Item 1.01
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Entry into a Material Definitive Agreement.
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On June 25, 2018, Agios Pharmaceuticals, Inc. (the
Company) entered into an exclusive license agreement (the License Agreement) with CStone Pharmaceuticals (CStone) for the development and commercialization of certain products containing ivosidenib in the forms
clinically developed by the Company (Licensed Products) in mainland China, Hong Kong, Macau and Taiwan (the Territory), either as a monotherapy or in combination with other therapies, in all therapeutic uses in humans,
excluding brain cancer, unless later added by the Company in its sole discretion (the Field). The Company retains development and commercialization rights with respect to Licensed Products in the rest of the world.
Pursuant to the License Agreement, CStone will initially be responsible for the development and commercialization of Licensed Products in acute myeloid
leukemia (AML) and cholangiocarcinoma in the Territory, as well as other indications that the parties mutually agree to in the future. CStone will also be responsible, at the Companys discretion, for the development and
commercialization of Licensed Products in brain cancer indications in the Territory. The Company has granted CStone specified intellectual property licenses to enable CStone to perform its obligations and exercise its rights under the License
Agreement, including license grants to enable CStone to conduct development and commercialization activities pursuant to the terms of the License Agreement.
Pursuant to the License Agreement, the Company is entitled to receive an upfront payment of $12 million and is entitled to receive up to an additional
$412 million in milestone payments upon the achievement of certain development, regulatory and sales milestone events. Approximately half of the milestone payments are related to the development and commercialization of Licensed Products in
AML, cholangiocarcinoma and other potential indications in the Territory. The other half of the milestone payments are related to the development and commercialization in the Territory of Licensed Products in brain cancer indications, including
glioma, to the extent they are included in the Field. The Company will also be entitled to receive tired royalties, ranging from 15 to 19 percent, on annual net sales, if any, of Licensed Products in the Territory.
CStone is responsible for all costs it incurs in developing, obtaining regulatory approval of, and commercializing Licensed Products in the Field in the
Territory, as well as certain costs incurred by the Company in conducting certain clinical trials that include clinical sites in the Territory.
During
the term of the License Agreement, each party and its affiliates are prohibited from developing or commercializing in the Field any other compound or product that inhibits
IDH-1
mutations at specified levels
of binding (Competing Products), in the case of CStone, anywhere in the world, and in the case of the Company, in the Territory. Subject to specified exceptions, CStone and its affiliates are also prohibited from developing or
commercializing certain other compounds or products that directly or indirectly treat AML, cholangiocarcinoma or, if added to the Field by the Company, glioma in patients that have an
IDH-1
mutation
(Restricted Products).
Unless earlier terminated, the License Agreement will expire upon the expiration of the last royalty term for the last
Licensed Product in the Field in the Territory. In the event that Agios does not obtain regulatory approval from the United States Food and Drug Administration for any Licensed Product in relapsed/refractory (R/R) AML by
December 31, 2018, CStone may terminate the License Agreement in its entirety upon 90 days prior written notice. At any time after CStone has obtained regulatory approval for a Licensed Product in mainland China in R/R AML and the last
patient has been enrolled in a specified clinical trial (or, if earlier, at any time that CStone acquires or is acquired by an entity with a Competing or Restricted Product), CStone may terminate the License Agreement in its entirety upon 12
months prior written notice. Either party may, subject to specified cure periods, terminate the License Agreement in the event of the other partys uncured material breach, and either party may terminate the License Agreement under
specified circumstances relating to the other partys insolvency. The Company has the right to terminate the License Agreement immediately if CStone or its affiliates or sublicensees or subcontractors challenges the validity, patentability, or
enforceability of certain patent rights that relate to ivosidenib and are owned by or licensed to the Company or its affiliates.
The License Agreement
contemplates that the Company will enter into ancillary arrangements with CStone, including clinical and commercial supply agreements and a pharmacovigilance agreement.
The foregoing description of certain terms of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the
License Agreement that the Company intends to file as an exhibit to its Quarterly Report on Form
10-Q
for the quarterly period ending June 30, 2018.