Clinical Trial 
Agreement

Empty space

PREPARED FOR
[University Name] 

PREPARED BY
[Sponsor Name] 

Clinical Trial Agreement

This Clinical Trial Agreement (hereinafter referred to as the "Agreement") is made and shall stand effective as of [Effective Date],
 
By and Between 
 
[University Name] (hereinafter referred to as the "University"), located at [University Address], and; 
 
[Sponsor Name] (hereinafter referred to as the "Sponsor"), located at [Sponsor Address]. 
 
Both the University and Sponsor shall hereinafter be referred to as the "Parties" and individually as the "Party."

RECITALS.

WHEREAS, the Sponsor intends to conduct clinical research (hereinafter referred to as the "Study") with the assistance of the University; 
 
AND WHEREAS, the Study is of mutual interest and benefit, furthering the instructional and research objectives of the University, consistent with its status as a non-profit educational and healthcare University; 
 
AND WHEREAS, in order to conduct the Study, the Sponsor desires to provide funding and drugs/devices to the University.
 
NOW, THEREFORE, in consideration of the mutual promises, the Agreement terms, and covenants mentioned herein, the Parties agree to the terms as laid henceforth:

TERMS AND CONDITIONS.

1. PERFORMANCE OF STUDY.

The Study shall be performed as [Study Protocol Title] under the guidance of [Principal Investigator Name] (hereinafter referred to as the "Investigator").
 
The University shall conduct the Study in accordance with the aforementioned protocol and this Agreement, and shall comply with all applicable laws and regulations. However, the Sponsor shall be held responsible for arranging and directing the Study in accordance with the aforementioned terms.

The Parties shall agree to all terms and abide by the applicable laws and regulations regarding research, including subject privacy, confidentiality, and data security, specifically including laws and acts concerning health, as of [Applicable Health Law or Act], and their respective implementation.

2. SUBSTITUTION.

The University understands that the Investigator shall play a vital role in the Study; accordingly, no substitution shall be permitted for the appointed Investigator. If the Investigator becomes unavailable or unwilling to conduct the Study further, the University shall nominate an equally qualified successor who meets the terms set by the Sponsor. However, if, despite everything, no successor is nominated or meets the requirements of the Sponsor within [Successor Nomination Time Period in Days] day(s), either Party shall be free to terminate this Agreement and the Study.

3. CONFIDENTIAL INFORMATION.

The Parties shall acknowledge that during the Agreement term, the Parties can equally gain access to several confidential and proprietary information, directly or indirectly, of the other Party. The Parties shall maintain the confidential information appropriately and shall refrain from the unauthorized publication or disclosure of such information. This provision shall be considered continuous unless the Agreement is terminated or canceled.

However, Study results shall not be considered confidential information for the purpose of publication. 

4. PUBLICATION.

The University and Investigator shall be free and unbound to publish or present data and results of the Study, which shall be submitted as a manuscript or presentation to the Sponsor at least [Number of Days Before Submission] day(s) before the submission for reviews and comments.

The Sponsor shall engage and ensure the registration of the Study on the authorized website according to the registration requirements of the clinical trials founded by [Medical Journal Editor]  so as to preserve publication rights.

5. INDEMNIFICATION.

The Sponsor shall indemnify, defend, and hold the University, Investigator, and other affiliates harmless from any loss, damage, claim, third-party liability, harm, or expenses, including reasonable legal and attorney fees and costs imposed or incurred upon the Party. However, if the Party causes the aforementioned situations through negligence or malice, the Sponsor shall not be liable for indemnification.

6. INSURANCE.

During the term of this Agreement, the Sponsor shall, at its own expense, maintain the following insurance coverage:

(a) Commercial General Liability Insurance
This includes coverage for premises, operations, and contractual liability, with minimum limits of [Commercial General Liability_Minimum Amount] per occurrence and [Commercial General Liability_Maximum Amount] annual aggregate.

(b) Workers' Compensation Insurance or approved self-insurance, as required by applicable law.

(c) Professional Liability (Errors & Omissions) Insurance
With limits of not less than [Professional Liability_Minimum Amount] per occurrence and [Professional Liability_Maximum Amount] aggregate, covering the Sponsor, its employees, directors, and officers.

(d) Clinical Trials Liability Insurance (Subject Injury Insurance)
With limits of not less than [Clinical Trial Liability_Minimum Amount] per occurrence and [Clinical Trial Liability_Maximum Amount] aggregate, providing coverage for injury to research subjects participating in the clinical trial.

The Sponsor shall solely be liable for any injury caused to the subject and shall indemnify and bear the expense of the same.

7. COMPENSATION.

The Sponsor shall provide the University with an invoice for [Invoice Amount]. The amount to be invoiced shall be outlined in accordance with the attached budget.

Service	Price Per Unit	Quantity	Amount
[Service Name]	$[Price Per Unit]	[Quantity]	$[Amount]
[Service Name]	$[Price Per Unit]	[Quantity]	$[Amount]
Total (Inclusive of all taxes): $[Total Amount]

8. TERMINATION.

The Agreement shall continue till the completion of the Study and the final payment receipt is received. In cases involving breach or dispute between the parties, they may bind upon neutral arbitration or terminate the Agreement immediately upon the written consent of both the Parties. However, confidential information mentioned any time during the course of the Agreement shall survive the termination of the Agreement, whatsoever.

9. ARBITRATION.

In the event of any dispute arising in and out of this Agreement between the Parties, it shall be resolved by arbitration. There shall be [Number of Arbitrators] arbitrator(s), who shall be appointed by [Arbitration Appointing Party Name]. The venue of arbitration shall be [Location of Arbitration], and the Seat shall be [State of Seat]. The arbitrators’ decision shall be final and binding upon both Parties.

10. SEPARATE PROPERTY.

The original existing inventions and technologies must be acknowledged as separate property or license of either the Sponsor or the University, accordingly, and thus, shall not be responsible for being affected by this Agreement; thereby, no Party shall claim rights in such separate breakthroughs.

11. NOTICES. 

Any notices required or permitted by this Agreement shall be in writing and delivered by certified mail or courier to the mentioned address. However, if an additional address is required, the Party may do so after sending written notice to the other Party.

12. NON-TRANSFERRABLE. 

No term of the Agreement shall be assigned or transferred by either Party.
 
13. AMENDMENT AND COUNTERPARTS. 

No modification or waiver of the provisions of this Agreement shall be valid or binding on either Party unless in writing and signed by both Parties. The Parties may execute this Agreement singly or in multiple counterparts, each of which constitutes the meaning of this Agreement herein.
 
14. GOVERNING LAW. 

This Agreement shall be governed by and construed in accordance with the laws of the State of [Governing Law].
 
15. SEVERABILITY. 

Suppose any provision of this Agreement is deemed invalid or unenforceable, in whole or in part. In that case, that part shall be severed from the remainder of this Agreement, and all other provisions shall remain in full force and effect as valid and enforceable.
 
16. FORCE MAJEURE. 

No Party shall be liable or responsible to the other for any loss or damage or for any delays or failure to perform under this Agreement due to causes beyond its reasonable control, including, but not limited to, acts of God, employee strikes, epidemics, war, riots, flood, fire, sabotage, terrorist acts or any other circumstances of like character.
 
17. INCLINATION. 

The Parties must acknowledge that this Agreement, hereinafter, is solely for the benefit of the Parties undersigned and serves no inclination to any Party, nor is it intended to confer any rights or remedies in favor of any person, Party, or affiliate other than the Parties duly undersigned.
 
18. ENTIRE AGREEMENT. 

This Agreement and other annexures, therefore, constitute the entire agreement between the Parties with respect to the matter of subject hereof and, thus, supersede all prior agreements, purchases, understandings, and negotiations, written or oral, between the Parties.

ACCEPTANCE AND SIGNATURE.

IN WITNESS WHEREOF, the undersigned Parties have duly executed the terms proposed herein in the Agreement as of the date mentioned above.

[University Name] 

[Sponsor Name] 

Name:

Name:

Signature:

Signature:

Date:

Date:

Clinical Trial Agreement Template

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