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  • on 19.11.2014
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AUXILIUM PHARMACEUTICALS INC FILES (8-K) Disclosing Other Events

Nov19

Item 8.01 Other EventsLitigation UpdateAs previously disclosed, Auxilium Pharmaceuticals, Inc. ("Auxilium" or the"Company") and FCB I Holdings Inc. ("FCB") have been litigating various matterswith Upsher-Smith Laboratories, Inc. ("Upsher-Smith") related to Upsher-Smith’sfiling of Paragraph IV certifications in connection with a 505(b)(2) New DrugApplication (the "505(b)(2) NDA") and an Abbreviated New Drug Application, ineach case, using Testim as the reference product. Subsequent to the withdrawalof Auxilium’s appeal in the litigation regarding the 505(b)(2) NDA, aspreviously disclosed, Upsher-Smith filed a motion with the District Courtseeking reimbursement of its legal fees by Auxilium.
On November 10, 2014, the Company and Upsher-Smith entered into a Settlement andMutual Release of Claims whereby the parties released each other from, andagreed to dismiss, any claims arising out of any of the pending litigationsbetween them, including any claim by Upsher-Smith for attorneys’ fees and costs,and pursuant to which the Company agreed to pay Upsher-Smith $750,000.
In addition to the recent studies of testosterone replacement therapies ("TRT"),the U.S. Food and Drug Administration’s ("FDA") class labeling changes for TRTproducts, the accumulating product liability suits against the manufacturers andmarketers of TRT products, and the FDA Advisory Committee on TRT products, onNovember 5, 2014, a putative class action complaint (Case Number 1:14cv8857) wasfiled on behalf of Medical Mutual of Ohio and similarly situated third partypayors in the United States District Court, Northern District of Illinoisagainst 19 manufacturers of TRT products, including the Company (the"Complaint"). The Complaint alleges substantially similar facts to those beingalleged in the TRT product liability suits to which the Company and many of theother defendants are currently a party. The Complaint requests relief fordamages, attorneys’ fees, and equitable relief on behalf of the putative classfor alleged violations of the federal civil RICO statute, state consumer fraudand deceptive trade practice act laws, negligent misrepresentation, common lawfraud, and unjust enrichment. The Complaint seeks damages from Auxilium forthese alleged violations with respect to its Testim and TESTOPEL products andagainst the other 18 defendants for their respective products. The Complaintdefines the class, in relevant part, as "[a]ll health insurance companies, thirdparty administrators, health organizations, self-funded health and welfarebenefit plans, third party payors and any other health benefit providers, in theUnited States of America and its territories, which paid or incurred costs forthe drug AndroGel, Testim, Testopel, Axiron, Fortesta, and/or Androderm forpurposes other than resale, since their respective approval dates." TheComplaint seeks an unspecified amount of damages. The Company is in the processof examining the allegations in the Complaint and intends to vigorously defendthe allegations made in the Complaint.
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