What is a CRADA?
The primary mission of the NIH is to improve human health by increasing scientific knowledge related to health and disease through the
conduct and support of biomedical and behavioral research. In pursuit of its mission, NIH supports a broad spectrum of research
approaches, ranging from basic laboratory research to clinical research. This continuum of research activities creates a
synergism essential to the effective advancement of knowledge. The synergy that exists among these research approaches is
dependent upon the ability of NIH investigators to discuss and explore new ideas freely and openly. The Federal Technology
Transfer Act of 1986 (FTTA) and Executive Order No. 12591 codified the principle that US industrial competitiveness can be greatly
enhanced if technology developed in Federal laboratories is commercialized. The FTTA authorizes and provides incentives for
Federal laboratories to enter into collaborations with other Federal laboratories, state and local governments, universities, and
the private sector. The CRADA is not a Federal contract, grant or Cooperative Agreement (as defined in 31 USC § 6303 et seq.).
Rather, it is a unique agreement between a federal laboratory and a non-federal party for conducting specified research or development.
CRADAs are authorized only with collaborators who will make significant intellectual contributions to the research project undertaken or
will contribute essential research materials or technical resources not otherwise reasonably available to NIH. CRADAs cannot attempt to
direct or restrict research in a NIH laboratory. Sponsored research, such as routine, conventional testing, with no collaborative,
intellectual contribution, is not appropriate for a CRADA.
Under the PHS CRADA, the NIH laboratory can provide personnel, services,
facilities, equipment or other resources with or without reimbursement (but not funds to non-federal parties) and the other party can provide
funds, personnel, services, facilities, equipment or other material
and/or technical resources. Importantly, the CRADA provides the non-Federal party the option to negotiate an exclusive license to the
resultant CRADA Subject Invention(s). The CRADA is the primary legal mechanism the Federal government has to convey such rights in
advance of an invention.
The model CRADA and model Materials CRADA (M-CRADA) are standard documents developed by PHS to facilitate the negotiation and approval process
and to incorporate PHS policies on collaborative agreements and technology transfer. The primary difference between the standard CRADA
and the Materials CRADA is the level of NIH collaborative involvement with the non-Federal party. Typically, the Materials CRADA involves
simply the transfer of proprietary material to the NIH laboratory where no collaboration is intended.
When do I use an MTA or a CRADA?
A Material Transfer Agreement (MTA) generally is utilized when any proprietary material is exchanged, when the receiving party
intends to use it for his/her own research purposes, and when no research collaboration between scientists is planned. However, unlike a CRADA,
neither a licensing option nor rights for commercial purposes may be granted under this type of agreement. MTAs define the terms and conditions
under which the recipients of materials, provided by either the NIH scientist or the other party, may use the materials. Included in the MTA are
provisions addressing confidentiality, data access and dissemination, publication, and the requirement that the material be used only for research
purposes. The NIH also requires that that all materials received by their scientists originating from humans, be collected under 45 CFR 46,
Protection of Human Subjects.
A standard CRADA generally is used when a collaborative R&D project between the NIH and a scientist from the
private sector is contemplated; when the exchange of material and/or research and development collaboration takes place over a period of time;
when staff or equipment is to be supplied by one or more parties; or when the private sector partner contributes funding or requests an exclusive
licensing option. A Materials CRADA may also be appropriate when a company is providing an otherwise unavailable material to the NIH and requires
an upfront option to an exclusive license.
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