There are many types of Cooperative R&D Agreement (CRADA) instruments and processes used by the Department of Defense (DoD), Department of Veterans Affairs (VA) and other Federal Agencies. Each type of CRADA presents a different mechanism or path to establishing meaningful and long-term collaborations between Federal and non-Federal entities to foster R&D innovation and improve the transition and commercialization of required technologies. This list of the types of CRADAs utilized by the DoD and VA is not all-inclusive — please feel free to provide comments or information on CRADA types for other Federal entities that you know of so that we can include these in future articles.
CRADAs typically serve as non-disclosure agreements (NDA), material transfer agreements (MTA) and contain a specific joint work plan via the statement of work (SOW). Under a CRADA, collaborators (e.g., companies, universities) have the option to exclusively license any inventions or intellectual property that are jointly developed as a result of the collaborative research.
In general, there are three broad types of CRADAs:
Special Purpose CRADAs are shorter versions of a CRADA to address a specific need. These may include a NDA and/or a MTA. An NDA is completed to protect proprietary discussions between parties. An MTA is a short-term agreement (no more than 1-2 years) in which a one-time transfer is made to test a material and/or information. The federal lab may be either the recipient or the provider.
Full/Standard CRADAs are longer-term (2-5 years; can be extended) formal collaborations with or without reimbursement funds, in which a SOW is jointly developed by the parties.
Master CRADAs are frequently implemented by the U.S. Army Medical Research and Materiel Command (MRMC) and VA. They are used with recurrent CRADA collaborators and can contain multiple SOW appendices, each of which constitutes a separate agreement, typically with a separate DoD or VA principal investigator (PI).
Currently, there are no government-wide regulations or templates for CRADAs. The broad range of Federal entity missions can explain much of the CRADA diversity, but there are efforts to standardize within technology areas such as healthcare. Because of this current diversity, each agency issues its own instructions and rules for CRADA development and implementation. In addition, the terms and conditions (T&C) and the Articles in CRADAs can vary in the different templates provided by the entities (e.g., U.S. Air Force Templates, U.S. Army Templates, U.S. Navy Templates (Section III), Veterans Affairs Templates).
If a project involves the use of sites from more than one DoD Service (e.g., Navy and Air Force, Air Force and Army, etc.), then either multiple CRADAs will need to be completed between the collaborator and each Service, or one site can take the lead with a Memorandum of Agreement (MOA; a binding legal document) or Memorandum of Understanding (MOU; nonbinding) established between the participating DoD sites. For the purposes of multiparty CRADAs, a DoD-wide template was released in 2015 that includes coverage of intellectual property related to software. Additional information on DoD/VA health-related research can be found in the 2013 VA/DoD Collaboration Guidebook for Healthcare Research.
U.S. Air Force
Full CRADAs
The Air Force has a standard CRADA template. Clinical research technology transfer (T2) mechanisms, including CRADAs, which are the most common agreement implemented by Air Force Medical Service (AFMS), are facilitated by Air Force Medical Service Office of Research and Technology Applications (ORTA) personnel. For some locations, authority to implement AFMS health-related CRADAs may be delegated to Medical Wings (e.g., 59th Medical Wing) and medical treatment facilities (MTFs; e.g., 60th Medical Group). Additional types of agreements utilized by the AFMS can be found in the 59 MDW Research Reference Guide.
U.S. Army
Special Purpose CRADAs
One-way NDA: Army discloses proprietary information to an outside party.
Mutual NDA: Both the Army and the outside party disclose proprietary information to each other.
Material Transfer CRADA: One-time transfer to test Material and/or Information between a laboratory and a non-federal party. No collaboration is contemplated.
Full CRADAs
For the U.S. Army Medical Research and Materiel Command (USAMRMC), CRADAs are the preferred agreement vehicle for collaborating with industry and academia. In addition, when collaborating with Army Research laboratories or Institutes, the U.S. Army delegates its CRADA implementation authority to individual labs (e.g., Walter Reed Army Institute of Research CRADA).
• A formal collaboration with or without reimbursement funds.
