Item 3. Legal Proceedings
ITEM 3.
LEGAL PROCEEDINGS
To our knowledge, neither the Company
nor any of our officers or directors is a party to any material legal proceeding or litigation and such persons know of no material
legal proceeding or contemplated or threatened litigation, other than as described below. There are no judgments against us or
our officers or directors. None of our officers or directors has been convicted of a felony or misdemeanor relating to securities
or performance in corporate office.
On November 13, 2019, the Patent Trial
and Appeal Board of the United States Patent and Trademark Office (the “PTAB”) issued a written decision in the inter
partes review action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”) against
us. In that action, Mallinckrodt sought to invalidate our previously-issued patent (U.S. Pat. No. 9,655,945, “Treatment of
Ascites”) (the “’945 Patent”). In its decision, the PTAB determined that all claims of the ‘945 Patent
were not patentable because they were either anticipated or obvious in light of prior art. The PTAB also denied our Motion to Amend
the claims on similar grounds. The result of the PTAB’s decision is that the ‘945 patent is no longer valid or enforceable.
ITEM 4.
MINE SAFETY DISCLOSURES
None.
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Table of Contents
PART II
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.