What is a Clinical Trial Agreement?
A Clinical Trial Agreement specifies what product (for example, the study drug or device) the sponsor will provide the institution, as well as any financial support, and/or proprietary information. Additionally, Clinical Trial Agreements specify what the institution will provide in the way of data, as well as resulting publication, and input into further intellectual property development. It is crucial that in setting up a clinical trial that all parties comply with existing laws. If you have any questions, it is a good idea to consult an attorney who specializes in clinical trials.
When to use a Clinical Trial Agreement:
- You're a company operator who wants to commission a clinical trial of a product.
- You work at an institution that conducts clinical trials.
- You've developed a product and needs to conduct a trial before selling your idea or product.
Clinical Trial Agreement
This CLINICAL TRIAL AGREEMENT (this "Agreement"), effective as of, (the "Effective Date"), is entered into by and among , , , , (herein after referred as the 'Institution'), and, , a corporation with its principal office and place of business located at , , , (hereinafter referred as 'Sponsor').
WHEREAS the Sponsor is an entity involved in the research, development, manufacture and sale of
WHEREAS the Sponsor is developing new products for its business expansion.
WHEREAS the Institution is engaged in the business of in of interest to the Sponsor.
WHEREAS, the Institution is desires to conduct a Clinical Trial (the 'Trial') of Sponsor's , in accordance with a mutually agreed Protocol, entitled , which shall be incorporated herewith as Exhibit A ("Protocol").
The Institution oversees the conduct of certain clinical trials managed by the institution faculty members (each person as "Principal Investigator"). The Principal Investigators shall perform the trial at the Institution. The Principal Investigator will be responsible for conducting this Trial. of the Institution shall serve as the Principal Investigator.
NOW THEREFORE, in consideration of the foregoing promises and the mutual covenants contained herein, the parties hereto agree as follows:
SCOPE OF WORK
The Principal Investigator shall perform the Trial in compliance with generally accepted standards of Good Clinical Practice as set forth in Title 21 of the U.S. Code of Federal Regulations (CFR), the Protocol , instructions provided by the Sponsor and all applicable local, state and federal laws governing the performance of clinical investigations including but not limited to the [10 Laws] and applicable of the Office for Human Research Protections. The Protocol attached to this Agreement explains the nature and conditions of the work. It describes the Clinical Trial and all amendments thereto as the Parties may from time to time agree.
This agreement begins on , and ends on . Either party can terminate the Agreement by giving days written notice to the other party.
Payment shall be made to the Institution, in the amount of upon completion of the trial and work described in this Contract. The Sponsor shall pay all costs of collection, including without limitation, reasonable attorney fees. In addition to any other right or remedy provided by law, if the Sponsor fails to pay for the Services provided by the Institution under this Agreement when due, the Institution has the option to treat such failure to pay as a material breach of this Contract, and may cancel this Contract and seek legal remedies.
The Institution will not disclose confidential information unless it is necessary to the Trial. Any information considered by the Sponsor to be confidential will be clearly marked by the Sponsor, in writing, as 'Confidential.' Any information that is transmitted orally or visually, in order to be protected hereunder, shall be identified as such by the disclosing party at the time of disclosure, and identified in writing to the receiving party, as Confidential Information. Except as required by law or with permission from the Sponsor, the Institution will not disclose confidential information for a period of from the end of this agreement. This obligation does not apply to information that was known to the Institution prior to its receipt from the Sponsor, is independently developed by the Institution, is required to be disclosed by law or regulation, or becomes known at any time to third parties through no fault of the Institution. The Institution will use reasonable efforts to protect the confidentiality of such information while in its possession.
The Institution will not publish Trial results nor disclose confidential information received from the Sponsor without the prior written consent of the Sponsor.
Title to any new inventions, developments, or discoveries resulting directly from the Trial shall be determined in accordance with U.S. Patent Law, Title 35 U.S. Code, in effect at the time of the invention, development, or discovery. For those inventions determined to be solely owned by the Institution, the Sponsor is granted an option for an exclusive license to the Institution's rights based on an amount to be negotiated by the parties. For those inventions determined to be jointly owned by the Sponsor and the Institution, an option is provided to the Sponsor to negotiate for a license to Institution's rights based on an amount to be negotiated by the parties. For those inventions determined to be solely owned by the Sponsor, the Institution shall claim no rights.
The Sponsor will not use the Institution's names to suggest that the Institution endorses a product or service. The Sponsor will not use the Institution's names without prior written approval, except to identify the Institution as the Trial site when required to do so by law.
