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POZN > SEC Filings for POZN > Form 8-K on 19-Nov-2013All Recent SEC Filings

Show all filings for POZEN INC /NC

Form 8-K for POZEN INC /NC


19-Nov-2013

Entry into a Material Definitive Agreement


Item 1.01. Entry Into A Material Definitive Agreement.

On November 18, 2013, POZEN Inc., a Delaware corporation ("POZEN"), and AstraZeneca AB, a Swedish corporation ("AstraZeneca") and Horizon Pharma USA Inc. ("Horizon"), entered into certain agreements in connection with AstraZeneca's divestiture of all of its rights, title and interest to develop, commercialize and sell VIMOVOŽ (naproxen / esomeprazole magnesium) delayed release tablets in the U.S. (the "Divestiture") to Horizon.

In order to facilitate the Divestiture, POZEN and AstraZeneca entered into an Amended and Restated Collaboration and License Agreement for the United States (the "U.S. Agreement") and an Amended and Restated License and Collaboration Agreement for Outside the United States (the "ROW Agreement"), which agreements collectively amend and restate that certain Collaboration and License Agreement, dated as of August 1, 2006, as amended, (the "Original Agreement") regarding the development and commercialization of proprietary fixed dose combinations of the proton pump inhibitor ("PPI") esomeprazole magnesium with the non-steroidal anti-inflammatory drug ("NSAID") naproxen, in a single tablet for the management of pain and inflammation associated with conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID associated gastric ulcers by separating the rights and obligations contained in the Original Agreement into the U.S. Agreement and the ROW Agreement. Otherwise, the material terms of the Original Agreement (as previously disclosed by POZEN) remain in effect and unchanged. AstraZeneca has assigned the U.S. Agreement to Horizon in connection with the Divestiture with POZEN's consent.

Immediately following the consummation of the Divestiture, POZEN and Horizon entered into Amendment No. 1 to the U.S. Agreement which, among other things, amends the royalty provisions of the U.S. Agreement to provide for a guaranteed annual minimum royalty amount of $5 million in calendar year 2014, and a guaranteed annual minimum royalty amount of $7.5 million in each calendar year thereafter, provided that the patents owned by POZEN which cover VIMOVO are in effect and no generic forms of VIMOVO are in the marketplace. Amendment No. 1 also provides that Horizon has assumed AstraZeneca's right to lead the on-going Paragraph IV litigation relating to VIMIVO currently pending in the United States District Court for the District of New Jersey and will assume all patent-related defense costs relating to such litigation, including reimbursement up to specified amounts of the cost of any counsel retained by POZEN, amends certain time periods for Horizon's delivery of quarterly sales reports to POZEN, and provides for quarterly update calls between the parties to discuss VIMOVO's performance and Horizon's commercialization efforts.

Lastly, POZEN, AstraZeneca and Horizon have executed a letter agreement whereby POZEN expressly consented to the assignment by AstraZeneca and the assumption by Horizon of the U.S. Agreement. In addition, the letter agreement establishes a process for AstraZeneca and Horizon to determine if sales milestones set forth in the Original Agreement are achieved on a global basis and other clarifications and modifications required as a result of incorporating the provisions of the Original Agreement into the U.S. Agreement and the ROW Agreement or as otherwise agreed by the parties.


The foregoing is a summary of the material terms of the Amendment, the U.S. Agreement and ROW Agreement and does not purport to be complete and is qualified in its entirety by reference to the full text of such agreements which will be filed as exhibits to the Company's next Annual Report on Form 10-K.


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