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): September 26, 2007
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| |
|
|
|
|
New Jersey
(State or other
jurisdiction of
incorporation)
|
|
0-19777
(Commission File
Number)
|
|
22-3103129
(IRS Employer
Identification
Number) |
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:
| 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 a Material Definitive Agreement |
On September 26, 2007, DUSA Pharmaceuticals, Inc. (“DUSA”) entered into Amendment No. 1 to the
Marketing, Distribution and Supply Agreement (the “Amendment”) with Stiefel Laboratories, Inc.
(“Stiefel”). The original Marketing, Distribution and Supply Agreement with Stiefel, dated January
12, 2006, (the “Agreement”) which was previously reported and filed, pertains to the appointment of
Stiefel as DUSA’s marketing and distribution partner for DUSA’s product, the Levulan®
Kerastick®, in Latin America. The Amendment was entered to recognize the delay in
receipt of acceptable pricing approval in Brazil, which the parties originally intended as the
first country for launch of the product. Since negotiations with Brazilian authorities are still
continuing, DUSA and Stiefel determined that it was in the best interest of both parties that the
product be launched earlier in other countries causing a need for adjustment for some of the
economic terms of the Agreement.
Pursuant to the Amendment, Stiefel will make aggregate milestone payments to DUSA of up to
$2,250,000, rather than up to $3,000,000 under the Agreement based upon the following: (1) the
launch date of the Levulan® Kerastick® in Mexico or Argentina, whichever occurs first, (2)
achievement of pre-determined minimum purchase levels in the territory and (3) based upon receipt
of final pricing approval of the Levulan® Kerastick® from Brazilian pricing authorities, each of
which are subject to certain terms and conditions. The timing and quantities of the minimum
purchase obligations were also amended. In addition, the transfer price for the product was
amended to set a fixed price plus a royalty on net sales, rather than a revenue-sharing arrangement
as under the Agreement. DUSA believes that the amended transfer price reduces some of the risk
related to currency and market price fluctuations during the ten-year term of the Agreement.
The Amendment also modifies certain responsibilities and obligations related to the regulatory
filings in the territory and clarifies the sharing of costs pertaining to the receipt of Brazilian
pricing approval.
Except for historical information, this report, including the attached press release, 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 the risks
relating to currency and market price fluctuations, launch of the product in Latin American
countries by Stiefel, and the expectation for additional international expansion. Furthermore, the
factors that may cause differing results include the ability to penetrate the market, the
regulatory approval process, receipt of acceptable pricing approval in Brazil, sufficient funding,
maintenance of DUSA’s patent portfolio, reliance on third parties, and other risks identified in
DUSA’s SEC filings from time to time.
On October 1, 2007, DUSA issued a press release, attached to and made part of this report,
announcing the shipment of the product to Mexico and Argentina and indicating that the Amendment
had been signed.