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Asruw.com.au


Pharmaceutical/Medical/ChemicalPublic & Products Liability InsuranceArranged through ASR Underwriting Agencies Pty Ltd Underwritten by Certain Underwriters at Lloyd's PLEASE READ THESE GUIDANCE NOTES BEFORE COMPLETING THE PROPOSAL FORM. WHERE FURTHER INFORMATION ISREQUIRED PLEASE ATTACH IT TO THIS PROPOSAL FORM.
This proposal must be typed, or completed in ink and signed and dated by such person (Proposer/You/Your) who must be of legal capacityand authorised by the Proposer to seek a quotation for Liability Insurance and any additional coverage that may be provided by the Insurer.
Please answer every question fully, and state "NIL" or "NONE" as applicable. Incomplete answers may not be accepted and can delayquotation.
Should there be insufficient room in the Proposal Form for full details, please attach further information on signed and dated sheets,wherever possible following the same format and paragraph number.
It is the duty of the Proposer to disclose all material facts to Insurers. Where this is omitted, the Insurers may avoid their obligation underthe Policy.
For the purpose of the Proposal and for all purposes relating to any policy issued pursuant to this Proposal, a ‘material fact' shall bedeemed to be one that would be likely to influence an Insurer's judgement and acceptance of Your Proposal.
Upon acceptance of the Insurers' terms and conditions and payment of the premium, all information provided by the Proposer togetherwith the guidance notes will be deemed to be incorporated in the contract between Insurers and the Proposer.
Your Duty of Disclosure
Before You enter into an insurance policy, it is Your duty The policy provides that You will be required to bear a to disclose every matter that You know, or could specified amount of all claims and this is for each and reasonably be expected to know, to be relevant to the every claim made against You including defence costs.
Insurer's decision whether to give You insurance cover We will let You know when the excess is payable.
and, if so, on what terms.
Consequences of Non-Disclosure or
Your Legal Liability
Misrepresentation
If You breach Your duty of disclosure; the Insurer(s) may
If you take out a Liability cover section, the financial risk be able to refuse to pay a claim or to cancel Your policy.
of court awards through litigation is ever increasing and The same applies where You have made a we recommend that You select a Limit of Liability that misrepresentation, if fraudulent (ie. done deliberately for takes into account the future cost of claims including the purpose of obtaining insurance, or for obtaining it on legal fees and costs of defence. Even higher limits are favourable terms) the Insurer(s) may be able to ‘avoid' available than your current limit if required. Defence Your policy. This means that the Insurer(s) can treat the costs are included within the limit of liability, when you policy as never having existed. Non-disclosure or take out a Liability cover section.
misrepresentation in relation to one policy may affectYour ability to obtain other insurance in the future.
Waiver of Rights
If You are unsure whether some information may bedisclosable or not we suggest You call Your insurance If You have entered into an agreement with another party, broker and seek guidance.
which prevents your Insurer from taking recovery actionfor compensation from that party it may affect Your rightsto cover under this Policy. Should You now be a party to such an agreement or be requested to enter such anagreement in the future, please advise your Broker in We are committed to protecting Your privacy. We only writing so we may notify the Insurer.
use the personal information You provide to us to quoteon and insure this risk. We only provide Your personalinformation to our Insurer(s) and Reinsurers (and theirrepresentatives) and those we appoint to assist us withclaims under Your policy (ies). We do not trade, rent orsell Your information. Some or all of the Insurer(s) andReinsurers may be overseas.
If You don't provide us with complete information, wecannot properly quote for Your insurance and we cannotinsure You. You can check the information we hold aboutYou at any time. For more information about our PrivacyPolicy, ask us for a copy. Copies of the Proposal Formshould be retained for Your own records.
