Exhibit 10.3
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [**], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
4th Amendment to the COLLABORATION AND LICENSE AGREEMENT
This 4th Amendment to the COLLABORATION AND LICENSE AGREEMENT (the “Amendment”) is made and entered into as of September 3, 2024, by and between RIGEL PHARMACEUTICALS, INC., a Delaware company having an address at 611 Gateway Blvd., Suite 900, 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 and the 1st Amendment to the COLLABORATION AND LICENSE AGREEMENT dated as of November 9, 2022 and 2nd Amendment to the COLLABORATION AND LICENSE AGREEMENT dated as of October 18, 2023 and 3rd Amendment to the COLLABORATION AND LICENSE AGREEMENT dated as of August 30, 2024 (the “License Agreement”); and
WHEREAS Rigel and Kissei have agreed to amend certain provisions of the License Agreement in relation to Transfer Price.
WHEREAS Rigel and Kissei have agreed that this new Transfer Price ** Drug Product **. For clarity, the Transfer Price ** Drug Product p**.
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 8.5 of the Agreement is hereby deleted and replaced in its entirety with the following: |
8.5 Transfer Price.
(i)In consideration for the quantity in units of the Drug Product provided by Rigel to Kissei for Commercial use (“Units Provided”), Kissei shall pay to Rigel a transfer price equal to the Units Provided ** (the “Transfer Price”). For clarity, the Parties will agree upon the ** for the initial order prior to the initial Purchase Order, and thereafter the Parties agree to review **. Additionally, Kissei shall pay to Rigel an amount to be calculated in accordance with the table below by multiplying the respective percentage rates set forth therein (the “Transfer Price Rate”) less the Transfer Price for all Product sold by Kissei or on behalf of Kissei or its Affiliates or Sublicensees (excluding China, Hong Kong, Macau and Taiwan) during the Commercialization Term (“True Up Transfer Price”). The Transfer Price amount shall be paid within ** after the ** in which Kissei receives Rigel’s invoice for such Units Provided. The True Up Transfer Price amount shall be calculated and paid in accordance with Section 8.5 (c) below. Notwithstanding anything to the contrary herein, Transfer Price for Kissei’s Sublicensees licensed for territories in China, Hong Kong, Macau and Taiwan shall be the equal to Rigel’s Cost of Goods. For the purposes of this Section 8.5, the term “Sublicensees” shall exclude Sublicensees licensed for territories in China, Hong Kong, Macau and Taiwan.
Annual Net Sales of all Products ** | Transfer Price Rate |
Portion less than or equal to $** | **% |
Portion greater than $** | **% |
Portion greater than $** | **% |
Annual Net Sales of all Products ** | Transfer Price Rate |
(Regardless of the sales scale) | **% |
2. | Capitalized terms not otherwise defined herein shall have the same meaning as set forth in the License Agreement. All other provisions in the License Agreement that have not been changed by this Amendment shall remain in full force and effect. |
3. | This Amendment may be executed by the Parties individually or in any combination, in one or more counterparts, each of which shall be an original and all of which shall together constitute one and the same agreement. Signatures transmitted by facsimile transmission, by electronic mail in “portable document format” (“.pdf”) form, or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document, shall have the same force and effect as physical execution and delivery of the paper document bearing the original signature. |
IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed and entered into by their duly authorized representatives as of the date hereof.
Rigel Pharmaceuticals, Inc. By: /s/ Raul R. Rodriguez Name: Raul R. Rodriguez Title: President and CEO | Kissei Pharmaceutical Co. Ltd. By: /s/ Mutsuo Kanzawa Name: Mutsuo Kanzawa Title: Chairman and CEO |
3rd Amendment to the COLLABORATION AND LICENSE AGREEMENT
This 3rd Amendment to the COLLABORATION AND LICENSE AGREEMENT (the “Amendment”) is made and entered into as of August 30, 2024, by and between RIGEL PHARMACEUTICALS, INC., a Delaware company having an address at 611 Gateway Blvd., Suite 900, 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 and the 1st Amendment to the COLLABORATION AND LICENSE AGREEMENT dated as of November 9, 2022 and 2nd Amendment to the COLLABORATION AND LICENSE AGREEMENT dated as of October 18, 2023 (the “License Agreement”); and
WHEREAS Rigel and Kissei have agreed to amend certain provisions of the License Agreement in relation to ** for China, Hong Kong, Macau and Taiwan.
