| Government R&D and Technology Transactions |
As the largest source of funding for commercial and institutional research and development, federal government laboratories and technology program offices provide crucial support for innovation across a wide range of industries. Government R&D resources reflect changing public policy and budgetary priorities, including major programs in defense, aerospace and aviation, homeland security, pharmaceuticals and biomedical, information technologies, agriculture, renewable energy, transportation, environmental protection and remediation, and basic science, among other fields.
WilmerHale has assisted clients in establishing collaborative projects with federal agencies, including leading federal research agencies such as DARPA, HS-ARPA and E-ARPA; the military research laboratories; the Energy Department national laboratories; the National Institutes of Health; the intelligence agencies; and others. The structure of these arrangements is critical for maximizing the value of government contributions and protecting corporate or institutional intellectual property and commercialization rights. We have helped our clients to leverage the full range of government resources, including:
- R&D procurement contracts to provide research and development services intended to advance the work of the sponsoring agency;
- Grants of financial assistance to promote innovation in targeted priority fields of science or technology;
- Cooperative agreements, in which government and non-government collaborators work together toward an R&D objective;
- Cooperative research and development agreements (CRADAs) that align non-government funding with non-financial federal agency support not readily replicated in the private sector, including facilities, equipment, technologies, and expertise;
- Other transaction agreements with flexible terms to encourage advanced, high-risk prototype, demonstration and other projects by entities not traditionally involved in federal contracting; and
- Loans and loan guarantees to encourage or supplement private financing for high-stakes projects in high-priority fields of science and technology.
In the market of innovative ideas, intellectual property rights are critically important. WilmerHale is experienced in the unique IP implications of government financial assistance and in-kind support. We have advised clients on the government reporting and licensing requirements of the Bayh-Dole Act and agency-specific implementing regulations to maximize ownership of federally-supported inventions and technical data, while developing long-term relationships with federal agencies that are frequently important consumers of the resulting commercial products and technologies. In collaboration with our Intellectual Property and Technology Transaction and Licensing colleagues, we have crafted agreements that not only reflect applicable regulatory requirements, but also fit seamlessly into our clients’ broader intellectual property strategies. For example, we recently:
- Negotiated IP licensing arrangements between a provider of advanced sensor equipment and the US Department of Defense.
- Advised on the terms of an investment and development agreement between a telecommunications equipment provider and In-Q-Tel, the venture capital affiliate of the Central Intelligence Agency.
- Counseled clients on strategies to protect pre-existing, privately developed technologies in federal grant applications and in resulting federally-funded research programs.
Reflecting the government’s leadership as a source of technological innovation, clients turn to WilmerHale for advice on government-to-industry technology transfer transactions, including identifying and licensing technologies that are owned by government agencies and available for commercial use.
Federal research and technology transactions provide opportunities for companies and institutions of all sizes. With a long history of advising early-stage and venture-backed companies, WilmerHale has enabled clients to leverage government programs to accelerate R&D and commercialization, without impeding private-sector funding plans. For companies eligible for Small Business Innovation Research (SBIR) grants and contracts or Small Business Technology Transfer (STTR) collaborations among universities and government laboratories, we have assisted clients in negotiating favorable technology licensing terms and setting up required reporting and compliance procedures. We have advised companies on changes in the eligibility standards for the SBIR program and appealed unfavorable size status determinations rendered by the Small Business Administration.
Federal research and technology transactions also present a wide range of compliance considerations. WilmerHale advises both seasoned contractors and new recipients of government funding and can help to reduce the costs of managing federal financial assistance. For example, we have:
- Counseled clients on the application of socioeconomic requirements, including equal employment opportunity, affirmative action, Section 508 accessibility standards and other requirements.
- Advised pharmaceutical and life science companies on the requirements of the Common Rule for protection of human research subjects in federally-funded clinical research, and prepared informed consent documentation for research subjects.
- Represented clients seeking waivers of the preference for US industry, under which exclusive licensees of federally-funded inventions must manufacture resulting products substantially in the United States.
- Facilitated participation by non-US entities in federally-funded research programs.
- Secured security clearances and export licenses to facilitate performance of government-supported research programs.
The passage of the American Recovery and Reinvestment Act (Recovery Act) in February 2009 substantially boosted federal financial support for research and technology transactions in health, transportation, energy, education, and other fields. The Recovery Act also added new reporting, disclosure and other administrative requirements for recipients of this increased funding. We regularly advise clients on the obligations they must fulfill under federal financial assistance agreements and have advised clients on the development of robust and effective compliance policies and procedures, in order to minimize exposure to penalties resulting from routine audits or other regulatory enforcement activities.
Government Research and Technology Transactions Internet Resources