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Public, products and employers liability

Level 3, 31 Ventnor Ave West Perth PO Box 1141 West Perth WA 6872 AUS (08) 9420 7900 New Business Questionnaire INT +61 8 9420 7900 W edgeunderwriting.com.au PUBLIC LIABILITY
PRODUCTS LIABILITY

IMPORTANT NOTICES
For your protection under legislation, we are required to inform you of your duty of disclosure and draw your attention to the following
important information.
DUTY OF DISCLOSURE
The Insurance Contracts Act 1984 requires insurance companies to provide certain information to people intending to insure with them. The
information concerns the duty of disclosure of an intending Insured and the effect of particular types of clauses in a proposed insurance policy.
Where an Insurance Broker is involved in the transaction, the information is to be provided by the broker. The Insurance (Agents and Brokers)
Act 1984 also requires us to inform you about some other matters where they are relevant to particular policies.

WHAT INFORMATION DOES AN INSURANCE COMPANY/BROKER HAVE TO GIVE YOU?
In general terms, the kind of information which an insurance company/broker must give you is as follows:

YOUR DUTY OF DISCLOSURE – CONTRACTS OF GENERAL INSURANCE SUBJECT TO INSURANCE CONTRACTS ACT
Before you enter into a contract of general insurance with an Insurer, you have a duty, under the Insurance Contracts Act 1984, to
disclose to the Insurer every matter that you know, or could reasonably be expected to know, that is relevant to the Insurer's decision whether to
accept the risk of the insurance, and if so on what terms.
You have the same duty to disclose those matters to the Insurer before you renew, extend, vary or reinstate a contract of general insurance.
Your duty, however, does not require disclosure of matter:

that diminishes the risk to be undertaken by the Insurer, that is of common knowledge, that your Insurer knows or, in the ordinary course of his business, ought to know, as to which compliance with your duty is waived by the Insurer.
NON-DISCLOSURE
If you fail to comply with your duty of disclosure, the Insurer may be entitled to reduce their liability under the contract in respect of a claim or may
cancel the contract.
If your non-disclosure is fraudulent, the Insurer may also have the option of avoiding the contract from its beginning.

CLAIMS MADE INSURANCE
Your attention is drawn to the fact that if the Errors & Omissions section of this policy is selected, the cover will be placed on a "claims made"
basis which means that claims first advised to you (or made against you) and reported to your insurer during the Period of Insurance are
recoverable irrespective of when the incident causing the claim occurred, subject to the provisions of any clause relating to a "retroactive date".
You should also note that, in terms of the provisions of Section 40(3) of the Insurance Contracts Act 1984, where you give notice in writing to the
Insurer of facts that might give rise to a claim against you as soon as is reasonably practicable after you become aware of those facts (but before
the insurance cover provided by the contract expires) then the Insurer is not relieved of liability under the contract in respect of the claim, when
made, by reason only that it was made after the expiration of the Period of Insurance cover provided by the contract.
Please note that your duty applies also when you seek to renew, extend, alter or reinstate a policy.
       QUESTIONS
Full Name (s) of all companies to be included: Address of Registered Office: Address(es) of any Overseas Offices to be Insured: Full Business Description: Website Address: When established: Is your company involved in Clinical Trials? If ‘YES' then please contact us for specific proposal form PLEASE ATTACH PRODUCT BROCHURES AND ADDITIONAL COMPANY INFORMATION AS PUBLIC AND PRODUCTS LIABILITY
Please complete all below Estimated annual turnover split between: i) Own Manufacture (where you hold the Product Licence) ii) Where you hold the Product Licence but manufacture is contracted to third party iii) Where you Contract Manufacture for third iv) Wholesale (unaltered from manufacturers) v) Parallel Import / Repackaged or relabelled Wholesale Products * Please provide full details of how income is generated (if appropriate please provide specimen
contracts):

