09/03/2024 | Press release | Distributed by Public on 09/03/2024 06:31
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.
Pursuant to the License Agreement, Kissei will make transfer price payments to Rigel for a term that continues, on a product-by-product and country-by-country basis, until the latter of (i) the expiration of certain patent claims related to olutasidenib, (ii) expiration of regulatory exclusivity in such country, and (iii) ten years after the first commercial sale of olutasidenib (the "Commercialization Term"). The Commercialization Term may continue if Kissei elects to continue commercializing olutasidenib in Japan, Korea or Taiwan and obtain its supply of olutasidenib for such purpose from Rigel. In such event, Rigel would continue to supply olutasidenib to Kissei at our cost to supply plus a markup.
The License Agreement commences today and shall continue until terminated. The License Agreement may be terminated for cause by either party based on uncured material breach of the other party, bankruptcy of the other party, or for safety reasons. Rigel may terminate the License Agreement if Kissei challenges or opposes any patent licensed under the License Agreement. Kissei may terminate the License Agreement for failure of local regulatory approval of the product or the companion diagnostic, or the companion diagnostic company's breach or termination of the agreement with such company. Prior to the first commercial sale of olutasidenib, Kissei may terminate the License Agreement without cause upon certain prior written notice to Rigel following the four-year anniversary of the License Agreement, and following the first commercial sale of olutasidenib, Kissei may terminate the License Agreement upon certain prior written notice to Rigel. Either party may terminate the License Agreement, on a product-by-product and country-by-country basis, without cause upon certain prior written notice to the other party so long as such termination becomes effective on or after the end of the Commercialization Term for such product in such country.