AstraZeneca PLC (AZN) is a global biopharmaceutical company incorporated in the United Kingdom and headquartered in London. Throughout the relevant period, AZN’s American Depositary Shares were registered with the SEC and publicly traded on the New York Stock Exchange.
As disclosed in its March 6, 2007, 6-K filing, in October 2006, AZN received a letter from the SEC requesting documents related to its business activities in Italy, Croatia, Russia and Slovakia. The SEC’s request sought documents concerning any payments to doctors or government officials and related internal accounting controls. The request also sought policies, correspondence, audits and other documents concerning compliance with the FCPA, as well as any allegations or communications with prosecutors’ offices relating to corruption or bribery of doctors or government officials. AZN also disclosed receipt of an inquiry from the DOJ in connection with an investigation into FCPA issues in the pharmaceutical industry, according to its 6-K filed on May 7, 2010.
AstraZeneca cooperated with these inquiries and also internally investigated, among other things, sales practices, internal controls, certain distributors, and interactions with healthcare providers, institutions, and other government officials, as well as investigated inappropriate conduct in certain countries, including China.
In August 2016, AstraZeneca entered into an administrative settlement with the SEC to resolve this matter. In its November 10, 2016 6-K report, the company disclosed that the DOJ had closed its inquiry into this matter.