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): August 12, 2008
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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| New Jersey
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0-19777
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22-3103129 |
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(Commission File
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Identification |
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25 Upton Drive
Wilmington, Massachusetts 01887
(Address of principal executive offices, including ZIP code)
(978) 657-7500
(Registrant’s telephone number, including area code)
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):
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 Securities 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 a Material Definitive Agreement.
As part of the settlement of litigation between DUSA Pharmaceuticals, Inc. and River’s Edge
Pharmaceuticals, LLC in October 2007, the parties entered into a Settlement Agreement and Mutual
Release (the “Settlement Agreement”) to dismiss the lawsuit brought by DUSA against River’s Edge
asserting a number of claims arising out of River’s Edge’s alleged infringement of DUSA’s Nicomide®
patent, U.S. Patent No. 6,979,468, under which DUSA has marketed, distributed and sold Nicomide®.
On August 12, 2008, DUSA entered into a worldwide non-exclusive patent license agreement to its
patent covering Nicomide® (the “License Agreement”) with River’s Edge and an amendment to the
Settlement Agreement (the “Amendment”). The Amendment allows River’s Edge to manufacture and
market a prescription product that could be substitutable for Nicomide® pursuant to the terms of
the License Agreement and changes certain payment obligations of River’s Edge for sales of its
substitutable product, NIC 750. Subject to certain terms and conditions, the License Agreement has
an initial term of 12 months, and thereafter, may be automatically renewed for consecutive periods
of 12 months at DUSA’s sole option. In consideration for granting the license, DUSA will be paid a
share of the net revenues, as defined in the License Agreement, of River’s Edge’s licensed product
sales under the License Agreement. The License Agreement is effective as of July 3, 2008.
On August 14, 2008, DUSA issued the press release attached to this report as Exhibit 99.1 and made
part of this report announcing its entry into the License Agreement.
These actions follow DUSA’s announcement on July 18, 2008 that it would no longer manufacture and
market Nicomide® as a prescription product in response to discussions with the FDA. DUSA is
relabeling a supply of product as a non-prescription dietary supplement in compliance with Dietary
Supplement Health and Education Act (“DSHEA”) for re-launch and is in discussions with the U.S.
Food and Drug Administration about appropriate DSHEA labeling.
Except for historical information, this report, including the exhibit, contains certain
forward-looking statements that involve known and unknown risk and uncertainties, which may cause
actual results to differ materially from any future results, performance or achievements expressed
or implied by the statements made. These forward-looking statements relate to payments from
River’s Edge, and DUSA’s cessation of marketing of Nicomide® as a prescription product, intention
to re-launch the product under DSHEA and beliefs regarding the value of Nicomide®.
These forward-looking statements are further qualified by important factors that could cause actual
results to differ materially from future results, performance or achievements expressed or implied
by those in the forward-looking statements made in this release. These factors include, without
limitation, actions by health regulatory authorities, ability to enter a supply arrangement for a
DSHEA product, reliance on third party manufacturers, DUSA’s ability to re-launch Nicomide® as a
non-prescription dietary supplement product and other risks and uncertainties identified in DUSA’s
Form 10-K for the year ended December 31, 2007, recent Form 10-Q for the period ended June 30, 2008
and other SEC filings from time to time.