• Life Science Pharmaceutical & Biotechnology Application Form 

  • Broker Information

  • Format: (000) 000-0000.

  • Application Information

  • Is Mailing address different from Location Address?

  • Company Information

  • Have you acquired any companies within the last 5 years?
  • Are you a subsidiary of another company?
  • Have you ever operated under another name?

  • Sales Turnover

  • Please provide a breakdown of your actual sales turnover for the past twelve (12) months and your projected sales turnover for the next twelve (12) months, in USD.
  • Sales Turnover
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  • Please list the Top 10 Products and the subsequent turnover to the United States, if applicable:
    Rows

  • Business Activities

  • Please provide a breakdown of your business activities
    Rows
  • Please list your 3 largest customers:
    Rows

  • Product Information

  • Please provide a breakdown of your products.
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  • Specified Products & Product Categories

  • Do any of your past or present products contain any of the following specified products or specified product categories, including any derivative thereof? Please indicate using Yes or No for each item below.

  • Specific Products and/or Categories

  • Bisphosphonates:
  • Bupropion:
  • Contraceptives, including birth control pills, fertility drugs and products specifically designed and/or marketed for use during and in connection with pregnancy:
  • Cox-2 inhibitors:
  • Di-(2-ethylhexyl) Phthalate, DEHP:
  • Diethylstilbestrol or Stilbestrol or DES; Docetaxel:
  • Ephedra, Ephedrine, Pseudoephedrine or Phenylpropanolamine:
  • GLP-1 Analogues:
  • Hormone Replacement Products or Therapy Products:
  • Isotretinoin, Retinoic Acid or its salts:
  • Inferior Vena Cava Filters:
  • Infusion Pump Machines:
  • Kava or Kava Kava:
  • Kratom:
  • Mercury, meaning any good or product containing mercury, including organomercury, where such good or product is or is intended to be implanted, ingested, injected, inhaled or absorbed:
  • Metal-on-metal implant, meaning any knee, hip or other joint implant, replacement or resurfacing system and the component parts of any of the foregoing, where: 1. A part of the implant designed for motion is made of metal; and 2. The moving part, while either at rest or in motion, contacts another metal part of the implant that is designed for motion, or designed to meet or serve as a socket or contact surface against which the moving part comes to rest.
  • Metoclopramide:
  • Pregabalin and/or Gabapentin:
  • Proton-Pump Inhibitors, PPIs:
  • Rhabdomyolysis and Myopathy arising out of the use of Statin alone or in combination with fibrates:
  • Selective Serotonin Reuptake Inhibitors, SSRI, or Selective Norepinephrine Reuptake Inhibitors, SNRI:
  • Skin Whitening Products:
  • Synthetic or Biologic mesh that is temporarily or permanently implanted into a human body:
  • Thalidomide
  • Thiazolidinediones, including but not limited to Rosiglitazone:
  • Vaccines:
  • Opioid or narcotic drug, opioid or narcotic medication, opioid or narcotic substance, or opioid receptor antagonist or partial antagonist of any type, nature or kind including, but not limited to codeine, fentanyl, hydrocodone, oxycontin, hydromorphone, meperidine, methadone, oxycodone, naltrexone or naloxone:

  • Additional Specific Product and/or Categories

  • Anticonvulsants, Antiepileptics:
  • Antidepressants:
  • Attention Deficit Hyperactivity Disorder, ADHD, drugs, e.g. Methylphenidate, Amphetamine:
  • Atypical Antipsychotics, e.g. Clozapine, Olanzapine, Risperidone, Quetiapine:
  • Birth control or Fertility Products:
  • Bisphosphonates, e.g. Alendronate, Risedronate:
  • Bodybuilding Supplements:
  • Blood Products:
  • Diazepines, Oxazepines or Thiazepines:
  • Dopamine Agonists, e.g. Apomorphine, Pramipexole, Ropinirole, Rotigotine, Pergolide:
  • Fibrate Products:
  • Gliptins, e.g. Sitagliptin, Vildagliptin, Alogliptin:
  • HIV/AIDS, TSE or Viral Hepatitis:
  • HMG CoA Reductase inhibitor products:
  • Hydroxyquinoline derivative products:
  • Impotence products, e.g. Sildenafil, Vardenafil:
  • Incretin Mimetics, e.g. Exenatide, Liraglutide:
  • Lifestyle drugs, i.e. non-life threatening / non-painful conditions, e.g. baldness, wrinkles, sexual performance, weight loss:
  • Nanotechnology:
  • Nontherapeutic cosmetics:
  • Products specifically designed for pregnant women:
  • Products used for weight management, e.g. Orlistat, Sibutramine, Rimonabant:
  • Prohibited or restricted herbal ingredient, as defined by Health Canada or local equivalent regulatory body:
  • Sports Supplements, performance enhancements:
  • Stem Cells, Embryonic:
  • Unapproved goods or products:
  • Controlled substances under the Controlled Substances Act or any similar federal, state, local or foreign act, statute, regulation, ordinance, requirement or law:

  • Product Approval & Distribution

  • Are all of your products approved for their intended purpose by the relevant regulatory body in the territory in which they are to be distributed?
  • Do any products have any safety warning labels such as Black Box Warnings?
  • Do you contract out product development, manufacturing, sales or distribution services?
  • Are any of your products sold under other's labels or as components of other's products?
  • Are any of the products or ingredients of the products imported from overseas?
  • Have any products been recalled in the past 5 years or are undergoing any recall?
  • Does your Company plan to introduce any new products or services within the next 12 months?
  • Does the insured test raw materials for product purity and quality prior to use/sale?
  • Does the insured formulate any products?
  • Does the insured distribute any products under its own label or brand?

  • Nutraceutical Products Exposure

  • If the insured has Nutraceutical products exposure, please confirm the following:
  • Do any of the products contain any active ingredients that would be defined by a regulatory body as a drug?
  • Are any of the products or ingredients of products imported from elsewhere?
  • Does the insured distribute any products under its own label or brand?

  • Regulatory & Compliance Information

  • To the best of your knowledge, are you currently in compliance with all applicable government regulations?
  • Have any of your products been subject to an inquiry or been investigated by any regulatory authority?
  • Have any of your products been recalled, withdrawn or discontinued due to a safety or performance reason, initiated by you or a regulatory authority?
  • Have all your manufacturing locations been inspected by the relevant regulatory authority?
  • Has your manufacturing license ever been withdrawn?

  • Risk Management Information

  • Do you have a formal quality control plan in place?
  • Do you have a formal recall plan in place?
  • Do you have a system for documenting incident reports and/or complaints?
  • Do you maintain samples of your products?
  • Do you comply with Good Manufacturing Practices, GMP?
  • Are you ISO certified and registered?

  • Do any of the contracts you sign up to include any of the following?

  • Limitation of Liabilities
  • Hold Harmless Agreements
  • Arbitration Clause
  • Guarantees or warranties
  • Consequential / Indirect Loss language
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  • Do you receive a certificate of products liability insurance from the manufacturer?
  • Are you added to the manufacturer's policy as an additional insured?
  • Do you retain right of recourse against the manufacturer?
  • Do you require certificates of insurance from all suppliers and sub-contractors?

  • Premises Information

  • Do you store any hazardous substances on your premises?
  • If Yes, are you in compliance with all applicable laws regarding hazardous materials handling and disposal?
  • Have you ever had a biohazard release?
  • Do you have any viruses on your premises?
  • Do you have any laboratory animals on your premises?

  • Coverage Requirements

  • Coverage Requirements
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  • If Errors & Omissions coverage is required, please confirm if you have a standard trading contract.
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  • Loss Information

  • Has your Company ever had a written demand or civil proceeding for damages made against them?

  • If Yes, please provide the following details on a separate sheet, for a minimum of 5 years (uploaded below):

    • Date of claim
    • Claimant's name
    • Nature of claim
    • Amount of indemnity payment and amount of defence costs 
    • Final dispositions or current status of claim
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  • Are you aware of any circumstances or occurrences that might give rise to a claim?

  • Insurance History

  • Is your company currently insured?
  • If Yes, please complete the Insurance History table below for the past 3 years.
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  • Has any insurance company ever:
  • Declined your application for insurance?
  • Refused to renew any insurance policy?
  • Cancelled any insurance policy?

  • Coverage Options

  • Please provide the following accompanying documents with this completed proposal form:
    • Current product list
    • Sample Service Contracts & Indemnification Agreements
    • Clinical Trial Protocols and Patient Informed Consent Forms, if applicable
    • Confirmation of patient numbers split by territory and Clinical Trial
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  • Declaration

  • Please read the declaration carefully and sign at the bottom.

