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Commitments And Contingencies
12 Months Ended
Dec. 31, 2018
Commitments And Contingencies [Abstract]  
Commitments And Contingencies

12.  Commitments and Contingencies



Leases



Our operating and capital lease obligations result from the lease of land and buildings that comprise our corporate headquarters and various manufacturing facilities, leases related to additional manufacturing, office, and warehouse space, leases on company vehicles, and leases on a variety of office and other equipment.



We had deferred rent obligations of $2.5 million and $2.9 million as of December 31, 2018 and 2017, respectively, primarily related to the lease on our corporate headquarters, which expires in 2022.  Total rental expense for operating leases was $6.4 million in 2018,  $4.9 million in 2017, and $4.3 million in 2016.  The increase in rent expense in 2018 is due to the JOTEC acquisition and our lease of equipment and manufacturing, warehouse, and office space in Hechingen, Germany.  The increase in rent expense in 2017 is due to a partial year of expense related to the JOTEC acquisition and our lease of equipment and manufacturing, warehouse, and office space in Hechingen, Germany.  We began subleasing some of our combined manufacturing and office space in February 2018 and some of our additional office space in December 2016 and earned $855,000 and $564,000 of sublease income in 2018 and 2017, respectively, and nominal sublease income in 2016. 



Future minimum lease payments and sublease rental income are as follows (in thousands):



 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 



Capital

 

Operating

 

Sublease



Leases

 

Leases

 

Income

2019

$

857 

 

$

6,122 

 

$

1,181 

2020

 

688 

 

 

5,555 

 

 

1,203 

2021

 

641 

 

 

4,758 

 

 

1,226 

2022

 

586 

 

 

2,461 

 

 

569 

2023

 

586 

 

 

1,456 

 

 

--

Thereafter

 

4,099 

 

 

6,389 

 

 

--

Total minimum lease payments

$

7,457 

 

$

26,741 

 

$

4,179 

Less amount representing interest

 

792 

 

 

 

 

 

 

    Present value of net minimum lease payments

 

6,665 

 

 

 

 

 

 

    Less current maturities

 

731 

 

 

 

 

 

 

        Capital lease obligations, less current maturities

$

5,934 

 

 

 

 

 

 



Assets acquired under capital leases are as follows (in thousands):





 

 

 

 

 

 

 

 



Gross

 

 

 

 

 

 



Carrying

 

Accumulated

 

Net Book



Value

 

Amortization

 

Value

Equipment

$

1,066 

 

$

375 

 

$

691 

Leasehold improvements

 

6,608 

 

 

507 

 

 

6,101 

        Total

$

7,674 

 

$

882 

 

$

6,792 



Liability Claims



At December 31, 2018 and 2017 our unreported loss liability was $1.7 million and $1.8 million, respectively.  As of December 31, 2018 and 2017, the related insurance recoverable amounts were $693,000 and $692,000, respectively.  We accrue our estimate of unreported product and tissue processing liability claims as other long‑term liabilities and record the related recoverable insurance amounts as other long‑term assets.  Further analysis indicated that the liability as of December 31, 2018 could be estimated to be as high as $3.5 million, after including a reasonable margin for statistical fluctuations calculated based on actuarial simulation techniques. 



Employment Agreements 



In July 2014 our Board of Directors appointed Mr. James P. Mackin as President and Chief Executive Officer (“CEO”), and we 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.  The agreement provides for a severance payment, which would become payable upon the occurrence of certain employment termination events, including termination by us without cause.



PerClot Technology



On September 28, 2010 we 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 has a term of 15 years, but we can terminate it for any reason before the expiration date by providing 180 days’ notice.  The Distribution Agreement also contains minimum purchase requirements that expire upon the termination of the Distribution Agreement or following U.S. regulatory approval for PerClot.  Separate and apart from the terms of the Distribution Agreement, pursuant to the License Agreement, as amended by a September 2, 2011 technology transfer agreement, we can manufacture and sell PerClot, assuming appropriate regulatory approvals, in the U.S. and certain other jurisdictions and may be required to pay royalties to SMI at certain rates on net revenues of products.



We paid $500,000 to SMI in January 2015 related to the achievement of a contingent milestone.  We may make additional contingent payments to SMI of up to $1.0 million if certain U.S. regulatory and certain commercial milestones are achieved.

We are conducting our pivotal clinical trial to gain approval to commercialize PerClot for surgical indications in the U.S. Enrollment was completed in January 2019.  We anticipate Premarket Approval (“PMA”) submission to the U.S. Food and Drug Administration (“FDA”) in early 2020.



As of December 31, 2018 we had $1.5 million in prepaid royalties, $2.3 million in net intangible assets, and $1.3 million in property and equipment, net on our Consolidated Balance Sheets related to the PerClot product line.  If we do not ultimately pursue or receive FDA approval to commercialize PerClot in the U.S., these assets could be materially impaired in future periods.