What Is A CRADA?

CRADAs are formal research and development agreements of limited duration and scope between PHS investigators and their colleagues from industry, academia, and elsewhere (for example, from other Federal agencies, State and local governments, and non-profit and not-for-profit institutions.)
In order to meet the standards of a CRADA, there must be an intellectual contribution from all parties to the agreement. This contribution can take the form of sole-source materials or instrumentation, as well as so-called "know-how," itself. CRADAs are a primary mechanism by which Government scientists can leverage their own research resources. In turn, their partners may do likewise, while collaborating in state-of-the-art PHS research.

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The Purpose of CRADAs

The purpose of a CRADA is to make available Government facilities, intellectual property, and expertise for collaborative interactions that lead to useful, marketable products that benefit public health. Under a fully executed CRADA, the NIMH investigator's laboratory can receive a variety of benefits in addition to intellectual collaboration. Specifically, the collaborator may provide monies, materials, equipment, and personnel to the investigator's laboratory. In turn, the investigator's laboratory may provide materials and personnel to the collaboration, but cannot provide funding to the collaborator. The largest benefit to the collaborator is that it may obtain a first option for licensing of patents which result from the CRADA.

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When To Use A CRADA

Because CRADAs involve patent rights, these rights must properly be considered before any outside collaborations and/or exchange of materials between NIMH and other parties are undertaken.
To protect these rights, the NIMH Technology Transfer Office should also be consulted at an early stage of collaboration by the NIMH investigator to assist in identifying and developing the proper documents and obtaining the required approvals for research to proceed.

A CRADA is used when the following circumstances obtain:
1. A cooperative research and development project between a Government scientist and a scientist from the private sector is contemplated.
2. The exchange of material and/or research and development collaboration takes place over a substantial period of time.
3. Staff or equipment is to be supplied by one or more parties; or,
4. the non-Federal partner contributes funding or requests the granting of intellectual property rights.

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When To Use A Materials CRADA

A CRADA may also be necessary in instances where, for example, a company is providing an otherwise non-available material and requests an option to exclusively license intellectual property arising from the research. The PHS Model Materials CRADA, available elsewhere on this web site, specifically addresses this issue. A Materials CRADA is limited in its term and scope and does not permit the provision of personnel to carry out the subject research project in the Federal laboratory.

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Finding A CRADA Partner

To begin a CRADA, a potential partner may first contact a NIMH scientist with whom it would like to collaborate. Alternatively, a Government scientist may choose a CRADA collaborator. In this instance, a competitive process is generally not required, except under limited circumstances pursuant to PHS "fair access" guidelines. NIMH may, however, choose to compete a CRADA when interested parties are unknown or the technology/project is such that competition is in the Government's and public's best interests. An announcement may be placed in the Federal Register or Commerce Business Daily with a selection made known to the responding parties. If appropriate, the Institute may establish an ad hoc evaluation committee to review submissions.

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