Michael E. Burke

Partner

Direct: 202.677.4046
Fax: 202.677.4047
Washington
2100 Pennsylvania Avenue NW
Suite 350S
Washington, District of Columbia 20037

Biography

Mike is a partner in the Corporate & Finance practice, co-chair of the International practice, and co-chair of the Life Sciences industry team. He also serves as the administrative partner of the Washington, D.C. office. With a proven track record of helping countless business from the Island of Ireland successfully expand into the U.S., Mike is adept at managing the complexities of international business growth.

Mike’s experience with cross-border transactions spans more than 50 jurisdictions. His extensive background in both domestic and international matters enables him to provide clients with practical, actionable guidance that effectively minimizes risks and maximizes returns. Mike’s approach is distinguished by his ability to deliver creative, efficient, and reliable advice, precisely when it is most critical for his clients’ current and future needs.

Companies seek advice from Mike given his extensive experience and knowledge of helping scaling companies access various state and federal incentives and grants in the U.S., as well as helping companies navigate the complexities of investing and expanding in the U.S., including business formations, mergers and acquisitions, joint ventures, and strategic alliances. He plays a pivotal role in establishing distribution and reseller networks, licensing intellectual property, and implementing quality and pharmacovigilance agreements. Additionally, Mike provides critical counsel on compliance with key U.S. regulations, including the Foreign Corrupt Practices Act, export controls, economic sanctions programs, and antiboycott regulations.

Mike is a frequent guest author and contributor to Ireland INC, which serves as a vital platform for maximizing the commercial potential of Irish businesses across the U.S. Additionally, Mike hosts the “AGG Talks: Cross-Border Business” podcast, where he delves into the intricacies of both inbound and outbound investments. His commitment to fostering transatlantic business relations is further demonstrated through his membership in organizations such as Scale Ireland and Catalyst, as well as his collaborations with NovaUCD, Enterprise Ireland, and InvestNI on U.S. investment matters. Mike also serves on the board of the Ireland America Science Forum, a project supported by the Irish Government’s Emigrant Support Programme.

A natural leader, Mike holds the distinction of being the youngest individual ever elected as chair of the American Bar Association (“ABA”) Section of International Law. His leadership within the ABA extends beyond this role, having also served as chair of the ABA’s Section Officers Conference and in the ABA’s House of Delegates. In addition, Mike co-chaired the ABA-United Nations Development Programme’s International Legal Resource Center and serves on the Advisory Committee to the International Bar Association’s Law Firm Management Committee.

An accomplished author, Mike has penned over 25 law review articles focused on cross-border business and has contributed to several authoritative books in the field. Notably, he is a co-editor and co-author of The Corporate Counsel’s Guide to Doing Business in China and Doing Business in Australia,. He has also contributed to Joint Ventures in the International Arena and Financial Restructuring and Reform in Post-WTO China.

 

Related Services

Related Industries

Related Markets

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

  • 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

  • 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

  • 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 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

  • 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

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

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

  • 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. 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

  • 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 U.S. health insurance provider in connection with formation of Irish affiliate and service offerings to U.S. students in Europe and Middle East

  • 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

Client Successes

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Credentials

Education
  • Georgetown University Law Center, Juris Doctor
  • Georgetown University, Bachelor of Science - Foreign Service,
    cum laude
    • Scholar’s Medal
Admissions
  • District of Columbia – 2002
  • State of New York – 2000
Court Admissions
  • United States Court of Appeals for the Federal Circuit – 2002
  • United States Court of International Trade – 2002
  • United States Supreme Court – 2002
Associations

  • 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 (2010-16)
    • ABA Section of International Law, ABA House of Delegates (2018-present)
    • American Bar Association Section Officer’s Conference (Chair, 2013-15) (Chair of Chair’s Class, 2011-12)
    • 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)
    • International Bar Association, Law Firm Management Committee Projects Subcommittee (Vice Chair)
    • 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, D.C. Super Lawyers, 2014-22
  • “The Irish Legal 100,” Irish Voice, 2012, 2013, 2015
  • AV Preeminent®, Martindale-Hubbell Peer Review Ratings, 2014
  • “100 Global Irish Business Leaders,” Business & Finance Magazine/Ireland INC, 2014

News & Insights

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AGG Talks: Cross-Border Business Podcast

Our podcast series, “AGG Talks: Cross-Border Business,” is hosted by Mike Burke, AGG Corporate partner, co-chair of the International practice, and administrative partner of the firm’s Washington, D.C. office. Mike is joined by fellow AGG attorneys and experts in cross-border business to discuss legal issues impacting both inbound and outbound foreign investment.