CRADA agreements do not have a binding duration, but they are often fixed for a period of 1 to 4 years. If the research plan is not substantially modified and a credit rating AGENCY has been in existence for less than four years, it may be extended by mutual agreement of the parties for a minimum period of time. However, as scientific objectives and circumstances change over time, substantial changes to the research plan need to be reviewed, if necessary, by CRADA`s NIH subcommittee or its chair. Although a fully signed CRADA can be modified during the research, all changes must be made through the NIMH technology transfer office. Informal changes between investigators cannot be considered valid. A Research and Development Cooperation Agreement (CRADA) is a written agreement between a private company and a government agency to work together on a project. It is one of the most important mechanisms used by federal laboratories to work with non-federal partners to achieve technology transfer objectives. It should be a flexible mechanism that can be adapted to a large number of cooperative efforts between federal and non-federal organizations and can be implemented relatively easily in a relatively short period of time. As a technology transfer mechanism, CRADA is a very useful tool for transferring federally funded research and development to the private sector. CRADA is an agreement under which the FDA laboratory contributes to the realization of certain research or development efforts in personnel, services, facilities, equipment or other resources, but not funding. The CRADA partner is involved in all necessary funding for the project, as well as staff, services, facilities, equipment or other resources. CRADA offers non-federal staff the opportunity to negotiate an exclusive or non-exclusive license for any CRADA Subject Invention resulting from the research.
CRADA is the only agreement that authorizes an IP licensing option developed during a collaborative research project. NiMH Principal Investigators (PIs) that sue the CRADAs are legally required to complete and attach a form for conflicts of interest and fair access investigation.