Michael E. Burke

Partner
1775 Pennsylvania Avenue NW
Suite 1000
Washington, DC 20006
202.677.4046 phone
202.677.4047fax

Representative Experience

Life Sciences

  • Advised early-stage pharmaceutical companies on a range of capital-raising efforts, including venture capital financing and use of royalty structures involving outside organizations
  • Developed the cross-border distribution platform for a U.S health pharmaceutical company by crafting client’s international distribution, quality, and pharmacovigilance agreements as well as agreements for obtaining marketing authorization approvals in foreign jurisdictions
  • Represented U.S. health pharmaceutical company in negotiation and execution of global supply agreement with medical device manufacturer and related global safety data exchange agreement
  • Advised U.S. medical device company on drafting of contract manufacturing agreements with suppliers in the U.S., European Union, and South Korea, and provided guidance on own brand labeling requirements related to supply arrangements
  • Represented U.S. affiliate of Israeli biopharmaceutical company in connection with successful release from U.S. Customs hold of active pharmaceutical ingredient imported to the U.S. for finishing and export purposes
  • Counseled Canadian cosmetics company on ‘Made in USA’ designation under U.S. Customs regulations and Federal Trade Commission regulations
  • Advised U.S. manufacturer of private brand OTC drugs and nutritionals on U.S. Customs rules of origin for active pharmaceutical ingredients sourced from around the world
  • Formed U.S. affiliate for Israeli cell culture media development and manufacturing company and created a U.S. joint venture for the distribution of its products in the U.S. and Canada
  • Counseled Canadian specialty pharmaceutical company in connection with U.S. Customs importer of record issues
  • Advised U.S. clinical stage biopharmaceutical company on cross-border distribution, quality, and pharmacovigilance agreements
  • Counseled U.S. precision immunotherapy company on clinical trial agreements for sites in the U.S. and in Europe, as well as on quality and pharmacovigilance agreements related to product testing
  • Represented U.S. specialty pharmaceutical company with the formation of its distribution platform in Mexico and Central America, including drafting of related distribution, quality, and pharmacovigilance agreements
  • Represented U.S. biopharmaceutical company in connection with supply and distribution agreements with specialty pharmacies
  • Advised U.S. specialty pharmaceutical company with restructuring of its international operations through a Luxembourg holding company and drafted related interservices agreement between U.S. parent and Luxembourg affiliate
  • Advised U.S. life sciences company on agreements with third-party logistics providers for transport and storage of biopharmaceuticals across United States

FCPA and Export Controls Compliance

  • Advised U.S. defense articles manufacturer on deemed export issues, and made license filings to employ foreign nationals in positions requiring disclosure of controlled technical data
  • Designed U.S. export compliance and anti-money laundering programs for global payments processing company
  • Represented broker in connection with obtaining Office of Foreign Assets Control license to sell oil equipment to South Sudan
  • Developed FCPA and U.S. export compliance policy and program for U.S. health pharmaceutical company operating in the European Union and in Sub-Saharan Africa
  • Advised U.S. biopharmaceutical company by auditing of its distribution network and implementing its U.S. export control compliance policy and program
  • Represented U.S. software developer during investigation by Directorate of Defense Trade Controls of possible violations of International Trade in Arms Regulations; investigation closed with no charges against client
  • Led life sciences client’s internal investigation into possible FCPA violations in China, Russia, and other jurisdictions, and made related voluntary disclosure to U.S. Department of Justice
  • Advised U.S. manufacturer of defense articles and provider of defense services on sales to Turkey and Saudi Arabia, including FCPA and U.S. export control compliance in connection with such transactions
  • Developed an export control compliance program for Texas liberal arts university
  • Represented U.S. pharmaceutical company with obtaining licenses to export pharmaceuticals to Iran and Sudan pursuant to Trade Sanctions Reform and Export Enhancement Act of 2000
  • Advised U.S. software as a service company in connection with export classification and encryption registration of main service offering, and license application to export service to international humanitarian non-governmental organization in Syria
  • Counseled U.S. logistics software developer on facilitation risk under U.S. sanctions and embargo programs associated with service model, and filed export license request to Office of Foreign Assets Control

