Document:

exv10w1

 

Exhibit 10.1

Confidential treatment has been requested for portions of this exhibit. The copy filed herewith
omits the information subject to the confidentiality request. Omissions are designated as [***]. A
complete version of this exhibit has been filed separately with the Securities and Exchange
Commission.

 

 

	 	 	 
	

	 	SUBCONTRACT
 

SUBCONTRACT
NUMBER: S2040823-1

Date: 08/23/04

To:

     Virtual Alert, Inc.

     7748 Herschell Avenue

     La Jolla, CA 92038

      

	 	 	 
	Attention:

	 	[***]
	 

	 	[***]

Ship To:

     Department of Homeland Security

     Science and Technology Directorate

     245 Murray Drive

     Building 410

     Washington, DC 20528

      

     Attention: Dr. Peter Estacio (202) 254-6073

     Fax (202) 254-6169; E-Mail: Peter Estacio@dha.gov

	 	 	 	 	 	 	 
	Project No.	 	Program Manager	 	Performance Period	 	Payment Terms
	1410

	 	Richard Basch
	 	08/23/04 — 02/04/05
	 	5 days after Government pay

	 	 	 	 	 	 	 	 	 	 	 
	Qty	 	Item	 	Description	 	Unit Price	 	Total
	 

	 	 	 	 	 	Services provided in connection with Department of Homeland
Security (DHS) Statement of Work entitles, “BioWatch Staffing,
Communication and Laboratory Data Integration” DHS Order Number
HSHQPA-04-F-00056 under CIO-SP2 Task Authorization Number
DHS-2004-C-2329-T-00, and the DHS-accepted A-TEK technical
proposal dated 09 August 2004 (both attached)	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	1

	 	 	0001	 	 	Base Period: 08/23/04 — 02/04/05:
	 	$[***]
	 	$[***]
	 

	 	 	 	 	 	To develop methods to improve and support the BioWatch Program,
in accordance with this Subcontract.	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	1

	 	 	0002	 	 	Option 1: 02/07/05 — 01/05/06: $[***]	 	 	 	 
	 

	 	 	 	 	 	Continued Support	 	 	 	 
	 

	 	 	 	 	 	To be executed upon receipt of corresponding Government Mod.	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	1

	 	 	0003	 	 	Option 2: 01/09/06 — 12/08/06: $[***]	 	 	 	 
	 

	 	 	 	 	 	Continued Support	 	 	 	 
	 

	 	 	 	 	 	To be executed upon receipt of corresponding Government Mod.	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Total Subcontract Award Amount: $[***]	 	 	 	 

SUBCONTRACT NOTES:

     This Subcontract, effective 23 August 2004, is entered into by and between A-TEK, Inc.,
hereinafter referred to as “A-TEK” or the “Contractor” and Virtual Alert, Inc., hereinafter
referred to as “Subcontractor.”

     WHEREAS, A-TEK and Subcontractor desire to enter into a Subcontract for supplies and/or
service to support A-TEK in performance of Department of Homeland Security Order Number
HSHQPA-04-F00056 under National Institutes of Health CIO-SP2 Contract Number 263-01-D-0084. Task
Authorization Number DHS-2004-C-2329-T-00. The applicable CIO-SP2 contract clauses can be found at
web site http://nitaac.nih.gov.

     NOW, THEREFORE, in consideration of the terms hereinafter agreed to, the mutual promises and
covenants hereinafter set forth, and other good and valuable considerations, the parties A-TEK and
Subcontractor, hereby mutually agree as reflected in the following pages of this Subcontract.

     IN WITNESS WHEREOF, the parties hereto have executed this Subcontract as shown herein.

	 	 	 
	TOTAL

	 	$[***]

A-TEK, Inc.

By: /s/ Debbie Rieger

Name: Debbie Rieger

Title: President

Date: 09/30/04

Virtual Alert, Inc.

By: /s/ Chris Popov

Name:  Chris Popov

Title: Executive Director

Date:  Sept 24, 2004

Page 1 of 14

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Table of Contents

	 	 	 	 	 
	A. — AUTHORITY
	 	 	3	 
	B. — SUPPLIES/SERVICES AND PRICE/COST
	 	 	3	 
	B.1 Schedule of Items
	 	 	3	 
	B.1.1. Task 1 - S2040823-1.1- Task Order Management
	 	 	4	 
	B.1.2. Task 2 - S2040823-1.2 - BioWatch Surveillance Team
	 	 	4	 
	B.1.3. Task 3 - S2040823-1.3 - BioWatch Surveillance Team — Surge Capacity
	 	 	5	 
	B.1.4. Task 4 - S2040823-1.4 - BioWatch Surveillance Team Training
	 	 	5	 
	B.1.5. Task 5 - S2040823-1.5 - BioWatch Information Systems Management
	 	 	6	 
	B.1.6. Task 6 - S2040823-1.6 - Administration and Personnel Management
	 	 	6	 
	B.1.7. Task 7 - S2040823-1.7 - BioWatch Operations and Enhancement Review Committee
	 	 	6	 
	B.1.8. Task 8 - S2040823-1.8 - BioWatch Signal Interpretation and Consequence
Management Facilitation
	 	 	7	 
	C. — STATEMENT OF WORK
	 	 	8	 
	D. — PACKAGING AND MARKING
	 	 	8	 
	E. — INSPECTION AND ACCEPTANCE
	 	 	8	 
	E.1 Clauses Incorporated by Reference
	 	 	8	 
	F. — DELIVERIES OR PERFORMANCE
	 	 	9	 
	F.1 Effective Period of the Subcontract
	 	 	9	 
	F.2 Place of Performance
	 	 	9	 
	F.3 Deliverables
	 	 	10	 
	F.4 Clauses Incorporated by Reference
	 	 	11	 
	G. — SUBCONTRACT ADMINISTRATION DATA
	 	 	11	 
	G.1 Technical and Contractual Representatives
	 	 	11	 
	G.2 Closeout
	 	 	12	 
	G.3 Past Performance Evaluation
	 	 	12	 
	G.4 Financial Obligation and Payment
	 	 	13	 
	H. — SUBCONTRACT PROVISIONS
	 	 	13	 
	H.1 Disclosure *
	 	 	13	 
	H.2 Indemnification
	 	 	13	 
	H.3 Non-Waiver of Rights
	 	 	14	 
	H.4 Solicitation for Employment
	 	 	14	 
	H.5 General Relationship *
	 	 	14	 
	H.6 Applicable State Law and Compliance
	 	 	14	 
	H.7 Entire Agreement
	 	 	14	 
	H.8 Conflict of Interest *
	 	 	14	 
	H.9 Conferences
	 	 	15	 
	H.10 Travel *
	 	 	15	 
	H.11 Key Personnel
	 	 	15	 
	H.12 Insurance Schedule *
	 	 	16	 
	H.12.1. Type of Insurance and Minimum Amounts
	 	 	16	 

Page 2 of 14

 

	 	 	 	 	 
	H.12.2. Certificates of Insurance
	 	 	17	 
	H.13 Security *
	 	 	17	 
	H.13.1 Information Technology Systems Security *
	 	 	17	 
	H.14 Government Furnished Equipment, Information or Services *
	 	 	17	 
	H.15 Press Releases *
	 	 	18	 
	H.17 Alternate Dispute Resolution Procedures (ADR)
	 	 	18	 
	H.18 Non-Personal Services *
	 	 	18	 
	H.19 SECTION 508 OF THE REHABILITATION ACT OF 1973 AS AMENDED *
	 	 	19	 
	I — FAR CLAUSES INCORPORATED BY REFERENCE *
	 	 	19	 
	J — LIST OF ATTACHMENTS
	 	 	19	 
	1 - Statement of Work
	 	 	 	 
	2 -
Technical Proposal
	 	 	 	 
	3 - Laboratory Labor Rates
	 	 	 	 
	4 - NITAAC Past Performance Evaluation Report
	 	 	 	 
	5 - FAR/HHSAR Clauses
	 	 	 	 

Page 3 of 14

 

A. — AUTHORITY

The authority for this procurement is under Department of Homeland Security (DHS) Systems
Engineering and Development Office, Order Number HSHQPA-04-F-00056 for “BioWatch Staffing,
Communications, and Laboratory Data Integration” Services under the National Institutes of Health
(NIH) CIO-SP2 Task Order Authorization Number DHS-2004-C-2329-T-00, as issued under A-TEK’s CIO-SP2
NIH, National Information Technology Acquisition and Assessment Center (NITAAC) Contract No.
263-01-D-0084, found in full text at http://nitaac.nih.gov.

B. — SUPPLIES/SERVICES AND PRICE/COST

The Subcontractor, acting as an independent contractor and not as an agent of the Government, shall
furnish all materials, personnel, facilities, support and management necessary to provide the
supplies and services as set forth below as defined in (1) the Statement of Work (SOW) entitled
“BioWatch Staffing, Communication, and Laboratory Data Integration” dated 07/19/04, incorporated as
Attachment 1 to this subcontract; and (2) the technical proposal submitted to DHS 09 August
2004, incorporated as Attachment 2, to this subcontract.

B.1 Schedule of Items

On a Time and Material-(T&M) type Task Order basis, the Subcontractor shall provide a full range of
supplies and services as specified and in accordance with the SOW. Base Period pricing is set
forth below by labor category and by individual SOW Task Number. Option Year pricing has been
calculated using the Base Period times 2 and escalated [***]% per year. Pricing shall be detailed
and provided with the corresponding subcontract exercising each Option Year.

T&M rates are inclusive of all labor, fringe, overhead, G&A, taxes, insurance and profit.
Materials and travel shall be invoiced at cost and supported by receipts for all material costs
exceeding $25. Travel shall be reimbursed in accordance with Section H.10 herein.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Task	 	Description	 	 	Base – 6 mo	 	 	Option Yr 1	 	 	Option Yr 2	 
	1
	 	Contract Level and Task Order Management	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	2
	 	BioWatch Surveillance Team	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	3
	 	BioWatch Surveillance Team- Surge Capacity	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	4
	 	BioWatch Surveillance Team Training	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	5
	 	BioWatch Information Systems Management	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	6
	 	Administration and Personnel Management	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	7
	 	BioWatch Operations &
Enhancement Review Committee	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	8
	 	BioWatch Signal Interpretation
& Consequence Management Facilitation	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	9
	 	BioWatch Research and Study Assistance	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Totals	 	$	[***]	 	 	$	[***]	 	 	$	[***]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	TOTAL VALUE	 	$	[***]	 

The
total funding available for this subcontract is for the Base Period
ONLY for $[***].

A breakdown of each task is provided below. Additional work for any given Task below may be incorporated my subcontract modification as
Work Assignments are provided by DHS.

[***] = Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 3 of 19

 

B.1.1. Task 1 — S2040823-1.1 — Task Order Management

	 	 	 	 	 	 	 	 	 	 	 
	 	 	CIO-SP2	 	CLIN	 	 	 	T&M	 	Total
	Task Order Position	 	Labor Category	 	No.	 	Hours	 	Rate	 	Price
	[***]

	 	[***]
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	 	[***]
	 

	 	 	 	 	 	 
	 	 
	 	 
	 

	 	 	 	Subtotal Task 1
	 	[***]
	 	 	 	[***]
	 

	 	 

	 	 	 	 	 	 	 	 	 
	Travel	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	 	Total Travel
     NOT TO EXCEED
	 	[***]	 	 	 	 
	Total Subcontract Task 1 – Contract-Level Program Management — Base Period [***]

     Option Year pricing has been calculated using the Base Period times 2 and escalated
[***] % per year.

	 	•	 	Option Year 1 $ [***]
	 
	 	•	 	Option Year 2 $ [***]

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 4 of 19

 

B.1.2. Task 2 — S2040823-1.2 — BioWatch Surveillance Team

	 	 	 	 	 	 	 	 	 	 	 
	 	 	CIO-SP2	 	CLIN	 	 	 	T&M	 	Total
	Task Order Position	 	Labor Category	 	No.	 	Hours	 	Rate	 	Price
	[***]

	 	[***]
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	 	[***]
	 	[***]
	 

	 	 
	 	 
	 	 
	 	 
	 	 
	Total Subcontract Task 2 – BioWatch Surveillance Team — Base Period	 	$ [***]

Option Year 1 pricing has been calculated using the pricing table of the top [***]
laboratory staff rates for the identified BioWatch cities included as Attachment 3 to
this subcontract and escalated [***] % for Option Year2.

	 	•	 	Option Year 1 $ [***]
	 
	 	•	 	Option Year 2 $ [***]

B.1.3. Task 3 — S2040823-1.3 — BioWatch Surveillance Team – Surge Capacity

	 	 	 	 	 	 	 	 	 	 	 
	 	 	CIO-SP2	 	CLIN	 	 	 	T&M	 	Total
	Task Order Position	 	Labor Category	 	No.	 	Hours	 	Rate	 	Price
	[***]

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	Total Subcontract Task 3 – BioWatch Surveillance Team – Surge Capacity – Base Period	 	$ [***]

     Option Year pricing has been calculated using the Base Period times 2 and escalated
[***] % per year.

	 	•	 	Option Year 1 $ [***]
	 
	 	•	 	Option Year 2 $ [***]

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 5 of 19

 

B.1.4. Task 4 — S2040823-1.4 — BioWatch Surveillance Team Training

	 	 	 	 	 	 	 	 	 	 	 
	 	 	CIO-SP2	 	CLIN	 	 	 	T&M	 	Total
	Task Order Position	 	Labor Category	 	No.	 	Hours	 	Rate	 	Price
	[***]

	 	[***]
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	 	[***]
	Total Subcontract Task 4 – BioWatch Surveillance Team Training – Base Period	 	$[***]

Option Year pricing has been calculated using the Base Period times 2 and escalated
[***] % per year

	 	•	 	Option Year 1 $ [***]
	 
	 	•	 	Option Year 2 $ [***]

B.1.5. Task 5 — S2040823-1.5 — BioWatch Information Systems Management

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	CIO-SP2	 	CLIN	 	 	 	T&M	 	Total	 	 
	Task Order Position	 	Labor Category	 	No.	 	Hours	 	Rate	 	Price	 	 
	[***]

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	 	Subtotal Labor Cost
	 	 	 	[***]
	 	 	 	 	 	[***]

	 	 	 	 	 	 	 	 	 
	Other Direct Costs	 	Unit	 	Qty	 	Unit Cost	 	Total Price
	[***]

	 	[***]
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	Total Subcontract Task 5 – BioWatch Information Systems Management – Base Period
	$[***]

Option Year 1 pricing has been calculated using the pricing table all staff rates for the
identified BioWatch cities included as Attachment 2 to this subcontract and escalated
[***] % for Option Year2.

	 	•	 	Option Year 1 $ [***]
	 
	 	•	 	Option Year 2 $ [***]

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 6 of 19

 

B.1.6. Task 6 — S2040823-1.6 — Administration and Personnel Management

Staff associated with the performance of this Task are funded as part of other Tasks within this
subcontract and not funded separately here.

B.1.7. Task 7 — S2040823-1.7 — BioWatch Operations and Enhancement Review Committee

	 	 	 	 	 	 	 	 	 
	Travel / Meeting Category	 	Item of cost	 	Unit Cost	 	 	 	Total Price
	Airfare

	 	[***]
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	Lodging

	 	[***]
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	Meals / Catering

	 	[***]
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	Meeting Room

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 

	 	 	 	 	 	 
	 	 
	 

	 	 	 	Total Cost Each Meeting
	 	 	 	[***]
	 

	 	 	 	Estimated [***] Meetings
	 	 	 	[***]
	Total Subcontract Task 7 – BioWatch Operations and Enhancement Review Committee – Base Period [***]

Option Year pricing has been calculated using the Base Period times 2 and escalated
[***] % per year.

	 	•	 	Option Year 1 $ [***]
	 
	 	•	 	Option Year 2 $ [***]

B.1.8. Task 8 — S2040823-1.8 — BioWatch Signal Interpretation and Consequence Management Facilitation

	 	 	 	 	 	 	 	 	 	 	 
	 	 	CIO-SP2	 	CLIN	 	 	 	T&M	 	Total
	Task Order Position	 	Labor Category	 	No.	 	Hours	 	Rate	 	Price
	[***]

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[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 7 of 19

 

	 	 	 	 	 	 	 	 	 	 	 	 	 
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	 	 	[***]	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	 	[***]	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	 	[***]	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	 	[***]	 
	 

	 	 	 	Total Labor Cost
	 	[***]
	 	 	 	 	[***]	 
	Travel
	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	 	 	 	 	 	 	 	[***]	 
	[***]

	 	[***]
	 	 	 	 	 	 	 	 	[***]	 
	[***]

	 	[***]
	 	 	 	 	 	 	 	 	[***]	 
	[***]

	 	[***]
	 	 	 	 	 	 	 	 	[***]	 
	[***]

	 	[***]
	 	 	 	 	 	 	 	 	[***]	 
	[***]

	 	[***]
	 	 	 	 	 	 	 	 	[***]	 
	 

	 	Total Travel
	 	NOT TO EXCEED
	 	 	 	 	 	$	[***]	 
	Total Subcontract Task 8 – BioWatch Signal Interpretation and
Consequence Management Facilitation – Base Period	 	$	[***]	

Option Year pricing has been calculated using the Base Period times 2 and escalated
[***] % per year.

	 	•	 	Option Year 1 $ [***]
	 
	 	•	 	Option Year 2 $ [***]

B.1.9. Task 9 — S2040823-1.9 — BioWatch Research and Study Assistance

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Unit	 	Total
	Period	 	Quantity	 	Price	 	Price
	Base

	 	 	1	 	 	[***]
	 	[***]

Option Year pricing has been calculated assuming two studies per Option Year.

	 	•	 	Option Year 1 $ [***]
	 
	 	•	 	Option Year 2 $ [***]

C. — STATEMENT OF WORK

This Subcontract hereby incorporates the full Statement of Work (SOW) entitled “BioWatch Staffing,
Communication, and Laboratory Data Integration” dated 07/19/04, incorporated as Attachment
1 to this subcontract, and the technical proposal submitted to DHS 09 August 2004, incorporated
as Attachment 2 to this subcontract.

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 8 of 19

 

D. — PACKAGING AND MARKING

The Subcontractor shall, through A-TEK, comply with the requirements of the corresponding
requirements of Section 12 of the SOW and Section of D the Prime CIO-SP2 Contract found in full
text at http://nitaac.nih.gov. Packaging and packing of all items for delivery shall be in
accordance with good commercial practice and adequate to assure safe arrival at destination.

E. — INSPECTION AND ACCEPTANCE

The Subcontractor shall, through A-TEK, comply with all requirements of the corresponding Section
13 of the SOW and Section of E the Prime CIO-SP2 Contract found in full text at
http://nitaac.nih.gov. All materials furnished and services performed pursuant hereto
shall be subject to inspection and test by Prime Contractor and its agents and by the Government
client at all times and places, during the period of performance, and in any event before
acceptance.

All deliverables shall be inspected for content, completeness, accuracy and conformance to SOW
requirements by the Contracting Officer’s Technical Representative (COTR). The basis for
acceptance shall be in compliance with the requirements set forth in the Statement of Work, the
Subcontractor’s proposal and other terms and conditions of this Subcontract. Travel and ODCs shall
be accepted upon receipt of proper documentation. Reports, documents and narrative type
deliverables shall be accepted when all discrepancies, errors or other deficiencies identified in
writing by the Government have been corrected. Prime Contractor’s acceptance of the work shall
occur upon successful completion of test and acceptance of the same by the Government.

The Government requires a period not to exceed thirty (30) days after receipt of final deliverable
items for inspection and acceptance or rejection unless otherwise specified by the Government. In
the event that material furnished or services supplied are not performed in accordance with the SOW
requirements, Prime Contractor may require Subcontractor to replace or correct services or
materials.

E.1 Clauses Incorporated by Reference

This Subcontract incorporates one or more FAR clauses by reference with the same force and effect
as if they were given in full text. Where necessary to make the context of these provisions
applicable to this Subcontract, the term “Government” and equivalent phrases shall mean A-TEK, the
term “Contractor” shall mean Subcontractor, and the term “Contract” shall mean this Subcontract.
Where any reference contains alternative clauses, that alternative shall apply to this Subcontract.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSES

	 	 	 	 	 
	Clause No.	 	Title	 	Date
	52.246-6

	 	Inspection – Time and Materials and Labor Hour
	 	JAN 1984

F. — DELIVERIES OR PERFORMANCE

The Subcontractor shall, through A-TEK, comply with the requirements defined in the Statement of
Work (SOW) entitled “BioWatch Staffing, Communication, and Laboratory Data Integration”
dated 07/19/04, incorporated as Attachment 1 to this subcontract; the technical proposal
submitted to DHS 09 August 2004, incorporated as Attachment 2 to this subcontract, and
Section of F the Prime CIO-SP2 Contract found in full text at http://nitaac.nih.gov.

Page 9 of 19

 

F.1 Effective Period of the Subcontract

This Subcontract shall remain in effect from 08/23/04 through 02/04/05, with two (2) Options with
periods of performance as set forth below, in accordance with the DHS Order to Prime Contractor:

	 	•	 	Base Period: 08/23/04 — 02/04/05
	 
	 	•	 	Option 1: 02/07/05 — 01/05/06
	 
	 	•	 	Option 2: 01/09/06 — 12/08/06

Options shall be executed and funded by Modification when the corresponding Modifications are
issued under the Prime Contract.

F.2 Place of Performance

As stated in Section 7.0 of the SOW, the primary on-site work is to be performed at the local
public health laboratory site, at the Department of Homeland Security location in Washington, D.C.
and at the Contractor’s site as agreed to by DHS. Tasks 2 through 6 take place at the Government’s
designated laboratory site at any designated city within the United States. Representative cities
include:

[***]

In performing work under this Subcontract on a Government installation or in a Government
building, the Subcontractor shall fully comply with rules and regulations of local installation,
city, state and federal laws, regulations and/or ordinances pertinent to performance of the
contractual services required under this contract. Specifically, the contractor shall:

	1.	 	Conform to the specific safety requirements established by the facility;
	 
	2.	 	The Subcontractor and his/her employees shall observe all rules and regulations issued
by the installation’s Senior Official pertaining to fire, safety, sanitation, severe
weather, admission to the installation, conduct not directly addressed in this Subcontract;

	3.	 	Take all reasonable steps and precautions to prevent accidents and preserve the life
and health of themselves, contractor and Government personnel connected in any way with
performance under this contract;

	4.	 	Take such additional immediate precautions as the Prime Contractor and/or Government
may reasonably require for safety and accident prevention purposes; and

[***] = Certain information on this page
has been omitted and filed separately with the Commission. Confidential treatment has been requested
with respect to the omitted portions.

Page 10 of 19

 

	 	5.	 	Conform to all security requirements as directed by the customer and or Prime
Contractor.

F.3 Deliverables

Subcontractor is to provide the deliverables as scheduled in Section 9.0 of the SOW. The
Government requires the delivery of all supplies and/or services ordered under this Subcontract be
made in accordance with the delivery schedule specified below. The place of performance and/or
delivery for all items to be acquired hereunder will be specified by the Government.

	 	 	 	 	 	 	 
	SOW	 	DELIVERABLE	 	DESCRIPTION	 	DUE DATE
	TASK	 	TITLE	 	 	 	 
	1

	 	Status Report
	 	Overall project performance categorized by Work Task.
Milestones, deliverables, and budget information to be
included. To be delivered in MS Word format to the
COTR, Contracting Officer and designated DHS Project
Manager.
	 	Monthly, on

10th
calendar day
	 
	 	 	 	 	 	 
	2

	 	Pilot Site Staffing
	 	Four lab analysts deployed to a DHS BioWatch Pilot Site.
	 	Within 30 days of award
	 
	 	 	 	 	 	 
	2

	 	Core Management

Staffing
	 	All Core Management Staff hired and engaged in
performance of the tasks outlined within this SOW.
	 	Within 30 days of
award
	 
	 	 	 	 	 	 
	3

	 	Surge Capacity

Staffing
	 	Plan Provide DHS BioWatch staff with a surge capacity
staffing plan for select cities. Plan is to be
delivered in MS Word format.
	 	Within 90 days of
award
	 
	 	 	 	 	 	 
	7

	 	Operations and
Enhancement Review
Committee
	 	Convene a BioWatch Operations and Enhancement Review
Committee.
	 	Within 60 days of
award
	 
	 	 	 	 	 	 
	1

	 	In-Process Review
	 	Deliver an In-Process Review and Briefing to key DHS
BioWatch Staff
	 	Within 90 days of
award and every 6
months thereafter
	 
	 	 	 	 	 	 
	4

	 	Updated Training

Material
	 	Provide DHS BioWatch staff with updated training
materials, including developed training exercises and
manuals.
	 	Within 180 days of
award
	 
	 	 	 	 	 	 
	5

	 	Data Integration

Roadmap
	 	Provide DHS BioWatch staff with a roadmap describing
how data and information contained within legacy
systems at the state and local laboratory level will be
integrated with specific BioWatch Information Systems.
To be delivered in electronic media format.
	 	Within 180 days of
award

The Subcontractor shall immediately notify the Prime Contractor in the event the delivery or
performance schedule deviates from the schedule in the SOW or any other schedule implemented by the
Prime Contractor or customer.

