by the parties as soon as practicable in accordance with Article 4] 

QuickLinks

Exhibit 10.19QuickLinks
 -- Click here to rapidly navigate through this document

 
 

Exhibit 10.20    
    

***Text Omitted and Filed Separately

Pursuant to a Confidential Treatment Request

Under C.F.R. §§ 200.80(b)(4) and Rule 406

of the Securities Act of 1933, as amended.  

	[LOGO]	 	12651 High Bluff Dr., Ste. 200

San Diego, CA 92130

P: (858) 509-0455 F: (858) 509-0456	 	PO #:

Date:	 	MFG 064

02/08/07

PURCHASE ORDER         

	Vendor Info.
	 	Ship To:

	Name	 	Patheon Italia S.p.A.	 	Name	 	Mark Mugerditchian
	Address	 	Viale G.B. Stucchi, 110	 	Address	 	12651 High Bluff Drive Suite 200
	City	 	Monza	 	State	 	Italy	 	Zip	 	20052	 	City	 	San Diego	 	State	 	CA	 	Zip	 	92130
	Ph/Fax:	 	919-479-8850	 	Ph/Fax:	 	858-523-4506
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	Qty
	 	Units
	 	Description
	 	Unit Price
	 	Total

	

1.0	
 	

lot	
 	

Product Development Service outlined in Patheon Proposal NOVC-FFT1-0207-0002-R1 attached dated February 9, 2007. The scope of this work is to transfer the manufacturing process from MOVA to Patheon Ferentino. The process developed and transferred to
the commercial manufacturing facility will be approvable in the US and Europe.	
 	

[. . .***. . .]	
 	

[. . .***. . .]

-

-

-

-

-

-

-

-

-

-
	

 	
 	

 	
 	

 	
 	

 	
 	

	

 	
 	

 	
 	

 	
 	

Sub Total	
 	

[. . .***. . .]
	

Date Required:	
 	

Apr-07	
 	

S&H	
 	

 
	

Est. Delivery Date:	
 	

Taxes:	
 	

State 0.00%	
 	

-
	

 	
 	

 	
 	

 	
 	

 	
 	

	

Dept & Acct to Charge:	
 	

 	
 	
TOTAL	
 	

$[. . .***. . .]
	

 	
 	

 	
 	

 	
 	

 	
 	

Approvals:  

	

Mark Mugerditchian/Feb 8, 2007
 Department Head / Date	
 	

/s/ Randall E. Woods/8 Feb 2007
 Pres & CEO / Date
	 	 	 

	Notes / Comments	 	 
	 	 	

	 	 	 
	 	 	

	 	 	 
	 	 	

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 1 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

PATHEON PROPOSAL: NOVC-FFT1-0207-0002-R1  

	1.	 	Parties:	 	Patheon Italia S.p.A.

("Patheon")
 Viale G.B. Stucchi, 110

20052 Monza (MI)

Italy	 	NovaCardia Inc.

("Client")
 12230 El Camino Real, Suite 300

San Diego, CA 92130

USA
	
2.	
 	
Product:	
 	

• KW3902 ("Product")
	
3.	
 	
Indication:	
 	

• To Be Confirmed
	

4.	
 	
Contract:	
 	

This Proposal (including the Project Scope, Budget Summary, Standard Terms and Conditions for Pharmaceutical Development Services ("Terms and Conditions") when accepted by Client shall become a contract binding on the parties
("Contract").
	
5.	
 	
Description of Services:	
 	

See Project Scope (Part A).
	
6.	
 	
Payment and Currency:	
 	

See Budget Summary (Part B).
	
7.	
 	
Legal Terms:	
 	

See Terms and Conditions (Part C).
	
8.	
 	
Effective Date:	
 	

                   , 200	
 	

 
	
9.	
 	
Term:	
 	

From the Effective Date until completion by Patheon of the pharmaceutical development services ("Services").
	
10.	
 	
Date of Confidentiality Agreement:	
 	

                   , 200
	
11.	
 	
Date of PatheonPartnerTM External User Account / Access Form	
 	

                   , 200 [If applicable]
	
12.	
 	
Date:	
 	

                   , 200	
 	

 
	 	 	 	 	 	 	 

	Patheon Italia S.p.A.	 	NovaCardia Inc.
	

By:	
 	

 	
 	

By:	
 	

 
	 	 	
	 	 	 	

	

Name:	
 	

 	
 	

Name:	
 	

 
	 	 	
	 	 	 	

	

Title:	
 	

 	
 	

Title:	
 	

 
	 	 	
	 	 	 	

KW3902

NovaCardia Inc.

Page 2 of 21 

CONFIDENTIAL  

Patheon Proposal NOVC-FFT1-0207-0002-R1

09th February 2007 

Table of Contents  

	Part A: PROJECT SPECIFICS AND DETAILS	 	 
	

1.	
 	
PROJECT SCOPE	
 	

5
	

2.	
 	
ENVIRONMENTAL, HEALTH & SAFETY	
 	

5
	

3.	
 	
