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Medafor Matters
12 Months Ended
Dec. 31, 2014
Medafor Matters [Abstract]  
Medafor Matters

8.  Medafor Matters

 

Investment in Medafor Common Stock

 

In 2009 and 2010 CryoLife purchased shares of common stock in Medafor, Inc. (“Medafor”).  The Company initially recorded its investment using the cost method as a long-term asset, investment in equity securities, on the Company’s Consolidated Balance Sheets.

 

On October 1, 2013 C.R. Bard, Inc. (“Bard”) and subsidiaries completed its previously announced acquisition of the outstanding shares of Medafor common stock.  The Company received an initial payment of approximately $15.4 million in the fourth quarter of 2013 for its 2.4 million shares of Medafor common stock, and received an additional payment of $530,000 in the fourth quarter of 2014 related to the release of funds in escrow.  Based on information provided by Medafor as part of its September 24, 2013 Proxy Statement, the Company could receive additional payments totaling up to $7.9 million upon the release of funds held in escrow and the satisfaction of certain contingent milestones, measurable through June 2015. 

 

The Company recorded a gain on the sale of approximately $12.7 million in the fourth quarter of 2013 and $530,000 in the fourth quarter of 2014.  Subsequent payments will be recorded as an additional gain if and when received by the Company.

 

Distribution Agreement and Legal Action

 

CryoLife distributed a powdered hemostat for Medafor from 2008 to 2010.  CryoLife filed a lawsuit against Medafor in 2009 in the U.S. District Court for the Northern District of Georgia (“Georgia Court”).  In 2010 Medafor filed counterclaims against CryoLife in the same case.  The litigation related to an exclusive distribution agreement that the parties entered into in April 2008.

 

In June 2012 the parties entered into a settlement agreement.  Per the settlement, Medafor paid $3.5 million in cash to CryoLife in the third quarter of 2012.  On June 29, 2012 the parties jointly filed stipulated dismissals with prejudice with the Georgia Court.  As a result of the settlement, CryoLife recorded a gain of $4.7 million as a reduction in general, administrative, and marketing expenses on its Consolidated Statements of Operations and Comprehensive Income in the second quarter of 2012 and recorded a reduction in accounts payable of $1.2 million to write off a payable for previous inventory purchases, which was discharged pursuant to the settlement agreement.

 

On April 28, 2014 CryoLife filed a declaratory judgment lawsuit (the “Original Complaint”) against Bard, and its subsidiaries Davol, Inc. and Medafor, Inc. (“Medafor”) (collectively, “Defendants”), in the U.S. District Court for the District of Delaware (the “Court”).  CryoLife requested that the Court declare that CryoLife’s manufacture, use, offer for sale, and sale of PerClot in the U.S. does not and would not infringe Bard’s U.S. Patent No. 6,060,461 (the “‘461 Patent”).  In addition CryoLife requested that the Court declare that the claims of the ‘461 Patent are invalid.  As part of the relief requested, CryoLife requested injunctive relief and an award of attorneys’ fees.

 

The lawsuit against the Defendants follows the receipt by CryoLife of a letter from Medafor in September 2012 stating that PerClot, when introduced in the U.S., will infringe the ‘461 Patent when used in accordance with the method published in CryoLife’s literature and with the instructions for use.  CryoLife received FDA 510(k) clearance for the sale of PerClot Topical in April 2014, began distributing PerClot Topical in September 2014, and received IDE approval in March 2014 to begin clinical trials for PerClot in certain surgical indications.

 

In June 2014 CryoLife filed an amended complaint, and the Defendants filed a counterclaim for infringement in August 2014.  The Defendants filed various motions to dismiss; the Court has not yet ruled on those motions.  On September 19, 2014 the Defendants filed a motion for a preliminary injunction, asking the Court to enjoin CryoLife’s marketing and sale of PerClot in the U.S.  The hearing with respect to the preliminary injunction motion was held on January 23, 2015; the Court is expected to issue a ruling on the motion imminently.