F.4 Clauses Incorporated by Reference

This Subcontract incorporates one or more FAR clauses by reference with the same force and effect
as if they were given in full text. Where necessary to make the context of these provisions
applicable to this Subcontract, the term “Government” and equivalent phrases shall mean A-TEK, the
term “Contractor” shall mean Subcontractor, and the term “Contract” shall mean this
Subcontract. Where any reference contains alternative clauses, that alternative shall apply to
this Subcontract.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSES

Page 11 of 19

 

	 	 	 	 	 
	Clause No.	 	Title	 	Date
	 
	52.242-15
	 	Stop Work Order (for other than Cost Reimbursement

	 	AUG 1989
	52.247-34
	 	F.O.B. Destination

	 	NOV 1991
	52.247-35
	 	F.O.B Destination, Within Consignee’s Premise

	 	APR 1984

G. — Subcontract Administration Data

The paragraphs that follow outline the procedures for administration of the subcontract.

G.1 Technical and Contractual Representatives

When, in the opinion of Subcontractor, technical direction constitutes a change to the Subcontract,
Subcontractor shall notify A-TEK immediately for authorization of such change. The Subcontract
shall be modified to the extent authorized and allowable by Modification to the Prime Contract Task
Order from the Client. Until authorization to proceed with the requested change is received,
Subcontractor shall perform in accordance with the Subcontract as written.

     NO CHANGE SHALL BE BINDING UPON EITHER PARTY UNLESS INCORPORATED IN A WRITTEN MODIFICATION TO
THE SUBCONTRACT AND SIGNED BY AN AUTHORIZED A- TEK REPRESENTATIVE.

	 	 	 	 	 
	 	 	The Contracts Manager for this contract is identified as:
	 

	 	Ms. Debbie Rieger
	 	Telephone No.: (703) 443-6900
	 

	 	602 South King Street, Suite 300
	 	Fax No.: (703) 443-0677
	 

	 	Leesburg, VA 20175
	 	E-mail Address: contracts@a-tek.net
	 
	 	 	 	 
	 	 	The Program
Manager for this contract is identified as:
	 

	 	Mr. Richard Basch
	 	Telephone No.: (703) 443-6900
	 

	 	602 South King Street, Suite 300
	 	Fax No.: (703) 443-0677
	 

	 	Leesburg, VA 20175
	 	E-mail Address: rbasch@a-tek.net

a. Changes. Notwithstanding any other provisions contained elsewhere in the documents of this
Subcontract, an authorized official of the Prime Contractor is the only person authorized to
approve changes in this Subcontract. No changes or deviation from the Statement of Work or any
other provision under this Subcontract shall be effected without a written modification to the
Subcontract executed by an authorized official of the Prime Contractor authorizing such changes.

b. Technical Coordination. All technical coordination shall be within the scope of the
Subcontract and provisions herein. No oral statements of any person whosoever will in any
manner or degree modify or otherwise affect the provisions or intent of this contract.
Technical coordination shall not result in any action that:

	 	(a)	 	Constitutes an assignment of additional work outside the SOW or the funding
document/order.
	 
	 	(b)	 	Constitutes a change as defined in the contract clause entitled “Changes” for
Firm Fixed Price, Time and Material contracts.
	 
	 	(c)	 	Causes an increase in the total contract ceiling, funding document/order price,
or total estimated cost, or the time required for contract or performance.
	 
	 	(d)	 	Changes any of the expressed terms, conditions or specifications of the
Subcontract, or

Page 12 of 19

 

	 	(e)	 	Interferes with the Subcontractor’s right to perform the provisions of the
Subcontract.

G.2 Closeout

When performance is completed, the COTR and the Customer CO sign the acceptance of the final
product or completion statement of effort for all deliveries/tasks issued, ensuring that all
requirements were met, e.g., all deliverables were received and were technically acceptable,
Government Furnished Equipment (GFE) and Government Furnished Information (GFI) have been
appropriately distributed, etc. The final invoice must include a statement that it is the “final
invoice and that all costs have been accounted for and billed.” The subcontract cannot be closed
until all past performance evaluation reports have been completed and received in accordance with
the Prime CIO-SP2 contract.

G.3 Past Performance Evaluation

Standard past performance evaluations are used for all CIO-SP2 Task Orders to monitor and record
overall performance of each Prime Contractor as included herein as Attachment 4, (NITAAC
Prime Contractor Past Performance Evaluation Report). This form must be used to evaluate overall
task order performance on an annual basis and upon Task Order completion. The COTR completes the
NIH form using our electronic system, obtains concurrence from the CO in writing and forwards it to
the Prime Contractor for comment. Contractor comments received by the customer within 30 days will
be considered in the final evaluation, and must be included in the evaluation form. Once
contractor comments are incorporated, the form is forwarded by the customer to the CIO-SP2 CO, for
entry into the NIH Past Performance Database. In order for the evaluation to be received on a
timely basis, it is required that the form be forwarded through the system to the CIO-SP2 CO no
later than 60 days after completion of each period and completion of the Prime contract Task Order.
The information collected on the Past Performance Database will be available to all Government
agencies and can be used as a source of information for evaluation of contractor past performance
for future opportunities.

Any disagreement between the Prime Contractor and the CO regarding an evaluation should be referred
to an individual in that customer’s agency one level above the CO, whose decision will be final.
The past performance evaluation report shall be submitted electronically. This information will be
linked to the NIH Contractor Performance System (CPS).

G.4 Financial Obligation and Payment

	 	a.	 	A-TEK’s financial obligation shall not exceed the amount funded by this subcontract.
	 
	 	b.	 	Subcontractor may invoice monthly or bi-monthly (days 1-15 and days 16-31). Invoices
must be received by A-TEK each month for the prior month’s services/deliveries in order to
be included in the current month invoice to the Government. Invoices will be mailed
and marked as an original and three (3) copies. All invoices must reference the Subcontract
Number and the Task Number provided at B.1. Schedule of Items, and identify costs separately
for each SOW Task.
	 
	 	c.	 	Payment shall be made within five (5) business days after A-TEK has received the
Government’s payment.

H. — SUBCONTRACT PROVISIONS

In addition to the provisions and requirements of the SOW and proposal to DHS, the following
provisions shall be applicable to this Subcontract. The provisions marked with an asterisk (“*”)

Page 13 of 19

 

as well as the General Clauses incorporated herein and provided as Attachment 5 to this
Subcontract are compulsory flow down provisions for Subcontractor’s low-tier subcontractors and
vendors providing materials and services under this Subcontract and/or the prime Task Order.

H.1 Disclosure *

A-TEK and its agents and Subcontractor and its agents agree to keep in confidence and to prevent
the disclosure of, to any person or persons outside their respective organizations or any
unauthorized person or persons within such organization, all technical, non-technical and/ or
business information designated in writing or by an appropriate stamp or legend by the disclosing
party to be proprietary, or orally received and indicated at the time of receipt as being
proprietary, provided, however, that neither party shall be liable for disclosure or use of such
data or information if the same:

	 	(a)	 	Was in public domain at the time it was disclosed;

	 
	 	(b)	 	Was known to the party receiving it at the time of receipt;
	 
	 	(c)	 	Is disclosed inadvertently despite the exercise of the same degree of care as the
recipient party takes to preserve or safeguard its own proprietary information;
	 
	 	(d)	 	Is independently developed by the receiving party; or
	 
	 	(e)	 	Becomes known to the party without breach of this Subcontract by the receiving party;
or is disclosed after 2 years from the date of this Subcontract. The 2-year period shall
survive the termination of this Subcontract.

H.2 Indemnification

Contractor and Subcontractor (each, the “Indemnifying Party”) shall indemnify and hold harmless the
other party, its officers and agents( the “Indemnified Party”) to the proportionate extent they are
responsible from and against any liabilities or harm including but not limited to death and/or
damages incurred by the Indemnified Party as a result of the negligence or gross negligence,
willful act, error or omission of the Indemnifying Party in performing in its obligations
hereunder, or as a result of a breach by the Indemnifying Party of its obligations hereunder. In
no event shall the Subcontractor or its vendors of any tier be eligible in Subcontract, tort,
strict liability, warranty, or otherwise, for any special, indirect, incidental, or consequential
damages. The Parties shall promptly notify each other of any claims, which are covered by this
indemnification provision.

H.3 Non-Waiver of Rights

The failure of A-TEK to insist upon strict performance of any of the provisions in the Subcontract
or to exercise any rights or remedies shall not be construed as a waiver of its rights
to assert any of the same or to rely on any such provisions at any time thereafter. The invalidity
in whole or in part of any provision of this Subcontract shall not affect the validity of other
parts hereof.

H.4 Solicitation for Employment

During the term of this Subcontract, neither party shall solicit for employment employees of the
other company who have been directly involved in the activities covered by this Subcontract unless
the respective company’s management has given its prior consent; the employee has voluntarily
terminated from the respective company, and notice of termination is given to the

Page 14 of 19

 

employee or to
the hiring company. This provision shall in no way be construed as to waive any rights and
obligations with respect to employment agreements.

H.5 General Relationship *

Subcontractor agrees that in all matters relating to this Subcontract it shall be acting as an
independent contractor and shall assume and pay all liabilities and perform all obligations,
imposed with respect to the performance of this Subcontract. Subcontractor, its agents and lower
tier providers are solely responsible for the health, safety, and willful act of its employees and
its subcontractors. Subcontractor shall have no right, power, or authority to create any
obligation, expressed or implied, on behalf of A-TEK and/or the Government and shall have no
authority to represent A-TEK in any capacity on its behalf.

H.6 Applicable State Law and Compliance

This Subcontract shall be governed by and construed in accordance with the laws of the Commonwealth
of Virginia. Subcontractor agrees to comply with the applicable provisions of any Federal, State
or local law or ordinance and all orders, rules and regulations issued there under.

H.7 Entire Agreement

Upon acceptance of this Subcontract, Subcontractor agrees that the provisions under this
Subcontract, including all documents incorporated herein by reference, shall constitute the entire
agreement between the parties hereto and supersede all prior agreements relating to the subject
matter hereto. This Subcontract may not be modified or terminated orally, and no modification nor
any claimed waiver of any of the provisions hereof shall be binding unless in writing and
signed by the party against whom such modification or waiver is sought to be enforced.

H.8 Conflict of Interest *

It is understood and agreed that the Subcontractor, under the provisions of this Subcontract, or
through the performance of the Statement of Work made a part of this Subcontract, is neither
obligated nor expected to deliver or provide material or perform work, which will place the
Subcontractor in an Organizational Conflict of Interest, which could serve as a basis for excluding
the Subcontractor from supplying products or services to the National Institutes of Health (NIH) or
other Government agencies. Further, during the course of this Subcontract, the Prime Contractor
will not knowingly unilaterally direct the Subcontractor to perform work, in contravention of the
above understanding. It will be the Subcontractor’s responsibility to identify and promptly inform
A-TEK of any situation in which the potential for or the appearance of an Organizational Conflict
of Interest exists or has the potential to materialize.
However, prior to the execution of any Task Order or amendment thereto, if the Contracting Officer
discerns the potential for an Organizational Conflict of Interest (OCI) insofar as the work to be
performed hereunder is understood to involve the preparation of a complete specification of
materials leading directly, predictably and without delay to a Statement of Work which will be used
in the competitive procurement of a system, the Contracting Officer shall notify the contractor,
and the parties shall mutually take action to resolve any potential OCI. This clause will be
included in any Subcontracts awarded under this contract. This clause does not relieve the
Subcontractor from following up with other contracting offices and their Contracting Officers
regarding potential organizational conflicts involving those procurements.

Page 15 of 19

 

H.9 Conferences

The Prime Contractor may call a conference from time-to-time as deemed necessary to discuss any
phase of performance under the Subcontract. All discussions, problems encountered, solutions
reached, and evaluations made during any conference shall be documented in the next Monthly Program
Status Report for current reporting period. In any case, such reporting shall not, in and of
itself, constitute formal direction to and/or Prime Contractor acceptance of the topics discussed.

H.10 Travel *

The Subcontractor shall comply with the requirements FAR 31.205, the Federal Travel Regulations,
the Prime CIO-SP2 contract, if applicable, and Section 15 of the SOW. It is expressly stipulated
that all travel in conjunction with the Subcontract requires prior approval by the COTR. A-TEK
will not reimburse Subcontractor for travel not properly authorized in advance. A-TEK will apply a
fixed 6% handling fee to all travel costs. Travel expenses over $25 not supported by receipts will
not be reimbursed.

H.11 Key Personnel

Key personnel are those personnel considered to be essential to the performance of the subcontract
as identified by the customer and as stipulated in Section 5 of the SOW. Prior to the replacing of
key personnel, the Subcontractor shall demonstrate to the satisfaction of the Prime Contractor and
COTR that the qualifications of the prospective replacement personnel are equal to or better than
the qualifications of any personnel being replaced.

The Key Personnel for this BioWatch SCLDI Project are as follows:

[***]

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 16 of 19

 

H.12 Insurance Schedule *

All costs associated with insurance requirements shall be borne by the Subcontractor and its
subcontractors at no cost to A-TEK or the Government and in accordance with FAR 52.228-7,
“Insurance Liability to Third Persons.” The Subcontractor shall maintain the types of insurance
and coverage listed below in accordance with FAR 28.307-2 Liability:

     H.12.1. Type of Insurance and Minimum Amounts

	 	a.	 	Worker’s Compensation and Employee Liability. Subcontractor and its
subcontractor’s are required to comply with applicable Federal and state worker’s
compensation and Occupational Disease Statutes. If occupational diseases are not
compensable under those statues, they shall be covered under the employer’s liability
section of the insurance policy, except when contract operations are so co-mingled with
a Subcontractor’s commercial operations that it would not be practical to require this
coverage. Employer’s liability coverage of at least $100,000 shall be required, except
in States with exclusive or monopolistic funds that do not permit worker’s compensation
to be written by private carriers. (See FAR 28.305c for treatment of contracts subject
to the Defense base Act.)
	 
	 	b.	 	General Liability. (1) The Subcontractor and its subcontractor’s shall
maintain bodily injury liability insurance coverage written on the compensative form of
policy of at least $500,000 per occurrence. (2) Property Damage Liability insurance
shall be required only in special circumstances as determined by the agency.
	 
	 	c.	 	Automobile Liability. The Subcontractor and its subcontractor’s shall maintain
automobile liability insurance written on the compensative form of policy. The policy
shall provide for bodily injury and property damage liability covering the operation of
all automobiles used in connection with performing the contract. Policies covering
automobiles operated in the United States shall provide coverage of at least $200,000
per occurrence and $500,000 per occurrence for bodily injury and $20,000 per occurrence
for property damage. The amount of liability coverage on other policies shall be
commensurate with any legal requirements of the locality and sufficient to meet normal
customary claims.
	 
	 	d.	 	Aircraft Public and Passenger Liability. When aircraft are used in connection
with performing the contract, the Subcontractor and its subcontractor’s shall maintain
Aircraft Public and Passenger Liability Insurance. Coverage shall be at least $200,000
pr person and $500,000 per occurrence for bodily injury, other than passenger
liability, and $200,000 per occurrence for property damage. Coverage for passenger
liability bodily injury shall be at least $200,000 multiplied by the number of seats or
passengers, which ever is greater.
	 
	 	e.	 	Vessel Liability. When contract performance involves use of vessels, the
Subcontractor and its subcontractor’s shall maintain, as determined by the agency,
vessel collision liability and protection and indemnity liability insurance.

     H.12.2. Certificates of Insurance

Prior to commencement of any work under this Subcontract, Subcontractor shall furnish Prime
Contractor Certificates of Insurance covering the entire period of performance of

Page 17 of 19

 

this Subcontract, in a format acceptable to Prime Contractor, evidencing the insurance
coverage required in this Agreement and containing the following information:

	 	a.	 	Identify A-TEK, Inc. as an “Additional Insured” with respect to all policies
except Workers’ Compensation and employers’ liability.
	 
	 	b.	 	State that all policies have been endorsed to waive subrogation in favor of
A-TEK, Inc.
	 
	 	c.	 	State that the underwriters agree to provide A-TEK with at least 30 days prior
written notice of any cancellation or material change in the coverage.

In addition, the Subcontractor shall furnish Prime Contractor with revised Certificates of
Insurance covering any and all subsequent extensions to the initial period of performance of
this Subcontract.

H.13 Security *

All individuals working in any laboratory must be certified for that specific laboratory and
cleared to handle “Sensitive” material. As stipulated in Section 10 of the SOW, Subcontractor
staff may be required to possess a “Secret” level clearance for a given task or site as identified
by DHS.

     H.13.1 Information Technology Systems Security *

The security of BioWatch Information Systems must comply with the Department of Homeland
Security — IT Security standards provided at task award. Changes to DHS standards will be
provided as they are adopted, and DHS and the Contractor/Subcontractor Team will determine
through mutual agreement how information systems must evolve to meet new standards.

H.14 Government Furnished Equipment, Information or Services *

Government Furnished Equipment (GFE) and/or Government Furnished Information (GFI) will be provided
in accordance with the SOW Section 11. All equipment and information provided to Subcontractor
shall be used, stored and maintained with the highest standard of care and only in accordance with
the purpose and intent for which it is provided. Subcontractor and its subcontractors are
responsible and liable for Government property in their possession pursuant to FAR 52.245-1 and
52.245-2 as applicable.

H.15 Press Releases *

As required by the CIO-SP2 contract, no news release (including photographs, films, and public
announcements) on any part of the subject matter of this Subcontract or any phase of any program
hereunder shall be made without prior approval of the Prime Contractor and the Government. This
restriction applies to all initial and newly developed marketing materials developed for
presentation to potential Government customers of this contract vehicle.

H.17 Alternate Dispute Resolution Procedures (ADR)

	 	a.	 	Background: Pub. L. 101-552 The Administrative Dispute resolution Act encourages the use of
alternative means of resolving disputes involving Government agencies. The Act is based on
Congress finding that alternative processes, including mediation, often yield decisions that

Page 18 of 19

 

	 	 	 	are faster, less expensive and less contentious and can lead to more creative, efficient and
sensible outcomes.
	 	b.	 	Partnering lays the foundation for better working relations on a project including better
dispute resolution. This partnership draws on the strengths of each organization in an effort
to achieve a quality project done right the first time, within budget and on schedule. This
partnership is bilateral in make-up and participation is totally voluntary.

H.18 Non-Personal Services *

	 	a.	 	As stated in the Office of Federal Procurement Policy Letter 92-1, dated September 23, 1992,
Inherently Governmental Functions, no personal services shall be performed under this
Subcontract. No Subcontractor employee will be directly supervised by the Government. All
individual employee assignments, and daily work direction, shall be given by the applicable
employee supervisor. If the Subcontractor believes any Government action or communication has
been given that would create a personal services relationship between the Government and any
Subcontractor employee, the Subcontractor shall promptly notify the Prime of this
communication or action.
	 
	 	b.	 	The Subcontractor shall not perform any inherently Governmental actions under this
Subcontract. No Subcontractor employee shall hold him or herself out to be a Government
employee, agent, or representative. No Subcontractor employee shall state orally or in
writing at any time that he or she is acting on behalf of the Government. In all
communications with third parties in connection with this Subcontract, Subcontractor employees
shall identify themselves as Subcontractor employees and specify the name of the company for
which they work. In all communications with other Government contractors in connection with
this Subcontract, the Subcontractor employee shall state that they have no authority to in any
way change the Subcontract and that if the other contractor believes this communication to be
a direction to change their contract, they should notify the Contracting Officer for that
contract and not carry out the direction until a clarification has been issued by the
Contracting Officer.
	 
	 	c.	 	The Subcontractor shall ensure that all of its employees working on this Subcontract are
informed of the substance of this clause. Nothing in this clause shall limit the Prime
Contractor’s or the Government’s rights in any way under any other provision of the
Subcontract, including those related to the Government’s right to inspect and accept the
services to be performed under this Subcontract. The substance of this clause shall be
included in all Subcontracts at any tier.

H.19 SECTION 508 OF THE REHABILITATION ACT OF 1973 AS AMENDED *

In accordance with Section 508 Requirements, electronic and information technology (EIT) procured
through this Agreement must meet the applicable accessibility standards at 36 CFR 1194, unless the
procuring Government Agency establishes a published exception to this requirement. Part 36 CRF
1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at
http://section508.gov. In accordance with Part 1194, the
Subcontractor shall indicate for each line item in the schedule whether each product or service is
compliant or non-compliant with the accessibility standards at 36 CFR 1194. Further, the
Subcontractor must indicate where full details of compliance can be found (e.g., Subcontractor’s
website or other exact location).

Page 19 of 19

 

I — FAR CLAUSES INCORPORATED BY REFERENCE *

The applicable Federal Acquisition Regulation (FAR) Clauses are hereby incorporated with the same
force and effect as if they were given in full text and included as part of Attachment 5.
Where necessary to make the context of these provisions applicable to this Subcontract, the term
“Government” and equivalent phrases shall mean A-TEK, the term “Contractor” shall mean
Subcontractor, and the term “Contract” shall mean this Subcontract. Where any reference contains
alternative clauses, that alternative shall apply to this Subcontract.

J — LIST OF ATTACHMENTS

1 — Statement of Work

2 — Technical Proposal

3 — Laboratory Labor Rates

4 — NITAAC Past Performance Evaluation Report

5 — FAR/HHSAR Clauses

Page 20 of 19

 

- — END OF SUBCONTRACT — -

Page 21 of 19

 

ATTACHMENT 1

 

 

 1

CIO-SP2i - NITAAC Statement of Work (SOW)

Task Order Title — BioWatch Staffing, Communication, and Laboratory Data Integration

As of – 07/19/04

Agency — The Department of Homeland Security (DHS)

1. Task Order Title

The Department of Homeland Security (DHS) Science and Technology Directorate has initiated the
BioWatch Program as part of its bio-security efforts to enhance our nation’s ability to be prepared
for and to respond to bioterrorism.

2. Background

The Department of Homeland Security (DHS) BioSecurity Program has been considering alternate models
of performing and managing certain activities under the BioWatch program. BioWatch laboratory
analysis currently operates mostly with temporary/term employees hired and managed by the Centers
for Disease Control under agreement with DHS. These temporary employees have been fielded in
public health laboratories across the United States. Functionally, each of these groups of
employees reports to a state or local public health agency laboratory manager.

[***]

Building on unprecedented investments in our public health and bio-surveillance infrastructure
since September 11, 2001 and the anthrax events of later that year, President Bush’s
Bio-Surveillance Program Initiative calls on DHS to expand and upgrade the BioWatch Program and
create a system to integrate a broad variety of surveillance data from across the Government. A
key component of this initiative is an expansion and deployment of the next generation of
technologies employed by the BioWatch Program, including enhanced situational awareness data
systems, that will provide an enhanced national bio-surveillance early warning system.

3. Objectives

The objectives of this Task Order are:

(1) To develop the capacity for, and carry out the staffing of, new BioWatch Program locations as
authorized;

[***] = Certain information on this page
has been omitted and filed separately with the Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

 

 2

(2) Augment existing BioWatch Program locations as needed, to include meeting surge requirements;
manage and integrate the BioWatch Information Systems and Web Portal with pertinent data sources;

(3) Facilitate bioterrorism consequence management capacity building; and

(4) Assist with the establishment and management of BioWatch research partnerships.

The resultant CIO-SP2 Task Order will be incrementally funded with Task descriptions defining the
specific use of those funds with the scope of the tasks below.

