Item 1.01 Entry into a Material Definitive Agreement.
On January 5, 2023, Intra-Cellular Therapies, Inc. (the "Company") entered into
a new supply agreement (the "Siegfried Agreement") with Siegfried AG
("Siegfried"), following the automatic expiration of the Company's prior supply
agreement with Siegfried on January 4, 2023. Under the Siegfried Agreement,
Siegfried has agreed to manufacture and supply the active pharmaceutical
ingredient (the "Product") that is used in the Company's product CAPLYTA
(lumateperone) in commercial quantities. Each month, the Company will provide
Siegfried with a rolling forecast of the Company's anticipated requirements for
supply of the Product. Under the agreement, the Company's purchase prices for
supply of the Product from Siegfried are specified prices based on the volume of
Product produced.
The initial term of the Siegfried Agreement extends for three years until
January 5, 2026. The Siegfried Agreement will automatically renew on an
evergreen basis for a consecutive one-year period, unless either party notifies
the other party of its election to not renew the agreement at least 12 months
prior to the end of the initial term or any renewal period then in effect.
Either party may terminate the agreement prior to its expiration upon an uncured
material breach by the other party, the liquidation or dissolution of the other
party, the commencement of insolvency procedures or other bankruptcy-related
proceedings that are not dismissed within a certain period of time, the
appointment of any receiver, trustee or assignee to take possession of the
properties of the other party, the cessation of all or substantially all of the
other party's business operations, or a continuing force majeure event affecting
the other party.
The foregoing summary of the Siegfried Agreement does not purport to be complete
and is qualified in its entirety by reference to the Siegfried Agreement, a copy
of which will be attached as an exhibit to the Company's Annual Report on Form
10-K for the year ended December 31, 2022.
This Current Report on Form 8-K contains forward-looking statements related to
future manufacturing and supply of the Product. These forward-looking statements
are based on the Company's current expectations and inherently involve
significant risks and uncertainties. The Company's actual results and future
events could differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which include, without
limitation, risks related to the Company's dependence on third-party suppliers
and manufacturers and the availability of other sources of supply. These and
other risk factors are discussed under "Risk Factors" in the Company's Annual
Report on Form 10-K for the year ended December 31, 2021 filed by the Company
with the Securities and Exchange Commission on March 1, 2022 and in our other
public filings subsequently filed with the Securities and Exchange Commission.
The Company undertakes no duty or obligation to update any forward-looking
statements contained in this Current Report on Form 8-K as a result of new
information, future events or changes in its expectations.
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