Docstoc

ACE LIFE SCIENCE APPLICATION ACE Group

Document Sample
ACE LIFE SCIENCE APPLICATION ACE Group Powered By Docstoc
					                                    Application for Life Sciences
                                         Liability Coverage
Instructions:
   Please type or print clearly.
   Please answer ALL questions completely, leaving no blanks. If there are questions, or a part of them, that do
    not apply, please print “N/A” in the space next to them.
   Please provide any supporting information on a separate sheet of paper, using your letterhead and referencing
    which answer they are supplementing
   For “Yes” or “No” answers, please click the correct box.
   This form must be completed, dated and signed by a principal of your organization.

Please submit the following information with this Application:
       Application Supplement – Nanotechnology, if applicable            Application
       Clinical trial protocols, informed consent documents & clinical trial agreements
       Most recent Annual Report/Audited Financial Statement or most recent 10K & 10Q.
       Manufacturing or service contracts & indemnification agreements
       Hard copy or electronic loss runs
       Senior staff curriculum vitae
       Outline of Quality Control Program
       Advertisements, brochures, descriptive literature

The above information may be necessary before a quotation can be obtained – failure to supply could
delay or prevent a quote.

The information requested in this application is for underwriting purposes only and does not constitute
notice to the Company under any Policy of a claim or potential claim. All such notices must be
submitted to the Company pursuant to the terms of the Policy, if and when issued.

I. APPLICANT
    A. Legal name and mailing address of the entity to be the first Named Insured exactly as it will appear
       on the policy.

First Named Insured                                      Street Address



City, State, Zip Code                                    Contact Name and Phone Number:




    B. Broker or Agent Contact Information and Applicant’s Home State as Determined by the Broker or
        Agent (Applicable to Surplus Lines Policies Only):
Name:
Firm:
Address:




PF-12861c (08/12)                                  ACE USA                                       Page 1 of 12
Phone:
Email:
Home State (applicable        Please provide home state (as defined by NRRA):
to Surplus Lines policies
only):



    C. Additional Named Insureds (Include ownership %-- must be > 50%):




    D. Additional Insureds:




    E. List all subsidiaries you have acquired or entities you have merged with in the last 5 years:
                         Name of Entity:                                    Date Acquired/Merged:




    F. Form of Business:
           Corporation      Partnership    Joint Venture   Limited Liability Company   Individual

   Other: (Please describe)




    G. What year was the company established? ___________



    H. Name and address of parent company, if any:




PF-12861c (08/12)                                   ACE USA                                         Page 2 of 12
      I.   Have you ever operated under another name?           Yes    No ( If so, please provide full details.)




II.   PRODUCT OR SERVICE REVENUE INFORMATION

      A. Revenues:                             U.S. Revenues:                                 Foreign Revenues:
Projected for Next Policy Period               $                                          $
(for this quote):
Last Year:                                     $                                          $

The Year before Last Year:                     $                                          $

 The Year before that:                         $                                          $



      B. Product or Service Revenue Profile (Please provide percentages.)

Source of Revenue                             % of                    Product or Service Description
                                            revenue

Proprietary Pharmaceuticals/Biologics

Medical Devices
Contract Research
Contract Manufacturing
Diagnostics
Generic Pharmaceuticals
Over the Counter Products
Distribution
Other (please explain)



      C. Breakdown by Percentage (%) of Revenue:
           1. Pharmaceuticals/Biologics, if applicable:
Vaccines                                                Cosmetics
Imaging/Diagnostic Agents                               Nutri-pharmaceuticals
Injectable/Oral Prescription                            Vitamins/Food Supplements




PF-12861c (08/12)                                     ACE USA                                             Page 3 of 12
Topical Prescription                                     Diet Aids
Drug Delivery                                            Other (please explain)




          2. Medical Devices, if applicable:
Cardiac                                                  Therapy/rehab
Anesthesia/respiratory                                   Dialysis
Implants – Active                                        Infusion
Implants – Non-Active                                    Non-Cardiac Catheters
Lasers                                                   Analytical Instruments
Surgical Devices                                         Diagnostic Kits
Dental Instruments                                       Durable Medical Equipment
Monitoring Devices                                       Hospital Products/Supplies
Imaging Devices                                          Other (please explain)