ANALYTICAL SERVICES	
 	

6
	 	 	3.1.	 	Cleaning Verification (Residuals) Assay [HPLC]—Method Assessment	 	6
	 	 	3.2.	 	Identification, Drug Product Potency and Related Substances Assay [HPLC]—Method Assessment	 	6
	 	 	3.3.	 	Physical Methods—Method Assessment (according to USP/EP)	 	6
	 	 	 	 	Methods anticipated to include: appearance, pH, viscosity and osmolality	 	6
	 	 	3.4.	 	Particle Size Analysis by [. . .***. . .]—Method Assessment	 	6
	 	 	3.5.	 	[. . .***. . .]—Method Development & Validation	 	7
	

4.	
 	
EQUIPMENT PROCUREMENT	
 	

7
	

5.	
 	
PROCESS TRANSFER & OPTIMISATION	
 	

8
	

6.	
 	
LABORATORY SCALE BATCH MANUFACTURE	
 	

9
	 	 	6.1.	 	Stability—Laboratory Scale Batch	 	10
	 	 	6.2.	 	Freeze/Thaw Study—Laboratory Scale Batch	 	10
	

7.	
 	
HOLDING TIME STUDY	
 	

11
	

8.	
 	
COMPATIBILITY STUDY	
 	

12
	

9.	
 	
CLEANABILITY STUDY	
 	

13
	

10.	
 	
PROJECT SUPPORT	
 	

13
	

11.	
 	
STANDARD ASSUMPTIONS	
 	

13

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 3 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

PART A:  

 KW3902

Sterile Injectable Emulsion

Process Assessment  

 For

NovaCardia Inc.  

 Proposal No.: NOVC-FFT1-0207-0002-R1

Dated: 09th February 2007  

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 4 of 21
	 	 	CONFIDENTIAL	 	 

1.     Project Scope  

Patheon
will perform the following non-cGMP activities to support the transfer of the manufacture of Client's KW3902 emulsion to the Patheon Italia, Ferentino facilities: 

	•
	Environmental,
Health & Safety

	•
	Analytical
Services

	•
	Equipment
Procurement

	•
	Process
Transfer & Optimisation

	•
	Laboratory
Scale Batch Manufacture & Stability

	•
	Holding
Time Study

	•
	Compatibility
Study

	•
	Cleanability
Study 

At
this stage, it is anticipated that [. . .***. . .] ml vials and
[. . .***. . .] mm stoppers will be used. The target fill volume is assumed to be approximately 60 ml. 

2.     Environmental, Health & Safety  

        Prior to the commencement of project activities, a thorough review by Patheon of the Environmental, Health and Safety (EH&S) requirements for the API will be
completed. 

        For
the purposes of this proposal it is assumed that the EH&S review has previously been completed and it has been determined that the API can be safely handled at Patheon. 

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 5 of 21
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3.     Analytical Services  

The precise scope of analytical work required to be performed has to be confirmed at this stage. For budget illustration purposes only a number of assumptions have been made
and example fee information included.

Where
appropriate, Patheon will perform method assessment, development and validation for Client to support project activities. An analytical method will be issued after each method assessment,
development and validation. 

Analytical Methods  

	3.1.
	Cleaning
Verification (Residuals) Assay [HPLC]—Method Assessment 

For
the purposes of this proposal it is assumed that a suitable, non-complex cleaning verification (residuals) method will be assessed for application on the equipment train that is
proposed for use at Patheon Italia's Ferentino facilities. At this stage, it is assumed that method development and/or validation will not be required. 

	3.2.
	Identification,
Drug Product Potency and Related Substances Assay [HPLC] -Method Assessment 

A
suitable, non-complex analytical method required for determination of drug product potency would be transferred to Patheon Italia. For the purposes of this proposal, it is assumed that
method development or validation would not be conducted by Patheon. 

It
is assumed that the HPLC conditions are suitable for use as a finished product test, as well as for the determination of related substances and for confirming the identification of the drug
substance/product. 

	3.3.
	Physical
Methods—Method Assessment (according to USP/EP)

Methods anticipated to include: appearance, pH, viscosity and osmolality

	3.4.
	Particle
Size Analysis by [. . .***. . .]—Method Assessment 

Samples
will be sent to MOVA and the results compared 

One
overall protocol and one overall report, (rather than individual protocols and reports), will be prepared for the Method Assessments 3.1 to 3.4 described above. 

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 6 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

	3.5.
	[. . .***. . .]—Method
Development & Validation 

[. . .***. . .]

4.     Equipment Procurement  

Dedicated
equipment will be required to be sourced and purchased at the sole expense of Client to support the manufacture of the emulsion at the PDS Patheon Italia, Ferentino laboratory. 

Fees
given are subject to change pending design of the manufacturing process and would be confirmed at the time of placing an order. The equipment
[. . .***. . .]. Equipment acquired for Client for this project
[. . .***. . .]. 

	Detailed Description
 
	 	Estimated Fee (US Dollars)

[excluding handling fee]

	[. . .***. . .]	 	$[. . .***. . .]
	[. . .***. . .]	 	$[. . .***. . .]
	[. . .***. . .]	 	$[. . .***. . .]
	[. . .***. . .]	 	To be confirmed
	 	Total:	 	$[. . .***. . .]

