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18th Annual FCPA & Anti-Corruption for the Life Sciences Industry

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MoFo partner James Koukios will be speaking in a session entitled, "Engaging with Foreign Governments and Providers: Special Considerations for Gaining Access to Government Formularies and the Sale of Drugs and Medical Supplies, Devices and Vaccine Procurement" at ACI's Annual FCPA & Anti-Corruption for the Life Sciences Industry conference on May 11, 2023. 

MoFo partner James Koukios will be speaking in a session entitled, "Engaging with Foreign Governments and Providers: Special Considerations for Gaining Access to Government Formularies and the Sale of Drugs and Medical Supplies, Devices and Vaccine Procurement" at ACI's Annual FCPA & Anti-Corruption for the Life Sciences Industry conference on May 11, 2023. The discussion will include:<ul><li>HCPs as government officials and how to mitigate risk when they may be wearing two hats;</li><li>The importance of including key contractual provisions, including audit rights, subcontractor notification requirements, annual compliance certifications, and mechanisms for billing for pass through costs;</li><li>Use of third-party intermediaries and the special risks they present in helping gain access to foreign markets; and</li><li>The proper role of political contributions and/or lobbying outside the United States.</li></ul>ACI's Annual FCPA & Anti-Corruption for the Life Sciences Industry conference is the premier event for legal and compliance professionals from pharmaceutical, medical device, CRO, and biotechnology companies to connect, compare notes and expand their networks.<a href="https://www.americanconference.com/fcpa-life-sciences/pricing/" target="_blank">Register</a> to attend.<hr>

