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In February 2023, the Office of the Attorney General for the State of Texas (“TX OAG”) informed BioReference that it believes that, from 2005 to the present, BioReference may have violated the Texas Medicaid Fraud Prevention Act with respect to claims it presented to Texas Medicaid for reimbursement.
−Removed: BioReference has not determined whether there is any merit to the TX OAG claims nor can it determine the extent of any potential liability.
+Added: BioReference cannot determine the extent of any potential liability at this time.
While management cannot predict the outcome of these matters at this time, the ultimate outcome could be material to our business, financial condition, results of operations, and cash flows.
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We cannot currently provide any assurance as to the outcome of this matter, including the likelihood of an unfavorable outcome.
−Removed: On or about September 13, 2018, Idan Sharon filed an Application for Approval of a Class Action in the Tel Aviv Israel District Court against the Company and certain of its current and former executive officers, and certain members of its Board of Directors (the “Sharon Claim”).
−Removed: This application was filed by a purported stockholder, both individually and on behalf of a putative class of the Company’s stockholders, claiming that in connection with the facts and circumstances underlying the allegations in the SEC Complaint, the Company engaged in fraudulent conduct and made false and misleading statements of material fact or omitted to state material facts necessary to make the statements made not misleading.
−Removed: The Sharon Claim sought both to declare the action a class action and monetary damages.
−Removed: The Court closed this case pending resolution of the U.S.-based class actions relating to the allegations in the SEC Complaint.
−Removed: class action lawsuit was settled, and the damages
−Removed: granted in that settlement are for both NASDAQ and TASE class members (the “ Sharon Settlement Agreement”), Sharon filed a motion and request that the Court order the TASE to provide the information required to allow distribution of payment to TASE class members, in accordance with the Sharon Settlement Agreement.
On March 1, 2019, the Company received a Civil Investigative Demand (“CID”) from the U.S.
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The CID sets forth document requests and interrogatories in connection with allegations that the Company and certain of its affiliates violated the False Claims Act and/or the Anti-Kickback Statute.
−Removed: On January 13, 2022, the Federal Government notified the U.S.D.C., Middle District Florida, Jacksonville Division, that it is declining to intervene in the matter but retains the right, via the Attorney General, to consent to any proposed dismissals of the action by the Court.
−Removed: On February 9, 2022, the States of Florida, Georgia, and Commonwealth of Massachusetts notified the U.S.D.C., Middle District Florida, Jacksonville Division, that they are declining to intervene in the matter.
+Added: On January 13, 2022, the Federal Government notified the U.S.D.C., Middle District Florida, Jacksonville Division, that it declined to intervene in the matter but retained the right, via the Attorney General, to consent to any proposed dismissals of the action by the Court.
+Added: On February 9, 2022, the States of Florida, Georgia, and Commonwealth of Massachusetts notified the U.S.D.C., Middle District Florida, Jacksonville Division, that they declined to intervene in the matter.
Notwithstanding the above declinations, on February 17, 2022, the Company was served with the Relator’s Summons and Complaint (“Complaint”), which had been previously sealed.
−Removed: The complaint alleges violations of the False Claims Act, the California Fraud Preventions Act, the Florida False Claims Act, the Massachusetts False Claims Act, the Georgia False Medicaid Claims Act, and illegal kickbacks.
−Removed: A motion to dismiss the Complaint was filed on April 25, 2022.
−Removed: Briefing on the motion to dismiss is complete.
−Removed: As of the date of this Annual Report on Form 10-K, the court has not decided the motion.
−Removed: While management cannot predict the outcome of these matters at this time, the ultimate outcome could be material to our business, financial condition, results of operations, and cash flows.
−Removed: On April 5, 2019, former shareholders of Claros Diagnostics, Inc.
−Removed: filed a complaint in the Chancery Court of Delaware against the Company, alleging among other things, that the Company breached the Agreement and Plan of Merger dated October 13, 2011 by and among the Company, Claros Merger Subsidiary, LLC and Claros Diagnostics, Inc.
−Removed: (the “Merger Agreement”):
−Removed: (i) by failing to make a milestone payment of $2.375 million (payable in OPKO Common Stock) upon obtaining FDA approval of the Claros PSA test;
−Removed: and (ii) by repudiating its obligations to make additional future milestone payments as required under the Merger Agreement.
−Removed: In January 2021, the Company and the shareholder representative entered into a settlement agreement providing, among other things, that it pay the shareholders $1.1875 million, which amount is equal to half the initial milestone payable under the Merger Agreement.
−Removed: A Stipulation of Dismissal With Prejudice was filed with the Court on February 8, 2021.
+Added: The complaint alleged violations of the False Claims Act, the California Fraud Preventions Act, the Florida False Claims Act, the Massachusetts False Claims Act, the Georgia False Medicaid Claims Act, and illegal kickbacks.
+Added: This case was dismissed with prejudice on January 23, 2024.
MINE SAFETY DISCLOSURES.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.