The Sponsor will indemnify, defend, and hold harmless the Institution, its trustees, officers, agents, and employees from any demands, claims, or costs of judgment that may be made or instituted against any of them by reason of injury (including death) to any person, or damage to property, arising out of or connected with performance of the Trial, provided, however, the Sponsor will have no liability for loss or damage resulting from failure to adhere to the terms of the Protocol or the Sponsor's written instructions concerning use of the Trial product or service, failure to comply with applicable government requirements, or negligence or willful malfeasance by the Institution, its trustees, officers, agents, and employees, but only to the extent that such demands, claims or judgments are due to the negligence or willful malfeasance of the Institution, its trustees, officers, agents, and employees.
Should a subject suffer any adverse effect caused by the test product, the study procedures, or laboratory work required by the Protocol, the Sponsor will pay for all reasonable medical and hospital costs required for the diagnosis and treatment of such adverse effect.
The Institution shall at all times retain ownership of all Original Source Documents generated by the Institution. All Sponsor-Deliverables shall be the property of Sponsor. All Data arising from this Study shall be the sole property of the Institution. The Sponsor shall have the right to freely utilize such Data resulting from this Study for any and all legal purposes. The Institution hereby grants the Sponsor a non-exclusive, royalty free, worldwide license, to use all such Data. The Institution shall promptly notify the Sponsor and shall assist the Sponsor in gaining patent protection for the New Invention or Discovery, if applicable. The Sponsor shall reimburse the Institution for all reasonable expenses incurred thereby, provided the Institution has given reasonable written notice prior to incurring such expenses. Any patent application shall be filed, maintained and prosecuted by the Sponsor or its designee. The Institution shall retain a royalty-free, irrevocable right to continue using the Invention or Discovery solely for its internal, non-commercial use. All Data arising from this Study shall be the sole property of the Institution. The Sponsor shall have the right to freely utilize such Data resulting from this Study for any and all legal purposes. The Institution hereby grants the Sponsor a non-exclusive, royalty free, worldwide license, to use all such Data.
USE OF NAME (ADVERTISING)
Each party shall obtain prior written consent from the other party before using the other party's name, symbols or marks in any form of publicity in connection with this Agreement or any Study. Under no circumstances may the Sponsor use the name, symbols or marks of the Institution in connection with any product advertisement.
CHANGES TO THE PROTOCOL
Any party who becomes aware of the need for a deviation from the Protocol will immediately inform the other party to this Agreement of the facts causing the deviation as soon as the facts are known to the party. The Sponsor may also, from time to time, make changes to any Sponsor-Initiated Protocol. Any such changes may not be implemented before approval by the other party.
TERMINATION OF AGREEMENT
This Agreement may be terminated:
-By either party upon thirty (30) days prior written notice ;
The laws of the state of govern this agreement.
This agreement represents the entire understanding of the parties with respect to the subject matter. Any modification of this agreement must be made in writing and signed by the parties.
The parties agree to be bound by applicable state and federal rules governing Equal Employment Opportunity and Non-Discrimination.
ENTIRE AGREEMENT; COUNTERPARTS
This Agreement together with all attachments and exhibits constitutes the entire agreement and understanding between the parties and supersedes any prior or contemporaneous negotiations, agreements, understandings, or arrangements, of any nature or kind, with respect to the subject matter herein. In the event of any inconsistency between this agreement and any Protocol, the terms of this Agreement shall govern. This Agreement may be executed in any number of counterparts, each of which shall be an original and all of which together shall be one document binding on all the parties even though each of the parties may have signed different counterparts. This Agreement shall also be considered executed by the parties upon receipt by the Sponsor by facsimile transmission of the counterparts signed by all the parties.
The invalidity or unenforceability of any term or provision of this Agreement shall not affect the validity or enforceability of any other term or provision of this Agreement.
Neither the Institution nor any Principal Investigator may assign or transfer any of their rights or obligations under this Agreement without the prior written consent of the Sponsor.
No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances shall be deemed to be or construed as a further or continuing waiver of the same term, provision or condition, or of any other term, provision or condition of this Agreement.
If any action at law or in equity is brought to enforce or interpret the provisions of this Agreement, the prevailing party will be entitled to reasonable attorneys' fees in addition to any other relief to which that party may be entitled.
IN WITNESS WHEREOF, the parties hereto have caused their duly authorized representatives to execute this Agreement as of the date first written above.
Exhibit A Protocol.