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 8.3 of the License Agreement is hereby deleted and replaced in its entirety with the following: |
Milestone Event | Milestone Payment | ||
For 1st Indication Achieved | For 2nd Indication Achieved | For 3rd Indication Achieved | |
** | $** | $** | $** |
** | $** | $** | $** |
** | $** | $** | $** |
For the application of the table above: (i) if ** is the ** Indication to achieve a milestone event, Kissei shall pay to Rigel the milestone payment for such milestone event set forth in the column for the ** Indication achieved, and for **, the milestone payment set forth in the column for the **Indication shall apply, unless such Indication is **, in which event the milestone payment set forth in the column for the ** Indication shall apply and the column for the ** Indication shall apply to achievement of the milestone event in a ** Indication; (ii) if ** is the ** Indication to achieve a milestone event, Kissei shall pay to Rigel the milestone payment for such milestone event set forth in the column for the ** Indication achieved, and for **, the milestone payment set forth in the column for the ** Indication shall apply, unless such Indication is **, in which event the milestone payment set forth in the column for the ** Indication shall apply and the column for the ** Indication shall apply to achievement of the
milestone event in a ** Indication; and (iii) if ** is the ** Indication to achieve a milestone event, Kissei shall pay to Rigel the milestone payment for such milestone event set forth in the column for the ** Indication achieved, and for **, the milestone payment set forth in the column for the ** Indication shall apply if such milestone payment for the ** Indication has not been made (i.e., **) or, the milestone payment set forth in the column for the ** Indication shall apply if such milestone payment for the ** Indication has previously been made. For clarity, each milestone payment above shall be paid not more than once for each Indication and overall for no more than three Indications under this Agreement, and the total amount payable by Kissei to Rigel pursuant to this Section 8.3(a) is **. By way of example only, **. By way of further example only, **. By way of further example only, **.
2. | Section 8.5 of the Agreement is hereby deleted and replaced in its entirety with the following: |
8.5 Transfer Price.
Annual Net Sales of all Products ** | Transfer Price Rate |
Portion less than or equal to $** | **% |
Portion greater than $** | **% |
Portion greater than $** | **% |
Annual Net Sales of all Products ** | Transfer Price Rate |
(Regardless of the sales scale) | **% |
(d) | Transfer Price Adjustments During the Commercialization Term. |
3. | A new Section 8.6 of the License Agreement is hereby added as follows: |
8.6 ** Sublicensees.
(a) China, Hong Kong, Macau and Taiwan. Notwithstanding anything to the contrary in this Agreement, Kissei will ** Kissei or its Affiliates by Kissei’s Sublicensees licensed for territories in China, Hong Kong, Macau and Taiwan. For clarity, **.
(b) Notice and Payment. Kissei shall notify Rigel in writing within ** after receipt by Kissei or its Affiliates by Kissei’s Sublicensees in China, Hong Kong, Macau and Taiwan of **. Promptly following receipt of any such notice from Kissei, Rigel will **. Kissei shall **.
4. | Capitalized terms not otherwise defined herein shall have the same meaning as set forth in the License Agreement. All other provisions in the License Agreement that have not been changed by this Amendment shall remain in full force and effect. |
5. | This Amendment may be executed by the Parties individually or in any combination, in one or more counterparts, each of which shall be an original and all of which shall together constitute one and the same agreement. Signatures transmitted by facsimile transmission, by electronic mail in “portable document format” (“.pdf”) form, or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document, shall have the same force and effect as physical execution and delivery of the paper document bearing the original signature. |
IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed and entered into by their duly authorized representatives as of the date hereof.
Rigel Pharmaceuticals, Inc. By: /s/ Raul R. Rodriguez Name: Raul R. Rodriguez Title: President and CEO | Kissei Pharmaceutical Co. Ltd. By: /s/ Mutsuo Kanzawa Name: Mutsuo Kanzawa Title: Chairman and CEO |
2nd Amendment to the COLLABORATION AND LICENSE AGREEMENT
This 2nd Amendment to the COLLABORATION AND LICENSE AGREEMENT (the “Amendment”) is made and entered into as of October 18th, 2023, by and between RIGEL PHARMACEUTICALS, INC., a Delaware company having an address at 611 Gateway Blvd., Suite 900, 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 the 1st Amendment to the COLLABORATION AND LICENSE AGREEMENT dated as of November 9, 2022; 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 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.”
2. | Capitalized terms not otherwise defined herein shall have the same meaning as set forth in the License Agreement. All other provisions in the License Agreement that have not been changed by this Amendment shall remain in full force and effect. |
3. | This Amendment may be executed by the Parties individually or in any combination, in one or more counterparts, each of which shall be an original and all of which shall together constitute one and the same agreement. Signatures transmitted by facsimile transmission, by electronic mail in “portable document format” (“.pdf”) form, or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document, shall have the same force and effect as physical execution and delivery of the paper document bearing the original signature. |
IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed and entered into by their duly authorized representatives as of the date hereof.
Rigel Pharmaceuticals, Inc. By: /s/ Raul R. Rodriguez Name: Raul R. Rodriguez Title: President and CEO | Kissei Pharmaceutical Co. Ltd. By: /s/ Mutsuo Kanzawa Name: Mutsuo Kanzawa Title: Chairman and CEO |
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.”
4. | Capitalized terms not otherwise defined herein shall have the same meaning as set forth in the License Agreement. All other provisions in the License Agreement that have not been changed by this Amendment shall remain in full force and effect. |
5. | This Amendment may be executed by the Parties individually or in any combination, in one or more counterparts, each of which shall be an original and all of which shall together constitute one and the same agreement. Signatures transmitted by facsimile transmission, by electronic mail in “portable document format” (“.pdf”) form, or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document, shall have the same force and effect as physical execution and delivery of the paper document bearing the original signature. |
IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed and entered into by their duly authorized representatives as of the date hereof.
Rigel Pharmaceuticals, Inc. By: /s/ Raul R. Rodriguez Name: Raul R. Rodriguez Title: President and CEO | Kissei Pharmaceutical Co. Ltd. By: /s/ Mutsuo Kanzawa Name: Mutsuo Kanzawa Title: Chairman and CEO |