It
is assumed that the purchase, installation and operation of the equipment will not necessitate any modifications to be made to the existing Patheon facilities. 

The
[. . .***. . .] needs to be upgraded according to the EU requirements. At this stage, Patheon are currently
investigating costings for this upgrade and, once available, the associated fees will be discussed and agreed with Client. 

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 7 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

5.     Process Transfer & Optimisation  

The precise scope of work to be performed has to be discussed and agreed with Client. At this stage, for budget illustration purposes only, a number of assumptions have been
made and example fee information is presented.

Patheon
will provide a protocol and report (at this stage the associated fee is included on a FTE basis as described below) for the Process Transfer and Optimisation of the KW3902 emulsion. 

The
manufacturing process will be transferred to the PDS Patheon Italia, Ferentino laboratory where the existing process used at MOVA will be assessed and subsequently optimised for application in the
Patheon Italia, Ferentino commercial facilities. 

At
this stage the following activities are anticipated to be conducted: 

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

	•
	[. . .***. . .]

It
is assumed that the necessary equipment for performing these steps can be installed without the requirement to modify existing Patheon facilities. 

The
approach used for the process transfer and optimisation would be outlined in a more detailed protocol prepared by Patheon and on request approved by Client. A progress report would be provided to
Client at the end of the studies and regular updates provided during the course of the studies. At this stage it is difficult to scope accurately these studies therefore a full time equivalents (FTE)
approach is adopted. One full time equivalent equates to [. . .***. . .] man-hours. An estimation of
[. . .***. . .] is anticipated to be required to support the process transfer and optimisation studies at this stage
(project support not included). 

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 8 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

6.     Laboratory Scale Batch Manufacture  

The precise scope of work to be performed has to be discussed and agreed with Client. At this stage, for budget illustration purposes only, a number of assumptions have been
made and example fee information is presented on a per-batch basis and has been included within the Budget Summary.

	•
	Emulsion,
[. . .***. . .] dose strength assumed (to be confirmed)

	•
	Number
of batches to be manufactured to be confirmed with Client

	•
	Batch
size to be confirmed with Client

	•
	Protocol

	•
	A
suitable portion of the batch will be manually filled into vials

	•
	Non-GMP

	•
	Non-sterile

	•
	Report

	•
	No
QA review

	•
	Product
will not be suitable for human use 

The
batch would be used to: 

	•
	Evaluate
critical manufacturing and processing parameters

	•
	Provide
emulsion to conduct a short-term stability study (Section 6.1)

	•
	Provide
emulsion to conduct a freeze/thaw study (Section 6.2)

	•
	Provide
emulsion to conduct holding time studies (Section 7)

	•
	Provide
emulsion to conduct a product contact part compatibility study (Section 8)

	•
	Provide
emulsion to conduct a cleanability study (Section 9)

	•
	Provide
emulsion for [. . .***. . .] validation (not included within this proposal) 

Finished
product testing will be performed and data from specific tests would also be used for Initial Time Point Stability. Finished product testing may include: 

	•
	Potency &
Related Substances

	•
	Physical
Methods—appearance, pH, viscosity and osmolality

	•
	Particle
Size Analysis by [. . .***. . .]

	•
	[. . .***. . .]

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 9 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

6.1.  Stability—Laboratory Scale Batch  

The precise scope of work required will be discussed and agreed with Client. At this stage, for budget illustration purposes only, a number of assumptions have been made and
example fees presented on [. . .***. . .].

Patheon
shall design a stability program (single orientation, single container type) to monitor: 

	•
	1
active laboratory scale batch

	•
	Additional
samples will be stored as contingency samples if required to generate long-term stability of the product 

        The
following storage conditions and test-points are suggested for testing: 

==>
[. . .***. . .] 

==>
[. . .***. . .] 

==>
[. . .***. . .] 

==>
[. . .***. . .] 

(* Tested only if required due to significant changes in the next level condition)

        Testing
per sample: 

	•
	Potency &
Related Substances

	•
	Appearance

	•
	pH

	•
	Osmolality

	•
	Viscosity

	•
	Particle
Size Analysis [. . .***. . .]

	•
	[. . .***. . .]

6.2.  Freeze/Thaw Study—Laboratory Scale Batch  

The precise scope of work required will be discussed and agreed with Client. At this stage, for budget illustration purposes only, a number of assumptions have been made and
example fees presented.

A
freeze / thaw study using samples from one batch of non-cGMP laboratory scale material (manufactured as described and costed for in Section 6 above) will be conducted according to
Patheon standard practices ([. . .***. . .] freeze/thaw cycles). 

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 10 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

Samples
would be tested for drug product potency and related substances following each of the [. . .***. . .] cycles.
Finished product testing data from the laboratory scale batch (Section 6) will be used as initial time point data. 

A
protocol and summary report will be prepared and provided to Client for review and approval. 

The
precise scope of the study would be discussed and agreed with Client. The cost given is only for budget illustration purposes at this stage. 

7.     Holding Time Study  

The precise scope of work to be performed has yet to be discussed and agreed with Client. At this stage, for budget illustration purposes only, a number of assumptions have
been made and example fee information is presented on [. . .***. . .].

