Cooperative Development Agreements

In support of NIH’s primary mission to improve national and global public health, the Office of Technology Transfer and Development (OTTAD) establishes formal collaborative agreements with industry, academia, and non-profits to facilitate cooperative development of early-stage discoveries, through the exchange and development of research materials, knowledge, and technologies. OTTAD can also help outside parties identify potential NIH intramural collaborators.

OTTAD uses three different cooperative development agreements to help industry and academia interact and partner with National Institutes of Health laboratories and scientists to support technology development activities:

Research Collaboration Agreements (RCAs)

An RCA is a technology transfer agreement between two entities where the contemplated research project represents a collaborative effort between the parties. This is unlike the work under a Material Transfer Agreement (MTA), where either an informal or limited collaboration, or no collaboration, is anticipated. The RCA outlines what materials or expertise each party will bring to the research project, and what portion of the project those materials and expertise will represent. OTTAD works with both parties to facilitate the RCA.

Essential Elements

  • Combines terms of a Confidential Disclosure Agreement (CDA) and MTA   
  • No funding from the outside party allowed
  • Simplified research plan                 
  • No license option
  • Exchange of new material created during the collaboration addressed
  • Rights to foreground intellectual property (IP) not addressed
  • No rights to background IP

Cooperative Research and Development Agreements (CRADAs)

A CRADA is a technology transfer agreement that makes available Government facilities, intellectual property, and expertise for collaborative interactions with commercial entities that lead to the development of improved biomedical products, processes, and services. OTTAD should be involved early in the development of a CRADA collaboration. CRADA opportunities at NHLBI and OTTAD's client Institutes can be viewed in TechFinder, a live search engine for use in locating technologies developed in the labs at NHLBI and OTTAD’s client Institutes, by keyword or taxonomy classification.

Essential Elements

For NIH

  • May receive funds or in-kind contributions for collaborative research project
  • Access to unique reagents and resources
  • Access to scientific and regulatory expertise
  • No rights to background IP

For Collaborator

  • Option to exclusively license any inventions that are developed by a Federal laboratory employee(s) as part of the collaborative research in specified field of use
  • Access to unique reagents and resources
  • Access to scientific and regulatory expertise
  • Access to Federal lab

Clinical Trial Agreements (CTAs) 

CTAs further the NIH mission by providing the opportunity for researchers at NHLBI and OTTAD’s client Institutes to partner with outside entities, to conduct clinical trials which test new drugs, devices, procedures, and other interventions on human subjects. Researchers at NHLBI and OTTAD’s client Institutes are world-renown in their fields of expertise, and the NIH Clinical Center offers a state-of-the art facility in which these clinical trials may be conducted.

Essential Elements

  • Covers investigational data, drugs, diagnostics, or devices
  • Clinical and non-clinical
  • No funding from the outside party required          
  • Addresses regulatory issues and monitoring
  • No option to license foreground IP            
  • Addresses Personally Identifiable Information (PII)
  • No rights to background IP           
  • Addresses data ownership, access and use terms
  • Addresses supply of clinical agents or devices

To facilitate any of the agreements above, please contact the Office of Technology Transfer and Development (OTTAD).