APPLICATION FOR SPECIFIED PRODUCTS AND COMPLETED OPERATIONS LIABILITY INSURANCE

Transcription

1 APPLICATION FOR SPECIFIED PRODUCTS AND COMPLETED OPERATIONS LIABILITY INSURANCE Notice: If the policy for which application is made is for claims made coverage: coverage applies only to claims first made during the "policy period," unless an extended reporting period is exercised. Please read the policy carefully. If space is insufficient to answer any question fully, attach a separate sheet. If response is none, state NONE. I. GENERAL INFORMATION 1. (a) Full name of Applicant: (b) Principal business premises address: (Street) (County) (c) (City) (State) (Zip) List the names of all predecessor organizations of the Applicant: (d) Audit contact name: (e) Phone Number: (f) Website address: (g) Date established (MM/DD/YYYY): (h) Applicant is a: [ ] corporation [ ] partnership [ ] sole proprietorship [ ] limited liability company (LLC) [ ] other 2. Is the Applicant controlled by, owned by, or commonly owned, affiliated or associated with any other organization?... Yes [ ] No [ ] (a) If Yes, provide details. II. SPECIFIED PRODUCTS AND COMPLETED OPERATIONS 1. Provide the following information for those products, goods and/or services the Applicant wants coverage for. Only those products, goods and services listed below will be considered for coverage. Products and Goods (or specific categories) Applicant Acts Does Applicant % of Products and as a(n) No. of Gross Repair or Goods sold to: M W R I MR Years Receipts Install? Service? W R C O M: manufacturer W: wholesaler R: retailer I: importer MR: manufacturer s rep. C: consumer direct O: other (describe) 2. Total gross receipts from all products, goods and services listed in Part II, Question 1. hereinabove: (a) Estimated annual gross receipts for the coming year: $ (b) Annual gross receipts last twelve months: Year: $ 3. Does the Applicant have any operations, and/or any receipts or income from any products, goods or services, NOT listed in Part II, Question 1. hereinabove?... Yes [ ] No [ ] If Yes, (a) Provide a detailed explanation. (b) Provide the following for ALL products, goods, services and operations. (i) Estimated annual gross receipts for the coming year: $ Annual gross receipts: (1) last twelve months: Year: $ (2) 1 st prior year: Year: $ 4. Is the Applicant presently considering any change in the mix of products, goods, services and/or operations, including adding new products, goods, services or operations, for the coming year?... Yes [ ] No [ ] (a) If Yes, provide details. PD /09 Page 1 of 3

2 5. Has the Applicant discontinued or is it considering discontinuing any product or service listed above?.. Yes [ ] No [ ] (a) If Yes, provide details. 6. Are any of the Applicant s products or services used in connection with aircraft/missiles/aerospace?... Yes [ ] No [ ] (a) If Yes, provide details. III. PROCESSING AND QUALITY CONTROL 1. PROCESSING (a) Do any products or ingredients or components thereof, originate from outside the United States?.. Yes [ ] No [ ] (i) If Yes, specify: (1) The country(ies) of origin: (2) The name of each manufacturer, distributor or supplier: (b) Do others manufacture, assemble, package or install products under Applicant s name or label?... Yes [ ] No [ ] (i) If Yes, provide the name(s) and address(es) of contract manufacturer(s): (c) Does the applicant manufacture, assemble, package or install products for others under their name or label?... Yes [ ] No [ ] (i) If Yes, explain. 2. QUALITY CONTROL AND RECORDKEEPING (a) Does the Applicant have a quality control and testing procedure?... Yes [ ] No [ ] (i) If Yes, how long does the Applicant keep quality control and testing records? (b) Can the Applicant identify its product(s) from those of competitors?... Yes [ ] No [ ] (c) Do all records show to whom and the date each product was sold?... Yes [ ] No [ ] (d) Does the Applicant require certificates of insurance evidencing Products Liability Insurance from suppliers?... Yes [ ] No [ ] (e) Who designs the Applicant s products? (f) Are product designs reviewed, tested and verified by others?... Yes [ ] No [ ] (g) Does the Applicant have a specific program to withdraw known or suspected defective products from the market?... Yes [ ] No [ ] (h) Has the Applicant ever recalled or is it considering recalling any product?... Yes [ ] No [ ] If Yes, attach an explanation. (i) Have any of the Applicant s products or ingredients or components thereof, ever been the subject of any investigation, enforcement action, or notice of violation of any kind by any governmental, quasi-governmental, administrative, regulatory or oversight body?... Yes [ ] No [ ] (1) If Yes, provide details. IV. INSURANCE INFORMATION 1. (a) Limits of Liability: Indicate the limits of liability requested: $ /$ (b) Deductible: Indicate the deductible requested: $ THE COMPANY DOES NOT GUARANTEE TO OFFER ANY OF THE ABOVE LIMITS AND/OR DEDUCTIBLES. 2. Provide the following for present Product Liability Insurance: If None, check here [ ] Insurance Limits of Deductible/ Expiration Dates Retroactive/ Company Liability SIR Premium (MM/DD/YYYY) Prior Acts Date 3. Has any insurer declined, canceled, or nonrenewed any Product Liability Insurance or any similar insurance on behalf of any person(s) or organization(s) proposed for this insurance?... [ ] Yes [ ] No (a) If Yes, provide details. V. CLAIM HISTORY 1. Has any claim for Product Liability been made against any person(s) or organization(s) proposed for this insurance during the last five (5) years?... [ ] Yes [ ] No If Yes, provide five (5) year loss history for all claims, including any predecessor. Attach a description of any loss greater than $10,000. Year No. of Claims Total Amounts Paid Amounts Reserved Total Incurred Date of Loss Info. PD /09 Page 2 of 3

