Application for Life Sciences
Liability Coverage
Instructions:
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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:
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Application
Application Supplement – Nanotechnology, if applicable
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:
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ACE USA
Page 1 of 12
Phone:
Email:
Home State (applicable
to Surplus Lines policies
only):
Please provide home state (as defined by NRRA):
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:
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I.
II.
Have you ever operated under another name?
Yes
No ( If so, please provide full details.)
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
revenue
Product or Service Description
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
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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:
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ACE USA
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D. Please list any discontinued products:
Discontinued Product:
Reason:
E. Are any products or parts manufactured outside the U.S.?
If yes, is the facility FDA approved?
Yes
Yes
No
No
F. Are any products or components imported?
If yes, are they FDA approved?
Yes
Yes
No
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):
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ACE USA
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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?
III.
Yes
No
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
CLINICAL TRIAL AND OTHER SERVICES YOU SUPPLY:
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
Product
&
Protocol Number
PF-12861c (08/12)
# of Test
# of Test
Subjects Subjects you Indication or
City &
enrolled
expect to
Disease
Country of
Last Policy enroll Next
testing for
Trials
Period Policy Period
ACE USA
Ongoing or
completed?
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* 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
Yes
No
N/A
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
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
(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?
(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.)
I.
VI.
Have any warning letters been issued against you or your Investigators in the
last 3 years?
(If yes, please explain and include copies of letters and responses.)
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.)
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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 necessary, please provide an attachment.)
If NONE, check here:
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
PF-12861c (08/12)
Carrier
Limits
ACE USA
Retention
Premium
CM or Occ
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Professional Liability:
Policy Period
Carrier
Limits
Retention
Premium
CM or Occ
Limits
Retention
Premium
CM or Occ
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.
INSURANCE COVERAGE REQUEST
Coverage
Limits Requested
Deductible or
SIR and Amount
Retro Date
Underlying Limits w
deducible/SIR:
Products/Completed
Operations Liability
N/A
Professional (E&O)
Liability
N/A
Excess
Products/Completed
Operations Liability
Excess Professional
Liability
Medical Malpractice
Liability - SMO
N/A
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
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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.
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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
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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
Signature of Applicant
X
Date
Signature of Broker/Agent
Name of Applicant
Name of Broker/Agent
Title
Signed by Licensed Resident Agent
(Where Required By Law)
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ACE USA
Date
Date
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