Federal Lab Collaborations
The organization in the United States chartered with the mission to promote and strengthen technology transfer is the Federal Laboratory Consortium for Technology Transfer (FLC). In the context of technology developed at federal laboratories (including those within the Department of Defense), technology transfer is explicitly defined as transfers occurring between the federal laboratories and any non-federal organization, such as private industry, academia, and state and local governments.
The purpose is to utilize innovations at federal labs to fulfill public and private technology needs. In some instances, it also includes technology that is brought from other laboratories or from outside parties into federal labs, in order to help the laboratories meet their goals.
The following information has been sourced exclusively from content available on numerous federal government websites, including those of the FLC, the National Institutes of Health (NIH), the National Institute of Standards and Technology (NIST), and was reviewed by the Technology Transfer Office of the U.S. Army Telemedicine & Advanced Technology Research Center (TATRC).
What are the paths for technology transfer from Federal Labs?
Similarly to universities, federal laboratories achieve technology transfer through one or more of the following mechanisms:
- Licensing of technology
- Material’s Transfer Agreements (MTA)
- Laboratory expertise (engineering/scientific assistance to businesses, incubators), facility use agreements (FUAs)
- Assistance to technology-based companies (business plan, strategic planning, sponsoring seed capital activities)
- Partnerships with industry in developing and implementing new technology
The Stevenson-Wydler Act of 1980 is intended to facilitate technology transfer between federal laboratories and outside parties, and provides them with a means to have access to discoveries and innovations at federal labs. This law requires laboratories to take an active role in technical cooperation and to set apart a percentage of the laboratory budget specifically for technology transfer activities. The law also established an Office of Research and Technology Applications (ORTA) in each laboratory to coordinate and promote technology transfer.
Just as it does for universities, the Bayh-Dole Act allows federal labs to obtain title to inventions, and they are permitted to grant exclusive patent licenses to commercial organizations.
What is a “Cooperative Research and Development Agreement”?
Federal labs have in place a mechanism to work with non-federal partners in achieving technology transfer activities, called the Cooperative Research and Development Agreement (CRADA). Very importantly, the agreement is intended to consider the needs and objectives of private industry when commercializing a product. Also, note that each agency or laboratory is free to develop its own CRADA model, which implies there is some flexibility in negotiating technology transfer agreements. More general information can be found by searching “CRADA” at this FLC website.
How do you pursue a CRADA?
Federal laboratories each have a standard document to begin negotiations, as well as a point of contact within the laboratory’s Technology Commercialization office. The office can also provide you with initial guidance on whether your project is best served by a CRADA.
If your company is seeking a collaboration with a federal laboratory and exploring a CRADA ...
Start by identifying and contacting the principal investigator with whom you wish to work. If during your initial conversations it appears there is common ground for a project, you will jointly draft a Statement of Work.
The investigator will then submit the Statement of Work to the commercialization office for approval. Next, a Sponsored Research Manager will put together a draft CRADA, which includes the Statement of Work and other information specific to the project. The draft is given to all participants for review, and once approved, copies are provided to the participants for signature.
What are the basic terms of a CRADA?
As a contract between a private company and the federal government, a CRADA’s provisions are driven by statutes and policy. They take into account the needs of the CRADA’s participants, while protecting the interest of the public.
Although each laboratory has its own specific form, all CRADAs have the following main components:
- Statement of Work: describes the work to be performed, technical tasks, deliverables and project timeline. The statement of work is drafted jointly by the laboratory’s principal investigator and the company’s representative.
- Funding contributions from each of the parties collaborating.
- Duration of the contract.
- Confidentiality provisions to protect confidential information outside of the CRADA.
- Disclaimer of warranties by the laboratory.
- Rights to intellectual property.
The latter section states how intellectual property resulting from the collaboration will be assigned. The general rule is that any invention made solely by the company participant is owned by the participant; those made solely by laboratory employees belong to the laboratory. It also contemplates joint ownership of inventions. The CRADA business participant is granted an option to negotiate an exclusive license of laboratory-owned inventions developed under the agreement.
Another strong point of this type of collaboration is that CRADA-generated, non-patentable information may be kept confidential for up to 5 years, providing a competitive advantage to the participant.
How is a CRADA different from Sponsored Research Agreements?
It’s important to state that CRADAs are not necessarily funding agreements, as in a university's Sponsored Research Agreements...
Rather, they are typically intended to give small companies an opportunity to access government resources that can save valuable time and money on R&D, and accelerate the commercialization of new technologies.
What is a Materials Transfer Agreement?
A Material Transfer Agreement (MTA) is used when any proprietary material is exchanged. In this case, the receiving party intends to use it for research purposes, and no research collaboration between scientists is planned. Unlike a CRADA, it does not grant a licensing option nor rights for commercial purposes. MTAs define the terms and conditions under which the recipients of materials may use them. Included in the MTA are provisions of confidentiality, data distribution, publication, and the requirement that the material be used only for research purposes. In the specific case of the NIH, it also requires that materials received by their scientists originating from humans, be collected under regulation 45 CFR46, Protection of Human Subjects.