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James Koukios is co-chair of Morrison Foerster’s Securities Litigation, Enforcement, and White Collar Defense Group and serves as co-head of the FCPA + Global Anti-Corruption Practice. James represents companies and individuals in high-stakes government enforcement actions and complex internal investigations. He has handled matters across a wide range of jurisdictions including Brazil, China, Greece, India, Russia, Venezuela, and Vietnam, among others. James draws on his experience as a federal prosecutor, when he tried over 20 federal jury cases and supervised hundreds of white collar investigations, to obtain the best results for his clients. He is consistently praised for his judgment and advocacy in complex investigations and enforcement actions. Chambers USA notes that he is “super experienced with excellent judgement regarding what the government is looking for and concerned about,“ while Chambers Global describes James as, “a forceful advocate when appearing before the government.”Before joining Morrison Foerster, James spent 10 years at the U.S. Department of Justice (DOJ), beginning as an Assistant United States Attorney in Miami and finishing as Senior Deputy Chief of the Criminal Division’s Fraud Section in Washington, D.C., where he supervised investigations, prosecutions, and resolutions in the Fraud Section’s FCPA, Health Care Fraud, and Market Integrity and Major Fraud Units. While at DOJ, James investigated and prosecuted health care fraud, procurement fraud, domestic and foreign corruption, money laundering, and export control offenses, working closely with state, federal, and foreign law enforcement officials, as well as the U.S. Securities and Exchange Commission (SEC), the U.S. Departments of Defense, State, and Commerce, and intelligence agencies.While at DOJ, James assisted in drafting the widely acclaimed DOJ and SEC joint publication A Resource Guide to the U.S. Foreign Corrupt Practices Act, which followed a series of consultations with business and compliance leaders. He was also a lead examiner for the Phase 2 examination of Russia’s compliance with the Anti-Bribery Convention of the Organisation for Economic Co-operation and Development (OECD).From 2010 to 2011, James served as Special Counsel to then-FBI Director Robert S. Mueller, III, advising the Director and other FBI executives on criminal policy issues, preparing FBI Executive Management for congressional testimony, representing the FBI at interagency meetings, and acting as a liaison between FBI and other DOJ components.James has been recognized as: a leading lawyer in FCPA (Nationwide and Global) by Chambers USA and Chambers Global; a recommended lawyer for corporate investigations and white collar defense by Legal 500; an “Expert” and a “Thought Leader” in investigations by Who’s Who Legal; and an “Attorney Who Matters” by the Ethisphere Institute for making an impact in the area of ethics and compliance. He also received the Assistant Attorney General’s Distinguished Service Award in recognition for his work on two landmark FCPA-related trials: United States v. Esquenazi and United States v. Duperval. James also served as a lead prosecutor in United States v. AEY Inc., a defense procurement fraud and export licensing case that served as the basis for the 2016 film War Dogs.James is a recognized thought leader on the latest legal trends and industry developments. Chambers Global notes that, “James has a keen ability to distill trends and enforcement down to their core. He is a crisp thinker and discerning with regards to the market.” He is the lead editor of our award-winning monthly newsletter, Top 10 International Anti-Corruption Developments, which succinctly summarizes important case and policy developments for busy in-house counsel, compliance professionals, and anti-corruption lawyers. James also served as an adjunct professor of trial advocacy at the Georgetown University Law Center for over 10 years and regularly guest lectures at leading law and business schools on investigations, white collar enforcement, and anti-corruption issues.<h4>Selected Significant Representations</h4><h5>FCPA and Global Anti-Corruption</h5><ul><li>Successful resolution of a transnational bribery investigation of a multinational pharmaceutical company, securing cooperation credit, avoiding the imposition of a corporate compliance monitor, and negotiating a deferred prosecution agreement with DOJ and an administrative resolution with the SEC.</li><li>Successful representation of a multinational medical device company in conducting an internal investigation into allegations of bribery in Vietnam that led to a deferred prosecution agreement with DOJ.</li><li>Representation of an international consulting firm in extensive, government-facing international corruption and money laundering investigations involving China, India, and other jurisdictions.</li><li>Representation of a multinational automotive company in an internal investigation into allegations of bribery in its Latin America operations and antitrust violations and whistleblower retaliation in its U.S. operations.</li><li>Representation of a consumer retail company in an internal investigation into allegations of bribery in its Indonesian operations.</li><li>Representation of business executives in government-facing FCPA investigations involving Brazil, China, Venezuela, and other jurisdictions.</li><li>FCPA legal advice, anti-corruption counseling, transactional due diligence, and post-acquisition integration advice to multinational corporations in several industries, including defense, extractive, financial services, food, gaming, health care, and technology.</li><li>Review of a multinational company’s compliance management system in connection with the spin-off of a subsidiary and investigations by multiple enforcement agencies.</li></ul><h5>Consumer Protection and Product Safety</h5><ul><li>Successful representation of a multinational consumer electronics company in the first-ever corporate criminal resolution of an alleged Consumer Product Safety Act (CPSA) violation, securing cooperation credit, avoiding the imposition of a corporate compliance monitor, and negotiating a deferred prosecution agreement for the parent company with DOJ.</li><li>Representation of a multinational vehicle manufacturer in a criminal CPSA investigation being led by DOJ’s Consumer Protection Branch.</li><li>Representation of the CEO of a consumer electronics company in a criminal CPSA investigation being led by DOJ’s Consumer Protection Branch.</li><li>Representation of the Supervisory Board of a car manufacturer in an investigation by DOJ, the U.S. Environmental Protection Agency, the California Air Resources Board, SEC, various state Attorneys General, German Prosecutors and the German vehicle admissions agency into potential violations of environmental, capital markets, consumer protection, antitrust and criminal laws.</li></ul><h5>Other White Collar and Civil Fraud Defense Matters</h5><ul><li>Representation of a multinational technology company in responding to a subpoena issued by the U.S. House of Representatives’ Judiciary Committee related to an investigation into alleged suppression or restriction of conservative opinions through “content moderation” policies on social media platforms.</li><li>Successful representation of a multinational defense contractor in conducting an internal investigation that led to a declination from the State Department for potential International Trafficking in Arms Regulation (ITAR) violations without referral to DOJ.</li><li>Representation of a consumer retail company in a DOJ insider trading investigation.</li><li>Representation of a company and several of its employees in connection with the Special Counsel investigation into Russian interference in the 2016 Presidential election.</li><li>Representation of Anthony Ornato, a former senior career civil servant who served as White House Deputy Chief of Staff of Operations, in the January 6 Select Committee investigation and related government investigations.</li><li>Representation of two former high-level executives of a public company in internal and external investigations concerning allegations of fraud, misuse of company funds, record violations, and disclosure violations and in a derivative lawsuit in the Delaware Chancery Court regarding alleged violations of fiduciary duty, corporate waste, and unjust enrichment.</li><li>Representation of business executives in anti-money-laundering, criminal securities fraud, whistleblower retaliation, government procurement fraud, and other DOJ investigations.</li><li>Defended independent directors against breach-of-fiduciary-duty claims in federal bankruptcy court, successfully moving to dismiss all claims against the directors with prejudice.</li></ul>