    3. Contracted Professional Services you supply, if applicable:
    Preclinical Testing                              Submission of Regulatory Filings
    Protocol Design                                  Quality Control
    Study Selection or Monitoring                    Manufacturing
    Clinical Staff Recruitment                       Repackaging/Assembly
    Clinical Staff Training                          Marketing
    Data Entry/Database Management                   Sales
    Publications/Software Design                     Distribution
    Biostatistics                                    Other (please explain)
    Please list your largest clients for current year:




If you have product sales, please fill in the rest of this section:
    C. Please list any new products you expect to produce or introduce in the coming policy year:




PF-12861c (08/12)                                   ACE USA                                Page 4 of 12
    D. Please list any discontinued products:
                    Discontinued Product:                                      Reason:




    E. Are any products or parts manufactured outside the U.S.?                            Yes     No
       If yes, is the facility FDA approved?                                               Yes     No
    F. Are any products or components imported?                                            Yes     No
       If yes, are they FDA approved?                                                      Yes     No
    G. Do any of your products include raw materials and/or components that contain or are composed of
       nanomaterials or involve nanomaterials or nanotechnology?                           Yes   No
         (If yes, please complete ACE Nanotechnology Supplement.)
    H. Please list any products or components imported from China:




    I.   Please list any products manufactured that are sold under another company’s label:
                         Product Name:                                      Other Company:




    J. Do you track the off-label sales of your products?                                  Yes     No    N/A

    K. Are you aware of any off-label sales of your products?                              Yes     No    N/A

    L. What percentage of your total product sales comes from off-label sales?_______%

    M. Are any of your products sold as components for other products?_____ If yes, list component and end
         product:




    N. Do you require Certificates of Insurance from your suppliers?               Yes    No
            If yes, what limits do you require?

          $ __________________ each Occurrence/$ __________________ Aggregate

          $ __________________ each Occurrence/$ __________________ Aggregate

    O. Please list any activities you contract out (e.g.: product development, manufacturing, sales, distribution
       services):




PF-12861c (08/12)                                     ACE USA                                     Page 5 of 12
       P. What percentage of the sales representatives’ compensation is commission? _______

            1. Do you use your own sales force, another company’s, or contract out?           ____________

            2. Do you train the sales force?       Yes   No         Please describe:




           3. Do any of your products training/certification programs require FDA approval?              Yes     No



III.   CLINICAL TRIAL AND OTHER SERVICES YOU SUPPLY:
       A. Do any of your employees provide direct patient care?                                          Yes     No
       B. Do any employees carry their own individual medical malpractice insurance?                     Yes     No
       C. Do you operate an in-patient facility?                                                         Yes     No
       D. Do any of your employees participate on an Institutional Review Board?                         Yes     No
       E. Do you or any of your employees have a financial interest in the products
          of your clients? (Please describe on separate attachment.)                                     Yes     No
       F. What financial or other incentives are provided to Clinical Investigators?
           None               Money            Stock in your company             Position in your company
              Other: (Please describe.)



       G. Do you or any of your employees ever act as both Trial Sponsor and
          Clinical Investigator? (If yes, please list trials on separate attachment.)           Yes     No
       H. How many subjects have you enrolled in clinical trials in the last 3 years? _____________



IV.    CLINICAL TRIALS YOU SPONSOR                            N/A
       (Please use attachment if necessary)

                      Protocol Name            # of Test   # of Test
       Product                &                Subjects Subjects you Indication or   City &           Ongoing or
                                               enrolled    expect to   Disease     Country of         completed?
                     Protocol Number          Last Policy enroll Next testing for    Trials
                                                Period Policy Period




PF-12861c (08/12)                                         ACE USA                                       Page 6 of 12
* Please attach FDA approved protocols & informed consent documents for active clinical trials, and draft protocols and
informed consents for planned trials .




V.    REGULATORY
      A. To the best of your knowledge are you in compliance with the Food and Drug Administration (FDA)
         Regulations and to the extent applicable, the foreign agency equivalent?         Yes      No
      B. List all of the FDA Centers you work with: (e.g.: CDER, CBER, CDRH)


      C. Have you had product recalls in the past year?                                                Yes    No      N/A
           (If yes, please provide details & recall status on a separate attachment.)

