Bristol-Myers Squibb Company and the Antitrust Division of the US Department of Justice (DoJ) have reached an agreement in principle to resolve the previously disclosed DOJ criminal investigation regarding the proposed settlement agreement between Bristol-Myers Squibb, its product partner, sanofi-aventis, and Apotex Inc., and Apotex Corp. (Apotex). The proposed settlement agreement was related to the Plavix patent litigation, which is pending before the US district court for the southern District of New York.
As part of the agreement with the DoJ, Bristol-Myers Squibb, or a subsidiary of the company, will plead guilty to criminal charges consisting of two counts of violating Section 1001 of US Code Title 18 (relating to false statements to a government agency), carrying an aggregate statutory maximum fine of $1 million. The charges relate to representations made by a former Bristol-Myers Squibb senior executive during the renegotiation of the proposed settlement agreement in May 2006 that were not disclosed to the US Federal Trade Commission.
Bristol-Myers Squibb has advised the US Attorney's Office for the District of New Jersey (USAO) of this agreement in principle. The USAO has advised the company that it believes Bristol-Myers Squibb has cured resulting breaches of the Deferred Prosecution Agreement (DPA) entered into between the company and the USAO by terminating the employment of certain former senior officers of Bristol-Myers Squibb, as well as by taking other actions to prevent the recurrence of the issues and events that led to this matter. The USAO has further advised Bristol-Myers Squibb that assuming resolution of this investigation in accordance with the agreement in principle and assuming the company's compliance with the DPA between this date and June 15, 2007, it is the USAO's intention to terminate the DPA on June 15, 2007.
"Full compliance with all of the laws and regulations governing our company remains the highest priority for our leadership team, and for me personally," said James M Cornelius, chief executive officer, Bristol-Myers Squibb. "As we move forward with our plans to grow our business and build shareholder value, compliance is an essential pillar that will support all of our goals."
Bristol-Myers Squibb does not believe this resolution of the investigation should have a material impact on its ability to participate in federal procurement or health care programs, although there can be no assurance of this.
The agreement in principle is contingent upon the parties' assent to the terms of a final agreement and acceptance of the plea by the court in which it is entered. There can be no assurance that an agreement will be finalized or that the plea will be accepted. Further, Bristol-Myers Squibb cannot predict the impact of the agreement in principle or final agreement on the previously disclosed investigations by the FTC or the New York State Attorney General into the proposed Plavix patent settlement.