A
holding time study will be performed for each step of the emulsion process for durations that will be discussed and agreed with Client. 

The
studies will include [. . .***. . .] and
[. . .***. . .] studies on the process. 

All
samples will be tested concurrently and may include: 

	•
	Potency &
Related Substances

	•
	Particle
Size Analysis [. . .***. . .] 

At
this stage, for budget illustration purposes only, the fee information presented below has been calculated based upon performing one set of each of the tests listed above. 

A
protocol and summary report will be prepared and provided to Client for review and approval. 

The
precise scope of the study would be discussed and agreed with Client. The cost given is only for budget illustration purposes at this stage. 

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 11 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

8.     Compatibility Study  

The requirements to conduct a compatibility study and the precise scope of work to be performed has yet to be discussed and agreed with Client. At this stage, for budget
illustration purposes only, a number of assumptions have been made and example fee information is presented.

A
study using one batch of non-cGMP laboratory scale material (manufactured as described and costed for in Section 6 above) will be performed to assess the compatibility of the
product with the below mentioned materials that are anticipated to be encountered during subsequent cGMP batch manufacture: 

	•
	Glass

	•
	Stainless
Steel

	•
	Tubing

	•
	Ceramic
(filling pumps) 

Samples
would be subjected to the worst case scenario with regards to time and surface area at one storage condition/temperature. Samples would be tested concurrently for drug product potency and
related substances at the following time points (to be confirmed): 

	•
	Initial,
24, 48 and 72 hours 

Finished
product testing data from the laboratory scale batch (Section 6) will be used as initial time point data. 

A
single protocol and a report will be prepared to cover the study and will be provided to Client for review and approval. 

The
precise scope of the study would be discussed and agreed with Client. The cost given is only for budget illustration purposes at this stage. 

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 12 of 21
	 	 	CONFIDENTIAL	 	 

9.     Cleanability Study  

A
cleanability study, using active material from a non-cGMP laboratory scale batch (manufactured as described and costed for in Section 6 above) will be performed, which will
include: 

	•
	Assessment
cleaning methodology of equipment.

	•
	Definition
of product contact parts.

	•
	Laboratory
scale studies to define pre-wash parameters and test for residues.

	•
	Manufacturing
scale studies confirming the automated wash cycle parameters using the optimum pre-wash parameters and tested for residues.

	•
	A
summary Cleaning Definition Document will be issued. 

10.   Project Support  

Patheon
will provide project management support to monitor the progress of the project against established timelines and will provide Client with frequent updates. The project manager will coordinate
regular [. . .***. . .] meetings and
[. . .***. . .] meetings. The fee for project management is incorporated in the breakdown cost for each activity in the
Budget Summary. 

11.   Standard Assumptions  

	1.
	The
approach used would be outlined in a more detailed protocol prepared by Patheon and on request approved by Client.

	2.
	The
manufacture of cGMP batches and any associated supporting activities (e.g. formal analytical method transfer, validation activities, etc.) are not included within this proposal.

	3.
	The
API will be supplied in a sufficient amount to perform the activities agreed within this proposal and will be in a suitable form for incorporation into the formulation and will not
require further processing at Patheon.

	4.
	Non-Patheon
standard components will be utilised.

	5.
	The
manufacturing process is [. . .***. . .] and requires no special temperature, atmospheric or light
control outside of Patheon's current capabilities. [. . .***. . .] overlay and headspace for analytics for
[. . .***. . .] is required during manufacture (to be confirmed with Client).

	6.
	If
required, batches will be supplied bulk packed to the Client. The bulk packing materials and excipients used are standard items of Patheon.

	7.
	Container
closure integrity testing is not required; where required this service can be provided by Patheon.

	8.
	It
is assumed that a [. . .***. . .] (transferred by MOVA) and
[. . .***. . .] Particle analyser (purchased by Client) will be available within the PDS Patheon Italia, Ferentino
laboratory.

	9.
	Finished
product samples will be tested at Ferentino and also at MOVA.

	10.
	Samples
(quantity to be decided based upon discussions with [. . .***. . .]) will be sent to
[. . .***. . .] Corporation for testing in their Ops Laboratories, to enable
[. . .***. . .] Corporation to recommend appropriate membrane area for the
[. . .***. . .]. 

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 13 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

	11.
	Where
Patheon is responsible for storage only of stability samples then a cost of $[. . .***. . .] (US
Dollars) per month per linear meter and a cost of $[. . .***. . .] (US Dollars) per handling operation will be charged.
Where Patheon is responsible for analytical testing of stability samples then there will be no additional cost for storage and handling. 

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 14 of 21
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Part B: Budget Summary  

BUDGET SUMMARY  

NovaCardia

KW 3902 

THE FOLLOWING COSTS ARE ALL QUOTED IN:            USD

All
amounts quoted are valid for sixty (60) days from the date of this Proposal. 

	ENVIRONMENTAL HEALTH AND SAFETY	 	USD
	

 	
 	

ACTIVITY	
 	

 	
 	

PRICE
	

 	
 	

EH&S Assessment	
 	

 	
 	

Completed
	
ANALYTICAL SERVICES	
 	

USD
	

 	
 	

ACTIVITY	
 	

 	
 	

PRICE
	

 	
 	

[. . .***. . .]	
 	

