Corporate Compliance Program

As part of Spectranetics´ continuing commitment to corporate compliance, Spectranetics declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code sections 119400 and 119402, it has adopted a Comprehensive Compliance Program as mandated by this California law. As of the date of this declaration, Spectranetics believes it is in compliance with its Commercial and Development Comprehensive Compliance Program in all material respects.

Consistent with Spectranetics´ understanding of the California statute, this declaration is limited to those activities undertaken by Spectranetics that are directed to California. Spectranetics makes this declaration, in good faith, in the absence of clarifying regulations or guidance from the State of California. This declaration reflects our consideration of the OIG Guidance, which gives broad discretion to manufacturers in the development, design, and definition of the scope of compliance programs.

As a part of the new Massachusetts state law, Massachusetts requires device manufacturers to provide an annual report to the Department of Public Health regarding a wide variety of financial interactions that medical device companies have with Massachusetts health care providers and certification of a compliance program that adheres to the Massachusetts Marketing Code of Ethics. As with other pharmaceutical and medical device manufacturers who do business in Massachusetts, Spectranetics will report all amounts over $50 that Spectranetics directly or indirectly pays to a Massachusetts licensed health care professional relating to sales and marketing activities from and after July 1, 2009. This will include reporting the name of the contracting party, the purpose of the payment, the amount and nature of any payments made and possibly other information about the payment.

As a part of the new Vermont state law, Vermont requires device manufacturers to provide an annual report to the Department of Public Health regarding a wide variety of financial interactions that medical device companies have with Vermont licensed health care providers and certification of a compliance program. As with other pharmaceutical and medical device manufacturers who do business in Massachusetts, Spectranetics will report all amounts over $25 that Spectranetics directly or indirectly pays to a Vermont health care professional relating to sales and marketing activities from and after July 1st, 2009.This will include reporting the name of the contracting party, the purpose of the payment, the amount and nature of any payments made and possibly other information about the payment.

As a part of the Nevada state law, Nevada requires device manufacturers to provide an annual report to the Board of Pharmacy regarding a wide variety of financial interactions that pharmaceutical and medical device companies have with Nevada health care providers. As with other pharmaceutical, biotech and medical device manufacturers who do business in Nevada, Spectranetics will report all amounts over $50 that Spectranetics directly or indirectly pays to a Nevada health care professional relating to sales and marketing activities from and after July 1, 2009. This will include reporting the name of the contracting party, the purpose of the payment, the amount and nature of any payments made and possibly other information about the payment.