Summary
Regeneron Pharmaceuticals, Inc. (REGN) has filed an 8-K report detailing significant amendments to its collaboration agreement with Sanofi-Aventis US LLC (Sanofi) concerning ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion. Effective February 23, 2015, the Amended and Restated Collaboration Agreement transfers sole responsibility for the global development and commercialization of ZALTRAP to Sanofi. This shift implies Sanofi will bear all associated costs, while Regeneron will be compensated through a tiered royalty ranging from 15% to 30% of aggregate net sales, plus payment for ZALTRAP manufactured by Regeneron. This amendment also relieves Regeneron from its obligation to reimburse Sanofi for 50% of past development expenses related to ZALTRAP. The agreement remains in effect until ZALTRAP is no longer being developed or commercialized by Sanofi or its affiliates. Additionally, an Amended and Restated Commercial Manufacturing and Supply Agreement was put in place, obligating Regeneron to manufacture and supply ZALTRAP to Sanofi's affiliate through at least 2021, or until Sanofi secures its own manufacturing capabilities.
Key Highlights
- 1Regeneron and Sanofi entered into an Amended and Restated Collaboration Agreement for ZALTRAP® on February 23, 2015.
- 2Sanofi assumes sole responsibility for the worldwide development and commercialization of ZALTRAP.
- 3Sanofi will bear all development and commercialization costs for ZALTRAP.
- 4Regeneron will receive a royalty percentage of 15% to 30% on aggregate net sales of ZALTRAP.
- 5Regeneron will be compensated for ZALTRAP quantities it manufactures.
- 6Regeneron is no longer required to reimburse Sanofi for 50% of prior ZALTRAP development expenses.
- 7A separate Amended and Restated Commercial Manufacturing and Supply Agreement ensures Regeneron will supply ZALTRAP to Sanofi's affiliate through at least 2021.