Item 1.01 Entry into a Material Definitive Agreement.
Amended and Restated Astellas Collaboration Agreement
On April 23, 2020, Cytokinetics, Incorporated
(the “Company” or “Cytokinetics”) and Astellas Pharma Inc. (“Astellas”) entered into two agreements,
which, taken together, amend and restate the Company’s research, development and commercialization collaboration with Astellas,
under their License and Collaboration Agreement dated June 21, 2013, as amended, (the “Original Collaboration Agreement”),
in follow up to the previously disclosed agreement in principle to revise the terms of such Original Collaboration Agreement.
Fast Skeletal Regulatory Activator Agreement
The Company and Astellas signed a Fast Skeletal
Regulatory Activator Agreement dated April 23, 2020 (the “FSRA Agreement”). As a result of the FSRA Agreement, the
Company will now have exclusive control and responsibility for the Company’s future development and commercialization of
reldesemtiv, CK-601 and other fast skeletal regulatory activator (collectively “FSRA”) compounds and products that
were subject to the Original Collaboration Agreement, and accordingly, Astellas has agreed to terminate its license to all FSRA
compounds and related products.
Astellas has agreed to pay one-third of the
out-of-pocket clinical development costs which may be incurred in connection with the Company’s potential Phase 3 clinical
trial of reldesemtiv in amyotrophic lateral sclerosis up to a maximum contribution by Astellas of $12 million. In addition, Astellas
has agreed to non-cash contributions to the Company, which include the transfer of its existing inventories of active pharmaceutical
ingredient of reldesemtiv and CK-601. Astellas has also agreed to the continued conduct of ongoing stability studies pertaining
to such existing inventories of active pharmaceutical ingredient, at its cost.
In exchange, the Company will pay Astellas a
low- to mid- single digit royalty on sales of reldesemtiv in the United States, Canada, United Kingdom and the European Union until
the later of (i) ten years following the first commercial sale of such product in a major market country, or (ii) December 31,
2034, subject to certain royalty reduction provisions. The Company would not owe Astellas royalties on sales of reldesemtiv in
any other country, or on the sale of any FSRA compounds or related products other than reldesemtiv.
Astellas has assigned to the Company all of
Astellas’ interest in intellectual property generated by any of the parties under the Original Collaboration Agreement that
solely relates to FRSA compounds and products. In addition, Astellas has granted an exclusive license to the Company under any
other intellectual property generated by any of the parties under the Original Collaboration Agreement and any intellectual property
owned or controlled by Astellas or its affiliates as of the effective date of the FSRA Agreement that is reasonably necessary or
useful to the development, manufacture or commercialization of FSRA compounds and products for such purposes. Finally, Astellas
has agreed to transfer to the Company related regulatory materials and provide the Company with technical assistance during the
transition of the program to the Company.
For a period of four years, Astellas has agreed
not to engage in any research and development activities on FSRA compounds and products with a carve-out mechanism for certain
of Astellas’ mergers and acquisitions activities. The parties also agreed that the option previously granted to Astellas
to receive a license to tirasemtiv, a FSRA compound for which the Company suspended clinical development in 2018, has expired
without exercise and has no further force or effect.
License and Collaboration Agreement for Other
Skeletal Sarcomere Activators
The Company and Astellas also signed a License
and Collaboration Agreement for Other Skeletal Sarcomere Activators, dated April 23, 2020 (the “2020 Collaboration Agreement”).
The 2020 Collaboration Agreement is an amendment and restatement of the Original Collaboration Agreement between the Company and
Astellas, and removes the FSRA compounds and products from the collaboration.
Under the 2020 Collaboration Agreement, Astellas
has extended the joint research program at the Company through December 31, 2020, with a minimum of fifteen (15) research FTE’s
being supported by Astellas. Astellas has exclusive rights to co-develop and commercialize skeletal sarcomere activators (other
than FSRA compounds and products) in all indications, subject to certain Cytokinetics’ development and commercialization
rights; Cytokinetics may co-promote and conduct certain commercial activities in the U.S., Canada and/or Europe under agreed scenarios.
Astellas will be responsible for the costs associated with the development of all collaboration products under the 2020 Collaboration
Agreement, subject to Cytokinetics’ option to co-fund certain development costs as described below. Cytokinetics retains
an option to conduct early-stage development for certain agreed indications at its initial expense, subject to reimbursement if
development continues under the collaboration. Astellas will reimburse Cytokinetics for certain expenses associated with its co-promotion
activities. The 2020 Collaboration Agreement also provides for Cytokinetics to lead certain activities relating to the commercialization
of collaboration products for neuromuscular indications in the U.S., Canada and Europe under particular scenarios. The research
term may be extended beyond December 31, 2020 by mutual consent.
If development candidates are identified and
advance in clinical research, the 2020 Collaboration Agreement contains provisions related to shared development roles between
the Company and Astellas, and opportunities for the Company to co-invest and/or co-promote under certain conditions. In the case
of molecules taken forward solely by Astellas, the Company would receive development and regulatory milestones of $25 to $35 million
per product, up to $250 million for all products, except under certain scenarios, commercial milestones of up to $200 million,
and royalties that range from a mid-single digit level to low double-digits. In the event of co-investment by the Company and approvals
in certain indications, the Company would receive royalties ranging from mid-to-high double digits (not to exceed an incremental
rate in the mid-twenties).
Astellas may terminate the 2020 Collaboration
Agreement as to any particular product or territory, or in its entirety, upon 180 days advance written notice following expiration
of the research term.
The above
description of the FSRA Agreement and the 2020 Collaboration Agreement is a summary of their material terms, does not purport to
be complete and is qualified in its entirety by reference to the FSRA Agreement and the 2020 Collaboration Agreement, which will
be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2020.