aon life sciences practice: providing end-to-end solutions for life

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Risk. Reinsurance. Human Resources. Aon Risk Solutions Life Sciences Practice Providing End-to-End Solutions for Life Sciences Companies Life Sciences Practice

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Page 1: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

Risk. Reinsurance. Human Resources.

Aon Risk SolutionsLife Sciences Practice

Providing End-to-End Solutions for Life Sciences CompaniesLife Sciences Practice

Page 2: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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Page 3: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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The Life Cycle Risk Continuum

Life Sciences companies face numerous and unique challenges as their life cycles evolve. How these risks are mitigated and identified can be the fundamental difference between financial success and business failure. Aon provides Life Sciences companies with end-to-end risk solutions, supporting organizations from the initial discovery phase to final product launch.

Discovery / Preclinical

Clinical (Phase 1)

Clinical (Phase 2 & 3)

Regulatory Approval /

Launch Preparation

Post Approval / Product Launch

1The Life Cycle Risk

Continuum

2

34

5

Page 4: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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The Life Cycle Risk Continuum

An overview of industry-specific risks a Life Sciences company will likely face during their growth phases:

• Strong life sciences industry and product expertise providing tailored risk management advice

• Dedicated claims advocacy and management for complex product liability litigation and securities class actions

• Specialized life sciences service team that proactively assesses your risk profile in a high growth environment

• Significant market relationships and industry presence to secure the broadest, most cost effective risk management program

• Aon Global Client Network—the largest equity-owned global client network to efficiently and effectively secure admitted policies for multi-country, multi-site clinical trials and additional global insurance needs

We Address Your Risk Management Needs

Workers’ Compensation

Risk

Minimal Employee Base

Minimal Exposure

O�ce/LabEquipment/R&D

Discovery/Preclinical Clinical Phase 1 Clinical Phase 2 and 3

Regulatory Approval/ Launch Preparation

Post Approval/Product Launch

Small Employee Base

Property/Raw Material Manufacturing

Raw Material Sources

U.S. ClinicalTrials

InternationalClinical Trials

Product Liability

Manufacturing Capacity

Environmental/Pollution Liability

Private D&O Public D&O (IPO)Fiduciary

Employer Practice Liability

Property/Business Interruption

Auto Fleet for Sales Force

Manufacturing/Transportation/Raw Materials/Third-Party

Trade Credit/Business Continuity/ERM

Medium/Large Employee Base

Auto/General Liability

Property

Product Safety

Executive Liability

Supply Chain

Builder’s Risk

Environmental

5 4 3 2 1

Page 5: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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Solutions Across the Life Cycle Risk Continuum

Life Sciences companies face a growing number of unique and complex risks in areas such as products and clinical trials, directors’ and officers’ and supply chain liability. Today’s companies need comprehensive solutions at every stage of product development, testing, regulatory review and launch.

Based on deep industry knowledge and years of experience, Aon Risk Solutions’ Life Sciences Practice offers a range of risk management solutions across the entire life cycle risk continuum. Coverage is designed to address specific industry requirements such as market trends and pricing, contract language, individual market risk appetites and how the Life Sciences industry views risk.

As a result, Aon professionals can provide Life Sciences companies with industry-specific solutions that offer the following advantages and benefits:

• A flexible, customized approach for each individual client

• Global reach and presence in every region and market in the world

• Adherence to industry best practices and the ability to replicate successful risk management strategies

• Use of key benchmarking and actuarial analytics to support decision-making for program structures such as limits, retentions and pricing

• Access to top-level executive underwriters at leading Life Sciences insurance companies

• A seasoned team of attorneys to offer proven claims advocacy expertise in large product-liability class action and securities class action litigation

Page 6: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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Worldwide Support from Aon Clinical Trial Specialists

As clinical trials have moved from the United States and Western Europe to emerging regions such as Eastern Europe, Latin America and Asia amid increased scrutiny and compliance regulations, the likelihood that a clinical trial may be negatively impacted is on the rise.