3 2. Is (are) any person(s) or organization(s) proposed for this insurance aware of any fact, incident, circumstance, situation, condition, defect or suspected defect which may result in a Product Liability claim, such that would fall under the proposed insurance?... [ ] Yes [ ] No If Yes, provide details. VI. ADDITIONAL INFORMATION As part of this application attach the following: Brochures; Labels; and Instructions. NOTICE TO THE APPLICANT - PLEASE READ CAREFULLY No fact, incident, circumstance, situation, condition, defect or suspected defect indicating the probability of a claim or action for which coverage may be afforded by the proposed insurance is now known by any person(s) or organization(s) proposed for this insurance other than that which is disclosed in this application. It is agreed by all concerned that if there is knowledge of any such fact, incident, circumstance, situation, condition, defect or suspected defect any claim subsequently emanating therefrom shall be excluded from coverage under the proposed insurance. This application, information submitted with this application and all previous applications related hereto and material changes to any of the foregoing of which the underwriting manager, Company and/or affiliates thereof receives notice is on file with the underwriting manager, Company and/or affiliates thereof and is considered physically attached to and part of the policy if issued. The underwriting manager, Company and/or affiliates thereof will have relied upon this application and all such attachments in issuing the policy. For the purpose of this application, the undersigned authorized agent of the person(s) and organization(s) proposed for this insurance declares that to the best of his/her knowledge and belief, after reasonable inquiry, the statements in this application and in any attachments, are true and complete. The underwriting manager, Company and/or affiliates thereof are authorized to make any inquiry in connection with this application. Signing this application does not bind the Company to provide or the Applicant to purchase the insurance. If the information in this application and any attachment materially changes between the date this application is signed and the effective date of the policy, the Applicant will promptly notify the underwriting manager, Company and/or affiliates thereof, who may modify or withdraw any outstanding quotation or agreement to bind coverage. If the policy for which application is made is for claims made coverage, the undersigned declares that the person(s) and organization(s) proposed for this insurance understand that coverage for which this application is made applies: (i) Only to claims first made during the policy period ; unless an extended reporting period is exercised. If an extended reporting period is exercised, the policy shall also apply to claims first made during the extended reporting period; and Unless amended by endorsement, the limits of liability contained in the policy shall be reduced, and may be completely exhausted by claim expenses and, in such event, the Company will not be liable for claim expenses or the amount of any judgment or settlement to the extent that such costs exceed the limits of liability in the policy and unless amended by endorsement, claim expenses shall be applied against the deductible. WARRANTY I/We warrant to the Company, that I/We understand and accept the notice stated above and that the information contained herein is true and that it shall be the basis of the policy and deemed incorporated therein, should the Company evidence its acceptance of this application by issuance of a policy. I/We authorize the release of claim information from any prior insurer to the underwriting manager, Company and/or affiliates thereof. Note: This application is signed by undersigned authorized agent of the Applicant(s) on behalf of the Applicant(s) and its owners, principals, partners, directors, officers and employees. Must be signed by the owner, principal, partner, executive officer or equivalent (within 60 days of the proposed effective date). Name of Applicant Title Signature of Applicant Date Notice to Applicants: 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 the person to criminal and civil penalties. PD /09 Page 3 of 3

