Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 367

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 367
---
 to support manufacturing needs for each other. Effective September 30, 2021, Sanofi and Regeneron signed an amendment to their collaboration agreement in order to specify allocations of responsibilities and associated resources between the two parties in connection with the co-promotion of Dupixent in certain countries. The terms of the collaboration relating to REGN3500 (SAR440340 – itepekimab) are unchanged. Effective July 1, 2022, Sanofi and Regeneron signed an amendment to their collaboration agreement in order to increase the additional portion of Regeneron’s quarterly profit-share attributable to Sanofi from 10% to 20% with retroactive impact as of April 1, 2022. Immuno-oncology (IO) collaboration agreements On July 1, 2015, Sanofi and Regeneron signed two agreements – the IO Discovery and Development Agreement and the IO License and Collaboration Agreement (IO LCA) – relating to new antibody cancer treatments in the field of immuno-oncology. The Amended IO Discovery Agreement, effective from December 31, 2018, was terminated through a Letter Amendment dated March 16, 2021 in which Sanofi formalized its opt-out from the BCMAxCD3 and MUC16xCD3 programs. LIBTAYO (cemiplimab) Under the 2015 IO LCA as amended in January 2018, Sanofi and Regeneron committed funding of no more than $ 1,640million , split on a 50 /50 basis ( $ 820million per company), for the development of REGN2810 (cemiplimab, trademark Libtayo), a PD-1 inhibitor antibody. The funding was raised to $ 1,840million by way of amendment effective on September 30, 2021. Regeneron was responsible for the commercialization of Libtayo in the United States, and Sanofi in all other territories. Sanofi has exercised its option to co-promote Libtayo in the United States. In 2021, Regeneron exercised its option to co-promote Libtayo in certain other countries. The IO LCA also provided for a one-time milestone payment of $ 375million by Sanofi to Regeneron in the event that sales of a PD-1 product were to exceed, in the aggregate, $ 2billion in any consecutive 12-month period. Under the IO LCA Sanofi and Regeneron