Aon assists Life Sciences companies conducting global clinical trials through a coordinated effort supported by clinical trials specialists housed within the world’s largest equity-owned network.

Eastern Europe

Latin AmericaAsia

These specialists are trained in: • Understanding the international

regulatory environment for clinical trials

• Developing programs designed to protect clients from liabilities

• Helping to ensure the proper certificates are issued to allow the trial to proceed

In addition, our clinical trials specialists support our Life Sciences clients with: • Access to insurance expertise in 120

countries

• Management of controlled global master programs with certificate issuance in almost every country around the world complementing insured, fronted and captive structures

• Coordination and timely delivery of clinical trial certificates with trial managers and Contract Research Organizations globally to satisfy regulatory and ethics committee requirements

• Proprietary database of global clinical trials regulations

Page 7: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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Eastern Europe

Latin AmericaAsia

HawaiianIslands (USA)

Gulf Of A

den

Red Sea

The Gul f

Car ibbean Sea

Nor thSea

T imorSea

TasmanSea

East S iber ian Sea

Ber ing Sea

Sea OfJapan

EastChina

Sea

SouthChina

Sea

Pacific Ocean

Mediter raneanSea

Caspian Sea

Bay Of Bengal

Arabian Sea

BlackSea

Gulf Of Mexico

Pacific Ocean

At lant ic Ocean

Indian Ocean

Arct ic Ocean

Sea OfOkhotsk

Barents Sea

Kara SeaLaptev Sea

Nor wegian Sea

Beaufor t Sea

Hudson Bay

Ba�n Bay

Davis St rait

At lant ic Ocean

Southern OceanScot ia Sea

Ascension Island (Uk)

St. Helena (Uk)

NetherlandsAntilles (Nl)

FalklandIslands (Uk)

Reunion Islands (Fr)

CaymanIslands (UK)

New Caledonia (Fr)

Sao Tome & Principe

Tahiti

Symbols Illustrating Clinical TrialsInsurance Characteristics

Compulsory Clinical TrialsInsurance 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

Compulsory Limit of Liability

Aon O�ce

Admitted Insurance LawsMay Apply

No CompulsoryClinical Trials Requirements

CompulsoryClinical Trials Requirements

Compulsory Clinical Trials Requirements with Extended Reporting orLife-of-Trial Requirements

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

No Compulsory Requirements; However, Standard Practice Dictates Clinical Trials Coverage

United Arab Emirates

Latvia

Ghana

French Guiana (Fr)

Cabinda (Angola)

Melilla (Spain)

Gibraltar (UK)Ceuta (Spain)

Canada

United StatesOf America

Mexico

Belize

Honduras

NicaraguaEl Salvador

Guatemala

Costa Rica

Panama

Bahamas

HaitiDominican Rep

Jamaica

St. Kitts&

Nevis

Antigua & Barbuda

Anguilla

Virgin Islands (US)

DominicaSt. Lucia

Barbados

Grenada

Trinidad & Tobago

Guyana

Suriname

Venezuela

Colombia

Ecuador

Peru

Bolivia

Brazil

Paraguay

Uruguay

Argentina

Chi

le

Greenland

Iceland

UnitedKingdom

Ireland

NorthernIreland

France

Spain

Germany

Italy

Norway

Swed

en

Denmark

Netherlands

Belgium

Guernsey

Isle of Man

Luxembourg

Liechtenstein

MonacoSan Marino

VaticanAndorra

Port

ugal

Austria Hungary

Poland

Ukraine

Belarus

Estonia

Finland

Romania

Montenegro

Moldova

BulgariaBosnia

Albania

Serbia

F.Y.R. Macedonia

Greece

Malta

CyprusLebanon

Palestine

Israel

Syria

Jordan

Turkey

Egypt

LibyaAlgeria

Tunisia

Mali

Western Sahara(Morocco)

