1st Amendment to the COLLABORATION AND LICENSE AGREEMENT
This 1st Amendment to the COLLABORATION AND LICENSE AGREEMENT (the “Amendment”) is made and entered into as of November 9th, 2022, by and between RIGEL PHARMACEUTICALS, INC., a Delaware company having an address at 1180 Veterans Blvd., South San Francisco, CA 94080, USA (“Rigel”) and KISSEI PHARMACEUTICAL CO. LTD., a Japanese company having an address at 19-48 Yoshino, Matsumoto, Nagano 399-8710, Japan (“Kissei”). Rigel and Kissei may be referred to herein individually as a “Party” or collectively as the “Parties”.
WHEREAS, Rigel and Kissei entered into and executed the COLLABORATION AND LICENSE AGREEMENT on Fostamatinib dated as of October 29, 2018 (the "License Agreement"); and
WHEREAS Rigel and Kissei have agreed to amend certain provisions of the License Agreement in relation to Taiwan among the Kissei Territory.
NOW, THEREFORE, pursuant to Section 16.2 of the License Agreement, and in consideration of the covenants and obligations contained herein and other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
1. | Section 1.32 of the Agreement is hereby deleted and replaced in its entirety with the following: |
“Drug Product” means the Compound manufactured into unit doses and provided in bright stock (unlabeled bottles) or as bulk tablets.
2. | Section 10.1(b)(ii) of the Agreement is hereby deleted and replaced in its entirety with the following: |
All data, Inventions, and Patents claiming such Inventions that relate to the composition, manufacture, or use of any Compound, or any improvement of any such composition, manufacture, or use, including in combination with other agents or components, together with all intellectual property rights therein, shall be deemed “Compound Inventions”. To the extent that any Compound Invention is made or acquired from a Sublicensee by Kissei, whether solely or jointly with Rigel, such Compound Invention shall be included in the license granted to Rigel by Kissei under Section 2.4, without additional consideration. Effective only upon the later of the expiration of the Commercialization Term or the expiration or termination of this Agreement: (A) Kissei hereby assigns to Rigel its rights, title, and interest in and to all Compound Inventions, and (B) solely in the event that the Commercialization Term expires, Rigel hereby grants to Kissei a fully-paid, royalty-free, perpetual, irrevocable, exclusive license under such Compound Inventions assigned by Kissei to Rigel for Kissei to use, sell, offer for sale, import, and otherwise Commercialize the Products in the Field in the Kissei Territory.
3. | Section 4.8 (c) of the Agreement is hereby deleted and replaced in its entirety with the following |
“(c) Sublicensing Requirements. If by the ** of the Effective Date Kissei has accomplished none of the following in China or Korea, and by the by the ** of the Effective Date Kissei has accomplished none of the following in Taiwan: (i) ** for the Product, or (ii) ** for the Product, or (iii) ** the Product, then Rigel shall inform Kissei of its decision to regain the right to the Product in the applicable country or region and the Parties shall promptly, and in any event within ** after Rigel so informs Kissei, confirm in writing that such country or region shall no longer be included in the Kissei Territory under this Agreement and shall become part of the Rigel Territory. For clarity, if the Parties fail to so confirm in writing that any such country or region is no longer included in the Kissei Territory within such ** period, such country or region shall automatically be deemed part of the Rigel Territory and excluded from the Kissei Territory upon the expiration of such ** period. In addition, prior to Kissei’s **, if Rigel or Kissei receives a sublicensing request under the licenses granted to Kissei under this Agreement to Develop and Commercialize the Product in such country, Kissei shall use good faith efforts to negotiate a sublicense agreement with the requesting party on commercially reasonable terms and in accordance with Section 2.2.”