[*] = 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.
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 ###-###-####, Japan (“Kissei”). Rigel and Kissei may be referred to herein individually as a “Party” or collectively as the “Parties”.
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:
Capitalized terms used in this Supply Agreement but not defined herein shall have the meanings set forth in the Collaboration and License Agreement.
1.1 “Batch” means the quantity of a Product produced in a single production run of such Product.
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.
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.
11.3 Notices. Any notice to be given under this Supply Agreement must be in writing and delivered either in person, by (a) air mail (postage prepaid) requiring return receipt, (b) overnight courier, or (c) facsimile confirmed thereafter by any of the foregoing, to the Party to be notified at its address(es) given below, or at any address such Party may designate by prior written notice to the other in accordance with this Section 11.3. Notice shall be deemed sufficiently given for all purposes upon the earliest of: (i) the date of actual receipt, (ii) if air mailed, [*] after the date of postmark, (iii) if delivered by overnight courier, the next day the overnight courier regularly makes deliveries, or (iv) if sent by facsimile, the date of confirmation of receipt if during the recipient’s normal business hours, otherwise the next business day.
If to Kissei, notices must be addressed to:
Kissei Pharmaceutical Co., Ltd
Chuo-ku, Tokyo 103-0022 Japan
Kissei Pharmaceutical Co., Ltd.
19-48 Yoshino, Matsumoto-City
Nagano-prefecture, 399-8710 Japan
If to Rigel, notices must be addressed to:
Rigel Pharmaceuticals, Inc.
1180 Veterans Blvd.
South San Francisco, CA 94080
11.4 Interpretation. The headings of clauses contained in this Supply Agreement preceding the text of the sections, subsections, and paragraphs hereof are inserted solely for convenience and ease of reference only and shall not constitute any part of this Supply Agreement, or have any effect on its interpretation or construction. All references in this Supply Agreement to the singular shall include the plural where applicable. Unless otherwise specified, references in this Supply Agreement to any Article shall include all Sections, subsections, and paragraphs in such Article, references to any Section shall include all subsections and paragraphs in such Section, and references in this Supply Agreement to any subsection shall include all paragraphs in such subsection. The word “including” and similar words means including without limitation. The word “or” means “and/or” unless the context dictates otherwise because the subjects of the conjunction are, or are intended to be, mutually exclusive. The words “herein”, “hereof”, and “hereunder” and other words of similar import refer to this Supply Agreement as a whole and not to any particular Section or other subdivision. All references to days in this Supply Agreement mean calendar days, unless
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