Michael E. Burke

Partner

Fax: 202.677.4047
Washington
1775 Pennsylvania Avenue NW
Suite 1000
Washington, District of Columbia 20006

Biography

Mike is a partner in the Corporate & Finance practice, co-chair of the Pharmaceuticals & Biologics industry team, and the administrative partner of the firm’s Washington, DC office. Focusing on productive business growth, Mike provides practical, actionable guidance that minimizes risk and maximizes return across a wide range of domestic and international businesses. He offers creative, efficient and sensible advice to clients when they most need it.

Clients work with Mike to complete business formations, structure and execute mergers and acquisitions, raise venture capital, build and operate joint ventures and strategic alliances, create distribution and reseller networks, license intellectual property, and establish quality and pharmacovigilance agreements. He also advises on compliance with the U.S. Foreign Corrupt Practices Act, U.S. export controls and economic sanctions programs, and U.S. antiboycott regulations. Mike’s vast experience with cross-border transactions spans 50 international jurisdictions and includes China-related investments, acquisitions, and technology ventures. He has a proven track record guiding multiple businesses from Ireland and Northern Ireland to successfully enter the U.S. market.

A natural leader, Mike has the distinction of being the youngest person ever elected as chair of the American Bar Association Section of International Law; he has also served as Chair of the ABA’s Section Officer’s Conference and currently serves in the ABA’s House of Delegates. Mike is on the Board of the Ireland America Science Forum, a project supported by the Irish Government’s Emigrant Support Programme.  Additionally, Mike Co-Chairs the ABA-United Nations Development Programme’s International Legal Resource Center.

Mike authors the Irish Export Insights blog, https://irishexportinsights.com/, a resource for Irish and Northern Irish businesses expanding to the U.S. market. He is also a co-editor and co-author of The Corporate Counsel’s Guide to Doing Business in China, published by Thomson Reuters.

Experience

  • 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

  • Advised early-stage pharmaceutical companies on a range of capital-raising efforts, including venture capital financing and use of royalty structures involving outside organizations

  • Counseled officers and directors of U.S. mining company on exercise of put option to sell controlling interest in company to Australian investors

  • Converted leading government contractor from limited liability company to corporation

  • Advised pain management provider in sale to portfolio company of Colorado-based private equity fund

  • Counseled U.S. specialty pharmaceutical company in obtaining $400 million loan facility

  • Advised background screening company in connection with development of its software as a service platform

  • Represented manufacturer of coaxial cables and related products on international distribution agreements

  • 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 telemedicine software provider on creation of, and compensation for, advisory board

  • Advised leading Turkish confectionary company on formation of U.S. affiliate and the development of its U.S. distribution network

  • Represented broker in connection with obtaining Office of Foreign Assets Control license to sell oil equipment to South Sudan

  • 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

  • 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

  • Counseled Canadian specialty pharmaceutical company in connection with U.S. Customs importer of record issues

  • 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 Canadian cosmetics company on ‘Made in USA’ designation under U.S. Customs regulations and Federal Trade Commission regulations

  • 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

  • Counseled Northern Irish developer of sports player tracking and analysis system in restructuring of its U.S. operations

  • 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

  • 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

  • Counseled U.S. medical device company on supply and quality agreements with Chinese components manufacturers

  • 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

  • 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

  • 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

  • Counseled U.S. third-party logistics provider on formation of Irish holding company

  • 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

  • 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

  • Advised U.S. biopharmaceutical company by auditing of its distribution network and implementing its U.S. export control compliance policy and program

  • Advised Northern Irish non-alcoholic beverage company on creation of U.S. distribution platform

  • Developed an export control compliance program for Texas liberal arts university

  • 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

  • Advised U.S. life sciences company on agreements with third-party logistics providers for transport and storage of biopharmaceuticals across United States

  • Designed U.S. export compliance and anti-money laundering programs for global payments processing 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

  • Counseled U.S. developer of software for customs compliance on terms and conditions of its software as a service offering

  • 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

  • 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

  • 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

  • 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

  • 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

  • Represented leading developer of museum exhibitions on design-install and related agreements for exhibition in to-be-constructed development in Macau

  • 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

  • Represented Northern Irish cloud based customer relationship management platform in connection with expansion to U.S. market

  • 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

  • Served as outside general counsel to 501(c)(3) non-profit organization of Irish scientists and engineers

  • Represented Irish medical device manufacturer on U.S. expansion, compliance with relevant U.S. Food and Drug Administration requirements, and execution of distribution agreement