[. . .***. . .]	
 	

 
	

 	
 	

[. . .***. . .]	
 	

[. . .***. . .]	
 	

 
	

 	
 	

[. . .***. . .]	
 	

[. . .***. . .]	
 	

 
	

 	
 	

[. . .***. . .]	
 	

[. . .***. . .]	
 	

 
	

 	
 	

[. . .***. . .]	
 	

[. . .***. . .]	
 	

 
	

 	
 	

[. . .***. . .]	
 	

[. . .***. . .]	
 	

 
	

 	
 	
TOTAL (Analytical Services)	
 	

 	
 	

[. . .***. . .]
	
PROCESS TRANSFER & OPTIMISATION	
 	

USD
	

 	
 	

ACTIVITY	
 	

PRICE	
 	

PRICE
	

 	
 	

Process Transfer & Optimisation	
 	

 	
 	

 
	 	 	[. . .***. . .] (1FTE = 150 man hours)	 	[. . .***. . .]	 	 
	 	 	Project Support	 	[. . .***. . .]	 	 
	

 	
 	
TOTAL (Process Transfer & Optimisation)	
 	

 	
 	

[. . .***. . .]
	
LABORATORY SCALE BATCH MANUFACTURE	
 	

USD
	

 	
 	

ACTIVITY	
 	

PRICE	
 	

PRICE
	

Per-batch	
 	

Laboratory Scale Batch Manufacture & Documentation	
 	

[. . .***. . .]	
 	

 
	 	 	Analytical Support	 	[. . .***. . .]	 	 
	 	 	Project Support	 	[. . .***. . .]	 	 
	

 	
 	
TOTAL (Per-Laboratory Scale Batch Manufacture)	
 	

 	
 	

[. . .***. . .]

	 	 	 	 	 
	 	 	 	 	KW3902

NovaCardia Inc.

Page 15 of 21
	 	 	CONFIDENTIAL	 	***Confidential Treatment Requested

	STABILITY—LABORATORY SCALE BATCH	 	USD
	

 	
 	

ACTIVITY	
 	

PRICE	
 	

PRICE
	

 	
 	

Number of Lots [. . .***. . .]	
 	

 	
 	

 
	 	 	Total Samples [. . .***. . .]	 	 	 	 
	 	 	 	 	 	 	 

	Pullpoint Month	 	T = 1	 	T = 2	 	T = 3	 	T = 6	 	 	 	 
	40°C / 75% RH	 	x	 	x	 	x	 	 	 	 	 	 
	25°C / 60% RH	 	x	 	x	 	x	 	x	 	 	 	 
	Samples per pullpoint	 	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]	 	 	 	 
	Cost per pullpoint	 	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]	 	[. . .***. . .]	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	TOTAL (Stability—Per-Lab Batch)	 	 	 	[. . .***. . .]
	
FREEZE/THAW STUDY	
 	

USD
	

 	
 	

ACTIVITY	
 	

PRICE	
 	

PRICE
	

 	
 	

Freeze/Thaw Study ([. . .***. . .] Cycles)	
 	

[. . .***. . .]	
 	

 
	 	 	Project Support	 	[. . .***. . .]	 	 
	

 	
 	
TOTAL (Freeze/Thaw Study)	
 	

 	
 	

[. . .***. . .]
	
HOLDING TIME STUDY	
 	

USD
	

 	
 	

ACTIVITY	
 	

PRICE	
 	

PRICE
	

 	
 	

Holding Time Study (per-day, per-set of analysis)	
 	

[. . .***. . .]	
 	

 
	 	 	Protocol & Report	 	[. . .***. . .]	 	 
	 	 	Project Support	 	[. . .***. . .]	 	 
	

 	
 	
Total (Holding Time Study)	
 	

 	
 	

[. . .***. . .]
	
COMPATABILITY STUDY	
 	

USD
	

 	
 	

ACTIVITY	
 	

PRICE	
 	

PRICE
	

 	
 	

Compatability Study	
 	

[. . .***. . .]	
 	

 
	 	 	Project Support	 	[. . .***. . .]	 	 
	
 	
 	

TOTAL (Compatability Study)	
 	

 	
 	

[. . .***. . .]
	
CLEANABILITY STUDY	
 	

USD
	

 	
 	

ACTIVITY	
 	

PRICE	
 	

PRICE
	

 	
 	

Cleanability Studies	
 	

[. . .***. . .]	
 	

 
	 	 	Project Support	 	[. . .***. . .]	 	 
	

 	
 	
TOTAL (Cleanability Study)	
 	

 	
 	

[. . .***. . .]
	
BILLBACK ITEMS	
 	

USD
	

 	
 	

Change parts for the laboratory capping machine ([. . .***. . .]) & [. . .***. . .] (estimated)	
 	

[. . .***. . .]	
 	

 
	 	 	[. . .***. . .] (estimated)	 	[. . .***. . .]	 	 
	 	 	[. . .***. . .] Particle Analyser	 	[. . .***. . .]	 	 
	 	 	[. . .***. . .] Upgrading	 	To Be Confirmed

	 	 	 	 	 
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	 	 	TOTAL (Billback Items)	 	 	 	[. . .***. . .]
	

