Item 8.01 Other Events.
On May 28, 2021, Bioverativ Therapeutics Inc. ("Bioverativ") filed a complaint
against Spectrum Pharmaceuticals, Inc. (the "Company"), in the U.S. District
Court for the District of Delaware, which alleges that the Company's proposed
manufacture, use and sale of ROLONTIS® (eflapegrastim), a novel long-acting
granulocyte colony-stimulating factor (G-CSF) analog for chemotherapy-induced
neutropenia, would, if approved, infringe claims of three patents owned by
Bioverativ (the "Subject Patents"). Bioverativ is seeking an unspecified amount
of damages and injunctive relief.
The Company believes that its manufacture, use and sale of ROLONTIS would not
infringe the Subject Patents and intends to vigorously defend its right to
develop and commercialize ROLONTIS in accordance with the terms of its
agreements with Hanmi Pharmaceutical Co. Ltd. ("Hanmi").
Pursuant to its agreements with Hanmi, the Company holds worldwide rights
(except for Korea, China, and Japan) to develop and commercialize ROLONTIS, a
drug based on Hanmi's proprietary LAPSCOVERY™ technology for the treatment of
chemotherapy induced neutropenia. The agreements with Hanmi contain typical
license terms including, without limitation, indemnification rights in favor of
the Company with respect to any claims of infringement from a third party with
respect to the Company's use of a licensed technology, product or compound
pursuant to such agreements.
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