      D. Within the past 12 months, have there been any MDR’s or AER’s filed?                          Yes    No      N/A
           (If yes, indicate the number of filings and the nature of each on a separate attachment.)

      E. Date and result of most recent FDA inspection.


           (Please submit a copy of any Form 483 and your documented response.)

      F. Have any of your products or company practices been subject to an investigation
         by any government agency? (If yes, please explain.)                                           Yes    No
      G. Have you had any clinical trials placed on a clinical hold? (If yes, provide details.)        Yes    No      N/A
      H. Do you audit Clinical Investigator performance?                                               Yes    No      N/A
      I.   Have any warning letters been issued against you or your Investigators in the
           last 3 years?                                                                               Yes     No     N/A
           (If yes, please explain and include copies of letters and responses.)


VI.   RISK MANAGEMENT
      A. Do you have a Loss Prevention/Control Program?                                                Yes    No


           (If yes, please provide the name and title of the person in charge of program.)

      B. Do you have a written Quality Control Program?                                                Yes    No
      C. Do you have a written Product Recall Plan?                                                    Yes    No
      D. Do you have a written Records Retention Program?                                              Yes    No



PF-12861c (08/12)                                            ACE USA                                         Page 7 of 12
        E. Do you have promotional materials, contracts, guarantees, & labeling
           jointly reviewed by each applicable discipline?                                         Yes     No
        F. Do you ever assume the liability of others in your contracts?                           Yes     No
        G. Do all your contracts contain hold harmless or indemnity agreements?                    Yes     No
        H. Please describe any other risk management processes, procedures or techniques:




 VII.   LOSS HISTORY
        A. List total incurred loss, including defense costs for the last five (5) years*: If NONE, check here:
                Policy Period               Insurer                  # of Claims            Total Cost Incurred




            *Attach previous carrier(s) hard copy loss runs or submit electronically

        B. Describe all incurred losses of $10,000 or more:                If NONE, check here:
        (If necessary, please provide an attachment.)




        C. Any known occurrence(s) not yet reported?                                        Yes    No
            (If yes, please provide details on an attachment.)


VIII.   PRIOR INSURANCE COVERAGE INFORMATION:
        A. Please list Insurance for the last three years:
             Products-Completed Operations Liability:
               Policy Period           Carrier             Limits           Retention       Premium        CM or Occ




 PF-12861c (08/12)                                               ACE USA                                  Page 8 of 12
           Professional Liability:
            Policy Period            Carrier            Limits        Retention      Premium        CM or Occ




           Umbrella/Excess Liability:
            Policy Period            Carrier            Limits        Retention      Premium        CM or Occ




      B. Has your insurance ever been canceled or non-renewed by a carrier?                  Yes    No
         (If yes, please provide details on a separate attachment.)

IX.   INSURANCE COVERAGE REQUEST
              Coverage               Limits Requested        Deductible or   Retro Date   Underlying Limits w
                                                            SIR and Amount                deducible/SIR:


      Products/Completed                                                                  N/A
      Operations Liability

      Professional (E&O)                                                                  N/A
      Liability

      Excess
      Products/Completed
      Operations Liability

      Excess Professional
      Liability

      Medical Malpractice                                                                 N/A
      Liability - SMO

         Please check the Policy Form you are requesting:
             Claims-Made & Reported              Claims-Made


X. FRAUD WARNING, DECLARATION & CERTIFICATION, AND SIGNATURE
         NOTICE TO ARKANSAS, LOUISIANA, WEST VIRGINIA & RHODE ISLAND APPLICANTS: Any
         person who knowingly presents a false or fraudulent claim for payment for a loss or benefit or
         knowingly presents false information in an application for insurance is guilty of a crime and may be
         subject to fines and confinement in prison.

         NOTICE TO COLORADO APPLICANTS: It is unlawful to knowingly provide false, incomplete, or
         misleading facts or information to an insurance company for the purpose of defrauding or attempting to
         defraud the company. Penalties may include imprisonment, fines, denial of insurance and civil



PF-12861c (08/12)                                         ACE USA                                  Page 9 of 12
        damages. Any insurance company or agent of an insurance company who knowingly provides false,
        incomplete, or misleading facts or information to a policyholder or claimant for the purpose of
        defrauding or attempting to defraud the policyholder or claimant with regard to a settlement or award
        payable from insurance proceeds shall be reported to the Colorado Division of Insurance within the
        Department of Regulatory Agencies.

