Navigators Life Sciences New Business Application This is an application for a CLAIMS MADE POLICY. Should this application be accepted by the Company, coverage will apply to claims first made against the insured during the policy period. No coverage will apply for claims first made against the insured after the end of the policy period unless the extended reporting period applies. No coverage will apply for claims first made prior to the retroactive date shown in the declarations page of the policy. The completion and submission of this application to the Company does not constitute a binder of insurance. All questions must be answered. If a question is not applicable, please answer "NA". If the answer to a question is none, state "None" or "0". If more space is required to answer a question completely, please provide a separate sheet and identify the question it responds to. Please check the appropriate response: [ ] Products/Completed Operations Liability or [ ] Professional Liability |1. Applicant: | | |2. Address: | | |3. Mailing | | |address: | | |4. Other | | |locations: | | |5. All Named | | |Insureds: | | |6. Additional | | |Insureds: | | |Explain | | |relationship(s) | | 7. If you have acquired any subsidiaries within the last 5 years, please identify them: |Entity |Date Acquired | | | | | | | 8. Named Insured is a(n): |[ ]|Individual |[ ]|Joint venture | |[ ]|Partnership |[ ]|Other (Describe): | |[ ]|Corporation | | |9. How long has the Named Insured been in | [ ] Years [ | |business? |] Months | |10. Do you have a parent company? |[ ] Yes [ ] No| |11. Have you operated under another name? |[ ] Yes [ ] No| |(If yes, please give details) | | | | |This Year |Last Year | | |20[ ] |20[ ] | |12. Annual U.S. gross | | | |revenue? | | | |13. Annual foreign gross | | | |revenue? | | | |14. Total gross revenue | | | 15. Product/Service Profile (by percentage) |Source of Revenue |% |Product or Service | | | |Description | |Proprietary chemically synthesized | | | |pharmaceuticals | | | |Generic chemically synthesized | | | |pharmaceuticals | | | |Proprietary bio-pharmaceuticals | | | |Generic bio-pharmaceuticals | | | |Medical devices | | | |Diagnostics | | | |Contract research | | | |Contract manufacturing | | | |Distribution | | | |Equipment rentals/leasing | | | |Repair/installation/service | | | |Other (please explain): | | | 16. Product/Service Detail (by percentage) Contracted Professional Services: | |% | |% | |Preclinical testing | |Biostatistics | | |Pharmacodynamics | |Submission of regulatory | | | | |filings | | |Pharmacokinetics | |Bioequivalency/bioavailabil| | | | |ity testing | | |Protocol design | |Quality control | | |Study selection or monitoring| |Manufacturing | | |Clinical investigations | |Repackaging/assembly | | |(indicate phases) | | | | |Clinical staff recruitment | |Sterilization services | | |Clinical staff training | |Marketing | | |Case report form design | |Sales | | |Data entry/database | |Distribution | | |management | | | | |Publications/software design | |Other (please explain): | | | | Medical Devices: | |% | |% | |Cardiac | |Therapy/rehab | | |Anesthesia/respiratory | |Dialysis | | |Implants - active | |Infusion | | |Implants - non-active | |Non-cardiac catheters | | |Lasers | |Analytical instruments | | |Surgical devices | |Diagnostic kits | | |Dental instruments | |Durable medical equipment | | |Monitoring | |Hospital products/supplies | | |Imaging devices | |Other (please explain): | | | | Pharmaceuticals: | |% | |% | |Vaccines | |Drug delivery | | |Hormones & steroids | |Imaging/diagnostic agents | | |Birth Control of any kind | |Nutraceuticals | | |Injectable/oral prescription | |Vitamins/food supplements | | |Topical prescription | |Diet aids | | | | |Other (please explain) | | | | |17. Are any of your products undergoing clinical trials, | | |or will be undergoing clinical trials during the current | | |year? If yes, please complete the attached clinical trials| | |worksheet and attach the protocols and informed consent |[ ]Yes [ | |documents for each study to be covered. |]No | |18. Will you be releasing any new products in the coming | | |year? If yes, on a separate sheet please list any new | | |products, their indications and when they are expected to |[ ]Yes [ | |be introduced. |]No | |19. Have you discontinued any products in the last 5 | | |years? If yes, on a separate sheet please list them, their| | |indications and the reason why they were discontinued. |[ ]Yes [ | | |]No | |20. Are any products you distribute manufactured outside | | |of the U.S.? If yes, on a separate sheet, please list all | | |countries where your product is manufactured, whether the |[ ]Yes [ | |manufacturing facilities are certified by the FDA, and the|]No | |date the facilities were last inspected by FDA? | | |21. Are any of your products components/ingredients | | |manufactured outside of the U.S.? If yes, on a separate | | |sheet, please list all countries where your | | |components/compounds are manufactured, whether the |[ ]Yes [ | |manufacturing facilities are certified by the FDA, and the|]No | |date the facilities were last inspected by FDA? | | |22. Are any products you manufacture