4. Scope

This work falls within the CIO-SP2 Task areas of 5 – Critical Infrastructure Protection and
Information Assurance and area 8 – Clinical Support, Research and Studies.

5. Specific Tasks

The following outline specific Tasks under this CIO-SP2 Contract Task Order:

5.1 Task 1 – Contract-Level and Task Order (TO) Management

5.1.1 Subtask 1 – Contract-Level Program Management

Contract Level Program Management is required to maintain compliance with all CIO-SP2 requirements
and ensure Quality Assurance.

5.1.2 Subtask 2 – Task Order Management

Project Level Task Order Management is required to manage the day-to-day performance and project
management to include productivity and management methods such as Quality Assurance, Configuration
Management, Staffing, Security Management and all centralized administrative and documentation
functions needed at the contract level. A monthly status report is required.

5.2 Task 2 – BioWatch Surveillance Team

The Contractor shall provide staff to manage and/or operate the day-to-day BioWatch activities at
state and municipal public health organizations within the United States, working closely with the
Environmental Protection Agency and Centers for Disease Control and Prevention staff at each
designated laboratory or field collection activity. The BioWatch Surveillance Team activities may
include:

	 	•	 	Field collection of samples from designated samplers
	 
	 	•	 	Receiving samples from the designated site of collection at least daily
	 
	 	•	 	Sample Intake to include sample categorization, batching, bar coding, scanning, and
entering the data into the BioWatch Information System for processing
	 
	 	•	 	Sample extraction and preparation for analysis
	 
	 	•	 	Analysis for threat agents and documentation of results

 

 

 3

	 	•	 	Data entry of analysis results into BioWatch Information System and processing for
dissemination to appropriate parties
	 
	 	•	 	Follow-on tracking of associated tests with input into the BioWatch Information System
	 
	 	•	 	Appropriate chain-of-custody tracking
	 
	 	•	 	BioWatch Information Systems “reach-back” from DHS to local/state laboratory through
either the Health Alert Network or other mechanism for follow up communications.

5.3 Task 3 – BioWatch Surveillance Team – Surge Capacity

The Contractor shall provide staff to manage the surge of BioWatch activities at any location that
detects unacceptable levels of biological threat agents, or as directed by DHS. This task includes
the same tasks as the day-to-day duties outlined in Task 2 above, but with increased frequency.
The Contractor will develop flexible and coordinated staffing models for surge capacity with public
health laboratories that are part of the BioWatch program.

5.4 Task 4 – BioWatch Surveillance Team Training

The Contractor shall provide and develop staff training, where necessary, for cross-training of lab
technician and microbiologist duties, to include web portal utilization training, as identified by
DHS.

The Contractor shall develop and run exercises and update training material for sample collection,
lab technician, microbiologist, and incident response duties as identified by DHS.

5.5 Task 5 – BioWatch Information Systems Management

The Contractor shall provide staff to manage BioWatch Information Systems with hosted
implementation to include the following:

	 	•	 	Maintain, administer, and enhance the BioWatch Information Systems, as needed.
	 
	 	•	 	Staff to assist in the overall of the BioWatch information systems and resources
	 
	 	•	 	Develop and maintain a web portal for outreach, coordination, and collaboration,
including Public Health Architecture and Informatics and IT architecture and IT Web
development; this will also include the development and maintenance of a secure portal for
Government use to include IT Systems Engineering to address security and enhancements
required for drills and events as identified by DHS
	 
	 	•	 	Develop and maintain the workflow process for the BioWatch Program’s data and
information management
	 
	 	•	 	Develop and maintain local and state laboratory integration of the BioWatch Information
Systems with appropriate Laboratory Information Management Systems, Lab Response Network
(LRN) and Health Alert Network (HAN) communications
	 
	 	•	 	Develop and maintain redundant BioWatch Information Systems message connection brokers
	 
	 	•	 	Support the interface of RODS and ESSENCE for designated BioWatch cities.
	 
	 	•	 	Staff to assist in the customized planning, implementation, and data integration
strategies for each participating laboratory as directed by DHS
	 
	 	•	 	Provide monthly uptime, usage, and performance reports on the web portal

 

 

 4

	 	•	 	Develop and maintain training, assessment, and support for field staff as well as the
collaboration tools for outreach
	 
	 	•	 	Develop and maintain clinical data sets in combination with syndromic surveillance
systems for cities as a part of BioWatch pilot and demonstration projects
	 
	 	•	 	Provide liaison among local public health laboratory’s information management units and

	 	•	 	The Environmental Protection Agency,
	 
	 	•	 	The Centers for Disease Control and Prevention and Food and Drug
Administration within the Department of Health and Human Services,
	 
	 	•	 	The Department of Agriculture,
	 
	 	•	 	Other federal agencies concerned with health or homeland security data,
	 
	 	•	 	The Association of Public Health Laboratories, and
	 
	 	•	 	Other national, state and local health and homeland security
organizations with an interest in BioWatch data,

5.6 Task 6 – Administration and Personnel Management

The Contractor shall provide staff to assist in the management of BioWatch administrative and
personnel management activities to include:

	 	•	 	Appropriate liaison to local public health laboratories and other stakeholder
organizations, e.g., the Association of Public Health Laboratories
	 
	 	•	 	Staff to assist in the customized personnel planning and implementation strategies for
each participating laboratory
	 
	 	•	 	Staff to assist in the overall management of the BioWatch program’s personnel and fiscal
processes.

5.7 Task 7 – BioWatch Operations and Enhancement Review Committee

The Contractor shall provide resources to host and facilitate meetings of the BioWatch Operations
and Enhancement Review Committee. The Committee will include approximately 8-10 members and 2-3
DHS staff. The Advisory Committee will meet up to 6 times a year in locations across the United
States.

5.8 Task 8 – BioWatch Signal Interpretation and Consequence Management Facilitation

The contractor will be responsible for working closely with other organizations to assist each
BioWatch city with signal interpretation integration and decisional analysis with consequence
management preparedness. This may include organizing and overseeing several Table Top exercises
across the nation, as well as various BioWatch consequence management workshops, where all involved
stakeholders can participate and obtain information and skills for development and enhancement of
their cities’ signal interpretation and consequence management plans. These Table Top exercises
will include participation from the following:

	 	•	 	Local City Officials – Mayor’s Office, Local Law Enforcement

 

 

 5

	 	•	 	Local and State Laboratory Response Network (LRNs) and Epidemiologists
	 
	 	•	 	Federal Law Enforcement Officials – FBI, Weapons of Mass Destruction Officials
	 
	 	•	 	Federal BioSecurity Officials

5.9 Task 9 – BioWatch Research and Study Assistance

Provide the necessary research, development, test, and evaluation coordination with pre-selected
BioWatch partnering cities, health departments, and universities to lead selected studies,
analyses, and technology deployment activities that will be implemented by the BioWatch Program
during the contract period of performance.

The contractor should be able to work with the selected partnering bodies in order to effectively
launch and carry-out critical research studies, in progress reviews, meetings, and conference
support for the BioWatch Program.

6. Contract Type

The resultant CIO-SP2 Task Order will be Time and Materials (T&M).

7. Place of Performance

Tasks 2 through 9 can take place at the Government’s laboratory site at any designated city within
the United States; representative cities include, but are not limited to:

[***]

[***] = Certain information on this page
has been omitted and filed separately with the Commission. Confidential treatment has been requested
with respect to the omitted portions.

 

 

 6

The BioWatch Information Systems Management support will be performed at the local public health
laboratory site, at the Department of Homeland Security location in Washington, DC, and at the
Contractor’s site as agreed to by DHS.

8. Period of Performance

The total period of performance for the scope of this contract will be for a six (6) month year
base period with two (2) one-year options to extend for a total performance period of two and a
half (2.5) years. Incremental funding will be provided for each site under each Task, as
needed.

	 	 	 
	Base Period

	 	Date of award – Six months post date
	Option Year 1

	 	One (1) year from end of base period contract
	Option Year 2

	 	One (1) year from end of Option Year 1

9. Deliverables/Delivery Schedule

Deliverables will be cited in each Task as it is funded. In addition, a monthly status report for
overall performance under the Task Order is required. The report should be organized by statement
of Work Tasks, milestones and deliverables for each task for each location. The report should also
include budgeted vs. actual expenditures.

	 	 	 	 	 	 	 
	SOW	 	 	 	 	 	 
	TASK	 	 	 	 	 	 
	#	 	DELIVERABLE TITLE	 	DESCRIPTION	 	DUE DATE
	1

	 	Status Report
	 	Overall project
performance
categorized by Work
Task. Milestones,
deliverables, and
budget information
to be included. To
be delivered in MS
Word format to the
COTR, Contracting
Officer, and
designated DHS
Project Manager.
	 	Monthly, on

10th
calendar day
	2

	 	Pilot Site Staffing
	 	Four lab analysts
deployed to a DHS
BioWatch Pilot Site
	 	Within 30 days of
award
	2

	 	Core Management

Staffing
	 	All Core Management
Staff hired and
engaged in
performance of the
tasks outline
within this SOW.
	 	Within 30 days of
award
	3

	 	Surge Capacity

Staffing Plan
	 	Provide DHS
BioWatch staff with
a surge capacity
staffing plan for
select cities.
Plan is to be
delivered in MS
Word format.
	 	Within 90 days of
award
	7

	 	Operations and
Enhancement Review
Committee
	 	Convene a BioWatch
Operations and
Enhancement Review
Committee
	 	Within 60 days of
award
	1

	 	In-Process Review
	 	Deliver on
In-Process Review
and Briefing to key
DHA BioWatch Staff.
	 	Within 90 days of
award and every 6
months thereafter

 

 

 7

	 	 	 	 	 	 	 
	SOW	 	 	 	 	 	 
	TASK	 	 	 	 	 	 
	#	 	DELIVERABLE TITLE	 	DESCRIPTION	 	DUE DATE
	4

	 	Updated Training

Material
	 	Provide DHS
BioWatch staff with
updated training
materials,
including developed
training exercises
and manuals.
	 	Within 180 days of
award
	5

	 	Data Integration

Roadmap
	 	Provide DHS
BioWatch staff with
a roadmap
describing how data
and information
contained within
legacy systems at
the state and local
laboratory level
will be integrated
with specific
BioWatch
Information
Systems. To be
delivered in
electronic media
format.
	 	Within 180 days of
award

10. Security

All individuals working in any laboratory must be certified for that specific laboratory and
cleared to handle “Sensitive” material. Contractor staff may be required to possess a “Secret”
level clearance for a given task or site as identified by DHS.

10.1 Information Technology Systems Security

The security of BioWatch Information Systems must comply with the Department of Homeland Security -
IT Security standards provided at task award. Changes to DHS standards will be provided as they
are adopted, and DHS and the Contractor will determine through mutual agreement how information
systems must evolve to meet new standards.

11. Government Furnished Equipment (GFE)/Government Furnished Information (GFI)

Since all laboratory diagnostic work will be performed at a local or state public health laboratory
site, all laboratory diagnostic GFE/GFI is anticipated to be provided by the hosting laboratory.
Information systems equipment will be maintained at a site of DHS’ direction which may include
government and/or contractor’s sites.

12. Packaging, Packing, and Shipping Instructions

The contractor shall ensure that all items are preserved, packaged, packed and marked in accordance
with best commercial practices to meet the packing requirements of the carrier and to ensure safe
and timely delivery at the intended destination.

All data and correspondence submitted shall reference:

1. The CIO-SP2i Task Order Authorization Number

2. The NITAAC Tracking Number

3. The government end user agency

4. The name of the COTR

Containers shall be clearly marked as follows:

1. Name of contractor

2. The CIO-SP2i Task Order Authorization Number

3. The NITAAC Tracking Number

4. Description of items contained therein

 

 

 8

5. Consignee(s) name and address

13. Inspection and Acceptance Criteria

A final inspection and acceptance of all work performed, reports and other deliverables will be
performed at the place of delivery.

14. Accounting and Appropriation Data

The resultant CIO-SP2 Task Order will be incrementally funded with the implementation of each Task.
Accounting and appropriation data will be specified with funding of each Task.

15. Travel

Contractor travel shall be required to support certain task orders within this SOW. All travel
required by the Government will be reimbursed to the Contractor in accordance with the Federal
Travel Regulations. The contractor shall be responsible for obtaining COTR approval, via
electronic mail, for all reimbursable travel in advance of each travel event.

16. Other Pertinent Information or Special Considerations

Travel may be required and will be identified within the Task as it is funded for laboratory staff.

Laboratory Staff must meet the following minimum requirements:

	 	•	 	Director-Microbiologists must possess a PhD and must be qualified to work in a Bio
Safety Level 3 Laboratory
	 
	 	•	 	Microbiologist must possess a Masters Degree and must be qualified to work in a Bio
Safety Level 3 Laboratory
	 
	 	•	 	Lab Technicians must possess a Bachelors Degree and must be qualified to work in a Bio
Safety Level 2 Laboratory

Administrative and Information System staff must meet the following minimum requirements. All
members of the administration and information systems unit must be proficient in:

	 	•	 	Public health system development
	 
	 	•	 	Pertinent CDC, HHS and DHS standards for the management and administration of health and
homeland security data and information
	 
	 	•	 	Creating and implementing programs and activities that are part of CDC’s Public Health
Information Network

The Administrative and Information Management System Staff are expected to work as a
cross-functional team. The Contractor must describe the team’s roles and identify key personnel
with qualifications. Contractor must also identify costs of travel for the Administrative Systems
staff for the base year.

 

 

 9

17. Post-Award Administration

The Contractor shall provide a monthly status review and Semi-Annual Program Review meetings to
discuss overall performance and requirements evolving within the general scope of work.

18. Evaluation Criteria

There are three major evaluation factors – (1) Technical/Management Approach (2) Past Performance
(3) Cost/Price. The following methodology will be used to evaluate the task order proposals
received.

	 	17.1	 	Technical/Management Approach (50%) – Technical/Management proposals shall describe the
capability of the offerer’s organization to perform the work in accordance with the contract
requirements, demonstrate a comprehensive understanding of the requirements. The proposal
shall be specific and complete in every detail and shall contain the information necessary to
evaluate the offerer’s proposal. In particular, the proposal shall demonstrate the
contractor’s knowledge of the BioWatch Program and Public Health environment and provide the
technical approach(s) for each Task requirement, as well as providing detailed information
regarding the contractor’s proposed staffing mix, including resumes for all key management
personnel that are part of the contractor’s team. The proposal will also show the
contractor’s ability to quickly staff and describe the staffing plan to identify and obtain
appropriately skilled individuals for this Task Order, to include:

	 	•	 	Phase-in plan;
	 
	 	•	 	Use of subcontractors (if proposed);
	 
	 	•	 	Corporate and on-site Task Order management;
	 
	 	•	 	General proposed staffing plan (including resumes for key project personnel)

	 	17.2	 	Past Performance (30%) – The Contractor shall identify three (3) contracts, which it has
recently performed, or is currently performing, that are similar in nature to this Task
Order. If the Contractor has not performed three such contracts, it shall identify as many
similar contracts as it has performed or is performing. The Contractor shall provide the
following information with respect to each of these contracts:

	 	•	 	Contract number, contract type, and dollar value;
	 
	 	•	 	Date of contract award and period of performance;
	 
	 	•	 	Name, address, and telephone number of all applicable contract points of
contact; and
	 
	 	•	 	Brief description of contract work, scope, and responsibilities.

	 	17.3	 	Cost/Price (20%) – The Contractor shall price each task and site for evaluation purposes
and to establish the ceiling for this effort. The cost will be evaluated for balance and
reasonableness of staffing based on the approach and relevant personnel experience. The
price proposal shall be developed on a time and materials basis, and be broken down by labor
and a Not to Exceed (NTE) amount for travel and Other Direct

 

 

 10

	 	 	 	Costs (ODCs). This contract will not be based solely on the lowest cost. Technical
approach will carry a higher score.

 

 

ATTACHMENT 2

 

 

Task Order Proposal

Under

CIO-SP2i Contract #263-01-D-0084

Task Order C-2329

BioWatch Staffing, Communications,

and Laboratory Data Integration

Prepared for:

The Department of Homeland Security

Office of Procurement Operations

1120 Vermont Avenue, NW

Washington, DC 20528

Attn:  Aaron H. Ford

Prepared by:

A-TEK, Inc.

602 South King Street

Suite 300

Leesburg, VA 20175

and

Virtual Alert, Inc.

Corporate Office and Administration

7748 Herschel Avenue

LaJolla, CA 92038

Proposal B2040730-1 — Revision 3

09 August 2004

This proposal includes data that shall not be disclosed outside the Government and shall not be
duplicated, used or disclosed in whole or in part for any purpose other than to evaluate this
proposal or quotation. If, however, a contract is awarded to A-TEK as a result of or in connection
with the submission of this data the Government shall have the right to duplicate, use, or disclose
the data to the extent provided in the resulting contract. This restriction does not limit the
Government’s right to use information contained in this data if it is obtained from another source
without restriction. The data on each sheet of this proposal is subject to this same
restriction.

 

 

	 	 	 
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

Table of Contents

	 	 	 	 	 
	A. TASK DESCRIPTION
	 	 	1	 
	 
	 	 	 	 
	B. POINTS OF CONTACT
	 	 	1	 
	 
	 	 	 	 
	C. INTRODUCTION
	 	 	1	 
	C.1. A-TEK, Inc.
	 	 	2	 
	C.2. Virtual Alert, Inc.
	 	 	2	 
	C.3. Public Health Foundation Enterprises, Inc.
	 	 	2	 
	C.4. Team Partners
	 	 	3	 
	 
	 	 	 	 
	D. UNDERSTANDING OF REQUIREMENT
	 	 	4	 
	D.1. Background
	 	 	4	 
	D.1.1. Initial Processing and Information Collection
	 	 	5	 
	D.1.2. Data Interchange with Initial Results
	 	 	6	 
	D.1.3. Signal Events, Automated Tools and Consequence Management
	 	 	7	 
	D.1.4. Integration with Existing Systems and Other Initiatives
	 	 	7	 
	D.2. Approach and Recommendations of the RFP Response
	 	 	8	 
	D.3. Analysis of SOW and Supplemental Information
	 	 	10	 
	D.3.1. Updated Definition of Deliverables and Assumptions
	 	 	13	 
	D.4. Supplemental Information
	 	 	16	 
	D.4.1. Core Management Staff
	 	 	16	 
	D.4.2. Exercise, Workshop and Training
	 	 	16	 
	D.4.3. Staffing for[**]and Data Connectivity
	 	 	16	 
	D.4.4. Workshop/Exercise Allocation
	 	 	16	 
	D.4.5. Pilot Lab Staffing
	 	 	17	 
	D.4.6. Allocation for Two OERC meetings
	 	 	17	 
	D.4.7. Travel Allocation for staff
	 	 	17	 
	D.4.8. Allocation for Local Lab Staff certification process
	 	 	17	 
	D.4.9. Surge Capacity Allocation
	 	 	17	 
	D.4.10. [**]
	 	 	17	 
	 
	 	 	 	 
	E. SPECIFIC TASKS
	 	 	17	 
	E.1. Task 1 - Contract-Level and Task Order (TO) Management
	 	 	18	 
	E.1.1. Subtask 1 - Contract-Level Program Management
	 	 	18	 
	E .1.2. Subtask 2 - Task Order Management
	 	 	19	 
	E.1.3. Staffing Estimate
	 	 	29	 
	E.2. Task 2 - BioWatch Surveillance Team
	 	 	30	 
	E.2.1. Response
	 	 	30	 
	E.2.2. Staffing Estimate
	 	 	32	 
	E.3. Task 3 - BioWatch Surveillance Team — Surge Capacity
	 	 	32	 
	E.3.1. Response
	 	 	33	 
	E.3.2. Staffing Estimate
	 	 	35	 

	 	 	 	 	 
	 
	    
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.
	    
	A-TEK, Inc.

	 	Page i
	 	8/09/04 — R3
	    
	 

 

	 	 	 
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

	 	 	 	 	 
	E.4. Task 4 - BioWatch Surveillance Team Training
	 	 	35	 
	E.4.1. Response
	 	 	35	 
	E.4.2. Exercises
	 	 	36	 
	E.4.3. Options
	 	 	37	 
	E.4.4. Staffing
	 	 	37	 
	E.5. Task 5 - BioWatch Information Systems Management
	 	 	37	 
	E.5.1. Response
	 	 	38	 
	E.5.2. Resource Estimates
	 	 	43	 
	E.6. Task 6 - Administration and Personnel Management
	 	 	44	 
	E.6.1. Response
	 	 	45	 
	E.6.2. Staffing Estimate
	 	 	45	 
	E.7. Task 7 - BioWatch Operations and Enhancement Review Committee
	 	 	45	 
	E.7.1. Response
	 	 	45	 
	E.7.2. Staffing Estimate
	 	 	46	 
	E.8. Task 8 - BioWatch Signal Interpretation and Consequence Management Facilitation
	 	 	46	 
	E.8.1. Response
	 	 	47	 
	E.8.2. Staffing Estimate
	 	 	53	 
	E.9. Task 9 - BioWatch Research and Study Assistance
	 	 	54	 
	E.9.1. Response
	 	 	54	 
	E.9.2. Staffing Estimate
	 	 	55	 
	 
	 	 	 	 
	F. OTHER PERTINENT INFORMATION
	 	 	55	 
	F.1. Security
	 	 	55	 
	F.2. Information Technology Systems Security
	 	 	56	 
	F.3. Government Furnished Equipment (GFE)/Government Furnished Information (GFI)
	 	 	56	 
	F.4. Travel
	 	 	56	 
	F.5. Staff Requirements
	 	 	56	 
	 
	 	 	 	 
	G. KEY PERSONNEL QUALIFICATIONS MATRIX
	 	 	57	 
	 
	 	 	 	 
	H. KEY PERSONNEL
	 	 	58	 

	 	 	 	 	 
	 
	    
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.
	    
	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

	 	 	 
	Contract
Number:

Task Order No.:

Contracting Officer:

COTR:

Contractor:

	 	263-01-D-0084

C-2329

Mr. Aaron H. Ford

Dr. Peter Estacio

A-TEK, Inc.

	    
	Task Order Title:

	 	BioWatch Staffing, Communications and

Laboratory Data Integration
	    
	 

A.     Task Description

This work is proposed to be performed under the A-TEK, Inc. CIO-SP 2 Innovations NIH Contract
Number 263-01-D-0084 and will provide services as defined in the July 23, 2004, Statement of Work
(SOW) for BioWatch Staffing, Communications and Laboratory Data Integration (SCLDI) in support of
the Department of Homeland Security (DHS) CIO-SP2 Tracking Number C-2329, as amended through
Amendment 6 dated July 29, 2004.

B.     Points of Contact

	 	 	 
	Contracting Officer:

	 	Mr. Aaron H. Ford

aaron.ford1@dhs.gov

202-357-8312

The Department of Homeland Security

Office of Procurement Operations

1120 Vermont Avenue, NW

Washington, DC 20528

	    
	COTR:

	 	Dr. Peter Estacio

peter.estacio@dhs.gov

202-654-6073

The Department of Homeland Security

Systems Engineering and Development Office

1120 Vermont Avenue, NW

Washington, DC 20528

C.     Introduction

The A-TEK Team proposed for this has been selected for their quality performance reputation and
relevant capabilities to assist with DHS’ requirement for BioWatch Staffing, Communication and
Laboratory Data Integration (SCLDI) services. A-TEK, Inc. proposes to use Virtual Alert, Inc.,
working with Public Health Foundation Enterprises, Inc., as our subcontractors to perform the
direct project management and all technical work on the BioWatch SCLDI task. A-TEK, Inc. will
provide the CIO-SP2 contract-level program management services required of Prime contractors under
the CIO-SP2 contract.

	 	 	 	 	 
	 
	    
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

C.1. A-TEK, Inc.

A-TEK, Inc. (A-TEK) is a small, minority, and woman-owned, SBA 8(a) certified firm with an
excellent performance record in the CIO-SP2 and Image World2 GWAC programs, successfully performing
on 80 separate orders totaling more than $20M in value and winning performance awards under each
contract. A-TEK enjoys an outstanding reputation for providing efficient cost control (always
meeting the client’s needs within budget), prompt delivery (always on time or ahead of schedule),
and consistently providing high quality products and services (overall best value). The A-TEK
Team’s senior management is led by successful professionals, each with more than 20 years of
experience in the services area. A-TEK’s customer-oriented methodology allows A-TEK to respond
quickly to resolve problems immediately and appropriately, minimizing cost implications for
clients. A-TEK has a DoD SECRET clearance, with TOP SECRET (TS/SCI) currently in process.

