Illinois Union Insurance Company
Westchester Surplus Lines Insurance Company
INA Surplus Insurance Company
Instructions:
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Life Sciences
Liability
Claims-Made
Application
Please type or print clearly.
Answer ALL questions completely, leaving no blanks. If any questions, or part thereof, do not apply, print
“N/A” in the space.
Provide any supporting information on a separate sheet using your letterhead and reference the applicable
question number.
Check Yes or No answers
This form must be completed, dated and signed by a principal of your organization.
Please check the applicable block(s) for type of coverage desired:
Products/Completed Operations Liability
Professional Liability (CROs)
Please submit the following information with the Application. This information is necessary before a
quotation can be obtained:
 Most recent Annual Report/Audited Financial Statement or most recent 10K & 10Q.
 Clinical trial protocols, informed consent documents & clinical trial agreements
 Manufacturing or service contracts & indemnification agreements
 Hard copy loss runs
 Senior staff curriculum vitae
 Outline of Quality Control Program
 Advertisements, brochures, descriptive literature
I.
GENERAL INFORMATION
A. Applicant Contact Information:
Applicant Name:
Address:
Mailing Address:
(If different from
above)
Web Site:
Contact Name and
Title:
Contact Phone
Number:
Contact Email
Address:
All Named Insureds:
Additional Insureds:
(Explain
relationships.)
PF-12861a (02/10)
ACE USA
Page 1 of 12
B. Broker or Agent Contact Information:
Name:
Firm:
Address:
Phone:
Email:
C. List all subsidiaries you have acquired or entities you have merged with in the last 5 years:
Name of Entity:
Date Acquired/Merged:
D. Form of Business:
Individual
Partnership
Corporation
Joint Venture
Limited Liability Company
Other: (Please describe)
E. How long has the Named Insured been in business?
F. Name and address of parent company, if any.
G. Have you operated under another name? (Please provide full details.)
H. Revenues:
U.S. Revenues:
Foreign Revenues:
2007:
$ __________________
$ ___________________
2008:
$ __________________
$ ___________________
2009:
$ __________________
$ __________________
Projected for Next Policy Period
(for this quote):
$ __________________
$ ___________________
PF-12861a (02/10)
ACE USA
Page 2 of 12
II. PRODUCT/SERVICE INFORMATION
A. Profile (Please provide percentages.)
Source/Potential Source of
Revenues
%
Product/Service Description
Proprietary
Pharmaceuticals/Biologics
Generic Pharmaceuticals
Over the Counter Products
Medical Devices
Diagnostics
Contract Research
Contract Manufacturing
Distribution
Other (please explain)
B. Breakdown (Please provide percentages.)
1. Pharmaceuticals/Biologics:
%
%
Vaccines
Cosmetics
Imaging/Diagnostic Agents
Nutripharmaceuticals
Injectable/Oral Prescription
Vitamins/Food Supplements
Topical Prescription
Diet Aids
Drug Delivery
Other (please explain)
2. Medical Devices:
%
%
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)
PF-12861a (02/10)
ACE USA
Page 3 of 12
3. Contracted Professional Services:
%
%
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)
C. List new products expected to be introduced:
D. List any discontinued products: (Please indicate reason)
Discontinued Product:
Reason:
E. Any distributed products manufactured outside the U.S.?
If yes, is facility FDA approved?
Yes
Yes
No
No
N/A
F. Any product components imported?
If yes, are they FDA approved?
Yes
Yes
No
No
N/A
G. Please list any products manufactured that are sold under others’ labels:
Product Name:
PF-12861a (02/10)
Other Company:
ACE USA
Page 4 of 12
H. Are you aware of any off-label sales of your products?
Yes
No
N/A
I.
Yes
No
N/A
Do you track the off-label sales of your products?
J. If you have product sales, about what percentage of your total product sales comes from off-label sales?
____%
K. Are any products sold as components for other products? (If so, what is the end product?)
L. Do you require Certificates of Insurance from your suppliers?
Yes
No
What limits do you require?
$ __________________
$ __________________
M. Please list any activities contracted out (e.g.: product development, manufacturing, sales, distribution
services):
N. What percentage of the sales representatives’ compensation is commission?
____%
O. Do you use your own sales force, another company’s, or contract out?
P. Do any of your products training/certification programs require FDA approval?
Yes
No
A. Do any of your employees provide direct patient care?
Yes
No
B. Do they 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
III. CLINICAL TRIAL AND OTHER SERVICES
F. What financial incentives are provided to Clinical Investigators?
None
Money
Stock in your company
N/A
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.)
