Chapter 19-400: Research Agreements, University of California: A Guide for Industry

The brochure "Research Agreements, University of California: A Guide for Industry" was produced by the Office of the President, Research Administration Office, to assist Contract and Grant Officers in negotiating agreements with private sponsors, particularly awards from for-profit companies. It constitutes a summary of the general provisions that would be applicable to all sponsored agreements. A copy of this brochure is reproduced at the end of this Manual chapter.

Agreements to perform research, training or public service with for-profit sponsors should not be classified as “Sales and Services.” OP RPAC Operating Guidance Memo 00-06, “Distinguishing between Private Gifts, Private Grants and Contracts; and Sales and Service Transactions” provides further guidance on making a distinction between contracts from industry and sales and service agreements. Specifically, the memo notes that:

Grants and Contracts are written agreements with external sponsors (generally not individuals) in which the University promises to provide research, training, public service, or nonstandardized testing/other services. An agreement which contains one or more of the following provisions is generally a contract or grant: (1) a research protocol or other statement of work, (2) a designated period of performance, (3) a budget, (4) an obligation to account for costs incurred and to return unspent funds, (5) disposition of intellectual property rights. The following are examples of grants and contracts which should not be classified as sales and services:

Agreements to test a company's drug or device Agricultural Marketing Board orders Sales of survey services (data collection and/or analysis) Service to industry agreements Use of unique facilities, when staff support or analytical services are also provided (i.e., not sold at pre-established, per unit, uniform prices f or standard routines) Agreements with an external party to run a conference Educational services provided at sponsor's site or for sponsor's personnel (e.g., through University Extension) Sales of consulting services Agreements with non-University hospitals or clinics to provide medical services (e.g., scarce anesthesiology or radiology services)

For information on distinguishing gifts from contracts or grants, see Chapter 9 in this Manual.

19-410 Clinical Trial Agreements

Clinical trial agreements apply to the testing of a private sponsor's proprietary product, such as a drug or device, on human subjects. The approved protocol to be followed in the testing may be that of the sponsor or of the University Principal Investigator. Clinical trials may be funded by corporate sponsors or the federal government.

OP RPAC negotiates clinical trial master agreements for the University system, provides campuses with guidance on clinical trial agreements, and assists campuses, as needed, in the negotiation on individual campus agreements. Master agreements and other materials are available to campuses on the OP RPAC clinical trial webpage.

19-420 Material Transfer Agreements

A Material Transfer Agreement (“MTA”) is an agreement in which one party agrees to provide physical materials or samples to another party for testing, evaluation, or experimentation. The physical sample may include biological materials (from DNA to live animals), chemical compounds, or even databases and software codes. Institutions involved in the exchange of unique materials (transfer of both incoming and outgoing research materials) include federal laboratories, industrial research laboratories, and laboratories in universities, hospitals, or independent research institutes. The most common subjects of Material Transfer Agreements are biological materials and chemical compounds. Materials used in humans do not fall under the MTA category; the use of such materials in research would fall under a clinical trial agreement described in the previous section. MTAs do not apply to such transfers.

OP RPAC negotiates MTA master agreements for the University system, provides campuses with guidance on MTAs, and assists campuses, as needed, in the negotiation of individual campus agreements. Master agreements and guidance materials for campus MTA negotiators and researchers are available on the OP Office of Technology Transfer Resources for Staff webpage.