  • Material Information

  • In deciding whether to accept the insurance and in setting the terms and premium, we have relied on the information you have given us.
  • You must:
    • Give a fair presentation of the risk to be insured. A fair presentation is one which clearly discloses in a reasonably clear and accessible manner all material facts which you, including your senior management and those responsible for arranging this insurance, know or ought to know following a reasonable search.
    • Take care when answering any questions we ask by ensuring that all information provided is true, accurate and complete.
    • Conduct a reasonable search of information available, including information held by third parties, and disclose all material facts and circumstances in a reasonably clear and accessible manner, whether or not those facts and circumstances are the subject of a specific question in this proposal form.
  • A material fact or circumstance is one which is likely to influence our acceptance or assessment of this proposal. If you are in any doubt as to what constitutes a material fact or circumstance you should consult your insurance broker.

  • Using Your Personal Information

  • We are committed to protecting your privacy. Insurance involves the use and disclosure of your data to various insurance participants such as intermediaries, insurers and reinsurers. We collect and process information about you in order to provide insurance policies and to process claims. Your information is also used for business purposes such as fraud prevention and detection and financial management. This may involve sharing your information with, and obtaining information about you from, our group companies and third parties such as brokers, loss adjusters, credit reference agencies, service providers, professional advisors, our regulators or fraud prevention agencies. We may record telephone calls to help us monitor and improve the service we provide.

  • Declaration

  • I/we confirm that the information given in this proposal form and any supplementary information provided is true, accurate and complete. I/we have made a fair presentation of the risk and have disclosed all facts and circumstances which would be material to your acceptance or assessment of the risk in a reasonably clear and accessible manner, whether or not those facts or circumstances were the subject of a specific question in this proposal form. I/we confirm that I/we have conducted a reasonable search of the information available to me/us, including information held by third parties, in order to reveal those facts and circumstances. If there are any material facts or circumstances not covered by a specific question on this proposal form, I/we have listed these on a separate sheet of paper which is signed and dated and attached to this proposal form. I/we understand that if I/we deliberately or recklessly failed to present the risk to you fairly, you may treat this insurance as if it never existed and refuse to make any payment under it. I/we understand that I/we must reimburse all payments already made by you and that you will also be entitled to retain all premiums paid. I/we understand that if I/we failed to present the risk to you fairly but that failure was not deliberate or reckless, the remedy available to you will depend upon what you would have done if I/we had made a fair presentation of the risk.
    I/we understand that you may:

    Treat this insurance as if it never existed and refuse to make any payment under it. I/we must reimburse all payments already made by you. You will refund any premium I/we have paid.


    Amend the terms and conditions of this insurance and apply those amended terms and conditions from the start of the period of insurance. I/we understand that this may result in a particular claim or loss not being paid. I/we will reimburse you for any payment already made that would not have been paid if such terms had been in effect.


    Reduce the amount of any claim in proportion to the premium that you would have charged if I/we had fairly presented the risk to you. I/we understand that this remedy may apply in addition to those shown in the paragraph above.

  • Please note that the signing of this proposal form does not bind you to complete or us to accept this insurance.
  • The person signing this proposal form is duly authorised to do so on behalf of the proposer.
    A copy of this proposal should be retained for your records.

  • Signature

  • If the information provided in this application should change between the date of the application and the effective date of the policy, the undersigned warrants that they will immediately report such changes to the insurer.
    The completion and signing of this application does not constitute a promise to provide coverage.

    However, if a policy is issued, this application shall serve as the basis of such contract and will be attached to, and form part of the policy.

  • THE UNDERSIGNED HEREBY ACKNOWLEDGES THE TRUTH OF THE STATEMENTS CONTAINED HEREIN.
    I AUTHORIZE YOU TO COLLECT, USE AND DISCLOSE PERSONAL INFORMATION AS PERMITTED BY LAW, IN CONNECTION WITH YOUR COMMERCIAL INSURANCE POLICY OR A RENEWAL, EXTENSION OR VARIATION THEREOF, FOR THE PURPOSES NECESSARY TO ASSESS THE RISK, INVESTIGATE AND SETTLE CLAIMS, AND DETECT AND PREVENT FRAUD, SUCH AS CREDIT INFORMATION, AND CLAIMS HISTORY.

  • For purposes of the Insurance Companies Act (Canada), this document was issued in the course of Lloyd's Underwriters' insurance business in Canada.

  • Should be Empty: