Contract Guidelines
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Whether you are initiating a new project or formalizing an ongoing collaboration, these guidelines are designed to clarify expectations, streamline negotiations and support successful research partnerships.
By addressing these early, we help companies focus on what matters most — advancing innovative research, accelerating discovery and building strong, long-term partnerships that deliver meaningful results.
Key Contract Considerations
The University of Louisville is a public institution of postsecondary education of the Commonwealth of Kentucky. The University of Louisville Research Foundation, Inc. (ULRF) is the legal entity which executes sponsored agreements for the University of Louisville. ULRF is a 501(c)3 nonprofit corporation acting as the agent for the university for the purpose of receiving grants and research agreements from external funding sources. ULRF also owns and controls intellectual property on behalf of the university.
Claims against the university must be brought under the Kentucky Board of Claims Act so we cannot be bound by another state’s laws or agree to the jurisdiction of another state’s courts. However, we can agree to leave the contract silent on governing law/choice of law.
The university cannot agree to binding arbitration, but we can agree to other alternative dispute resolution processes.
The university generally does not provide warranties. Alternatively, the university can “represent” or “certify” to its reasonable knowledge or “agree.”
University intellectual property (IP) rights are governed by the university’s intellectual property policy and, because the University receives a great deal of federal funding, often by the Bayh-Dole Act. Rarely can the university assign or exclusively license intellectual property in advance of its creation. The university can assign ownership in specific work products (e.g., technical reports) generated in performance of a sponsored project, but not the underlying ideas, technology or tools. If development of IP was supported, even in part, by any federal funding, the United States has certain nonexclusive rights by law. The internal Revenue Service (IRS) has ruled advance licensing may violate a university’s nonprofit status. Because of these considerations, the university’s preference is to grant exclusive first options for licenses on terms customary in the applicable industry.
In the case of multicenter, industry-sponsored, industry-created protocols, the university will assign IP to the sponsor for any IP created while conducting the study in accordance with the protocol.
University researchers and their students need the ability to use data and other research work products for noncommercial educational and research purposes and the right to independently publish. This right can be provided under license, can be limited by a sponsor’s right of review, or can be delayed for a short period to permit the protection of IP rights.
In the case of multicenter, industry-sponsored, industry-created clinical trial protocols, the university researcher’s right to independently publish may be waived with the researcher’s and his department chair’s permission; provided the sponsor is willing to agree to make the clinical trial/study results public within two years of completion of the study.
Under IRS regulations, nonprofit status can be jeopardized if royalty rates are set in advance. Instead, the university grants to its corporate sponsors an exclusive first option to license IP which results from the company-funded project, on terms reasonable for the industry, including a good-faith negotiation of fair royalties.
The university is subject to the Kentucky prompt payment statute which allows for recovery of interest on late payments.
Kentucky law does not permit the university to indemnify or hold harmless another party. Negligence claims against the university are subject to the Kentucky Board of Claims (KRS 44.070 et. seq.).
In most cases, the sponsor is expected to indemnify the university, ULRF and the PI for conducting the sponsored project. Exclusions should only apply to the extent those actions or inactions by the university or PI contributed to the liability/claim.
Kentucky law does not permit the university to indemnify or hold harmless another party. Negligence claims against the university are subject to the Kentucky Board of Claims (KRS 44.070 et. seq.) The hospital/facility sites will not indemnify the clinical research organization (CRO) or sponsor (nor provide cross-indemnification).
Each of the respective hospital/facility sites requires a letter of indemnification (LOI) equivalent to the terms provided for the university and principal investigator. This may be provided by the CRO or by the sponsor separately.
The university does not directly provide medical/professional liability insurance for its faculty. Medical malpractice insurance is obtained by the physician via the professional services corporation/private practice group and is separate from the university’s general liability insurance. Clinical trial agreement templates typically need to be revised to accommodate this provision.
The university’s facilities and administrative (F&A) charge for industry-sponsored clinical trials is 26%. All expenditures/expenses of the study are subject to these charges.
The UofL Institutional Review Board (IRB) handles all research involving human subjects for university faculty at all hospital/facility sites. The university IRB maintains a federal wide assurance (FWA). CROs/sponsors should pay the fees directly to the IRB upon invoice to avoid facilities and administrative charges on the IRB fee. If payment is not received before the IRB review is complete, the IRB will give a conditional approval to begin the study pending payment of the fee. See the UofL Human Subjects Protection Program webpage for more details.
The university IRB also serves as the UofL Privacy Board for approval of HIPAA-required research authorizations.
The preferred contract structure is for ULRF to execute a clinical trial agreement with the clinical research organization (CRO)/sponsor and the CRO/sponsor provides a letter of indemnification for each of the respective hospital/facility sites at which the study will be conducted.
In the alternative, the respective hospital/facility may be willing to sign a separate facility use agreement between the site and the CRO/sponsor. Three-party agreements among ULRF, the site and CRO/sponsor are discouraged as three-party agreements can significantly lengthen the timeframe it takes to execute a clinical trial agreement.
University researchers typically conduct clinical trials at one or more of the following hospitals/facilities: Norton Healthcare, Jewish Hospital HealthCare Services and University of Louisville Hospital (both of which are part of KentuckyOne Health), University of Louisville Physicians, and the Veteran’s Administration Medical Center. Each of these facilities is affiliated with the university and permits research to be conducted on site by university researchers, but each is a separate legal entity.
The university obtains the appropriate approvals from the respective sites before subject enrollment is permitted.
Inside UofL
Outside UofL
University researchers typically conduct clinical research at one or more of the following hospitals/facilities. Each of these facilities is affiliated with the university and permits research to be conducted on site by university researchers, but each is a separate legal entity. The university obtains the appropriate approvals from the respective sites before subject enrollment is permitted.
In addition, the operators of such facilities do not want to be held liable for the industry-sponsored clinical research UofL performs. By entering into separate agreements with the sponsors of the clinical research, the sponsor agrees to relieve the facilities of such liability. The nature of these agreements depends upon the study; less complicated studies require only a letter of indemnification (LOI) while more complicated research generally necessitates a facility use agreement (FUA).
- University of Louisville Physicians
- Brown Cancer Center
- University of Louisville Hospital
- Jewish Hospital
- Norton Healthcare