Hawaiian Islands (USA) G u l f O f A d e n R e d S e a T h e G u l f Caribbean Sea North Sea Timor Sea Tasman Sea East Siberian Sea Bering Sea Sea Of Japan East China Sea South China Sea Pacific Ocean M e d i t e r r a n e a n S e a C a s p i a n S e a Bay Of Bengal Arabian Sea Black Sea Gulf Of Mexico Pacific Ocean Atlantic Ocean Indian Ocean Arctic Ocean Sea Of Okhotsk Barents Sea Kara Sea Laptev Sea Norwegian Sea Beaufort Sea Hudson Bay Baffin Bay Davis Strait Atlantic Ocean Southern Ocean Scotia Sea Ascension Island (Uk) St. Helena (Uk) Netherlands Antilles (Nl) Falkland Islands (Uk) Reunion Islands (Fr) Cayman Islands (UK) New Caledonia (Fr) Sao Tome & Principe Tahiti United Arab Emirates Latvia Ghana French Guiana (Fr) Cabinda (Angola) Melilla (Spain) Gibraltar (UK) Ceuta (Spain) Canada United States Of America Mexico Belize Honduras Nicaragua El Salvador Guatemala Costa Rica Panama Bahamas Haiti Dominican Rep Jamaica St. Kitts & Nevis Antigua & Barbuda Anguilla Virgin Islands (US) Dominica St. Lucia Barbados Grenada Trinidad & Tobago Guyana Suriname Venezuela Colombia Ecuador Peru Bolivia Brazil Paraguay Uruguay Argentina Chile Greenland Iceland United Kingdom Ireland Northern Ireland France Spain Germany Italy Norway Sweden Denmark Netherlands Belgium Guernsey Isle of Man Luxembourg Liechtenstein Monaco San Marino Vatican Andorra Portugal Austria Hungary Poland Ukraine Belarus Estonia Finland Romania Montenegro Moldova Bulgaria Bosnia Albania Serbia F.Y.R. Macedonia Greece Malta Cyprus Lebanon Palestine Israel Syria Jordan Turkey Egypt Libya Algeria Tunisia Mali Western Sahara (Morocco) Niger Chad Sudan Mauritania Morocco Cape Verde Guinea Burkina Faso Benin Cameroon Gabon Central African Republic Nigeria Uganda Zambia Namibia Botswana Zimbabwe South Africa Tanzania Madagascar Mozambique Ethiopia Kenya Eritrea Yemen Oman Bahrain Qatar Saudi Arabia India Bhutan Burma (Myanmar) Sri Lanka Maldives Seychelles Comoros Mauritius Thailand Cambodia Vietnam Macau Hong Kong Singapore Brunei Russia Kazakhstan Mongolia China Uzbekistan Turkmenistan Tajikistan Afghanistan Kyrgyzstan Azerbaijan Georgia Armenia Pakistan Iran Iraq Malaysia Indonesia Japan North Korea South Korea Taiwan Philippines Micronesia Palau Guam Papua New Guinea Timor Leste Solomon Islands Vanuatu Fiji New Zealand Tasmania Samoa Niue (Nz) French Polynesia Tonga Australia South Australia St. Vincent Aruba Kiribati Tuvalu Nauru Marshall Islands (Usa) Alaska (US) Togo Cote D'ivoire Congo Angola Cuba Djibouti Laos Nepal Bangladesh Somalia Eq Guinea Gambia Guinea Bissau Lesotho Liberia Burundi Rwanda Malawi Senegal Sierra Leone Swaziland Slovakia Czech Rep Lithuania Slovenia Switzerland Puerto Rico (US) Bermuda (UK) Croatia Guadeloupe (Fr) Democratic Republic Of Congo Kuwait Aon Life Sciences Clinical Trials Risk Map Aon Risk Solutions Life Sciences Group 6 th Edition Aon Life Sciences Group One Liberty Place 1650 Market Street, Suite 1000 Philadelphia, PA 19103 t: 1+215.255.1857 e: [email protected] About Aon Aon plc (NYSE:AON) is a leading global professional services firm providing a broad range of risk, retirement and health solutions. Our 50,000 colleagues in 120 countries empower results for clients by using proprietary data and analytics to deliver insights that reduce volatility and improve performance. © Aon plc 2018. All rights reserved. The information contained herein and the statements expressed are of a general nature and are not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information and use sources we consider reliable, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate professional advice after a thorough examination of the particular situation. www.aon.com GDM05431 Aon Life Sciences Clinical Trials Risk Map The globalization of clinical trials continues to be on the rise, leading to a plethora of regulatory and operational challenges for the Life Sciences industry. Aon’s 6th edition Clinical Trials Risk Map highlights clinical trials insurance regulations and complexities for over 80 countries throughout the world leveraging Aon’s global network and