Item 8.01 Other Events

As previously disclosed, the enforcement division staff of the Securities and Exchange Commission conducted an investigation into the accuracy of certain statements in the Company’s Form 10 registration statement filed June 2, 2016, as amended, and its Form 10-K annual report filed May 8, 2017. The staff’s inquiry was focused on the Company’s disclosure language in those filings relating to the FDA requirements for the Company’s consumer transdermal patch products. On August 10, 2018, the Company, the chief executive officer and the chief financial officer received a Wells notice from the enforcement division staff in connection with the investigation and, on September 7, 2018, the Company and the officers filed a Wells submission in response. After engaging in settlement discussions with the staff about the matters under investigation, the Company and the officers submitted an offer of settlement to resolve the investigation without admitting or denying any violations of the federal securities laws.

On December 26, 2018, the SEC announced that it has accepted the settlement offer and instituted settled administrative cease-and-desist proceedings against the Company and the officers. The SECs administrative order, dated December 26, 2018, finds that the Company and the officers consented – without admitting or denying any findings by the Commission – to cease-and-desist orders against them for violations by the Company of Sections 12(g) and 13(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rules 12b-20 and 13a-1 thereunder, which require issuers to file accurate registration statements and annual reports with the Commission; violations by the officers for causing the Company’s violations of the above issuer reporting provisions; and violations by the officers of Rule 13a-14 of the Exchange Act, which requires each principal executive and principal financial officer of issuers to attest that annual reports filed with the Commission do not contain any untrue statements of material fact. In addition to consenting to the cease-and-desist orders, the officers have each agreed to pay a $25,000 civil penalty to resolve the investigation. The administrative order does not impose a civil penalty or any other monetary relief against the Company.