California Pharmaceutical Company Settles Charges of
Unlicensed Exports of Biological Toxin

The U.S. Department of Commerce today announced that Elan Pharmaceuticals, Inc. (Elan) of South San Francisco, California, agreed to pay a $31,000 civil penalty to settle charges that it exported PRIALT, a sub-unit of conotoxin, to Belgium in violation of the Export Administration Regulations (EAR). Under the terms of the settlement agreement, Elan is required to perform an internal audit of its export compliance program.

The Commerce Department’s Bureau of Industry and Security (BIS) charged that between May 2000 and April 2002, Elan committed eight violations of the EAR stemming from four exports of the controlled biological toxin to Belgium. These exports were made with reason to know that the required Department of Commerce export licenses would not be obtained.

BIS enforces export control and related public safety laws to advance U.S. national security, foreign policy, and economic interests. Export controls on biological toxins are part of U.S. obligations as a member of the Australia Group, a multilateral regime whose members are committed to curbing the proliferation of chemical and biological weapons. All member countries are committed to maintaining export controls on both chemicals and biological toxins that could be used for weapons proliferation purposes.

Elan voluntarily self-disclosed the violations and cooperated fully in the investigation. BIS considers voluntary self-disclosures to be a substantial mitigating factor when negotiating settlements of administrative cases.

Acting Assistant Secretary for Export Enforcement Wendy L. Wysong commended the Special Agents of BIS’s Office of Export Enforcement, San Jose Field Office, for their work in this investigation.