C.2. Virtual Alert, Inc.

Virtual Alert, Inc. (Virtual Alert) is a leading Public Health systems integrator that offers a
comprehensive software platform that enables state and local government organizations to
disseminate public health and safety alerts and advisories to first responders and other parties.
Emergency warnings concerning communicable diseases and other epidemiological threats flow
seamlessly to appropriate state, county and local agencies, clinicians and other professionals
involved in Public Health. Using the company’s suite of products and services, public health and
homeland security agencies can quickly respond to terrorism, bio-emergency and other events from
within the jurisdiction, from neighboring states or as appropriate from the U.S. Department of
Homeland Security as well as other Federal Agencies. As an information technology provider,
Virtual Alert affords state and local governments the information technology capability to interact
with the emergency personnel, to prepare for disaster and to keep the public informed.

Virtual Alert will be working with Public Health Foundation Enterprises, Inc. predominantly to
accommodate the staffing of the BioWatch Surveillance Team and Surge Capacity tasks.

C.3. Public Health Foundation Enterprises, Inc.

Public Health Foundation Enterprises, Inc. (PHFE) Management Solutions, a California 501(c)3
nonprofit organization, provides infrastructure support and management services to a wide array of
nonprofit, government and for-profit programs throughout the United States, and internationally.
For more than 34 years, PHFE has provided nationally recognized expertise in capacity building,
fiscal intermediary and management and administrative services through the seamless delivery of
four integrated core competencies: Program Development, Human Resources, Fiscal Services, and
Evaluation & Contract Administration. PHFE Management Solutions is dedicated to improving the
health and well being of people and communities by providing a wide spectrum of quality management
services. As a nonprofit organization, PHFE serves as a catalyst to meet the public health
challenges of tomorrow in partnership with government, nonprofit and for-profit organizations.

	 	 	 	 	 
	 
	    
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

C.4. Team Partners

The A-TEK BioWatch SCLDI Team will utilize several additional strategic partners in the performance
of this project, as needed. The most significant partners are as follows:

State and Local Health Informatics Consortium

The State and Local Health Informatics Consortium (SLHIC) is a 501c3 non-profit organization
working to further the active use of information technology and open standards in Public Health
Informatics. SLHIC is a Community of Practice that focuses on collaboration within and between
jurisdictions and works to provide a forum to develop recommendations and further best practices
for communication protocols between federal agencies and state and local public health agencies.
SLHIC is an evolving entity meant to complement other national organizations and efforts with
different foci.

Virtual Reality Medical Center and the Interactive Media Institute

Virtual Reality Medical Center (VRMC) currently uses virtual reality exposure therapy
(3-dimensional computer simulation) in combination with physiological monitoring and feedback to
treat panic and anxiety disorders. These conditions include specific phobias such as fear of
flying, fear of driving, fear of heights, fear of public speaking, fear of thunderstorms,
claustrophobia, agoraphobia, social phobia, panic disorder, and posttraumatic stress disorder due
to motor vehicle accidents. General stress management and relaxation skills are taught for
stress-related disorders.

The Interactive Media Institute (IMI) is a 501(c)3 non-profit organization working to further the
application of advanced technologies for patient care. IMI sponsors national and international
workshops, meetings, and continuing education courses. The Institute is also active in conducting
research and clinical trials, and specializes in virtual reality, telehealth, videogame virtual
reality, and human-computer interaction research. IMI is actively working with world leaders who
are experts in utilizing virtual reality, multimedia, computer-generated avatars, personal robots
and other technologies to treat patients with both mental and physical disorders.

The SIMI Group, Inc.

The SIMI Group (SIMI) is a private consulting firm that specializes in the development of
information and knowledge infrastructures for public health. SIMI is a leading implementer of
laboratory information management systems; data sharing and exchange systems and technologies;
patient and contact tracking systems; disease and health surveillance systems and complex public
health vocabulary and coding systems. SIMI is a member of HL7 and has received recognition from
HIMSS/IHE for demonstrating interoperability of public health systems.

	 	 	 	 	 
	 
	    
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

UC Davis Medical Informatics Program

The UC Davis Health System, already having developed a nationally recognized program in
Telemedicine and Telehealth, has recognized that the field of Medical Informatics is a closely
allied discipline that provides the training and research opportunities for individuals to assess,
develop, and implement new technologies that will provide decision support to health care
professionals and biomedical scientists. The program is designed to provide knowledge about the
way information is handled in the health industry. Coursework is designed to allow
medically-oriented individuals with some background in computer programming to study Biomedical
Informatics as it pertains to (1) Database modeling and design of non-graphical information (e.g.
patient records); (2) the storage and metadata of graphical datasets (e.g. MRI scans); (3)
informational linking and retrieval of graphical and non-graphical datasets.

D. Understanding of Requirement

Building on unprecedented investments in our public health and bio-surveillance infrastructure
since September 11, 2001 and the anthrax events of later that year, President Bush’s
Bio-Surveillance Program Initiative calls on DHS to expand and upgrade the BioWatch Program and
create a system to integrate a broad variety of surveillance data from across the Government. A
key component of this initiative is an expansion and deployment of the next generation of
technologies employed by the BioWatch Program, including enhanced situational awareness data
systems that will provide an enhanced national bio-surveillance early warning system.

There are many aspects to the BioWatch Program that must work in concert to achieve maximum
effectiveness. The success of BioWatch to date has demonstrated the potential that can be realized
through expansion and deployment of the next generation of technologies. By seizing on the present
opportunity, the A-Tek BioWatch Staffing, Communication, and Laboratory Data Integration team
(BioWatch SCLDI Project Team) will work to improve the impact, effectiveness and timeliness of the
situational awareness data used by DHS at local and state levels.

D.1. Background

As a part of this RFP process, the BioWatch SCLDI team members reviewed BioWatch processes,
implementations and potential with a number of existing, former and non-customers. This review
process was critical to the development of our approach to furthering the BioWatch effort and our
response to this RFP. From an informatics perspective, it is helpful to look at BioWatch in four
ways:

	•	 	Initial Processing and Information Collection
	 
	•	 	Data Interchange with Initial Results
	 
	•	 	Signal Events, Automated Tools and Consequence Management
	 
	•	 	Integration with Existing Systems and Other Initiatives

	 	 	 	 	 
	 
	    
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

D.1.1. Initial Processing and Information Collection

The following are high level steps in the initial processing and information collection workflow
that appear to be common across the BioWatch community:

	 	•	 	Initial data collection is done on a [**] by [**] at the site of [**];
	 
	 	•	 	The [**] sample and information is transported by [**] and received at [**];
	 
	 	•	 	The [**] receives a [**] data and follows a [**]to log and prepare the sample
for tests;
	 
	 	•	 	Tests are performed and data is output from the test device. [**];
	 
	 	•	 	The BioWatch Management System transmits the data entered to the CDC or some
other location.

Note that in some jurisdictions, a separate database application has been developed in order to
log locally the same data that is input into the BioWatch Information System.

This process is not new to Public Health. It is an example of the implementation of a
Laboratory Information Management Systems (LIMS) specific to a need. This has been the
traditional approach to the development of LIMS, but significant progress has been made in
defining new directions to LIMS from an enterprise-wide standpoint. The Association of Public
Health Laboratories has developed a set of recommendations for LIMS that should be included in
the BioWatch process. This is especially important for multiple jurisdictions that have had a
recent decline in from their existing LIMS vendor.

There are a number of opportunities that can be addressed in this process:

	 	•	 	Automating a number of manual steps of the process to reduce manual data entry
and opportunities for error;

	 	•	 	Using electronic tools such as individual RFID tags or smartcards for users to
improve the speed and quality of the chain-of-control process;

	 	•	 	Capturing the test results electronically, in detail, so that they can be used
locally at a later time, or more easily be combined with other test data;

	 	•	 	Use the Health Alert Network to communicate and collaborate internally and with
key partners (i.e. DHS, CDC and the local FBI liaison;

	 	•	 	Providing an expansion of the BioWatch Management System capabilities to remove
the need for duplicative data entry systems, allow for local control of the data, how
it is used and what detail is transmitted to specific partners; and,

	 	•	 	Further integrating the data into the local laboratory information process so
that it can subsequently be used for analysis or on a regional/state basis.

These new processes must be developed and deployed recognizing the technical, physical and
policy challenges. An example, is the connectivity issue of how [**]

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

	 	 	 	 	 
	 
	    
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

[**] connect, to the [**] network or the Internet in a secure manner. Local rules and
policies must be observed to allow the BioWatch enhancements to be incorporated into the
existing information technology environment.

The BioWatch SCLDI team has developed tools to address this particular problem directly. A
piece of code is installed on the [**] where it can securely be logged and integrated with [**]
to reduce errors and provide additional information.

This is one example illustrating how the BioWatch SCLDI team will use technology to facilitate
the acceptance and use of BioWatch at the local level.

D.1.2. Data Interchange with Initial Results

Data Interchange with Initial Results is critical and many state and local jurisdictions are
expending tremendous resources to incorporate Integrated Message Broker technologies internally
within their organization. Not only is this a component of the guidance for the NEDSS funding,
and updated in the PHIN guidance, it is a practical realization of the value of messaging-based
concepts and the powerful flexibility of XML.

Implementing a message broker into an information technology environment is a non-trivial
effort, with many vendors and contractors vying for that business. It is crucial that the
competitive process be carried out through the use of standards-based interfaces to allow the
various BioWatch components to work in these environments.

[**]. The BioWatch SCLDI effort will embrace the concept of integration using open
standards and support communication with a variety of message broker and security technology.

Local control of who gets what and how much data or information is paramount to the acceptance
of any system that has data that can be interpreted in a variety of ways. The BioWatch SCLDI
approach will provide [**] with the tools to configure and audit what and how data is
transferred, and to what party, will be included.

The people and policy processes must be incorporated into the training, exercises and use of the
BioWatch system so that practical decisions can be made as to what level of granularity [**] is
provided to partners. This decision and formatting should be done locally, with secure
connections to each partner.

This will help to build the “trust” between the members of the BioWatch Community of Practice.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

	 	 	 	 	 
	 
	    
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

D.1.3. Signal Events, Automated Tools and Consequence Management

The interpretation of the data from the current BioWatch implementation is a concern at both the
local laboratory and the political levels. The opportunities outlined in the previous two
sections will help to address these concerns and to build trust. It is important that all
aspects of this phase be well-documented and understood.

A good example was presented at a gathering of public health informatics professionals when the
initial signal event is potentially positive. It was clear that [**]. There were many
questions on what the protocol would be for communications, and even more on the supporting
technology:

	•	 	Who will notify [**]

	•	 	Why do I send these results to the [**]

	•	 	How will I inform the [**] that this is related to one of my cases?

	•	 	How will we securely collaborate?

	•	 	How will I be notified [**]

[**]

It is through the use of training, education and exercises that these lessons and best practices
can be shared to reinforce the overall goals and objectives of the BioWatch program. When
combined with the Community of Practice and the tools that will be available on the [**], the
local partners can be assured that their input and perspectives are being addressed within the
context of national, and international, demands for homeland security.

D.1.4. Integration with Existing Systems and Other Initiatives

[**]:

	•	 	Align guidance from the various grants and programs across the federal
government so that state and local partners have a unified, clear direction on how to
incorporate BioWatch into other efforts;

	 	 	[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted
portions.

	 	 	 	 	 
	 
	    
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

	•	 	Promote or develop exemplar instantiations of BioWatch that are fully integrated
within the laboratory and public health information infrastructure;

	•	 	Integrate [**];

	•	 	Provide best practices for the use, training, education and exercises to
promote the many aspects of BioWatch from both technology and people perspectives; and,

	•	 	Use Open Standards and processes that are well documented to encourage the
acceptance by state and local information technology professionals.

It is clear to the BioWatch SCLDI team that, working together, we can quickly enhance and
improve the use, understanding and acceptance of BioWatch to further enhance Homeland Security
and the general health of the public.

D.2. Approach and Recommendations of the RFP Response

Our approach for assisting in the process of implementing the next generation of BioWatch is
dependent on empowering local and state public health professionals and systems to be further
integrated into the overall process. This will be accomplished by formalizing and cultivating a
Community of Practice for BioWatch; building rich content and forums for communication and
collaboration of tools, techniques and best practices; delivering training materials and exercises
so BioWatch becomes a comfortable part of day-to-day activities; providing local control of how and
when data and information is exchanged; and clarifying the guidance attached to funding efforts to
encourage the integration of BioWatch with other systems in a unified and well-defined manner.

It is important to note that advanced algorithms for determination of sentinel events or
interpretation of BioWatch test data is not included in the approach or recommendations at this
time. It is not that they are without merit, certainly one of the goals of Public Health is to be
able to improve the accuracy and recommendations from these tools and techniques to improve the
decision making capabilities of Public Health professionals.

We feel strongly that current efforts are focused on improving the baseline functionality and use
of BioWatch in local and state programs. BioWatch must be integrated with the people and processes
in the labs, and data shared with other systems, to provide better contextual information in order
to make more informed and knowledgeable decisions. This effort should work in parallel with, and
we hope to improve, the development of advanced algorithms and analysis and we will continue to
work to those ends.

Staffing for the BioWatch Program must be coordinated across all areas in order to provide
consistent levels of service and data quality. Training, exercises and surge capacity are
inter-related and must incorporate ongoing feedback and education to improve the value of BioWatch

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

	 	 	 	 	 
	 
	    
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

at all levels. The BioWatch Project Team recommends the consolidation and coordination
of DHS-provided lab personnel as well as unified business processes for training, exercises, surge
capacity and on-going education.

Crucial to the success of this effort is to recognize the differing needs of the various
participants in the BioWatch Program:

	•	 	Local health departments running the BioWatch Management System;

	•	 	Health departments in surrounding jurisdictions that provide lab support;

	•	 	Local and state health departments with surveillance data;

	•	 	Hospitals and First Responders with intake data;

	•	 	EPA and CDC staff supporting BioWatch; and,

	•	 	Homeland Security and Emergency Management for response.

Clear and consistent communication and collaboration of all participants is necessary for overall
success. The BioWatch Project Team recommends building and extending on an existing infrastructure
for this Community of Practice that is in place with the Health Alert Network.

Public Health labs are rich and diverse in their staffing, local characteristics and use of
information technology. This is especially true of Laboratory Information Management Systems and
data sharing with partner laboratories, both public and private. As information systems evolve and
are implemented at various levels, interdependencies must be reduced to the greatest extent
possible. The BioWatch SCLDI Project Team recommends the secured use of [**] of [**] to ensure
compliance with the CDC Public Health Information Network initiative as well as ongoing efforts for
the National Health Information Infrastructure.

Based upon examination of the implementations of BioWatch at local levels, [**]. The desire of the
public health labs is to have BioWatch fully integrated into their business processes and support
chain-of-custody as a part of normal operations and remove duplicative data entry and cumbersome
processes. Data transmission is a concern to ensure that sensitive data is controlled at the local
level and shared with audiences with only those details that audience requires at that time. [**].

The appropriate use of Information Technology for the BioWatch Program must be standards-based to
support integration with any product, from any vendor. These standards must be available today,
and provide for extensions for the future. Most importantly, information security must be
addressed at all levels and incorporated into the infrastructure and processes to ensure privacy,
build trust, and empower users to make complex decisions. The BioWatch Program Team recommends the
use of [**], with audit trails, as a part of the BioWatch SCLDI Systems Architecture and
Information Infrastructure.

Recognizing the inter-dependencies of the BioWatch program with numerous other initiatives, the
BioWatch SCLDI Project Team recommends the development and dissemination of “best practices” for
local and state public health, homeland security and emergency management

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

	 	 	 	 	 
	 
	    
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BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

programs to determine the best way to integrate and leverage complementary guidance and
initiatives from the US Centers for Disease Control and Health Resources Services Agency. This
will further empower public health labs to shorten information systems development time, recognize
cost savings and share information between the BioWatch program and complementary data from other
systems.

All of this effort must be validated through task-specific education, exercise and follow-on
evaluation. Given the diversity of the lab environments, and rapid evolution of technology, the
BioWatch SCLDI Project Team recommends the use of [**].

The BioWatch SCLDI Project Team was organized specifically to take advantage of existing work on
local, state, regional and national levels to bring a coordinated approach to enhancing BioWatch.
Together, the Team has deep experience in successfully addressing aforementioned goals at the
local, state and federal levels. The primary A-Tek subcontractor, Virtual Alert, is the leading
systems integrator of solutions for the CDC Health Alert Network initiative and for Mass
Prophylaxis and Vaccinations. Together, A-Tek and Virtual Alert organized the BioWatch SCLDI
Project Team specifically for the BioWatch program to ensure that the many aspects of the BioWatch
Program are addressed in a coordinated, uniform manner.

The BioWatch SCLDI Project Team incorporates non-profits, such as PHFE Management Solutions with
many years of Public Health staffing experience; leading participants in public health informatics
with experience at the Association of Public Health Labs, State and Local Health Informatics
Consortium; HL7, HIMSS and IHE interoperability; recognized national experts in advance training
and education using Virtual Reality and other information technology; and organizations working on
the implementation of vocabularies [**].

This proposal provides just a summary of our rich knowledge of the practice of public health
laboratories, training and education, staffing and surge capacity; and public health informatics.
When combined with our proven record of past performance and experience in meeting the specific
challenges that the next generation of BioWatch demands, we look forward to working in partnership
with DHS and its many partners to further ensure Homeland Security.

D.3. Analysis of SOW and Supplemental Information

Given the nature of the amendments and subsequent questions, we are providing the below information
for clarification purposes as well as identifying specific modifications to our formal submission.
The cost elements in Task 5.5 in the original response were based on the full production cost for
hardware and software design and development for fully customized, integrated connectivity to local
BioWatch labs. This included purchasing of hardware and software for each of the local labs.

By changing the assumption (as stated into the question) to [**]

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

	 	 	 	 	 
	 
	    
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BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

[**].

In order to provide the requisite detail for the questions, the following summary of deliverables
and assumptions is provided:

Deliverables:

	1.	 	The deliverables and delivery schedule, as specified in the CIO-SP2i NITAAC Statement of
Work, Element 9 are:

	 	1.1.	 	Monthly status report – Due on the 10th calendar day of each month
	 
	 	1.2.	 	Pilot site staffing – Four lab analysts deployed to a DHS BioWatch pilot site within 30
days of the award
	 
	 	1.3.	 	Core Management Staffing – All Core Management Staff hired and engaged in the
performance of the tasks outlined within the SOW within 30 days of award
	 
	 	1.4.	 	Surge Capacity Staffing Plan – Provide DHS BioWatch staff with a surge capacity
staffing plan for each city in MS Word format within 90 days of award
	 
	 	1.5.	 	Operations and Enhancement Review Committee – Convene a BioWatch Operations and
Enhancement Review Committee meeting within 60 days of award
	 
	 	1.6.	 	In-Process Review – Deliver an In-Process Review and Briefing to key DHS BioWatch staff
within 90 days of award and every six months afterwards
	 
	 	1.7.	 	Updated training material – Provide BioWatch staff with updated training materials,
including developed training exercises and manuals within 180 days of award
	 
	 	1.8.	 	Data Integration Roadmap – Provide DHS BioWatch staff with a roadmap describing how
data and information contained within legacy systems at the state and local laboratory
level will be integrated with specific BioWatch Information Systems within 180 days of
award

	2.	 	Additional clarifications and definitions were provided in Amendments 1-6 subsequent to the
release of the SOW and how they can impact the deliverables identified in item #1:

	 	2.1.	 	Amendment #1 has no impact on the SOW deliverables

	 
	 	2.2.	 	Amendment #2 clarifies items 1.2, 1.3 and 1.4 above

	 	2.2.1.	 	Items 1.2 and 1.4 are clarified in that there will [**] (Amendment #2 items 5 and 7)
	 
	 	2.2.2.	 	Item 1.3 is clarified that the expectation is that the core management team will
require between [**] FTE (Amendment #2 item 6)

2.3. Amendment #3 clarifies:

	 	2.3.1.	 	A new deliverable related to SOW Task Item 5.8 that there will be [**] workshops per
year (Amendment #3, item 3).
	 
	 	2.3.2.	 	A new deliverable related to SOW Task ITEM 5.9 that there will [**] studies per
year, (Amendment #3, item 4).
	 
	 	2.3.3.	 	Clarification of Item 1.2 (Pilot) and 1.4 (Surge) the work location for at
state/local laboratories (Amendment #3, item 5)
	 
	 	 	 	[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted
portions.

	 	 	 	 	 
	 
	    
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.
	    
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

	 	2.3.4.	 	Clarification of Item 1.3 (Core Management Team) for developing cost estimates
for new BioWatch locations (Amendment #3, item 8)

	 	2.3.5.	 	Clarification of Item 1.3 for the roles and duties of Core Staff (Amendment #3, item
11)

	 	2.4.	 	Amendment #4 has no impact on the SOW deliverables

	 
	 	2.5.	 	Amendment #5

	 	2.5.1.	 	Clarification of Item 1.3 for the development of a staffing plan within the core
team (Amendment #5, item 1)

	 	2.5.2.	 	Clarification of the delivery capabilities for staffing for Task Items 5.2, 5.3 and
5.6 (Amendment #5, item 1)

	 	2.5.3.	 	Clarification of the delivery capabilities for staffing [**] for Task Items 5.2, 5.3
and 5.6 (Amendment #5, item 2)

	 	2.5.4.	 	Clarification related to the support and estimated work effort for [**] surges, [**]
weeks in length each at [**] sites (Amendment #5, item 3)

	 	2.6.	 	Amendment #6 has no impact on the SOW

	3.	 	Additional Deliverables are proposed within the Specific Task Orders

	 	3.1.	 	Task 5.1 – no impact on deliverables
	 
	 	3.2.	 	Task 5.2 – the inferred deliverables were clarified in the amendments above that the
services be delivered by the Core Management Team
	 
	 	3.3.	 	Task 5.3 – the deliverables for this task element were clarified in the amendments
above that the capacity and planning should be delivered by the Core Management Team, the
estimated work effort will be for [**] surges, [**] weeks in length each at [**] sites, and
the A-Tek BioWatch SCLDI team should demonstrate capabilities to provide these staff in a
timely manner as identified by DHS BioWatch Staff
	 
	 	3.4.	 	Task 5.4 – Clarification related to the development and facilitation of exercises and
clarified item 1.7 above for updated training material. From the amendments above, these
services will be provided by the Core Management Team
	 
	 	3.5.	 	Task 5.5 – This task identifies multiple deliverables that were not previously
identified

	 	3.5.1.	 	A new deliverable to provide staff to manage BioWatch
Information Systems
	 
	 	3.5.2.	 	A new deliverable (clarified in the Questions provided) to provide [**]
	 
	 	3.5.3.	 	Additional deliverables that were quantified and detailed within the initial A-TEK
RFP response but need to be further researched and defined within the first contract
period

	 	3.6.	 	Task 5.6 – the inferred deliverables were clarified in the amendments above that the
service be delivered by the Core Management Team
	 
	 	3.7.	 	Task 5.7 – A clarification of Deliverable 1.5 for meetings up to [**] times per year
	 
	 	3.8.	 	Task 5.8 – An optional new Deliverable to organize and oversee several exercises and
workshops in the year, which was further clarified in Amendment #3 above
	 
	 	3.9.	 	Task 5.9 – the inferred deliverables were clarified in the amendments above that the
service be delivered by the Core Management Team

	 	 	[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted
portions.

	 	 	 	 	 
	 
	    
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.
	    
