Authority to Contract
Faculty and staff are encouraged to discuss ideas for potential research projects with industry representatives. Actual work should not begin on a project until the appropriate documents are submitted through the WFUHS's internal review process and both parties sign a mutually acceptable agreement. The Office of Sponsored Programs is authorized by WFUHS to negotiate and legally accept sponsored agreements on behalf of the University. Faculty members cannot obligate WFUHS in this manner.
Parties
Agreements shall be between the company and Wake Forest University Health Sciences and not with the investigator personally. Faculty members cannot be a party to agreements.
Confidentiality
While confidentiality provisions may assure sponsors of some protection against dissemination, WFUHS is a place of open exchange among researchers and students in order to foster learning and to develop knowledge. The obligation to maintain secrecy and confidentiality is not “second nature”.
WFUHS can agree to protect the sponsor's confidential information in the same way that it protects its own, assuring that it will not be published or presented publicly. However, to limit its liability, WFUHS asks that sponsors restrict disclosure to essential information and clearly identify confidential information as confidential. WFUHS also asks for an express limitation of its liability in the unlikely event of a breach of confidentiality; that is, the amount of money received by WFUHS for its work on the project.
Data Ownership
As an academic institution, WFUHS must ensure the data and information generated during the course of research remain widely available for academic dissemination and scientific validation. As the grant recipient and the party obligated, through the investigator, to perform the research and to generate the raw data, WFUHS is the legal owner of such data, with full rights to use and to publish them accordingly. Retaining such rights in research projects allows WFUHS to ensure that its faculty can pursue their research without undue impediments. Conceding study data ownership may impair the faculty member’s ability to publish the research findings, as well as use certain information in future research.
Publications
The academic mission of WFUHS and its status as a tax-exempt, nonprofit organization require that the faculty must be free to publish the results of their research in a timely manner and without censorship. In addition, allowing restrictions on the free dissemination of information generated by WFUHS employees or students may lead to export control restrictions. Because certain information supplied to WFUHS during a study may be confidential and proprietary to the sponsor, sponsors will ordinarily be granted the right to review a proposed publication, normally not more than 30 days. This right is confined to review and comment and not to approve, to consent to, or to edit the publication. Sponsors may be given a limited right to delay publication in order to obtain protection for its confidential or proprietary information, however, such a delay should not normally be more than 60 to 90 days.
Intellectual Property
WFUHS owns inventions and discoveries, including copyrightable software, made by faculty and staff as part of sponsored research. The University can grant the sponsor the first opportunity, under commercially reasonable terms, a royalty-bearing exclusive license to the invention or discovery for commercialization under a limited term option. If the company insists on a longer option period, funding of continued research during such a period could be negotiated.
Indemnification
Research by nature is unpredictable and inherently involves some risk. University research is conducted on a “best efforts” basis and without guarantee of successful results. WFUHS requests that sponsors indemnify the university against all claims, damages, liabilities, costs, fines, penalties, losses, and expenses, except where WFUHS engages in gross negligence or willful misconduct. The sponsor should represent that it has adequate insurance (or self-insured programs) to cover this indemnity and should agree to provide WFUHS with evidence of such insurance.
Limitation of Liability
As an academic institution, WFUHS cannot put its assets at risk for the benefit of a commercial entity. Therefore, Wake Forest requires language in all contractual arrangements that limits its liability stating that WFUHS will not be liable for special, consequential, indirect or incidental damages or for lost profits. Further, in most cases WFUHS’ sole liability for other, proven damages will be limited to the amount paid by the commercial entity to WFUHS under the applicable agreement.
Warranty
WFUHS makes no representations or warranties, express or implied, under any agreement with respect to the services it performs thereunder and any deliverables resulting from such performance, including their condition, conformity to any representation or description, the existence of any latent or patent defects therein, and their merchantability or fitness for a particular use or purpose.
Governing Law
WFUHS requires that North Carolina law govern all research agreements, since they are entered into and performed in North Carolina. The university will also consider contractual silence regarding this issue.
Termination
Generally, either party may terminate the research agreement provided that either party determines that the research project is no longer academically, technically or commercially feasible. However, WFUHS cannot incur financial losses resulting from termination. In the event an agreement is terminated, the sponsor will be expected to reimburse WFUHS for all project costs incurred through the date of termination, including non-refundable start-up expenses, IRB fees, if applicable, and non-cancelable obligations.
Facilities and Administration Expenses
WFUHS’ Facilities and Administration (F&A) rate is governed by our negotiated rate with the Department of Health and Human Services (DHHS). The institution must charge industry the same rate as is applicable to all government-funded research, except for industry-sponsored clinical trials which have an established for-profit clinical trials rate.