Clinical Trials Insurance

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1 Allianz Global Corporate & Specialty Clinical Trials Insurance Global solutions for clinical trials liability

2 Specialist cover for clinical research The challenges of international clinical research are increasing faster than ever. Pharmaceutical companies and research organisations face complex worldwide regulations alongside other challenges such as trial safety, speed and quality. The opportunities presented by emerging clinical trial locations are balanced by the need for local support and knowledge, with an absolute requirement for reliable service in these new territories. Global Partnership for Global Trials Allianz Global Corporate & Specialty recognises the complexity of today s clinical research environment. Our dedicated Clinical Trials underwriters, working in partnership with clients and their brokers, offer specialist insurance services to cover trials around the world, from single studies to multi-location research programs. Backed by the unique combination of Allianz s industry, delivered locally but coordinated centrally through your primary entry point for Allianz Global Corporate & Specialty at your location. With an established reputation and proven capabilities, Allianz Global Corporate & Specialty is committed to developing long term relationships with clients and brokers throughout the Clinical Trials sector. Allianz Global Corporate & Specialty Clinical Trials cover provides: Indemnity to the insured as trial sponsor, including pharmaceutical companies and contract research organisations Liability for injury to a trial participant, including no-fault compensation where required Coverage is provided for the full length of the trial

3 Tailor-made solutions for individual needs No clinical research program is the same as another - so we at Allianz ensure that each coverage offered. Our underwriting teams which include pharmaceutical experts work closely with the client and their brokers to establish the exact coverage requirements in each case. So whether it is for a single trial or for the most complex trial programs in multiple territories, we can offer tailor- Cover for clinical trials with drugs (from Phase I to IV) and medical devices including non-compulsory studies The Allianz cover is generally provided on a local basis in every territory in which trials are performed We offer a large underwriting capacity regardless of the number of trials undertaken by an individual client so we can accommodate clients with large clinical trial programs No fault compensation is offered where required Local policies are generally provided in local languages Full english language translations of local language policies are available upon request All policies are in line with local statutory limits and coverage For clients performing a limited number of trials, policies can be provided on an individual stand alone basis or as part of a global program In Practice - example coverage. ABC plc a mid sized pharmaceutical company - is now embarking on investigational product ABC-993. Trials are planned over a 10 month period in 7 territories including Asia and Eastern Europe. ABC requires: Local language fully admitted policies in each territory Compliance with the local level of cover in all territories Rapid delivery of documentation to comply with the trial submission dates at each location The Allianz Solution requirements of the trial and how Allianz can provide the best possible cover: Individual per trial cover is underwritten and quoted for by Allianz Global Corporate & Specialty fully compliant local policies to ensure the clinical trials can proceed without delay Global master policy can be provided to deliver Difference in Limits cover above the locally issued policy limits Both ABC and their broker have a single point of contact to central underwriters and claims teams through appointed client team contacts within Allianz Global Corporate & Specialty Outcome ABC receives rapid and comprehensive cover for this series of trials, satisfying local regulatory needs per trial whilst having the protection of a harmonised and consistent global insurance program, centrally managed and coordinated via one primary point of contact.

4 Global service in practice Allianz Global Corporate & Specialty has a proven reputation as a leading provider of International Insurance Programs, with in-depth experience of delivering tailor-made insurance solutions for clients with exposure to international multi-location clinical trials. Worldwide reach Working through the Allianz global network and with the client s brokers, Allianz Global Corporate & Specialty currently offer tailor-made solutions for multi-national clinical research programs in more than 100 countries worldwide including important expanding markets in Africa, Asia, Latin America and the Middle East. Such international insurance programs are suitable for clients with multiple clinical trials in multiple territories based on multiple protocols. Speed of response Consistent cover, centrally managed Typically a multi-national Clinical Trials program will consist of a combination of global Master Policy plus individual local policies on a per trial/per country basis. harmonised and consistent insurance program with internationally recognised terms and conditions. The Master Policy provides additional increased limits (DIL) which are required for larger trials with many research subjects. Coverage is provided on a trials attaching basis, covering all trials commencing in the policy period. We recognise that time is of the essence in clinical trials. This is why our service is designed to provide clients with a rapid response and fast turnaround to coverage requests. Annually we provide Clinical Trials coverage, both for single and multi centre studies, for over 150 clients worldwide. By adopting an individual approach to each client s needs, Allianz Global Corporate & Specialty can reduce both the administrative burden that is associated with such insurance and the time to issue and large programs, we work with the client and their broker to classify all clinical trials activities into categories to which we can apply pre-agreed rates. This helps to avoid pricing delays and enables clients to determine their annual insurance budget more accurately. The Master Policy provides cover for the full length of each trial (including monitoring periods) that commences during the policy period.

5 Local policies for Clinical Trials Insurance issued by Allianz Global Corporate & Specialty or our network partners, are available in the following countries Europe Albania Armenia Austria Azerbaijan Belgium Bosnia & Herzegovina Bulgaria Croatia Czech Republic Denmark Estonia Finland France Georgia Germany Greece Hungary Iceland Ireland Italy Kosovo Latvia Lithuania Luxembourg Macedonia Malta Moldova Montenegro Netherlands Norway Poland Portugal Romania Russia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Ukraine United Kingdom Africa - Middle East Bahrain Burkina Faso Cameroon Egypt Ghana Israel Jordan Australia Bangladesh Cambodia China Hong Kong India Indonesia Japan The Americas Argentina Bahamas Bolivia Brazil Canada Chile Colombia Costa Rica Kenya Kuwait Lebanon Mali Mozambique Nigeria Oman Kazakhstan Krgyzstan Malaysia Nepal New Zealand Pakistan Papua New Guinea Philippines Dominican Republic Ecuador El Salvador Guatemala Haiti Honduras Mexico Nicaragua Saudi Arabia* South Africa Tanzania Tunisia United Arab Emirates Zambia Singapore South Korea Sri Lanka Taiwan Thailand Vietnam Panama Paraguay Peru Uruguay USA Venezuela

6 Your local Allianz Global Corporate & Specialty Clinical Trials contacts Dirk Antonissen Phone: +32 (0) Mobile: +32 (0) dirk.antonissen@allianz.com Phone: +32 (0)3 304

7 Allianz Global Corporate & Specialty Comprehensive risk management solutions worldwide Allianz Global Corporate & Specialty is one of the few specialist corporate insurers with a genuine global market presence. Providing a one carrier insurance solutions across the whole spectrum of corporate and specialty risks including: Aerospace Airlines Cargo Energy Engineering Financial Lines General Aviation Liability Marine Hull Property Risk Consultancy Yachts and Pleasure Craft Allianz Global Corporate & Specialty SE Key Facts: Serves clients through the Allianz network in more than 160 countries Provides insurance for nearly three quarters of the Fortune Global 500 companies and large specialty clients Employs more than 3,500 people worldwide Standard & Poor s of AA ( Very Strong ) (May 2016)

8 Disclaimer The material contained in this publication is designed to provide general information only and does not form the basis of a contract or policy wording. While every effort has been made to ensure that the information provided is accurate, this information is provided without any representation or warranty of any kind about its accuracy and Allianz Copyright 2017 Allianz Global Corporate & Specialty SE. All rights reserved.