Dec 30 2009
Spectranetics Corporation (“Company”) (Nasdaq:SPNC) today reported the
settlement of matters related to the federal investigation initiated by
the Food & Drug Administration and U.S. Immigration and Customs
Enforcement, which was previously announced in a press release dated
September 4, 2008.
The resolution includes a non-prosecution agreement and a civil
settlement agreement with the United States Department of Justice, as
well as a Corporate Integrity Agreement with the Office of the Inspector
General for the United States Department of Health and Human Services.
Significant terms of the agreements, subject to certain conditions
outlined therein, include an agreement not to prosecute the Company, a
$4.9 million payment in consideration of a release from certain civil or
administrative monetary claims resulting from certain alleged conduct
associated with the federal investigation, and a separate agreement that
specifies certain corporate integrity obligations. In addition, the
Company has agreed to a forfeiture of $100,000 in cash or property to be
executed in the near future. There are no criminal charges against the
Company.
Emile J. Geisenheimer, Chairman, President and Chief Executive Officer,
stated, “I am pleased that we have resolved our issues with the
government. I believe that our level of cooperation and responsiveness
and our demonstrable efforts at compliance, much of which preceded the
onset of the federal investigation, were critical components that led to
the resolution of this matter with no charges filed against
Spectranetics.”
http://www.spectranetics.com/