4 DISCLOSURE NOTICE OF TERRORISM INSURANCE COVERAGE AND ELECTION FORM RE: Risk ID. No.: You are hereby notified that under the Terrorism Risk Insurance Act of 2002 (the Act ), effective November 26, 2002, and extended on December 22, 2005, that you now have a right to purchase insurance coverage for losses arising out of acts of terrorism, as defined in Section 102(1) of the Act ( Terrorism Coverage ): The term act of terrorism means any act that is certified by the Secretary of the Treasury, in concurrence with the Secretary of State, and the Attorney General of the United States to be an act of terrorism; to be a violent act or an act that is dangerous to human life, property; or infrastructure; to have resulted in damage within the United States, or outside the United States in the case of an air carrier or vessel or the premises of a United States mission; and to have been committed by an individual or individuals acting on behalf of any foreign person or foreign interest, as part of an effort to coerce the civilian population of the United States or to influence the policy or affect the conduct of the United States Government by coercion. You should know that Terrorism Coverage required to be offered by the Act for losses caused by certified acts of terrorism is partially reimbursed by the United States under a formula established by federal law. Under this formula, the United States pays 90% (85% in 2007) of covered terrorism losses exceeding the statutorily established deductible paid by the insurance company providing the coverage. The premium charged for this Terrorism Coverage is provided below and does not include any charges for the portion of loss covered by the federal government under the Act. SELECTION OR REJECTION OF TERRORISM INSURANCE COVERAGE PLEASE ENTER X IN ONE OF THE BOXES BELOW AND SIGN AND DATE WHERE INDICATED BELOW. Alaska, Florida, Georgia and Oklahoma Applicants: Please be advised that in the event a policy is purchased, the policy premium will include a 1% surcharge for Terrorism Coverage unless you elect to decline Terrorism Coverage. You need to enter an "X below if you wish to decline Terrorism Coverage. I hereby elect to purchase the Terrorism Coverage required to be offered under the Act. I understand that my policy premium will include a 3% surcharge for this coverage. I decline to purchase the Terrorism Coverage required to be offered under the Act. I understand that my policy will be endorsed to exclude the Terrorism Coverage required to be offered under the Act. Name of Applicant Title (Officer, partner, etc.) Signature of Applicant Date SIGNING this Disclosure Notice does not bind the Applicant or the Insurer or the Underwriting Manager to complete the insurance. ZZ /08

5 APPLICATION FOR SPECIFIED PROFESSIONS PROFESSIONAL LIABILITY INSURANCE AND SERVICE AND TECHNICAL PROFESSIONAL LIABILITY INSURANCE (Claims Made Basis or Claims Made and Reported Basis) If space is insufficient to answer any question fully, attach a separate sheet. I. GENERAL INFORMATION 1. Full name of Applicant: 2. Principal business premise address: (Street) (County) 3. Address(es) of Branch Office(s): (City) (State) (Zip) 4. Web Site Address(es): 5. Phone Number: 6. Number of employees including principals: Full-time Part-time Seasonal Total 7. Business is a: [ ] corporation [ ] partnership [ ] individual [ ] other 8. Date organized (MM/DD/YYYY): 9. Is the Applicant controlled by, owned by, or commonly owned, affiliated or associated with any other organization?... Yes [ ] No [ ] If Yes, are any services provided to such organization(s)?... Yes [ ] No [ ] If Yes, to either of the above, provide details. 10. During the last year has the Applicant been involved in, or are they presently considering or contemplating: (a) Any merger, consolidation or acquisition?... Yes [ ] No [ ] If Yes, provide a complete explanation detailing liabilities assumed and any professional liability coverage purchased by any predecessor organization. (b) A change in the nature of business operations?... Yes [ ] No [ ] If Yes, provide details. 11. During the last year has the name of the Applicant been changed?... Yes [ ] No [ ] If Yes, provide details. II. ADDITIONAL INFORMATION 1. If you are a new Applicant with this company, attach: (a) (b) (c) (d) A list of owners, partners and officers and percentage of ownership of each of the Applicant(s) named in Part I Item 1. above. Latest annual financial statements (annual report or income statement and balance sheet). (Omit if gross revenues are $500,000 or less.) Professional qualifications (i.e. resume or c.v.) of each of the owners, partners, officers and key employees of the Applicant(s) named in Part I Item 1. above. Professional societies and organizations to which the Applicant and its owners, partners, officers and key employees belong(s). EO /08 Page 1 of 4

6 (e) (f) (g) Advertisements, brochures, and descriptive literature on the Applicant s business. Sample contract for services between the Applicant and its clients. A list of and description of affiliations with any organization owned by any owner, partner or officer of any Applicant. 2. If you are applying for renewal with this company, attach: (a) A list of owners, partners and officers and percentage of ownership of each in the Applicant(s) named in Part I. Item 1. above. (b) (c) Latest annual financial statements (annual report or income statement and balance sheet). (Omit if gross revenues are $500,000 or less.) Any changes in any items provided last year pursuant to Items (c), (d), (e), (f) or (g) above. III. PROFESSIONAL ACTIVITIES AND SPECIALTY 1. Describe all professional services performed for others and indicate the percentage of gross revenues derived from each activity. Professional Services 2. (a) Estimated annual gross revenues for the coming year: $ (b) Percentage of annual gross revenues for the coming year: (i) Domestic: % Foreign: % (c) Annual gross revenues for the last three years: (i) last twelve months: Year: $ 1 st prior year: Year: $ (iii) 2 nd prior year: Year: $ 3. Describe Applicant s five largest jobs in the last three years: Percent of Gross Revenues Client Name Professional Services Gross Revenues % % % 4. Is the Applicant engaged in any business or profession other than as described in Item 1 above?... Yes [ ] No [ ] If Yes, explain. 5. Were more than 50% of the Applicant s gross revenues for any of the last three years derived from any one contract?... Yes [ ] No [ ] If Yes, specify client, professional services and duration of contract. 6. Does the Applicant utilize the services of independent contractors or sub-consultants?... Yes [ ] No [ ] If Yes, indicate percentage of billings and whether a certificate of professional liability insurance is required of each. EO /08 Page 2 of 4

