BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. An.

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BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. An Overview of the Foreign Corrupt Practices Act Joseph B. Tompkins, Jr. Sidley Austin LLP Washington, DC Presentation to: Ninth Annual Pharmaceutical Regulatory and Compliance Congress Washington, DC October 27-29, 2008

FCPA Overview Anti-bribery Rules Enforcement and Penalties OECD and United Nations Anti-bribery Conventions Enforcement Environment and Trends Actual Prosecutions

Anti-bribery Rules

U.S. Foreign Corrupt Practices Act (FCPA) FCPA first enacted in 1977 Criminalizes the bribery of foreign officials anywhere in the world where the purpose of the bribe is to influence an official decision in order to obtain or retain business. Jointly enforced by the U.S. Department of Justice and the U.S. Securities and Exchange Commission

Elements of an FCPA Violation A “covered” person / entity Must offer or give something of “value” To a “foreign official” To “obtain or retain business” With “corrupt” intent

Who is a “Covered” Person? Issuers of registered securities in the U.S. (includes non- U.S. companies who trade ADRs on U.S. stock exchanges) All “domestic concerns” meaning U.S. citizens, residents, companies, and foreign branches of U.S. companies Officers, directors, employees, and agents of the above Foreign companies or persons who commit acts in furtherance of corrupt payments while in the U.S. or who cause others to do so.

What is “Value”? Anything of value broadly construed –Cash and cash equivalent –Extravagant hosted travel and non-monetary gifts –Intangible benefits such as enhanced reputational value for the official or benefit conferred to favored cause or charity –Benefit to third persons with connection to government officials Includes offer or promise alone NO de minimis exception if improper intent

Who is a “Foreign Official”? Foreign officials at all levels very broadly defined –any officer or employee of a government or any department, agency, or instrumentality of a government; –any person acting in an official capacity on behalf of a government; –any officer or employee of a company or business owned in whole or part by a government; –any officer or employee of a public international organization such as the World Bank or the United Nations; –any officer or employee of a political party or any person acting in an official capacity on behalf of a political party; and/or –any candidate for political office.

Is the Payment to “Obtain or Retain Business”? Payment made to obtain or retain business by: –Influencing any official act or decision –Inducing official to do or omit to do acts in violation of official duties –Securing any improper advantage –Inducing official to influence acts of government Need not relate to specific business opportunity Bribes with any “business nexus” such as to reduce foreign duties/taxes can violate FCPA

Is There a “Corrupt” Intent? Benefit conferred or offered to induce foreign official to abuse or misuse his/her position or authority through action or inaction Quid pro quo generally assumed –Gift/payment made with reasonable expectations of some official favor in return –Quid pro quo need not be executed –Official need not be able to deliver “quo” herself Government need not establish defendant knew his/her conduct violated FCPA

Indirect Offers/Payments Prohibited Payment or offers/promises to pay any person while knowing all or portion of value will be given, directly or indirectly, to any foreign official are prohibited “Knowing” means: –Actual awareness –A firm belief as to the existence of such circumstance or that such circumstance will occur –A high probability of the existence of circumstance unless the person “actually believes that such circumstance does not exist” –No “willful blindness” - i.e., conscious disregard or deliberate ignorance of known circumstances that should alert one to FCPA violations is not permitted

Exceptions and Affirmative Defenses Exception –“Routine” governmental action - i.e., “grease payments” Affirmative Defenses –Payments authorized by written foreign law –Bona fide business expenditures

Exception: “Routine” Governmental Action Anti-bribery rules do not apply to payment to secure “routine” governmental action Examples –Obtain permits, licenses, visas –Secure police protection, timely official inspections –Provide phone, mail, power, water service, loading/unloading cargo, protecting perishable products –“Actions of a similar nature” Ministerial acts, not discretionary actions Perform official function faster, not make a different substantive decision

Affirmative Defense: Written Foreign Law Lawful under written law of host country –Informal business customs or practices NOT covered Examples –Lawful political contributions, modest gifts, training of officials Limited Utility –Must be explicitly authorized –Significant downside risks

Affirmative Defense: Bona Fide Expenditures Reasonable Business Expenditures –Directly related to legitimate promotional or contract activities –Reasonable under the circumstances –Bona fide and made in good faith Examples –Reimbursement for travel, meals, entertainment –Product samples –Customer training

Record Keeping Requirements Keep accurate books, records and accounts – In reasonable detail to accurately and fairly reflect the transactions and dispositions of the assets of the issuer – Requirement can apply to foreign subsidiaries Adhere to internal controls to ensure compliance – Expenditures have proper management authorization – In accordance with GAAP principles – Audited to show existing assets match books and records

Enforcement and Penalties

Anti-bribery Penalties: Companies Criminal Penalties –Up to $2 million criminal fine per violation Civil Penalties –Up to $11K civil fine per violation –Up to $25M for books and records violations Collateral Consequences –Harm to public relations and reputation –Inability to partake in U.S. government procurement or receive export licenses –Unlawful FCPA payments are not tax deductible as business expense, but are taxable items

Anti-bribery Penalties: Individuals Criminal Penalties –Up to $100K criminal fine per violation –Up to 5 years’ imprisonment per violation –Up to $5M or 20 years in prison for books and records violation Civil Penalties –Up to $11K civil fine per violation –SEC may seek additional fines up to $100K based on expected profit Collateral Consequences –Fines are NOT reimbursable by the company

OECD and United Nations Anti-bribery Conventions

OECD Anti-bribery Convention “Globalization” of U.S. law by Organization for Economic Cooperation & Development (OECD) –Establishes standard to be met by all Parties in defining offense of bribery of foreign officials, which is similar to FCPA –Calls upon Parties to take all necessary measures to establish bribery of foreign officials as a criminal offense –Requires Parties to adopt effective, proportionate and dissuasive criminal penalties for bribery of foreign officials Ratified by 30 OECD countries and 6 non-OECD countries All ratifying countries have enacted some form of implementing legislation

Ratification of OECD Convention United States Other OECD Countries Australia Austria Belgium Canada Czech Republic Denmark FinlandItaly Ireland Iceland Hungary Greece Germany FranceJapan Korea Luxembourg Mexico The Netherlands New Zealand Norway United Kingdom Turkey Switzerland Sweden Spain Portugal Poland Non-OECD Countries Argentina Brazil Bulgaria Chile Estonia Slovenia + Slovak Republic

United Nations Convention Against Corruption Entered into force on December 14, 2005 Key Provisions: –Standards for corruption prevention applicable to both public and private sectors –Criminalization requirements for corruption offenses –International cooperation in the investigation and prosecution of cases –Asset recovery mechanisms and private rights of action for victims of corrupt practices Anticipate increased international cooperation in investigations and prosecutions