Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 461

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 461
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ofi pursuant to its FOIA request. The government has produced certain documents since the filing of the lawsuit. The government responded to Sanofi’s complaint on August 2, 2024 and the parties completed summary judgment briefing on December 9, 2024. In an effort to further mitigate 340B program fraud and abuse, in November 2024, Sanofi announced its intention to implement a 340B Credit Model, where Sanofi will provide credits to covered entities for the difference between the 340B price and the price initially paid by the covered entity to reflect the 340B discount. On December 16, 2024, Sanofi filed a lawsuit against HHS, HRSA and their respective administrators, seeking a court order: (i) declaring that HHS’s letter informing Sanofi that its Credit Model violates 340B is unlawful and setting it aside; (ii) declaring that Sanofi’s Credit Model complies with Section 340B; and

| F-88 | SANOFIFORM 20-F2024 |

| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |

(iii) enjoining defendants from taking enforcement action against Sanofi relating to its Credit Model. In January 2025, the court entered a scheduling order. Several manufacturers (including Johnson & Johnson, Eli Lilly, Bristol Myers Squibb, and Novartis) as well as information technology company Kalderos have filed similar lawsuits in the District Court for the District of Columbia. ADR Proceedings In January 2021, the National Association of Community Health Centers (NACHC) filed an ADR proceeding before HRSA on behalf of a number of covered entities, seeking to require Sanofi and AstraZeneca to supply contract pharmacies with 340B discounts without conditions. On August 10, 2022, the ADR panel granted the motions to dismiss filed both by Sanofi and AstraZeneca, holding that the Delaware district court’s decision granting AstraZeneca’s motion for summary judgment precluded NACHC’s ADR claims against both AstraZeneca and Sanofi. In September 2023, the University of Washington Medical Center and Harborview Medical Center filed a petition for monetary and equitable relief against Sanofi before the ADR Panel. The petition alleges that Sanofi has violated Section 340B, by imposing data reporting requirements on “Covered Entities” that are authorized under that statute to receive discounts on certain prescription drugs and that in June 2023, Sanofi further restricted