Background - Practices (Regulatory & Policy) - 2016 Update

Regulatory & Policy

Representative Engagements

Antitrust

  • Represented a multinational client in twin 2019 acquisitions in the water filtration industry. We coordinated filings in multiple jurisdictions in Europe, Latin America, and Asia, obtained clearance in an informal merger review process with the Australian Competition and Consumer Commission (ACCC), and obtained clearance from Brazil’s Conselho Administrativo de Defesa Econômica (CADE).
  • Providing ongoing antitrust counseling and training to staff of a major American/ Taiwanese manufacturer of displays, covering employees located in China, Taiwan, Japan, Korea, and Singapore.
  • Advising a major consumer-facing company regarding the applicability of pricing controls in the State of California triggered by the governor’s coronavirus-related declaration of a state of emergency.
  • Advising a major pharmaceutical association on antitrust aspects of collaboration between pharmaceutical companies in Europe to ensure appropriate supply of essential drugs in the fight against COVID-19.

Energy & Environment

  • Providing strategic counselling and advocacy for a forest industry trade group on Clean Water Act and Endangered Species Act of interest to forest owners, including those that arise in citizen suit and regulatory litigation and in pending EPA rulemakings. We prepared the organization’s comments on regulatory proposals and requests for comment issued by EPA and the Department of the Interior.
  • Representing farm industry trade group in Clean Water Act regulatory proceedings before EPA, including efforts to regulate nutrient pollution; the definition of "waters of the United States"; regulation of indirect discharges to “waters of the United States”; the regulation of pesticides; and the applicability of EPCRA release reporting requirements to air emissions from animal waste on farms.
  • Advising one of the largest and oldest chemical companies in the world with respect to pesticide and chemical regulatory, compliance, and enforcement issues.
  • Advising producers and sellers of antimicrobial pesticide products about how to expedite EPA approval of new coronavirus efficacy claims under the Agency’s policy for emerging viral pathogens.

Government Contracts

  • Advocated for and secured bipartisan passage of a major, standalone acquisition reform bill.
  • Advocated for and ensured inclusion of acquisition reform provisions in the annual National Defense Authorization Acts.
  • Worked with GSA and SBA to deviate from the requirements of a governmentwide acquisition vehicle to allow for more small business participation.
  • Advising a Fortune 50 company on engagement with the federal government to provide medical equipment pursuant to emergency acquisition authority.
  • Advising large manufacturer regarding delay, disruption, interference, and related performance issues related to COVID-19 in connection with a major DoD procurement.

Health Care

  • Advising one of the largest health insurance companies in the U.S. on a variety of digital health regulatory issues, including interoperability, and health information privacy policy.
  • Providing guidance to one of the “big four” American multinational technology companies regarding direct health care arrangements between patients and physicians via telemedicine and on-demand health services in patients’ homes.
  • Conducting provider compliance assessments, including review of physician contracting processes providing recommendations for process improvement.
  • Advising Medicare Advantage and Medicaid managed care plans on financial relief from the impact of mandated cost-sharing waivers for testing and other procedures in response to COVID-19.
  • Advising health care providers, including laboratories, physician practices, and hospitals, on continuity of care and licensure compliance in light of COVID-19 regulatory and legislative changes.

International Trade

  • Representing U.S. information and software provider in responding to, and successful closure of, an OFAC subpoena related to Russia sanctions matters.
  • Counseled a multinational publishing company on sales to Iran under the Informational Materials exemption and Publishing General Licenses.
  • Assisted a major publicly-traded multinational manufacturer of network devices with encryption functionality on all matters relating to exports and imports of items, including U.S. licenses and classification requests and coordination with foreign counsel in multiple countries on foreign import and export requirements for encryption software and hardware.
  • Assisted a global manufacturer realize millions of dollars in duty refunds and duty savings based on an innovative interpretation of the NAFTA rules of origin related to U.S. exports of home appliances.
  • Designed AML compliance program for multiple banks, a blockchain consortium, a virtual currency exchanger, and a government sponsored enterprise.
  • Serving as lead legal advisor for American multinational aircraft manufacturer with respect to its international employment strategies in Latin America and Asia.
  • Advised on all aspects of international employment in connection with the spin-off and formation of a publicly traded health care company in Asia and Latin America.

Labor & Employment

  • Helped several leading technology, healthcare, and professional services companies design compensation and performance management policies, practices, and auditing programs to yield industry-leading pay equity programs.
  • Represented one of the “big four” U.S. technology companies in connection with more than a dozen audits conducted by the Department of Labor’s OFCCP. These audits examined the company’s compliance with federal non-discrimination and affirmative action obligations.
  • Advising a semiconductor and software manufacturer on employment-related options for screening employees for coronavirus.

Life Sciences

  • Advising a consumer product company on the advertising of its products as capable of “sanitizing” versus “sterilizing” to help them avoid any FTC or FDA issues in affirmatively positioning products to address the virus. 
  • Advising a major multinational biopharmaceutical company on its strategy for communicating to policymakers from around the world the implications of COVID-19 for global supply chain security, shortages, and quality of both active pharmaceutical ingredients and finished dosage forms.

Privacy & Cybersecurity

  • Advising an engineering services firm on the information security compliance implications of increasing its employees’ remote access to sensitive information as part of its internal response to coronavirus concerns.
  • Advising an international engineering company regarding privacy and data security risk management implications of domestic and foreign responses to coronavirus, including the use of thermal scanners at facility entrances.
  • Conducted holistic assessment and revision of its group-wide privacy compliance and cybersecurity programs of a global technology company in the wake of several acquisitions. We drafted group-wide privacy and cybersecurity compliance policies, procedures, a contractual framework for international transfers of personal data, as well as customer- and vendor-facing data processing agreements.
  • Retained by global shipping company to serve as its privacy and cybersecurity counsel in connection with responding to cybersecurity incidents as well as counselling on compliance with the latest U.S. laws, including CCPA.

Transportation

  • Served as lead counsel to the nation’s largest automaker in connection with the ventilator contract negotiations with the U.S. Government.  Led all government contracts aspects of the company’s engagement with the U.S. Government about contract negotiation, administration, and performance for this nearly $500 million contract. We also provided regulatory and contractual advice relating to production, distribution, and sale of products (including masks and other personal protective equipment) for use in connection with COVID-19 response.
  • Counseling a multinational air carrier on its obligations to comply with government requests to collect and share information about passengers traveling from areas affected by coronavirus.