7 7. (a) Does the Applicant, any of its subsidiaries and/or affiliates build, service, repair, install, manufacture or fabricate anything?... Yes [ ] No [ ] (b) Does the Applicant, any of its subsidiaries and/or affiliates sell any product other than computer software?... Yes [ ] No [ ] If Yes, to either (a) or (b) describe. 8. Is any principal, partner, owner, officer, director, employee, manager or managing member of the Applicant a certified public accountant, an attorney or lawyer, an architect or engineer, a provider of any form of healthcare services or responsible for supervision or management of others who are providers of healthcare services?... Yes [ ] No [ ] If Yes, advise of the name of the individual(s), their position(s) with the Applicant and the nature of services they perform for clients of the Applicant. IV. CLAIMS/HISTORY 1. During the last five years, have there been any claims or proceedings arising out of professional services against the Applicant, or any of its principals, partners, owners, officers, directors, employees, managers, managing members, its predecessors, subsidiaries, affiliates, and/or against any other person or organization proposed for this insurance?... Yes [ ] No [ ] If Yes, attach complete details including description of allegations, status of claim, amounts demanded or paid, date of claim, and action taken to prevent the same type of claim in the future. 2. Is the Applicant or any principal, partner, owner, officer, director, employee, manager or managing member of the Applicant or any person(s) or organization(s) proposed for this insurance aware of any fact, circumstance situation, incident or allegation of negligence or wrongdoing, which might afford grounds for any claim such as would fall under the proposed insurance?... [ ] Yes [ ] No If Yes, provide details. 3. Has any insurer cancelled, rescinded, nonrenewed or declined any similar insurance for the Applicant, its predecessors, subsidiaries, affiliates and/or for any other person or organization proposed for this insurance in the last five years?... Yes [ ] No [ ] If Yes, attach a copy of such insurer s notice. 4. Has the Applicant and/or any of its principals, partners, owners, officers, directors, managers and/or managing members or employees, its predecessors, subsidiaries, affiliates, and/or any other person or organization proposed for this insurance been involved in or have knowledge of any pending or completed investigative or administrative proceedings or governmental regulatory proceedings, actions or notices?... Yes [ ] No [ ] If Yes, provide details on a separate sheet. 5. Previous Professional Liability Insurance: Policy Period Insurer Indicate whether Claims Made or Occurrence policy Limits of Liability Deductible Retro Date 6. Does the Applicant carry General Liability Insurance?... Yes [ ] No [ ] If Yes, provide: Insurer: Limits: Does coverage include Products/Completed Operations Hazards?... Yes [ ] No [ ] EO /08 Page 3 of 4

8 NOTICE TO THE APPLICANT - PLEASE READ CAREFULLY No fact, circumstance or situation indicating the probability of a claim or action for which coverage may be afforded by the proposed insurance is now known by any person(s) or entity(ies) proposed for this insurance other than that which is disclosed in this application. It is agreed by all concerned that if there be knowledge of any such fact, circumstance or situation, any claim subsequently emanating therefrom shall be excluded from coverage under the proposed insurance. The policy applied for is SOLELY AS STATED IN THE POLICY, if issued, which provides coverage on a claims made basis for ONLY THOSE CLAIMS THAT ARE FIRST MADE AGAINST THE INSURED DURING THE POLICY PERIOD, unless the extended reporting period option is exercised in accordance with the terms of the policy. The policy has specific provisions detailing claim reporting requirements. The underwriting manager, Company and/or affiliates thereof are authorized to make any inquiry in connection with this application. Signing this application does not bind the Company to provide or the Applicant to purchase the insurance. This application, information submitted with this application and all previous applications and material changes thereto of which the underwriting manager, Company and/or affiliates thereof receives notice is on file with the underwriting manager, Company and/or affiliates thereof and is considered physically attached to and part of the policy if issued. The underwriting manager, Company and/or affiliates thereof will have relied upon this application and all such attachments in issuing the policy. If the information in this application or any attachment materially changes between the date this application is signed and the effective date of the policy, the Applicant will promptly notify the underwriting manager, Company and/or affiliates thereof, who may modify or withdraw any outstanding quotation or agreement to bind coverage. WARRANTY I/We warrant to the Company, that I/We understand and accept the notice stated above and that the information contained herein is true and that it shall be the basis of the policy and deemed incorporated therein, should the Company evidence its acceptance of this application by issuance of a policy. I/We authorize the release of claim information from any prior insurer to the underwriting manager, Company and/or affiliates thereof. Must be signed within 60 days of the proposed effective date. Name of Applicant Title (Officer, partner, etc.) Signature of Applicant Date SPECIALTY SUPPLEMENT REQUIRED Appraiser Business or Property Building/Home Inspector Collection Agency Crane Inspector Employment Related Services Escrow Only Executive Recruiting Consultants Freight Forwarder/Customs Broker Insurance Related Services Media Related Service Mortgage Broker Premium Finance Real Estate Agent/Property Manager Testing Lab Employment Related Services Third Party Administrator Title, Escrow & Closing Travel Related Services Our Supplements and Applications are available at ALTERNATE APPLICATION REQUIRED Association Computer Related Other Than Consulting Environmental Franchisor Trustees Notice to Applicants: 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 the person to criminal and civil penalties. EO /08 Page 4 of 4