sold under others' | | |labels? If yes, on a separate sheet please list those |[ ]Yes [ | |products, and under whose label they are sold. |]No | |23. Are any products sold as components or ingredients for| | |other products? If yes, on a separate sheet please list | | |those components or ingredients and their likely end |[ ]Yes [ | |products. |]No | |24. Do you require Certificates of Insurance from your |[ ]Yes [ | |suppliers? |]No | |25. Do you contract out product development, | | |manufacturing, sales, or distribution services? If yes, on|[ ]Yes [ | |a separate sheet, please indicate the activities you |]No | |contract. | | |26. Do any of your products training/certification |[ ]Yes [ | |programs require FDA approval? |]No | |27. Are your manufactured products UL listed and/or CSA |[ ]Yes [ | |certified? |]No | |28. Do you use a facility for reliability/design |[ ]Yes [ | |validation? |]No | 29. Professional Services: |Do any of your employees provide direct patient care? |[ ]Yes [ | | |]No | |Do they carry their own individual medical malpractice |[ ]Yes [ | |insurance? |]No | |Do you operate an in-patient facility? |[ ]Yes [ | | |]No | |Do any of your employees participate on an Institutional |[ ]Yes [ | |Review Board? |]No | |Do any of your employees participate on a Scientific |[ ]Yes [ | |Advisory Board? |]No | |Do you or your employees have a financial interest in your|[ ]Yes [ | |client's products? |]No | |On a separate sheet, please list your 5 largest clients for current year| |and the values of your contracts. | 30. Regulatory: |To the best of your knowledge are you in compliance with | | |FDA regulations or foreign agency equivalent? |[ ]Yes [ | | |]No | |Have you had any product recalls in the past year? If yes,| | |on a separate sheet, please list the product(s), the |[ ]Yes [ | |reason(s),and the date(s) of the recall(s) |]No | |Within past 12 months, has there been any MDR's or AER's | | |filed? If yes, on a separate sheet, please indicate the |[ ]Yes [ | |number of and nature of each filing. |]No | |What was the date and result of your most recent FDA | | |inspection? Please submit a copy of Form 483 and your | | |documented response. | | |Have any products or company practices been subject to an | | |investigation by any government agency? If yes, on a |[ ]Yes [ | |separate sheet, please explain. |]No | |Have any of your clinical trials placed on a clinical | | |hold? If yes, on a separate sheet, please provide the |[ ]Yes [ | |details. |]No | |Do you audit clinical investigators' performance? |[ ]Yes [ | | |]No | |Have any warning letters been issued against you in the | | |last 3 years? If yes, on a separate sheet, please provide |[ ]Yes [ | |the details. |]No | 31. Risk Management |Do you have a documented loss prevention/loss control | | |program? If yes, on a separate sheet, please name person |[ ]Yes [ | |in charge of the program. |]No | |Do you have a written quality control program? |[ ]Yes [ | | |]No | |Do you have a written product recall plan? |[ ]Yes [ | | |]No | |Do you have a written records retention program? |[ ]Yes [ | | |]No | |Are promotional materials, contracts, guarantees, and | | |labeling jointly reviewed by each applicable discipline? |[ ]Yes [ | | |]No | 32. Loss History *Total aggregate cost (losses from ground up including defense) for last five years |Policy Period|Insurer |# of Claims |Total Incurred | | | | | | | | | | | | | | | | | | | | | | | | | | *Attach previous carrier loss runs |Describe all incurred losses of $10,000 or more: | | | | | |Any known occurrence(s) not yet reported? (If yes, please submit | |details) | | | | | 33. Coverage History |Policy |Primary & Excess |Carriers |Retro Date | |Period |Limits | | | | | | | | | | | | | | | | | | | | | | | | | | | | |Has your insurance ever been canceled or | | |non-renewed by a carrier? If yes, on a |[ ] Yes [ | |separate sheet please explain. |] No | |What limit of liability are you seeking? | | |What amount of Deductible or SIR are you |[ ] SIR or [ ] | |prepared to carry? |DED | *If requesting excess coverage, please provide the underlying premium and policy limits, terms & conditions. Please include the following with this application: o Your most recent audited financial statement o Clinical trials worksheet including the protocols and informed consent documents for each study requiring coverage o Senior staff curriculum vitae o Outline of your quality control program o Advertisements, brochures, descriptive literature o Sample service contracts and indemnification agreements Any person who knowingly and with intent to defraud any insurance company or other person files an application for insurance or statement of claim containing any materially false information or conceals for the purpose of misleading, information concerning any fact material thereto commits a fraudulent insurance act, which is a crime and subjects such person to criminal and civil penalties, including but not limited to fines, denial of insurance benefits, civil damages, criminal prosecution and confinement in state prison. | | | |Signature |Title | | | | |Print Name |Date | ----------------------- Insuring A World In Motion