        NOTICE TO DISTRICT OF COLUMBIA APPLICANTS: WARNING: it is a crime to provide false or
        misleading information to an insurer for the purpose of defrauding the insurer or any other person.
        Penalties include imprisonment and/or fines. In addition, an insurer may deny insurance benefits if false
        information materially related to a claim was provided by the Applicant.

        NOTICE TO FLORIDA APPLICANTS: Any person who knowingly, and with intent to injure, defraud, or
        deceive any insurer files a statement of claim or an application (or any supplemental application,
        questionnaire or similar document) containing any false, incomplete or misleading information is guilty
        of a felony of the third degree.

        NOTICE TO KANSAS APPLICANTS: Any person who, knowingly and with intent to defraud, presents, causes to be
        presented or prepares with knowledge or belief that it will be presented to or by an insurer, purported insurer, broker
        or any agent thereof, any written statement as part of, or in support of, an application for the issuance of, or the rating
        of an insurance policy for personal or commercial insurance, or a claim for payment or other benefit pursuant to an
        insurance policy for commercial or personal insurance which such person knows to contain materially false
        information concerning any fact material thereto; or conceals, for the purpose of misleading, information concerning
        any fact material thereto commits a fraudulent insurance act.

        NOTICE TO KENTUCKY APPLICANTS: Any person who knowingly and with intent to defraud any
        insurance company or other person files an application for insurance 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.

        NOTICE TO MAINE APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading
        information to an insurance company for the purposes of defrauding the company. Penalties may
        include imprisonment, fines or a denial of insurance benefits.

        NOTICE TO MARYLAND APPLICANTS: Any person who knowingly or willfully presents a false or
        fraudulent claim for payment of a loss or benefit or who knowingly or willfully presents false information
        in an application for insurance is guilty of a crime and may be subject to fines and confinement in
        prison.

        NOTICE TO MINNESOTA APPLICANTS: Any person who knowingly and with intent to defraud any Insurance
        company or Another person, files an application for insurance containing any materially false information, or conceals
        information for the purpose of misleading, commits a fraudulent insurance act, which is a crime and MAY subject such
        person to criminal and civil penalties.

        NOTICE TO NEW JERSEY APPLICANTS: Any person who includes any false or misleading
        information on an application for an insurance policy is subject to criminal and civil penalties.

        NOTICE TO NEW MEXICO APPLICANTS: ANY PERSON WHO KNOWINGLY PRESENTS A FALSE
        OR FRAUDULENT CLAIM FOR PAYMENT OF A LOSS OR BENEFIT OR KNOWINGLY PRESENTS
        FALSE INFORMAITON IN AN APPICATION FOR INSURANCE IS GUILTY OF A CRIME AND MAY
        BE SUBJECT TO CIVIL FINES AND CRIMINAL PENALTIES.

        NOTICE TO NEW YORK 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 shall also be subject to
        a civil penalty not to exceed five thousand dollars and the stated value of the claim for each such
        violation.




PF-12861c (08/12)                                          ACE USA                                              Page 10 of 12
        NOTICE TO OHIO APPLICANTS: Any person who, with the intent to defraud or knowing that he is
        facilitating a fraud against an insurer, submits an application or files a claim containing a false or
        deceptive statement is guilty of insurance fraud.

        NOTICE TO OKLAHOMA APPLICANTS: WARNING: Any person who knowingly, and with intent to
        injure, defraud, or deceive any insurer, makes any claim for the proceeds of an insurance policy
        containing any false, incomplete or misleading information is guilty of a felony.

        NOTICE TO OREGON APPLICANTS: WARNING: Any person who knowingly and with intent to
        defraud any insurance company or another person, files an application for insurance or statement of
        claim containing any materially false information, or conceals information for the purpose of misleading,
        information concerning any fact material thereto, may be committing a fraudulent insurance act, which
        may be a crime and may subject such person to criminal and civil penalties.

        NOTICE TO PENNSYLVANIA 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
        such person to criminal and civil penalties.

        NOTICE TO TENNESSEE & VIRGINIA AND WASHINGTON APPLICANTS: It is a crime to knowingly
        provide false, incomplete or misleading information to an insurance company for the purpose of
        defrauding the company. Penalties include imprisonment, fines and denial of insurance benefits.

