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Pre-Award Negotiations

Award Negotiations

Award negotiations, as defined in this section, means the scope of activities between proposal submission and the acceptance of an award by the University. During this period, the award mechanism (grant, cooperative agreement or contract) and the sponsor will largely determine the length and complexity of the negotiation process. The end result of award negotiations is a mutually agreeable set of terms under which the University will conduct the proposed project.

Who Can Negotiate the Award?

The authority to negotiate an award on behalf of the University has been delegated from The Regents to the Chancellor and the Chancellor has redelegated this authority to Sponsored Projects Administration (SP). SP works in conjunction with the Principal Investigator to negotiate an award that is acceptable to the University, Principal Investigator, and sponsor.

Changes to the Scope of Work and/or Budget

Any time a sponsor requests or requires a change in the originally proposed budget or scope of work, the Principal Investigator should always notify and coordinate a response through their Grants or Contracts Officer before submitting a revised budget or scope of work to the sponsor.

Grants and Cooperative Agreements

Grants and cooperative agreements usually contain references to a sponsor's established grants management policies or in the case of government grants, government-wide regulations, laws or directives.

Clinical Trial Contracts

Contracts with clinical trial sponsors (e.g., pharmaceutical or medical device companies, clinical research organizations) cover human testing activities related to an investigational drug, compound or device leading to approval by the Food and Drug Administration for commercial distribution.

As a public, nonprofit educational institution, the University is bound by certain policies and regulations regarding what it can and cannot accept in a clinical trail contract. These policies are designed to protect the welfare of individuals participating as research subjects; foster the University's basic mission of teaching, research and public service; and minimize the various forms of liability associated with human research.

For-profit private sponsors, such as pharmaceutical companies, are motivated by different forces than the University. As a result, they sometimes do not understand the ideals and principles behind our policies. Consequently, additional time may be required for contract negotiations while SP works with the sponsor to arrive at a mutually acceptable agreement.

When negotiating clinical trial contracts, the University primarily focuses on securing acceptable contract clauses regarding high-risk issues such as subject injury, indemnification, confidentiality, ownership of data, patent rights and publication rights.

The University's standard clinical trial agreement and the clauses proposed by the University during contract negotiations are based on the following assumptions.

That the clinical investigation is conducted under a protocol that is a FDA Phase I, II, II, or IV drug study or a FDA regulated medical device study;

That the sponsor provides its proprietary product and study protocol to the University for the purpose of conducting a clinical trial; and

That the sponsor will fully fund the cost of the trial (i.e., no work will be supported in whole or in part with other funds, including Federal funds).

Principal Investigators should discuss all aspects of the clinical trial with their Contracts Officer prior to the start of negotiations.

The involvement of UCI faculty in protocol development and/or study design creates additional issues that both parties must fully address. As a result, different or additional contract terms must be negotiated.

Industry Research Contracts

Agreements with private sponsors cover many activities including basic, applied or developmental research, collaborative research, and various types of testing.

As a public, non-profit educational institution, the University is bound by certain policies and regulations regarding what it can and cannot accept in an agreement. These policies are designed to foster the University's basic mission of teaching, research and public service and to ensure the academic freedom of our faculty. Because for-profit private sponsors are motivated by different forces, they sometimes do not understand the ideals and principles behind our policies. Consequently, negotiations can take additional time while SP works with the sponsor to arrive at a mutually acceptable agreement.

Whenever possible, the University tries to negotiate an agreement using the appropriate standard University contract language for the activity proposed. These standard agreements address key concepts required by University policy. When a private sponsor prepares an agreement or insists on controlling the preparation of an agreement, these concepts may or may not be addressed and can lead to protracted negotiations.

Contract negotiations with private sponsors can be difficult and complex because the agreements must address a large number of issues such as budget, scope of work, intellectual property rights, publication rights, indemnification, termination and confidentiality.

Principal Investigators should discuss all aspects of the proposed project with their Contracts Officer prior to the start of negotiations. In particular, SP needs to know whether graduate students will be involved in the project, and whether existing University or sponsored-owned intellectual property will be used in conducting the project.

Federal/State Contracts

Contract negotiations with a government agency primarily focus on budget and scope of work issues.

The terms and conditions of the award are usually fixed by law or regulation. However, it is important to make sure that the terms and conditions imposed by the agency are appropriate for the work proposed and applicable to the University.