CTTG - CRADAs

CTTG - Clinical Technology Transfer Group

Experienced Legal Representation in Clinical Research

A CRADA is a contractual agreement between a Federal laboratory (e.g. the National Institutes of Health) and a corporate collaborator for the purpose of conducting a specific research project of interest to both parties. CRADAs are usually multi-year agreements involving significant research projects, such as the conduct of clinical trials.

The CRADA is the only agreement under which the Government may grant future intellectual property rights to a Collaborator. Typically, the government grants the collaborator an option to an exclusive, partially exclusive or non-exclusive license to inventions developed by government employees under the CRADA research project. In the absence of a CRADA, government inventions must be made available for competitive licensing. Prospective CRADA collaborators often see the grant of CRADA invention rights as a prerequisite to making the significant corporate investment required by most CRADA research projects.

A CRADA is not a funding mechanism. In fact, under a CRADA, the industry Collaborator often provides funds to the Federal agency to support the government’s role in the project. In addition to providing direct funding to support the government’s involvement in the research project, the collaborator may also commit personnel, services, facilities, equipment or other resources to the project. Under a CRADA a Federal laboratory, such as NIH, may provide “in-kind support" to the research project. “In-kind support” might include the commitment of specific personnel to the research project, laboratory or other services, facilities, equipment or other resources unique to the government.

A Clinical Trial CRADA (CT-CRADA) is used when the government laboratory and the industry partner collaborate on the development and design of a clinical trial to assess the safety and effectiveness of a study agent (e.g. a drug, medical device, or dietary supplement) for a specific indication. Typically (although not always) the study agent is proprietary to the Collaborator and the indication for use is of interest to the federal government. The Federal agency generally provides the knowledge and expertise of its staff to assist in the design of the clinical trial as well as the network of investigators to conduct the research. This is often a significant “in-kind” contribution to the CRADA. The CRADA collaborator generally also participates in the design of the trial and provides the study agent free of charge that is needed for any trials proposed.

The CRADA agreement includes a research plan (written by both parties), a budget outlining the financial commitments of both parties, and any changes to the terms of the standard CRADA contract language. The “standard CRADA contract language” may vary somewhat among the Federal agencies. Typically, the CRADA contract includes terms governing the conduct of the CRADA with provisions for termination and dispute settlement, as well as other conventional contract language. It also includes contract terms unique to the government regarding the disposition of intellectual property rights, licensing of government-owned inventions, and the procedures for publication of the research results by the government. A CT –CRADA has additional terms, which address issues such as the process used for design of the clinical trial, drug supply, and ownership and use of the trial data for regulatory purposes.

CTTG’s attorneys have experience drafting and negotiating CRADA agreements. As technology transfer professionals at the National Institutes of Health, they assisted government scientists and researchers to establish partnerships with industry for the development of a wide range of technology. In private practice they have assisted pharmaceutical companies and other law firms in negotiating CRADAs with the federal government.

If you need assistance in negotiating a CRADA or just have a CRADA related question, CTTG can help. Call us at (703) 734-0484.