330 03 00
Products Liability Application
(including Clinical Trials coverage) for the:
Medical Device Industry
Pharmaceutical Industry
Biologics Industry
INTERNATIONAL PROGRAM MANAGERS, LTD.
SUITE 219
1726 REISTERSTOWN ROAD
BALTIMORE, MARYLAND 21208 USA
PHONE 410 486 2400
FAX 410 486 2998
M E D M A R C
I N S U R A N C E
G R O U P
MEDMARC
INSURANCE
APPLICATION
LIABILITY COVERAGE DESIRED:
 Commercial General Liability including Products/Completed Operations

Products/Completed Operations Liability Only
A. GENERAL INFORMATION
1) Named Insured (as it should appear on policy)
SuperDimension
 Individual
 Partnership
Corporation
 Joint Venture
 Other (Describe)
Names of all subsidiaries to be insured:
___________________________________
___________________________________
___________________________________
___________________________________
Address (street, city, state, zip code)
Phone Number
Primary Contact Name:
Fax Number
Web Address
Title:
Mailing Address (If Different):
Main Phone Number
Fax Number:
Email Address:
SIR Billing Contact Name:
Title:
Mailing Address (If Different):
Main Phone Number:
Fax Number:
Email Address:
Loss Prevention Coordinator:
M E D M A R C
Title:
I N S U R A N C E
G R O U P
1
Mailing Address (If Different):
Main Phone Number:
Fax Number:
Email Address:
Claim Contact Name:
Title:
Mailing Address (If Different):
Main Phone Number:
Fax Number:
Email Address:
2) Have you acquired or sold any companies during this past year? (If yes, please provide name, business description, location and date of
acquisition/divestiture)
3a) What, if any, change have taken place involving your product(s) or operations, particularly new or discontinued products (Please
describe, e.g., dates discontinued, reason, expected useful life, total units sold, date of resubmitted 510K, etc.)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
3b) Are any products currently under development? (If yes, please provide details, i.e. current FDA status, etc.)
Yes
No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
4)
5)
Proposed Policy Period
Retro Date
August 2, 2006 – August 9, 2007
October 1, 2003
Limits of Insurance (between $1 mil & $10 mil)
Self Insured Retention (SIR) - Deductible (Per Occ./Agg.)
$5
million
$ 10,000 occurrence / $50,000 Aggregate
$
million
$
million
M E D M A R C
I N S U R A N C E
G R O U P
2
6)
Provide most recent Annual Report, Financial Statement or SEC Reports (10K, 10Q).
7)
Date business was founded.
For companies in business less than 3 years, provide resumes or biographies of key management / executives.
8)
Provide a brief description of your operations.
9)
Provide loss history (including paid, reserves and defense cost) for the past 5 years. Describe all claims over $10,000.
Year
# of claims
Amount Paid
Reserves
Defense Cost
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
10) List any incident(s) and/or circumstance(s) which may result in a claim against you under the coverage requested in this
application.
11) List current products liability insurance carrier.
Is policy form occurrence coverage or claims made?
If claims made, what is the retro date?
Reporting Period
12) Current policy limits $
Current deductible or SIR $
13) Have any insurance companies canceled or refused to renew your products or general liability insurance?
If yes, please explain.
14) List any product(s) specifically excluded from current coverage.
15) Are defense costs (supplementary payments) included within or separate from the policy’s limit of insurance?
If separate, what is the Defense (Supplementary Payment) Limit?
M E D M A R C
I N S U R A N C E
G R O U P
3
*** Check the boxes applicable for your business ***
Medical Device

