Government R&D and Technology Transactions REGULATORY AND GOVERNMENT AFFAIRS

As the largest source of funding for commercial and institutional research and development, US federal government laboratories and technology program offices provide crucial support for innovation across a wide range of industries. Federal R&D resources reflect changing public policy and budgetary priorities, including major programs in defense, aerospace and aviation, homeland security, biotechnology and pharmaceuticals, information technology, nanotechnology, agriculture, renewable energy, transportation, environmental protection and remediation, and basic science, among other fields.

WilmerHale assists clients in establishing collaborative projects with federal agencies, including defense research sponsors, such as DARPA, the Missile Defense Agency, the Joint IED Defeat Organization and the Army, Navy and Air Force research laboratories, which account for more than half of federal R&D spending. Among non-defense agencies, we advise clients on R&D collaborations with leading federal research institutions such as the National Institutes of Health, HS-ARPA and ARPA-E, the Energy Department's national laboratories and the intelligence community. The structure of these arrangements is critical for maximizing the value of government contributions while protecting corporate or institutional intellectual property and commercialization rights. We help 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
  • Loans and loan guarantees to encourage or supplement private financing for high-stakes projects in high-priority fields of science and technology

WilmerHale is experienced in the unique IP implications of government financial assistance and in-kind support. We advise 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 may be leading consumers of the resulting commercial products and technologies. In collaboration with our Intellectual Property and Technology Transaction and Licensing colleagues, we craft agreements that not only reflect the unique requirements affecting federally-sponsored research, 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
  • Secured an investment and technology development agreement between a telecommunications equipment provider and In-Q-Tel, the non-profit strategic investment affiliate of the Central Intelligence Agency
  • Advised a major international pharmaceutical company on the implications of federal financial support for technologies developed by and subsequently licensed from a US university
  • Negotiated Space Act Agreements to facilitate advanced research collaborations between an emerging technology company and two NASA space flight centers 
  • 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 enables 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 assist clients in negotiating favorable technology licensing terms and setting up required reporting and compliance procedures. We advise 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:

  • Counsel clients on the application of socioeconomic requirements, including equal employment opportunity, affirmative action, Section 508 accessibility standards and other requirements
  • Advise 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
  • Represent 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
  • Facilitate participation by non-US entities in federally-funded research programs
  • Secure security clearances and export licenses to facilitate performance of government-supported research programs

As the largest source of funding for commercial and institutional research and development, US federal government laboratories and technology program offices provide crucial support for innovation across a wide range of industries. Federal R&D resources reflect changing public policy and budgetary priorities, including major programs in defense, aerospace and aviation, homeland security, biotechnology and pharmaceuticals, information technology, nanotechnology, agriculture, renewable energy, transportation, environmental protection and remediation, and basic science, among other fields.

WilmerHale assists clients in establishing collaborative projects with federal agencies, including defense research sponsors, such as DARPA, the Missile Defense Agency, the Joint IED Defeat Organization and the Army, Navy and Air Force research laboratories, which account for more than half of federal R&D spending. Among non-defense agencies, we advise clients on R&D collaborations with leading federal research institutions such as the National Institutes of Health, HS-ARPA and ARPA-E, the Energy Department's national laboratories and the intelligence community. The structure of these arrangements is critical for maximizing the value of government contributions while protecting corporate or institutional intellectual property and commercialization rights. We help our clients to leverage the full range of government resources, including:

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Preston_Stephen

Stephen W. Preston

Chair, Defense, National Security and Government Contracts Practice

+1 202 663 6900 (t)

stephen.preston@wilmerhale.com