FORM 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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)
January 25, 2006 (January 23, 2006)
Endo Pharmaceuticals Holdings Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-15989 |
13-4022871 |
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(State or other jurisdiction of incorporation)
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(Commission File Number) |
(IRS Employer Identification No.)
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100 Endo Boulevard, Chadds Ford, PA
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19317 |
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(Address of principal executive offices)
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(Zip Code)
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Registrant's telephone number, including area code
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(610) 558-9800 |
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 1.01. Entry into or Amendment of Material Definitive Agreement.
On January 23, 2006, DURECT Corporation (DURECT) and the
Registrants
wholly owned subsidiary, Endo Pharmaceuticals Inc. (Endo), entered into Amendment No. 3 to the
Development, Commercialization and Supply License Agreement dated November 8, 2002
(the Agreement) relating to the development and
commercialization of the CHRONOGESICTM product candidate in the U.S. and Canada. Prior to the
present amendment, in addition to other specified termination rights provided to both parties,
the Agreement provided Endo with a right to terminate the Agreement starting January 1, 2006 in the event that
DURECT had not commenced a specified clinical trial for the CHRONOGESICTM product candidate on or
before January 1, 2006, provided that Endo provided DURECT written notice of such termination prior to January 31, 2006.
Under Amendment No. 3, the foregoing termination right was amended to provide Endo with the right to
terminate the Agreement in the event that (i) DURECT had not delivered to Endo on or before March 31, 2007 a
written notice (the Notice) that a human
pharmacokinetic trial had been completed with the CHRONOGESICTM product candidate,
together with a full study report of the results of the trial or (ii) Endo, determines,
in its sole discretion, to terminate the Agreement during the sixty-day period after DURECTs
delivery of the Notice, provided that, in each case Endo delivers to DURECT its written notice of
termination prior to April 30, 2007. Under Amendment No. 3, Endo
shall not be responsible for any development costs for the CHRONOGESICTM product candidate prior to May 1, 2007.
Commencing on May 1, 2007, unless the Agreement is earlier terminated by Endo,
Endo will fund 50% of the ongoing development costs for the CHRONOGESICTM product candidate in accordance
with the terms of the Agreement. A copy of Amendment No. 3 to the Development, Commercialization and
Supply License Agreement between DURECT Corporation and Endo is attached as Exhibit 10.42.4 hereto and
is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(a) Financial Statements of Business Acquired.
Not applicable.
(b)
Pro Forma Financial Information.
Not applicable.
(c)
Exhibits.
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Exhibit Number
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Description
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10.42.4 |
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Amendment No. 3 to the Development, Commercialization and Supply License
Agreement between DURECT Corporation and Endo Pharmaceuticals Inc. |
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.
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ENDO PHARMACEUTICALS HOLDINGS INC. |
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(Registrant)
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By: |
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/s/ CAROLINE B. MANOGUE |
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Name: Caroline B. Manogue
Title: Executive Vice President, Chief Legal Officer & Secretary |
Dated: January 25, 2006
INDEX TO EXHIBITS
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Exhibit No.
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Description
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10.42.4 |
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Amendment No. 3 to the Development, Commercialization and Supply License
Agreement between DURECT Corporation and Endo Pharmaceuticals Inc. |