Search the web
Welcome, Guest
[Sign Out, My Account]
EDGAR_Online

Quotes & Info
Enter Symbol(s):
e.g. YHOO, ^DJI
Symbol Lookup | Financial Search
ACUR > SEC Filings for ACUR > Form 8-K on 9-Oct-2013All Recent SEC Filings

Show all filings for ACURA PHARMACEUTICALS, INC | Request a Trial to NEW EDGAR Online Pro

Form 8-K for ACURA PHARMACEUTICALS, INC


9-Oct-2013

Other Events, Financial Statements and Exhibits


Item 8.01 Other Events.

A. Settlement of Patent Infringement Litigation with Par Pharmaceutical

On October 4, 2013, Acura Pharmaceuticals, Inc. ("Acura") and Par Pharmaceutical, Inc. ("Par") entered into each of a License Agreement dated September 27, 2013 (the "Par Agreement") to settle the parties patent infringement litigation concerning OxectaŽ (oxycodone HCI tablets) pending in the United States District Court for the District of Delaware (the "Acura/Par Suit"). In the suit, Acura alleges that a generic OxectaŽ product for which Par is seeking approval to market in the U.S. pursuant to an Abbreviated New Drug Application ("ANDA") filing with the U.S. Food and Drug Administration ("FDA") infringes a U.S. patent owned by Acura (the "Acura Patent"). Par is the first ANDA filer for a generic OxectaŽ product and is entitled to the 180-day first-filer exclusivity period provided in the Drug Price Competition and Patent Term Restoration Act of 1984, as amended (the "Hatch-Waxman Act").

The Par Agreement provides for a full settlement of all claims that were asserted in Acura/Par Suit. Under the terms of the Par Agreement, Acura will grant Par a non-exclusive, royalty-bearing future license to the Acura Patent and other current and future Orange Book listable patents to market, manufacture and sell a generic version of OxectaŽ in the United States (the "Licensed Patents"). Par's license becomes effective January 1, 2022, approximately 23 months prior to the expected expiration of the Acura Patent in November, 2023. The license granted to Par would become effective earlier if each of the Licensed Patents is held invalid or unenforceable, or not infringed with respect to a third party's generic version of OxectaŽ, or if a third party sells a generic version of OxectaŽ under a license or other authorization from Acura. In consideration for the license grant, Par is required to pay Acura royalties in an amount ranging from 10% to 15% of Par's net profits from the sale of its generic OxectaŽ product.

The Par Agreement will remain in effect until the expiration of the term of the license granted by Acura to Par. The Par Agreement also contains customary confidentiality provisions and representations and warranties of the parties.

Promptly following execution of the Par Agreement, the parties are required to file dismissals without prejudice with the United States District Court for the District of Delaware, which will conclude the Acura/Par Suit. The Par Agreement also provide that the parties file the License Agreement with both the U.S. Federal Trade Commission ("FTC") and the Antitrust Division of the U.S. Department of Justice ("DOJ") as required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. There can be no assurance that the FTC and/or the DOJ will not raise objections to, or request modifications to, the Par Agreement; that any such modifications will be acceptable to the parties; or that the Par Agreement will continue to be effective.

B. Settlement of Patent Infringement Litigation with Impax Laboratories

On October 7, 2013, Acura and Impax Laboratories, Inc. ("Impax") entered into a License and Settlement Agreement, dated September 27, 2013 (the "Impax Agreement") to settle the parties' patent infringement litigation concerning OxectaŽ pending in the United States District Court for the District of Delaware (the "Acura/Impax Suit"). In the suit, Acura alleges that a generic OxectaŽ product for which Impax is seeking approval to market in the U.S. pursuant to ANDA filing with the FDA infringes the Acura Patent.

