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Item 7.01
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Regulation FD Disclosure.
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On December 7, 2018, the Company issued a press release announcing
the events described above, among other things. A copy of the press release is furnished as Exhibit 99.1 to this Current Report
on Form 8-K.
The information contained in this Item 7.01 as well as in Exhibit
99.1 is furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the “
Exchange Act
”), or otherwise subject to the liabilities of that section, and such information
shall not be deemed to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as
amended, or the Exchange Act.
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K includes statements that may
constitute “forward looking statements”, including expectations to rebuild shareholder value, improve processes in
response to regulatory requirements, reduce operating costs, and other statements regarding Akorn’s goals and strategy. When
used in this document, the words “anticipate,” “plan,” “will,” “continue,” “believe,”
“estimate,” “intend,” “believe,” “anticipate,” “could,” and “expect”
and similar expressions are generally intended to identify forward-looking statements. These statements are made pursuant to the
safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. A number
of important factors could cause actual results of Akorn and its subsidiaries to differ materially from those indicated by such
forward-looking statements. These factors include, but are not limited to: (i) the effect of the court decision described in the
attached press release on Akorn’s ability to retain and hire key personnel, its ability to maintain relationships with its
customers, suppliers and others with whom it does business, or its operating results and business generally, (ii) the risk that
ongoing or future litigation related to the court decision described in the attached press release may result in significant costs
of defense, indemnification and/or liability, (iii) the outcome of the investigation conducted by Akorn with the assistance of
outside consultants, into alleged breaches of FDA data integrity requirements relating to product development at Akorn and any
actions taken by Akorn, third parties or the FDA as a result of such investigations, (iv) the difficulty of predicting the timing
or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any, (v) the timing
and success of product launches, (vi) difficulties or delays in manufacturing, and (vii) such other risks and uncertainties outlined
in the risk factors detailed in Part I, Item 1A, “Risk Factors,” of Akorn’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2017 (as filed with the Securities and Exchange Commission (“
SEC
”) on February
28, 2018) and in Part II, Item 1A, “Risk Factors,” of Akorn’s Quarterly Reports on Form 10-Q for the periods
ended March 31, June 30, and September 2018 (as filed with the SEC on May 2, August 1, and November 6, 2018), and other risk factors
identified from time to time in our filings with the SEC. Readers should carefully review these risk factors, and should not place
undue reliance on our forward-looking statements. These forward-looking statements are based on information, plans and estimates
at the date of this report. Akorn undertakes no obligation to update any forward-looking statements to reflect changes in underlying
assumptions or factors, new information, future events or other changes.