Item 1.01.
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Entry into a Material Definitive Agreement.
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Effective October 11, 2017, Karyopharm
Therapeutics Inc. (the
Company
) entered into a License Agreement (the
Agreement
) with Ono Pharmaceutical Co., Ltd., a corporation organized and existing under the laws of Japan
(
Ono
), pursuant to which the Company granted Ono exclusive rights to develop and commercialize, at its own cost, selinexor
(KPT-330),
the Companys lead, novel, oral Selective
Inhibitor of Nuclear Export (SINE) compound, as well as
KPT-8602,
the Companys second-generation oral SINE compound, for the diagnosis, treatment and/or prevention of all human oncology
indications (the
Field
) in Japan, Republic of Korea, Republic of China (Taiwan) and Hong Kong as well as in the ten Southeast Asian countries currently comprising the Association of Southeast Asian Nations (the
Ono Territory
). In addition, upon Onos election and the parties full execution of a manufacturing technology transfer plan and satisfaction of other specified conditions (the
Manufacturing
Election
), the Company will grant to Ono
non-exclusive
rights to manufacture selinexor,
KPT-8602
and products containing such compounds in or outside of
the Ono Territory solely for development and commercialization in the Field in the Ono Territory.
Under the terms of the Agreement, the
Company will receive an upfront cash payment of ¥2.5 billion (US$22.3 million), and the Company retains all rights to selinexor and
KPT-8602
outside the Ono Territory. The Company is entitled to
receive up to ¥10.15 billion (US$90.5 million at the current exchange rate) in milestone payments from Ono if certain development goals are achieved and up to ¥9.0 billion (US$80.2 million at the current exchange rate) in
milestone payments from Ono if certain sales milestones are achieved. The Company is further eligible to receive royalties in the low double digits based on future net sales of selinexor and
KPT-8602
in the
Ono Territory, subject to certain customary adjustments.
The Company is responsible for conducting certain development activities and
ongoing clinical trials involving selinexor and
KPT-8602
at its own cost and expense. The Company expects to continue all ongoing clinical trials involving selinexor and
KPT-8602
as they are currently being conducted. As part of the Agreement, Ono will also have the right to participate in global clinical studies of selinexor and
KPT-8602,
and will bear the cost and expense for patients enrolled in clinical studies in the Ono Territory. Ono is responsible for seeking regulatory and marketing approvals for selinexor and
KPT-8602
in the Ono Territory, as well as any development of the products specifically necessary to obtain such approvals. Ono is also responsible for the commercialization of products containing selinexor or
KPT-8602
in the Field in the Ono Territory at its own cost and expense.
Subject to Onos
Manufacturing Election, the Company will furnish clinical supplies of drug substance to Ono for use in Onos development efforts pursuant to a clinical supply agreement to be entered into by the Company and Ono, and Ono may elect to have the
Company provide commercial supplies of drug product to Ono pursuant to a commercial supply agreement to be entered into by the Company and Ono, in each case the costs of which will be borne by Ono.
Each party has also agreed to indemnify the other party from certain liabilities specified in the Agreement.
The Agreement will continue in effect on a
product-by-product,
country-by-country
basis until the later of the tenth anniversary of the first commercial sale of the applicable product in such country or the expiration of specified
patent protection and regulatory exclusivity periods for the applicable product in such country. However, the Agreement may be terminated earlier by (i) either party for breach of the Agreement by the other party or in the event of the
insolvency or bankruptcy of the other party, (ii) Ono on a
product-by-product
basis for certain safety reasons or on a
product-by-product,
country-by-country
basis for any reason with 180 days prior notice or (iii) the Company in the
event Ono challenges or assists with a challenge to certain of the Companys patent rights.
As previously disclosed by the Company
in its Annual Report on Form
10-K
for the year ended December 31, 2016, the Company is a party to a research agreement with the Multiple Myeloma Research Foundation, or MMRF. Under this research
agreement, the Company is obligated to make certain payments to MMRF, including if the Company
out-licenses
selinexor. The terms of this research agreement do not apply to
KPT-8602.
In connection with the transactions contemplated under the Agreement, the Company expects that it will be obligated to pay to MMRF approximately ¥225 million (approximately US$2.0 million)
of the upfront cash payment from Ono, as well as a percentage of any milestone payments from Ono and a
mid-single-digit
percentage of any royalty payments from Ono. The maximum aggregate amount the Company may
be obligated to pay to MMRF under the research agreement is $6.0 million.
The Company expects to file the Agreement as an exhibit to its Annual Report on Form
10-K
for the year ending December 31, 2017. The foregoing description of certain terms of the Agreement is intended to be a summary of the material terms and is qualified in its entirety by reference to the
text of the Agreement when filed.
A copy of the Companys press release announcing the entry into the Agreement is filed as Exhibit
99.1 to this Current Report on Form
8-K
and is incorporated herein by reference.