MASTER CLINICAL SERVICES AGREEMENT
Exhibit 10.44
CERTAIN INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
MASTER CLINICAL SERVICES AGREEMENT
This MASTER CLINICAL SERVICES AGREEMENT (this “Agreement”), effective as of the last date of authorized signature herein (the “Effective Date”), is made by and between Apnimed, Inc., a Delaware corporation with principal offices located at ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (“Sponsor”), and Syneos Health, LLC, a Delaware limited liability company with principal offices located in the United States at ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, together with Syneos Health UK Limited, a company with principal offices located at Farnborough Business Park, ▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇ (“Syneos Health”).
WITNESSETH:
WHEREAS, Sponsor is engaged in the business of developing, manufacturing, distributing, and/or selling pharmaceutical products, biotechnological products, and/or medical devices;
WHEREAS, Syneos Health is engaged in the business of providing clinical research services, data management, and related services in the pharmaceutical, biotechnology, and medical device industries; and
WHEREAS, Sponsor and Syneos Health desire to agree on terms which will be applied to govern Syneos Health’s provision of services for Sponsor in connection with a particular Study or Studies (as defined herein).
NOW, THEREFORE, in consideration of the foregoing and for other good and valuable consideration, the receipt and adequacy of which hereby are mutually acknowledged, the Parties intending to be legally bound do hereby agree as follows:
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Nothing in this Agreement shall restrict a Receiving Party from disclosing Confidential Information as required by Applicable Law or court order or other governmental order or request, provided in each case the Receiving Party shall, to the extent permitted by Applicable Law, timely inform the Disclosing Party and use Commercially Reasonable Efforts to limit the disclosure to the minimum Confidential Information required to be disclosed, determined in the reasonable discretion of the Receiving Party in consultation with the Receiving Party’s legal counsel, and maintain the confidentiality of such Confidential Information. The Receiving Party shall permit the Disclosing Party to attempt to limit such disclosure by appropriate legal means.
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Syneos Health will Process Personal Data in accordance with Data Protection Laws. To the extent the Services involve the Processing of Personal Data, the Parties agree that such Processing will be governed by the terms set forth in Appendix B to this Agreement. Defined terms in this section not otherwise defined in this Agreement are defined as set forth in Appendix B. The Parties agree to negotiate in good faith and enter into a Personal Data Processing Addendum, which will become part of this Agreement after it is executed by both Parties. The Parties agree that Sponsor will not require Syneos Health to perform Services that require Processing of Personal Data prior to the execution of the Personal Data Processing Addendum. To the extent the Services involve the Processing of Personal Data the Parties agree that such Processing will be governed by the terms set forth in the Personal Data Processing Addendum.
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If mediation does not result in resolution or [***] have elapsed since notification of the dispute pursuant to Section 14.6, for disputes with an amount in controversy less than $[***], the Parties agree to resolve the dispute through arbitration before a single arbitrator in accordance with the Commercial Arbitration Rules of the AAA, then pertaining (available at ▇▇▇.▇▇▇.▇▇▇), except where those rules conflict with this provision, in which case this provision controls. For disputes with an amount in controversy greater than or equal to [***], the Parties agree to proceed under the AAA’s Streamlined Three-Arbitrator Panel Option, with each Party appointing a single arbitrator, who both will then select the third neutral arbitrator. Any court with jurisdiction shall enforce this clause and enter judgment on any award. Within [***] of initiation of arbitration, the Parties shall agree upon and follow procedures assuring that the arbitration will be concluded and the award rendered within no more than [***] from selection of the arbitrator(s) or, failing agreement, procedures meeting such time limits designated by the AAA. The arbitration shall be held in New York, New York, conducted in the English language and shall apply the substantive law of Delaware, except that the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration Act. The arbitrator shall be bound by the expressed terms of this Agreement. Each Party shall bear their own costs in connection with
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any of the remedial actions set forth above. By agreeing to arbitration, the Parties do not intend to deprive any competent court of such court’s jurisdiction to issue a pre-arbitral injunction, pre-arbitral attachment or other order in aid of the arbitration proceedings and the enforcement of any award or judgment. Without prejudice to such provisional remedies in aid of arbitration as may be available under the jurisdiction of a court of competent jurisdiction, the court of arbitration shall have full authority to grant provisional remedies and to award damages for failure of any Party to respect the court of arbitration’s order to that effect.
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If to Syneos Health: |
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If to Sponsor: |
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Syneos Health, LLC Attn: Legal Department 1030 Sync Street Morrisville, NC 27560 Phone: [***] Email: [***] |
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▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇: Chief Executive Officer |
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[SIGNATURE PAGE FOLLOWS]
IN WITNESS WHEREOF, the undersigned have caused this Agreement to be executed by a duly authorized individual on behalf of each requisite Party effective as of the Effective Date. In the event that the Parties execute this Agreement by exchange of portable document format, other electronically signed copies or facsimile signed copies, the Parties agree that, upon being signed by both Parties, this Agreement shall become effective and binding and that such copies will constitute evidence of the existence of this Agreement.
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SYNEOS HEALTH, LLC |
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By: |
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/s/ ▇▇▇▇▇ ▇▇▇▇▇▇ |
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By: |
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/s/ ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ |
Name: ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇: Sr Director, Corporate Counsel
Date: May 12, 2023 |
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Name: ▇▇▇▇▇▇▇▇ ▇. Miller Title: President
Date: May 12, 2023 |
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SYNEOS HEALTH UK LIMITED |
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By: |
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/s/ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ |
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Name: ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇: SVP, Global Pricing and Deal Management
Date: May 15, 2023 |
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APPENDIX A
EARLY PHASE SERVICES
[***]
Appendix A – Early Phase Services
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APPENDIX B
DATA PROCESSING
[***]
Appendix B – Data Processing
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