Co-Development Agreements
The NCI's Technology Transfer Center (TTC) recognizes the importance of co-development in order to translate early-stage discoveries to outside entities to benefit public health. In support of this goal, the TTC establishes formal collaborative agreements with industry, academia, and non-profits to facilitate co-development through the exchange and development of research materials, knowledge, and technologies.
The TTC uses three different co-development agreements to help industry and academia interact and partner with National Institutes of Health laboratories and scientists to support technology development activities:
Collaboration Agreement (CA)
Permits a two-way exchange of materials and information, and assumes exchange of results and/or conclusions will occur between NIH and companies, universities, state/local governments, Federal labs, and non-profits.
- Combines terms of a CDA and MTA
- Simplified research plan
- Exchange of new material created during the collaboration is addressed
- No funding from the outside party allowed
- No license option
- Rights to foreground IP are not addressed
- Human and non-human materials covered
Cooperative Research and Development Agreement (CRADA)
Permits co-development of NIH or outside invention involving companies, universities, state/local governments, Federal labs, and non-profits.
For NIH:
- May receive funds or in-kind contributions for collaborative research project
- May provide confidentiality for research results up to five years after development
For Collaborator:
- Exclusive option to license any inventions that are developed by a Federal laboratory employee(s) as part of the collaborative research
- Access to unique reagents and resources
- Access to scientific and regulatory expertise
- Access to Federal lab
CRADA Guide and Overview:
There are three NIH CRADA models commonly used by TTC to facilitate a collaboration between an NIH Institute and an outside party. This new guide outlines these models.
Clinical Trial Agreement (CTA)
Transfers material into NIH for research in Human Subjects from companies, state/local governments, non-profits, and universities
- Covers investigational data, drug, diagnostic, or device
- No funding from the outside party required
- No option to license foreground IP
- Clinical and non-clinical
- Addresses regulatory issues and monitoring
- Addresses Personally Identifiable Information (PII)