Collaboration Agreements

The University of Wisconsin School of Medicine and Public Health welcomes opportunities to participate in collaborative research with industry. These opportunities arise when a UW School of Medicine and Public Health investigator and an industry partner identify a research area of mutual interest, which could include:

• Laboratory research
• Research involving human subjects (note that clinical trials are a special class of human subjects research that are handled separately)
• Non-laboratory-based scholarly activity

The proposed project is a collaboration in which both the university and company provide resources to support the work by performing part of the project at each facility. Data and, sometimes, research materials are exchanged, and the parties are jointly responsible for a successful outcome.

Such research benefits the university by allowing academic investigators and their students to gain insight into industry problems and access research support that industry can uniquely provide. Industry benefits in turn by accessing the basic science competency and laboratory resources that may not be able to afford to maintain internally.

The challenge is to identify a mutually acceptable set of terms controlling how the research will be conducted, bridging the gap between academia’s mission (educating students and creating and disseminating new knowledge) and private sector drivers (making a profit and gaining a competitive edge over others). These terms are negotiated and recorded in a legal contract called a collaboration agreement.

Negotiating Collaboration Agreements

The UW School of Medicine and Public Health’s Office of Industry Engagement (OIE) can provide a standard collaboration agreement which can be used for most projects. Any changes to this agreement, or any agreement proposed by the sponsor requires review and, typically, negotiation. Collaboration agreements contain legally binding terms that dictate each party’s rights and obligations with respect to publication, access to data and results, rights to intellectual property arising from the research, and many other areas.

These issues are often challenging to reach agreement on, due to the university’s and the industry collaborator’s divergent goals for use of the results of the research, and the legal risks each party is willing to accept to conduct the research. These issues are discussed in more detail below. In many cases, detailed analysis of legal language may be required, and input from multiple offices within both the university and the company may be needed.

How Long Will This Take?

The standard collaboration agreement can be executed within two weeks, once the sponsor and investigator agree upon a scope of work and budget. Negotiating changes to the standard collaboration agreement or review and negotiation of a sponsor’s agreement may take from one to six months or longer, depending upon the degree of divergence in initial positions.

Hence, the overall timeline for placing a sponsored research project may be similar to that for applying for a grant: the reduction in time related to grant review for an NIH proposal is often offset by time needed for the university and the company to define a mutually acceptable working relationship.

Procedures for Establishing Collaboration Agreements

1. Establish the scope of work and cost

The investigator works with the company to agree upon a scope of work, detailing which parts of the project will be done at each facility.

2. Identify the sponsored research agreement to be used

Contact the OIE for the correct standard agreement to propose to the sponsor. Use of the standard university collaboration agreement is the key to rapid initiation of collaborative research. If the sponsor insists that their agreement be used, obtain a copy, preferably as a Microsoft Word document. Sponsor agreements require review and, in most cases, negotiation.

3. Prepare the WISPER Record

The principal investigator and/or staff, with the help of departmental administration as needed, completes the WISPER record. Questions regarding this procedure should initially be directed to departmental administrators, who have been trained to enter agreements into WISPER. Note especially the following items in WISPER that need to be completed before OIE’s review of a sponsored research agreement:

• If the project requires biohazard approval or involves human subjects, list the protocol numbers for the approval covering this project. If the project involves vertebrate animals, upload the approval letter received from Research Animal Resources Center (RARC) to the WISPER record. If these are pending, note this in the WISPER record. While we can continue to process the agreement, the project cannot begin until the approvals are in place.
• If the agreement is to be sent to the sponsor by overnight delivery, scan and upload the shipping label. There is no need to send an envelope through the system.
• Under the Comments tab, provide the name, e-mail address and/or phone number for the person at the providing institution/company to whom questions about the contract language should be addressed. Also, any background information on the history of the request, such as e-mails, may be inserted, and can be useful for negotiations.
• Under Submission Instructions, provide the full name and address to which the signed agreement should be sent. If there are other submission instructions, make sure you include them here, including the number of signed copies of the sponsored research agreement that need to be sent to the sponsor.
• Upload the proposed sponsored research agreement to the WISPER record under the attachments tab.

4. Prepare the agreement for submission

• The agreement should be read by the principal investigator, and any concerns noted in the Comments section of the WISPER record.
• All blanks in the agreement should be filled in before routing the record to the Dean’s office, except a space left for insertion of the date of execution, typically in the first paragraph, and the spaces for institutional signature and identification of the institutional signatory.
• The agreement should list, as the university party, the “Board of Regents of the University of Wisconsin System on behalf of the University of Wisconsin-Madison,” and if a business address is required, normally in the opening paragraph, it should be “21 N. Park St., Suite 6401, Madison, Wisconsin 53715.” Do not list the name and address of the PI, department, or SMPH as the recipient party.
• If the agreement requires that the PI be named, the person should be a faculty member with a tenure-track, CHS or Clinical appointment, or a UW investigator with permanent or temporary PI status. Do not list graduate students, post-docs, etc. If an individual without PI status is named in the agreement, the agreement will be returned for revision.
• The PI should only sign the agreement if there is a blank labeled specifically as a PI signature line. The PI should not sign in a space intended for the institutional signature.

5. Send PI signature request for WISPER record and chair approval for sign-off

Then route to SMPH for dean’s office review.

6. Route paper copies

If a principal investigator’s signature on the agreement is required, send two paper copies of the agreement, each with an original signature, to Andy Chen at OIE.

7. Sponsored research agreement processing by the Office of Industry Engagement and Research and Sponsored Programs.

• The OIE will review the WISPER record for completeness, and route the record back to the listed departmental contact if all the required information is not filled in, or if additions or corrections are needed. Note that this adds effort and delays the process, so it is important for the WISPER record to be complete upon initial routing.
• Once the WISPER record is complete, the OIE will review the agreement itself. If it is a standard university agreement, it can be sent by OIE to the Office of Industrial Partnerships (OIP) for signature without further action by OIE. If not, OIP will review the SRA for consistency with university policy, and negotiate changes with the provider where needed.
• Once the terms and conditions in the SRA conforms to university policy, OIP will sign. The principal investigator and departmental contact will be notified when this occurs.
• The Office of Industrial Partnerships will perform a final review of all documents and sections of WISPER. OIP will then send the agreement to the sponsor based upon the original submission method listed. After receiving a fully executed agreement from the sponsor, OIP will upload a scanned version to WISPER, and change the record status to 6-Completed. The PI, department contact, and OIE will receive a WISPER notification of this status change. The PI can now obtain the requested materials or begin the research project.