9 APPLICATION FOR CLINICAL RESEARCH ORGANIZATIONS & CLINICAL TRIALS FOR PROFESSIONAL AND GENERAL LIABILITY INCLUDING PRODUCTS LIABILITY INSURANCE (Claims Made Basis) APPLICANT S INSTRUCTIONS: 1. Answer all questions. If the answer requires detail, please attach a separate sheet. 2. Application must be signed and dated by owner, partner or officer. 3. Please do not complete application earlier than 45 days before proposed effective date of coverage. 4. PLEASE READ CAREFULLY THE STATEMENTS AT THE END OF THIS APPLICATION. (PLEASE TYPE OR PRINT IN INK) 1. APPLICANT INFORMATION a. Full name of Applicant: b. Principal business premise address: (Street) (County) (City) (State) (Zip) c. Number of Employees: Full time Part time Seasonal Total d. Additional office locations: e. Name of parent company: f. Please describe all operations to be insured: g. Phone: ( ) h. [ ] Corporation [ ] Partnership [ ] Joint Venture [ ] Sole Proprietor [ ] Other i. Date Established: 2. APPLICANT OPERATIONS a. Fees and Receipts Estimate for Current Year Date: From to Estimate for Next Fiscal Year Dates: From to b. Percentage of foreign professional services and provide the names of the countries involved: c. Do you manufacture or sell any products?... [ ] Yes [ ] No If Yes, please attach a detailed description of your current products and any future products being researched. d. Please indicate the phase of testing for which you are seeking coverage: Phase (i) Please describe this phase: Will this phase be performed in accordance with an FDA approved protocol?... [ ] Yes [ ] No If No, please explain. (iii) Please indicate IND number: (iv) Will this phase and have all previous related phases been performed in accordance with an FDA approved protocol?... [ ] Yes [ ] No If No, please explain. SM /03 Page 1 of 4

10 e. Will you or your employees provide any health care services in conjunction with this trial?...[ ] Yes [ ] No If Yes: Professional Title: Description of services provided: f. Is the clinical investigator an employee of your firm?... [ ] Yes [ ] No g. Is the clinical investigator an employee of the test site facility?... [ ] Yes [ ] No h. (i) Please provide the name and the proposed use or function of the product being tested. Are you aware of any other approved uses or functions of the product being tested?... [ ] Yes [ ] No If Yes, please attach a detailed explanation. (iii) Do you have any knowledge that this product or any of its components might cause or contribute to any immune system reactions?... [ ] Yes [ ] No If Yes, please attach a detailed explanation. i. Please provide the name of the product manufacturer (if other than yourself): j. Is the Applicant a Covered Entity under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule?... [ ] Yes [ ] No If Yes, (i) Has the Applicant implemented procedures to comply with the HIPAA Privacy Rule?... [ ] Yes [ ] No Provide the name and title of the Applicant s Privacy Officer. Our Business Associate Agreement is available at This is the only Business Associate Agreement we will recognize. 3. TESTING INFORMATION a. Please indicate the anticipated number of test subjects over the next 12 months: b. Please give the sex and age of the test subjects: c. How will test subjects be recruited? Please provide a detailed explanation. d. Will test subjects be required to sign an informed consent document?... [ ] Yes [ ] No e. The anticipated trial period: From To f. How will the trial be conducted and by whom? Please attach a detailed explanation. g. How will the trial be funded? h. Where will the trial be performed? Please check the appropriate response. [ ] Facility & Location [ ] Non-Profit Testing Institute [ ] Clinical Research Center [ ] Other (please describe) (Please attach a list if additional space is needed.) i. (i) Will an Institutional Review Board oversee the trials?... [ ] Yes [ ] No Are you a member of this Board?... [ ] Yes [ ] No j. Please indicate the number of employed professionals or independent contractors. (IF NONE, STATE NONE.) Contractor Employee Independent Total (i) RN/LPN Lab Tech. (iii) Clinical Investigator (iv) Clinical Research Assoc. SM /03 Page 2 of 4

11 Contractor Employee Independent Total (v) Physician (vi) Medical Monitor (vii) Engineer (viii) Biostatistician (ix) Data Entry (x) Legal Counsel (xi) Other k. Do you perform any environmental testing or consulting?... [ ] Yes [ ] No If Yes, please attach a detailed explanation. l. Please indicate testing performed on specified products over the last 12 months and anticipated testing to be performed over the next 12 months: Last Next 12 Months 12 Months (i) Hormones & Steroids Vaccines (iii) Injectables (iv) Prescription Products (v) Over the Counter (vi) Diet Aids (vii) Vitamins (viii) Food Supplements (ix) Novel Drugs (x) Generic Off-Patient (xi) Products, Other than Above (xii) Instruments (x-diagnostic) (xiii) Cosmetics, Health & Beauty Aids (xiv) Surgical Equipment (xv) Diagnostic Instruments & Equipment (xvi) Therapeutic Devices (xvii) Life Support (xviii) Other 4. APPLICANT HISTORY a. Provide a brief description of the results of any previous related trials: b. Fully describe any adverse results from previous related trials including animal studies and/or toxicity studies: c. List any claims related information provided in 4(a) and 4(b) above: Date Claimant of Loss Expense Indemnity Nature of Injury SM /03 Page 3 of 4