	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

	4.	 	The Questions for Clarification Received on August 3, 2004:

	 	4.1.	 	Requesting for clarification and confirmation of key personnel
	 
	 	4.2.	 	Provide additional detail of specific past experiences and current capabilities for
staffing
	 
	 	4.3.	 	Revisit the cost estimate for the execution of Task 5.5
to be done [**]
	 
	 	4.4.	 	Provide details of Table Top Exercises with detailed
specifics

	 	D.3.1.	 	Updated Definition of Deliverables and Assumptions

	 
	 	 	The deliverables and delivery schedule, as specified in the CIO-SP2i NITAAC Statement of Work,
Element 9 with the additional items identified in the Amendments, Tasks and Questions are:

	 	1.	 	Monthly status report – Due on the 10th calendar day of each month

	 	•	 	This effort will be provided by the Core Management Team

	 	2.	 	Pilot site staffing – Four lab analysts deployed to a DHS BioWatch pilot site within 30
days of the award

	 	•	 	Additional laboratory staffing estimates are provided in the Appendix

	 	3.	 	Core Management Staffing – All Core Management Staff hired and engaged in the
performance of the tasks outlined within the SOW within 30 days of award

	 	•	 	The Core Management Team staffing identified will be available in the
prescribed thirty (30) day period and cost elements have been separated for Core
efforts and those efforts that will be expended for Exercise and Training development
	 
	 	•	 	Additional Key Staff being added are (summary resumes attached) in order to
support specific deliverables within the initial year and will include:

	 	o	 	[**] – exercise, training and workshops
	 	o	 	[**] – exercise, training and workshops
	 	o	 	[**] – liaison, exercise, training and workshops
	 	o	 	[**] – Epidemiologist, exercises and workshops
	 	o	 	[**] – Epidemiologist, Microbiologist, exercises

	 	•	 	Additional staff including clerical, training, operations, engineering and
development are being allocated from existing Virtual Alert staff

	 	4.	 	Surge Capacity Staffing Plan – Provide DHS BioWatch staff with a surge capacity
staffing plan for select cities in MS Word format within 90 days of award

	 	•	 	Surge capacity staff budget estimating information is provided in Appendix 1

	 	5.	 	Operations and Enhancement Review Committee – Convene a BioWatch Operations and
Enhancement Review Committee within 60 days of award

	 	•	 	Support for two meetings are identified in the first year budget summary

	 	6.	 	In-Process Review — Deliver an In-Process Review and Briefing to key DHS BioWatch staff
within 90 days of award and every six months afterwards

	 	•	 	These services will be provided under the Core Management Staff engagement

	 	7.	 	Updated training material – Provide BioWatch staff with updated training materials,

	 	 	[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted
portions.

	 	 	 	 	 
	 
	    
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.
	    
	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

	 	 	including developed training exercises and manuals within 180 days of award

	 	•	 	These services will be provided under the Core Management Staff engagement

	 	8.	 	Data Integration Roadmap – Provide DHS BioWatch staff with a roadmap describing how
data and information contained within legacy systems at the state and local laboratory
level will be integrated with specific BioWatch Information Systems within 180 days of
award

	 	•	 	These services will be provided under the Core Management Staff engagement

	 	9.	 	Host [**] workshops per year, exercises and training (Task Item 5.8, Amendment #3, Item
3; Task items 5.4 and 5.8)

	 	•	 	These services will be delivered by the Core Management Staff

	 	•	 	An additional budget allocation is made for supporting [**] workshops to
support local efforts. It is assumed that there will be some in-kind contribution by
the local jurisdiction

	 	10.	 	Support [**] research studies per year (Task Item 5.9, Amendment #3, Item 4)

	 	•	 	These services will be delivered by the Core Management Staff

	 	11.	 	Support work efforts for [**] surges, [**] weeks in length each at [**] sites
(Amendment #5, Item 3)

	 	•	 	The planning and oversight services will be delivered by the Core Management
Staff

	 	•	 	The allocation for laboratory surge capacity is identified in the budget
summary

	 	12.	 	Provide staff to support BioWatch Information Systems (Task 5.5)

	 	•	 	The additional staff to support the BioWatch Information System effort are
identified in the Core Management Staff

	 	•	 	Development and maintenance of the [**] for the BioWatch Program’s data and
information management

	 	•	 	Staff to assist in the customized planning, implementation, and data
integration strategies for each participating laboratory as directed by DHS

	 	•	 	Development and maintenance of training, assessment, and support for field
staff as well as the collaboration tools for outreach

	 	•	 	Development and maintenance [**]

	 	•	 	Liaison support by Core Management Staff and BioWatch Information System
technical staff with:

	 	o	 	The Environmental Protection Agency,

	 	o	 	The Centers for Disease Control and Prevention and Food and Drug
Administration within the Department of Health and Human Services,

	 	o	 	The Department of Agriculture,

	 	o	 	Other Federal agencies concerned with health or Homeland Security data,

	 	o	 	The Association of Public Health Laboratories, and

	 	o	 	Other national, state and local health and Homeland Security
organizations with an interest in BioWatch data.

	 	13.	 	Provide a [**] solution for BioWatch Information System to support elements identified
in the SOW (from Task 5.5 and Question list)

	 	 	[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted
portions.

	 	 	 	 	 
	 
	    
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.
	    
	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084
	    
	 

	o	 	[**]

	•	 	The system is based on the leading [**] and [**] offering:

	o	 	A customized version of the Virtual Alert Bio-Terrorism Readiness Suite

	o	 	Virtual Alert vaGateway single-sign-on gateway

	o	 	Connectivity to [**] compliant and [**]

	•	 	[**] capacity was estimated on providing the
following:

	o	 	[**] DHS and partner staff

	o	 	[**] local BioWatch laboratory staff ([**] locations, [**] staff per location)

	o	 	[**] Local BioWatch Community participants

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted
portions.

	 	 	 	 	 
	 
	    
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.
	    
	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

D.4.    Supplemental Information

The following paragraphs provide supplemental information:

D.4.1.       Core Management Staff

The Core Management Staff provides administrative and programmatic operations and expertise to
the overall program. The Team consists of practitioners with a rich and diverse background to
bring to the BioWatch project and experience in public health at federal, state and local
levels. Specific knowledge of public health informatics standards, CDC initiatives, data
sharing, connectivity and communications are well represented. The Team consists of recognized
leaders in communication and collaboration in the local, state and inter-jurisdictional spaces,
as well as general public health. Programmatically, the members have a track record for
projects of similar scope and complexity.

D.4.2.       Exercise, Workshop and Training

Effort is required to develop the content and programs for exercises, workshops and training, as
well as delivering the content. Some of the staff time for this effort will be delivered by
members of the Core Management Team. Additional key staff has been identified for this effort
in this updated response. The number of workshops and exercises for the first year is less than
for subsequent years in order to provide for the development of the appropriate materials.

D.4.3.       Staffing for [**] and Data Connectivity

Staffing for providing [**] and data connectivity is broken out separately for those elements in
Task 5 that require the development and maintenance of the BioWatch Information System (BIS), as
well as [**]. Additional work efforts will be for training, educating and supporting users of
BIS.

D.4.4.       Workshop/Exercise Allocation

In order to facilitate workshops and exercises, an allocation is made for defraying the cost of
the exercises. This is based on the [**] exercises in the first year, subsequent to the
development of the content. This estimate is based on team experience for defraying the cost of
participation by state and local jurisdictions.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 16
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

D.4.5.       Pilot Lab Staffing

This item allocates the money for four pilot staff for a laboratory that will be brought on line
in the first thirty days at a location specified by DHS.

D.4.6.       Allocation for [**] OERC meetings

An allocation is provided for carrying out [**] OERC meetings at a location and time to be
determined by DHS.

D.4.7.       Travel Allocation for staff

An allocation is made for staff travel, including the pilot and surge staff for the laboratory.
This allocation assumes that the BIS portal will be utilized as much as possible for
communication and collaboration to reduce the cost and time for travel.

D.4.8.       Allocation for Local Lab Staff certification process

During the surge process, surge lab staff must be certified to operate in the local laboratory.
This line item allocates funds to pay for the overtime for existing staff to support ongoing
operations during the certification of surge staff, as well as for the certification itself.

D.4.9.       Surge Capacity Allocation

This line item allocates funds to support the specified [**] surges, [**] weeks in length each,
at [**] sites.

D.4.10.       [**]

[**]

E.       Specific Tasks

The following sections address each of the specific tasks outlined in the SOW -

	 	1.	 	Contract Level and Task Order Management
	 
	 	2.	 	BioWatch Surveillance Team
	 
	 	3.	 	BioWatch Surveillance Team – Surge Capacity
	 
	 	4.	 	BioWatch Surveillance Team Training
	 
	 	5.	 	BioWatch Information Systems Management
	 
	 	6.	 	Administration and Personnel Management

     [**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

	 	7.	 	BioWatch Operations and Enhancement Review Committee

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 17
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

	 	8.	 	BioWatch Signal Interpretation and Consequence Management Facilitation
	 
	 	9.	 	BioWatch Research and Study Assistance

E.1.       Task 1 — Contract-Level and Task Order (TO) Management

Task: Contract Level Program Management is required to maintain compliance with all CIO-SP2
requirements and ensure Quality Assurance. Project Level Task Order Management is required to
manage the day-to-day performance and project management to include productivity and management
methods such as Quality Assurance, Configuration Management, Staffing, Security Management and all
centralized administrative and documentation functions needed at the contract level. A monthly
Status Report is required.

Response: The A-TEK Team follows strong management processes that have proven success in
previous support efforts in which we’ve teamed. Using best practices, lesson learned management
and functional training and involving senior managers in ongoing program review, our project
team will deliver BioWatch SCLDI support to the DHS. We will stress the need at all levels on
the project team for customer satisfaction with problem resolution and emphasize the value of
clear concise communications to the DHS. Our practice is to clearly define the responsibilities
at each level of the project delivery team, ensuring that the team responds immediately to all
the DHS requests.

E.1.1.       Subtask 1 — Contract-Level Program Management

A-TEK will function as the Prime contractor and will maintain full responsibility for contract
performance and product delivery, along with the CIO-SP2 contract-level program management
services required of prime contractors under the CIO-SP2 contract. A-TEK’s President, Debbie
Rieger, has 20+ years managing and administering Government contracts, and proven success in
delivering solutions to Government Clients. This experience will prove invaluable when
developing and implementing the requirements of this program. Virtual Alert, performing as
subcontractor to A-TEK, will perform the majority of the direct project management and, working
with PHFE, perform all technical work on the task. A-TEK will provide the technical and
functional activities at the contract level needed for program management of this SOW, including
productivity and management methods such as Quality Assurance, Configuration Management, Work
Breakdown Structure, and Human Engineering at the Contract level. A-TEK will also provide the
centralized administrative, clerical, documentation, and other related functions.

Richard Basch is assigned as the CIO-SP2 Contract Vehicle Program Manager working from A-TEK’s
corporate office and reporting directly to A-TEK’s President and CEO, Ms. Rieger. He will be
supported by all administrative functions. Mr. Basch brings to this project all the requisite
skills, developed over 25 years of management experience. Mr. Basch will communicate regularly
with the A-TEK Team’s BioWatch SCLDI Project Manager (PM) and the DHS’ Project Manager to ensure
that all deliverables are provided and to ensure customer satisfaction.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 18
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

A-TEK’s program management approach utilizes proven planning, budgeting, scheduling, performance
monitoring, communication and liaison, and status reporting procedures. Based on sound program
management fundamentals, these procedures will be implemented in a way that is structured to
provide firm project control and yet be flexible enough to meet the dynamic requirements of the
DHS. Our program management methods provide approaches, methods, and tools that assist the
Program Manager to execute his/her key responsibilities. In addition to enabling firm program
control, the program management methods have features that allow the Project Manager to tailor
support for changing needs in a real time environment.

Performance monitoring at the project level focuses on the three major aspects of successful
contract performance: technical, schedule, and cost. At the program level, performance
monitoring will focus on the overall performance of the Program.

E.1.1.1.       Technical Performance

From a management control perspective, effective technical performance is a function of
clearly defined tasks, intelligent staffing decisions, precisely defined technical
performance requirements, clear and frequent communication, and sound technical leadership
designed to eliminate barriers to effective performance. Technical performance monitoring
will be achieved through the day-to-day interaction and communication between the Project
Manager and the A-TEK Team Program Manager. Both technical progress and technical quality
will be measured by empirical means, when appropriate.

E.1.1.2       Schedule

A-TEK’s CIO-SP2 Program Manager proactive monitors the project schedule to ensure all
deliverables are met and to track use of funding as it relates to the period of performance
of each task and subtask, as well as the overall project.

E.1.1.3.       Cost Performance

A-TEK’s accounting system receives inputs from source documents such as timesheets, staff
member expense reports, vendor invoices, and consultant and subcontractor invoices. At the
end of each accounting period, the charges and labor hours for each project and task are
totaled and a variety of project financial and labor utilization reports are distributed to
corporate management. Upon receipt of the program financial reports for a given month, the
Program Manager compares actual program financial performance with the appropriate budgets.
These variance analyses consist of comparing budgeted with actual expenditures for each
category of program expense, calculating the amount and direction of the difference, judging
the significance of the difference, and investigating the cause of the difference if it is
material. Once the cause of any material variance has been identified, the project and
appropriate task manager(s) is directed to take corrective measures. This process also
ensures accurate invoicing.

E.1.2.       Subtask 2 — Task Order Management

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 19
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

Upon contract award, a representative of the A-TEK Team will contact the
contracting representatives to establish lines of communication and points of
contact. The A-TEK Team BioWatch SCLDI Project Manager (PM) will report
directly to the CIO-SP2 Project Manager of A-TEK and will serve as a single
point of contact for executive corporate level communications, with full access
to corporate resources. The BioWatch SCLDI PM will be responsible for all
aspects of performance from initial contract award to contract completion, and
will be accountable for people, time, finances, activity, and information. The
sections below describe the proposed project management approach of the A-TEK
Team to implement the Task Order Management as follows:

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 20
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

[**] of Virtual Alert is assigned as the BioWatch SCLDI Project Manager working from Washington,
DC and Virtual Alert’s corporate office and reporting directly to the A-TEK’s CIO-SP2 Program
Team. He will be supported by the BioWatch SCLDI Management Team as well as the Virtual Alert
staff. [**] brings to this project all the requisite skills, developed over 22 years of IT,
Program, Systems and Development design and management experience. [**] also brings seven years
of Public Health Informatics and Data Sharing expertise to the project. [**] will communicate
regularly with the A-TEK Team’s CIO-SP2 Program Manager [**] and the DHS’ PM to ensure that all
deliverables are provided and to ensure customer satisfaction.

E.1.2.1.       Approach to Project Management. The A-TEK Team management approach is founded on
sound, ethical business practices, conservative fiscal operations and superior technical
performance. Managers at A-TEK, Virtual Alert and PHFE adhere to process controls and
continuous process improvements, industry standards in management oversight, documented
policies and procedures, fair hiring practices, financial oversight, competitive employee
compensation and retention. This ensures that the A-TEK Team will deliver an outstanding
quality of products and services to the Department of Homeland Security. Corporate
commitment to performance measurement

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 21
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

and continuous improvement in quality services is a hallmark of the A-TEK Team, and an
effective program management approach and experienced personnel provide the resources
necessary to fulfill contract requirements. The A-TEK Team applies proven management
controls and dedicates the necessary resources to support project requirements on time and
within budget.

The A-TEK Team’s project planning and control systems are organized in a top down manner.
This system helps control contract execution to achieve high quality deliverables and
performance. The success of planning and a control system rests on the corporate commitment
to quality, use of management controls, access to corporate resources, support of upper
management, and structured management methods.

E.1.2.2.    Commitment to Quality. The A-TEK Team is uncompromising in our commitment to
quality. Quality is a priority in all aspects of the A-TEK Team’s performance and conduct.

	 	•	 	Management: The A-TEK Team’s managers take an active role in establishing an
environment that promotes continuous improvement and that encourages change,
innovation, and pride. The BioWatch SCLDI Project Manager will be an integral part of
the quality process during every phase of the contract.
	 
	 	•	 	Employees: Every employee is responsible for quality. All employees are
encouraged to recommend improvements and offer suggestions that will increase
productivity.
	 
	 	•	 	Customer Feedback: The A-TEK Team emphasizes customer satisfaction. Positive
relationships with our customers ensure timely, quality products and services.
Concise, mutual understanding is the key to successful completion of project
objectives. We continuously invite our customers to provide feedback and to critique
our performance. This relationship ensures that the customer and the A-TEK Team agree
on the project’s needs.
	 
	 	•	 	Continuous Improvement: We analyze the processes we use to achieve project
goals. We ensure that each step of the process improves the quality of service.
	 
	 	•	 	Quality Management and Control: We provide a comprehensive quality control
program for all contractual efforts. Directed from the corporate level, the
responsibility for quality is clearly defined and administered throughout the
corporation. The BioWatch SCLDI Project Manager, A-TEK contracts department, and task
leads will apply quality standards to contract deliverables emphasizing clear
organization, technical accuracy, understandable language, and adherence to
requirements. These are fundamental criteria in evaluating contract deliverables.

E.1.2.3.    Task Management Methodology. The BioWatch SCLDI Project Team’s task management
methodology is based on our established methodology, describing the following:

	 	•	 	Approved policies and approaches

	 	•	 	Roles and responsibilities of task managers and task leads

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 22
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

	 	•	 	Procedures for planning, estimating, organizing, controlling, and measuring work

	 	•	 	Management/status reviews

	 	•	 	Risk management

The proposed BioWatch SCLDI Project Team is represented as follows:

[**]

The BioWatch SCLDI Project Team’s task management approach will follow the SEI CMM Level 3,
IEEE and Project Management Institute PMP best practices for systems and software
development. SEI CMM Level 3 encompasses project management and tracking, requirements
management, subcontract management, quality assurance (QA), configuration management (CM),
organizational processes, training programs, testing, peer reviews, product integration,
inter-group coordination, and product delivery. These standards will be tailored to fit the
BioWatch Program and will take into account DHS’ unique requirements and emerging standards
and architecture.

As part of our management framework, we will use earned value to assess task progress and
efficiency. Earned value is the measurement of physical performance against a detailed plan
to allow for the accurate prediction of final costs and schedule results for a given
project. It provides managers with an “early warning” alarm, allowing them to take
necessary corrective actions if a task is spending more money than planned.

We will use Microsoft Project and Microsoft Project Server to support earned value analysis.
In addition to planning and tracking support, this tool provides standard reports;
user-defined report formats with numerous sort, conditioning, summary, and time window
options; variance analysis; and required government report formats including cost
performance reports, cost/schedule status reports, and contractor cost data reports.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 23
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

We anticipate the BioWatch SCLDI Program will involve multiple simultaneous subtasks.
Our Project Management lead and supporting staff are experienced in this type of
environment, and we will plan and control each subtask within the context of the overall
Contract-Level Management. For example, each subtask will be assigned a unique accounting
code to enable us to report to the DHS Project Team the budget status of each individual
effort.

Earned value and other metrics will be shared with the BioWatch DHS PM during meetings and
in weekly status reports. Deliverable products and schedules are described in their
respective sections. At least three plans are anticipated consisting of a Management Plan,
Ramp Up Plan, and Communications Plan.

E.1.2.4.    Management Plan. After contract award and the initial kick-off meeting with the DHS
team, we will develop a management plan that will prioritize the activities for the
lifecycle of the contract. The management plan will address the processes and subtasks that
will be incorporated in the BioWatch SCLDI engagement. Additional elements include initial
assumptions, risk assessment and mitigation strategies.

E.1.2.5.    Ramp-up Plan. After contract award, we will develop a ramp-up plan that complements
the Management Plan. The ramp-up plan will address key early-stage activities and schedules
associated with task ramp-up such as employee hiring, orientation, and training;
coordination and planning meetings with the BioWatch DHS PM and other BioWatch DHS Program
entities; and development and finalization of standard operating procedures (SOPs) and
documentation.

E.1.2.6.    Personnel Management. Task planning and execution are only as good as the people
assigned. All BioWatch SCLDI Project Team personnel will be screened and interviewed to
ensure they are fully qualified and committed to the program. Once on the job, they will
receive periodic training to ensure they remain proficient. Virtual Alert will maintain a
group of qualified engineers and clinical personnel who can be assigned to tasks as needed
to augment our team’s full-time core staff. To minimize key personnel turnover, the Team
will put into place a set of incentives, bonus plans, and training opportunities to motivate
managers both to excel and remain on the job. All key personnel bid on the BioWatch Program
will be assigned to the contract for a period of no less than 180 days, except as
necessitated by sudden illness, death, or termination of employment.

E.1.2.7.    Subcontractor Management. BioWatch SCLDI Project Team’s rigorous evaluation process
will ensure all subcontractors and vendors are fully qualified for the program. All
subcontractors must follow these standards and we will perform audits and reviews of all
processes and work. The BioWatch SCLDI Project Team implements Federal Acquisition
Regulations (FAR) with respect to competing, awarding, and administering lower tier
subcontractors.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 24
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

E.1.2.8.    Communication Plan. This section outlines the protocols and communications and also
identifies the points of contact for the US Department of Homeland Security and the
continued development of the BioWatch SCLDI project (see the BioWatch SCLDI Project Team
organizational chart above). This plan will be updated after initial kick off and
organizational meetings as well as after initial BioWatch SCLDI Collaboration Portal system
implementation to reflect communications procedures for the system once it is in maintenance
mode.

Immediately upon contract signing, the timeline for BioWatch SCLDI development will begin.
This document will assist DHS and the BioWatch SCLDI Team in facilitating and monitoring
communication between the two entities, and create a structure for official communications
to follow. This document should be considered a living document and will be updated as
progress moves toward completion. Any changes that occur in the structure of communication
between the two parties will be reflected in an updated Communication Plan.

E.1.2.9.    General Protocols. The BioWatch SCLDI Project Team will be responsible for
coordinating efforts, organizing, defining, scheduling resources, internal system design,
training, educational material, exercises and establishing timelines to ensure that DHS
service and task orders are addressed in a timely and coordinated fashion.

The BioWatch SCLDI Project Team will monitor resources and make requests with appropriate
lead time from DHS for approval of additional resources in order to meet project timeliness.

The DHS Project Manager will monitor the progress of this project with the BioWatch SCLDI
Project Team providing monthly updates via a Status Report on the 10th of each
month, in accordance with the RFP.

The DHS Project Manager is responsible for evaluating project status, any requests to the
BioWatch SCLDI Project Team for additional resources, and for obtaining necessary decisions
and approvals from DHS management.

The BioWatch-SCLDI Project Team will document questions and answers received from DHS in
order to establish a clear decision record.

The DHS Project Team leads will be defined by DHS during the initial kick-off meeting.

The BioWatch SCLDI Project Team is defined as the entire project team — with key
communications personnel being the BioWatch SCDLI Project Manager [**], Project Office [**],
Public Health Staffing [**], Project Control [**], Public Health Informatics Director [**]
and Senior Medical Director [**].

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 25
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

E.1.2.10.    Team Collaboration Tool. The BioWatch SCLDI Collaboration [**] will be used
as the primary collaboration tool for the BioWatch SCLDI project. It will be used in the
following areas:

[**]

E.1.2.11.    Meetings. Status meetings will be held between DHS and the BioWatch SCLDI Project
Team as a way to monitor deliverables and action items. The schedule for these meetings
will be established at the kick-off meeting.

The BioWatch SCLDI Project Team will formally communicate project status information to DHS
through the monthly BioWatch SCLDI Status and Planning Meetings held the 10th day
of each month. This meeting will be facilitated by the BioWatch SCLDI Project Manager and
will be used to:

	 	•	 	Review project status relative to the timeline
	 
	 	•	 	Raise discussion and review the status of issues and action items
	 
	 	•	 	Review upcoming tasks
	 
	 	•	 	Review and update new and existing task orders
	 
	 	•	 	Review status of any open Decision Logs

Work group meetings will be scheduled on an as-needed basis. These meetings will be used to
discuss and resolve specific project issues.

The BioWatch SCLDI Project Team will be responsible for creating and distributing all
meeting agendas, meeting minutes, and documents intended for project monitoring as outlined
in the document. If possible, meeting requests will be issued no later than two days before
a meeting and will include a proposed agenda. These guidelines apply to conference calls as
well as face-to-face meetings. All meeting requests that involve individuals outside the
immediate DHS personnel must be reviewed and approved by the DHS Project Manager or his/her
designee.

