Jazz Agreement Connection
Because of Jazz`s taking responsibility, its cooperation in the government investigation and its willingness to make restitution and take significant corrective action, Jazz is not being prosecuted for the illegal practices of orphaned workers, provided that Jazz fully complies with the terms of its agreement with the government. However, if Le Jazz violates one of the terms of the non-persecution agreement or commits other crimes, it is subject to criminal prosecution, including the continuation of the conduct described in the complaints filed by the government. BROOKLYN, NY – Jazz Pharmaceuticals, Inc. («Jazz») has agreed to pay $20 million in penalties and compensation to resolve parallel criminal and civil investigations by the U.S. Attorney`s Office for the Eastern District of New York into the illegal marketing practices of its wholly owned subsidiary Orphan Medical, Inc. (Orphan). As part of this resolution, Orphan pleaded guilty this morning to making an error in violation of the Food, Drug, and Cosmetic Act (21 U.C No. 331(a) and 333 (a) (a)) in connection with its illegal promotion of Xyrem, a medically prescribed drug also known as gamma-hydroxybutyrate or «GHB» for unauthorized purposes. GHB is a powerful and rapid depressive central nervous system that has been used as a recreational drug and is considered by the Department of Health and Health Services (HHS) to be a «date rape drug». The admission of guilt was made before U.S. District Judge Eric N. Vitaliano.
Jazz also agreed to implement the terms of an enterprise integrity agreement required by the HHS Office of General Inspector, and has taken other proactive and remedial measures, including the implementation of a code of conduct prohibiting the promotion of unauthorized or «off-label» use, requiring compliance training for advertising and commercial agents, and replacing former orphaned regional distribution managers responsible for monitoring the behaviour of distribution agents in their respective jurisdictions. In accordance with the PTA order, after the mass purchase of SIM cards, the customer is responsible for indicating the registration information (including the name, CNIC/Passport no, present and permanent address) of certain users/persons to whom the SIM card or cards are issued on his or her behalf on the customer`s header within one week of the issuance of SIM cards by PMCL. If the information is not received within the allotted time, PMCL may block the SIM card or cards against which the customer has not received any information. 1 On March 9, 2007, a former orphan sales manager pleaded guilty to making a mistake in the «off-label» marketing system described above. I recognize that information relating to the account holder and all accounts to be reported may be made available to the tax authorities of the country in which this account is held and communicated with the tax authorities of another country in which the account holder is established on the basis of intergovernmental agreements concerning the exchange of financial account information. «The illegal behavior that is now being charged puts the benefits above public health,» said the U.S. Food and Drug Administration, Office of Criminal Investigations, Special Agent-in Charge Kim A. Rice. «The FDA will continue to seek the type of criminal resolution and severe sanctions that are involved in this agreement when pharmaceutical companies seriously undermine the licensing process by dangerously promoting drugs for unauthorized purposes.» Given your acceptance of oral instructions from me over the phone, by fax or by the execution of other instructions, provided that they are transmitted electronically in connection with facilities that may be part of the account and services you offer in accordance with your Policy from time to time, I agree irrevocably and unconditionally, and I undertake to accept the accuracy of these instructions and your execution of the account and services for all purposes.