Ireland and Northern Ireland

  • Counseled Northern Irish cosmetics company on expansion to the U.S. market, including formation of U.S. affiliate, compliance with relevant U.S. Food and Drug Administration requirements, and negotiation and drafting of supply agreements with U.S. cosmetics chains
  • Advised Northern Irish non-alcoholic beverage company on creation of U.S. distribution platform
  • Counseled Northern Irish developer of mobile workforce management software in U.S. expansion, and ‘Americanized’ client’s software-as-a-service and related terms and conditions
  • Represented Northern Irish cloud based customer relationship management platform in connection with expansion to U.S. market
  • Advised Irish animal health company on sales and distribution network for U.S. market, and related U.S. Food and Drug Administration compliance issues
  • Counseled Northern Irish distillery on import issues, alcohol sales regulations, and distribution agreements for U.S. market
  • Represented Irish medical device manufacturer on U.S. expansion, compliance with relevant U.S. Food and Drug Administration requirements, and execution of distribution agreement
  • Counseled Northern Irish developer of sports player tracking and analysis system in restructuring of its U.S. operations
  • Advised Northern Irish provider of specialist data management, data analytics, and data mining services on formation of U.S. affiliate and roll-out of service offering in the United States
  • Counseled U.S. third-party logistics provider on formation of Irish holding company
  • Represented U.S. health insurance provider in connection with formation of Irish affiliate and service offerings to U.S. students in Europe and Middle East
  • Served as outside general counsel to 501(c)(3) non-profit organization of Irish scientists and engineers

Corporate and Commercial

  • Represented Spanish manufacturer of generic pharmaceutical products in its formation of a U.S. affiliate and subsequent purchase by that affiliate of U.S generic pharmaceutical manufacturer
  • Counseled U.S. specialty pharmaceutical company in obtaining $400 million loan facility
  • Advised pain management provider in sale to portfolio company of Colorado-based private equity fund
  • Counseled U.S. directional drilling equipment manufacturer and service provider on supply and services agreements with oil and gas producer for hydraulic fracturing projects
  • Represented U.S. telehealth provider in Seed and Series A financing rounds
  • Advised U.S. technology company on compliance with filing requirements of the Committee of Foreign Investment in the United States related to company’s sale to Brazilian purchaser
  • Counseled officers and directors of U.S. mining company on exercise of put option to sell controlling interest in company to Australian investors
  • Advised leading Turkish confectionary company on formation of U.S. affiliate and the development of its U.S. distribution network
  • Counseled U.S. developer of software for customs compliance on terms and conditions of its software as a service offering
  • Advised purchaser in connection with its acquisition of leading manufacturer of nonwoven products for the automotive, mattress, healthcare and other industrial industries
  • Advised background screening company in connection with development of its software as a service platform
  • Counseled telemedicine software provider on creation of, and compensation for, advisory board
  • Converted leading government contractor from limited liability company to corporation
  • Represented manufacturer of coaxial cables and related products on international distribution agreements

China

  • Counseled U.S. medical device company on supply and quality agreements with Chinese components manufacturers
  • Advised U.S. mining original equipment manufacturer on developing and securing China-originating supply chain for drilling products
  • Represented leading developer of museum exhibitions on design-install and related agreements for exhibition in to-be-constructed development in Macau
  • Effectively structured Swedish multinational software company’s China operations
  • Represented U.S. life sciences company on acquisition of Chinese biopharmaceutical company
  • Advised U.S. e-commerce platform on expansion to Chinese market, and devised related operational risk mitigation and intellectual property protection strategies
  • Counseled U.S. heavy equipment manufacturer on sales and distribution issues involving Chinese market