The Impax Agreement provides for a full settlement of all claims in the Acura/Impax Suit. Under the terms of the Impax Agreement, Acura will grant Impax a non-exclusive, royalty free, future license to the current and future Orange Book listable patents to market, manufacture and sell a generic version of OxectaŽ in the U.S. (the "Licensed Patents"). Impax's license becomes effective 180 days following the first sale of a generic OxectaŽ product in the United States by an entity that is entitled to the 180 day first-filer exclusivity provided in the Hatch-Waxman Act (or if no entity is entitled to the 180 day first-filer exclusivity provided in the Hatch-Waxman Act, the date on which a generic OxectaŽ product is first sold in the United States or November 27, 2021, whichever date occurs first). The license granted to Impax would become effective earlier, if each of the Licensed Patents is held (1) invalid or unenforceable, or (2) not infringe with respect to a third-party's generic version of OxectaŽ if that third party's generic version of OxectaŽ received final approval from the FDA, or (3) if a third party sells a generic version of Oxecta under a license or other authorization from Acura.

The Impax Agreement will remain in effect until the expiration of the Licensed Patents. The Impax Agreement also contains customary confidentiality provisions and representations and warranties of the parties.

Promptly following execution of the Impax Agreement, the parties are required to file the Impax Agreement with both the FTC and the DOJ as required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. There can be no assurance that the FTC and/or the DOJ will not raise objections to, or request modifications to the Impax Agreement; that any such modifications will be acceptable to the parties; or that the Impax Agreement will continue to be effective. The Impax agreement also requires the parties to file dismissals without prejudice with the United States District Court for the District of Delaware forty-five days after submission of the Impax Agreement to the FTC and DOJ. The dismissal will conclude the Acura/Impax Suit.

The Par Agreement and the Impax Agreement do not affect the status of Acura's separate OxectaŽ patent litigations against Sandoz and Ranbaxy pending in the United States District Court for the District of Delaware.

Safe Harbor

This filing contains forward-looking statement regarding the anticipated results of the settlement with Par. There are many important factors that could cause actual result to differ materially from those in these forward-looking statements. These factors include, among others, the following: that the U.S. District Court does not approve the stipulation of dismissal of each of the Acura/Par Suit and the Acura/Impax Suit, that the FTC or DOJ challenge the enforceability of the Par Agreement or the Impax Agreement, or that private plaintiffs challenge the Par Agreement or the Impax Agreement, whether or not additional third parties may seek to market generic versions of OxectaŽ and the results of any litigation that we have filed or may file to defend and/or assert our patents against such companies; the possible occurrence of one of the specific events that would result in Par or Impax marketing a generic OxectaŽ earlier than we anticipate; our ability to protect the proprietary technologies and intellectual property related to OxectaŽ and to secure and maintain additional intellectual property protection for OxectaŽ; and a variety of other risks common to our industry. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Acura's recent annual and quarterly reports filed with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings, which are incorporated in this filing by this reference.

Forward-looking statements speak only as of the date of this filing, and Acura undertakes no obligation to update or revise these statements.

A Press Release regarding the settlements is furnished as Exhibit 99.1.



Item 9.01 Financial Statements and Exhibits

Exhibit
Number        Description

              Press Release dated October 9, 2013 Regarding Settlements With Par
99.1          Pharmaceutical, Inc. and Impax Laboratories, Inc.

  Add ACUR to Portfolio     Set Alert         Email to a Friend  
Get SEC Filings for Another Symbol: Symbol Lookup
Quotes & Info for ACUR - All Recent SEC Filings
Sign Up for a Free Trial to the NEW EDGAR Online Pro
Detailed SEC, Financial, Ownership and Offering Data on over 12,000 U.S. Public Companies.
Actionable and easy-to-use with searching, alerting, downloading and more.
Request a Trial      Sign Up Now


Copyright © 2014 Yahoo! Inc. All rights reserved. Privacy Policy - Terms of Service
SEC Filing data and information provided by EDGAR Online, Inc. (1-800-416-6651). All information provided "as is" for informational purposes only, not intended for trading purposes or advice. Neither Yahoo! nor any of independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. By accessing the Yahoo! site, you agree not to redistribute the information found therein.