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.
COLLABORATION AND LICENSE AGREEMENT
by and between
Rigel Pharmaceuticals, Inc.,
and
KISSEI PHARMACEUTICAL CO., LTD.
September 3, 2024
COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (this “Agreement”) is entered into as of September 3, 2024 (the “Effective Date”), by and between Rigel Pharmaceuticals, Inc., a Delaware company having an address at 611 Gateway Boulevard, 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”.
RECITALS
WHEREAS, Rigel is a biopharmaceutical company that conducts research, development, manufacturing and commercialization of pharmaceutical products in the U.S.;
WHEREAS, Rigel has entered into a worldwide exclusive license with respect to Olutasidenib (also known as REZLIDHIA® in the U.S.) under that certain License and Transition Services Agreement between Rigel and Forma Therapeutics, Inc. (now Novo Nordisk) dated July 27, 2022 (“Rigel-Forma Agreement”);
WHEREAS, Olutasidenib has been approved by the FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test;
WHEREAS, Kissei is a pharmaceutical company possessing substantial resources and expertise in the development and commercialization of pharmaceutical products; and
WHEREAS, Kissei desires to obtain, and Rigel is willing to grant, an exclusive sublicense under the Rigel-Forma License Agreement to Develop and Commercialize the Product in the Field in Japan, Republic of Korea and Taiwan (defined as the “Kissei Territory” below), subject to the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties hereby agree as follows:
1. | DEFINITIONS |
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:
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(a)trade, quantity and cash discounts, credits or allowances actually given;
(b)allowances for returns or rejections (due to spoilage, damage, expiration of useful life or otherwise);
(c)freight and insurance, if separately identified on the invoice;
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(d)Third Party rebates, chargebacks, hospital buying group/group purchasing organization administration fees or managed care organization rebates actually given and other similar administrative fees, rebates and allowances granted to any non-related party, including to Governmental Authorities, purchasers, reimbursors, customers, distributors and wholesalers;(e)value-added tax, sales, use or turnover taxes, excise taxes and customs duties assessed by Governmental Authorities on the sale of the Product;
(f)retroactive price reductions or billing corrections.
In the case of any sale or other disposal for value, such as barter or counter-trade, of a Product, or part thereof, other than in an arm’s length transaction exclusively for cash, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of such Product in the country of sale or disposal, as determined in accordance with GAAP.
For clarity, named-patient sales shall be included in “Net Sales”.
Notwithstanding the foregoing, the following shall not be included in Net Sales: (i) sales between or among Kissei and its Related Parties (but Net Sales shall include sales to the first Third Party (other than a Sublicensee) by Kissei or its Related Parties); and (ii) samples of Product used to promote additional Net Sales, in amounts consistent with normal business practices of Kissei or its Related Parties where the Product is supplied without charge or at or below the actual manufacturing cost thereof (without allocation of indirect costs or any mark-up).
In the event that a Product is sold as a Combination Product, Net Sales, for the purposes of determining royalty payments on the Combination Product, means the aggregate gross invoiced sales prices from sales of all units of such Combination Product sold by a Party and its Related Parties to independent Third Parties in accordance with GAAP less the deductions set forth in clauses (a) – (f) above, multiplied by a proration factor that is determined as follows:
(A)If the Product and the other Active Ingredients in such Combination Product are both sold separately during the same or immediately preceding Calendar Quarter, then Net Sales for the Product shall be calculated by multiplying actual Net Sales of such Combination Product during such period by the fraction A/(A+B), where: “A” is the average gross invoiced sales price of the Product during such period when sold separately in the same formulation and dosage; and “B” is the average gross invoiced sales price of the Active Ingredients contained in the Combination Product during such period when sold separately in the same formulation and dosage.
(B)If the Product is sold separately during the same or immediately preceding Calendar Quarter in the same formulation and dosage as in the Combination Product, but the other Active Ingredients contained in the Combination Product are not sold separately during such period in the same formulation and dosage as in the Combination Product, then Net Sales for the Product shall be calculated by multiplying actual Net Sales of such Combination Product during such period by the fraction A/C, where “A” is the average gross invoiced sales price of the Product during such period when sold separately in the same formulation and dosage and “C” is the average gross invoiced sales price of the Combination Product during such period;
(C)If the Product is not sold separately during the same or immediately preceding Calendar Quarter in the same formulation and dosage as in the Combination Product, but the other Active Ingredients contained in the Combination Product are sold separately during such period in the same formulation and dosage as in the Combination Product, then Net Sales for the Product shall be calculated by multiplying actual Net Sales of such Combination Product by the result of 1 – (B/C), where “B” is the average gross invoiced sales price of the other Active Ingredients contained in the Combination Product during such period when sold separately in the same formulation and dosage and “C” is the average gross invoiced sales price of the Combination Product during such period; or
(D)If neither the Product nor the other Active Ingredients contained in the Combination Product were not sold separately during the same or immediately preceding Calendar Quarter, the proration factor shall be determined by the Parties in good faith negotiations based on the relative value contributed by each component.
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2. | LICENSES; EXCLUSIVITY |
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3. | GOVERNANCE |
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4. | DEVELOPMENT |
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5. | REGULATORY MATTERS |
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6. | COMMERCIALIZATION |
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7. | MANUFACTURE AND SUPPLY |
8. | FINANCIAL PROVISIONS |
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** Milestones | Milestone Payment |
** | $** |
** | $** |
**Milestones | Milestone Payment |
** | $** |
** | $** |
**Milestones | Milestone Payment |
** | $** |
** | $** |
**Milestones | Milestone Payment |
** | $** |
** | $** |
For clarity, each milestone payment above shall be paid not more than once for each Indication, and the total amount payable by Kissei to Rigel pursuant to this Section 8.2.1 is **.
Aggregate Net Sales of all Products ** in a Calendar Year | Milestone Payment |
Equal or exceed $** | $** |
Equal or exceed $** | $** |
Equal or exceed $** | $** |
Equal or exceed $** | $** |
Equal or exceed $** | $** |
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Annual Net Sales of all Products ** | Transfer Price Rate |
Portion less than or equal to $** | **% |
Portion greater than $** and less than or equal to $** | **% |
Portion greater than $** | **% |
Annual Net Sales of all Products in ** | Transfer Price Rate |
Regardless of the sales scale | **% |
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9. | INTELLECTUAL PROPERTY |
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10. | REPRESENTATIONS, WARRANTIES AND COVENANTS |
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11. | INDEMNIFICATION |
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12. | CONFIDENTIALITY |
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13. | TERM AND TERMINATION |
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14. | DISPUTE RESOLUTION |
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15. | GENERAL PROVISIONS |
The rights and obligations of the Parties under this 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 15.5. Any assignment not in accordance with this Section 15.5 shall be null and void. For clarity, neither Party’s rights and obligations under this Agreement shall be affected by the other Party’s assignment of this Agreement.
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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: **Email: **
with a copy to
Kissei Pharmaceutical Co., Ltd.
19-48 Yoshino, Matsumoto-City
Nagano-prefecture, 399-8710 Japan
Attention: **
Facsimile: **
Email: **
If to Rigel, notices must be addressed to:
Rigel Pharmaceuticals, Inc.
611 Gateway Boulevard, Suite 900
South San Francisco, CA 94080
USA
Attention: **
Email: **
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{Signature Page Follows}
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IN WITNESS WHEREOF, the Parties hereto have caused this Collaboration and License 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 |
{Signature Page to Collaboration and License Agreement}
Schedule 1.134
Rigel Product Marks
**
Schedule 4.3
Initial Development Plan and Budget
**