	BUDGET TOTAL	 	USD	 	[. . .***. . .]
	

	Deposit*	 	To be Confirmed
	

*
The deposit amount will require further assessment once additional information on the Client's financial arrangement is provided. This proposal will only be approved once Patheon's Finance
Department has determined that the Client has the necessary financial resources to support the project outlined in this document. 

	 	 	 	 	 
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PART C

STANDARD TERMS AND CONDITIONS

FOR PHARMACEUTICAL DEVELOPMENT SERVICES  

	1.
	Services:

	(a)
	Patheon
agrees to perform the pharmaceutical development services described in the Project Scope ("Services").

	(b)
	Parties
must agree on changes, deletions or additions to the Services ("Changes").

	(c)
	Minor
Changes shall be confirmed by electronic mail,facsimile or other written document. Significant Changes (such as a request by the Client to change the Project Scope) shall be
confirmed by a Change of Scope Agreement.

 

	2.
	Payment and Deposit:

	A.
	Payment

	(a)
	Client
shall pay Patheon for the Services as outlined in this Contract and for any Changes which shall be invoiced separately at Patheon's
[. . .***. . .].

	(b)
	The
costs of all third party suppliers' fees and the purchase of project specific items [. . .***. . .]
("Project Specific Items") necessary for Patheon to perform the Services shall be charged to Client.

	(c)
	If
Client causes any delay to Patheon's provision of Services for reason within its control (such as a delay in responding to a Patheon inquiry or a delay in the delivery of the
active pharmaceutical ingredient ("API")), then Patheon [. . .***. . .].

	(d)
	Each
Patheon invoice shall be due and payable within [. . .***. . .] of the date of such invoice.

	(e)
	If
any portion of an invoice is disputed, then Client shall pay Patheon the undisputed amounts and the parties shall use good faith efforts to reconcile the disputed amount as soon as
practicable. Client shall pay interest in an amount equal to [. . .***. . .] ruling at the time when payment became due,
accruing [. . .***. . .], on all undisputed amounts owing hereunder and not paid by the due date.

 

	B.
	Deposit

	(a)
	Prior
to the commencement of the Services, Client shall deliver to Patheon the deposit ("Deposit") set out in the Budget Summary.

	(b)
	Deposit
shall be held by Patheon [. . .***. . .].

	(c)
	Deposit
[. . .***. . .] for the Services and any remaining balance shall be returned to the Client.

	(d)
	Patheon
may apply all or a portion of the Deposit against any accounts overdue in excess of [. . .***. . .]
from the date of the invoice.

	(e)
	Patheon
may, at its option, [. . .***. . .] until such time as any outstanding invoices have been paid in
full and the original amount of the Deposit has been replenished.

 

	3.
	Supply of API and Materials:

	(a)
	Client
shall, at its expense, supply Patheon with sufficient quantities of the API for Patheon's use in performing the Services.

	(b)
	Other
than Project Specific Items, all other materials (such as excipients, packaging and raw materials) required to perform the Services shall be purchased by Patheon and charged to
Client at Patheon's cost [. . .***. . .].

	(c)
	If
applicable, Patheon and the Client will cooperate and provide such assistance to each other as may be reasonably necessary to permit the import of the API and other materials into
the country where the Services will be performed.

 

	4.
	Termination and Cancellation:

	(a)
	Either
party may terminate this Contract if the other party is in material breach of any provisions of this Contract and the other party fails to remedy such breach within
30 days of the date of notice of such breach by the non-breaching party.

	(b)
	Client
may terminate this Contract immediately for any business reason.

	(c)
	Any
re-scheduling of any part of the Services beyond [. . .***. . .] requested by Client shall,
at Patheon's option, be deemed to be a termination of the Contract.

	(d)
	If
the Client terminates the Contract for any business reason or if Patheon terminates the Contract because of: (i) Client's failure to cure any default within the
30 day notice period; or (ii) Client rescheduling any part of the Services beyond the [. . .***. . .], then
Client shall pay to Patheon:

	•
	any
fees and expenses due to Patheon for the Services rendered up to the date of termination;

	•
	all
actual costs incurred by Patheon to complete activities associated with the termination and close of the Services rendered up to the date of termination; and

	•
	any
additional costs incurred by Patheon in connection with the Services that are required to fulfill applicable regulatory and contractual requirements.

	(e)
	Client
shall arrange for the pickup from the Patheon site of all materials and supplies owned by Client
[. . .***. . .] after the earlier of the termination or expiration of this Contract. Patheon shall charge a
[. . .***. . .] per square foot per month storage fee for all materials and supplies stored at the Patheon site after the
fifth day following the termination of the Contract.

	(f)
	In
the event of cancellation by the Client within [. . .***. . .] of the due start date of manufacture, for
whatever reason, the [. . .***. . .]. In the event of 

	 	 	 	 	 
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cancellation
by Client within [. . .***. . .] of the due start date of manufacture, for whatever reason,
[. . .***. . .]. If cancellation is within
[. . .***. . .] of the due start date, the
[. . .***. . .]. If work is stopped within
[. . .***. . .] of the week of manufacture due to the nature of the API or other reasons due to the Client,
[. . .***. . .] 

