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Partnering with NIH

The mission of NIH is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. Through partnerships, NIH can leverage its resources with those of industry and academia, and, by working together, more effectively apply its knowledge to development of new diagnostics and therapeutics.

There are a variety of mechanisms by which NIH can partner with other organizations to pursue research and development. In general, the most appropriate mechanism will be determined by the type of partner with which NIH will be working, as well as the specific research project to be done. A detailed comparison can be found here.

For most University researchers, exchanging research materials with an NIH scientist may only require a Material Transfer Agreement (MTA) to memorialize the transfer. If confidential or proprietary information is to be exchanged, a Confidential Disclosure Agreement (CDA) may be used to limit the public release of the information. For on-going research collaborations, a Collaboration Agreement combines the advantages of a CDA and an MTA so that collaborators can freely exchange proprietary materials and information.

On the other hand, collaboration with industry can be far more complex. A for-profit corporation may require that inventions made during the course of the research be licensed to them preferentially. While a Collaboration Agreement provides faster entry into a collaborative research project with an NIH inventor, it does not offer intellectual property rights for inventions made during the project and does not provide for outside funding to occur to cover expenses. A Cooperative Research and Development Agreement (CRADA) allows NIH to offer license options to inventions made in NIH laboratories during the performance of a CRADA collaboration with a company, and also allows NIH to receive funds and other resources to support the research. There are several variations of CRADAs that allow transfer of proprietary materials (Materials-CRADA), and co-development within clinical trials (Clinical Trials CRADA).

NIH often collaborates with other parties to perform clinical trials to develop new methods of treatment. A Clinical Trial Agreement (CTA) is designed to address the unique demands of performing clinical research on patients. A CTA defines who will perform the trials, who is responsible for providing the drug or other materials needed, as well as detailed terms assigning responsibility for complying with Federal regulations on protecting human subjects.

If you are interested in partnering with NIH to further your research, please contact the Technology Transfer office of the appropriate institute for further information and guidance.

Deciding which type of agreement to use can be a challenge. Therefore, the TTC highly recommends discussions with one of our Technology Transfer Specialists or our Invention Development and Marketing Unit to determine which agreement best suits the type of collaboration needed.

Thursday, June 2, 2016