       Please list your three largest selling products / are they Own Manufacture / date first supplied : 1. Please state estimated
ii) Product
iii) Contract
vi) Other
annual turnover to:
Manufacture
Manufacture
Wholesale
Are any exports sent direct to customer from manufacturers outside Australia
If ‘YES' please advise territory sent from:
Is there a formal contract in place regarding Quality
Control?:
USA/CANADA
Please answer this question ONLY if you export to A full description of all products exported How long have you been producing each Do you comply with the State/Federal Laws applicable to each product? Do you have any Power of Attorney or assets in the USA/Canada? If ‘YES' do they arrange separate insurance including Completed Operations/Products        Are you required to Indemnify any Vendors and/or Distributors in USA/Canada If ‘YES' please provide names and addresses If ‘NO' do they maintain their own insurance for Completed Operations/Products? State limit if known If you import products please state from which countries obtained and approximately percentage of total turnover against each. PRODUCTS
Do products comply with all relevant:- a) Australian Standard, Industry and Trade Standards or Government Safety Licensing Regulations or equivalent local legislation. b) Official Standard or Government Regulations laid down in countries to which Products are exported? Are any new products likely to be marketed during the next 12 months. If ‘YES' please advise product name and product type a) Please give full details and percentage of total turnover of products that are: manufactured/supplied to own manufactured/supplied to a design/specification/formulation laid down by a customer b) Do you have a separate design team? Describe extent and type of tests and checks undertaken before Product goes into production.        QUALITY CONTROL
a) Do you have a written policy relating to Quality How often is it reviewed? b) Do you have a specific Quality Control Team? (i) who has overall responsibility? (ii) can control be overridden by Design Production or Marketing Personnel? c) Does Quality Control involve the testing of a sample percentage of product? If Yes, please state: a) percentage of products checked b) Failure rate. d) Are sampling inspections made on incoming e) What is the procedure for dealing with customers complaints? Are records of complaints retained? If ‘YES' for how long a) Is it possible to trace the ultimate customer of individual products or batches in order to recall the products? b) Is there an formal procedure for emergency c) Has recall every been necessary or been considered? If YES, please give details d) Please give details of Product lines discontinued because of incidence or injury or damage, or where potential hazards have been identified – stating when manufacture or supply ceased        MARKETING
a) Are products labelled and supplied with clear instructions in the language of the country to which they are supplied? b) Are products hazard warnings clearly shown on Products, Packaging and/or Instruction Manuals? c) Do your Legal and/or Design Departments have sight of all advertising material, sales brochures, operating manuals etc. To check for misleading statements? d) Are your Representatives warned against overstating usage or effectiveness of Products? a) Do you maintain an adequate system of records which would enable identification of:- (please indicate period records are kept for) source of Product/raw materials/component parts purchased? source of design of Products Quality control and testing procedures effective at the time of design and/or manufacture? Research undertaken to minimise risk to health and safety.        SPECIFIED PRODUCTS
UNLESS IT IS SPECIFICALLY AGREED WITH UNDERWRITERS COVER PROVIDED MAY
EXCLUDE ANY LIABILITY ARISING OUT OF THE FOLLOWING.
Agent Orange – Dichlorophenoxyacetic Acid (2,4-D) and Trichlorophenoxyacetic Acid (2,4, 5-T) Alosetrin Methyl Tertiary Butyl Ether Any product that does not have regulatory approval Apomorphine Blood Borne Pathogens Blood/Plasma Products Pertussis Vaccine Bromfenac Sodium Phenylpropanolamine (PPA) Primodos/Amenorone Forte Rapacuronium Bromide (i) the concomitant or combined use of two or more different products which contain a) a Statin and b) a Fibrate (ii) Rhabdomyolysis arising out of either of the above Chromated Copper Arsenate RotaShield Vaccine Contraceptives (including birth Selective Seritonin Reuptake control pills) fertility drugs and products specifically designed and marketed for use during and in connection with pregnancy Cox – 2 Inhibitors Dexfenfluramine Fenfluramine or Silicone – any product containing silicone which is in any form implanted or injected in the body Dicyclomine when give to children Skin whitening and lightening under 4 years of age Diethylstilbestrol or Stilbestrol or        Swine-Flu Vaccine Ephedrine Ma Huang Pseudoephedrin Chinese Ephedra Mahuang Extract Ephedra Ephedra Sinica Ephedra Extract Ephedra Herb Powder Epitonin or any derivative thereof Ethylenediaminetetraacetic Acid (EDTA) Fialuridine 2,3,8 – Tetrachlorodibenzo-p- dioxin (2,3,7,8 – TCDD) Halogenated 8 & Hydroxy Quinoline Hormone Replacement Therapy of Thimerosal or Thiomersal Animal Origin Hydroquinone Isotretinoin or Accutane Tobacco or any tobacco products (or ingredients thereof) Latex &/or latex protein &/or latex derivatives &/or latex substances howsoever the latex, latex protein, latex derivatives or latex substances are named, identified, described or classified. Leflunomide Trovafloxacin or Alatrofloxacin Urea Formaldehyde or any products containing Formaldehyde       
If you have answered YES to any of the products above please provide full details as follows:
a)
Are products supplied on a Named Patient Basis only or in accordance with Specials Licence granted? If YES please provide details of licence held If NO please provide the following: Product details enclosing Data Safety Sheets where possible If manufactured, to whose formula/specification. If marketed only, are rights of recourse maintained against manufacturers/suppliers? How long have you marketed or manufactured the products. Estimated annual turnover per specific If exports involved details of territories to be supplied and estimated turnover. PREMISES
a) Have all Manufacturing location by inspected by TGA/FDA or other regulatory body? If YES what was date of lost inspection b) Have you ever had a manufacturing licence withdrawn? If YES please give details including remedies        Has any Insurer ever:- Declined your proposal for Public &/or Products Liability insurance refused your renewal for Public &/or Products Liability insurance Terminated your Insurance for Public &/or Products Liability. Have any incidents occurred during the last five years resulting, or alleged to have resulted in death, injury or disease to third parties or damage to their property? If YES, please give full details below: Brief Details of Incident whether or not an
Paid Amount
Insurers
insurance claim has been made
Outstanding
If possible please supply confirmed claims experience from previous / current Insurers
Are you aware of any circumstances that might give rise to a claim? If YES, please give details d) Please state if your existing cover for Products Liability is on a "Claims made" basis or a "Losses occurring" basis. If on a "Claim made" basis please state retroactive date currently applied to your policy e) Who are your current Insurer(s)? If currently uninsured please state. f) What is the renewal date of your current Insurance policy covering Public and Products Liability?

       g) Please state Limit(s) of Indemnity for which a quotation is required or local currency equivalent I/We declare that to the best of my/our knowledge and belief the above statements are true and
complete and will form part of the contract between me/us and the Underwriters.

Name and position of person completing this Edge Underwriting Pty Ltd Level 3, 31 Ventnor Avenue West Perth WA 6005 ABN 50 150 700 468 AFS licence No. 407682

Source: http://edgeunderwriting.com.au/insurance/2016/02/20120101-CGL-Prop-Pharm.pdf