	5.
	Intellectual Property:

	(a)
	The
term "Intellectual Property" includes, without limitation, rights in patents, patent applications, formulae, trade-marks, trade-mark applications, trade-names, trade
secrets, inventions, copyright, industrial designs and know-how.

	(b)
	For
the term of this Contract, Client hereby grants to Patheon, a non-exclusive, paid-up, royalty-free, non-transferable license of
Client's Intellectual Property which Patheon must use in order to perform the Services.

	(c)
	All
Intellectual Property generated or derived by Patheon in the course of performing the Services, to the extent it is specific to the development, manufacture, use and sale of the
Client's Product that is the subject of the Services, shall be the exclusive property of Client.

	(d)
	All
Intellectual Property generated or derived by Patheon in the course of performing the Services which have application to manufacturing processes or formulation development of drug
products or drug delivery systems shall be the exclusive property of Patheon.

 

	6.
	Indemnity:

	A.
	Indemnification by Client

Subject
to Sections 6B and 6C(c), Client shall defend, indemnify and hold Patheon, its affiliates and their respective directors, officers, employees and agents (collectively, "Patheon Indemnitees")
harmless from and against any and all third-party actions, causes of action, costs (including reasonable legal fees), claims, damages, liabilities and expenses (collectively, "Losses") relating to or
arising from: 

	•
	the
manufacture (except as may be contemplated by the Services) or distribution of the Client's Product or the use of the Client's Product by patients either as part of or
outside of the scope of any clinical trials;

	•
	the
performance of the Services in accordance with the terms of this Contract;

	•
	any
misrepresentation, negligence or willful misconduct by Client or any of its affiliates and their respective directors, officers, employees and agents (collectively,
"Client Indemnitees");

	•
	any
breach by the Client of the Client's obligations or warranties under this Contract; or

	•
	any
claim of infringement or alleged infringement of any third party's intellectual property rights in respect of the Client's Product. 

This
indemnity shall not apply to the extent that such Losses are: 

	•
	determined
to have resulted from the negligence or willful misconduct of Patheon; or

	•
	for
which Patheon is obligated to indemnify the Client Indemnitees pursuant to Section 6B.

	B.
	Indemnification by Patheon

Subject
to Sections 6A and 6C(c), Patheon shall defend, indemnify and hold the Client Indemnitees harmless from and against any and all Losses resulting from, relating to or arising from the breach by
Patheon of any of its obligations or warranties under this Contract except to the extent that such Losses are: 

	•
	determined
to have resulted from the negligence or willful misconduct of Client; or

	•
	for
which Client is obligated to indemnify the Patheon Indemnitees pursuant to Section 6A.

	C.
	Limitation of Liability

	(a)
	If
Patheon fails to materially perform any part of the Services in accordance with the terms of this Contract, then Client's sole remedy shall be to request Patheon to:

	•
	repeat
that part of the Service at Patheon's costs provided that Client provides the API; or

	•
	reimburse
Client for the price for that part of the Service, [. . .***. . .]

	(b)
	Under
no circumstances whatsoever shall Patheon [. . .***. . .].

	(c)
	Under
no circumstances whatsoever shall either party be liable to the other in contract, tort, negligence, breach of statutory duty or otherwise for any loss of profits, of
production, of anticipated savings, of business or goodwill or for any liabilities, damages, costs or expenses of any kind incurred by the other party of an indirect or consequential nature,
regardless of any notice of the possibility of such damages.

	(d)
	Nothing
in this Contract shall limit either party's liability for death, personal injury or fraudulent misrepresentation.

	(e)
	Nothing
in this Contract shall confer or be construed as conferring on any third party any benefit or the right to enforce any express or implied term of this Contract. Pursuant to
section 1(2)(a) of the Contracts (Rights of Third Parties) Act 1999 ("The Act") the parties intend that, to the fullest extent permissible by law, no term of this Agreement may be enforced by a
Third Party (as described in The Act).

	D.
	No Warranty

PATHEON
MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS CONTRACT. PATHEON MAKES NO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE
OR WARRANTY OF MERCHANTABILITY IN RESPECT OF THE CLIENT'S PRODUCT. 

	7.
	Regulatory Filings:

	(a)
	Client
shall have the sole responsibility for filing of all documents with the applicable regulatory authority (such as the United States Food and Drug Administration ("FDA"), the
Medicines and Healthcare Products Regulatory Agency ("MHRA") or the European Medicine Evaluation Agency (collectively the "Regulatory Authority") and to take any other actions that may be required for
the receipt of approval from the Regulatory Authority for the commercial manufacture of the Client's Product. 

	 	 	 	 	 
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	(b)
	At
least [. . .***. . .] prior to filing any documents with the Regulatory Authority that incorporate data
generated by Patheon, Client shall provide Patheon with a copy of the documents incorporating such data so as to give Patheon the opportunity to verify the accuracy and regulatory validity of such
documents as it relates to the Patheon-generated data.

