Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 462

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 462
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 access to 340B discounted drugs. On August 14, 2024, HRSA informed petitioner that the petition was complete. Sanofi’s response was submitted on December 11, 2024. Enforcement Proceedings and Investigations In September 2021, HRSA referred Sanofi (as well as other manufacturers) to the HHS Office of the Inspector General (OIG) in accordance with the 340B Program Ceiling Price and Civil Monetary Penalties Final Rule. The Third Circuit’s decision and the District Court’s injunction and declaratory judgment (described above) would preclude action against Sanofi based on the particular program at issue in the Third Circuit case. In February 2021, the Vermont Attorney General issued a Civil Investigative Subpoena seeking certain information about Sanofi’s participation in the 340B program. Sanofi cooperated with this investigation, including producing documents to the Vermont Attorney General’s office. State Litigation PhRMA and certain manufacturers have filed lawsuits challenging laws passed in certain states purporting to force manufacturers to provide 340B-pricing to contract pharmacies in their respective states. Those cases are in various stages of litigation. The most advanced of those cases, was brought by PhRMA challenging an Arkansas 340B law. In that case, the Eighth Circuit held on March 12, 2024, that the Arkansas statute was not preempted by the federal 340B statute. On December 9, 2024, the Supreme Court denied PhRMA’s petition for certiorari. On July 23, 2024, Sanofi filed its own lawsuit challenging the Arkansas law. Sanofi seeks a declaratory judgment that the Arkansas law is preempted to the extent it requires Sanofi to deliver 340B-priced drugs to contract pharmacies that obtain title to those drugs in violation of federal law and to enjoin enforcement against Sanofi for its updated integrity initiative. This case is stayed pending resolution of a case filed by AstraZeneca challenging the Arkansas law. In the interim, Arkansas has agreed not to pursue enforcement action against Sanofi in connection with its updated integrity initiative. In lawsuits filed by PhRMA and certain other manufacturers challenging a law passed by the State of West Virginia, the court granted plaintiffs a preliminary injunction enjoining the State from enforcing its contract pharmacy law and denying defendants’ motion to dismiss the PhRMA action. The State of West Virginia has appealed that decision to the Fourth Circuit. Mosaic Health In July 2021, Mosaic Health Inc. and