Ann M. Nagele

Exports/BIS and DDTC

Advised a broad range of companies on compliance with U.S. export controls on commercial/dual-use items under the Export Administration Regulations administered by the U.S. Department of Commerce's Bureau of Industry and Security (BIS) and on defense articles under the International Traffic in Arms Regulations administered by the U.S. State Department's Directorate of Defense Trade Controls (DDTC). Submitted and obtained numerous export licenses and classification requests including for encryption items. Prepared and handled voluntary self-disclosures. Drafted and implemented corporate export compliance management systems and related policies for clients in a variety of industry sectors. Conducted export control compliance training.

U.S. Trade Embargoes and Sanctions/OFAC

Counseled clients on U.S. embargoes/sanctions programs administered by the U.S. Treasury Department's Office of Foreign Assets Control (OFAC). Prepared and obtained export licenses from OFAC, including under the Trade Sanctions Reform Act (TSRA). Developed and implemented corporate OFAC compliance programs, including prohibited party screening mechanisms. Developed and conducted client internal OFAC compliance training. Prepared and handled voluntary self-disclosures to OFAC.

Foreign Trade Regulations/Automated Export System

Counseled variety of clients on compliance with the Foreign Trade Regulations (FTR), including filing of electronic export information (EEI) via AES/AES Direct to the U.S. Customs and Border Protection. Prepared and handled voluntary self-disclosures under the FTR.

Commodity Jurisdiction

Advised clients regarding agency jurisdictional issues (State Department/Directorate of Defense Trade Controls vs. Commerce Department/Bureau of Industry and Security) related to U.S. export controlled items, as well as the International Traffic in Arms Regulations (ITAR) in connection with such matters.

U.S. Customs Compliance/CBP

Counseled clients on customs issues involving import transactions including entry, classification, valuation, marking and rules of origin requirements. Advised clients on development and implementation of internal import compliance programs. Submitted and negotiated Petition for Relief for mitigation of U.S. Customs assessed penalties.

Exon-Florio/CFIUS

Counseled companies regarding the Exon-Florio Amendment and multi-agency Committee on Foreign Investment in the United States (CFIUS), including compliance with FINSA regulations. Advised on compliance with FINSA regulations and related issues (e.g., whether proposed transactions are "covered transactions" that may raise national security concerns, as well as on filing of voluntary notifications with CFIUS).

Licensing and Technology Transactions

Drafted and negotiated the following for a wide variety of clients: software license agreements; OEM and reseller agreements; marketing and sales agreements; and consulting, services and Web hosting agreements. Prepared and negotiated trademark and patent licenses. Prepared Website terms of use and user agreements for various Internet and e-commerce companies. Conducted privacy audits and advised various companies regarding development of privacy policies, practices and related agreements.

FDA Regulatory Counseling/Medical Devices

Provided counseling to various medical device companies regarding compliance with FDA regulations. Assisted with FDA regulatory matters arising in various transactions, including mergers, acquisitions and stock purchase agreements involving medical device companies.

Immigration

Pro bono experience assisting individuals seeking political asylum and U-visas (for U.S. immigrants that are victims of criminal activity), with the Department of Homeland Security's U.S. Citizenship and Immigration Services.

Government Contracts

Experience with the Federal Acquisition Regulations subcontractor "flowdown" requirements, as well as General Services Administration (GSA) contracts and related documents.