Email Address:
  
  Password:
  
  



Exhibit 10.16

SUPPLIER SET-UP FORM

 

 

December 8, 1999
Date

 

DiaSys Corporation


 

Waterbury


 

CT


 

06702-2115


 

Supplier Name

City

State

Zip

 

 

 

 

49 Leavenworth Street


 

Waterbury


 

CT


 

06702-2115


 

Supplier Address

City

State

Zip

 

 

 

 

Same as above


 


 


 


 

Address Purchase Orders To

City

State

Zip

 

 

 

 

Same as above


 


 


 


 

Address Payment To

City

State

Zip

 

 

 

 

Same as above


 


 


 


 

Product Returns To

City

State

Zip

 

Telephone#: 203/755-5083

 

Corporate HIN # 06-1339248

 

800 #: 800/360-2003     

 

 

 

Fax#:  203/755-5105     

 

 

 

14 Days ARO


 

 

Monday


 

 

General Lead Time

 

Preferred Day to Receive
Stock Purchase Orders

 


Please give a brief description of your product line(s).


 

Laboratory instruments which automate and standardize routine urine sediment analysis


 


Please indicate the size of your company.

o    Over 500 employees (Large Firm)

ý    Under 500 employees (Small Firm)


If you are a small firm, please indicate if your firm can be classified by one or more of the following SBA categories:

o   Not Applicable

ý    Small

o   Small-Disadvantaged

o   Woman-Owned

 

o   Sheltered Workshop

ý    HUB Enterprise Zone

o   Disabled Am. Veteran-Owned


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?

Medical Device    ý

Drug    o

Food    o

Cosmetic    o

Biologic    o

Other (Explain):_______________________________________________________________________

If the category is Drug, is your company's manufacturing site registered with FDA as a Drug Establishment?

 

YES, Registration #      N/A      

Yes o        No o

 

If yes, please provide a copy of the Drug Listing Form FDA-2657

 

 

Are any products labeled as prescription drugs?

Yes o        No o


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

 

YES, Registration #   1223854        

Yes ý        No o

 

Are any product(s) pre-enactment medical devices

Yes o        No ý

 

If yes, please provide a copy of the Device Listing Form FDA-2892 Are any of the product(s) post-enactment medical devices?

Yes ý        No o

 

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?

Yes o        No ý

 

Are any products expiration dated?

Yes o        No ý

Do any products contain natural rubber latex?

Yes o        No ý

Do any products require a warning as a Carcinogen or Reproductive Toxicant as defined by California Proposition 65?

Yes o        No ý

Are any products labeled "Sterile"

Yes o        No ý

Are any of your products manufactured with or contain CFCs?

Yes o        No ý

Are any of your products considered hazardous (including Consumer Commodity, ORM-D) by the Department of Transportation while in transit?

Yes o        No ý

Do any products have Material Safety Data Sheets?

Yes o        No ý

Do any product labels state storage temperature ranges or requirements?

Yes ý        No o

Do any products require special shipping conditions for temperature control?

Yes o        No ý

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.)?

Yes o        No ý


Page 2 of 14




SUPPLIER SET-UP FORM

RA/QA Information

Do any products contain a microprocessor, electronic controller, hardware or software that has a calendar or real time clock?

Yes ý        No o

 

 

If yes, do you certify that all such products will function properly without regard to Year 2000 issues?

Yes ý        No o

 

If no, please attach a detailed explanation of product related issues which may arise as a result of Year 2000.

 

 

Do you anticipate manufacturing private label products for Allegiance?

Yes o        No ý

Do any of your products require tracking to the patient level per 21 CFR 821?

Yes o        No ý

 

 

 

 

 

 

 

 

 

 

 

 











Page 3 of 14



SUPPLIER PROFILE

I.

PRIMARY CONTACT(S )

 

 

 

 

Name

Title

Phone

E Mail

 

Todd M. DeMatteo


 

President/CEO


 

203/755-5083


 

diasyscorp.com


 

 

Marketing

 

 

 

 

 

 

 

 

 

Todd M. DeMatteo


 

"


 

"


 

"


 

 

Sales

 

 

 

 

 

 

 

 

 

Carol Bopp


 

Customer Service


 

"


 

"


 

 

Customer Service

 

 

 

 

 

 

 

 

 

N/A


 


 


 


 

 

National Accounts/Multi-Healthcare Systems

 

 

 

 

 

 

 

 

Richard Manville


 

Manager-Finance


 

"


 

"


 

 

Accounting

 

 

 

 

 

 

 

 

 

Carol Bopp


 

Customer Service


 

"


 

"


 

 

RA/QA

 

 

 

 

 

 

 

 

 

Richard Manville


 

Manager-Finance


 

"


 

"


 

 

Shipping

 

 

 

 

 

 

 

 

 

Laura Marshall


 

Field Services


 

"


 

"


 

 

EDI

 

 

 

 

 

 

 

 

 

Todd m. DeMatteo


 

President/CEO


 

"


 

"


 

 

Pricing

 

 

 

 

 

 

 

 

II.

BACKGROUND INFORMATION

 

 

A.

Marketing Overview

 

 

 

 

 

1.

Description of Product Category(ies)

Laboratory testing of bodily fluids.

 

 

2.

Total Industry Sales per Category

N/A                                                      

 

 

3.

Supplier's Annual Sales Per Category

N/A                                                      

 

 

4.

Current Sales Trend Per Category

N/A                                                      
Yellow

 

 

 

5.

Top 3 Competitive Products
(include Supplier name)

1) Iris   
2) UF100
3) Kova 

- Iris
- Sysmex Corp of Am.
- Hycor Biomedical


Page 4 of 14



SUPPLIER SET-UP FORM
Supplier Profile

B.

Specific Supplier Information

 

 

1.

Is your Business

o    Domestic

o    International

ý    Both?

 

 

 

 

 

 

 

2.

Is your Company

o    International

ý    Publicly Held?

 

 

 

 

 

 

 

 

3


This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more