EXPLANATORY NOTE
This Schedule 13D (the
Statement
) is filed (i) to amend and restate the Schedule 13D filed by OPKO Health, Inc.
(
OPKO
) with the Securities and Exchange Commission (the
SEC
) on March 22, 2013 (the
Original 13D
), as amended on January 10, 2017, and the Schedule 13G filed by OPKO with the SEC on
January 12, 2017 and (ii) by Phillip Frost, M.D. and Frost Gamma Investments Trust (
FGIT
).
On
September 7, 2018, the SEC filed a civil complaint in the Southern District of New York (the
Complaint
), against a number of individuals and entities, including OPKO and its CEO and Chairman, Dr. Frost.
In December 2018, OPKO, Dr. Frost and FGIT entered into settlements with the SEC, which, upon approval by the court in January 2019,
resolved the claims against OPKO, Dr. Frost and FGIT. Pursuant to the settlement between OPKO and the SEC, and without admitting or denying any of the allegations of the Complaint, OPKO agreed to be enjoined from future violations of
Section 13(d) of the Securities Exchange Act of 1934 (the
Exchange Act
), a claim that requires no showing of scienter, and to pay a civil monetary penalty, which has been paid. OPKO also agreed, within certain stipulated time
periods, to: (i) establish a Management Investment Committee (
MIC
) that will make recommendations to an Independent Investment Committee (
IIC
) of OPKOs board of directors in connection with existing
and future strategic minority investments; and (ii) retain an Independent Compliance Consultant (
ICC
) on a time-limited basis to, among other things, advise OPKO on whether filings pursuant to Section 13(d) of the
Exchange Act for previous strategic minority investments made at the suggestion of or in tandem with Dr. Frost and his related persons or entities should be made or amended to reflect group membership with Dr. Frost.
Under the terms of the settlement between the SEC, Dr. Frost and FGIT, and without admitting or denying any of the allegations in the
Complaint, Dr. Frost agreed to injunctions from violations of Sections 5(a) and (c) and 17(a)(2) of the Securities Act of 1933, claims which may be satisfied by strict liability and negligence, respectively, and Section 13(d) of the
Exchange Act, also a strict liability claim; to pay a civil monetary penalty, disgorgement and
pre-judgment
interest, which have been paid; and to be prohibited, with certain exceptions, from trading in penny
stocks.
The ICC has concluded his work, determined that certain prior investments in the Issuer by OPKO and Dr. Frost should have
been grouped under Section 13(d) of the Exchange Act, and recommended the filing of this form.
OPKO has now established the MIC and
IIC, and following the establishment of these committees, any group between OPKO, Dr. Frost, and his affiliated entities with respect to investments in the Issuer has ceased to exist.