James Koukios é co-líder do grupo de Contencioso de Valores Mobiliários e Defesa de Colarinho Branco e atua como co-líder global do grupo FCPA (Foreign Corrupt Practices Act) + Anticorrupção. James representa empresas e indivíduos em ações governamentais de alto risco e investigações internas complexas.James, um experiente advogado de litígios e ex-promotor federal, litigou mais de 20 casos federais de júri, inclusive sendo o principal promotor em dois julgamentos históricos relacionados à FCPA: Estados Unidos v. Esquenazi e Estados Unidos v. Duperval. James também atuou como promotor-chefe nocaso Estados Unidos v. AEY Inc., um caso de fraude de aquisição de defesa e licenciamento de exportação que serviu de base para o filme de 2016 chamado "Cães de Guerra".<h4>Casos Representativos</h4><ul><li>Representou empresas multinacionais de dispositivos médicos e farmacêuticos em investigações da FCPA perante o governo.</li><li>Representou empresas e organizações multinacionais em vários setores a conduzir investigações internas sobre possíveis violações de FCPA, ITAR, sobre informações privilegiadas, entre outras violações.</li><li>Representou uma empresa e vários de seus funcionários em investigações do Conselho Especial.</li><li>Representou uma empresa de produtos de consumo em uma investigação criminal de segurança de produtos perante o governo.</li><li>Forneceu consultoria jurídica sobre FCPA, consultoria anticorrupção, due diligence transacional e consultoria de integração pós-aquisição a empresas multinacionais em vários setores, incluindo defesa, extração, serviços financeiros, alimentos, assistência médica e tecnologia.</li><li>Representou indivíduos em casos de investigações anti-corrupção, lavagem de dinheiro, fraude criminal em valores mobiliários, retaliação de denunciantes, fraude de compras do governo, dentre outras.</li><li>Defendeu conselheiros independentes contra reclamações por quebra de obrigações fiduciárias no tribunal federal de falências.</li></ul>Antes de ingressar na Morrison Foerster, James trabalhou  por 10 anos no Departamento de Justiça dos Estados Unidos, começando sua carreira como Advogado Assistente dos Estados Unidos em Miami e encerrando seu mandato no Departamento de Justiça como Chefe Adjunto de Seção de Fraude da Divisão Criminal em Washington, DC, onde supervisionou investigações, processos e resoluções na Seção de Fraude em FCPA, Fraude em Assistência Médica, e em Valores Mobiliários e na Unidade de Fraude Financeira. Enquanto estava no Departamento de Justiça, James investigou e processou fraudes na área da saúde, fraude de compras, corrupção doméstica e estrangeira, lavagem de dinheiro e infrações de controle de exportação, trabalhando em estreita colaboração com autoridades estaduais, federais e estrangeiras, bem como a Comissão de Valores Mobiliários dos Estados Unidos (SEC); Departamentos de Defesa, Estado e Comércio dos Estados Unidos; e agências de inteligência. Ele ajudou na redação da amplamente divulgada publicação conjunta da SEC e do Departamento de Justiça, “Guia de Recursos da Lei de Práticas de Corrupção no Exterior dos Estados Unidos (“A Resource Guide to the U.S. Foreign Corrupt Practices Act”), que seguiu uma série de consultas com os líderes de negócios e conformidade. Ele também foi examinador principal da Fase 2 da avaliação de conformidade da da Rússia com a Convenção Anti-suborno da Organização para Cooperação e Desenvolvimento Econômico (OCDE).De 2010 a 2011, James atuou como consultor especial do então diretor do FBI Robert S. Mueller, III, assessorando o diretor e outros executivos do FBI em questões de política criminal, preparando a Diretoria Executiva do FBI para testemunhar perante o Congresso, representando o FBI em reuniões entre agências e atuando como uma ligação entre o FBI e outros componentes do Departamento de Justiça.James foi reconhecido como um dos principais advogados da FCPA, nacional e globalmente, pela Chambers USA e pela Chambers Global, "recomendado" para investigações corporativas e advocacia de colarinho branco pelo Legal 500, um "especialista" e um "líder de pensamento" nas investigações do Who is Who Legal e um "advogado que importa" pelo Instituto Ethisphere por ter um impacto na área de ética e conformidade. Ele também recebeu o Prêmio de Serviço Distinto do Procurador Geral em reconhecimento ao seu trabalho nos julgamentos de Esquenazi e Duperval durante seu período no Departamento de Justiça.James é professor adjunto de defesa de julgamento no Centro de Direito da Universidade de Georgetown e é regularmente convidado para palestras nas principais faculdades de administração e direito sobre investigações, fiscalização de colarinho branco e questões anticorrupção.

