Novartis Deferred Prosecution Agreement

As part of Novartis` agreement with Greece, Novartis has agreed to continue cooperating with the US government in an ongoing or future criminal investigation against Novartis` Greece, its executives, staff or agents. In addition, Novartis Greece and its parent company Novartis AG agreed, as part of the agreement, to improve their compliance programs and report to the government on the implementation of their extensive compliance programs. [2] While the DOJ and SEC royalty documents, comparative agreements and related press releases do not mention informants, a private law firm issued a press release referring to their presentation of “confidential and anonymous Greek whistleblowers” and the DOJ and the SEC “work effectively with whistleblowers.” The loading document, which refers to the audio recordings, does not mention the nature or source of the audio recordings. Alcon Pte Ltd, a subsidiary of Novartis AG at the time of the misconduct, separately entered into a deferred prosecution agreement in connection with a criminal investigation filed today in the Von New Jersey District, accusing Alcon Pte Ltd of conspiracy in violation of the book and registration provisions of the FCPA. Under the Deferred Criminal Prosecution Agreement, Alcon Pte Ltd agreed to pay a total fine of approximately $8.9 million. In order to resolve the SEC investigation, Novartis AG entered into an agreement on internal controls, books and records violations in Greece, Vietnam and South Korea. The offences in Greece relate to the behaviour related to Lucentis treated in the Novartis Hellas DPA, as well as the control problems of Novartis Hellas post-authorization studies, which were identified by an internal audit in 2012 and resolved until 2013. In Vietnam, the offences relate to activities involving an Alcon distributor that are the subject of Alcon`s data protection authority. And in South Korea, the violations relate to behavior that Novartis has previously assumed responsibility for in South Korea, where the company is in the final stages of resolving these issues with local authorities.

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