clinical trials expertise. Our global network is positioned to help life sciences companies efficiently and effectively secure international clinical trials coverage that complies with the regulatory requirements of individual countries, ultimately minimizing the risk of financial volatility. Aon Life Sciences Group The Aon Life Sciences Group has been assisting life sciences companies with securing international clinical trials insurance for over 30 years. We have the largest equity-owned global network in the world, housing clinical trials specialists who provide our life sciences clients with industry-leading expertise and accountability. Our experts constantly review country-by-country clinical trials regulations in order to provide our clients with industry-leading risk management advisory and brokerage services. Symbols Illustrating Clinical Trials Insurance Characteristics Compulsory Clinical Trials Insurance Requirements Key to Symbols Medical Malpractice is a Standard Policy Extension Foreign Entity may be Listed as Named on a Local Policy High Compulsory Limit of Liability = >$5MM Compulsory Aggregate Limit of Liability = <$5MM Admitted Insurance Laws May Apply No Compulsory Clinical Trials Requirements Compulsory by Law Compulsory by Law with high ERP or/and LoT No Data Available Coverage is Available on a No Fault Basis Standard Clinical Trials Insurance Coverage may not include Trial Participant Pre-Enrollment Screening Clinical Trials Insurance Policies allow Direct Reimbursements to Trial Participants Required as per local guidelines and/or standard practice Symbol Definitions: Compulsory Clinical Trials Insurance Requirements: Government-mandated clinical trial liability insurance, evidence of which must be provided by sponsors to regulators before regulatory authorities will grant approval to commence the trial. Extended Reporting or Life-of-Trial Requirements: Government-mandated insurance regulations requiring that clinical trials insurance include extended reporting or “tail” liability for a period of time following the completion of a clinical trialor Life-of-Trial coverage. Compulsory Limit of Liability: Government-regulated clinical trial insurance with limit of liability requirements (in some countries limit requirements vary by trial size/number of human subjects). High Compulsory Limit of Liability: Government-regulated clinical trial insurance with limit of liability requirements in excess of $5 million (in some countries limit requirements vary by trial size/number of human subjects). Medical Malpractice is a Standard Policy Extension: Professional liability coverage for trial investigators as part of their participation in the study is a standard coverage under thelocal clinical trials liability policy. Coverage is Available on a No Fault Basis: A type of clinical trial liability policy under which insureds areindemnified for losses regardless of fault. Foreign Entity may be Listed as a Named Insured on a Local Policy: A foreign sponsor can be listed as the named insured under the localclinical trial liability policy without the need of a local legal representative. Admitted Insurance Requirements May Apply: Local country law requires that insurance be purchased from an admitted or locally licensed insurance company in the country in which the clinical trial is being conducted. Aon Office: Countries where Aon has a physical presence (in one or multiple cities) and can assist life sciences clients in obtaining local clinical trial insurance and can provide input on local customs and regulations. The information contained in this map is based on Aon experience as of the publishing date (04/18). The environment (both regulatory and practical) for clinical trials is constantly changing and this map should not be solely relied upon without further consultation from an Aon Life Sciences professional. In addition, ethics committees, regulatory authorities and published guidelines within individual countries can differ depending upon individual study requirements and the views of individual regulators and ethics committees.