As previously disclosed, on January 11, 2021, BeiGene Switzerland GmbH ("BeiGene Switzerland"), a wholly-owned indirect subsidiary of BeiGene, Ltd. (the "Company"), reported to have entered into a Collaboration and License Agreement (the "License Agreement") with Novartis Pharma AG ("Novartis"), pursuant to which BeiGene Switzerland granted Novartis the right to develop, manufacture and commercialize the Company’s anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan (Filing, 8-K, BeiGene, SEP 17, 2023, View Source [SID1234635238]). Under the License Agreement, Novartis was responsible for regulatory submissions and had the right to commercialize in these licensed countries following regulatory approvals.
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On September 17, 2023, BeiGene Switzerland and Novartis entered into a Mutual Termination and Release Agreement (the "Agreement") to mutually terminate the License Agreement, effective immediately. Pursuant to the Agreement, BeiGene Switzerland regained full, global rights to develop, manufacture and commercialize tislelizumab with no royalty payments due to Novartis. Novartis may continue its ongoing clinical trials and has the ability to conduct future combination trials with tislelizumab subject to the Company’s approval. The Company has agreed to provide Novartis with ongoing clinical supply of tislelizumab to support its clinical trials. Pursuant to the Agreement, Novartis will provide transition services to the Company to enable key aspects of the tislelizumab development and commercialization plan to proceed without disruption, including manufacturing, regulatory, safety and clinical support.
The foregoing description of the terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, which the Company intends to file as an exhibit to a subsequent periodic report or on an amendment to this Current Report on Form 8-K.