Cooperative Research & Development Agreements (CRADAS)

HOW AND WHEN TO USE CR.ADAs

http://intramural.nimh.nih.gov/techtran/cradal.htm

When To Use A
CRADA

When To Use A
Materials
CRADA
Finding A
CRADA Partner

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.
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.
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.
A full CRADA requires two types of negotiations, the Research Plan and
the "boilerplate." The Research Plan is a detailed description of the
research to be performed. The reagents to be used, the methods to be used,
the problem to be solved, and the relative contributions of the parties need
to be set forth in great detail.
The Principal Investigators on both sides of the CRADA work together to
sculpt a proper Research Plan. The NIMH Technology Transfer Office
assists them, by providing guidance with regard to the format required for
NIH review of the CRADA. As appropriate, the "boilerplate" may be
modified by the parties, subject to conformance to applicable law and
policy.
As soon as both participating scientists negotiate the Research Plan
(namely, the written description of the research and development project,
including each party's contribution to the planned research and
development), a written CRADA should be developed.
NIH has a model CRADA, available elsewhere on this web site, which is
required and used as the basis for all negotiations with outside parties.
The model CRADA contains three appendices:

Negotiating A
CRADA

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3/24/98 2:49 AM