Collaborative Research Agreements

OTTAD establishes formal collaborative research agreements with industry, academia, and non-profits that facilitate the exchange and development of research materials, knowledge, and technologies, and enable the cooperative development of early-stage discoveries.

OTTAD can also help outside parties identify potential NHLBI and OTTAD Client Institute intramural collaborators.

OTTAD uses three different collaborative research agreements to help industry and academia interact and partner with NHLBI and OTTAD Client Institute scientists to support technology development activities that advance public health.

Research Collaboration Agreements (RCAs)

  • For contemplated collaborative research project between two or more parties.
  • Outlines materials or expertise each party brings to the research project, and what their anticipated contribution of each.

Essential Elements

  • Terms for sharing confidential information.
  • Terms for sharing non-human and/or human subject material/data.
  • No funding from the outside party allowed.
  • Simplified research plan.                 
  • Exchange of new material created during the collaboration is addressed.
  • Rights to foreground IP are not addressed.
  • No rights to background IP.

Cooperative Research and Development Agreements (CRADAs)

Provide commercial entities with access to Government facilities, intellectual property, and expertise for collaborative research interactions that may lead to the development of improved biomedical products, processes, and services.

Essential Elements

For NHLBI and OTTAD Client Institutes:

  • 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:

  • Access unique reagents and resources.
  • Access to scientific and regulatory expertise. 
  • Access to NIH labs.
  • Exclusive option to elect to apply for an exclusive license to any inventions that are developed by a Federal laboratory employee(S) as part of the collaborative research in specific field of use.

Clinical Trial Agreements (CTAs) 

  • Allows NHLBI and OTTAD Client Institutes to partner with outside entities, to conduct clinical trials that test new drugs, devices, procedures, and other inventions on human subjects.
  • The NIH Clinical Center offers a state-of-the art facility in which these clinical trials may be conducted.

Essential Elements

  • Covers investigational data, drug, diagnostic, or device.
  • 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 agent or device.