UVA regularly enters into confidential disclosure agreements (CDAs) and non-disclosure agreements (NDAs) with external parties allow open collaboration while protecting intellectual property and other non-public information. Generally, UVA does not agree to keep the existence of an agreement or our relationships secret. Further, certain aspects of an agreement may also be disclosed as required by law. As a state agency that enters into hundreds of confidentiality agreements each year, UVA is unable to agree to indefinite obligations of confidentiality and therefore includes a term of years for all obligations of confidentiality. The university further requires that any incoming confidential information be appropriately marked or, if disclosed orally, confirmed in writing. Finally, UVA is subject to federal, state, and institutional document retention policies that may impact the university’s ability to destroy files that may contain confidential information. UVA’s compliance with these policies will not otherwise impact the university’s ability to meet its contractual confidentiality obligations.

UVA is required to execute all Agreements as “The Rector and Visitors of the University of Virginia.”

All Principal Investigators (PIs) and other Key Personnel involved in sponsored research at UVA are employees and/or faculty members of UVA and are not included as parties to UVA Agreements. The PI may sign the UVA Agreement as read and acknowledged.

As a Virginia state agency, UVA must explicitly approve any use of its name, logos or trademarks other than those uses required by law.

Because UVA is a covered entity under the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA), the university is obligated to impose specific requirements on any external party that will receive data that could be used to identify our patients. These requirements include, without limitation, prohibitions on the use or disclosure of any patient data except as specifically authorized by the patient through the execution of an informed consent or alternative HIPAA authorization.

Although in some cases a sponsor may claim ownership of the data, results, and other deliverables generated in the performance of a sponsored research project, UVA requires all agreements to provide for the university’s continued use of any data that it generates for ongoing nonprofit academic purposes.

Pursuant to Va. Code § 2.2-4366, UVA is prohibited from agreeing to binding arbitration as a means of dispute resolution.

As a Virginia state agency, UVA is not authorized to explicitly agree to any governing law, jurisdiction or venue other than the laws and state courts of the Commonwealth of Virginia.

With few exceptions, UVA requires for-profit sponsors to indemnify the university for any claims or liabilities arising from the performance of the sponsored research.

Pursuant to VA Code, section 2.2-1837, UVA is prohibited from agreeing to indemnify an outside party for liability arising in relation to a research Agreement. In addition, as a Virginia state agency, UVA is explicitly prohibited from agreeing to hold any counterparty harmless for such liability.

UVA, as an agency of the Commonwealth of Virginia, participates in the Commonwealth’s self-insured program and does not purchase additional insurance policies or add additional insureds.

UVA is self-insured pursuant to UVA Policy and applicable State and Federal Statutes, including:

• VA Code, section 2.2-1837: Permits a state agency to establish risk management policies, including self-insurance.
• FDA Amendments Act, section 8.01-581.15: Limitations on recovery in certain medical malpractice actions.

See the UVA Finance page on Risk Management for more detail about UVA's insurance coverage.

As a leading research university, UVA is well-versed in and fully capable of protecting the background intellectual property (IP) of the parties as well as developing innovative and adaptive protections for jointly created project IP that benefit both the sponsor and the university. For more complex licensing arrangements, UVA may defer management and negotiation to the University of Virginia Patent Foundation d/b/a The University of Virginia Licensing and Ventures Group, an affiliated foundation but independent legal entity which UVA has contracted to manage the university’s intellectual property portfolio.

As a Virginia state agency, UVA is not authorized to prospectively foreclose any specific legal claims, remedies, or defenses it may have (e.g., stipulating that a breach of a confidentiality agreement would necessarily cause irreparable harm and justify injunctive relief).

UVA applies 30% overhead to total direct costs on all industry clinical trials. As the 30% rate is already a discounted rate, UVA is substantially supporting the companies' research without full compensation. 

The letter on overhead rates on industry clinical trials may be shared with outside parties.

Central to UVA’s mission is the dissemination of information. Consequently, maintaining a PI’s right to publish results and findings is paramount. Where a Sponsor’s confidential or proprietary information is used or included in publication, the Sponsor generally retains the right to review publications for the express purpose of ensuring any publication does not contain any confidential or proprietary information, patentable subject matter, or personally identifiable information. Generally, the Sponsor’s right to review is limited to requested redaction of confidential or proprietary information and does not include editorial control. In addition, UVA prioritizes timely dissemination of knowledge and therefore requires reasonable limits to the duration of any delays granted for Sponsor review of a proposed publication and/or patent filings.

For interventional industry-sponsored clinical trials, UVA requires for-profit sponsors to pay the medical expenses of study subjects that are injured as a result of their participation in the trial. 

The Informed Consent Form (signed by a study patient) must include UVA’s exact language, as stated on the attached letter on participant injury.

Representations are express or implied statements about a past or existing fact at the time a contract is executed. Warranties differ slightly in that they are express promises about an existing fact or set of facts that operate as an ongoing obligation to ensure they remain true. While UVA can and does make representations in agreements, the university cannot make warranties as they constitute open-ended obligations. UVA delivers research results on an as-is, reasonable effort basis.