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): September 11, 2012
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| (Exact name of registrant as specified in its charter) |
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(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
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630 Fifth Avenue, Suite 2260, New York, New York | |
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Registrant’s telephone number, including area code: (212) 729-4962
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| (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 (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
On September 11, 2012, FCB I LLC (“FCB”) and Auxilium Pharmaceuticals, Inc. (“Auxilium”) learned that Upsher-Smith Laboratories, Inc. (“Upsher-Smith”) had filed on September 10, 2012 in the United States District Court for the District of New Jersey a complaint for declaratory judgment seeking a declaration of non-infringement and/or invalidity of FCB’s U.S. Patent Nos.: 7,608,605; 7,608,606; 7,608,607; 7,608,608; 7,608,609; 7,608,610; 7,935,690; and 8,063,029. FCB is an indirect, majority-owned subsidiary of Xstelos Holdings, Inc. (“Xstelos”). As Xstelos has previously disclosed, all of the eight referenced patents cover Auxilium’s Testim® 1% testosterone gel, and the eight referenced patents are among the ten FCB patents covering Testim that are currently listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration. The referenced patents will expire between 2023 and 2025. FCB and Auxilium are currently reviewing the details of the complaint from Upsher-Smith and intend to pursue all available legal and regulatory options in defense of Testim, including enforcement of FCB’s and Auxilium’s intellectual property rights and approved labeling.
SIGNATURE
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.
| | XSTELOS HOLDINGS, INC. |
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| Dated: September 14, 2012 | By: | |
| | | Name: | Jonathan M. Couchman |
| | | Title: | President, Chief Executive Officer and Chief Financial Officer |
