Contracts at the University of Virginia
Research-related Agreements at the University of Virginia are negotiated and executed by the Office of Sponsored Programs (OSP). Members of the research community can submit requests for review, drafting, negotiation, and execution of an Agreement via the process outlined in the Job Aid: Submitting an Agreement.
Following submission to OSP, each Agreement is assigned a unique record ID in ResearchUVA Powered By Huron, which indicates the Agreement type and a numeric identifier. Agreements are assigned based on OSP portfolios and distributed to either a member of the OSP Contracts Team or OSP Pre-Award team depending on the agreement type, sponsor, and complexity. The responsible OSP team member will review the Agreement to ensure compliance with institutional policies as well as applicable state and federal laws and regulations. Once the terms and conditions have been finalized and all supporting documentation has been provided, OSP will manage the execution process and if the agreement involves incoming funding or an outgoing subaward, OSP will create or modify an account in UVA’s financial system, Workday Financials.
OSP’s goal is to facilitate the performance of world-class research at the University of Virginia by partnering with and providing high quality services and expertise to researchers and administrators across the university. The OSP Contracts Team is available to provide strategic consultation on all aspects of industry, federal, and non-profit contracting, and members of the research community are encouraged to reach out to their Contract Negotiators with any questions.
HIGH LEVERAGE CONTRACTUAL ISSUES
OSP’s goal is to negotiate and execute all Agreements as quicky and efficiently as possible. However, there are certain subjects that have historically been the cause of extended negotiations and may require coordination with other university officials. UVA’s positions with regard to those issues are summarized below:
UVA regularly enters into CDAs and NDAs with external parties to allow the parties to openly collaborate while protecting their intellectual property and other non-public information. Generally, as a state institution and as a matter of public policy 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.
Contractual Party/Use of Name
UVA is required to execute all Agreements as “The Rector and Visitors of the University of Virginia.”
All Principal Investigators and other Key Personnel involved in sponsored research at the university are UVA employees and are not included as parties to institutional Agreements.
As a Virginia state agency, UVA must explicitly approve any use of its name, logos or trademarks other than those uses required by law.
Data and Results
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.
European Union General Data Protection Regulation (GDPR)
The GDPR came into effect in 2016 and has worldwide application protecting the “Personal Data” of individual EU residents, which is defined as (a) any information (b) relating to (c) an identified or identifiable (d) natural person. The regulation imposes complex technical and organizational requirements—requirements that UVA, like many U.S. institutions, is not currently able to meet. Its treatment of deidentified data is substantially different than the treatment that category of data receives in the U.S., and deidentification does not remove the data from GDPR protection. Only anonymized data is excluded from GDPR’s provisions and certain data such as genetic and biometric data can never be deidentified. GDPR imposes harsh penalties on entities that obtain an EU resident’s Personal Data and fail to comply with GDPR’s protection regime. Any Personal Data transferred from an EU member state is protected, whether or not the Agreement expressly references the GDPR. Because of the stringent technical and organization requirements imposed by the regulation, UVA is not currently in a position to receive Personal Data of EU residents. Therefore, researchers who intend to engage in work that may involve the collection of data from EU residents are encouraged to consult OSP as early possible so that the office can explore alternative avenues to facilitate the performance of the project.
For more information on the GDPR, please see the following presentation.
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.
Indemnification and Subject Injury
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. 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.
Pursuant to Va. Code § 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.
While industry standards generally require proof of insurance, 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.
As a leading research university, UVA is well-versed in and fully capable of protecting the background 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.
Legal and Equitable Remedies
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).
Overhead on Industry Clinical Trials
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 attached letter 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.
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 operates 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.