In contrast, a standard CRADA is used when a collaborative R&D project between the federal lab and scientists from the private sector is contemplated.
How do you license technology from Federal Labs?
The process for licensing technology is very similar to that of universities. You begin by examining the available technology for licensing, commonly listed on each laboratory’s website. The FLC also has implemented the FLC Locator Network, which puts potential partners in contact with a federal laboratory with expertise and capability in a specific area of interest. The process itself is facilitated by the ORTA at each laboratory (this office may utilize other names, but there will be an individual serving this function at each federal lab). This office negotiates and manages license agreements, partnerships, sponsored research, etc., and will be the point of contact for initiating the licensing process between your company and the laboratory.
If you are a FLC researcher, the ORTA office screens the technology in your organization, conducts application assessments, and actively pursues marketing to the outside world.
A recent and excellent source for information regarding technology licensing from federal laboratories, including tech transfer process, CRADAs, and technology licensing can be found here at the Technology Transfer Desk Reference of the FLC.
Federal Lab Outreach Programs
Although many of the federal labs are actually small organizations distributed across the country, the largest of federal labs have their own outreach programs with respect to technology available for licensing. Some examples relevant to medical technologies are the following:
To support technology licensing from the National Institutes of Health (NIH), the NIH has recently developed and made available a short-term, exclusive Start-up Evaluation License Agreement (Startup EELA), and a Start-up Exclusive Commercial License Agreement (Startup ECLA) with the intent of facilitating and expediting the licensing of NIH and FDA inventions to startup companies. These new Licenses are offered to assist start-up companies less than 5 years old, with less than $5M in capital raised, and with fewer than 50 employees to obtain an exclusive license from the NIH for early- stage biomedical inventions . Details of this new program and a summary of key features of the NIH Start-up License Agreement —including royalty levels and schedule—can be examined at the NIH Office of Tech Transfer.
At the Department of Commerce, NIST has its Technology Partnerships Office which provides seed money to help U.S. businesses in developing technologies with high commercial potential. Its R&D facilities in Gaithersburg, MD and Boulder, CO are made available to businesses. It also assists small and medium businesses in acquiring manufacturing expertise through its manufacturing technologies centers (MTCs) across the country.
U.S. Army Medical Research & Materiel Command (USAMRMC) identifies, develops and procures the medical technologies that will best support the rapidly deployable and responsive modern Army. USAMRMC operates six medical research laboratories and institutes in the United States and supports a large extramural contract research program and numerous cooperative research and development agreements with leading R&D organizations in the civilian sector.
U.S. Army Telemedicine & Advanced Technology Research Center (TATRC) is an agency of USAMRMC, which manages core Research Development Test and Evaluation (RDT&E) and congressionally mandated projects in telemedicine and advanced medical technologies.
What conditions must an outside partner satisfy when licensing technology from Federal Labs?
Similarly to universities...
The company must present the government a convincing development and marketing plan, and evidence of its ability to execute it.
The company must also commercialize the invention within a specified time frame and make available to the public the benefits of the invention. Generally, it is also required that the company licensing the technology will develop products manufactured substantially in the United States. Note that the government reserves the right to practice or use the invention royalty-free.
What type of licenses can a company obtain from the government?
As with universities, they can be of three types: nonexclusive, partially exclusive, or exclusive licenses. Non-exclusive licenses are granted when it is anticipated that more than one company can better serve the objectives of developing and using an invention, or when the invention is at an advanced stage of development. Note that non-exclusive licenses may be granted without the publication of any notice, in contrast to exclusive licenses, which must be published in the Federal Register a few months in advance.
Among other requirements, an exclusive licensing from federally funded laboratories is granted after the following points have been fulfilled:
- Availability of the invention has been advertised in the Federal Register
- The invention and prospective licensee have been disclosed and published, in order to receive any potential objections
- It is believed that granting the license will not substantially lessen competition, will not concentrate a line of business in a single geographical region, or violate antitrust laws.
- Preference is given to small businesses capable of bringing the invention to an application.
Small Business Innovation Research (SBIR) and Small Business Tech Transfer (STTR) programs
Although not strictly a technology transfer activity, SBIR programs reside within each of the Federal Agencies and provide seed funding for early stage R&D with commercialization potential. More related to technology transfer, the STTR programs require initial (Phase I and Phase II) collaboration between a small or medium business and a non-profit research institution, such as a university or federally-funded R&D center. For detailed information on SBIR/STTR programs and participating agencies see the related section of this guide, Funding Opportunities or visit the SBA SBIR website.
Licensing and Technology Transfer Online Resources
Association of University Technology Managers (AUTM)
Federal Laboratory Consortium (FLC)
Licensing Executive Society International (LES)
World Intellectual Property Organization