Item 3. Legal Proceedings
ITEM
3. LEGAL PROCEEDINGS
On
August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA
by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act. On November
14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma. Elite obtained agreement with Purdue
to stay the litigation for six months. Elite’s launch of a generic Oxycontin will depend on approval by the FDA and the outcome
of various litigations involving Purdue or the expiry of the patents listed on the Orange Book.
In
the ordinary course of business, we may be subject to litigation from time to time. There is no current, pending or, to our knowledge,
threatened litigation or administrative action to which we are a party or of which our property is the subject (including litigation
or actions involving our officers, directors, affiliates, or other key personnel, or holders of record or beneficially of more than 5%
of any class of our voting securities, or any associate of any such party) which in our opinion has, or is expected to have, a material
adverse effect upon our business, prospects financial condition or operations. A significant increase in the number of claims or an increase
in amounts owing under successful claims could materially adversely affect our business, financial condition, results of operations and
cash flows.
ITEM
4. MINE SAFETY DISCLOSURES
Not
Applicable.
44
PART
II
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