        NOTICE TO VERMONT APPLICANTS: Any person who knowingly presents a false statement in an application for
        insurance may be guilty of a criminal offense and subject to penalties under state law.

        NOTICE TO ALL OTHER APPLICANTS:

        ANY PERSON WHO KNOWINGLY AND WITH INTENT TO DEFRAUD ANY INSURANCE
        COMPANY OR ANOTHER PERSON, FILES AN APPLICATION FOR INSURANCE OR
        STATEMENT OF CLAIM CONTAINING ANY MATERIALLY FALSE INFORMATION, OR
        CONCEALS INFORMATION FOR THE PURPOSE OF MISLEADING, COMMITS A
        FRAUDULENT INSURANCE ACT, WHICH IS A CRIME AND MAY SUBJECT SUCH PERSON
        TO CRIMINAL AND CIVIL PENALTIES.

        DECLARATION AND CERTIFICATION
        BY SIGNING THIS APPLICATION, THE APPLICANT WARRANTS TO THE COMPANY THAT
        ALL STATEMENTS MADE IN THIS APPLICATION AND ANY SUPPLEMENTS ATTACHED
        HERETO ABOUT THE APPLICANT AND ITS OPERATIONS ARE TRUE AND COMPLETE, AND
        THAT NO MATERIAL FACTS HAVE BEEN MISSTATED OR MISREPRESENTED IN THIS
        APPLICATION OR HAVE BEEN SUPPRESSED OR CONCEALED.
        THE APPLICANT AGREES THAT IF AFTER THE DATE OF THIS APPLICATION, ANY
        INCIDENT, OCCURRENCE, EVENT OR OTHER CIRCUMSTANCE SHOULD RENDER ANY OF
        THE INFORMATION CONTAINED IN THIS APPLICATION OR ANY OTHER DOCUMENTS
        SUBMITTED IN CONNECTION WITH THE UNDERWRITING OF THIS APPLICATION
        INACCURATE OR INCOMPLETE, THEN THE APPLICANT SHALL NOTIFY THE COMPANY OF
        SUCH INCIDENT, OCCURRENCE, EVENT OR CIRCUMSTANCE AND SHALL PROVIDE THE
        COMPANY WITH INFORMATION THAT WOULD COMPLETE, UPDATE OR CORRECT SUCH
        INFORMATION. ANY OUTSTANDING QUOTATIONS OR BINDERS MAY BE MODIFIED OR
        WITHDRAWN AT THE SOLE DISCRETION OF THE COMPANY.
        COMPLETION OF THIS FORM DOES NOT BIND COVERAGE.          THE APPLICANT’S
        ACCEPTANCE OF THE COMPANY’S QUOTATION IS REQUIRED BEFORE THE APPLICANT
        MY BE BOUND AND A POLICY ISSUED. THE APPLICANT AGREES, IF THE INSURANCE
        COVERAGE APPLIED FOR IS WRITTEN, THAT THIS APPLICATION SHALL BE THE BASIS



PF-12861c (08/12)                                    ACE USA                                        Page 11 of 12
         OF THE CONTRACT WITH THE INSURANCE COMPANY, AND BE DEEMED TO BE A PART
         OF THE POLICY TO BE ISSUED AS IF PHYSICALLY ATTACHED THERETO. THE
         APPLICANT HEREBY AUTHORIZES THE RELEASE OF CLAIMS INFORMATION FROM ANY
         PRIOR INSURERS TO THE COMPANY.
         THE APPLICANT AGREES TO COOPERATE WITH THE COMPANY IN IMPLEMENTING AN
         ONGOING PROGRAM OF LOSS-CONTROL AND WILL ALLOW THE COMPANY TO REVIEW
         AND MONITOR SUCH PROGRAMS THAT THE APPLICANT UNDERTAKES IN MANAGING ITS
         EXPOSURES.


X                                         X
 Signature of Applicant           Date     Signature of Broker/Agent                 Date


 Name of Applicant                         Name of Broker/Agent


 Title                                     Signed by Licensed Resident Agent         Date
                                           (Where Required By Law)




PF-12861c (08/12)                        ACE USA                               Page 12 of 12

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:4
posted:10/22/2012
language:Unknown
pages:12