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$Rigel Pharmaceuticals (RIGL.US)$ Item 1.01. Entry into a Material Definitive Agreement.

On September 3, 2024, Rigel Pharmaceuticals, Inc. (“Rigel”) entered into a collaboration and license agreement (the “License Agreement”) and a supply agreement (the “Supply Agreement”) with Kissei Pharmaceutical Co., Ltd. (“Kissei”). Pursuant to the terms of the License Agreement, Kissei received exclusive rights to develop and commercialize olutasidenib in all human diseases in Japan, the Republic of Korea (Korea) and Taiwan (the “Kissei Territory”). The parties’ collaboration is governed through a joint steering committee and appropriate subcommittees.

Kissei is responsible for performing and funding the development activities for olutasidenib in the Kissei Territory and Rigel retained the co-exclusive right to conduct development activities in the Kissei Territory solely for the purpose of supporting and obtaining regulatory approval of and commercializing olutasidenib in the world outside the Kissei Territory. Rigel retained the global rights, excluding the Kissei Territory, to commercialize olutasidenib.

Under the terms of the License Agreement, Rigel will receive an upfront cash payment of $10.0 million, with the potential for an additional $152.5 million in development, regulatory and commercial milestone payments, and will receive mid twenty to lower thirty percent, tiered, escalated net sales-based payments for the supply of olutasidenib, subject to certain customary reductions and offsets. Pursuant to the License Agreement, Kissei is responsible for companion diagnostic development in Japan, for which Rigel will share fifty percent of the costs incurred by Kissei, up to $3.0 million, which are creditable against future milestones and transfer price payments owed to Rigel.

In August 2022, Rigel and Forma Therapeutics, Inc., now Novo Nordisk (“Forma”) announced an exclusive, worldwide license agreement to develop, manufacture and commercialize olutasidenib. Forma is entitled to a certain portion of Rigel’s sublicensing revenue for olutasidenib from Kissei, including $2.3 million upon Rigel’s receipt of the upfront cash payment of $10.0 million.

Rigel remains responsible for the manufacture and supply of olutasidenib for all development and commercialization activities under the License Agreement. Pursuant to the concurrently executed Supply Agreement, Rigel will supply Kissei with bulk drug product for use under the License Agreement.
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