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| CRADAs & MTAs |
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Initiating a CRADA
Companies can initiate the CRADA discussions by contacting a
NIH scientist with whom they would like to work. Participants
in CRADAs can include the individual NIH institute and one or more
other parties (other agencies, state and local governments,
non-profit and not-for-profit institutions, private corporations).
A competitive process is generally not required in choosing a
CRADA partner, although it is required by NIH fair access guidelines under
limited circumstances. An agency may choose to use competition
in a collaboration when interested parties are unknown or the
technology/ project is such that competition is in the public's
best interest. An announcement may be placed in the Federal Register
or Commerce Business Daily with a selection made known to
the responding parties. An ad hoc evaluation committee
may be formed to review submissions, if appropriate.
A written CRADA document should be developed as soon as
both participating scientists negotiate the Research
Plan (the written description of the research and development project,
including each party's contribution to the planned research and development).
Federal laboratories may contribute staff, facilities, equipment,
and supplies, but not funds. The collaborating party may contribute
funds in addition to staff, facilities, equipment, and supplies.
NIH has a model CRADA which is required and used as the basis
for all negotiations with outside parties. The model CRADA
contains three appendices: a) the Research Plan,
b) Financial and Staffing Contributions of the Parties,
and c) Exceptions or Modifications to this CRADA.
Public Health Service (PHS) scientists are required to fill out and attach a Conflict
of Interest and Fair Access Survey form. The purpose of this
form is to assure that a NIH scientist does not have a conflict
of interest regarding the CRADA research (such as consulting
with the same company) and that proper consideration has
been given to fair access guidelines.
Each PHS agency has a
Technology Development Coordinator
(TDC) who facilitates the drafting of an
acceptable CRADA and related Appendices, advising the NIH scientist
in the development of the overall agreement. The CRADA and Appendices are
generally negotiated by the TDC in conjunction with the other party.
The negotiated CRADA must be approved by the NIH scientist,
the Laboratory or Branch Chief, and the Scientific Director.
The TDC then forwards the agreement to the Office of Technology Transfer
(OTT) and the Office of General Counsel for review, who then forward
the agreement to the CRADA Subcommittee of the Technology Transfer
Policy Board for final approval recommendation. Generally,
all CRADAs containing exclusive licensing-related clauses
must be reviewed by the agency's CRADA Review Subcommittee.
The Federal Technology Transfer Act provides for a 30-day
period in which to disapprove or modify a CRADA after its
finalization. When there are no changes required, the CRADA
is signed and returned to the TDC at each NIH institute.
The TDC is responsible for obtaining the proper signatures
required for execution by the company. Agreements have no
mandatory term length and can be extended by the mutual
agreement of the parties if there is no substantial change
in the Research Plan. Because scientific objectives and
circumstances change, it is essential to include in a
CRADA a specific time period for financial accountability
and provisions for early termination.
In order to expedite the commencement of the Research Plan, prior to
final execution of the CRADA, an interim Letter of Intent may be
signed with the company. Once an invention is made within the
scope of a CRADA agreement, the OTT will negotiate the
CRADA-related license with the commercial partner.
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