Contact Name
ASR Underwriting Agencies ABN 84 113 542 233 AFSL 291522 Full Name of Insured(s) Address of Registered Office Address(es) of any OverseasOffices to be Insured Full Business Description On what date was the Company first established / commenced trading Is your company involved in Clinical Trials? If yes, then please contact us for a specific proposal form Estimated annual turnover split between:
Own Manufacture (where you hold the Product Licence) Where you hold the Product licence but manufacture is contracted Where you Contract Manufacture for third parties Wholesale (unaltered from manufacturers) Parallel Import / Repackaged or relabelled Wholesale Products Other (Please provide full details of how income is generated - if appropriate, please provide specimen contracts) Please list your three largest selling products
1. Exports
Please state estimated
Product Licence Contract
annual turnover to
Are any exports sent direct to customer from manufacturers outside of Australia? If yes, please advise territory sent from Is there a formal contract in place regarding Quality Control? ASR Underwriting Agencies ABN 84 113 542 233 AFSL 291522 2. USA / Canada
Please answers these questions ONLY if you export to the USA / Canada
Please provide a full description of all products exported How long have you been producing each product? 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? i) If yes, do they arrange separate insurance including Completed Operations/Products? Are you required to indemnify any Vendors and/or Distributors in USA / Canada? i) If yes, please provide names and addresses ii) If no, do they maintain their own insurance for Completed Operations/Products? iii) State limit if known 3. Imports
If you import products, please state from which countries obtained and approximately percentage of total turnover againsteach.
4. Products
Do Products comply with all relevant:
Australian Standard, Industry and Trade Standards or Government Safety Licensing Regulations or equivalent local legislation.
Official Standard or Government Regulations laid down in countries to which Products Are any new Products likely to be marketed during the next 12 months? If yes, please advise Product name and Product type.
Please give full details and percentage of total turnover of Products that are: i) manufactured/supplied to own design/specification/formulation ii) manufactured/supplied to a design/specification/formulation laid down by a customer Do you have a separate design team? Describe extent and type of tests and checks undertaken before Product goes into production ASR Underwriting Agencies ABN 84 113 542 233 AFSL 291522 6. Quality Control
Do you have a written policy relating to Quality Control? i) If yes, how often is it reviewed? Do you have a specific Quality Control Team? i) If yes, who has overall responsibility? ii) Can control be overridden be Design Production or Marketing Personnel? Does Quality Control involve the testing of a sample percentage of Product? i) If yes, please state percentage of Products checked ii) If yes, please state failure rate Are sampling inspections made on incoming raw materials? What is the procedure for dealing with customers complaints? Are records of complaints retained? i) If yes, for how long? 7. Recall
Is it possible to trace the ultimate customer of individual Products or batches in order to recall the Products? Is there a formal procedure for remergency Product recall? Has recall ever been necessary or been considered? i) If yes, please provide details Please provide details of Product lines discontinued because of incidence or injury or damage, or where potentialhazards have been identified - stating when manufacture or supply ceased 8. Marketing
Are products labelled and supplied with clear instructions in the language of the country to which they are supplied? Are products hazard warnings clearly shown on Products, Packaging and/or Instruction Do your Legal and/or Desgin departments have sight of all advertising material, sales brochures, operating manuals etc., to check for misleading statements? Are your Representatives warned against overstating usage or effectivenes of Products? 9. Records
Do you maintain an adequate system of records which would enable identification of: Period records arekept for i) Source of Product/raw materials/component parts purchased? ii) Source of design of Products manufactured? iii) Quality control and testing procedures effective at the time of design and/or manufacture? iv) Research undertaken to minimise risk to health and safety? ASR Underwriting Agencies ABN 84 113 542 233 AFSL 291522 10. Specified Products