Niger

Chad

Sudan

Mauritania

Morocco

Cape Verde

Guinea

BurkinaFaso

Benin

Cameroon

Gabon

CentralAfrican Republic

Nigeria

Uganda

Zambia

Namibia

Botswana

Zimbabwe

SouthAfrica

Tanzania

Madagascar

Mozambique

Ethiopia

Kenya

EritreaYemen

Oman

Bahrain

Qatar

Kuwait

SaudiArabia

India

Bhutan

Burma(Myanmar)

Sri Lanka

Maldives

Seychelles

Comoros

Mauritius

Thailand

Cambodia

Vietnam

MacauHong Kong

Singapore

Brunei

Russia

Kazakhstan

Mongolia

China

Uzbekistan

TurkmenistanTajikistan

Afghanistan

KyrgyzstanAzerbaijan

Georgia

Armenia

Pakistan

IranIraq

Malaysia

Indonesia

Japan

North Korea

South Korea

Taiwan

Philippines Micronesia

Palau

Guam

Papua NewGuinea

Timor Leste

Solomon Islands

VanuatuFiji

New Zealand

Samoa

Niue (Nz)French

Polynesia

Tonga

Australia

St. VincentAruba

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)

Victoria

New SouthWales

Sarajevo

Bermuda (UK)

Croatia

Guadeloupe (Fr)

Democratic RepublicOf Congo

Symbol Definitions:

Compulsory Clinical Trials Insurance Requirements:Government mandated clinical trial liability insurance, evidence ofwhich must be provided by sponsors to regulators before regulatoryauthorities will grant approval to commence the trial.

Extended Reporting or Life-of-Trial Requirements:Government mandated insurance regulations requiring that clinicaltrials insurance include extended reporting or “tail” liability for a periodof time following the completion of a clinical trial or life-of-trial coverage.

Compulsory Limit of Liability:Government regulated clinical trial insurance with limit of liabilityrequirements (in some countries limit requirements vary bytrial size/number of human subjects).

High Compulsory Limit of Liability:Government regulated clinical trial insurance with limit of liabilityrequirements in excess of $5 million (in some countries limitrequirements 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 the local 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 anadmitted or locally licensed insurance company in the countryin 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 insuranceand can provide input on local customs and regulations.

Risk. Reinsurance. Human Resources.

Aon Life Sciences Clinical Trials Risk Map Aon Risk Solutions | Life Sciences Grouptel: 1+215.255.1857

e-mail: [email protected]

© Copyright Aon plc 2015. All rights reserved. Published by Aon Global Corporate Marketing and Communications.

The information contained in this map is based on Aon experience as of the publishing date (05/1). 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 di�er depending upon individual study requirements and the views of individual regulators and ethics committees.

Aon’s proprietary database contains information on local and regional regulations, ethics committee requirements and market practices for clinical trials insurance for individual countries. Based on this wealth of information, Aon Risk Solutions’ Life Sciences Practice develops a Clinical Trials Risk Map as a resource for Life Sciences companies conducting or planning to conduct clinical trials abroad.

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Powerful Tools for Risk Management Decision-Making

Product benchmarking

The industry’s largest proprietary products liability and D&O database, providing relevant data tailored to specific size and needs

Actuarial risk analysis

An industry-leading actuarial practice that provides loss forecasts and analysis specific to Life Sciences companies

Industry analysis

Aon Risk Solutions’ Life Sciences Industry Report, covering industry-specific insurance and financial trends, product benchmarking and peer risk management insight

Aon has invested significant resources to create a comprehensive platform of

analytical tools to help Life Sciences companies make informed risk management

decisions. These resources include:

Page 9: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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Page 10: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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Our expertise, your resource–across the industry and around the world

Aon Risk Solutions’ Life Sciences Practice serves more than 400 organizations worldwide, ranging from early-stage research and development units up to large pharmaceutical companies. Backed by the resources of more than 69,000 professionals in 120 countries, we can apply our collective experience and expertise to the specific challenges of individual clients such as:

• Pharmaceutical manufacturers

• Generic and OTC pharmaceutical companies

• Biotechnology and biopharmaceutical companies

• Genomic and proteomic companies

• Drug delivery system companies

• Diagnostic substance companies

• Medical device and equipment manufacturers

• Life Sciences services: Contract Research Organizations, Contract Marketing Organizations and drug distributors

An Unparalleled Offering of Products and Client Services

Page 11: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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A leader working with leaders

We are a recognized leader in risk management advisory services for Life Sciences companies. Our clients include:

50%of the NYSE Arca Biotech

Index

6of the 10

largest pharma companies

8of the 10

largest biotech companies

of the 10 largest medical device

companies

54of the 6 largest clinical research

organizations

Page 12: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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A major presence in the market

Effectively managing risk for the most complex Life Sciences companies in the world requires a service and product offering unparalleled in the industry and is dependent upon ongoing product innovation. Aon Risk Solutions’ Life Sciences Practice offering includes the following products and services:

• Insurance Broking—unparalleled product knowledge across all areas of risk in the industry

• Global Clinical Trials Insurance—coordination and placement

• Captive Insurance— Management and Services

• Risk Quantification and Modeling

• Enterprise Risk Management

• Business Continuity Management

• Supply Chain Management

• Business Interruption Valuation

• Property Engineering and Risk Control

• Crisis Management and Communication

• Reputational Risk Management and Brand Restoration

• Claims Response Planning

• Product Recall Assessment

• Human Capital Management

• Health and Benefits

An unwavering commitment to the

highest levels of service and innovation

for our clients.

Our presence in specialized Life Sciences

products includes:

USD200M USD100M

USD78B

in annual Clinical Trials and Product Liability premiums

in Life Sciences D&O premiums

in premium managed globally, across industries

Management of more than and more than

backed by

Page 13: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

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Aon Client Promise Framework—Our Commitment to You

The Aon Client Promise framework includes the five pillars of our promise, a comprehensive training curriculum, and a robust methodology for ensuring a consistent client experience.

Aon Client PromiseComprised of five pillars—partnership, expertise, innovation, excellence, and results—the Aon Client Promise articulates the commitment we make to our clients.

Aon Client Promise AcademyThe Academy offers unique learning experiences focused on listening for and responding to client needs, building knowledge of the full breadth of Aon capabilities, and understanding the pillars of the Aon Client Promise.

Aon Client Promise Methodology

Discover We will collaborate to understand both your near- and long-term business priorities, how we can add value to your organization, and help you respond to changing market dynamics.

Develop We will jointly author a plan to define how we will work together during the year, outline our commitments to you, and define how we will measure our success.

Deliver We will follow through on our plan, executing with excellence and tracking outcomes.

Review We will seek your input on how we are doing both through informal feedback sessions and annual surveys.

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Contact Aon Today

Aon professionals can provide your organization with the experience, tools and deep industry expertise required to maintain a competitive edge in today’s marketplace. Contact the following representatives to learn more about specialized solutions from Aon Risk Solutions’ Life Sciences Practice.

Jim WaltersManaging DirectorAon Risk Solutions Life Science Practice+1.215. [email protected]

Edwin AlbersDirectorAon Risk Solutions Life Science [email protected]

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 industryleading 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.

About Aon Life Sciences Group

Page 16: Aon Life Sciences Practice: Providing End-to-End Solutions for Life

About Aon Aon plc (NYSE:AON) is a leading global provider of risk management, insurance brokerage and reinsurance brokerage, and human resources solutions and outsourcing services. Through its more than 69,000 colleagues worldwide, Aon unites to empower results for clients in over 120 countries via innovative risk and people solutions. For further information on our capabilities and to learn how we empower results for clients, please visit: http://aon.mediaroom.com.

© Aon plc 2015. 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 profes-sional advice after a thorough examination of the particular situation.

www.aon.com

16908 05/15

Risk. Reinsurance. Human Resources.