(Complete Section B)
Pharmaceutical / Biologics

(Complete Section C)
Human Clinical Trials

(Complete Section D)
M E D M A R C
I N S U R A N C E
G R O U P
4
B. MEDICAL DEVICES – PRODUCT INFORMATION
1)
Describe product(s). Include brochures, warning labels, etc. where appropriate.
2)
Revenues (Projected next 12 months)
U.S. / Canada
Other Foreign
Manufacturing (proprietary products)
$
$
OEM (products sold under other labels)
$
$
Distribution
$
$
Equipment Rental
$
$
Installation / Repair / Service
$
$
Percentage breakdown of products: Medical/Dental______________% Other:_____________%
Total revenues for past 3 years
Year
$
Year
$
Year
$
3)
List any product(s) expected to be introduced in the next 12 months.
4)
List any product(s) that have been discontinued in the past 3 years.
5)
List and describe any product(s)
a)
you manufacture for other companies to sell under their label.
b)
manufactured by other companies for sale under your label.
Do you require certificates of insurance from the manufacturer(s)?
6)
List any product(s) you make which are a component for others’ final product(s).
7)
List product(s) you sell, or components in your product(s) which are imported from a foreign supplier.
M E D M A R C
I N S U R A N C E
G R O U P
5
8)
Has the FDA visited any of your sites?
If yes, was notice of adverse findings issued?
Summarize and
provide your response to the FDA.
9)
Have you had any product recalls?
If yes, were they voluntary or FDA mandated?
Enclose details of
recall.
10) Do you have a written plan for product recalls?
11) Have any products or company practices been subjected to an investigation by the FDA or any other governmental
organization (U.S. or foreign)? If yes, please explain.
12) Do you have a loss prevention program in place?
Provide name, title and phone number of person in charge of
this program.
Name
Title
13) Have you filed any adverse events in the past 12 months?
Phone
Enclose detailed listing of each.
14) With respect to production records, do you have a record retention policy?
How many years do you retain records?
15) Provide the name of the person at your firm who should be contacted should we desire to schedule a physical inspection of
your operations.
Name
Title
Phone Number
M E D M A R C
I N S U R A N C E
G R O U P
6
C. PHARMACEUTICALS / BIOLOGICS
1)
Revenues
U.S. / Canada
Other Foreign
Prescription (ethical) products
$
$
Over the counter products
$
$
Vitamins / Nutritional Supplements
$
$
Other
$
$
Total revenues for past 3 years
Year
$
Year
$
Year
$
2)
List product(s). For nutraceuticals, provide ingredient label(s).
3)
List any new product(s) expected to be introduced in the next 12 months.
4)
List any product(s) that have been discontinued in the past 3 years.
5)
List and describe any product(s)
a) you manufacture for other companies to sell under their label.
b)
manufactured by other companies for sale under your label.
Do you require certificates of insurance from the manufacturer(s)?
6)
Has the FDA visited any of your sites?
If yes, was notice of adverse findings issued?
Summarize and
provide your response to the FDA.
M E D M A R C
I N S U R A N C E
G R O U P
7
7)
Do you have a written plan for product recalls?
8)
Have you had any product recalls?
9)
Have any product(s) or company practice been subjected to an investigation by the FDA or any other governmental
organization (U.S. or foreign)?
If yes, were they voluntary or FDA mandated?
Provide details of recall.
If yes, please provide details.
10) Do you have a loss prevention program in place?
If yes, please provide the name, title and phone number of
person in charge of this program.
Name
Title
Phone
11) Have you filed any adverse events in the past 12 months?
Enclose detailed listing of each.
12) With respects to production records, do you have a record retention policy?
How many years do you retain records?
13) Do you do any direct to consumer advertising?
If yes, please advise what from this takes (i.e. magazines,
television, internet, etc.)
14) Provide the name of the person at your firm who should be contacted should we desire to schedule a physical inspection of
your operations.
Name
Title
Phone Number
M E D M A R C
I N S U R A N C E
G R O U P
8
D. HUMAN CLINICAL TRIALS
1)
List all products that will be in the human clinical trial phase during the next 12 months. Provide copy of the protocol(s),
including informed consent document(s).
Product
2)
Have any trials been suspended?
M E D M A R C
Description
Number
Trial
Trial
of Patients
Phase
Length
Trial Location
If yes, please explain.
I N S U R A N C E
G R O U P
9
Notice To Applicant - Please Read Carefully
Insurance Fraud Warning
For your protection, the following warning is required by various state laws: Any person who knowingly and with the intent to
injure, defraud, or deceive any insurance company or other person, files a statement of claim or an application containing any
false, incomplete, or misleading information is guilty of a crime and may be subject to criminal and civil penalties which may
include imprisonment, fines, and denial of insurance.
Colorado Fraud Warning: 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 policyholders 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.
The undersigned hereby represents to the company the accuracy of the information provided on this application and
acknowledges the company is relying on the accuracy of such information in determining eligibility and qualification for
insurance.
Completing and signing this application does not bind coverage. Coverage will not be bound, nor will a policy be issued until the
applicant signifies acceptance of the company’s premium quotation.
Company Name
Signature
Title
Print Name
Date
E-Mail Address
M E D M A R C
I N S U R A N C E
G R O U P
8
Policyholder Contact List
Medmarc Casualty Insurance Company
Contact Name:
Title:
Physical Address:
Mailing Address:
Direct Dial #:
Fax Number:
Email Address:
M E D M A R C
I N S U R A N C E
G R O U P
9