[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit 10.48
SUPPLY AGREEMENT
This Supply Agreement (the “Supply Agreement”) is entered into as of October 29, 2018 (the “Effective Date”) 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”.
RECITALS
Whereas, Rigel, a biopharmaceutical company, has developed its proprietary compound fostamatinib disodium hexahydrate, also known as TAVALISSE™ in the United States, which has been approved by the FDA for the treatment of chronic immune thrombocytopenia and is under development for the treatment of autoimmune hemolytic anemia, IgA nephropathy, and potentially other indications;
Whereas, Rigel and Kissei are parties to a certain Collaboration and License Agreement of even date hereof (the “Collaboration and License Agreement”), under which Rigel has granted Kissei the right to develop and commercialize fostamatinib disodium hexahydrate in the Kissei Territory; and
Whereas, the Collaboration and License Agreement contemplates that Rigel will manufacture, or have manufactured, and supply fostamatinib disodium hexahydrate to Kissei for development and commercial use, and Rigel is willing to manufacture and supply fostamatinib disodium hexahydrate to Kissei, on the terms and conditions set forth below.
Now, Therefore, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
Article 1
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Capitalized terms used in this Supply Agreement but not defined herein shall have the meanings set forth in the Collaboration and License Agreement.
1.2 “Business Day” means a day that is not a Saturday, Sunday, or a day on which banking institutions in [*] are authorized by Applicable Law to remain closed. |
1.3 “Claim” had the meaning set forth in Section 9.3. |
1.4 “Collaboration and License Agreement” has the meaning set forth in the Recitals. |
1.5 “Compound” means fostamatinib disodium hexahydrate, having the chemical structure set forth in Exhibit A. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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2.4 Supply. |
(b) Traceability. Rigel shall mark the Drug Product shipment supplied to Kissei with a lot number for the purposes of traceability. Kissei shall record the lot number of each Drug Product used for each Clinical Trial, promotion and marketing event, distributed to each patient in an expanded access program, or sold to each customer, and shall retain all such records for at least [*] after the date of termination or expiration of this Supply Agreement to facilitate in the event of a Recall under Section 5.7 of the Collaboration and License Agreement. |
(d) Finished Product Release. Kissei (by itself or through its contract manufacturer) shall conduct release tests of the Product, and the Parties will agree to a mechanism in the Quality Agreement for the shipment of test samples of each Batch of the Drug Product to Kissei for local release testing purposes. |
(f) Product Shelf Life. The Product supplied by Rigel to Kissei hereunder shall have a remaining shelf life of [*]. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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continuously on a first to expire, first out basis. Each Party shall be responsible for the cost of maintaining its own safety stock. |
(a) Non-Conforming Product. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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2.8 Allocation in the Event of Product Shortages. |
(a) This Section 2.8 shall apply in the event that Rigel is unable to supply, with respect to a Calendar Quarter, [*] (i) Product ordered by Kissei pursuant to Sections 2.2 and 2.3 for delivery in such Calendar Quarter, plus (ii) Product required by Rigel or its Affiliates or other licensees for their own use with respect to such Calendar Quarter (such event, a “Shortfall”). The purpose of these allocation rules is to permit Kissei (with respect to the Kissei Territory) and Rigel (with respect to the Rigel Territory) to independently make their respective long-term purchase decisions for the Product, with the benefits and risks of such purchase decisions to be allocated to Kissei or Rigel, as the case may be. |
(b) If Rigel is unable to supply [*] (i) Product ordered by Kissei pursuant to a Purchase Order plus (ii) Product required by Rigel or its Affiliates or other licensees for their own use, then the available Product in each Calendar Quarter in which a Shortfall occurs shall be [*]. |
(c) The allocation rules set forth in this Section 2.8 shall restart for each Calendar Quarter, without any carryover of a Shortfall realized by either Kissei or Rigel in the prior Calendar Quarter. |
(d) If Rigel determines that it will not be able to deliver the quantities of the Product specified in the Purchase Order on the requested delivery date, or Rigel is made aware of any future anticipated shortages, then Rigel shall promptly notify Kissei of such determination, and in any event, no later than [*] following such determination. Such notification shall include the reasons for and the expected duration of Rigel’s anticipated inability to deliver such quantities of the Product. Promptly thereafter, but in no event more than [*] after such notification, the Parties shall discuss in good faith the matters set forth in such notification and begin good faith negotiations with respect to an alternative delivery schedule or alternative sourcing for such Product; provided that any such negotiations shall not relieve Rigel of its obligations hereunder. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Article 3
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(a) Development Use. All Drug Product supplied by Rigel to Kissei for use for Development purposes shall be at the applicable price set forth in Section 7.1 of the Collaboration and License Agreement. |
(b) Commercial Use. All Drug Product supplied by Rigel to Kissei for use for Commercial purposes shall be equal to the Transfer Price calculated in accordance with Section 8.5 of the Collaboration and License Agreement. |
(a) for Product and its placebo supplied for Development purposes, in accordance with Section 7.1 of the Collaboration and License Agreement, |
(b) for Product supplied for Commercial purposes during the Commercialization Term, in accordance with Section 8.5(c) of the Collaboration and License Agreement, and |
(c) for Product supplied for Commercial purposes during the Extended Commercialization Term, Kissei shall pay to Rigel a Transfer Price equal to [*]. |
Kissei shall pay each invoice, in U.S. Dollars, within [*] Kissei receives such invoice by wire transfer of immediately available funds into an account designated by Rigel. Financial audits shall be conducted in accordance with Section 9.4 of the Collaboration and License Agreement, and late payments shall bear interest as set forth in Section 9.5 of the Collaboration and License Agreement.
3.4 Tax. Kissei shall pay any and all taxes (other than taxes based on Rigel’s income), duties, assessments, and other charges and expenses imposed by any Governmental Authority in connection with the supply and transfer of Product to Kissei. If a withholding or deduction obligation occurs, then the sum payable by Kissei (in respect of which such deduction or withholding is required to be made) shall be increased to the extent necessary to ensure that Rigel receives a sum equal to the sum which it would have received had no such withholding or deduction occurred. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Article 4
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4.3 Inquiries and Customer Complaints. Kissei shall comply with the Pharmacovigilance Agreement and Section 5.4 of the Collaboration and License Agreement with respect to all inquiries, complaints, and adverse events regarding the Products in the Kissei Territory. |
5.1 Confidentiality. Any and all Information disclosed by a Party to the other Party under this Supply Agreement shall be deemed Confidential Information of such Party under the Collaboration and License Agreement and subject to the confidentiality provisions set forth in Article 13 of the Collaboration and License Agreement. |
Article 6
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6.1 Intellectual Property. Any and all inventions, whether patentable or not and including all intellectual property rights therein, generated by either Party in the course of conducting their activities under this Supply Agreement shall be deemed to be generated under the Collaboration and License Agreement and subject to the rights and obligations of the Parties as set forth therein. |
Article 7
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7.1 Force Majeure. Notwithstanding anything to the contrary in this Supply Agreement, both Parties shall be excused from the performance of their obligations under this Supply Agreement to the extent that (a) force majeure prevents such performance or, with respect to Rigel’s supply obligations pursuant to Article 2, prevents the |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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combined supply of (i) Product specified in accepted orders placed by Kissei in accordance with Section 2.3(a) and (ii) Product required by Rigel and its Affiliates, and (b) the nonperforming Party promptly provides notice of the force majeure to the other Party. Such excuse shall continue so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Supply Agreement, force majeure shall include conditions beyond the reasonable control of the applicable Party, including an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm, or like catastrophe. Notwithstanding the foregoing, a Party will not be excused from making payments owed hereunder because of a force majeure affecting such Party. If a force majeure persists for more than [*], then the Parties will discuss in good faith the modification of the Parties’ obligations under this Supply Agreement in order to mitigate the delays caused by such force majeure. |
Article 8
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8.1 Mutual Representations and Warranties. Each Party represents and warrants to the other that, as of the Effective Date: (i) it is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate or other power and authority to enter into this Supply Agreement and to carry out the provisions hereof, (ii) it is duly authorized to execute and deliver this Supply Agreement and to perform its obligations hereunder, and the person or persons executing this Supply Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership action, and (iii) this Supply Agreement is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument, or understanding, oral or written, to which it is a Party or by which it may be bound, nor violate any material law or regulation of any court, governmental body, or administrative or other agency having jurisdiction over it. |
(a) all Product supplied to Kissei pursuant to this Supply Agreement shall be Manufactured in conformity with GMPs; |
8.3 Disclaimers. Except as expressly stated in this Supply Agreement, no representations or warranties whatsoever, whether express or implied, including warranties of merchantability, AND fitness for a particular purpose, are made or given by or on behalf a Party, and all representations and warranties, whether arising by operation of law or otherwise, are hereby expressly excluded. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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including reasonable legal expenses and attorneys’ fees (collectively, “Losses”), to which any Kissei Indemnitee may become subject as a result of any claim, demand, action, or other proceeding by any Third Party to the extent such Losses arise out of or result from: (a) the negligence or willful misconduct of any Rigel Indemnitee, or (b) the breach by Rigel of any warranty, representation, covenant, or agreement made by Rigel in this Supply Agreement; except, in each case (a)-(b), to the extent such Losses arise out of any activities set forth in Section 9.2(a), (b), (c), or (d) for which Kissei is obligated to indemnify any Rigel Indemnitee(s) under Section 9.2. |
9.4 Insurance. Each Party, at its own expense, shall maintain insurance as set forth in Section 12.4 of the Collaboration and License Agreement. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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10.1 Term. This Supply Agreement shall commence on the Effective Date and shall continue until terminated as provided in this Section 10.2 (the “Term”). |
(c) After the Commercialization Term. Either Party shall have the right to terminate this Supply Agreement, on a Product-by-Product and country-by-country basis, without cause upon [*] 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. |
Article 11
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11.1 Governing Law; Dispute Resolution. This Supply Agreement, and all questions regarding the existence, validity, interpretation, breach, or performance of this Supply Agreement, shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, United States, without reference to its conflicts of law principles. The application of the U.N. Convention on Contracts for the International Sale of Goods (1980) is excluded. Any controversy or claim arising out of, relating to, or in connection with any provision of this Supply Agreement shall be resolved in accordance with Article 15 of the Collaboration and License Agreement. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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acknowledgment or acceptance of any Purchase Order or shipping instruction forms or similar documents containing terms or conditions at variance with or in addition to those set forth herein. |
If to Kissei, notices must be addressed to:
Kissei Pharmaceutical Co., Ltd
1-8-9 Nihonbashi-Muromachi,
Chuo-ku, Tokyo 103-0022 Japan
Attention: [*]
Facsimile: [*]
【cc.】
Kissei Pharmaceutical Co., Ltd.
19-48 Yoshino, Matsumoto-City
Nagano-prefecture, 399-8710 Japan
Attention: [*]
Facsimile: [*]
If to Rigel, notices must be addressed to:
Rigel Pharmaceuticals, Inc.
1180 Veterans Blvd.
South San Francisco, CA 94080
USA
Attention: [*]
Facsimile: [*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(a) in connection with the assignment of the Collaboration and License Agreement to a Third Party as set forth in Section 16.5 of the Collaboration and License Agreement; or |
The rights and obligations of the Parties under this Supply Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties specified above, and the name of a Party appearing herein will be deemed to include the name of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Section 11.4. Any assignment not in accordance with this Section 11.4 shall be null and void.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Neither Party is a legal representative of the other Party and neither Party can assume or create any obligation, representation, warranty, or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever. |
{Signature Page Follows}
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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In Witness Whereof, the Parties hereto have caused this Supply Agreement to be executed and entered into by their duly authorized representatives as of the Effective Date.
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 |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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List of Exhibits
Exhibit A:Compound
Exhibit B: Form of Order Forecast
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit A:Compound
fostamatinib disodium hexahydrate (“Compound”)
Chemical Name: disodium (6-[[5-fluoro-2-(3,4,5-trimethoxyanilino)pyrimidin-4-yl]amino]-2,2-dimethyl-3-oxo-pyrido[3,2-b][1,4]oxazin-4-yl)methyl phosphate hexahydrate
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Exhibit B: Form of Order Forecast
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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