Item
4.01 Changes in Registrant’s Certifying Accountant
(a)
Dismissal of Previous Independent Registered Public Accounting Firm
On
August 2, 2021, the Audit Committee (the “Audit Committee”) of our Board of Directors (the “Board”) dismissed
Marcum LLP as our independent registered public accounting firm. Marcum LLP had served as our independent registered public accounting
firm since 2012.
Marcum
LLP’s most recent reports on our consolidated financial statements for the years ended December 31, 2019, 2018 and 2017 did not
contain an adverse opinion or a disclaimer of opinion, and were not qualified or modified as to uncertainty, audit scope or accounting
principle, except that the reports were qualified on the basis of the substantial doubt about the Company’s ability to continue
as a going concern.
During
our two most recent fiscal years ended December 31, 2020 and 2019 and the subsequent interim period through August 2, 2021, there were
no disagreements (as defined in Item 304(a)(1)(iv) of Regulation S-K and related instructions) between us and Marcum LLP on any matter
of accounting principles or practices, financial statement disclosure, or auditing scope or procedures, which disagreements, if not resolved
to the satisfaction of Marcum LLP, would have caused Marcum LLP to make reference thereto in its reports on our consolidated financial
statements for such years.
During
the two most recent fiscal years ended December 31, 2020 and 2019 and through the subsequent interim period preceding Marcum LLP’s
dismissal, there were no reportable events, as defined in Item 304(a)(1)(v) of Regulation S-K, except for the material weaknesses in
our internal control over financial reporting as of December 31, 2019 previously reported in the annual report on Form 10-K filed with
the Securities and Exchange Commission (the “SEC”) on April 23, 2021. The material weaknesses related to the lack of a sufficient
number of personnel with an appropriate level of knowledge and experience in the application of GAAP commensurate with our financial
reporting requirements at the time; the lack of sufficient complement of personnel to permit the segregation of duties among personnel
with access to accounting and information systems; and our failure to maintain appropriate tax work papers to properly support amounts
disclosed in the financial statements.
We
provided Marcum LLP with a copy of the disclosure we are making in this report and requested that Marcum LLP furnish us with a copy of
its letter addressed to the SEC, pursuant to Item 304(a)(3) of Regulation S-K, stating whether or not Marcum LLP agrees with the statements
related to them by us in this report. Marcum LLP’s response letter dated August 6, 2021, is filed as Exhibit 16.1 to this report.
(b)
Engagement of Independent Registered Public Accounting Firm
On
August 2, 2021, the Audit Committee approved the appointment of RAM Associates, LLP (“RAM Associates”) as our new independent
registered public accounting firm, effective immediately, to perform independent audit services for the fiscal years ending December
31, 2021 and 2020. RAM Associates has served as the auditor for Nostrum Laboratories, Inc. and its affiliates, which are subsidiaries
of Nostrum Pharmaceuticals LLC, our largest shareholder, since 2008.
During
the fiscal years ended December 31, 2020 and 2019, and during the subsequent interim period through August 2, 2021, neither we, nor anyone
on our behalf, consulted RAM Associates regarding either (i) the application of accounting principles to a specified transaction, either
completed or proposed, or the type of audit opinion that might be rendered with respect to our consolidated financial statements, and
no written report or oral advice was provided to us by RAM Associates that was an important factor considered by us in reaching a decision
as to any accounting, auditing or financial reporting issue; or (ii) any matter that was the subject of a disagreement (as defined in
Item 304(a)(1)(iv) of Regulation S-K and the related instructions) or a reportable event (as that term is defined in Item 304(a)(1)(v)
of Regulation S-K.