Item 8.01 Other
Events.
On December 9, 2022, or the Effective
Date, Eagle Pharmaceuticals, Inc., or the Company, entered into a definitive settlement agreement, or the Settlement Agreement, with
Accord Healthcare, Inc., or Accord, relating to the Company’s product BENDEKA® (rapidly infused bendamustine hydrochloride).
This settlement resolves patent litigation brought by the Company and its marketing partners Teva Pharmaceuticals International, GmbH
and Cephalon, Inc. relating to the alleged infringement of Orange Book listed United States Patent Nos. 11,103,483 and 9,572,887,
or the Asserted Patents, with respect to Accord’s 505(b)(2) New Drug Application, or NDA, No. 212209. Pursuant to the
terms of the Agreement, the Company will grant Accord a license to market Accord’s product made under NDA 212209 in the United States
beginning on January 17, 2028 (subject to U.S. Food and Drug Administration approval), or earlier under certain circumstances. Additionally,
in accordance with the Agreement, the parties will terminate all ongoing litigation among the Company, Teva Pharmaceuticals International,
GmbH and Cephalon, Inc. and Accord regarding the Asserted Patents pending in the United States District Court for the District of
Delaware. The Agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
On December 12, 2022, the Company issued
a press release announcing the Settlement Agreement.
A copy of the full text of the press release
referenced above is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Safe Harbor for Forward-Looking Statements
This Current Report on Form 8-K contains
“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other
securities law. Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,”
“forward,” “will,” “would,” “may,” “remain,” “potential,” “prepare,”
“expected,” “believe,” “plan,” “near future,” “belief,” “guidance,”
“opportunity,” “estimate,” and similar expressions are intended to identify forward-looking statements. These
statements include, but are not limited to, statements regarding future events such as: the resolution of patent litigation and all related
settlement terms, including dates of market entry and the potential for earlier market entry under certain circumstances and submission
of the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review; the strength of the Company’s
intellectual property rights for BENDEKA and BELRAPZO; and the expected expansion, defense and enforcement of intellectual property rights.
All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the
Company’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the
forward-looking information and statements. Such risks and uncertainties include, but are not limited to: the impacts of the ongoing COVID-19
pandemic, including interruptions or other adverse effects on clinical trials and delays in regulatory review or further disruption or
delay of any pending or future litigation; delay in or failure to obtain regulatory approval of the Company's product candidates and successful
compliance with FDA, European Medicines Agency and other governmental regulations applicable to product approvals; the outcome of litigation
involving any of its products or that may have an impact on any of its products; the strength and enforceability of the Company’s
intellectual property rights or the rights of third parties; the risks inherent in drug development and in conducting clinical trials;
and those risks and uncertainties identified in the “Risk Factors” sections of the Company's Annual Report on Form 10-K
for the year ended December 31, 2021, filed with the Securities and Exchange Commission (the “SEC”) on March 8,
2022, the Company’s Quarterly Reports on Form 10-Q for the quarter ended March 31, 2022, June 30, 2022 and September 30,
2022, filed with the SEC on May 9, 2022, August 9, 2022, and November 9, 2022, respectively, and its other subsequent filings
with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements contained
in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes
no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.