12 5. CLAIMS (Attach a detailed explanation for any Yes answers) a. Are you aware of any incidents or circumstances which are likely to result in claims against you under the coverage sought herein?... [ ] Yes [ ] No b. Have you ever been inspected, surveyed, or audited by the Food & Drug Administration, the Center for Drug Evaluation and Research, or the Center for Biologics Evaluation and Research?... [ ] Yes [ ] No c. Have you ever been subject to any inquiry or investigation by any federal, state or local agency concerning your professional services?... [ ] Yes [ ] No d. Do you operate in compliance with the FDA s Good Clinical Practice Guidelines?... [ ] Yes [ ] No e. Have you ever been cited for any non-compliance of Good Clinical Practices or any federal, state or local law, ordinance, directive or regulation?... [ ] Yes [ ] No 6. COVERAGE a. Limits of liability desired: $ b. Amount of deductible desired: $ c. Present coverage Claims Made? Carrier Prof GL Deductible/SIR Limits Yes No If Yes, please provide an explanation. d. Retroactive date (if applicable) 7. ADDITIONAL INFORMATION Please provide the following information with this application: (i) Advertisements, brochures, descriptive literature. Sample contract between you and the clinical trial investigator, if the investigator is not your employee or an employee of the test site facility. (iii) Informed consent document. (iv) Most recent Annual Report or audited financial statement (v) Copy of letterhead or other business stationary. * NOTICE TO APPLICANT: The coverage applied for is SOLELY AS STATED IN THE POLICY, which provides coverage on a "CLAIMS MADE" basis for ONLY THOSE CLAIMS THAT ARE FIRST MADE AGAINST THE INSURED DURING THE POLICY PERIOD unless the extended reporting period option is exercised in accordance with the terms of the policy. WARRANTY: I/We warrant to the Insurer, that I understand and accept the notice stated above and that the information contained herein is true and that it shall be the basis of the policy of insurance and deemed incorporated therein, should the Insurer evidence its acceptance of this application by issuance of a policy. I/We authorize the release of claim information from any prior insurer to the underwriting manager, Company and/or affiliates thereof. Name of Applicant* Title (Officer, partner, etc.) Signature of Applicant* Signing this application does not bind the Applicant or the Insurer or the Underwriting Manager to complete the insurance, but one copy of this application will be attached to the policy, if issued. Date SM /03 Page 4 of 4

13 APPLICATION FOR SPECIFIED MEDICAL PROFESSIONS FOR PROFESSIONAL LIABILITY INSURANCE (Claims Made Basis) APPLICANT S INSTRUCTIONS: 1. Answer all questions. If the answer requires detail, please attach a separate sheet. 2. Application must be signed and dated by owner, partner or officer. 3. Please do not complete application earlier than 45 days before proposed effective date of coverage. 4. PLEASE READ CAREFULLY THE STATEMENTS AT THE END OF THIS APPLICATION. (PLEASE TYPE OR PRINT IN INK) 1. APPLICANT INFORMATION a. Full name of Applicant (include professional degree if applicant is an individual): b. Principal business premise address: (Street) (County) (City) (State) (Zip) Please attach a list of additional office addresses. c. Number of Employees: Full time Part time Seasonal Total d. Business Phone: ( ) Home Phone: ( ) e. Date of Birth: Place of Birth: Are you a U.S. citizen? [ ] Yes [ ] No. If No, your status, date of entry into USA: f. Square feet of total office space (all locations): g. Your practice: [ ] Solo practitioner (unincorporated) [ ] Professional corporation (for profit) [ ] Solo practitioner (incorporated) [ ] Professional corporation (non-profit) [ ] Partnership [ ] Employee of [ ] Professional Association (Give name of employer) [ ] Other (please describe) h. Formal business, corporate or partnership name: i. Please list the names of all partners or members of your professional association/corporation who provide professional services: j. Please attach a copy of your letterhead. k. Is the Applicant a Covered Entity under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule?... [ ] Yes [ ] No If yes, (i) Has the Applicant implemented procedures to comply with the HIPAA Privacy Rule?... [ ] Yes [ ] No Provide the name and title of the Applicant s Privacy Officer. Our Business Associate Agreement is available at This is the only Business Associate Agreement we will recognize. MASM 5018 (02/10) Page 1 of 6

