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Cooperative R&D agreements (CRADAs) serve as a mechanism to facilitate collaborative research and development (R&D) between the federal government and non-federal entities. Benefits in establishing a CRADA with a federal lab include reduced R&D costs, a concentrated effort resulting in reduced time between innovation and production, and the ability to commercialize inventions developed under the CRADA.

A Brief History

Following WWII, the U.S. federal government was providing 70% of all R&D funding. Federal employees owned their government-funded inventions up until 1950, when an Executive Order changed the process so that the federal government owned the inventions that arose from their grants and procurement contracts.

A significant economic problem during the 1970’s was that the technologies being developed with government funds were not being transferred into commercial production to create products and jobs, because there were no means to do so. With the passing of the federal technology transfer legislation of 1980, it became a mission of the federal government to transfer technologies invented in federal labs to state/local governments and to the private sector. In addition, small businesses, universities, and non-profits were once again able to retain rights to their federally-funded inventions. (For more information, see Robert Charles’ FLC CRADA Workshop.)

So What IS a CRADA?

CRADAs are one of the most frequently used mechanisms for facilitating technology transfer (T2) between private industry and Department of Defense (DoD) labs, such as the Army Research Laboratory (ARL), Air Force Research Laboratory (AFRL), and Naval Research Laboratory (NRL). The Federal Technology Transfer Act of 1986 further gave federal labs the authority to enter into CRADAs with public, private, and nonprofit organizations. A CRADA is a written legal agreement between one or more federal laboratories and one or more non-federal parties. The purpose of this agreement is to leverage each other’s resources in order to conduct collaborative R&D that is in alignment with the federal laboratory’s mission.

Under a CRADA, federal laboratories may provide non-federal parties with:

The non-federal parties may provide the same resources that the federal laboratory can provide, as well as funds.

Under a CRADA, the non-federal party obtains a non-exclusive, paid-up, royalty-free license for any patents resulting from the collaboration, and can negotiate an exclusive or non-exclusive commercial license. A CRADA also provides proprietary information protection.

Types of CRADAs

Although we are focusing here on full CRADAs, it is worth noting that there are a few additional types:

• Special Purpose CRADAs are shorter versions of a CRADA to address a specific need:
  • A Material Transfer Agreement (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.
  • A Non-Disclosure Agreement (NDA) is completed to protect proprietary discussions between parties.
• A Full CRADA is a longer-term (2-3 years; can be extended) formal collaboration with or without reimbursement funds, in which a Statement of Work (SOW) is jointly developed by the parties.
• Master CRADAs are primarily implemented by the US Army Medical Research and Materiel Command (MRMC) and Veterans Affairs (VA). They are used with recurrent CRADA collaborators and can contain multiple SOWs appendices, each of which constitutes a separate agreement.

Who May Participate in CRADAs?

CRADA Process

On average, the CRADA development process takes about 3 months, but this may vary considerably depending on the complexity of the CRADA.

1. Identify Collaborators – There are many federal laboratories and medical treatment facilities (MTFs) that offer collaborative opportunities through CRADAs. Learn more about how often CRADAs are implemented by each Federal Agency here. It is important to identify labs with missions that are aligned with your company’s vision, mission and objectives.
2. Draft CRADA – Complete the federal laboratory’s Office of Research and Technology Applications (ORTA) checklist and CRADA template, including a Statement of Work (SOW).
3. CRADA Review – The non-federal party reviews the CRADA and provides final edits to the federal entity. The federal scientist (e.g., DoD PI) subsequently reviews the CRADA before it is sent back to ORTA for preparation of a final draft for legal review.
4. CRADA Implementation – Once the final draft is prepared, signatures are obtained from each collaborating party and the finalized CRADA is returned to each federal and non-federal participant.

CRADA Elements

A CRADA typically consists of the following elements:

• CRADA Articles prior follow a boiler template. Thousands of companies have accepted the template over the decades; however, requests for changes to the articles can be submitted for review by MRMC judge advocate general (JAG) personnel at the Clinical Investigation Regulatory Office (CIRO).
• A Statement of Work (SOW) sets forth the nature and scope of the work to be performed.
• Financial Obligations define what amount of funds, if any, the non-federal party will contribute.
• Patents define the rights of the parties in regard to inventions.
• Copyrights define ownership of copyrighted works of the non-federal party.
• Proprietary Information defines the rights and protections brought to the agreement, as well as those developed under the agreement.
• Liability defines the liability, if any, regarding any property furnished, inventions or other intellectual property, and collaborating employees.

What Now?

CRADAs offer an effective means to facilitate productive and long-term R&D collaborations with the Department of Defense. Tier Seven has successfully established multiple CRADAs with each DoD service and Tier Seven has compiled numerous CRADA resources from the Air Force, Army and Navy on website under CRADA Resources.

If you would like more information on how Tier Seven can assist your company in identifying and connecting with potential DoD partners and developing a CRADA, please contact us.

Published June 11th, 2016