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
April 28, 2010
Date of Report (Date of earliest event reported)
Medicis Pharmaceutical Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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001-14471
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52-1574808 |
(State of Incorporation)
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(Commission File Number)
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(IRS Employer
Identification Number) |
7720 North Dobson Road
Scottsdale, Arizona 85256
(Address of principal executive offices) (Zip Code)
(602) 808-8800
(Registrants telephone number, including area code)
N/A
(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 a Material Definitive Agreement.
On May 4, 2010, Medicis Pharmaceutical Corporation (the Company) entered into a License and
Settlement Agreement (the Settlement Agreement) with Ranbaxy Inc. and Ranbaxy Laboratories
Limited (together, Ranbaxy). Pursuant to the Settlement Agreement, the Company and Ranbaxy
agreed to terminate all legal disputes between them relating to SOLODYN® (minocycline HCl, USP)
Extended Release Tablets. In addition, Ranbaxy confirmed that the Companys patents relating to
SOLODYN® are valid and enforceable, and cover Ranbaxys activities relating to Ranbaxys generic
SOLODYN® products under Abbreviated New Drug Application (ANDA) No. 91-118. Ranbaxy also agreed
to be permanently enjoined from any distribution of generic SOLODYN® except as described below.
Under the Settlement Agreement, the Company granted to Ranbaxy a license to make and sell its
generic version of SOLODYN® 45mg, 90mg and 135mg under the SOLODYN® intellectual property rights
belonging to the Company commencing in November 2011, or earlier under certain conditions. The
Company also granted to Ranbaxy a license to make and sell generic versions of SOLODYN® 65mg and
115mg under the Companys SOLODYN® intellectual property rights upon certain conditions but not
upon any specified date in the future. The Settlement Agreement provides that Ranbaxy will be
required to pay the Company royalties based on sales of Ranbaxys generic SOLODYN® products
pursuant to the foregoing licenses.
In addition, the Settlement Agreement provides for the Companys grant to Ranbaxy of a license
to make and sell a branded proprietary dermatology product currently under development by Ranbaxy,
which is not therapeutically equivalent to any of the Companys currently marketed dermatology
products, under certain intellectual property rights belonging to the Company commencing the later
of August 2011 or upon the sale of such product by Ranbaxy following approval by the U.S. Food and
Drug Administration. Ranbaxy will be required to pay the Company a royalty based on sales of such
product pursuant to the license.
Item 2.02 Results of Operations and Financial Condition.
On May 5, 2010, the Company issued a press release announcing its financial results for the
quarter ended March 31, 2010. A copy of the press release is furnished herewith as Exhibit 99.1
and is incorporated by reference herein.
The information in this Item 2.02, including the accompanying exhibit, is being furnished and
shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, or otherwise subject to the liabilities of that Section. The information in this Item
2.02 shall not be incorporated by reference into any registration statement or other document filed
pursuant to the Securities Act of 1933, as amended, regardless of any general incorporation
language in such filing.
Item 8.01 Other Events.
On April 28, 2010, the Company filed suit against Taro Pharmaceuticals U.S.A., Inc. and Taro
Pharmaceuticals Industries, Ltd. (collectively, Taro) in the United States District Court for the
District of Delaware and the United States District Court for the Southern District of New York
seeking an adjudication that Taro has infringed one or more claims of the Companys U.S. Patent No.
6,765,001, U.S. Patent No. 7,220,424 and U.S. Patent No. 7,217,422 by submitting to the FDA an ANDA
for a generic version of VANOS® (fluocinonide) Cream 0.1%. The relief
requested by the Company includes a request for a permanent injunction preventing Taro from
infringing the patents by selling a generic version of VANOS® prior to the
expiration of the asserted patents.
Item 9.01 Exhibits.
(d) Exhibits
99.1 |
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Press Release dated May 5, 2010. |