14 2. EDUCATION/EXPERIENCE (Individual Applicant Only) Institution Name and Address Years of Training Degree or Certification Attained From To From To From To (i) Where have you practiced your profession during the last ten years? In From To In From To In From To Have you ever failed any professional licensing or specialty organization examination?... [ ] Yes [ ] No If yes, please attach a detailed explanation including the dates and location. 3. APPLICANT PRACTICE a. Please list all the states where you are licensed to practice. If NONE, please attach an explanation. b. Please indicate your professional specialty (CHECK ONE): [ ] Chiropractor [ ] Naprapath [ ] Pharmacist [ ] Counselor ( Describe) [ ] Nurse, Licensed Practical [ ] Physical Therapist [ ] Nurse, Registered [ ] Psychologist [ ] Dental Hygienist [ ] Nurses Registry [ ] Social Worker [ ] Hearing Aid Fitter [ ] Occupational Therapist [ ] Speech Therapist [ ] Home Health Care Agcy. [ ] Optician [ ] Veterinarian [ ] Inhalation Therapist [ ] Optometrist [ ] Visiting Nurse Assoc. [ ] Laboratory Technician [ ] Orthotist [ ] X-ray Technician [ ] Medical Personnel Pool [ ] Perfusionist [ ] Other (Specify) c. Please indicate the sources and amounts of actual and projected revenue: Source Amount This Fiscal Year Amount Next Fiscal Year (i) Charitable Contributions: $ $ Government Funding: $ $ (iii) Fee for Services: $ $ (iv) Other: $ $ TOTAL GROSS REVENUE $ $ d. Please provide the number of patient or client visits: Number of Visits Number of Visits Type of Visit Last 12 Months Next 12 Months Clinic Laboratory Other (specify) TOTAL NUMBER OF VISITS e. Please specify any professional societies or associations in which you are a member: f. Are you associated with or do you work for a physician or surgeon?... [ ] Yes [ ] No If yes, please give the name and the specialty of the physician: MASM 5018 (02/10) Page 2 of 6

15 g. Please give the approximate percentage of time spent in the following work locations: % Administrative Office % Laboratory % Hospital Ward (specify) % Classroom % Operating Room % Emergency Dept of Hospital % Outpatient Clinic % Professional Office (specify profession) % Nursing Home % Patient s Home % Other (specify) h. Please indicate the approximate division of your patients or clients among: % Hemodialysis % Psychiatric % Bariatrics % Holistic Medicine % Drug Addicts % Physical Rehabilitation % Surgical % Alcoholics % Disability Evaluation % Stress Testing % Obstetrical % Research or Experimental % Communicable % Dental % % Family Planning % Pediatric % i. Please indicate the number and type of your employees and/or volunteers. IF NONE, STATE NONE. Type of Profession No. Type of Profession No. Inhalation Therapists Opticians Laboratory Technicians Optometrists Nurse Anesthetists Perfusionists Nurses, Licensed Practical Pharmacists Nurse Practitioner Physiotherapists Nurses, Registered Social Workers Speech Therapists Other (please specify) j. Are all of the above individuals licensed in accordance with applicable state and federal regulations? [ ] Yes [ ] No If no, please attach an explanation. 4. APPLICANT PROCEDURES a. Do you render professional services directly to patients? [ ] Yes [ ] No. If yes, please describe in detail and indicate the extent of supervision by others. Percent of Qualifications Description of Professional Services Time Supervised of Supervisor % % % b. Do you render professional services that do not involve contact with a patient? [ ] Yes [ ] No. If yes, please describe these services in detail. c. (i) Do you perform or assist in any surgical procedures? [ ] Yes [ ] No Please list ALL surgical procedures performed (including minor surgery): (iii) Is anesthesia (other than topical or by means of local infiltration) administered by either yourself or others? [ ] Yes [ ] No. If yes, please attach a detailed explanation. (iv) Do you perform or assist in any surgical procedure(s) in a professional office or similar non-hospital facility? [ ] Yes [ ] No. If yes, please attach a detailed explanation. d. Do you perform radiation therapy?... [ ] Yes [ ] No e. Do you perform psychiatric shock therapy?... [ ] Yes [ ] No f. Do you compound in bulk, manufacture or wholesale medicine?... [ ] Yes [ ] No If yes, please provide a detailed explanation. MASM 5018 (02/10) Page 3 of 6