Please tick if any of the following Products are used. Unless it is specifically agreed with, Underwriters cover providedmay exclude any liability arising out of the following. Any Product that does not have regulatory approval i) the concomitant or combined use of two or more different products which contain a) a Statin andb) a Fibrate ii) Rhabdomyolysis arising out of either of the above Contraceptives (including birth control pills), fertility drugs and Products specifically designed and marketed for use duringand in connection with pregnancy Cox - 2 Inhibitors Diethystilbestrol or Stilbestrol or DES Ephedrine Ma Huang Pseudoephedrin Chinese Ephedra Mahuang Extract Ephedra Ephedra Sinica Ephedra Extract Ephedra Herb Powder Epitonin or any derivative thereof Isotretinoin or Accutane Latex &/or latex protein &/or latex derivatives &/or latex substances howsoever the latex, latex protein, latex derivativesor latex substances are named, identified, described or classified Methyl Tertiary Butyl Ether (MTBE) Pertussis Vaccine Selective Seritonin Reputake Inhibitors Silicone - any product containing silicone which is in any form implanted or injected in the body Thimerosal or Thiomersal Tobacco or any tobacco products (or ingredients thereof) If you have ticked any of the Products above, please provide full details as follows:
Are Products supplied on a Named Patent Basis only or in Accordance with Specials i) If yes, please provide details of licence held ii) 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 manufacturerd the Products?- Estimated annual turnover per specific product- If exports involved details of territories to be supplied and estimated turnover ASR Underwriting Agencies ABN 84 113 542 233 AFSL 291522 11. Premises
Have all Manufacturing locations been inspected by TGA/FDA or other regulatory i) If yes, what was the date of the last inspection? Have you ever had a manufacturing licence withdrawn? i) If yes, please provide details including remedies 12. General
Has any Insurer ever: i) Declined your proposal for Public &/or Products Liability Insurance? ii) Refused your renewal for Public &/or Products Liability Insurance? iii) Terminated your Insurance for Public &/or Products Liability Insurance? If yes, please provide full details 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 provide full details below: Insurers Outstanding Brief details of Incident whether or not an insurance claim has been made 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 provide full details Please state the basis of your existing cover for Products Liability i) If on a "Claims Made" basis, please state retroactive date currently applied to your policy Who are your current Insurer(s)? If currently uninsured please state What is the renewal date of your current Insurance policy covering Public and Products Liability? Please state Limit(s) of Indemnity for which a quotation is required or local currency equivalent ASR Underwriting Agencies ABN 84 113 542 233 AFSL 291522 Declaration of Your Duty of Disclosure
I am authorised on behalf of the insured(s) to sign this proposal.
I understand that the duty of disclosure applies to all insured(s). The answers are provided on behalf of all persons/entities comprising the insured(s).
I understand the questions in the proposal.
Whilst some or all of the answers to the questions may not be checked by me I certify they are correct to the best of my knowledge and belief.
Do you consider that your establishment is a good insurance risk? AUTHORISED SIGNATORY NAME OF SIGNATORY ASR Underwriting Agencies ABN 84 113 542 233 AFSL 291522

Source: http://asruw.com.au/proposals/Pharmaceutical_Liability_Proposal.pdf

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Social Studies of Science A history of deep brain © The Author(s) 2013 Reprints and permissions: stimulation: Technological innovation and the role of clinical assessment tools John Gardner Department of Sociology and Communications, Brunel University London, London, UK AbstractDeep brain stimulation involves using a pacemaker-like device to deliver constant electrical stimu-lation to problematic areas within the brain. It has been used to treat over 40,000 people with Parkinson's disease and essential tremor worldwide and is currently undergoing clinical trials as a treatment for depression and obsessive–compulsive disorder. This article will provide an his-torical account of deep brain stimulation in order to illustrate the plurality of interests involved in the development and stabilization of deep brain stimulation technology. Using Latour's notion of immutable mobiles, this article will illustrate the importance of clinical assessment tools in shaping technological development in the era of medical device regulation. Given that such tools can serve commercial and professional interests, this article suggests that it is necessary to scru-tinise their application in research contexts to ensure that they capture clinical changes that are meaningful for patients and their families. This is particularly important in relation to potentially ethically problematic therapies such as deep brain stimulation for psychiatric disorders.

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Amorphization of Pharmaceuticals by Co- grinding with Neusilin® Amorphization of crystalline drugs can be achieved In a previous report, we discussed solid dispersion through several methods. The most common method methods using Neusilin as an adsorption carrier to is melting and solidifi cation by rapid cooling over liquid improve dissolution and bioavailabilty of poorly water