If a meeting must be cancelled, the meeting requestor will send a cancellation notice via
[**] to all participants as soon as possible. The cancellation notification will be sent as
a ‘high’ priority email and should identify the meeting in detail and provide a reason for
the cancellation. If it is appropriate to postpone a meeting, a new and/or revised meeting
request should be included in the message regarding the original postponement. The agenda
should be attached to the new and/or revised meeting request.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 26
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

E.1.2.12.    Meeting Agendas. The agenda [**] should include a brief description of the
topics for discussion in the meeting in order for the State to arrange for the appropriate
stakeholders to attend. Agendas will include the following information:

	 	•	 	Date, time, and location of the meeting
	 
	 	•	 	If a follow up meeting, review of minutes/action items from prior meeting, as
appropriate
	 
	 	•	 	Each of the topics that will be discussed
	 
	 	•	 	Start and end times for each topic, if possible.

Any recommended changes to the agenda should be communicated using the discussion feature of
[**].

E.1.2.13.    Minutes. Minutes will be prepared by the BioWatch SCLDI Project Team and
distributed via [**] to DHS and BioWatch SCLDI Project Team staff for all status and work
group meetings within three (3) working days of the meeting. A low priority email will be
sent notifying attendees of the posting. All meeting attendees prior to the subsequent
meeting will review minutes. Significant corrections of minutes should be sent by email to
the BioWatch SCLDI Project Manager prior to the subsequent meeting. Corrections received by
the BioWatch SCLDI Project Team will be circulated to all involved individuals. Corrections
to minutes will be discussed at the beginning of the subsequent meeting and revised meeting
minutes will be distributed to all involved parties. Revisions to the original minutes will
be highlighted and then notated with the initials of the person making the requested change.

Meeting minutes will include the following sections:

	 	•	 	Purpose of the meeting

	 	o	 	Discussion Items, including:
	 
	 	o	 	Areas of discussion or review

	 	•	 	Decisions made

	 	•	 	Action items, including deadline and person assigned to complete the item

E.1.2.14.       Deliverables Matrix

The SCLDI Team will produce the following deliverables per the schedule identified below.
Details of how these deliverables will be produced are included in the narrative of each
task.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 27
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	SOW	 	 	 	 	 	 	 	 	 	 
	 	TASK	 	 	DELIVERABLE	 	 	 	 	 	 	 
	 	#	 	 	TITLE	 	 	DESCRIPTION	 	 	DUE DATE	 
	 	1

	 	 	Status Report
	 	 	Overall project
performance
categorized by Work
Task. Milestones,
deliverables, and
budget information
to be included.
	 	 	Monthly, on

10th
calendar

day	 
	 	2

	 	 	Pilot Site Staffing
	 	 	Four lab analysts
deployed to a DHS
BioWatch Pilot Site
	 	 	Within 30
days of award	 
	 	2

	 	 	Core Management

Staffing
	 	 	All Core Management
Staff in place and
fully operational
	 	 	Within 30
days of award	 
	 	3

	 	 	Surge Capacity

Staffing Plan
	 	 	Provide DHS

BioWatch staff with

a surge capacity

staffing plan for

select cities
	 	 	Within 90
days of award	 
	 	7

	 	 	Advisory Group
	 	 	Convene a BioWatch
Operations and
Enhancement
Advisory Group
	 	 	Within 45
days of award	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	SOW	 	 	 	 	 	 	 	 	 	 
	 	TASK	 	 	DELIVERABLE	 	 	 	 	 	 	 
	 	#	 	 	TITLE	 	 	DESCRIPTION	 	 	DUE DATE	 
	 	1

	 	 	In-Process

Review
	 	 	Deliver an
In-Process Review
and Briefing to key
DHS BioWatch Staff
	 	 	Within 90 days of
award and every 6
months thereafter	 
	 	4

	 	 	Updated

Training

Material
	 	 	Provide DHS
BioWatch staff with
updated training
materials,
including developed
training exercises
and manuals
	 	 	Within 180 days of
award	 
	 	5

	 	 	Data

Integration

Roadmap
	 	 	Provide DHS
BioWatch staff with
a roadmap
describing how data
and information
contained within
legacy systems at
the state and local
laboratory level
will be integrated
with specific
BioWatch
Information Systems
	 	 	Within 180 days of
award	 
	 

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 28
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

The SCLDI team has also identified the following “deliverables “ that are derived from the
various amendments and the questions made regarding this offering from Mr. Ford in his
correspondence of 3 August 2004:

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	SOW	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	TASK	 	 	"DELIVERABLE"	 	 	 	 	 	 	 	 	 	 
	 	#	 	 	TITLE	 	 	DESCRIPTION	 	 	DUE DATE	 	 	DUE DATE	 
	 	8

	 	 	Workshops &

Exercises
	 	 	Deliver [**]

Workshops per year
	 	 	After initial ramp-

up period, [**]

workshops will be

provided within

[**] days
	 	 	Amendment 3, Item 3	 
	 	9

	 	 	Special Studies
	 	 	Deliver resources

for [**] special

studies per year
	 	 	Within [**] days of
identification of
special studies
	 	 	Amendment 3, Item 4	 
	 

E.1.3.       Staffing Estimate

The following staffing table reflects the full Management Team for this Task.

	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Role	 	 	Name	 	 	A-TEk Item	 	 	Hours	 
	 	A-TEK President & CEO

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	A-TEK Program Manager

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	BioWatch SCLDI Program Manager

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	BioWatch SCLDI Product Manager

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	BioWatch SCLDI Senior Medical Director

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	BioWatch SCLDI Public Health &

Informatics Director

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	Project Control

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	Project Management

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Role	 	 	Name	 	 	A-TEK Item	 	 	Hours	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 

[**] = Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 29
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

E.2.       Task 2 — BioWatch Surveillance Team

Task:    The Contractor shall provide staff to manage and/or operate the day-to-day BioWatch
activities at state and municipal public health organizations within the United States, working
closely with the Environmental Protection Agency and Centers for Disease Control and Prevention
staff at each designated laboratory or field collection activity. The BioWatch Surveillance Team
activities may include:

	 	•	 	Field collection of samples from designated samplers receiving samples from the
designated site of collection at least daily
	 
	 	•	 	Sample Intake to include sample categorization, batching, bar coding, scanning, and
entering the data into the BioWatch Information System for processing
	 
	 	•	 	Sample extraction and preparation for analysis
	 
	 	•	 	Analysis for threat agents and documentation of results
	 
	 	•	 	Data entry of analysis results into BioWatch Information System and processing for
dissemination to appropriate parties
	 
	 	•	 	Follow-on tracking of associated tests with input into the BioWatch Information System
	 
	 	•	 	Appropriate chain-of-custody tracking
	 
	 	•	 	BioWatch Information Systems “reach-back” from DHS to local/state laboratory through
either the Health Alert Network or other mechanism for follow-up communications.

E.2.1.       Response

The BioWatch SCLDI Project Team will provide staffing to perform laboratory functions at the
technician and the analyst levels [**]. This staffing will occur first at [**] and will be
followed by the creation of customized staff management plans developed in conjunction with DHS
and each BioWatch laboratory. The activities of these staff will focus on the collection and
receipt of field samples utilizing appropriate chain of custody procedures, analyzing these
samples for threat agents and documenting the results using data entry and automated data
exchange procedures. Also included is the performance and tracking of appropriate follow-on
tests as necessary, and that data and information will be processed and exchanged with state
local and federal parties using protocols for data exchange and information sharing that are
described in Section E.5 that follows.

The BioWatch SCLDI Project Team offers significant experience in the hiring and deployment of
laboratory analysts and technicians. Currently the team employs staff at all levels of
proficiency at [**]. The BioWatch SCLDI Project Team currently has the capacity to employ staff
in every state in the nation, and can bring new staff on board in a matter of hours.

The Human Resources management component of the BioWatch SCLDI Project Team has years of
experience in tailoring an entire HR “system” to meet the specific needs of the

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 30
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

client, offering assistance with the development of job descriptions, performance
evaluations, policies and procedure manuals and employee handbooks. Additionally, the BioWatch
SCLDI Project Team offers one of the nation’s most comprehensive benefits program including such
critical benefits as: full medical and health coverage plans, flexible spending accounts, tax
deferred annuities, 403(b) retirement accounts, EAP services and numerous other benefits.

The BioWatch SCLDI Project Team has years of experience working to develop custom solutions to
human resource management needs of the client. Staff hired to be members of the BioWatch staff
teams will be required to be certified to work in BSL-3 laboratories for analysts and BSL-2
laboratories for technicians. Certification will be in accordance with laboratory certification
standards in the jurisdiction where the BioWatch laboratory is located. In addition, the
BioWatch SCLDI Project Team will coordinate training activities with local and regional academic
institutions, the National Laboratory Training Network, and distance learning programs within
the service area of BioWatch cities.

The BioWatch SCLDI Project Team can mobilize immediately to begin operations at the BioWatch
laboratory as needed. In developing staff management plans, the BioWatch SCLDI Project Team
will work individually with each BioWatch laboratory to develop a staffing plan that meets the
needs of the individual laboratory and the Department of Homeland Security. Staffing may be
accomplished via an arrangement where staff employed by the host laboratory or the Centers for
Disease Control could be working alongside, staff provided under this contract. Developing the
staff management plans will be accomplished by conducting site visits with each of the
laboratories, and determining in conjunction with the laboratory director how to develop a plan
that will utilize a combination of certified laboratory technicians and analysts that are
existing employees of the BioWatch Program, other staff that are employed at the public health
laboratory, retired laboratory staff and laboratory professionals employed at other facilities
in the region of the BioWatch laboratory.

The BioWatch SCLDI Team has extensive experience and current capabilities in recruiting and
providing staff to public health laboratories across the entire field of laboratory practice.
The team currently employs program directors, microbiologists and microbiology technicians,
chemists, biologists, molecular epidemiologists and technicians, research scientists and
assistants, post-doctoral fellows, physicians and laboratory assistants. These staff work in
programs housed in the [**]. These laboratory professionals are involved in a variety of
activities including mycobacterium testing, arbovirus research, cryptosporidiosis testing,
immunoserology, HIV testing and research, Legionella research, virology research, virus
isolation, retrovirus research and vector borne disease testing.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 31
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

Beyond the provision of this diverse array of laboratory staffing to the above programs,
the SCLDI team has experience in managing seven national centers of the National Laboratory
Training Network. The NLTN is a joint collaboration of the association of Public Health
Laboratories and the Public Health Program Practice Office of the CDC and provides training and
resources to over 10,000 laboratorians, physicians, clinicians and public health leaders
annually.

Within the first 30 days, the BioWatch SCLDI Project Team will develop a Staff Management Plan
and deploy staff at a DHS designated pilot site.

The BioWatch SCLDI Project Team will also in conjunction with activities under task 5.3 develop
a staff management plan for each BioWatch laboratory within the first 90 days.

During the first 60 days of the award, an outreach effort will take place to each of the
BioWatch laboratories to develop the parameters for completion of the customized staffing plans.
During the first 180 days, a comprehensive BioWatch Surveillance Team Management Plan for local
and cross-local mobilization of BioWatch surge capacity team will be developed.

E.2.2.       Staffing Estimate

Laboratory analysts and technicians for the Pilot site, [**], are estimated to be [**] full time
people and would be made available within one month of AFTER CONTRACT AWARD.

Costs for staffing positions at other BioWatch cities for all levels of proficiency is included
in the Laboratory Professional Compensation Rates included within Appendix A. The SCLDI
proposal for Option Years 1 & 2 identifies resources necessary to staff BioWatch laboratories in
all identified cities as [**] teams, with one position taken from each of the top [**] position
categories identified in Appendix A.

Costs for the development of laboratory staffing plans will be incurred in conjunction with the
core management team.

	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Role	 	 	Name	 	 	A-TEK Item	 	 	Hours	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 

E.3.       Task 3 — BioWatch Surveillance Team — Surge Capacity

Task:     The Contractor shall provide staff to manage the surge of BioWatch activities at any

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 32
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

location that detects unacceptable levels of biological threat agents, or as directed by DHS.
This task includes the same tasks as the day-to-day duties outlined in Task 2 above, but with
increased frequency. The Contractor will develop flexible and coordinated staffing models for
surge capacity with public health laboratories that are part of the BioWatch program.

Surge capacity benchmarks will be established for all BioWatch laboratories in conjunction with DHS
and other partners as appropriate. These surge capacity benchmarks will specify [**]. Regional
models will be developed to ensure adequate surge and baseline capacity through different levels
and locations of “events”. It is critical that staff be rapidly mobilized to other laboratories to
meet increased demand.

E.3.1.       Response

This task is designed to assure that each BioWatch laboratory is prepared increase the volume
and periodicity of sample collection and laboratory analysis activities to a 24 hour a day, 7
day a week schedule upon direction of the Department of Homeland Security in the event of
elevation of the national or a regional threat level or during a designated national security
event. Staff from other Biowatch laboratories may be re-assigned on a temporary basis until the
event or threat is sufficiently addressed and surge capacity teams will be developed for each
laboratory. During such re-assignments, staffing levels in all BioWatch laboratories will be
maintained at appropriate levels to continue “normal” testing activities.

The BioWatch SCLDI Project Team offers significant experience in the hiring and deployment of
laboratory analysts and technicians. Currently the BioWatch SCLDI Project Team employs staff at
all levels of proficiency at [**]. The BioWatch SCLDI Project Team currently has the capacity
to employ staff in every state in the nation, and can bring new staff on board in a matter of
hours.

The Human Resources management component of the BioWatch SCLDI Project Team has years of
experience in tailoring an entire HR “system” to meet the specific needs of the client, offering
assistance with the development of job descriptions, performance evaluations, policies and
procedure manuals and employee handbooks. Additionally, the BioWatch SCLDI Project Team’s
offers one of the nation’s most comprehensive benefits program including such critical benefits
as: full medical and health coverage plans, flexible spending accounts, tax deferred annuities,
403b retirement accounts, EAP services and numerous other benefits.

The BioWatch SCLDI Project Team has years of experience working to develop custom solutions to
human resource management needs of the client. Staff hired to be members of the BioWatch Surge
Capacity Teams will be required to be certified to work in BSL-3 laboratories for analysts and
BSL-2 laboratories for technicians. Certification will be in

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 33
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

accordance with laboratory certification standards in the jurisdiction where the
BioWatch laboratory is located. In addition, the BioWatch SCLDI Project Team will coordinate
training activities with local and regional academic institutions and distance learning programs
within the service area of BioWatch cities.

The BioWatch SCLDI Project Team can mobilize immediately to escalate operations at the BioWatch
laboratory as needed. In developing Surge Capacity Plans, the BioWatch SCLDI Project Team will
work individually with each BioWatch laboratory to develop a custom surge capacity plan that
meets the needs of the individual laboratory and the Department of Homeland Security. This will
be accomplished by conducting site visits with each of the laboratories, and determining in
conjunction with the laboratory director how to develop a plan that will utilize a combination
of certified laboratory technicians and analysts that are existing employees of the BioWatch
Program, other staff that are employed at the public health laboratory, retired laboratory staff
and laboratory professionals employed at other facilities in the region of the BioWatch
laboratory.

The BioWatch SCLDI Team has extensive experience and current capabilities in recruiting and
providing staff to public health laboratories across the entire field of laboratory practice.
The team currently employs program directors, microbiologists and microbiology technicians,
chemists, biologists, molecular epidemiologists and technicians, research scientists and
assistants, post-doctoral fellows, physicians and laboratory assistants. These staff work in
programs housed in [**]. These laboratory professionals are involved in a variety of activities
including mycobacterium testing, arbovirus research, cryptosporidiosis testing, immunoserology,
HIV testing and research, Legionella research, virology research, virus isolation, retrovirus
research and vector borne disease testing.

Beyond the provision of this diverse array of laboratory staffing to the above programs, the
SCLDI team has experience in managing [**].

Each BioWatch laboratory’s surge capacity plan will compensate members of the local surge
capacity team at a rate that is comparable to that of staff performing similar functions within
that individual public health laboratory. Upon development and DHS approval of the particular
BioWatch laboratory’s surge capacity plan, the BioWatch SCLDI Project Team will recruit and hire
on a contingency basis the technicians and analysts that will comprise that laboratory’s surge
capacity team, and will work to assure that each member of the team is properly trained in
performing functions as necessary as a member of that team.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 34
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

Within the first 90 days, the BioWatch SCLDI Project Team will deliver customized Surge Capacity
Plans for Laboratories located in BioWatch cities.

Within the first 180 days, the BioWatch SCLDI Project Team will develop a comprehensive Surge
Capacity Management Plan that will allow DHS to respond to mobilize surge capacity teams that
need to be shifted to another BioWatch city during an escalation of the threat level.

E.3.2.       Staffing Estimate

Based on the clarification on the RFP, the estimate is based upon [**] surges, [**] weeks in
length each, at [**] sites. Assuming [**] people per location (in position categories 2, 3, 4,
5), two locations at the same time, this works out to [**]. For pricing purposes we are
projecting the need for surge capacity will for [**] surges, [**] weeks in length, to occur in
the cities of [**]. Please see Appendix A for the detail of rates for these cities.

	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Role	 	 	Name	 	 	A-TEK Item	 	 	Hours	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 

E.4.       Task 4 — BioWatch Surveillance Team Training

Task: The Contractor shall provide and develop staff training, where necessary, for cross-training
of lab technician and microbiologist duties, to include web portal utilization training, as
identified by DHS.

The Contractor shall develop and run exercises and update training material for sample collection,
lab technician, microbiologist, and incident response duties as identified by DHS.

E.4.1.       Response

The training will be developed utilizing the BioWatch SCLDI project team’s background and
specific expertise to address the planning, implementation and data integration needs of
individual laboratories across local, regional, state and cross jurisdictional boundaries. The
expertise lies not only in the fields of microbiology and information technology but also in the
complex communications and consequence management strategies necessary to rapidly mitigate an
actual event.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 35
	 	8/09/04 — R3

 

 

 

			
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI
	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

The BioWatch SCLDI Project Team will coordinate training activities with local and regional
academic institutions, the National Laboratory Training Network, and distance learning programs
within the service area of BioWatch cities. Staff members of the BioWatch laboratory staff
teams will be required to be certified to work in BSL-3 laboratories for analysts and BSL-2
laboratories for technicians. Certification will be in accordance with laboratory certification
standards in the jurisdiction where the BioWatch laboratory is located.

Comprehensive training materials specific to the cross-training of lab technician and
microbiologist duties will be developed and implemented for the [**]. The training will be
conducted to achieve competency in [**].

Training strategies will include direct classroom training as well as train-the-trainer courses
to bolster training staff numbers and multi-media training and education programs (basic and
refresher) that will be directly linked or available through the portal. Exercises will provide
additional training to all levels of users as well as provide outreach capability to the local
response and emergency management community. The scenario-driven exercises will provide
decision-makers within the BioWatch community the opportunity to discuss and solve several
challenging issues related to the response to a positive BioWatch sample finding and how to use
the BioWatch SCLDI as a valuable tool in the response process.

Upon completion of the review, documentation, analysis and development of the Integration and
Communication Plans for the BioWatch Sites, documentation and information will be available [**]
regarding:

[**] This resource information will be also be utilized in the development of the training
resources and plans for use in system drills and exercises.

E.4.2.       Exercises

A series of tabletop and functional exercises will be developed that directly involve the use of
the portal as a daily operations tool as well as a consequence management mitigation tool. The
scenario-driven exercises will not only test and evaluate [**] use and efficiency but will also
provide several challenging obstacles for the public health, medical, public safety and
emergency management agencies within the BioWatch community to address. After Action Reports
will be developed as part of the exercise process and will be used to identify gaps in planning
and response, as well as potential corrective action measures for use of the portal and response
strategies in general. The After Action Reports will be developed with significant local input
to ensure corrective action strategies are realistic for the involved community.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 	 	 	 	 
	A-TEK, Inc.
	 	Page 36
	 	8/09/04 — R3

 

 

 

	 	 	 
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

E.4.3. Options

The BioWatch SCLDI team has specific expertise in the use of virtual reality and serious gaming
technologies which may be of use for specific areas of training, education, validation,
certification or updates. [**], Senior Medical Director, has a team with real-world experience
through work with DARPA. At the request of DHS, the BioWatch SCLDI team makes these services
available. The cost for virtual reality and serious gaming development can not be estimated
without an understanding of the environment, audience and expected outcomes.

E.4.4. Staffing

Augmenting their roles and participation as key members of the BioWatch SCLDI management team,
the training and exercise effort will require the following staffing effort, starting after
contract award plus 30 days for content development, and after contract award plus 60 days for
delivering training.

	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Role	 	 	Name	 	 	A-TEK Item	 	 	Hours	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 

E.5. Task 5 — BioWatch Information Systems Management

Task: The Contractor shall provide staff to manage BioWatch Information Systems (BIS) with [**] to
include the following:

Task 5 — BioWatch Information System Management

	 	5.1.	 	Maintain, administer, and enhance the BioWatch Information Systems, as needed

	 
	 	5.2.	 	Staff to assist in the overall of the BioWatch information systems and resources
	 
	 	5.3.	 	Develop and maintain a [**] for outreach, coordination, and collaboration,
including [**] and IT architecture and IT Web development; this will also include the
development and maintenance of a [**] for Government use to include IT Systems
Engineering to address security and enhancements required for drills and events as
identified by DHS
	 
	 	5.4.	 	Develop and maintain the [**] for the BioWatch Program’s data and information
management

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

	 	Page 37
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

	 	5.5.	 	Develop and maintain local and state laboratory integration of the BioWatch
Information Systems with appropriate Laboratory Information Management Systems, [**]
communications
	 
	 	5.6.	 	Develop and maintain redundant BioWatch Information Systems message connection
brokers
	 
	 	5.7.	 	Support the interface of [**] for designated BioWatch cities
	 
	 	5.8.	 	Staff to assist in the customized planning, implementation, and data
integration strategies for each participating laboratory as directed by DHS
	 
	 	5.9.	 	Provide monthly uptime, usage, and performance reports on the [**]
	 
	 	5.10.	 	Develop and maintain training, assessment, and support for field staff as well
as the collaboration tools for outreach
	 
	 	5.11.	 	Develop and maintain [**]
	 
	 	5.12.	 	Provide liaison among local public health laboratory’s information management
units and:

	 	5.12.1.	 	The Environmental Protection Agency,
	 
	 	5.12.2.	 	The Centers for Disease Control and Prevention and Food and Drug
Administration within the Department of Health and Human Services,
	 
	 	5.12.3.	 	The Department of Agriculture,
	 
	 	5.12.4.	 	Other Federal agencies concerned with health or Homeland Security data,
	 
	 	5.12.5.	 	The Association of Public Health Laboratories, and
	 
	 	5.12.6.	 	Other national, state and local health and Homeland Security organizations
with an interest in BioWatch data.

E.5.1. Response

The BioWatch SCLDI team has reviewed the items within this task and mapped them to the
deliverables and other task elements. There are four components in our solution for this task:

	 	•	 	[**];
	 
	 	•	 	Staff to train, support, maintain and operate the BioWatch Information System;
	 
	 	•	 	Support Laboratory and Data Integration [**]; and
	 
	 	•	 	Promote collaborative relationships and act as [**].

The following sections summarize these efforts.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

	 	Page 38
	 	8/09/04 – R3
	 
	 	 	 	 
	 

 

	 	 	 
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

E.5.1.-A. [**] BioWatch Information System

The BioWatch SCLDI team will provide [**] for BioWatch Information System providing:

	 	•	 	[**].

	 	•	 	Security and permissions assigned to users will be managed
according to the communications plan and protocols established by [**].
	 
	 	•	 	The [**] access will not be accessible by users unless
specifically requested by [**].
	 
	 	•	 	[**].
	 
	 	•	 	[**].

	 	•	 	[**].
	 
	 	•	 	[**];
	 
	 	•	 	[**];
	 
	 	•	 	Functionality to securely interconnect local and state laboratory components of [**]
with appropriate [**] systems and communications;
	 
	 	•	 	A redundant BioWatch Information Systems [**];
	 
	 	•	 	Capabilities to interface with [**] systems in designated BioWatch cities;
	 
	 	•	 	[**]

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

	 	Page 39
	 	8/09/04 – R3
	 
	 	 	 	 
	 

 

	 	 	 
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

	 	•	 	[**]

The BioWatch SCLDI [**] offers the extensive services of the leading [**]:

	 	•	 	[**]

[**] capacity was estimated on providing the following:

	 	•	 	[**] DHS and partner staff
	 
	 	•	 	[**] local BioWatch laboratory staff ([**] locations, [**] staff per location)
	 
	 	•	 	[**] Local BioWatch Community participants
	 
	 	•	 	[**]

E.5.1.-B. Provide staff to support BioWatch Information Systems

The staff to support the BioWatch Information System effort is identified below. In addition to
providing maintenance and operations of the BioWatch Information System, the staff will provide
training via interactive web-based sessions, end-user documentation and quick-access guides,
telephone support and systems backup.

Security is paramount for the System, and will be maintained at numerous levels within the
architecture, network, application, protocol and access control levels including [**].

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

	 	Page 40
	 	8/09/04 – R3
	 
	 	 	 	 
	 

 

	 	 	 
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

As additional data feeds are added, the staff will maintain workflow, data and information
processes and schemas to support other efforts, including the studies identified in Task 9. Key
public health clinical data sets, including [**], will be maintained and coordinated with
partners.

E.5.1.-C Support Laboratory and Data Integration

Crucial to the successful deployment and use of the BioWatch SCLDI systems are the initial
planning processes. The BioWatch SCLDI Project Team is rich and diverse with the necessary
expertise to develop a plan that addresses the needs of the disparate user communities. Key
knowledge sets that our team has include:

	 	•	 	Systems and Security for the development of secure, stable, robust, flexible and
highly available systems that provide key services and support appropriate failover,
recovery, resiliency and redundancy as permitted by underlying services;
	 
	 	•	 	Role-based Access Control that meets and exceeds CDC requirements and is enforced at
the architecture, protocol, data and application layers to ensure safeguards for
information and contexts;
	 
	 	•	 	CDC Guidance and Standards including PHIN, NEDSS, PHCDM, HAN, EPI-X;
	 
	 	•	 	Relevant Public Health and Information Technology Open Standards including HL7,
ICD-9CM, CPT, HL7 Reference Information Model as well as LDAP, XML and Web Services;
	 
	 	•	 	Public Health Informatics and Disease Surveillance including SNOMED codes and the
various elements of the PHIN architecture;
	 
	 	•	 	Communication and Collaboration to extend the capabilities of the Health Alert
Network from [**]; and
	 
	 	•	 	The language of Public Health laboratories for information and experience [**] and
the many physical processes that must be supported.

The BioWatch SCLDI team has rich experience in the development of strategies and tactics to
successfully assess, plan and implement data sharing and integration strategies. Team members
are full participants in the HL7 process and have implemented multiple data systems and
exchanges that support HL7 and transformation to/from other formats. FTP, messaging and
uploaded file transfers are all supported. Many tools are available to expedite the sharing of
data, with security and access controls, to provide assurances to local health jurisdictions
prior to sharing clinical data and results.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

	 	Page 41
	 	8/09/04 – R3
	 
	 	 	 	 
	 

 

	 	 	 
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

Clinical data sets are necessary to derive information from the data, and the BioWatch
SCLDI team is representative of leadership in these areas, and beyond theory with the actual use
of [**] and other standards. Working with local informatics professionals, interpretations can
be accommodated while minimizing the impact on local systems, assisting in the collaborative
effort.

The Core team includes members that were the architects and implementers of the [**] working
prototype based on messaging protocols, as well as [**]. Recognizing unique jurisdictional
needs, as well as the data requirements at local, state and federal levels is crucial when
working with disease surveillance and other efforts. The team has worked at all levels, and
implemented production systems for disease surveillance, laboratory information management
systems, electronic laboratory reporting as well as reporting and visualization tools. Data
exchanges and integrated message brokers represent new efforts at the local and state levels, as
communicated at the recent NHII session. The team has already implemented data exchanges and
integrated message brokers, and also incorporated electronic laboratory reporting and
surveillance systems with a CDC-compliant Integrated Data Broker.

These skills, knowledge and techniques are a critical toolset to empower local jurisdictions to
share their BioWatch data. Developing trust, recognizing and working within the constructs of
the local jurisdictions, and accommodating local data and information policies is crucial. The
BioWatch team will work with the locals to ascertain and meet their needs, and also to develop
assessment and evaluation tools, demonstration systems, guidance for systems implementation and
best practices leveraging the BioWatch Information Systems collaboration portal.

E.5.1.-D. Promote collaborative relationships

The BioWatch operation provides services to many independent organizations that have little or
no common structure for communications, data sharing or management. The BioWatch SCLDI [**]
will provide a framework that will allow users from these diverse specialties to access
essential secure information for operations, communications and coordination. While bringing
these operational groups together it is essential, due to the sensitivity of the information
being collected and disseminated, that these users have access to only that information that is
germane to their operations.

Critical to the success of the overall project is full participation by partners at the local,
state and federal levels. The BioWatch SCLDI Management Team and project members were selected,
in part, due to their knowledge and relationships within the industry. The BioWatch program is
dependent on the trust of the partners to share information, ideas and the status of

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

potential signals. Building on the trust that has already been established is a
component of the duties of each member of the BioWatch SCLDI project. Specifically:

	 	•	 	With the Environmental Protection Agency (EPA) to coordinate activities with
existing staff providing transport of lab samples, as well as planning for future
installations and coordination for training, exercises and consequence management -
[**] has working relationships with the EPA;
	 
	 	•	 	With the various agencies within DHHS especially:

	 	•	 	The Centers for Disease Control (CDC) and interoperability with the
numerous initiatives the CDC has in place at the local, state and national levels
including vocabulary services, the Public Health Information Network, the current
BioWatch Management System in use at specific locations, and the Laboratory
Response Network -[**] have working relationships with various units within the
CDC, [**]; and
	 
	 	•	 	The Food and Drug Administration (FDA) with the eLEXnet network of
laboratories that will be participating in planning, training and consequence
management.

	 	•	 	The Department of Agriculture (USDA) for data sharing, exercises and communication
of lab systems – [**] and others have worked with the USDA for the testing of BSE and
FMD;
	 
	 	•	 	Other Federal agencies and the various entities within the Department of Homeland
Security realm — many members of the BioWatch SCLDI team have working relationships
with NSF, DARPA and other programs;
	 
	 	•	 	The Association of Public Health Laboratories (APHL) – [**] is currently the [**] at
APHL; and,

Other national, state and local health and Homeland Security organizations with an interest in
BioWatch data –[**] and others are recognized throughout the sector for their knowledge and
expertise and have established relationships at local, state and federal levels throughout the
United States.

E.5.2. Resource Estimates

Resources for this task include [**] costs, [**] staff, laboratory and data integration, and
collaborative relationships:

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

E.5.2.-A. [**] Costs

[**] will be provided by Virtual Alert at a facility with appropriate physical and logical
security controls, access controls and 24x7 operations with [**]. The [**] pricing estimate is
provided as a [**] based on [**], as identified in the task detail. For pricing estimates,
growth is anticipated for up to [**] in the 2nd and 3rd years. [**].

E.5.2.-B. [**] Staff

[**] Staff will be provided by Virtual Alert’s Operations Center in [**].

	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	A-TEK	 	 	 	 
	 	Role	 	 	Name	 	 	Item	 	 	Hours	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 	[**]

	 	 	[**]
	 	 	[**]
	 	 	[**]	 
	 

E.5.2.-C. Laboratory and Data Integration Staff

The staffing for this effort will be provided by the Core Management Team and Key staff
during the first year. This effort may expand in Years Two and Three in order to support
the many data feeds and services required.

E.5.2.-D. Collaborative Relationships

This is an assumed activity by the entire BioWatch SCLDI team and is not funded separately.

E.6.
Task 6 - Administration and Personnel Management

Task: The Contractor shall provide staff to assist in the management of BioWatch administrative
and personnel management activities to include:

	 	•	 	Appropriate liaison to local public health laboratories and other stakeholder
organizations, e.g. the Association of Public Health Laboratories

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

	 	•	 	Staff to assist in the customized personnel planning and implementation strategies for
each participating laboratory
	 
	 	•	 	Staff to assist in the overall management of the BioWatch program’s personnel and fiscal
processes

E.6.1. Response

This task is designed to assure that all activities engaged throughout this contract are
coordinated and effectively managed. By utilizing a comprehensive approach that relies upon the
cooperation and teamwork of core management team participants, located in a virtual workspace,
the BioWatch SCLDI Team can effectively assure that all activities undertaken are coordinated.

Staff that form the BioWatch SCLDI Team come from a variety of backgrounds and experiences but
all represent the “best of the best” in relation to their accomplishments and work experiences
over the course of their careers.

Within the first 30 days, core management staffing will be complete.

E.6.2. Staffing Estimate

Staffs that comprise the Core Management Team are covered in Sections 5.1 as well as appropriate
other sections. No additional staffing is needed.

E.7.
Task 7 - BioWatch Operations and Enhancement Review Committee

Task: The Contractor shall provide resources to host and facilitate meetings of the BioWatch
Operations and Enhancement Review Committee. The Committee will include approximately [**] members
and [**] DHS staff. The Committee will meet up to [**] times a year in locations across the United
States.

E.7.1. Response

It is understood that this task is designed to assure consistent and clear input from a variety
of stakeholders through coordinated and regular meetings of a committee that will offer
practical suggestions for improving staffing at participating BioWatch laboratories and
information sharing and exchange between BioWatch laboratories and the Department of Homeland
Security. These meetings will occur up to [**] times per year at locations across the United
States for a BioWatch Operations and Enhancement Review Committee of [**] members and [**] DHS
staff.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
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	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

The BioWatch SCLDI Project Team has significant experience in hosting and arranging these
sorts of meetings for groups of 6 to 6,000. The BioWatch SCLDI Project Team currently manages
the meeting arrangements of [**]. The BioWatch SCLDI Project Team has experience in organizing,
providing on-line registration and other logistical services to its client organizations in
order to assure that the organization of such meetings runs smoothly from an operational
perspective, so that the purpose of the meeting can receive the maximum of attention from the
participants.

The BioWatch SCLDI Project Team also has the capacity to arrange customized travel to meetings
through its travel partner at American Express to the members of the BioWatch Operations and
Enhancement Review Committee.

Through its agreement with the University of California — Los Angeles — Pacific Public Health
Training Center, the BioWatch SCLDI Project Team can offer continuing education credits to
physicians and other health care providers.

Activities under this task will be coordinated through the BioWatch SCLDI Project Team.

The BioWatch SCLDI Project Team will organize, contract with meeting facilities and make
necessary arrangements to host meetings of the BioWatch Operations and Enhancement Review
Committee up to [**] times per year. Included within that task are making necessary travel
arrangements for meeting participants, assuring that appropriate lodging and catering services
are provided and providing on-line registration for meeting participants.

Upon award of the contract the BioWatch-SCLDI Project Team can arrange for the first meeting of
the BioWatch Operations and Enhancement Review Committee to occur in as little as [**].

Costs will vary depending on the location of the meeting and the amount of lead time provided to
the BioWatch-SCLDI Project Team to begin making necessary arrangements. These costs are
comprised of:

E.7.2. Staffing Estimate

No additional staffing is anticipated for this task effort. Travel costs will be reimbursable
at cost plus a general

E.8.
Task 8 - BioWatch Signal Interpretation and Consequence Management Facilitation

Task: The contractor will be responsible for working closely with other organizations to assist

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
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	A-TEK, Inc.

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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

each BioWatch city with signal interpretation integration and decisional analysis with
consequence management preparedness. This may include organizing and overseeing several Table Top
exercises across the nation, as well as various BioWatch consequence management workshops, where
all involved stakeholders can participate and obtain information and skills for development and
enhancement of their cities’ signal interpretation and consequence management plans. These Table
Top exercises will include participation from the following:

	•	 	Local City Officials — Mayor’s Office, Local Law Enforcement
	 
	•	 	Local and State Laboratory Response Network (LRN) and Epidemiologists
	 
	•	 	Federal Law Enforcement Officials — FBI, Weapons on Mass Destruction Officials
	 
	•	 	Federal BioSecurity Officials

E.8.1. Response

The BioWatch SCLDI Project Team has rich experience in the planning, development and execution
of exercises with these audiences. Recognizing the many potential participants for the BioWatch
consequence management process, the BioWatch SCDLI Team has assembled a rich and diverse team
with complementary qualifications, expertise, knowledge and experience in order to be able to
address the unique needs of individual local jurisdictions while ensuring to develop a uniform
model for response. The skill sets, and audience experience, is best described through the
experience of the Workshop, Exercise and Training staff members. In summary, the Team has been
at the forefront of delivery for Exercises, SandBoxes, TableTops, Drills and Live Events:

	 	i.	 	Local City Officials — the Mayor’s office, City/Town Council, Schools,
Churches, Local Law Enforcement and Neighborhood organizations
	 
	 	ii.	 	Local and State Laboratory Response Network and Epidemiologists — State, Local,
Commercial and Hospital laboratories, LRN response as well as live sample management
processes during the Washington DC anthrax events in October, 2001.
	 
	 	iii.	 	Federal Law Enforcement Officials — The team has experience in working with FBI
and other Federal organizations involved in weapons of mass destruction as well as the
communications between State, Local and Federal law enforcement. Team members have
also facilitated exercises between state health departments and the state national
guard.
	 
	 	iv.	 	Federal BioSecurity Officials — Communications with BioSecurity officials from
the State and Local level are new initiatives that are gaining traction. The Virtual
Alert team has been involved in numerous efforts to facilitate these communications
through their work with the NSF Infectious Disease Informatics working prototype,
public health laboratory, disease and other health-related information and
fundamentally as an enabling infrastructure through the [**] and reach-back products,
tools and services. Additionally, Virtual Alert’s products and staff are leaders in

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
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BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

providing updated, real-time communications based on the Virtual Alert
BioTerrorism Readiness Suite that has been used as a tool in many live events as
well as exercises.

The science of signal interpretation is subject to much debate. The BioWatch SCLDI architecture
supports the integration of [**] in order to provide full communications capabilities to
participants. The BioWatch SCLDI is designed to utilize tools and techniques as they are
identified, or communicate directly with individual subject matter experts to provide feedback
and opinions. Alternatively, threshold-based alerts may be defined to [**] provide additional
data and details via integration and collaboration with state and local instances of the Health
Alert Network. The team described below can effectively work with each BioWatch city to develop
and test their signal interpretation and consequence management plans.

Furthermore, the BioWatch SCDLI team has proven experience and capacities in the development and
delivery of direct, web-based and virtual reality/gaming training, education and exercises. [**]
is a recognized leader in hands-on instruction using virtual reality techniques under contract
for DARPA, [**] has real-world experience with handling lab samples during a live event in
cooperation with local, regional and federal labs, and [**] has specific experience with the
Department of State, Drug Enforcement Agency and DHS Air Marshall Program.

[**]

[**] as part of his DARPA program, developed and deployed a CB consequence management system
that was used by the Marine CBIRF unit and the City of Denver as their Command/Control system
during the G8 meeting in Denver, 1997. As a part of that operational effort, local city
officials, departments of health, local health personnel, local police and FBI were involved in
setting up and training on the system. There were no WMD or BioSecurity officials at that time.

Subsequently, [**] was deployed with CBIRF to major events in which the system was used by local
officials during the State of the Union addresses and inaugurations in 1997 and 2001.

[**] also has crucial real-world experience with the handling of large numbers of laboratory
samples based on his work in DC during the Anthrax events in 2001. These efforts will provide
crucial situational experience to the SCDLI team deliverables.

[**]

[**] in his DARPA effort, is a leader in the development of virtual realty training and
exercise programs for training of field staff and personnel in the military, law enforcement and
WMD. His team has the capacity to create rich training and exercise

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

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BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

experience in the virtual reality gaming world, replicable on CDs to be used on personal
computers. Other options include the use of specific training with avatars with touch and depth
feedback. [**] team provides exciting new capabilities to public health and to BioWatch
specifically.

[**]

[**] brings a career of knowledge and experience in training, exercises and actual events
that cross many jurisdictions at the Federal, State and Local levels. Both in his career with
ATF and now as an Adjunct Instructor, National Center for Biomedical Research and Training,
Academy of Counter-Terrorist Education at Louisiana State University and is under contract as an
Instructor, International Training Section, Anti-Terrorism Assistance Program, US Department of
State, Bureau of Diplomatic Security, Dower has developed relationships and skills with:

	 	•	 	Local officials, law enforcement, public safety, emergency management and
response
	 
	 	•	 	State and local collaboration and cross jurisdictional communications
	 
	 	•	 	Work with FBI, State, ATF and other Federal and International organizations
	 
	 	•	 	Leading edge work at the Academy of Counter-Terrorist Education at LSU

[**] has been an active participant in the development of training and instruction
material, and overseen exercises, feedback and improvement, in specific WMD, firearms and has
experience in chemical and other potential terrorism activities. Combined with his work
training US Air Marshall Service, [**] rounds out our team of Subject Matter Experts and
Liaisons.

[**]

In his multi-faceted role as Chief, Emergency Preparedness and Disaster Medical Response for San
Diego County, [**] participated in the planning, development and execution of many exercises
with multiple audiences. [**] was part of both local and state demonstrations and preparedness
program staff and participated in more than seventy (70) table top exercises in which local law
enforcement has been a key participant. While it is sometimes difficult to engage local
political leadership, many communities have sent representatives of local political leadership
including mayoral aides, Board of Supervisor aides and township Judges’ aides. Additional staff
has had representation from the aforementioned groups in an additional 50 functional command
posts, and full scale exercises involving a variety of scenarios. Local microbiologists and
epidemiologists have been represented in nearly all of these exercises.

The local FBI WND specialists in San Diego County were integral components of the local response
system and participated in nearly every local exercise planned locally since 1996. This
includes in excess of twenty table top, functional and full-scale exercises. Additionally, the
FBI WMD coordinators were regular participants in many domestic preparedness program exercises
facilitated by [**] staff throughout the County. Federal law

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
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	A-TEK, Inc.

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BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

enforcement participation was not confined to just the FBI, but also included ATF, Coast
Guard, Military Police, Secret Service, Customs and Border Protection.

[**]

As the Health Alert Network Coordinator, Risk Communications Informatics Manager and Geographic
Information Systems (GIS) resource for the Emergency Preparedness Office of the California
Department of Health Services (CDHS), [**] developed those related components for both exercises
and table tops. The planning, setup and execution of these exercises were coordinated with the
Governor’s Office of Emergency Services (OES) and Emergency Medical Services Authority (EMSA),
California National Guard (CNG) and participating local jurisdictions and hospitals. The
integration of the following areas of responsibility was represented within the design of the
communications and GIS information technology tools: emergency management, planning, logistics,
command, and administration components of the emergency response operations. Training and
briefings were conducted to familiarize exercise and table top participants in the capabilities
and use of the communications, alerting and GIS tools that would be utilized as resources during
the event. The participants in the exercises included:

	 	•	 	State Departments (Mental Health, Department of Aging, OES, EMSA, CNG and
Office of State Wide Health Planning and Development)
	 
	 	•	 	Laboratories (State, regional and local jurisdiction public health
laboratories)
	 
	 	•	 	Local Jurisdictions (approximately 29 of 61 jurisdictions participated in the
statewide exercise)
	 
	 	•	 	Hospitals, emergency management services, and epidemiologists
	 
	 	•	 	Local Emergency Management System participants such as 911 call centers, law
enforcement dispatch, police, sheriff and local public officials.

[**] also provided guidance and training to local jurisdictions in the use of the California
Health Alert Network as the communications and alerting component in their exercise development
and emergency plans. The planning and development of the local alerting and response directory
included hospitals, physicians, first responders (police, sheriff, fire, and EMS), community
leaders (City and County executives, and politicians), media (TV, radio and news papers),
contacts and spokespersons for special populations (large employers, non-English speaking
populations, Native American reservations, and other specific populations within a
jurisdiction).

[**]

[**] designed, developed, tested and implemented interdisciplinary TableTop exercises designed
for implementation at the local health jurisdiction level that included as participants health
officers, epidemiologists, environmental health officials, laboratorians, emergency managers,
sheriffs and chiefs of police, hospital personnel, city and county elected officials, fire and
EMS Staff and community based organizations such as the American Red Cross. These exercises
occurred in each community in Washington and several communities in Idaho. The object of the
exercises were to test and coordinate public

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
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BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

health system responses with emergency management, law enforcement, hospital and
emergency medical system responses in order to evaluate current states of readiness and to
develop the synergy to foster improved coordination and readiness of public health authorities
to effectively interact with other emergency response sectors.

[**]

[**] has long experience in many aspects of exercise development and execution through his work
as Chief of Police for a small California town, and in his years of work for Placer County.
Examples include:

	 	•	 	Desk Top Exercise, 1999 Atherton Regional Emergency Preparedness Task Force of
a simulated earthquake in San Mateo County. As Chief of Police, [**] coordinated the
use of resources from County, State and Federal EMS, Sheriff, California Highway
Patrol, Fire, Ambulance, County Medical, Coroner. [**] set up communications between
county, state OES officials and utilized EAS link to local radio station to broadcast.
	 
	 	•	 	Desk Top Exercise, 1986 Placer County Regional Emergency First Responders of a
simulated major aircraft accident. In his role at Placer County Sheriff’s office, [**]
coordinated with County & State Office of Emergency Services, California Highway
Patrol, local Police and established communications set up through county mobile
communication command post.
	 
	 	•	 	Actual Disaster Management in 1985 Placer County, Lake Tahoe of a major
avalanche claiming 6 lives, community w/o power or ingress/egress for 6 days. [**]
worked with numerous organizations to provide remote logistical support through land
line between Auburn & Lake Tahoe involving County, State and Federal Offices of
Emergency Services, local EMS, hospital, fire and the FAA to close the dangerous areas
to flights. He also worked with FEMA to coordinate assistance efforts.
	 
	 	•	 	Actual Disaster Management of a high profile SAR in Lake Tahoe. [**] worked
with local and state Office of Emergency Services, Fire departments, the California
Highway Patrol and worked with federal support from the White House and US Army.
Additional activities included request for services from the US Army Mountain Survival
search Team and subsequent coordination of efforts.

[**]

Through her roles in Ventura County and Los Angeles County, [**] has been a planner and
participant in the planning and execution of a number of workshops and exercises at the local
level. Some of these include live management as Director of the Ventura County Smallpox
Vaccination Clinics, 2002-2003 (100 vaccinated) and IT experience as PVS Manager for Ventura
County smallpox data, 2003. Gwen was a planner and participant in the Ventura County SARS
Exercise at Ojai Hospital, 2003; a planner and DOC participant in the Ventura County Plague
Exercise, 2003; a participant in the Los Angeles County Inter-Agency Plague Exercise, 2002; and
a guest observer in the San Diego County Regional Exercise, multiple threat scenario; [**] has
also participated in Public Health Disaster Recovery Efforts including the Ventura County Fires
Disaster Recovery (EOC participant,

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
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	A-TEK, Inc.

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BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

assistant to Health Officer), fall 2003; the Los Angeles County Public Health Anthrax/white
powder incident Phone Response Team; the Ventura County Health Participant, “Lessons Learned”;
Alaska Airlines Flight 261 Crash and the Santa Barbara Painted Cave Fires Recovery (volunteer),
1990

In these efforts, [**] has worked with:

	 	•	 	Local and State Health and Public Health Agencies,
	 
	 	•	 	Local and Regional Fire and Law Enforcement,
	 
	 	•	 	FBI, Terrorism Warning Groups,
	 
	 	•	 	PH Laboratories,
	 
	 	•	 	HAZMAT, EMS, Coroner, Local Hospitals, Military Bases

[**]

[**] workshops/exercises/drills experience includes facilitating a multidisciplinary
emergency response group from Seattle in a bioterrorism TableTop Drill provided by Association
of Professionals in Infection Control and Epidemiology (APIC) and The Center for the Study of
Bioterrorism and Emerging Infections. She has also delivered hands-on training for Public
Health Emergencies, provided by the Washington State Department of Health and the Northwest
Center for Public Health Practice. She has facilitated over 10 county exercises. For the
Washington Smallpox Response Plan, she was responsible for sections concerning disease
surveillance (including syndromic, active, and routine), contact tracing, and data management.
For the complementary Washington Smallpox Vaccination Plan, she contributed to the data
management section and was responsible for active surveillance section. In the development of
the Washington SARS plan, she contributed to the surveillance and epidemiology response section.

