Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 452

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 452
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 neuro- developmental disorders (NDD). This decision is based on the conclusions of a criminal expert report within the frame of ongoing criminal proceedings, for which the Chambre de l’Instruction of the Appeal Court of Paris had ordered a counter-expertise (see below). The APESAC, Sanofi and its insurers appealed the Judicial Tribunal of Paris’ ruling related to the class action. On July 21, 2021, the Judicial Tribunal of Créteil (France) dismissed a claim for damages brought against Sanofi regarding a child born in 1995. The Judicial Tribunal considered that the risk of occurrence of NDD in children born to a mother exposed to sodium valproate during pregnancy was not demonstrated by the state of scientific knowledge at the time of her pregnancy. This decision was appealed and the proceeding is now pending before the Appeal Court of Paris, which had ordered a stay in the proceeding until the end of the criminal investigation. Several questions on the Product Liability Directive have been referred to the Court of Justice of the European Union (CJEU ), which will have an impact on the pending Depakine cases. A ruling from the CJEU is expected between September and December 2025. Since July 2020, a collective redress has been filed against the French affiliate representing as of December 2024 approximately 76 f amilies (with 288 claimants including 111 people exposed in utero), seeking indemnification for a prejudice of anxiety. I n August 2024, the court denied Sanofi’s request related to the stay of proceeding pending the CJEU ruling and rejected Sanofi's statute of limitation arguments. In September 2024, Sanofi filed an appeal. Criminal investigation A criminal investigation was initiated in May 2015 before the Paris Civil Court. In January 2020, the French affiliate of Sanofi was indicted for aggravated deception and involuntary injuries and in July 2020 for involuntary manslaughter. In July 2020, a judicial supervision of the affiliate was ordered, together with the implementation of financial guarantees. In November 2020, the Health Authority ( ANSM) was similarly indicted for involuntary injuries and involuntary manslaughters. On March 9, 2022, the Chambre de l’Instruction of the Appeal Court of Paris (Cour d’appel) ruled that certain complaints for involuntary manslaughter and several others for aggravated deception and involuntary injuries were time-barred. The Public Prosecutor, as well as the civil parties, have brought the matter before the Chambre Criminelle of