Cooperative Research and Development Agreement
A Cooperative Research and Development Agreement (CRADA) is an agreement used when the National Institutes of Health (NIH) and industry collaborate to further develop a technology for commercialization. The word "CRADA" is generic and includes a standard CRADA, Clinical Trial CRADA, or Materials CRADA.
NIH scientists should be aware of the following facts when contemplating entering into any CRADA, specifically a standard CRADA, Clinical Trial CRADA, or Materials CRADA. The word "CRADA" is generic and includes all three types of agreements.
- The CRADA is a contractual agreement between the NIH and the collaborator where the collaborator has the option to exclusively license inventions developed jointly or independently by NIH scientists.
- CRADA Research Plans and financial information are CONFIDENTIAL and should not be disclosed to anyone outside the collaboration.
- All staff members associated with a CRADA share the responsibilities regarding CRADA confidentiality particularly in relationship to other research collaborations in which they may be involved and/or employment activities they may be pursuing.
- The materials or funds provided by the collaborator are to be used ONLY in the CRADA as identified in the research plan by those under the supervision of the CRADA Principal Investigator (PI) and will not be distributed to third parties.
- CRADA collaborators review all publications/oral presentations related to the research plan of the CRADA for CONFIDENTIAL or inventive information prior to any public disclosure (including submission for public disclosure consideration).
Letter of Intent for CRADA
A letter of intent may be signed before final approval of a CRADA, allowing the research to proceed pending final negotiation and review. A model agreement developed by the NCI is provided.
Materials-Cooperative Research and Development Agreement (Materials CRADA)
A simpler form of CRADA, limited in time to one year. A Materials CRADA does not allow funding for support of research personnel, but does provide for the transfer of intellectual property rights to the collaborator. A model agreement developed by the NCI is provided.
Materials Transfer Agreement
A Material Transfer Agreement (MTA) is a document that is used by scientists and their institutions when they wish to transfer materials to other scientists and institutions. The National Institutes of Health (NIH) Simple Letter Agreement for the transfer of materials protects the scientist and the NIH against liability for improper use of materials.
Although the NIH MTA is designed to both provide and receive materials, some institutions will prefer to use their own MTA when they are providing materials. Many of these agreements are acceptable to the NIH, and many are not. MTAs provided by outside organizations may contain clauses that are not consistent with NIH policy and/or federal law. Signing one of these agreements could severely impede a scientist's ability to carry out his or her research or to publish in a timely fashion.
A Uniform Biological Materials Transfer Agreement (UBMTA) has also been implemented in an effort to streamline the process of transferring materials. The UBMTA is an MTA that NIH and more than 120 institutions have agreed to use. Among institutions that have signed the UBMTA Master Agreement, materials can be transferred upon execution of an Implementing Letter.
Confidential Disclosure Agreement
A Confidential Disclosure Agreement (CDA) used for the exchange of confidential research information. Several different model versions of CDA's developed by the NCI are provided.
