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SEC Filings

10-Q
HEARTWARE INTERNATIONAL, INC. filed this Form 10-Q on 11/02/2015
Entire Document
 


    identifying, assessing and developing (or acquiring/in-licensing) new product candidates;

 

    negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; and

 

    maintaining, protecting and expanding Valtech’s portfolio of intellectual property rights, including patents, trade secrets and know-how.

Even if the product candidates that Valtech develops is approved for commercial sale, it anticipates incurring significant costs to commercialize Valtech’s products. Valtech’s expenses could increase beyond expectations if Valtech is required by the U.S. Food and Drug Administration, the European Medicines Agency, other regulatory agencies, domestic or foreign, or by any unfavorable outcomes in intellectual property litigation filed against Valtech, to change Valtech’s manufacturing processes or to perform clinical, nonclinical or other types of studies in addition to those that Valtech currently anticipates. If the market for Valtech’s product candidates (or Valtech’s share of that market) is not as significant as expected, the indication approved by regulatory authorities is narrower than expected or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, Valtech may not generate significant revenue from sales of such products, even if approved. If Valtech is unable to successfully complete development and obtain regulatory approval for Valtech’s product candidates, particularly Cardioband and Cardiovalve, Valtech’s future business and the business of the combined company may suffer. Additionally, if Valtech is not able to generate revenue from the sale of any approved products, Valtech and the combined company may never become profitable.

Claims that Valtech’s current or future products infringe or misappropriate the proprietary rights of others could adversely affect Valtech or the combined company’s ability to sell those products and cause Valtech or the combined company to incur additional costs.

Substantial litigation over intellectual property rights exists in the medical device industry. HeartWare and Valtech expect that Valtech could be increasingly subject to third-party infringement claims as its revenue increases, the number of technology holders grows and the functionality of products and technology in different industry segments overlaps. Third parties may currently have, or may eventually be issued, patents on which Valtech’s current or future products or technologies may allegedly infringe.

There can be no certainty that litigation will not arise in relation to third party intellectual property or, if it does arise, whether or not it will be determined in a manner which is favorable to Valtech. Any litigation, regardless of its outcome, would likely result in the expenditure of significant financial resources and the diversion of management’s time and resources. In addition, litigation in which Valtech is accused of infringement may cause negative publicity, adversely impact prospective customers, cause product shipment delays, prohibit Valtech and the combined company from manufacturing, marketing or selling Valtech’s current or future products, require Valtech to develop non-infringing technology, make substantial payments to third parties or enter into royalty or license agreements, which may not be available on acceptable terms or at all. If a successful claim of infringement were made against Valtech and Valtech could not develop non-infringing technology or license the infringed or similar technology on a timely and cost-effective basis, the expected future revenue of Valtech or the combined company may decrease substantially and Valtech or the combined company could be exposed to significant liability. A court could enter orders that temporarily, preliminarily or permanently enjoin Valtech or Valtech’s customers from making, using, selling, offering to sell or importing Valtech’s current or future products, or could enter an order mandating that we undertake certain remedial activities. Claims that Valtech has misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on Valtech’s reputation, business, financial condition or results of operations.

 

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