Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2013 |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | -9 | Commitments and Contingencies |
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Boston Scientific Corporate Litigation |
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On May 16, 2013, the Company filed a patent infringement complaint in the United States District Court for the District of Minnesota against Boston Scientific Corporation (Boston Scientific). The complaint alleges that Boston Scientific has infringed three patents owned by the Company concerning rapid exchange guide extension technology by manufacturing and selling its Guidezilla™ guide extension catheter, which received FDA 510(k) clearance in March 2013. The Company is seeking an injunction against Boston Scientific prohibiting the manufacture and sale of its Guidezilla catheter, as well as damages for lost profits and legal costs. On June 10, 2013, the Company filed a motion for preliminary injunction asking the court to enjoin Boston Scientific’s manufacture and sale of the Guidezilla catheter during the pendency of the litigation. On July 11, 2013, Boston Scientific filed its answer and counterclaim, alleging that the Company’s patents are invalid, that the Guidezilla catheter does not infringe, and that the Company’s manufacture and sale of its GuideLiner® catheter violates a U.S. patent owned by Boston Scientific that has recently expired. The counterclaim seeks unspecified damages and payment of Boston Scientific’s attorney’s fees, expenses and costs. The Court held a hearing on the Company’s motion for a preliminary injunction on August 27, 2013, but has not yet issued its ruling. |
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Terumo Medical Corporation Litigation |
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On February 14, 2013, Terumo Corporation and Terumo Medical Corporation (Terumo) filed a complaint for patent and trademark infringement against the Company and Lepu Medical Technology (Beijing) Co. in the United States District Court for the District of New Jersey. The complaint alleged that the R-Band™ radial compression device that was previously distributed by the Company and manufactured by Lepu Medical Technology infringed a Terumo patent, U.S. Patent No. 7,498,477 (the ‘477 Patent). Terumo also alleged that the Company’s previous use of the product name R-Band infringed trademark rights it claims in its product name TR-Band™. Terumo’s complaint sought unspecified damages and an injunction against further sales of the R-Band product. In May 2013, the Company introduced its Vasc™ Band radial compression hemostatic device. On July 29, 2013, Terumo filed an amended complaint, alleging that the Company’s Vasc™ Band product also infringed the ‘477 Patent. On October 11, 2013, the Company and Terumo reached an agreement to settle the litigation, whereby the Company will make a one-time payment to Terumo in the amount of $812,000 and Terumo will agree that the current design of the Vasc Band product does not infringe any claim of any issued Terumo patent and will not sue the Company on any future issued patent concerning the current design of the Vasc Band. The Company’s settlement payment was accrued as litigation expense in the third quarter of 2013 and is expected to be paid to Terumo in the fourth quarter of 2013. |
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Governmental Proceedings |
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On June 28, 2011, the Company received a subpoena from the U.S. Attorney’s Office for the Western District of Texas under the Health Insurance Portability & Accountability Act of 1996 (HIPAA) requesting the production of documents related to the Company’s Vari-Lase products, and in particular the use of the Vari-Lase® Short Kit for the treatment of perforator veins. The U.S. Attorney’s Office also has commenced a criminal investigation of the same matter. The Vari-Lase Short Kit has been sold under a 510(k) clearance for the treatment of incompetence and reflux of superficial veins in the lower extremity since 2007 with total U.S. sales through September 30, 2013 of approximately $471,000 (0.1% of the Company’s total U.S. sales for such period) and has not been the subject of any reported serious adverse clinical event. On August 14, 2012, the United States District Court for the Western District of Texas unsealed a qui tam complaint that had been filed on November 19, 2010 by Desalle Bui, a former sales employee of the Company, which is the basis for the U.S. Attorney’s civil investigation, to which the federal government, after three extensions of time, has elected to intervene. The complaint contains allegations of off-label promotion of Vari-Lase products for the treatment of perforator veins, re-use of single-use Vari-Lase products and Company-provided kickbacks to physicians, resulting in alleged damages to the government of approximately $20 million. An amended complaint limited to allegations of off-label promotion of the Vari-Lase Short Kit resulting in an unspecified amount of damages and penalties was filed by the U.S. Attorney’s Office in December 2012. The parties are in the discovery phase of the civil case, and the Court has set the civil case for trial in January 2015. No schedule has been established for the criminal investigation. |
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The Company believes the allegations are factually inaccurate and without merit, and therefore the Company intends to both fully comply with the U.S. Attorney’s investigations and defend the litigation. |
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From time to time, the Company is involved in additional legal proceedings arising in the normal course of business. As of the date of this report, the Company is not a party to any legal proceeding not described in this section in which an adverse outcome would reasonably be expected to have a material adverse effect on the Company’s results of operations or financial condition. |
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King Agreements |
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On January 9, 2007, the Company entered into a License Agreement and a Device Supply Agreement with King (See Note 8). King was acquired by Pfizer, Inc. on February 28, 2011. Under the License Agreement, the Company licensed the exclusive rights to the Company’s products Thrombi-Pad®, Thrombi-Gel® and Thrombi-Paste® to King in exchange for a one-time license fee. Under the Device Supply Agreement, the Company agreed to manufacture the licensed products for sale to King in exchange for an initial payment. The unamortized license fee was $662,000 and $815,000 at September 30, 2013 and December 31, 2012, respectively. Amortization of the deferred revenue will be $51,000 per quarter for the remainder of the 10-year license period. The amortization of license fee was $153,000 for the nine months ended September 30, 2013 and 2012. |
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Nicolai GmbH Agreement |
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Effective April 1, 2008 the Company entered into a five-year distribution agreement with Nicolai GmbH. As a result of entering into this distribution agreement, the Company no longer maintains a direct sales force in Germany. In connection with this distribution agreement, the Company received 500,000 Euros from Nicolai GmbH, which was deferred and was being recognized ratably over the five-year term of the distribution agreement. |
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The agreement included provisions requiring the Company to pay Nicolai GmbH specific amounts if the Company terminated the distribution agreement prior to the end of the five-year term. The Company did not terminate the distribution agreement prior to the termination date. The unamortized license fee was $-0- and $36,000 at September 30, 2013 and December 31, 2012, respectively. The amortization of license fee was $36,000 and $73,000 for the nine months ended September 30, 2013 and 2012, respectively. |
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Radius Medical Technologies, Inc. Contingent Consideration |
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On October 20, 2010, the Company acquired the assets related to the snare and retrieval product line business from Radius Medical Technologies, Inc. and Radius Medical, LLC (collectively, “Radius”). Under the terms of the agreement the Company paid Radius a total of $6,449,000, consisting of $5,000,000 paid in cash at October 20, 2010 and $1,449,000 which was paid on June 9, 2011 upon the successful completion of the transfer of the manufacturing processes from Radius to the Company along with all fixed assets and inventory. In addition, Radius is entitled to receive an annual cash contingent consideration payment based on 25% of the net sales of the acquired products which exceed $2.0 million, $2.5 million, and $3.0 million for the calendar years ending December 31, 2011, 2012 and 2013, respectively. The range of possible contingent consideration payments is from $-0- if no sales are made in excess of the thresholds, to an undeterminable amount as the agreement does not contain a cap on the payment amounts. In accordance with ASC 805, Business Combinations, a reduction of $79,000, $136,000, $96,000 and $586,000 in the liability amount for contingent consideration was recorded at May 31, 2013, December 31, 2012, March 31, 2012 and September 30, 2011, respectively, and a corresponding gain was recognized in operating expenses within the general and administrative expenses. At September 30, 2013 and December 31, 2012, the Company has recorded a liability for these contingent consideration payments in the amount of $-0- and $79,000, respectively. |