PF-12861a (02/10)
ACE USA
Yes
No
Page 5 of 12
H. How many subjects have you enrolled in clinical trials in the last 3 years?
I.
____
Please list your largest clients for current year:
N/A
IV. SPONSORED CLINICAL TRIALS
(Please use attachment if necessary)
Protocol Name
Product
&
Protocol Number
|Number of Subjects|
# of Test
# of Test
Subjects
Subjects
enrolled expected to
Last Policy be enrolled
Period
Next Policy
Period
Indications
City &
Country
of Trials
Status of Trial
[Ongoing?
Completed?]
* 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 FDA Regulations
or foreign agency equivalent?
Yes
No
Yes
No
N/A
Yes
No
N/A
B. List all of the FDA Centers you work with: (e.g.: CDER, CBER, CDRH)
C. Any product recalls in the past year?
(If yes, please provide details & recall status on a separate attachment.)
D. Within past 12 months, has there been any MDR’s or AER’s filed?
(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 Form 483 and your documented response.)
PF-12861a (02/10)
ACE USA
Page 6 of 12
F. Have any products or company practices been subject to an investigation by
any government agency? (If yes, please explain.)
Yes
No
G. 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.
Yes
No
N/A
Yes
No
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
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
Any warning letters issued against you or your Investigators in the last 3 years?
(If yes, please explain and include copies of letters and responses.)
VI. RISK MANAGEMENT
A. Do you have a Loss Prevention/Control Program?
(If yes, please provide the name and title of the person in charge of program.)
Other (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 loss runs
B. Describe all incurred losses of $10,000 or more:
(If necessary, please provide an attachment.)
C. Any known occurrence(s) not yet reported?
If NONE, check here:
Yes
No
(If yes, please provide details on an attachment.)
PF-12861a (02/10)
ACE USA
Page 7 of 12
VIII. INSURANCE COVERAGE INFORMATION
A. Prior Insurance: (Please list last 3 years)
Products-Completed Operations Liability:
Policy Period
Carrier
Limits
Retention
Premium
CM or Occ
Carrier
Limits
Retention
Premium
CM or Occ
Limits
Retention
Premium
CM or Occ
Professional Liability:
Policy Period
Umbrella/Excess Liability:
Policy Period
Carrier
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. COVERAGE REQUEST
A. Coverage
Coverage
Limits Requested
Deductible or SIR
Retro Date
Underlying Limits
with Ded./SIR
Products/Completed
Operations Liability
------------------------- -------------------------
Professional
Liability
----------------------------------------------------
Excess
Products/Completed
Operations Liability
----------------------------------------------------------------------
Excess
Professional
Liability
----------------------------------------------------------------------
*When requesting excess coverage please provide underlying premium figures and policy terms and
conditions as well as a copy of the underlying Quotation.
PF-12861a (02/10)
ACE USA
Page 8 of 12
B. What is the effective date of this policy? ___________________
C. Deductible or SIR:
1. What Deductible or SIR are you prepared to carry?
Deductible $_________________
SIR
$_________________
X. FRAUD WARNING, DECLARATION & CERTIFICATION, AND SIGNATURE
NOTICE TO ARKANSAS 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 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 LOUISIANA APPLICANTS: Any person who knowingly presents a false or
fraudulent claim for payment of 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 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 and willfully presents a false
or fraudulent claim for payment of a loss or benefit or who knowingly and 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 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.
PF-12861a (02/10)
ACE USA
Page 9 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 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 RHODE ISLAND APPLICANTS: Any person who knowingly presents a false or fraudulent
claim for payment of 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 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 WEST VIRGINIA APPLCIANTS: Any person who knowingly presents a false or
fraudulent claims for payment of 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 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.
PF-12861a (02/10)
ACE USA
Page 10 of 12
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 THAT THIS
APPICATION, IF THE INSURANCE COVERAGE APPLIED FOR IS WRITTEN, SHALL BE THE
BASIS 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 MEDICAL PROFESSIONAL EXPOSURES.
Signature of Applicant
Signature of Broker/Agent
Title
Date
PF-12861a (02/10)
ACE USA
Page 11 of 12
Date
PF-12861a (02/10)
Signed by Licensed Resident Agent
(Where Required By Law)
ACE USA
Page 12 of 12