Material Transfer Agreements Export Controls Sean Hayes, J.D., - PowerPoint PPT Presentation

Material Transfer Agreements Export Controls Sean Hayes, J.D., Ph.D. Research Advisor June 13, 2017

Material Transfer Agreements • Establishes rights and obligations of parties when research material is exchanged. • Webform established to process, monitor, and track MTAs.

Material Transfer Agreements – The provider retains ownership of the material. – The material is provided “AS-IS.” – The material will not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subjects without the written consent of the Provider. – If material to be used for commercial purposes then a commercial license may be required. – will not be transferred to anyone else within the Recipient organization without the prior written consent of the Provider.

Material Transfer Agreements • Webform established at University to monitor and track MTAs. • When the University of Delaware is the recipient of the materials, the MTA triggers appropriate health and safety alerts to the Environmental Health and Safety Office concerning the materials received. • When the University of Delaware is sending materials off campus, the MTA permits review of applicable shipping regulations. • An MTA permits review of intellectual property rights to protect the interests of the University of Delaware and individual University of Delaware researchers.

Material Transfer Agreements • Restricted Party Screening • Export Control Screening a. Keyword search b. Input from investigator c. Establish Technology Control Plan (TCP)

Export Controls

Export Controls The U.S. Government controls exports of sensitive equipment, software and technology as a means to promote our national security interests and foreign policy objectives. Through our export control system, the U.S. government can effectively: • Provide for national security by limiting access to the most sensitive U.S. technology and weapons • Promote regional stability • Take into account human rights considerations • Prevent proliferation of weapons and technologies, including of weapons of mass destruction, to problem end-users and supporters of international terrorism • Comply with international commitments, i.e. nonproliferation regimes and UN Security Council sanctions and UNSC resolution 1540

Export Controls WHAT IS AN EXPORT? Any item that is sent from the United States to a foreign destination is an export. “Items” include commodities, software, and technology. How the item is transported outside of the U.S. does not matter in determining export license requirements

Export Controls • Exports are physical things, such as electronic information, sent to foreign countries as well as disclosing information to foreign persons in the US (deemed export) • Exports are controlled for National Security and Foreign Policy Objectives

Export Controls A “deemed” export is the release within the U.S. of a technology or source code to a foreign national

Export Controls Exports are controlled by: • U.S. Department of State: ITAR (International Traffic in Arms Regulations) United States Munitions List (USML) • U.S. Department of Commerce: EAR (Export Administration Regulations) Commerce Control List (CCL) • U.S. Department of the Treasury: OFAC (Office of Foreign Assets Control)

Fundamental Research Information resulting from basic and applied • research in science and engineering conducted at an accredited institution of higher education in the U.S. that is ordinarily published and broadly shared within the scientific community.

Fundamental Research • Publication restrictions • Restrictions on foreign national participation

EAR • To determine whether an export license is needed from the Department of Commerce – need to know whether the item you intend to export has a specific Export Control Classification Number (ECCN). • The ECCN is an alpha-numeric code, e.g., 3A001, that describes the item and indicates licensing requirements. • All ECCNs are listed in the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR). • The CCL is divided into ten broad categories, and each category is further subdivided into five product groups. • • If item falls under U.S. Department of Commerce jurisdiction and is not listed on the CCL, it is designated as EAR99. EAR99 items generally consist of low- technology consumer goods and do not require a license in many situations. • However, if you plan to export an EAR99 item to an embargoed country, to an end-user of concern, or in support of a prohibited end-use, you may be required to obtain a license - OFAC.

EAR Categories Product Groups 0 Nuclear & Miscellaneous Materials, Chemicals, A Systems, Equipment 1 Microorganisms and Toxins and Components 2 Materials Processing B Test, Inspection and Production Equipment 3 Electronics C Material 4 Computers D Software 5 Part 1 Telecommunications E Technology 5 Part 2 Information Security 6 Sensors and Lasers 7 Navigation and Avionics 8 Marine 9 Aerospace and Propulsion 3A001 (Electronics, Systems, Equipment and Components, Supplement No. 1 to Part 774 of EAR)

EAR 8A001 Submersible vehicles and surface vessels, as follows (see List of Items Controlled) • 8 – Marine • A - Systems, Equipment and Components • 001 - Supplement No. 1 to Part 774 of EAR

EAR License Exception An authorization that allows you to export or reexport, under stated conditions, items subject to the EAR that would otherwise require a license. Part 740

EAR List-Based License Exceptions – Shipments to B Countries (GBS) – Civil End Users (CIV) – Limited Value Shipments (LVS) – Technology and Software Restricted (TSR) Availability Based on ECCN

EAR Transaction Based License Exceptions • TMP - Temporary Imports, Exports & Reexports • RPL - Service & Replacement of Parts & Equipment • TSU - Technology & Software Unrestricted

ITAR Exporting Requirements - Generally, any person or company who intends to export or to temporarily import a defense article, defense service, or technical data must obtain prior approval from DDTC (Directorate of Defense Trade Controls). The appropriate license form must be submitted for the purpose of seeking approval. Furthermore, in most cases, in order for a license to be considered, you first must be registered with DDTC.

ITAR Request must be submitted by a U.S. person who is a defense trade registrant. DSP-5 to permanently export unclassified defense articles DSP-61 to temporarily import unclassified defense articles DSP-73 to temporarily export unclassified defense articles

Commodity Jurisdiction • A commodity jurisdiction (CJ) request is used to determine whether an item or service is covered by the U.S. Munitions List (USML) and therefore subject to export controls administered by the U.S. Department of State pursuant to the Arms Export Control Act and the International Traffic in Arms Regulations (ITAR) • Commodity Jurisdiction requests are processed by DDTC

Commodity Jurisdiction • DDTC licenses defense articles and services covered by the U.S. Munitions List (USML), subject to the International Traffic Arms Regulations (ITAR). • A Commodity Jurisdiction determination will only identify the proper licensing authority for an item, and is not a license or approval to export. Bureau of Industry and Security (BIS) is the licensing • agency for exports subject to the Export Administration Regulations (EAR)

Classification Number Three ways to determine Export Control Classification Number (ECCN) for an item 1. Go to Manufacturer 2. Self-classify 3. Request an official classification

Commodity Classification Request • If your item is subject to the jurisdiction of the U.S. Department of Commerce, you must then determine if your item has a specific Export Control Classification Number (ECCN) found on the Commerce Control List (CCL). • Request to make determination of whether or not authorization is required to export • Note - Items subject to the Export Administration Regulations (EAR) that are not listed on the CCL are designated EAR99 • Other agencies such as the Departments of State and Energy, the Nuclear Regulatory Commission, and the Patent and Trademark Office have jurisdiction over certain items.

UD Export Control Policy 6-17 Export Controls and Trade Sanctions • http://www.udel.edu/ExecVP/policies/research/6-17.html Export Compliance Manual • http://www.udel.edu/research/pdf/ExportComplianceManual.pdf