Empty space
1x
2x
3x
Company Logo
Drag & drop image files orbrowse to upload
Clinical Trial Agreement
Empty space
1x
2x
3x
Prepared for:
[University Name]

Prepared by:
[Sponsor Name]
Empty space
1x
2x
3x
Empty space
1x
2x
3x
Empty space
1x
2x
3x

Clinical Trial Agreement

This Clinical Trial Agreement (hereinafter referred to as the "Agreement") is made and shall stand effective as on [Effective Date] (hereinafter referred to as the "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 "Parties" and individually as "Party".

Recitals

WHEREAS, the Sponsor intends to conduct clinical research (hereinafter referred to as "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 on providing funding and drug/devices (hereinafter referred to as "Drug/Devices") to the University;

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 Condition

1. Performance of Study

The Study shall be performed as [Study Protocol] (hereinafter referred to as the "Protocol") under the guidance of [Principal Investigator] (hereinafter referred to as the "Investigator").

The Study shall be conducted by the University in accordance with the aforementioned Protocol, this Agreement, and the conformance of the applicable governing 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, subject privacy, confidentiality, and data security, specifically including laws/acts centered around health as of the [Health Concerning Law/Act statement], and their respective implementation.

2. Substitution

The University understands that the Investigator shall be playing a vital role in the matter of Study and thus, no substitution shall be allowed in place of the appointed Investigator for the study. If the Investigator becomes unavailable or is not willing to conduct the study any further, another equally qualified successor shall be nominated by the University meeting the terms set by the Sponsor. However, if despite everything no successor is nominated or meets the worth of the Sponsor within [Number] days, 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 Study data and results of the Study, which shall be submitted as manuscript or presentation to the Sponsor at least [Number of Days] before the submission for reviews and comments.

The Sponsor shall engage and ensure for registration of the study on the authorized website according to the registration requirement of the clinical trials founded by the [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 of any loss, damage, claim, third party liability, harm, or expenses, which shall include reasonable legal and attorney fees and expenses, imposed or incurred upon the Party. However, if the Party causes the aforementioned situations due to negligence, or vengeance, the Sponsor shall not be liable for indemnification.

6. Insurance

During the term of this Agreement, the Sponsor shall carry and maintain all form of insurance at their own expense for the following specified:
  1. Commercial General Liability shall include coverage for premises and operations and contractual liability for all operations with limits from [Minimum Amount] per occurrence and [Maximum Amount] annual aggregate.
  1. Worker's Compensation insurance or approved self-insurance.
  1. Professional liability with limits between [Minimum Amount] per occurrence and [Maximum Amount] aggregate for the Sponsor, its employee, directors, or officers.

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 [Amount] as an invoice to the University. The amount that is to be invoiced shall be set forth in accordance with the budget attached.
Service
Quantity
Price Per Unit
Amount

1
$0.00
$0.00

1
$0.00
$0.00
Grand Total (Inclusive of Tax): $0.00

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 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], which shall be appointed by the Parties. The place of Arbitration shall be [Place of Arbitration] and Seat shall be [State of 'State']. The Arbitrators’ decision shall be final and will be binding upon both Parties.

10. Miscellaneous

  1. 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 to be affected by this Agreement, thereby, no Party shall claim rights in such separate breakthroughs.
  1. Notices: All notices, written or digital, must be notified to the Parties respectively through their certified mailing address or email as is mentioned below herein the Agreement. However, if an additional address needs to be adjoined, the Party may do so after sending a written notice to the other Party addressing the same.
  1. Non-transferrable: No terms set herein the Agreement shall be assignable or transferrable by either Party.
  1. 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.
  1. Governing Law: This Agreement shall be governed by and construed in accordance with the jurisdiction laws of the State of [State].
  1. Severability: If any provision herein the Agreement is deemed as unenforceable, invalid, or illegal by the judicature of the [State], it shall be severed and the remaining provisions in the Agreement shall be enforceable, valid, and binding, and shall continue in full force and effect.
  1. Force Majeure: No Parties shall be held liable for any breach or dispute in cases of Force Majeure Event.
  1. 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 intended to confer any rights or remedies in favor of any person, party, or affiliate, other than the Parties duly undersigned.
  1. Entirety: This Agreement and other annexures, therefore, constitute the entire agreement between the Parties with respect to the matter of subject hereof and thus, supersedes all prior agreements, purchases, understandings, and negotiations, written or phonated, between the Parties.

Acceptance and Signature

In witness whereof, the undersigned Parties have duly executed the terms proposed herein the Agreement as of the aforementioned date.
Signature
Assign signer 1
Name
Assign signer 1
Date
Assign signer 1
Signature
Assign signer 2
Name
Assign signer 2
Date
Assign signer 2

Free Clinical Trial Agreement Templates

Still worrying how to outline your clinical trial and proceed to your next breakthrough? Join us with our virtuously designed Clinical Trial Templates