	(c)
	At
least [. . .***. . .] prior to filing with the Regulatory Authority any documentation which is or is
equivalent to the FDA's Chemistry and Manufacturing Controls ("CMC") portion of the New Drug Application or of the Abbreviated New Drug Application, as the case may be, Client shall provide Patheon
with a copy of the CMC portion as well as all supporting documents which have been relied upon to prepare the CMC portion so as to permit Patheon to verify that the CMC portion accurately describes
the work that Patheon has performed and the manufacturing processes that Patheon will perform pursuant to this Contract.

	(d)
	If
Client does not provide Patheon with the documentation requested above within the time stipulated and if Patheon reasonably believes that Patheon's relationship with the Regulatory
Authority may be jeopardised, Patheon may, in its sole discretion, delay or postpone the Regulatory Authority inspection which is or is equivalent to the FDA's pre-approval inspection
("PAI") until such time as Patheon has reviewed the requested documentation and is satisfied with its contents.

	(e)
	If
in Patheon's sole discretion, acting reasonably, Patheon determines that any of the information provided by the Client is inaccurate or deficient in any manner whatsoever (the
"Deficiencies"), Patheon shall notify the Client in writing of such Deficiencies. Until such Deficiencies have been resolved or agreement has been reached with the Client for such resolution, Patheon
reserves the right not to participate in the PAI. In such event, Patheon's non-participation in the PAI shall not be construed as a breach of any of its obligations under this Contract.

 

	8.
	Shipping (if applicable):

Shipments
(if applicable) of Client's Product shall be made [. . .***. . .] Patheon's shipping point unless otherwise
mutually agreed. Risk of loss or of damage to such Product shall [. . .***. . .]. The Product shall be transported in
accordance with the Client's instructions. 

	9.
	Miscellaneous:

	A.
	Assignment

Neither
this Contract, nor any of either party's rights hereunder, may be assigned or otherwise transferred by either party without the prior written consent of the other party, which consent shall
not be unreasonably withheld. 

	B.
	Force Majeure

Except
for payment obligations, neither party will be responsible for delay or failure in performance resulting from acts beyond the reasonable control and without the fault or negligence of such
party, including, but not limited to, strikes or other labour disturbances, lockouts, quarantines, communicable disease outbreaks, riots, wars, acts of terrorism, fires, floods, storms, interruption
of or delay in transportation, defective equipment, lack of or inability to obtain fuel, power or components or compliance with any order or regulation of any government entity. 

	C.
	Survival

Any
termination or expiration of this Contract shall not affect any outstanding obligations or payments due hereunder prior to such termination or expiration, nor shall it prejudice any other remedies
that the parties may have under this Contract. The Confidentiality Agreement and sections 4, 5, 6 and 7 of the Contract shall survive the expiration or termination of this Contract. 

	D.
	Independent Contractors

The
parties are independent contractors and this Contract shall not be construed to create between Patheon and the Client any other relationship such as, by way of example only, that of
employer-employee, principal, agent, joint-venturer, co-partners or any similar relationship. 

	E.
	Confidentiality

The
Confidentiality Agreement entered into between the parties shall apply to all confidential information about the parties and the Services to be conducted under this Contract and such
Confidentiality Agreement is deemed to be incorporated herein by reference. If the Confidentiality Agreement expires or terminates prior to the expiration or termination of this Contract, then the
terms of the Confidentiality Agreement shall nonetheless continue to govern the parties' obligations of confidentiality for the term of this Contract and for
[. . .***. . .] thereafter. 

	F.
	Taxes

In
the event that any taxes or duties, of whatever nature, are required to be withheld on payments made by Client pursuant to this Contract by any state, federal, provincial or foreign government,
including, but not limited to, Value Added Tax, Client shall be responsible and promptly pay said taxes and duties to the appropriate taxing authority without any deduction to any amount owed to
Patheon. Client shall secure and deliver to Patheon any official receipt for any such taxes paid. 

	G.
	Other Terms

No
terms, provisions or conditions of any purchase order or other business form or written authorisation used by Client or Patheon will have any effect on the rights, duties or obligations of the
parties, or otherwise modify, this Contract, regardless of any failure of Client or Patheon to object to such terms, provisions, or conditions unless such document specifically refers to this Contract
and is signed by both parties. 

	H.
	Insurance

Each
party shall maintain during the term of this Contract general liability and product liability insurance. Either party may request evidence of such insurance. 

	I.
	Entire Agreement

This
Contract constitutes the complete agreement between the parties with respect to this subject matter and supersedes all other prior agreements and understandings, whether written or oral. Any
modifications, amendment or supplement to this Contract must be in writing and signed by authorised representatives of both parties. 

	J.
	Facsimile

	 	 	 	 	 
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This
Contract may be signed in counterparts and by facsimile. 

	K.
	Choice of Law

This
Contract is governed by the laws of the England, without regard to any conflicts-of-law principle that directs the application to another jurisdiction's law. Both parties
hereby submit to the exclusive jurisdiction of the English courts 

	 	 	 	 	 
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QuickLinks

Exhibit 10.20

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00120-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00120-of-00352.parquet"}]]