Cooperative Research And Development Agreements (CRADAs) and Material Transfer Agreements (MTAs)
CRADAs provide an exciting opportunity for NIH investigators to
join with their colleagues from industry and academia in the
joint pursuit of common research goals. Government scientists
can leverage their own research resources, as well as serve
the larger mission of NIH, to facilitate the development
and commercialization of health-care pharmaceuticals
and products. Companies also can leverage their own
R&D efforts while collaborating in state-of-the-art
The purpose of a CRADA is to make Government facilities,
intellectual property, and expertise available for collaborative
interactions to further the development of scientific and
technological knowledge into useful, marketable products.
Each NIH institute has a Technology Development Coordinator (TDC)
who should be consulted at an early stage of collaboration
by the company and the NIH investigator to assist in
identifying and developing the proper documents and obtaining
the required approvals.
The intent of Congress in establishing CRADAs was to promote
national technological competitiveness and the rapid transfer
of the fruits of innovation to the marketplace. CRADA
research and development at the NIH should be directed
to the development of biological and behavioral technology,
products, and processes by transferring relevant knowledge
acquired from NIH research efforts to state and local
governments, universities, and the private sector.
Advances in biomedical and behavioral research depend
on a continuum of research efforts, from those aimed
at discovering new knowledge, to those aimed at expanding
existing knowledge, to those aimed at developing new
procedures and products. There is not always a clear
distinction among these research activities to allow a
concise definition of which activities are appropriate
for a CRADA. All CRADAs must be consonant with the
primary biomedical research mission of the PHS and the specific
laboratory involved, ensuring that no aspect of that mission is
compromised. For example, a proposed CRADA would not be appropriate
if the fundamental mission of the NIH is compromised by creating,
either explicitly or indirectly, more than minimal constraints
on research freedom and communication.
Although there is no restriction on the topic of research
appropriate for a CRADA, all CRADA research projects must
be highly focussed and delineated and each proposed CRADA
must be carefully assessed for its overall research objectives.
In considering a proposed CRADA, PHS operating components will
determine if the objectives of a proposed collaboration warrant
the establishment of a CRADA or if its goals are more appropriately
met through a procurement contract, material transfer agreement,
cooperative agreement or other contractual mechanism. Also,
the proposed collaborator's scientific and business capabilities
will be assessed.
Prohibition on General Funding
A CRADA is not intended to be a general funding mechanism
to support directed research in a NIH laboratory. The
majority of a laboratory's resources should not derive
from CRADAs. CRADA-derived funds may not supplant appropriated
funds in supporting NIH research. They are to be used only
to defray the cost of the project specified in the CRADA.
Laboratories must be prepared to address the impact on the
ongoing research if a CRADA and related financial support
is terminated unexpectedly. The sole purpose of a CRADA
cannot be to support post-doctoral fellows and/or technicians,
to obtain funds, or to purchase equipment and/or supplies.
Conversely, the sole justification of a CRADA cannot be for
a NIH laboratory to conduct research or tests for the collaborator.
Ensuring Research Freedom
NIH investigators generally are free to choose the
subject matter of their research, consistent with
the mission of their Institute and the research programs
of their Laboratories. No CRADA may contravene this freedom.
CRADAs that explicitly attempt to direct NIH research are
not appropriate. Additionally, in considering any proposed
CRADA, attention must be given to whether directed research
implicitly will be the net effect. For example, the greater
the extent to which a laboratory's resources derive from a
CRADA, the less likely it will be that the laboratory will
pursue other research opportunities outside of the CRADA;
the broader the scope of a CRADA research plan, the less
able a laboratory will be to provide fair access and
interact with others. The achievement of this balance
will be considered in the decision-making process.
Thus, consideration should be given to:
a. the fraction of a laboratory's appropriated resources devoted to CRADA research;
b. the fraction of a laboratory's total resources that derive from CRADA support,
and the time and scope of work devoted to a given CRADA;
c. the amount of time that any one investigator would give to one or more CRADAs;
d. the number of CRADAs an investigator or Laboratory/Branch has with one company; and
e. the number of CRADAs that any given company might have with the PHS and its operating components.
Scientific Communication and Dissemination of Research Results
It is fundamental to the mission of NIH that research results be
published and discussed at public fora. Further, NIH scientists
must operate within an atmosphere of scientific collegiality.
Reasonable confidentiality requirements and brief delays in
dissemination of research results are permitted under a CRADA,
as necessary, in order to protect proprietary materials
and intellectual property rights. CRADAs which in any way
attempt to unreasonably restrict or constrain scientific
interaction or the dissemination of research information
will not be approved. In considering any proposed CRADA,
consideration must be given to the possibility that the
level of confidentiality associated with that CRADA
project might, on balance, inappropriately impair
the degree of openness necessary to maintain
effective scientific communication and to serve the public interest.
Requirement of Intellectual Contribution by Collaborator
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.
Avoidance of Conflict of Interest
Pursuant to the CRADA-authorizing statute, every federal
laboratory must ensure that there are no conflicts of
interest in any CRADA. Extramural NIH staff scientists
who administer grants and contracts may have an inherent
conflict of interest that would preclude their participation
in CRADAs. Intramural NIH scientists also may have conflicts
of interest, in that they serve as a project officer on
a contract or have authority over funding decisions in the
course of their research. In both cases, the employee may
have financial interests that would be affected by their
proposed CRADA. Therefore, any conflict of interest--actual
or apparent--must be addressed in the review and
approval of CRADAs.
Fair Access to CRADA Opportunities
In compliance with the intent of the Federal Technology Transfer Act (FTTA) and the PHS Policy for
Promoting Fair Access to CRADA Opportunities, the NIH shall ensure
that outside organizations have fair access to collaborative
opportunities, the licensing of federal technologies, and NIH
scientific expertise, giving special consideration to small
business and preference to those that are located in the U.S.
and agree to manufacture in the U.S. products developed under the CRADA.
Fair access to CRADAs is not to be considered as synonymous with the term
"open competition," as defined for contracts and small purchases.
Evidence of fair access or discussion of unique resource
requirements should be maintained as part of the official NIH Institutes and Centers (IC) CRADA file.
A MTA generally is utilized when any proprietary material
is exchanged, and when the receiving party intends to use it
for his/her own research purposes. Neither rights in intellectual
property 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 the requirements that the materials be used for
research purposes only and that the materials cannot be used
in human subjects. The NIH also requires that all materials
received by their scientists originating from humans be
collected under 45 CFR 46, Protection of Human Subjects.
Contact the Technology Development Coordinators at the relevant institute for further information.