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PerClot Technology Acquisition
3 Months Ended
Mar. 31, 2012
PerClot Technology Acquisition [Abstract]  
PerClot Technology Acquisition

6.  PerClot® Technology Acquisition

 

Overview

 

        On September 28, 2010 CryoLife entered into a worldwide distribution agreement (the “Distribution Agreement”) and a license and manufacturing agreement (the “License Agreement”) with Starch Medical, Inc. (“SMI”) of San Jose, California for PerClot, a polysaccharide hemostatic agent used in surgery.  PerClot is an absorbable powdered hemostat that has CE Mark designation allowing commercial distribution into the European Community and other markets.  It is indicated for use in surgical procedures, including cardiac, vascular, orthopaedic, neurological, gynecological, ENT, and trauma surgery, as an adjunct hemostat when control of bleeding from capillary, venous, or arteriolar vessels by pressure, ligature, and other conventional means is either ineffective or impractical.  Under the terms of the agreements, CryoLife received the worldwide rights, subject to certain exclusions, to commercialize PerClot for all approved surgical indications and a license to manufacture the PerClot product.  CryoLife also received an assignment of the PerClot trademark from SMI as part of the terms of the agreements. 

 

        The Distribution Agreement contains certain minimum purchase requirements and has a term of 15 years.  CryoLife may begin manufacturing PerClot under the terms of the License Agreement, which extends for an indefinite period.  Upon FDA approval, the Company may terminate such minimum purchase requirements.  Following the start of manufacturing and U.S. regulatory approval, CryoLife may terminate the Distribution Agreement and sell PerClot pursuant to the License Agreement.  CryoLife will pay royalties to SMI at stated rates on net revenues of products manufactured under the License Agreement.  In addition to allowing CryoLife to manufacture PerClot, the License Agreement granted CryoLife a three-year option to purchase certain remaining related technology from SMI, which the Company exercised in September 2011.

 

        As part of the initial transaction, CryoLife paid SMI $6.75 million in cash, which included $1.5 million in cash for prepaid royalties, and approximately 209,000 shares of restricted CryoLife common stock.  CryoLife made an additional contingent payment of $250,000 in 2011 and will pay additional contingent amounts of up to $2.5 million to SMI if certain FDA regulatory and other commercial milestones are achieved.

 

Accounting for the Transaction

 

        CryoLife accounted for the agreements discussed above as an asset acquisition.  The initial consideration aggregated approximately $8.0 million, including: $6.75 million in cash, restricted common stock valued at approximately $1.0 million, and direct transaction costs.  CryoLife recorded a non-current asset for the $1.5 million in prepaid royalties, recorded a deferred tax asset of $145,000, and allocated the remaining consideration to the individual intangible assets acquired based on their relative fair values as determined by a valuation study.  As a result, CryoLife recorded intangible assets of $327,000 for the PerClot trademark, $2.6 million for the PerClot distribution and manufacturing rights in certain international countries, and $3.5 million for the PerClot distribution and manufacturing rights in the U.S. and certain other countries which do not have current regulatory approvals.  This $3.5 million was considered in-process research and development, as it is dependent upon regulatory approvals which have not yet been obtained.  Therefore, CryoLife expensed the $3.5 million as in-process research and development upon acquisition in the third quarter of 2010.  The PerClot trademark acquired by the Company has an indefinite useful life; therefore, that asset will not be amortized, but will instead be subject to annual impairment testing.  The $2.6 million intangible asset will be amortized over its useful life of 15 years. 

 

        CryoLife expects to record future contingent payment amounts of up to $2.5 million initially as research and development expense or, after FDA approval or issuance of a patent, as acquired intangible assets.  In the year ended December 31, 2011 CryoLife recorded research and development expenses of $250,000 for the contractual milestone payment due to SMI upon filing of the investigational device exemption.

       

Starch Technology Purchase

 

                On September 2, 2011 CryoLife entered into an additional license agreement with SMI to purchase the technology to produce and use modified starch, the key component for manufacturing PerClot, for $1.0 million plus transaction related expenses.  The Company recorded the technology purchased as an intangible asset which will be amortized over its useful life of 14 years.