James Koukios es copresidente del grupo de Litigios de Valores, Aplicación de la Ley y Defensa de Cuello Blanco de la firma y se desempeña como codirector global del grupo de FCPA (Foreign Corrupt Practices Act) + Anticorrupción de la firma. James representa a empresas e individuos en acciones gubernamentales de alto riesgo e investigaciones internas complejas.James, un abogado con experiencia litigando y ex fiscal federal, ha litigado más de 20 casos de jurado federal, incluyendo ser el fiscal principal en dos juicios históricos relacionados con la FCPA: Estados Unidos v. Esquenazi y Estados Unidos v. Duperval. James también se desempeñó como fiscal principal en Estados Unidos v. AEY Inc., un caso de fraude de adquisición de defensa y licencias de exportación que sirvió de base para la película de 2016 llamada “War Dogs”.<h4>Experiencia Representativa</h4><ul><li>Representó a compañías multinacionales de dispositivos médicos y farmacéuticos en investigaciones de la FCPA ante el gobierno.</li><li>Asistió a compañías y organizaciones multinacionales en varios sectores llevando a cabo investigaciones internas sobre posibles FCPA, ITAR, abuso de información privilegiada y otras violaciones.</li><li>Representó a una empresa y a varios de sus empleados en relación con las investigaciones sobre delitos de investigación del Consejo Especial.</li><li>Representó a una compañía de productos de consumo en una investigación criminal de seguridad de productos del gobierno.</li><li>Brindó asesoramiento legal de FCPA, asesoramiento anticorrupción, diligencia debida transaccional y asesoramiento de integración posterior a la adquisición a corporaciones multinacionales en varias industrias, incluyendo defensa, extracción, servicios financieros, alimentos, atención médica y tecnología.</li><li>Representó a personas en anticorrupción, anti-lavado de dinero, fraude de valores criminales, represalias de denunciantes, fraude de compras gubernamentales y otras investigaciones.</li><li>Defendió a directores independientes contra demandas por incumplimiento de obligaciones fiduciarias en un tribunal federal de quiebras.</li></ul>Antes de unirse a Morrison Foerster, James trabajó 10 años en el Departamento de Justicia de los Estados Unidos, comenzando su carrera como Asistente del Fiscal de los Estados Unidos en Miami y terminando su mandato en el Departamento de Justicia como Subjefe Principal de la Sección de Fraude de la División Criminal en Washington, D.C., donde supervisó investigaciones, enjuiciamientos y resoluciones en la FCPA de la Sección de Fraude, Fraude de Atención Médica y Unidades de Valores y Fraude Financiero. Mientras estuvo en el Departamento de Justicia, James investigó y procesó el fraude a la atención médica, el fraude de adquisiciones, la corrupción nacional y extranjera, el lavado de dinero y los delitos de control de exportaciones, trabajando en estrecha colaboración con los funcionarios estatales, federales y extranjeros encargados de hacer cumplir la ley, así como con la Comisión de Bolsa y Valores de EE. UU. (SEC); Departamentos de Defensa, Estado y Comercio de los Estados Unidos; y agencias de inteligencia. Asistió en la redacción de la publicación conjunta del Departamento de Justicia y la SEC, ampliamente aclamada, “Guía de recursos de la Ley de prácticas corruptas en el extranjero de EE. UU.” (“A Resource Guide to the U.S. Foreign Corrupt Practices Act”), que siguió a una serie de consultas con líderes empresariales y de cumplimiento. También fue un examinador principal para el examen de Fase 2 del cumplimiento de Rusia con la Convención Antisoborno de la Organización para la Cooperación y el Desarrollo Económico (OCDE).De 2010 a 2011, James se desempeñó como Asesor Especial del entonces Director del FBI Robert S. Mueller, III, asesorando al Director y a otros ejecutivos del FBI sobre cuestiones de política criminal, preparando a la Dirección Ejecutiva del FBI para el testimonio ante el Congreso, representando al FBI en las reuniones interinstitucionales, y actuando como enlace entre el FBI y otros componentes del Departamento de Justicia.James ha sido reconocido como abogado líder en FCPA tanto nacionalmente como globalmente por Chambers USA y Chambers Global, "recomendado" para investigaciones corporativas y defensa de cuello blanco por Legal 500, un "experto" y un "líder de pensamiento" en investigaciones de Who's Who Legal, y un "Abogado que importa" por Ethisphere Institute por tener un impacto en el área de ética y cumplimiento. También recibió el Premio al Servicio Distinguido del Fiscal General Adjunto en reconocimiento por su trabajo en los juicios de Esquenazi y Duperval durante su tiempo en el Departamento de Justicia.James es profesor adjunto de defensa de juicios en el Centro de Leyes de la Universidad de Georgetown y regularmente es invitado a conferencias en las principales escuelas de derecho y de negocios sobre investigaciones, aplicación de cuello blanco y temas anticorrupción.

18th Annual FCPA & Anti-Corruption for the Life Sciences Industry

10 May 2023 - 11 May 2023