Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 453

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 453
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 the Supreme Court (Cour de cassation) . In September 2022, the investigating judges appointed two experts for a counter-expertise following the Chambre de l’Instruction’s ruling handed down end of 2021. Since 2022, several individual medical assessments have been ordered by the investigating judge. In June 2023, the Chambre Criminelle of the French Supreme Court ( Cour de cassation ) confirmed the Paris Court of Appeal’s decision ( Chambre de l’Instruction ) dated March 2022 which had ruled that certain complaints for involuntary manslaughter and several others for aggravated deception and involuntary injuries were time-barred. In August 2023, Sanofi received the counter expertise report and sent its comments in November 2023.

| SANOFIFORM 20-F2024 | F-85 |

| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |

Public compensation scheme In 2017, the French government set up a public compensation scheme to indemnify patients for damages suffered in connection with the prescription of sodium valproate and its derivatives. The scheme was further amended through the 2020 Finance Law, with notably the introduction of presumptions of failure to inform the mother since 1982 for malformations and since 1984 for NDD. The scheme was amended again through the 2021 Finance Law in order to increase the maximum premium applicable in the event of refusal to make an offer (or making an insufficient offer) where this would be deemed unjustified by a court ruling. The committee of the compensation scheme has issued several final opinions holding the French affiliate liable for damages either in full or in part along with the French State, and, in some cases, healthcare practitioners. The French affiliate disagreed with the committee’s conclusions and has accordingly not offered indemnification to the claimants who have received compensation from the ONIAM (Office National d’Indemnisation des Accidents Médicaux) . The ONIAM is now seeking reimbursement from Sanofi, which has filed legal actions to oppose ONIAM’s payment orders. Administrative Actions In July 2020, March and June 2021, the Montreuil Administrative Court held the French State liable in five administrative proceedings initiated by families against the State. In March 2021, the Administrative Court did not find any failure to inform the mother regarding the risk of neurodevelopmental disorders for births in 1999 and in 2002, based on the state of scientific knowledge at the time. However, regarding the risk of malformations