  • Advised U.S. mining original equipment manufacturer on developing and securing China-originating supply chain for drilling products

  • 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. clinical stage biopharmaceutical company on cross-border distribution, quality, and pharmacovigilance agreements

  • 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 purchaser in connection with its acquisition of leading manufacturer of nonwoven products for the automotive, mattress, healthcare and other industrial industries

  • Advised U.S. e-commerce platform on expansion to Chinese market, and devised related operational risk mitigation and intellectual property protection strategies

  • Represented U.S. life sciences company on acquisition of Chinese biopharmaceutical company

  • Counseled U.S. heavy equipment manufacturer on sales and distribution issues involving Chinese market

  • Effectively structured Swedish multinational software company’s China operations.

  • Counseled Irish private equity fund in connection with acquisition of U.S. medical device company

  • Counseled telemedicine software provider on creation of, and compensation for, advisory board

  • Guided multiple Irish and Northern Irish businesses, across a range of economic sectors (but with a focus in life sciences), on all aspects of expansion to the U.S. market

  • Represented portfolio company of U.S. private equity fund in acquisition of competitor medical device company and competitor’s manufacturing affiliates in China, Hong Kong, and Mexico

Credentials

  • Georgetown University Law Center, Juris Doctor — 1998
  • Georgetown University, Bachelor of Science - Foreign Service — 1993,

    cum laude

    • Scholar’s Medal
  • District of Columbia 2002
  • State of New York 2000
  • United States Court of Appeals for the Federal Circuit 2002
  • United States Court of International Trade 2002
  • United States Supreme Court 2002
  • Professional:

    • American Bar Association–Section of International Law (Chair, 2011–12) (Chair-elect, 2010–11) (Vice Chair, 2009–10) (Secretary, Operations Officer, 2008–09) (Liaison Officer, 2007–08) (Technology Officer, 2002–06) (Member of the Section Council, 2002–06; 2007–present) (Co-chair, International Legal Exchange Program to Australia and New Zealand, 2010) (Co-chair, International Legal Exchange Program to South Korea, Japan, China and Hong Kong, 2008) (Spring Meeting Co-chair, 2007) (Chair, 2004–07, Vice Chair, 1999–2004, China Committee)
    • LAWASIA, United States Country Councillor (2010-2016)
    • ABA Section of International Law, ABA House of Delegates (2018-present)
    • American Bar Association—Section Officer’s Conference (Chair, 2013-2015) (Chair of Chair’s Class, 2011-2012)
    • American Bar Association—ABA-United Nations Development Programme International Legal Resource Center (Co-Chair, 2015-present)
    • American Bar Association’s Law Student Division, Advisory Council member (2017-present)
    • Liaison between the American Bar Association Section of International Law and each of the Law Society of Ireland, the General Council of the Bar of Ireland, the Law Society of Northern Ireland, and the Bar of Northern Ireland (2015-present).
    • U.S. delegate to the Legal Exchange of the U.S. Joint Commission on Commerce and Trade (2003)
    • Technical Legal Assistance Projects: Socialist Republic of Vietnam (Unified Enterprise Law and Unified Common Investment Law); People’s Republic of China (Regulation of Chinese Enterprises by Foreign Investors; Securities Law; Company Law; and the Regulation on the Administration of Foreign-invested Venture Capital Enterprises); and the Federal Democratic Republic of Nepal (Federalism and Drafting of new Constitution)
    • Catalyst, Inc. Connect (formerly NISP Connect), Belfast, Northern Ireland
    • PorterShed, Galway, Ireland

     

    Community:

    • Georgetown University Alumni Association
    • Friends of the Baseball Hall of Fame
    • Red Sox Nation

Recognition

  • Washington DC Super Lawyers, 2014-2019
  • Irish Legal 100, 2012, 2013, 2015
  • AV Preeminent™ Rating, Martindale-Hubbell, 2014
  • 100 Global Irish Business Leaders, Business & Finance Magazine/Ireland INC, 2014

News & Insights

Irish Exports Insights

Ireland and Northern Ireland create cutting-edge, world class products and services. The United States is a natural market for these products and services, but suffers from a perception that the market is ‘risky’ or ‘difficult.’ Not so. With practical advance planning and understanding of potential risk points, the operational risk of exporting or expanding to the U.S. can be controlled and mitigated. We call that “smart exporting.” The Irish Exports Insights blog will provide information so that Irish and Northern Irish companies can engage in “smart exporting.”