IRONHEALTH. Life Sciences Liability Coverage
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1 IRONHEALTH Life Sciences Liability Coverage
2 The clear choice for Life Sciences liability coverage Companies within the fast-paced, complex, high-risk Life Science industry require unique coverage to provide the maximum insurance protection. Good insurance not only protects the company from liability exposure, it also provides an increased level of confidence for stakeholders by demonstrating prudent financial management and accountability. A unit of IronHealth, Ironshore s Life Sciences practice will underwrite General and Product Liability insurance coverages for Biotechnology Companies, Specialty and Generic Pharmaceutical Companies, Medical Products and Medical Device Manufacturers, as well as industry distributors. We also offer coverage for clinical trials that take place throughout the world. THOUGHTFUL SOLUTIONS to the UNTHINKABLE Knowing exactly where the company does or does not have coverage can mean the difference of millions of dollars in a potential judgment. Ironshore Production Specialists are invested in understanding the nuances of the Life Science industry, deftly applying vital intellectual capital and a firm grasp of the science associated with different product classes to highly specialized coverage. Likewise, we keep pace with the rapidly changing legal and regulatory environment. Our Production Specialists have the expertise and the authority to help meet the needs of your Life Science customers.
3 IRONHEALTH FOR LIFE SCIENCES COVERAGE HIGHLIGHTS One Policy Aggregate for Products-Completed Operations Separate Policy Aggregate available for General Liability Claims Made and reported for products liability Occurrence and Claims Made available for premises operations Sublimit for Product Recall Expense (CLASS I RECALLS only) $50,000 per occurrence subject to $50,000 policy aggregate excess over a separate SIR or Deductible (minimum $25,000 each and every). Sublimit included within the Policy Aggregate for Products and Completed Operations Med Pay for Clinical Trials -$1,000 per patient subject to $10,000 policy aggregate (included within the Policy Aggregate for Products and Completed Operations) and no deductible Repair or Replacement Expense -$10,000 pays costs to repair or replace a defective product component without the need to physically recall the product. No deductible applies to this coverage part, but coverage subject to $10,000 policy aggregate (included within the policy limit aggregate for Products and Completed Operations) Privacy Protection (HIPAA) Coverage for Clinical Trials $25,000 sublimit with $5,000 deductible 7-year ERP available upon request; additional premium not to exceed 250% of policy premium Option to provide Professional Liability (no separate aggregate/ limit included in Products-Completed Operations) Silent on punitive damages Blanket additional insured coverage Notice of Circumstance language Worldwide Territory 90-day notice of cancellation, 10 days for non payment Automatic Coverage for TRIA (No A/P) Underwriter Appetite Medical products and medical device manufacturers and distributors Specialty and generic pharmaceutical companies Biotechnology companies, including companies engaged in human clinical trials Clinical research organizations Capacity Up to $ 20 million
4 NEW STATE OF THE ART LIFE SCIENCES PRODUCT & GENERAL LIABILITY EXCESS POLICY FORM UNDERWRITING APPETITE Coverage Highlights True follow-form policy Claims made coverage for Products-Completed Operations liability Claims made or Occurrence coverage for Commercial General Liability Defense within the limits Duty to Defend when underlying policy is duty to defend Deletion of Mandatory Arbitration Drop Down Coverage Enhancements: Personal Protection Information Event Expense - $25,000 Human Clinical Trial Medical Expense- $10,000 per participant/$25,000 aggregate FDA Withdrawal Expense - $25,000 Medical Monitoring Expense - $10,000 per participant/$25,000 aggregate Medical Waste Civil Fines - $25,000 Underwriter Appetite Capacity Medical products and medical device manufacturers and distributors Specialty and generic pharmaceutical companies Biotechnology companies, including companies engaged in human clinical trials Clinical research organizations Up to $ 20 million Minimum premium $5,000 per million limit of liability
5 Underwriting Capabilities Primary and Excess Coverage Comprehensive Managed Care E&O coverage $25 million capacity Coverage available on a duty to defend or reimbursement basis Directors & Officers Liability coverage is available to our E&O insureds Payment Plans Annual or quarterly payment options are available. Quarterly payment option includes no installment fee. Ancillary Products Directors & Officers Liability insurance Benefit Plan Sponsor Liability insurance Accountable Care Organization Liability Coverage Integrated Delivery Organization Liability Coverage Underwriter Appetite IronHealth underwrites the full range of managed care organizations. We understand and have expertise in underwriting not only the large traditional managed care organizations such as HMOs and PPOs, but also the myriad of other organizations which provide managed care services including ACOs, IPAs, PHOs, UROs, MSOs, TPAs, PROs, QIOs, CVOs, care management and disease management companies, and healthcare consultants.
6 FOREIGN CLINICAL TRIALS COVERAGE Coverage Highlights Phase I Phase IV coverage including coverage for non compulsory studies Indemnity to the insured as a clinical trial sponsor including pharmaceutical companies, biotech companies and clinical research organizations No-fault compensation where required Coverage for the full length of a trial, per patient limit, and/or annual policies Fast response time: 5 business days or less turnaround for complete submissions Underwriting Appetite Biotechnology companies Pharmaceutical companies Clinical research organizations engaged in foreign clinical trials Policies issued in local language when required AGCS offers a large underwriting capacity regardless of the number of Ironshore has established a collaborative working agreement with Allianz Global Corporate & Specialty. AGCS provides global solutions for foreign clinical trials liability. Ironshore provides brokers with direct access to ALLIANZ and a dedicated Allianz underwriter to service Ironshore accounts. Please contact your Ironshore Life Sciences Production Specialists for additional information. Capacity Up to $10 million trials undertaken by an individual client Contacts & Submissions KEVIN DEAN Senior Vice President kevin.dean@ironshore.com IRONHEALTH 175 Powder Forest Drive Weatogue, CT Fax ironhealthsubs@ironshore.com Ironshore, a Liberty Mutual Company, provides broker-sourced specialty property and casualty insurance coverages for varying risks located throughout the world. Select specialty coverages are underwritten at Lloyd s through Ironshore s Pembroke Syndicate The Ironshore group of companies is rated A (Excellent) by A.M. Best with a Financial Size Category of Class XIV and A (Stable) by Standard & Poor s. Pembroke Syndicate 4000 operates within Lloyd s where the market rating is A (Excellent) by A.M. Best, AA- (Very Strong) by Fitch, and A+ (Strong) by Standard & Poor s. For more information, please visit: The information contained herein is for general informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any product or service. Any description set forth herein does not include all policy terms, conditions and exclusions. Bound insurance policies, rather than summaries thereof, govern. Not all insurance coverages or products are available in all states or regions and policy terms may vary based on individual state or region requirements. Some policies may be placed with a surplus lines insurer. Surplus lines insurers generally do not participate in state guaranty funds and coverage may only be obtained through duly licensed surplus lines brokers. 10/17
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