16 g. (i) Do you perform veterinary services?... [ ] Yes [ ] No If yes, please indicate the approximate division of your work among the following categories. % Greyhounds % Thoroughbreds % Animals valued over $5,000. Please attach an explanation including the frequency and the type(s) of animals treated. h. Do you administer artificial insemination?... [ ] Yes [ ] No If yes, please answer the following questions: (i) What type(s) of animals are involved? Are you responsible for the storage of the semen?... [ ] Yes [ ] No If yes, please explain. (iii) What percent of your practice is involved with artificial insemination? % i. Are you ever responsible for identifying contagious diseases in your locality and/or for recommending remedial action?... [ ] Yes [ ] No 5. PERSONNEL If yes, please attach a detailed explanation. a. Please list the number and type of independent contractors who provide professional services on your behalf. IF NONE, STATE NONE. No. Type of Profession No. Type of Profession No. Type of Profession Inhalation Therapists Laboratory Technicians Nurse Anesthetists Nurses, Licensed Practical Nurse Practitioner Nurse, Registered Opticians Optometrists Perfusionists Pharmacists Physiotherapists Social Workers Speech Therapists Other (specify) b. Do you supervise any individuals who are not your own employees? [ ] Yes [ ] No. If yes, please provide a detailed explanation of responsibilities and relationships to the entity which employs these individuals. c. Please indicate by profession the number of individuals you supervise. No. Type of Profession No. Type of Profession Physicians Laboratory technicians X-ray technicians Other (please specify): 6. APPLICANT AFFILIATIONS a. Do you own or operate any business other than that shown in Question 1(a) above?... [ ] Yes [ ] No If yes, please give details on a separate sheet. b. Are you employed by any individual or entity other than that shown in Question 1(a) above?... [ ] Yes [ ] No If yes, please attach an explanation describing details of your responsibilities. c. Are you under contract to any individual or entity other than that shown in Question 1(a) above?... [ ] Yes [ ] No If yes, please attach an explanation describing details of your responsibilities. If your contract contains a hold-harmless agreement, a copy of the contract must be attached. d. Are you employed by or under contract to any government entity?... [ ] Yes [ ] No If yes, please attach an explanation including the details of your responsibilities. e. Do you advertise your professional services in any manner (other than a simple listing in a telephone directory)?... [ ] Yes [ ] No If yes, please attach a copy of ALL of your advertisements. f. Are you associated with any agency or organization that engages in any kind of advertising for, or solicitation of, patients?... [ ] Yes [ ] No If yes, please attach a detailed explanation and a copy of ALL of your advertisements. g. Do you own (wholly or in part), operate, or administer any hospital, nursing home or other institutions where medical services are customarily rendered?...[ ] Yes [ ] No MASM 5018 (02/10) Page 4 of 6

17 If yes, please give details including the name, location, size and number of beds. h. If you have a training school, please complete the following. Attach a separate sheet if needed. Specify Profession Max. No. Of No. of % of Time For Which Students Students Sessions Involved in Number of Qualifications of Faculty Are Being Trained Per Session Per Year Clinical Setting Faculty (e.g. MD, RN, PhD, etc.) i. (i) Do you use a collection agency?...[ ] Yes [ ] No If yes, please state the name of the agency Does the agency have the authority to file a collection suit at its discretion?... [ ] Yes [ ] No 7. APPLICANT HISTORY/CLAIMS (Attach a detailed explanation for any YES answers) a. Have you or any of your employees: (i) Ever been the subject of disciplinary or investigative proceedings or reprimand by a governmental or administrative agency, hospital or professional association?... [ ] Yes [ ] No Ever been convicted for an act committed in violation of any law or ordinance other than traffic offenses?... [ ] Yes [ ] No (iii) Ever been treated for alcoholism or drug addiction?... [ ] Yes [ ] No (iv) Ever had any state professional license or license to prescribe or dispense narcotics refused, suspended, revoked, renewal refuses or accepted only on special terms or ever voluntarily surrendered same?... [ ] Yes [ ] No (v) Ever had any insurance company or Lloyd s cancel, decline, refuse to renew or accept only on special terms their malpractice insurance?... [ ] Yes [ ] No b. Please list prior professional liability insurance carried for each of the past four years. IF NONE, STATE NONE. Was this a Policy Policy Limits of Deductible Inception Expiration Claims Made Insurance Carrier Number Liability (If any) Premium Mo./Day/Yr. Mo./Day/Yr. Policy Form? Retro Date Yes No [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] c. Does the Applicant currently participate in or plan to participate in a state patient compensation fund, health care stabilization fund or other governmentally established malpractice liability funding mechanism?... [ ] Yes [ ] No d. Has any claim or suit been brought against you and/or any of your employees?... [ ] Yes [ ] No If yes, a Supplemental Claim Information Form must be completed for each claim or suit. e. Are you aware of any circumstances which may result in a malpractice claim or suit being made or brought against you or any of your employees?... [ ] Yes [ ] No If yes, please give details on a separate sheet. * NOTICE TO APPLICANT: The coverage applied for is SOLELY AS STATED IN THE POLICY, which provides coverage on a "CLAIMS MADE" basis for ONLY THOSE CLAIMS THAT ARE FIRST MADE AGAINST THE INSURED DURING THE POLICY PERIOD unless the extended reporting period option is exercised in accordance with the terms of the policy. MASM 5018 (02/10) Page 5 of 6

18 WARRANTY: I/We warrant to the Insurer, that I understand and accept the notice stated above and that the information contained herein is true and that it shall be the basis of the policy of insurance and deemed incorporated therein, should the Insurer evidence its acceptance of this application by issuance of a policy. I/We authorize the release of claim information from any prior insurer to the underwriting manager, Company and/or affiliates thereof. Name of Applicant Title (Officer, partner, etc.) Signature of Applicant SIGNING this application does not bind the Applicant or the Insurer or the Underwriting Manager to complete the insurance, but one copy of this application will be attached to the policy, if issued. Date MASM 5018 (02/10) Page 6 of 6