PHARMASURE PUBLIC AND PRODUCT LIABILITY APPLICATION FORM Form A ( Complementary, OTC & Cosmetics)

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1 PharmaSure Insurance Services Suite 202, 103 Miller Street, North Sydney NSW 2060 Australia Postal Address: PO Box 1678 North Sydney NSW 2059 Australia Phone: Fax: Web: PHARMASURE PUBLIC AND PRODUCT LIABILITY APPLICATION FORM Form A ( Complementary, OTC & Cosmetics) Your Duty of Disclosure Before You enter into a contract of general insurance with Us, You have a duty under the Insurance Contracts Act 1984 to disclose to Us every matter You know or be expected to know, is relevant to Our decision whether to insure You; or anyone under the policy and if so, on what terms and conditions. Your duty of disclosure applies when You enter into a policy with Us, renew Your policy, alter or, extend, replace or reinstate Your policy. You must answer all Our questions truthfully, and tell Us every thing You know, or a reasonable person in Your circumstances should be expected to know would be relevant to Our decision to insure You. However, You are not required to disclose to Us any matter: that reduces the risk to be insured. that is common knowledge. that We know or in the course of Our business or, We ought to know. that We tell You that We do not want to know. Non Disclosure If You do not disclose to Us relevant information, or You do not answer our questions truthfully, We may reduce the amount We pay for a claim, or We can cancel Your policy, if Your non-disclosure is fraudulent We may treat the policy as it never has existed and refuse to pay a claim. THE APPLICANT(S) Name(s) in Full Full Business Description Tax Status Registered Business Yes No ABN TGA Licence No Taxable % Postal Address Contact Details Phone: ( ) Fax: ( ) Web site address: Period of Insurance From: / / / to / / PharmaSure Public & Product Liability Proposal Form A v6 13/01/2012 Page 1 of 8

2 GENERAL INFORMATION 1. Who is your current insurer for public and product liability, Please specify 2. Have you had any claims made against you (whether insured or not) or have you recalled any of your products during the last 7 years? If Yes, please give details. Yes No 3. Have you had any incident or accident occur which would have been covered by the proposed insurance policy? If Yes, please give details. Yes No 4. Have you had any insurance declined or cancelled, proposal rejected, renewal refused, claim rejected, special conditions or special excess imposed by an insurer? Yes No If Yes, please give details. INDEMNITY LIMIT Limit of Indemnity Required Public Liability $ Products Liability $ Deductible $ (any one occurrence) (in the aggregate per period of insurance) ESTIMATED PAYROLL 1. Estimated annual payroll (including earnings of principals, directors, partners) No. of staff Managerial, Clerical and Sales $ Manufacturing $ Installation $ Other $ TOTAL $ 2. Do you employ contractors or subcontractors? Yes No If Yes, please complete a, b, c and d below. a) Estimated annual payment. Labour Only $ Labour & Plant $ Labour, Plant and Materials $ b) Nature of work usually carried out. c) Precautions taken to identify the adequacy of their liability and workers compensation insurance arrangements. d) Are you always named as principals on contracts and/or sub-contractors liability policy? Yes No PharmaSure Public & Product Liability Proposal Form A v6 13/01/2012 Page 2 of 8

3 DETAILS OF THE BUSINESS / PREMISES 1. Do you have representation outside Australia? Yes No If Yes, where and what is the nature of your representation in such country (e.g. domicile employee, power of attorney, branch subsidiary, agency, etc)? 2. Number of years in this business. years 3. Location of Premises occupied for the purpose of conducting the business Owned Leased Location of Premises owned BUT not occupied by you for which property owners cover is required Type of building e.g. Shopping Centre, Office Block, etc. 5. Do you or does anyone on your behalf operate, manage or own or offer or in any way are connected with any of the following? Yes No If Yes, please provide details a. First Aid Facility b. Pressure Vessels c. Car Parks d. Lifts, Escalators, Hoists, Cranes e. Unregistered Vehicles f. Railway e.g. siding 6. Do you store, transport, use or handle any hazardous good e.g. chemicals, radioactive materials, gases, etc.? If Yes, please provide details. Yes No 7. Does your operation/business create trade waste? Yes No If Yes, please provide details. PharmaSure Public & Product Liability Proposal Form A v6 13/01/2012 Page 3 of 8

4 CARE CUSTODY AND CONTROL Coverage is provided for property (excluding any vehicle which is registered or which is required to be registered) in your physical or legal control for the purpose of repair, service, maintenance or alteration or which is on temporary hire or loan to you, subject to a maximum indemnity of $50,000 for any one occurrence and in the aggregate for any one period of insurance. Do you require an amount in addition to the above limit? Yes No If Yes, please answer questions What Limit of Indemnity do you require? $ 2. What is the total value of such property? $ 3. What is the maximum value at any one time? $ 4. Provide brief details of the property. 5. Is the property insured under any other Policy? If Yes, please provide details. Yes No PRODUCT INFORMATION / TERRITORIAL LIMITS 1. Give details of all products in respect of which insurance is required. Attach brochures and other product literature. If more than four (4) products, attach an additional list. Product Name Date First Marketed Product Description Product Use THE FOLLOWING DETAILS ARE REQUIRED FOR EXPORTED PRODUCTS ONLY Turnover Exported $ $ $ $ Country Sold To Company Representation in this Country Power of Attorney Branch Power of Attorney Branch Power of Attorney Branch Power of Attorney Branch Representative Representative Representative Representative Other (specify) Other (specify) Other (specify) Other (specify) Coverage for PRODUCTS EXPORTED TO USA OR CANADA is excluded from this insurance. Coverage will be provided only if specifically agreed by Insurer and then subject to additional terms and conditions and payment of an extra premium. A USA/Canada export questionnaire will have to be completed. Any additional information supplied in respect of such exports shall be deemed to form part of this application. 2. Can you with certainty, identify the source of every item used in the manufacture of the products? If No, please provide reason. Yes No 3. Do you have re-call procedures in place? If Yes, please provide full details. Yes No 4. Have you discontinued manufacturing, processing or handling any products? Yes No If Yes, please provide details of reason, type of product, year, etc. PharmaSure Public & Product Liability Proposal Form A v6 13/01/2012 Page 4 of 8

