Exhibit 10.16
SUPPLIER SET-UP
FORM
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DiaSys
Corporation
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Waterbury
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CT
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06702-2115
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Supplier
Name
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City
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State
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Zip
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49 Leavenworth
Street
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Waterbury
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CT
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06702-2115
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Supplier
Address
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City
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State
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Zip
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Same as
above
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Address
Purchase Orders To
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City
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State
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Zip
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Same as
above
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Address
Payment To
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City
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State
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Zip
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Same as
above
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Product
Returns To
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City
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State
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Zip
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Telephone#: 203/755-5083
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Corporate
HIN # 06-1339248
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800
#: 800/360-2003
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Fax#: 203/755-5105
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14 Days ARO
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Monday
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General Lead Time
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Preferred Day to Receive
Stock Purchase Orders
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Please give a brief description of your product
line(s).
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Laboratory
instruments which automate and standardize routine urine sediment
analysis
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Please indicate the size of your company.
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o
Over 500 employees
(Large Firm)
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ý Under 500 employees (Small Firm)
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If you are a small firm, please indicate if your firm can be
classified by one or more of the following SBA
categories:
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o
Not
Applicable
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ý Small
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o
Small-Disadvantaged
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o
Woman-Owned
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o
Sheltered
Workshop
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ý HUB Enterprise Zone
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o
Disabled Am.
Veteran-Owned
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Please indicate your firms SBA Standard Industrial Classification
(SIC) Code 3841 -0000 & 3826-0300
Page 1 of 14
SUPPLIER SET-UP FORM
REGULATORY AFFAIRS AND QUALITY
ASSURANCE INFORMATION
Which categories describe your product line?
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Medical
Device ý
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Drug
o
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Food
o
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Cosmetic
o
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Biologic
o
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Other
(Explain):_______________________________________________________________________
If the category is Drug, is your company's manufacturing site
registered with FDA as a Drug Establishment?
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YES,
Registration #
N/A
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Yes
o
No
o
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If yes, please
provide a copy of the Drug Listing Form FDA-2657
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Are any
products labeled as prescription drugs?
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Yes
o
No
o
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If the category is Biologic, please provide the license numbers for
each of the products. N/A
If the category is Medical Device, is your company's manufacturing
site registered with the FDA as a Device Establishment
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YES,
Registration #
1223854
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Yes
ý No
o
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Are any
product(s) pre-enactment medical devices
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Yes
o
No
ý
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If yes, please
provide a copy of the Device Listing Form FDA-2892 Are any of the
product(s) post-enactment medical devices?
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Yes
ý No
o
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If yes, please
provide a copy of the FDA Premarket Notification (510k) clearance
letter or the premarket approval response. Also, please provide a
copy of the Device Listing Form FDA-2892. Are any products labeled
as prescription devices?
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Yes
o
No
ý
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Are any
products expiration dated?
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Yes
o
No
ý
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Do any products
contain natural rubber latex?
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Yes
o
No
ý
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Do any products
require a warning as a Carcinogen or Reproductive Toxicant as
defined by California Proposition 65?
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Yes
o
No
ý
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Are any
products labeled "Sterile"
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Yes
o
No
ý
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Are any of your
products manufactured with or contain CFCs?
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Yes
o
No
ý
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Are any of your
products considered hazardous (including Consumer Commodity, ORM-D)
by the Department of Transportation while in transit?
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Yes
o
No
ý
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Do any products
have Material Safety Data Sheets?
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Yes
o
No
ý
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Do any product
labels state storage temperature ranges or requirements?
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Yes
ý No
o
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Do any products
require special shipping conditions for temperature
control?
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Yes
o
No
ý
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Are any of the
products a chemical, chemical reagent, or impregnated with a
chemical (for example: detergent, disinfectant, germicide, hand
lotion, soap, alcohol swabs, cream, gel, paste, powder, acid, base,
solvent, adhesive, etc.)?
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Yes
o
No
ý
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Page 2 of 14
SUPPLIER SET-UP FORM
RA/QA Information
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Do any products
contain a microprocessor, electronic controller, hardware or
software that has a calendar or real time clock?
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Yes
ý No
o
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If yes, do you
certify that all such products will function properly without
regard to Year 2000 issues?
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Yes
ý No
o
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If no, please
attach a detailed explanation of product related issues which may
arise as a result of Year 2000.
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Do you
anticipate manufacturing private label products for
Allegiance?
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Yes
o
No
ý
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Do any of your
products require tracking to the patient level per 21 CFR
821?
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Yes
o
No
ý
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Page 3 of 14
SUPPLIER PROFILE
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I.
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PRIMARY
CONTACT(S )
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Name
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Title
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Phone
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E
Mail
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Todd M.
DeMatteo
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President/CEO
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203/755-5083
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diasyscorp.com
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Marketing
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Todd M.
DeMatteo
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"
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"
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"
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Sales
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Carol
Bopp
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Customer
Service
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"
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"
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Customer
Service
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N/A
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National
Accounts/Multi-Healthcare Systems
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Richard
Manville
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Manager-Finance
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"
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"
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Accounting
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Carol
Bopp
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Customer
Service
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"
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"
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RA/QA
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Richard
Manville
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Manager-Finance
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"
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"
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Shipping
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Laura
Marshall
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Field
Services
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"
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"
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EDI
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Todd m.
DeMatteo
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President/CEO
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"
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"
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Pricing
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II.
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BACKGROUND
INFORMATION
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A.
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Marketing
Overview
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1.
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Description of
Product Category(ies)
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Laboratory
testing of bodily fluids.
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2.
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Total Industry
Sales per Category
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N/A
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3.
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Supplier's
Annual Sales Per Category
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N/A
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4.
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Current Sales
Trend Per Category
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N/A
Yellow
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5.
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Top 3
Competitive Products
(include Supplier name)
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1) Iris
2) UF100
3) Kova
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- Iris
- Sysmex Corp of Am.
- Hycor Biomedical
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Page 4 of 14
SUPPLIER SET-UP FORM
Supplier Profile
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B.
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Specific
Supplier Information
|
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1.
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Is your
Business
|
o
Domestic
|
o
International
|
ý Both?
|
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2.
|
Is your
Company
|
o
International
|
ý Publicly Held?
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