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): December 30, 2015 (December 30, 2015)
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ENDO INTERNATIONAL PLC
(Exact Name of Registrant as Specified in Its Charter)
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Ireland | 001-36326 | 68-0683755 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland | Not Applicable |
(Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code 011-353-1-268-2000
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:
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.02. Termination of a Material Definitive Agreement.
On December 30, 2015, the Registrant’s subsidiaries, Auxilium Pharmaceuticals, Inc. (“Auxilium”) and Endo Ventures Limited (“Endo Ventures”), provided written notice to VIVUS, Inc. (“VIVUS”) that: (i) Auxilium was terminating the License and Commercialization Agreement (the “License Agreement”), by and between Auxilium and VIVUS; and (ii) Endo Ventures was terminating the related Commercial Supply Agreement (the “Supply Agreement” and, together with the License Agreement, the “VIVUS Agreements”), by and between Endo Ventures (by assignment from Auxilium) and VIVUS. The effective date of the termination is June 30, 2016. Auxilium and Endo Ventures are terminating the VIVUS Agreements in accordance with their terms and the termination will not give rise to any early termination fees or penalties.
Under the License Agreement, Auxilium has the exclusive right to commercialize VIVUS’s pharmaceutical product STENDRA® (avanafil) for the treatment of any urological disease or condition in humans, including male erectile dysfunction, in the U.S. and Canada and their respective territories. During the term of the License Agreement, royalty payments are payable to VIVUS based on tiered percentages of the aggregate annual net sales of STENDRA®. The royalty payments may increase with the achievement of specified thresholds of aggregate annual net sales of the product and may decrease with the entry of a generic product to the market.
Pursuant to the related Commercial Supply Agreement, VIVUS exclusively supplies and manufactures STENDRA®, directly or through one or more third party subcontractors, for Endo Ventures. Endo Ventures pays to VIVUS its manufacturing cost plus a certain percentage mark up for each unit of STENDRA®.
A copy of the notice of termination is filed herewith as Exhibit 10.1 and is incorporated herein by reference.
Item 8.01. Other Events.
On December 30, 2015, the Registrant’s subsidiary, Endo Ventures Bermuda Limited (“Endo Bermuda”), provided written notice to Acerus Pharmaceuticals Corporation (f/k/a Trimel BioPharma SRL, “Acerus”) that Endo Bermuda was terminating the License, Development and Supply Agreement (“Acerus Agreement”), by and between Endo Bermuda and Acerus. The effective date of the termination is June 30, 2016. Endo Bermuda is terminating the Acerus Agreement in accordance with its terms and the termination will not give rise to any early termination fees or penalties.
Pursuant to the Acerus Agreement, Endo Bermuda acquired from Acerus the sole and exclusive commercial rights in the U.S. and Mexico of Natesto™ (testosterone nasal gel), the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism.
Item 9.01. Financial Statements and Exhibits.
(d) | Exhibits. |
Exhibit No. | Description |
10.1 | Notice of Termination, effective as of June 30, 2016, of (i) the License and Commercialization Agreement by and between Auxilium and VIVUS and (ii) the Commercial Supply Agreement, by and between Endo Ventures (by assignment from Auxilium) and VIVUS. |
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.
ENDO INTERNATIONAL PLC | |
(Registrant) | |
By: | /s/ Matthew J. Maletta |
Name: | Matthew J. Maletta |
Title: | Executive Vice President, Chief Legal Officer |
Dated: December 30, 2015
INDEX TO EXHIBITS
Exhibit No. | Description |
10.1 | Notice of Termination, effective as of June 30, 2016, of (i) the License and Commercialization Agreement by and between Auxilium and VIVUS and (ii) the Commercial Supply Agreement, by and between Endo Ventures (by assignment from Auxilium) and VIVUS. |
Exhibit 10.1
December 30, 2015
Via Fax (650.934.5320) and US Mail
John Slebir
General Counsel
VIVUS, Inc.
351 E. Evelyn Ave.
Mountain View, CA 94041
General Counsel
VIVUS, Inc.
351 E. Evelyn Ave.
Mountain View, CA 94041
Re: Termination Notice
Dear Mr. Slebir:
Auxilium Pharmaceuticals, Inc., an Endo international company (“Auxilium”), hereby provides notice of termination of the License and Commercialization Agreement between Vivus, Inc. (“Vivus”) and Auxilium dated October 10, 2013 (the “License Agreement”) pursuant to Section 12.2(c) of the License Agreement. With this termination of the License Agreement, Auxilium desires to abandon and relinquish all rights with respect to the Auxilium License (as defined in the License Agreement) as of the date hereof.
Concurrently with the termination of the License Agreement, Endo Ventures Limited (“Endo”) also hereby terminates the Commercial Supply Agreement between Vivus and Endo dated October 10, 2013, pursuant to Section 9.3 thereof.
Endo acknowledges that it will continue to perform its applicable obligations under the License Agreement and the Supply Agreement as expressly provided in that certain Transition Services Agreement between Endo and Vivus, which the parties are currently negotiating.
With the execution of this termination letter, the parties hereto acknowledge Auxilium's abandonment of all rights under the Auxilium License. Moreover, Auxilium and Vivus agree that no value whatsoever was provided by Vivus to Auxilium in exchange for Auxilium's relinquishment of the Auxilium License and intend for this arrangement to qualify as an abandonment of the License Agreement for the purposes of Section 165 of the Internal Revenue Code of 1986 as amended.
Sincerely,
AUXILIUM PHARMACEUTICALS, INC.
/s/ Deanna Voss
Deanna Voss
Assistant Secretary
Exhibit 10.1
ENDO VENTURES LIMITED
/s/ Orla Dunlea
Orla Dunlea
Director
cc: | Shane Albright Hogan Lovells US LLP 525 University Avenue 3rd floor Palo Alto, CA 94301 Fax: 650.463.4199 |