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Commitments and Contingencies
9 Months Ended
Jan. 25, 2013
Commitments and Contingencies [Abstract]  
Commitments and Contingencies

Note 11.  Commitments and Contingencies

 

Litigation.

 

On July 24, 2012, the United States District Court for the District of New Jersey unsealed a qui tam action filed against Cyberonics, Inc. under the Federal False Claims Act (“FCA”) and the false claims statutes of 21 different states.  The FCA prohibits the submission of a false claim or the making of a false record or statement in order to secure reimbursement from, or limit reimbursement to, a government-sponsored program.  A “qui tam” action is a lawsuit brought by a private individual purporting to act on behalf of the government.  The government, after reviewing and investigating the allegations, may elect to participate, or intervene, in the lawsuit.  The United States Department of Justice declined to intervene in this qui tam action, which was filed under seal on March 9, 2010 by Stefan P. Kruszewski, M.D., but reserved the right to do so in the future. In September 2012, the plaintiff voluntarily dismissed the complaint without prejudice, and the United States consented to the voluntary dismissal.  Thereafter, the district court dismissed the lawsuit without prejudice.

 

We are named as a defendant in lawsuits or are the subject of governmental inquiries from time to time arising in the ordinary course of business. The outcome of such lawsuits or other proceedings cannot be predicted with certainty and may have a material adverse effect on our consolidated financial position or net income

 

Post-Approval Conditions and Clinical Study Agreements.    

 

Pursuant to the post-approval conditions specified as part of our U.S. Food and Drug Administration (“FDA”) marketing approval for treatment-resistant depression (“TRD”) in July 2005, we were required to conduct a longitudinal registry that follows patients with TRD for up to five years in two groups – one group of patients with TRD receiving vagus nerve stimulation therapy (“VNS Therapy”) and one other group of patients with TRD receiving ongoing treatment-as-usual. We expect the TRD registry to be completed in calendar year 2015. We expect to spend approximately  $0.2 million over the next three years on the TRD registry. In addition, to the post-approval TRD registry, we have agreements associated with our other clinical studies and registries in connection with which we expect to spend approximately $2.0 million over the next two years.

 

 

Licensing and Investment Agreements. 

 

We executed a license agreement, dated March 15, 1988 with Dr. Jacob Zabara providing us with worldwide exclusive rights under a number of U.S. patents (and their international counterparts) covering the method and devices of the VNS Therapy® System for vagus nerve and other cranial nerve stimulation for the control of epilepsy and other movement disorders, as well as a number of other conditions and disorders including depression (“Zabara License”). Under the terms of the Zabara License, we paid royalties at a rate of 3% of net sales of generators and leads. In accordance with the terms of the Zabara License, we discontinued paying this royalty on July 16, 2011, the expiration date of the last of the patents covering our existing products. The royalty payments pursuant to the Zabara license were expensed as cost of goods sold as incurred and amounted to  $1.2 million for the thirteen weeks ended July 29, 2011.  Since then, we have had no other royalty payments as a component of cost of goods sold.

 

Effective December 17, 2007, we entered into a license agreement granting an exclusive license to a third party under certain of our patents and patent applications pertaining to weight reduction, hypertension and diabetes in exchange for an up-front, non-refundable payment, plus a royalty on future commercial sales of any product covered by the licensed patents. The unamortized deferred revenue in our condensed consolidated balance sheet as of January 25, 2013 is $1.8 million. We retained the responsibility to prosecute the licensed patent applications and to maintain the licensed patents, including the obligation to pay related expenses for U.S. patents and applications.  We estimate that our obligation to prosecute the licensed patent applications will be satisfied by the end of April 2014.  

 

In October 2009, we entered into a contractual arrangement with Flint Hills Scientific, L.L.C. related primarily to cardiac-based seizure detection patents. We agreed to future cancellable minimum or milestone-based fees for intellectual property licensing, patent issuance fees, and consulting and royalty fees. We expect future minimum expenditures of approximately $3.0 million through fiscal year 2018 under our agreement with Flint Hills.

 

In October 2011, we entered into an investment agreement with ImThera, a private company developing a neurostimulation medical device for the treatment of obstructive sleep apnea. We agreed to future milestone-based investments and expect future investments of $4.0 million by June 2013

 

In June 2012, we entered into a patent license agreement and an agreement with Imricor Medical Systems, Inc., for the integration of  MRI-compatibility into our leads. We agreed to future milestone-based payments and minimum royalties and expect future minimum expenditures of $4.3 million through fiscal year 2018.

 

In September 2012, we entered into an investment agreement and marketing arrangement with Cerbomed GmbH, a privately-held, development-stage company working on a transcutaneous (non-invasive) vagus nerve stimulation device for the treatment of epilepsy. This agreement includes future optional milestone-based investments of €3.5 million.

 

Lease Agreements.    

 

We lease the following facilities and equipment with non-cancellable leases accounted for as operating leases: (i) a storage and distribution facility in Austin, Texas, (ii) administrative and sales offices in Brussels, Belgium and elsewhere in Europe, (iii) sales offices in Beijing, China and Hong Kong, and (iv) transportation and office equipment. During the quarter ended October 28, 2011, we acquired the land and building in which we headquarter our operations in Houston, Texas and terminated the related lease.  In addition, we plan to move our Brussels offices to a new building by the end of April 2013, we committed to a new $2.2 million, nine-year lease beginning March 2013.

 

Land Purchase and Building Construction Contracts.    

 

We are in the process of constructing a manufacturing in Costa Rica. We have contracted to purchase the land and building shell for $3.0 million. Future expenditures under this contract are expected to amount to $1.3 million and are expected to be paid prior to August 2013.

 

Distribution Agreements.  

 

We have distribution agreements with independent distributors that grant the right to distribute our products in designated territories located in Canada, Mexico, Central and South America, Asia, including Japan, Australia, the Middle East, Africa and parts of Europe. The distribution agreements generally grant the distributor exclusive rights for the designated territory for a specified period of time, generally one to three years. Under the terms of the distribution agreements, we may be required to compensate the distributor in the event that the agreement is terminated by us or is not renewed upon expiration.