• Each Party to the CRADA agrees to certain tasks under a SOW that is jointly developed by the Parties.
• Longer term agreement; routinely for three (3) years, but may be modified if the Parties choose to continue to continue to work on the same SOW.
U.S. Navy
Helpful information on Navy CRADAs can be found in this presentation.
Special Purpose CRADAs
Limited Purpose CRADA: Material transfer of samples or data for research use.
Clinical Limited Purpose CRADA: Material transfer of clinical samples for research use.
Full CRADAs
Standard CRADA: Pre-clinical collaborative research that meets the conditions outlined in Section I-2 of the Navy Standard Cooperative Research and Development Agreement Handbook.
Non-Standard CRADA: Deviates from the conditions of the Standard CRADA. These include:
• Clinical Trial CRADA: Collaborative research involving tests of drugs, vaccines, or devices for FDA approval; requires considerable additions to the Standard CRADA.
• Observational Clinical CRADA: Collaborative research involving human data or samples, but no drug, vaccine, or device testing for FDA approval.
Veterans Affairs
The VA Technology Transfer Program Model Agreements can be found here.
Special Purpose CRADAs
Material Transfer CRADA: MT CRADAs are used when the VA is the recipient of a material and the company would like the right to license any improvement or intellectual property (IP) that might stem from the research conducted from the transfer of the material.
How does an MT CRADA differ from a Material Transfer Agreement (MTA)? MTAs are only for use with non-profit or academic recipients. The MTA may only be used when VA is the recipient or provider of material and no IP (e.g., patent) rights are transferred.
Full CRADAs
Basic Science CRADA: Basic collaborative R&D, software, engineering, testing or evaluation studies in which the VA’s PI developed or substantially contributed to the research plan.
Data Collection Agreement: Used when the following criteria are met:
1. The SOW calls for the retrospective or prospective collection of data from patient medical records, such as registries, data mining, and outcomes analysis.
2. The SOW does not call for any interaction with patients.
3. No intellectual property is anticipated from the project and neither party is interested in pre-commitment of intellectual property rights.
4. The sponsor is not seeking individually identifiable patient information.
Investigational Device Clinical CRADA: Clinical studies involving an investigational device (e.g., stent, prosthetic) that is subject to FDA oversight. Note that the rules for devices that are subject to FDA oversight will change with implementation of new FDA guidance or policies.
Clinical Trial CRADAs: The Phase 1/2 Clinical CRADA is used in those Phase 1 (i.e., safety; determine pharmacological actions; study metabolism; dosing) and Phase 2 (i.e., efficacy; side effects) clinical trials where the collaborator is the Sponsor, holds the IND, and has substantially developed the protocol. The VA receives a proprietary experimental compound (Test Article) from the collaborator.
Phase 3/4 Clinical CRADAs are similar to Phase 1/2 Clinical CRADAs except that they are used for Phase 3 (i.e., additional efficacy and safety in a larger cohort) and Phase 4 (i.e., post-approval) clinical trials.
Principal Investigator Initiated (PII) CRADA: Clinical research with a drug that is subject to FDA oversight in which the VA investigator has developed the protocol.
What Now?
At this time, each service has different CRADA templates and implementation processes. However, for DoD medical treatment facilities (MTFs) the Defense Health Agency (DHA) is working on common business practices to streamline CRADA processes and tri-service initiatives. There are also numerous efforts to accelerate the benefits to industry, DoD and VA collaborators. For example, Special Operations Forces Acquisition, Technology and Logistics (SOF AT&L) has developed a streamlined Overarching CRADA and we will write about this helpful instrument in an upcoming article.
Visit Tier Seven’s CRADA Resources page to find instructions, guidelines, CRADA models, and other information on CRADAs for the Air Force, Army, Navy, VA, and Special Operations Command (SOCOM). We are focused on the identification of biomedical or human weapon system-focused technologies that serve our military personnel, Veterans, and their families. If you would like more information on how we can assist with identifying and connecting your company to a DoD or VA researcher for a potential CRADA development and implementation, please contact us.
22 Jun
2017