UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): September 10, 2015
Commission File Number |
Exact name of registrant as principal office and address |
State of incorporation or organization |
I.R.S. Employer Identification No. | |||
001-36867 | Allergan plc Clonshaugh Business and Technology Park (862) 261-7000 |
Ireland | 98-1114402 |
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 (see General Instruction A.2. below):
¨ | 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) |
Item 7.01 | Regulation FD Disclosure. |
On September 10, 2015, Allergan plc (the Company) issued a press release announcing that its subsidiaries Forest Laboratories, LLC (Forest LLC) and Forest Laboratories Holdings, Ltd. (Forest Holdings and, together with Forest LLC, Forest), along with Adamas Pharmaceuticals, Inc. (Adamas), have entered into a settlement agreement with Amneal Pharmaceuticals LLC and related companies and subsidiaries (Amneal). The settlement relates to a patent infringement litigation brought by Forest and Adamas in response to Amneals abbreviated new drug application (ANDA) seeking approval to market generic versions of the Companys NAMENDA XR® (memantine hydrochloride) extended release capsules (NAMENDA XR). Under the terms of the settlement agreement, and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest and Adamas will grant Amneal a license to market generic versions of the Companys NAMENDA XR beginning on January 31, 2020, following receipt by Amneal of final approval from the U.S. Food and Drug Administration on its ANDA for generic NAMENDA XR. Alternatively, under certain circumstances, Amneal has an option to launch an authorized generic version of NAMENDA XR beginning on January 31, 2021. Other terms of the settlement were not disclosed.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed filed for purposes of Section 18 of the Exchange Act of 1934, as amended (the Exchange Act), or as otherwise subject to liability of that section, nor shall such information be deemed to be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit |
Description of Exhibit | |
Exhibit 99.1 | Press Release dated September 10, 2015. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: September 11, 2015 | ALLERGAN PLC | |||||
By: | /s/ A. Robert D. Bailey | |||||
Name: | A. Robert D. Bailey | |||||
Title: | Chief Legal Officer and Corporate Secretary |
Exhibit Index
Exhibit |
Description of Exhibit | |
Exhibit 99.1* | Press Release dated September 10, 2015. |
* | Exhibits filed herewith |