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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or Section 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 18, 2022

 

 

 

AVADEL PHARMACEUTICALS PLC

(Exact name of registrant as specified in its charter)

 

 

 

Ireland 001-37977 98-1341933
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)

 

10 Earlsfort Terrace

Dublin 2, Ireland, D02 T380

 

Not Applicable

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: +353 1 920 1000

 

Not applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

 

Title of each class Trading Symbol(s) Name of each exchange on which
registered

American Depositary Shares*

Ordinary Shares, nominal value $0.01 per share**

AVDL

N/A

The Nasdaq Global Market

 

*American Depositary Shares may be evidenced by American Depositary Receipts. Each American Depositary Share represents one (1) Ordinary Share.

 

 

** Not for trading, but only in connection with the listing of American Depositary Shares on The Nasdaq Global Market.

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 7.01Regulation FD Disclosure.

 

On November 18, 2022, Avadel Pharmaceuticals plc (the “Company”) issued a press release titled “Avadel Pharmaceuticals Announces Favorable Ruling on Motion to Delist REMS Patent from FDA’s Orange Book.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information furnished under this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01Other Events.

 

As previously disclosed, on June 23, 2022, Avadel CNS Pharmaceuticals, LLC (“Avadel CNS”), a subsidiary of the Company, filed a Renewed Motion for Judgment on the Pleadings, with respect to its counterclaim against Jazz Pharmaceuticals, Inc. (“Jazz”), seeking to have U.S. Patent No. 8731963 (the “REMS Patent”) de-listed from the U.S. Food and Drug Administration’s (“FDA”) Orange Book. On November 15, 2022, the United States District Court for the District of Delaware (the “Delaware Court”) held a hearing on that motion. On November 18, 2022, the Delaware Court issued its written opinion ordering Jazz to request delisting of the REMS Patent. With the issuance of this ruling, the Company intends to seek final FDA approval for LUMRYZ upon removal of the REMS Patent from the FDA’s Orange Book.

 

Item 9.01.Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No. 
 
  Description  
99.1    Press release issued by Avadel Pharmaceuticals plc on November 18, 2022
104   Cover Page Interactive Data File (the cover page XBRL tags are embedded in the Inline XBRL document).

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: November 18, 2022 AVADEL PHARMACEUTICALS PLC
     
  By: /s/ Jerad G. Seurer
    Name: Jerad G. Seurer
    Title: General Counsel & Corporate Secretary

 

 

 

 

 

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