5 CONTRACTUAL LIABILITY Coverage for liability assumed under agreement or contract will be limited to lease liability or liability assumed under a warranty of fitness or quality as regards your products, or specifically agreed contracts Do you assume liability under contract or hold others harmless (other than lease liability)? Yes No If Yes, please provide details and attach copies of all agreements (other than lease liability). Coverage will be provided only if specifically agreed by Insurer. BREAKDOWN OF TURNOVER For your current financial year please provide a breakdown of your estimated turnover by product and indicate whether such turnover is derived from manufacture / Wholesaler / Retailer / Packager / & Sponsor 1. Products and occupational category Occupation A) Manufacturer of your own products Product Classification Prescription OTC (S1) OTC (S2) OTC Sunscreen Complement $ $ $ $ $ $ B) Contract Manufacturer $ $ $ $ $ $ C) Sponsor $ $ $ $ $ $ D) Packager $ $ $ $ $ $ E) Wholesaler $ $ $ $ $ $ F) Retailer $ $ $ $ $ $ g) Others $ $ $ $ $ $ TOTAL TURNOVER Cosmetics 2. Please provide percentage of turnover per State/Territory as follows: State / Territory ACT NSW NT QLD SA TAS VIC WA % 3. If you are exporting your products overseas, please provide percentages of export to your total turnover: Exports % Export to USA and Canada Export to Europe and Japan Export to other countries PharmaSure Public & Product Liability Proposal Form A v6 13/01/2012 Page 5 of 8

6 SCOPE OF BUSINESS 1. Does the business operate to a recognised Quality Management System (QMS)? Yes No If Yes, please provide details below. Accredited? If Yes, please specify. Yes No GMP ISO 9000/2000 EN NATA Other 2. Are manufacturing / distribution QMS: If Yes, by whom? Licensed Yes No Accredited Yes No Certified Yes No Please attach copy of Licence, etc. PRODUCT AUTHORISATION PROFILE 1. Do you have products sold at wholesale level? Yes No If Yes, do they require Regulatory approval? Yes No If Yes, please identify Authority. 2. How many products do you market? SYSTEM CONTROL INDICATORS 1. Has a licence/certification/accreditation to manufacture ever been cancelled, suspended, refused or limited? If Yes, please detail briefly. Yes No 2. Has the company had any product recalls in the last 3 years (Voluntary, Mandatory)? Yes No If Yes, please list and briefly describe circumstances and outcomes (business and other). 3. Does the company have a stable production and quality management team? Yes No Does the company have a documented training system and training records? Yes No Please indicate level of staff turnover in the last three years. 4. Does the company have a documented system for recording, analysing, correcting and reporting customer complaints, recalls, rejects, reworks, corrective actions, etc? Yes No 5. Does the company have a documented Internal Audit system? Yes No Is it fully implemented and records kept? Yes No PharmaSure Public & Product Liability Proposal Form A v6 13/01/2012 Page 6 of 8

7 6. Does the company have a factory wide engineering maintenance system with records? Yes No 7. Have there been any incidents causing adverse regulatory activity of any kind in the last 3 years? If Yes, please describe. Yes No 8. Do you have security systems in place to avoid theft, mix up, deterioration of products? Yes No If Yes, briefly explain. 9. Does the company have documented policy/procedures regarding goods return, inspection, reissue? If Yes, briefly explain. Yes No GENERAL INFORMATION 1. Has insurance of any kind been refused on the basis of products, personnel, manufacturing inadequacies, other reasons? If Yes, please explain. Yes No 2. Has any officer of the company been declared unfit for office by any Regulatory Authority? If Yes, please explain. Yes No 3. Is your company a member of a recognised industry association? Yes No If Yes, please specifies. Do you adhere to the above association s Code of Practice? Yes No PharmaSure Public & Product Liability Proposal Form A v6 13/01/2012 Page 7 of 8

8 DECLARATION In accordance with my/our duty of disclosure, I/We declare that the whole of these answers in this Proposal Form are true and that I/We have not withheld any information whatever that might tend in any way to increase Your risk, or to influence your decision regarding this Application Form. I/We agree that this Application Form shall be the basis of the contract between me/us and You. I/We further agree that this Application Form, in any part, is completed and signed by any other person; such person shall be deemed my/our agent(s) and not the agent of You. Signature Name in Print Title Date / / Please sign and return PharmaSure Insurance Services is a business name owned by Asia Mideast Insurance and Reinsurance Pty Ltd ACN AFS Licence No Level 2, 103 Miller St, North Sydney NSW 2060 AUSTRALIA Postal Address: PO Box 1678 North Sydney NSW 2059 AUSTRALIA Phone: Fax: Website: PharmaSure Public & Product Liability Proposal Form A v6 13/01/2012 Page 8 of 8

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