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Commitments And Contingencies
6 Months Ended
Jun. 30, 2015
Commitments And Contingencies [Abstract]  
Commitments And Contingencies

12.  Commitments and Contingencies 

 

Liability Claims 

 

The Company’s estimated unreported loss liability was $1.5 million as of June 30, 2015 and $1.4 million as of December 31, 2014.  The related recoverable insurance amounts were $630,000 and $600,000 as of June 30, 2015 and December 31, 2014, respectively.  The Company accrues its estimate of unreported product and tissue processing liability claims as a component of other long‑term liabilities and records the related recoverable insurance amount as a component of other long‑term assets, as appropriate.  Further analysis indicated that the liability as of June 30, 2015 could have been estimated to be as high as $2.7 million, after including a reasonable margin for statistical fluctuations calculated based on actuarial simulation techniques. 

 

Employment Agreements

 

In July 2014 the Company’s Board of Directors appointed Mr. J. Patrick Mackin as President and Chief Executive Officer (“CEO”), and the Company and Mr. Mackin entered into an employment agreement, which became effective September 2, 2014.  The employment agreement has an initial three-year term.  Beginning on the second anniversary of the effective date, and subject to earlier termination pursuant to the agreement, the employment term will, on a daily basis, automatically extend by one day.  In accordance with the agreement, on September 2, 2014, Mr. Mackin received a one-time signing bonus of $200,000, a grant of 400,000 stock options, and a performance stock award grant of 250,000 shares.  The agreement also provides for a severance payment, which would become payable upon the occurrence of certain employment termination events, including termination by the Company without cause.

 

The employment agreement of the Company’s former President, CEO, and Executive Chairman, Mr. Steven G. Anderson, conferred certain benefits upon his retirement or termination of employment in conjunction with certain change in control events.  As of December 31, 2014 the Company had $2.2 million in accrued expenses and other current liabilities on the Summary Consolidated Balance Sheet, including approximately $2.0 million representing severance payable upon Mr. Anderson’s voluntary retirement.  Mr. Anderson’s employment agreement took effect on January 1, 2013 and would have terminated on December 31, 2016.

 

On April 9, 2015 Mr. Anderson retired from service as an employee of the Company and a member of its Board of Directors, and entered into a Separation Agreement (the “Agreement”) with the Company.  In accordance with the Agreement, in addition to the severance benefit discussed above, Mr. Anderson will receive an additional $400,000 in cash; 25% of the annual bonus he would have been entitled to under his employment agreement, estimated at target payout rates to be approximately $100,000; reimbursement of a Medicare supplement policy for Mr. Anderson and his spouse for the duration of their lives; accelerated vesting of all outstanding and unvested stock options and awards; and reimbursement of attorneys’ fees not to exceed $20,000.  The Company recorded expense of approximately $1.4 million related to the Agreement in the second quarter of 2015.  The acceleration of Mr. Anderson’s stock options and awards was effective as of the date of his retirement.  As of June 30, 2015 the Company had $2.6 million, primarily in accrued compensation, on the Summary Consolidated Balance Sheet, representing severance and cash payments that are expected to be made in October 2015, six months after Mr. Anderson’s retirement.  The annual bonus payment is expected to be made in February 2016 at the same time as annual bonus payments, if any, are made to the Company’s officers.

 

PerClot Technology

 

On September 28, 2010 the Company entered into a worldwide distribution agreement (the “Distribution Agreement”) and a license and manufacturing agreement (the “License Agreement”) with Starch Medical, Inc. (“SMI”) for PerClot, a polysaccharide hemostatic agent used in surgery.  The Distribution Agreement contains certain minimum purchase requirements and has a term of 15 years.  Following U.S. regulatory approval and the start of U.S. manufacturing, CryoLife may terminate the Distribution Agreement and the related requirements to purchase minimum amounts of PerClot manufactured by SMI.  Upon termination of the Distribution Agreement, CryoLife would manufacture and sell PerClot pursuant to the License Agreement.    The Company will pay royalties to SMI at stated rates on net revenues of products manufactured under the License Agreement.

 

In April 2014 CryoLife received 510(k) clearance from the FDA to market PerClot Topical in the U.S.  PerClot Topical is a version of the Company’s PerClot product, which was manufactured by the Company at its headquarters and labeled for use in certain topical indications.  CryoLife launched PerClot Topical in August 2014.  In March 2015 CryoLife ceased all marketing, sales, and distribution of PerClot, including PerClot Topical, in the U.S. in accordance with the District Court’s order discussed in Note 7. 

 

The Company is currently initiating its pivotal clinical trial to gain approval to commercialize PerClot for surgical indications in the U.S.  Management believes that the costs of this clinical trial will be significant in 2015 and 2016.  The Company began enrollment in the second quarter of 2015 and currently expects to receive PMA from the FDA in 2018.  However, if the Company does not prevail or reach a settlement with respect to the patent litigation discussed in Note 7,  the timing of the launch of PerClot in the U.S. may be delayed until early 2019, when the ‘461 Patent expires.

 

CryoLife paid $500,000 to SMI in January 2015 related to the achievement of a contingent milestone.  The Company expects to make additional contingent payments to SMI of up to $1.0 million if certain FDA regulatory and other commercial milestones are achieved.

 

Direct Sales in France

 

In June 2015 CryoLife signed a Business Transfer Agreement with its French distribution partner to facilitate an orderly transition of the Company to a direct sales model in France.  As a result of the agreement, the Company will acquire certain intangible assets, including commercial and business information, assignment of contracts, and a non-compete agreement with the French distribution partner for a purchase price of 1.2 million Euros.  The Company expects the transaction to close and the purchase price to be paid in October 2015.  As a result of this transaction, certain members of the distributor’s sales team who are currently responsible for selling the Company’s products in France will become CryoLife employees.