Industry Contracts Agreements
Various types of non-federal awards/agreements are made to the University of Louisville Research Foundation (ULRF) to support work at the University of Louisville. All awards must adhere to the basic policies of the university. Special considerations inherent in the acceptance of these awards are provided below.
Industry Sponsored Agreements
The University of Louisville encourages interactions and research with the private sector. These interactions are essential to the vitality of the University and the community it serves and are recognized as an integral part of the University mission and goals.
An agreement outlining the responsibilities of the ULRF and the industry sponsor must be in place prior to beginning work on a project. The agreement must contain basic understandings including an agreed-upon statement of work, an agreement on the University's ability to publish (which may include a sponsor's right to review and comment but not edit University data or conclusions), and the ownership of intellectual property. Grants Management is responsible for negotiating terms and conditions. Project Directors should be familiar with the following and convey these accurately to a potential sponsor during preliminary discussions. This promotes understanding between the parties and allows negotiations to proceed smoothly.
The following considerations are important in dealing with industrial sponsors:
- The statement of work should be detailed enough to allow a clear understanding of the research project and the expected deliverables (e.g., the technical reports or a prototype).
- A fixed time period, with provisions for extension or renewal of the project, should be included. Provisions for mutual termination, such as would occur with the departure of a PI/PD or other unforeseen circumstances should be stated.
- Full costs of the research, including recovery of the University of Louisville corporate indirect cost rate, must be included in the budget.
- The University may not warranty nor guarantee research products but will use best and reasonable efforts, consistent with good scientific practices. Reasonable changes in research direction by the PI/PD should be allowed and if the change is significant allowances for a cost adjustment included.
When the above considerations are used as guidelines, the final agreement should be one that is mutually beneficial to the University of Louisville and the sponsor. A standard Research Agreement, which may be sent to prospective sponsors, is available.
Clinical Drug and Device Studies
Clinical trial agreements provide for testing of a drug or device on a human subject. In addition to the considerations given above for industry sponsored agreements, other considerations apply to clinical trial agreements.
- Clinical trials expose the investigator and the ULRF to legal action by third parties claiming to be harmed directly or indirectly by the research protocol. Therefore, clinical trial agreements must include an appropriate liability/indemnification clause.
- Clinical trials carry a risk for unanticipated adverse effects, injuries illnesses or reactions and the sponsor is normally expected to pay for any injuries to subjects resulting from the use or application of the sponsor's investigational drug or device in the study.
- The agreement must allow for the maintenance of the confidentiality of patient records.
The standard ULRF Clinical Study Agreement is available.
Service Agreements
Service agreements enable the conduct of a specific procedure, usually on specific material supplied by the sponsor. An example would be the testing of a sponsor-furnished compound with University owned equipment.
- The agreement should reserve the right to use the results for academic and research purposes, including publication of overall results or methods.
- Financial considerations include recovery of the full direct costs and the corporate overhead rate. If equipment purchased with federal funding is used, the revenue may be accountable as program income to the federal award. Arrangements must be competitive with costs assessed by commercial organizations for comparable work and may be subject to unrelated business income tax.
The standard ULRF Service Agreement is available.
Equipment Loan Agreements
If a university researcher wishes to participate in a joint research program involving the loan of equipment such as hardware or software for research use, an agreement that minimizes ULRF risk and liability, defines the responsibility for maintenance and the disposition of the loaned Equipment must be in place.
Questions or issues regarding the above agreements should be referred to the Office of Industry Contracts.
Material Transfer Agreements (MTAs)
Material Transfer Agreements (MTAs) are required when the University accepts a proprietary substance or product from an outside entity for use or testing. Typically these require that some deliverable is provided to that outside entity (e.g., a written report) and specify limitations on what can be done with the proprietary substance or product. These substances are often unique and can include biological materials, chemical compounds, pharmaceutical preparations, other types of tangible research materials and at times even software. While there is often no financial commitment from either party, there are often issues of intellectual property, confidentiality, hazardous materials and protection of humans that must be addressed. The agreement must be in place and endorsed by both parties in order to protect the liability of both the Investigators and the University. If the outside entity is a signatory of the Uniform Biological Material Transfer Agreement (UBMTA) or can accept the terms of the UBMTA, this can speed the processing. When submitting a MTA for processing, include the name, address and contact information (e-mail address, phone number, fax number) of the appropriate person at the outside entity should any of the issues needing negotiation be present in the agreement.
As of January, 2002, the Office of Technology Transfer processes MTAs.