In the area of Public Health Disaster Recovery Efforts, [**] was involved in several disease
outbreaks and other cases of public health significance, including campylobacteriosis in a
correctional facility, suspected cases of SARS, white powder reports, E. coli at a family
gathering, and vaccinia adverse events. In these efforts she has been involved with a wide
variety of organizations, such as:

	 	•	 	Emergency Management at the State and Local Levels
	 
	 	•	 	Local, state and federal public health agencies
	 
	 	•	 	Public Safety — Sheriff and Police
	 
	 	•	 	Fire, EMS, Ambulance Companies and Hospitals
	 
	 	•	 	Laboratories
	 
	 	•	 	Press, Elected officials, Red cross
	 
	 	•	 	Military
	 
	 	•	 	Schools, Churches
	 
	 	•	 	Coroner
	 
	 	•	 	Pharmacists
	 
	 	•	 	Medical examiner

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
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	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

	 	•	 	Parks & Services
	 
	 	•	 	Department of Transportation
	 
	 	•	 	Neighborhood block watch
	 
	 	•	 	Department of Agriculture

The science of signal interpretation is subject to much debate. The BioWatch SCLDI architecture
supports the integration of [**] in order to provide full communications capabilities to
participants. BioWatch SCLDI is designed to utilize tools and techniques as they are
identified, or communicate directly with individual subject matter experts to provide feedback
and opinions. Alternatively, threshold-based alerts may be defined to [**] to provide
additional data and details via integration and collaboration with state and local instances of
the Health Alert Network. These activities are related to other duties in regards to training,
education and content development addressed in other task elements identified in Section E.4.
Core Management Team would oversee the definition of the details in concert with the DHS Project
team.

E.8.2. Staffing Estimate

These efforts would be initiated [**] to assist in training exercises. This is expected to
start [**] after contract award and will necessitate [**] full time Subject Matter Experts to
develop and deliver the initial content, and one staff person to assist. This estimate is based
on [**] workshops per year, [**] days each.

	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Role	 	 	Name	 	 	A-TEK Item	 	 	Hours	 
	 	[**]

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[**] = Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

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BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

	 	 	 	 	 	 	 	 	 	 	 	 
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E.9. Task 9 — BioWatch Research and Study Assistance

Task: Provide necessary research, development, test, and evaluation coordination with pre-selected
BioWatch partnering [**] that will be implemented by the BioWatch Program during the contract
period of performance.

The contractor should be able to work with the selected partnering bodies in order to effectively
launch and carry-out critical research studies, in progress reviews, meetings, and conference
support for the BioWatch program.

E.9.1. Response

The major activities associated with this task have been addressed Section E.4 and E.5 in this
response. The outcomes from those tasks will deliver documentation, tools and techniques that
may be used by identified partners for further research and analysis.

If desired by DHS, [**] can be created to support bio-surveillance analyst activities.
Authorized partners and analysts will collaborate using BioWatch SCLDI multilevel security
tools. Finally, the BioWatch SCLDI Project Team can create an Extensible Analytic Toolkit
framework that contains an initial set of algorithms for visualization, temporal-spatial,
linkage and other sophisticated analyses. The framework will allow plug and play addition of
other analytic tools.

Alternatively, the BioWatch SCLDI Project Team can work with partners to define and utilize
[**].

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
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BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

The use of messaging technologies with “just-in-time” reach back is crucial. Successful
mitigation of bio-warfare attack or natural outbreaks requires minimal latency in our early
detection and warning systems. Recent analysis of large-scale anthrax releases (100,000
casualties) suggests that over 500 new casualties per hour will enter hospital systems within 72
hours after an attack. Thus, partner data feeds, other sources of data and BioWatch SCLDI must
be architected to be highly sensitive, aggressively and rapidly analyze all anomalies and warn
responsible agencies and partners without administrative or system delays. [**].

E.9.2. Staffing Estimate

Reasonable support for the activities under this task is anticipated to be within the hours
allocated to the BioWatch SCLDI Management Team as well as Functional Subject Matter Experts
utilized in specific activities. If support demands exceed these expectations, the Functional
Subject Matter Expert, Data Standardization Expert, Data Security Specialist and Information
Resource Management Analyst staffing levels may need to be augmented. This estimate is based on
[**] study for the base period, and [**] for each option year, estimated for [**] and [**].

F. Other Pertinent Information

The following section addresses miscellaneous items and requirements within the SOW.

F.1. Security

All individuals working in any laboratory must be certified for that specific laboratory and
cleared to handle [**] material. Contractor staff may be required to possess a [**] level
clearance for a given task or site as identified by DHS.

	 	•	 	At the direction of DHS all staff requiring clearance to handle [**] material will
obtain the necessary background clearances and certification prior to being given access to
such materials.
	 
	 	•	 	Contractor staff requiring [**] level clearance for given tasks or sites as identified
by DHS will obtain the necessary background clearances and certification prior to being
allowed to engage in such tasks or gain access to such sites.
	 
	 	•	 	Information meeting both the [**] and [**] level clearance will be secured and will not
be accessible to any staff or contract staff without appropriate certification levels.
Data stored on the BioWatch SCLDI [**] that is of these classifications will not be visible
or accessible by staff or contract staff not having the appropriate level of clearance.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

F.2. Information Technology Systems Security

The security of BioWatch Information Systems must comply with the Department of Homeland Security -
IT Security standards provided at task award. Changes to DHS standards will be provided as they
are adopted, and DHS and the Contractor will determine through mutual agreement how information
systems must evolve to meet new standards.

	 	•	 	The BioWatch SCLDI [**] and information systems will be in compliance with the DHS IT
Security standards at the time of task award.
	 
	 	•	 	A process to obtain agreement on how effected information technology systems will
evolve to adapt and adopt new DHS security standards will be established.

	 	 	 
	F.3.

	 	Government Furnished Equipment (GFE)/

Government Furnished Information (GFI)

Since all laboratory diagnostic work will be performed at a local or state public health laboratory
site, all laboratory diagnostic GFE/GFI is anticipated to be provided by the hosting laboratory.
Information systems equipment will be maintained at a site of DHS’ direction which may include
government and/or contractor’s sites.

	 	•	 	The BioWatch SCLDI team will adhere to the direction provided by DHS regarding the
hosting location of information systems equipment and information.

F.4. Travel

Travel will be authorized as identified within the task as it is funded for laboratory and core
management staff.

The Administrative and Information Management System Staff will work as a cross-functional team.
Travel costs are detailed in the Pricing Section within this proposal.

F.5. Staff Requirements

Laboratory Staff will meet the following minimum requirements:

	 	•	 	Director-Microbiologists will possess a PhD or MD and will be qualified to work in a
Bio Safety Level 3 Laboratory and possess clearance to handle sensitive agents.
	 
	 	•	 	Microbiologist will possess at least a Masters Degree and will be qualified to work in
a Bio Safety Level 3 Laboratory and possess clearance to handle sensitive agents.
	 
	 	•	 	Lab Technicians will possess at least a Bachelors Degree and will be qualified to work
in a Bio Safety Level 2 Laboratory.

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
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	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

Administrative and Information System staff will meet the following minimum requirements. All
members of the administration and information systems unit will be proficient in:

	 	•	 	Public health system development
	 
	 	•	 	Pertinent CDC, HHS and DHS standards for the management and administration of health
and homeland security data and information
	 
	 	•	 	Creating and implementing programs and activities that are part of CDC’s Public Health
Information Network
	 
	 	•	 	Managing federal contract dollars according to Office of Management and Budget
Standards

G. Key Personnel Qualifications Matrix

The following matrix highlights that the A-TEK BioWatch SCLDI Team meets or exceeds the
requirements. More comprehensive information is found in the resumes provided.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Proposed Personnel	 	 	 	 	 	 	 	 	 	 	 	Task Requirements	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Qualifications	 
	 	 	 	 	1	 	 	2	 	 	3	 	 	4	 	 	5	 	 	6	 	 	7	 	 	8	 	 	9	 	 	 	 
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[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

	 	Page 57
	 	8/09/04 – R3
	 
	 	 	 	 
	 

 

	 	 	 
	DHS/Systems Engineering and Deployment Unit

BioWatch SCLDI

	 	CIO-SP2 Tracking No. C-2329

Contract #263-01-D-0084

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
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Key Qualifications Matrix

H. Key Personnel

The Key Personnel for this BioWatch SCLDI Project are as follows:

[**]

[**] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

	 	 	 	 	 
	 
	Disclosure of the data contained on this sheet is subject to the restrictions on the title page of this proposal.

	 
	 	 	 	 
	A-TEK, Inc.

	 	Page 58
	 	8/09/04 – R3
	 
	 	 	 	 
	 

 

ATTACHMENT 3

 

 

			
	DHS/Systems Engineering and Deployment Unit
	 	CIO-SP2 Tracking No. C-2329
	BioWatch SCLDI
	 	Contract #263-01-D-0084

Appendix A – Annualized Laboratory Professional Compensation Table – Fully Burdened Rates

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Position 3 –	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Position	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	MS Journey	 	 	 	 	 	 	Position 4 –	 	 	 	 	 	 	Doctoral /	 	 	 	 
	 	 	Position 1 – BS	 	 	Pro-Rated	 	 	Position 2 – BS	 	 	Pro-Rated	 	 	Level or BS	 	 	Pro-Rated	 	 	Ph.D. or MS	 	 	Pro-Rated	 	 	Medical	 	 	Pro-Rated	 
	City	 	Entry Level	 	 	Hourly Rate	 	 	Journey Level	 	 	Hourly Rate	 	 	Supervisor	 	 	Hourly Rate	 	 	Supervisor	 	 	Hourly Rate	 	 	Supervisor	 	 	Hourly Rate	 
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	 	 	[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 83

 

ATTACHMENT 4

 

 

NITAAC Prime Contractor Past Performance Evaluation Report

 

	 	 	 	 	 
	FINAL REPORT

	 	INTERIM REPORT
	 	(Check one)
	REPORTING PERIOD: (from mm/dd/yy)	 	(to mm/dd/yy)
	NIH CONTRACTING TEAM

	 	 	 	CIO-SP2
	NIH CONTRACT NUMBER
	 	 	 	 

 

NITAAC CIO-SP2 ORDER

 

	 	 	 
	TASK ORDER AUTHORIZATION NUMBER:
	 	 
	 

	 	 

CUSTOMER INFORMATION:

	 	 	 	 	 	 	 
	 	 	Agency Name:	 	 
	 	 	Address:	 	 
	 
	 	 	 	 	 	 
	 

	 	Email:	 	 	 	 
	 

	 	 	 	 	 	 

PRIME CONTRACTOR INFORMATION:

	 	 	 	 	 	 	 
	 	 	Name:	 	 
	 

	 	Address:	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	Email:	 	 	 	 
	 

	 	 	 	 	 	 

	 	 	 
	ORDER AWARD DATE: (mm/dd/yy)
	 	 
	 

	 	 
	ORDER EXPIRATION DATE: (mm/dd/yy)
	 	 
	 

	 	 
	ORDER VALUE: $
	 	 
	 

	 	 
	 
	 	 
	ORDER TITLE: (Description of Requirements)
	 	 
	 

	 	 
	 
	 	 
	 

	 	 

 

 

 

RATINGS

 

Summarize contractor performance and circle the number which corresponds to the rating for each
rating category.

Using the rating guideline, assign each area a rating of 0 (unsatisfactory), 1 (poor), 2 (fair), 3
(good), 4 (excellent), or 5 (outstanding). Provide a brief narrative (500 characters or less) for
each of the categories to support the rating assigned. The categories are: quality of product or
service, cost control, timeliness of performance, and business relations. At this time comments
are limited to 500 characters.

	 	 	 	 	 
	QUALITY OF PRODUCT OR SERVICE
	 	 	 	 
	Comments:

	 	Rating:
	 	0          1          2          3          4          5
	 
	 	 	 	 
	COST CONTROL
	 	 	 	 
	Comments:

	 	Rating:
	 	0          1          2          3          4          5
	 
	 	 	 	 
	TIMELINESS OF PERFORMANCE
	 	 	 	 
	Comments:

	 	Rating:
	 	0          1          2          3          4          5
	 
	 	 	 	 
	BUSINESS RELATIONS
	 	 	 	 
	Comments:

	 	Rating
	 	0          1          2          3          4          5

 

SUBCONTRACTS

 

Are Subcontracts involved? (Check One) YES o NO o

Comments (Please comment on those Subcontractors that have provided a significant contribution to
overall contract performance.)

 

KEY PERSONNEL

 

	 	 	 
	PROJECT MANAGER (Name):

	 	 
	 
	Comments:
	 	 
	 
	 
	 	 
	 
	 
	 	 
	KEY PERSON (Name):
	 	 
	 
	Comments:
	 	 
	 
	 
	 	 
	 
	 
	 	 
	KEY PERSON (Name):
	 	 
	 
	Comments:
	 	 
	 
	 
	 	 
	 

 

 

 

RATINGS

 

Summarize contractor performance and circle the number which corresponds to the rating for each
rating category.

Using the rating guideline, assign each area a rating of 0 (unsatisfactory), 1 (poor), 2 (fair), 3
(good), 4 (excellent), or 5 (outstanding). Provide a brief narrative (500 characters or less) for
each of the categories to support the rating assigned. The categories are: quality of product or
service, cost control, timeliness of performance, and business relations. At this time comments
are limited to 500 characters.

	 	 	 	 	 
	QUALITY OF PRODUCT OR SERVICE
	 	 	 	 
	Comments:

	 	Rating:
	 	0          1          2          3          4          5
	 
	 	 	 	 
	COST CONTROL
	 	 	 	 
	Comments:

	 	Rating:
	 	0          1          2          3          4          5
	 
	 	 	 	 
	TIMELINESS OF PERFORMANCE
	 	 	 	 
	Comments:

	 	Rating:
	 	0          1          2          3          4          5
	 
	 	 	 	 
	BUSINESS RELATIONS
	 	 	 	 
	Comments:

	 	Rating
	 	0          1          2          3          4          5

 

SUBCONTRACTS

 

Are Subcontracts involved? (Check One) YES o NO o

Comments (Please comment on those Subcontractors that have provided a significant contribution to
overall contract performance.)

 

KEY PERSONNEL

 

	 	 	 
	PROJECT MANAGER (Name):

	 	 
	 
	Comments:
	 	 
	 
	 
	 	 
	 
	 
	 	 
	KEY PERSON (Name):
	 	 
	 
	Comments:
	 	 
	 
	 
	 	 
	 
	 
	 	 
	KEY PERSON (Name):
	 	 
	 
	Comments:
	 	 
	 
	 
	 	 
	 

 

 

 

CUSTOMER

SATISFACTION

 

Is/was the contractor committed to customer satisfaction? (Check One) YES o NO o

If this is the Final Report: (Check One)

Would you recommend selection of this firm again? YES o NO o

Comments:

PROJECT OFFICER/COTR:

	 	 	 	 	 
	(Last Name)

	 	(First Name)
	 	(MI)
	SIGNATURE:

	 	Date: (mm/dd/yy)	 	 
	Phone: ( )

	 	FAX: ( )	 	 
	Internet Address:
	 	 	 	 

CONTRACTING OFFICER/Accountable Management Official (AMO) CONCURRENCE:

	 	 	 
	(Initial)

	 	Date: (mm/dd/yy)

 

	 	 	 	 	 
	CONTRACTOR’S REPRESENTATIVE: (Title)	 	 
	(Last Name)

	 	(First Name)
	 	(MI)
	 
	 	 	 	 
	SIGNATURE:

	 	Date: (mm/dd/yy)	 	 
	Phone: ( )

	 	FAX: ( )	 	 
	Internet Address:
	 	 	 	 

 

SUMMARY RATINGS:

 

	 	 	 
	QUALITY:

	 	COST CONTROL:
	 
	TIMELINESS OF PERFORMANCE:

	 	BUSINESS RELATIONS:

 

	 	 	 	 	 
	CONTRACTOR’S REPRESENTATIVE: (Title)	 	 
	(Last Name)

	 	(First Name)
	 	(MI)
	SIGNATURE:

	 	Date: (mm/dd/yy) 	 	 
	Phone: ( )

	 	FAX: ( )	 	 
	Internet Address:
	 	 	 	 

 

 

CONTRACTOR’S REVIEW:

Were comments, rebuttal, or additional information provided? (Check One) YES o NO o

	 	 	 	 	 
	(If yes: They are on file in):
	 	 	 	 
	 	 	 
	 

	 	(Location)
	 	(Phone)

          Attached o (Check if attached)

AGENCY REVIEW:

Were contractor comments reviewed at a level the contracting officer/AMO? (Check One) YES o NO o

	 	 	 	 	 
	(If yes: They are on file in):
	 	 	 	 
	 	 	 
	 

	 	(Location)
	 	(Phone)

          Attached o (Check if attached)

 

NATIONAL INSTITUTES OF HEALTH

CONTRACTOR PERFORMANCE REPORT INSTRUCTIONS

	1.	 	Check the appropriate block to indicate the type of report (Interim, Final). The final
evaluation of the contractor’s performance must satisfy the reporting requirement stipulated
in the FAR. and Health and Human Services Acquisition Regulations
	 
	2.	 	Indicate the period covered by the report.
	 
	3.	 	Identify the customer office. Identify the location of the customer
	 
	4.	 	Identify the contract number of the contract being evaluated and the Task Order or Delivery
Order Authorization Number.
	 
	5.	 	List the name and address of the contractor.
	 
	6.	 	Enter TIN and SIC
	 
	7.	 	Indicate the order award date and order expiration date.
	 
	8.	 	State the order value, including any option amounts.
	 
	9.	 	Provide a brief description of the work being performed under the order (the title of the
order).

 

RATINGS

 

Using the rating guideline, assign each area a rating of 0 (unsatisfactory), 1 (poor), 2 (fair), 3
(good), 4 (excellent), or 5 (outstanding). Provide a brief narrative (500 characters or less) for
each of the categories to support the rating assigned. The categories are: quality of product or
service, cost control, timeliness of performance and business relations.

 

 

 
SUBCONTRACTORS 

Indicate whether Subcontracts are/were involved. Briefly summarize (500 characters or less) the
performance of any Subcontractors that have major responsibilities under the contract or are
required to perform a significant part of the contract requirement. This space may also be used to
evaluate a Prime Contractor’s management of a Subcontractor.

 
KEY PERSONNEL 

List the name of the project manager and the names of two other key personnel (optional). Briefly
describe the performance of the key personnel listed. (500 characters or less)

 
CUSTOMER SATISFACTION 

Check the appropriate answer to indicate whether the contractor was committed to customer
satisfaction. For the final report, indicate whether you would recommend selection of the firm
again.

 
PROJECT OFFICER/CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE/COTR SIGNATURE 

The Project Officer/COTR signs this block.

 
CONTRACTING OFFICER AMO CONCURRENCE 

The Contracting Officer/AMO initials this block, indicating concurrence with the initial rating.

 
CONTRACTORS REPRESENTATIVE 

The Contractor signs this next block indicating review of the rating.

 
SUMMARY RATINGS 

Indicate the rating given for each of the rating categories: quality of goods or services, cost
control, timeliness of performance, and business relations.

 
CONTRACTING OFFICE/AMO SIGNATURE 

The contracting officer/AMO signs the report when all actions are completed. If changes were made
to the ratings or the narrative during the rebuttal process, a copy of the report, as revised,
shall be promptly furnished to the contractor.

	 
	 
CONTRACTOR’S REVIEW 

Indicate whether the contractor submitted a rebuttal or comments. Attach a copy of the
contractor’s rebuttal to this report, or indicate its location, if filed separately.

 

 

 
AGENCY REVIEW 

If the contracting officer /AMO and the contractor are unable to agree on a final rating, the
matter is to be referred to an individual one level above the contracting officer/AMO. Attach a
copy of the agency’s decision to this report, or indicate its location, if filed separately.

 

 

Subcontract No. S2040823-1

ATTACHMENT 5

FAR & HHSAR CLAUSES

 

					
	A-TEK, Inc.
	 	Attachment 3 — Page 1 of 4
	 	Subcontract No. S2040823-1

 

 

GENERAL CLAUSES

Time and Material or a Labor Hour Contract

CONTRACT CLAUSES INCORPORATED BY REFERENCE

	 	 	 	 	 
	Contract Reg	 	Clause Date	 	Clause Title
	FAR52.202-1

	 	Oct 1995
	 	Definitions
	FAR52.203-3

	 	Apr 1984
	 	Gratuities (Over $100,000)
	FAR52.203-5

	 	Apr 1984
	 	Covenant Against Contingent Fees (Over $100,000)
	FAR52.203-6

	 	Jul 1995
	 	Restrictions on Subcontractor Sales to (Over $100,000)
	FAR52.203-7

	 	Jul 1995
	 	Anti-Kickback Procedures (Over $100,000)
	FAR52.203-8

	 	Jan 1997
	 	Cancellation, Rescission, and Recovery of Funds for
Illegal or Improper Activity (Over $100,000)
	FAR52.203-10

	 	Jan 1997
	 	Price or Fee Adjustment for Illegal or Improper
Activity (Over $100,000)
	FAR52.203-12

	 	Jun 1997
	 	Limitation on Payments to Influence Certain Federal
Transactions (Over $100,000)
	FAR52.204-4

	 	Jun 1996
	 	Printing/Copying Double-Sided on Recycled Paper (Over
$100,000)
	FAR52.209-6

	 	Jul 1995
	 	Protecting the Government’s Interests When
Subcontracting With Contractors Debarred, Suspended,
or Proposed for Debarment (Over $25,000)
	FAR52.215-2

	 	Jun 1999
	 	Audit and Records — Negotiation (Over $100,000)
	FAR52.215-8

	 	Oct 1997
	 	Order of Precedence — Uniform Contract Format
	FAR52.215-10

	 	Oct 1997
	 	Price Reduction for Defective Cost or Pricing Data
	FAR52.215-12

	 	Oct 1997
	 	Subcontractor Cost or Pricing Data (Over $500,000)
	FAR52.215-14

	 	Oct 1997
	 	Integrity of Unit Prices (Over $100,000)
	FAR52.215-15

	 	Dec 1998
	 	Pension Adjustments and Asset Reversions
	FAR52.215-18

	 	Oct 1997
	 	Reversion or Adjustment of Plans for Post-Retirement
Benefits (PRB) other than Pensions
	FAR52.215-19

	 	Oct 1997
	 	Notification of Ownership Changes
	FAR52.215-21

	 	Oct 1997
	 	Requirements for Cost or Pricing Data or Information
Other Than Cost or Pricing Data — Modifications
	FAR52.219-8

	 	Oct 1999
	 	Utilization of Small Business Concerns (Over $100,000)
	FAR52.219-9

	 	Oct 1999
	 	Small Business Subcontracting Plan (Over $500,000)
	FAR52.219-16

	 	Jan 1999
	 	Liquidated Damages — Subcontracting Plan (Over
$500,000)
	FAR52.222-20

	 	Dec 1996
	 	Walsh-Healey Public Contracts Act
	FAR52.222-26

	 	Feb 1999
	 	Equal Opportunity
	FAR52.222-35

	 	Apr 1998
	 	Affirmative Action for Disabled Veterans and Veterans
of the Vietnam Era
	FAR52.222-36

	 	Jun 1998
	 	Affirmative Action for Workers with Disabilities
	FAR52.222-37

	 	Jan 1999
	 	Employment Reports on Disabled Veterans and Veterans
of the Vietnam Era
	FAR52.223-6

	 	Jan 1997
	 	Drug-Free Workplace
	 
	 	 	 	 

					
	A-TEK, Inc.
	 	Attachment 3 — Page 2 of 4
	 	Subcontract No. S2040823-1

 

 

	 	 	 	 	 
	FAR52.223-14

	 	Oct 1996
	 	Toxic Chemical Release Reporting
	FAR52.225-1

	 	Feb 2000
	 	Buy American Act — Balance of
Payments Program —
Supplies
	FAR52.225-13

	 	Feb 2000
	 	Restrictions on Certain Foreign Purchases
	FAR52.227-1

	 	Jul 1995
	 	Authorization and Consent
	FAR52.227-2

	 	Aug 1996
	 	Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000)
	FAR52.229-3

	 	Jan 1991
	 	Federal, State and Local Taxes (Over $100,000)
	FAR52.229-5

	 	Apr 1984
	 	Taxes — Contracts Performed in U.S. Possessions or
Puerto Rico
	FAR52.232-7

	 	Mar 2000
	 	Payments under Time-and-Materials and Labor-Hour
Contracts
	FAR52.232-8

	 	May 1997
	 	Discounts for Prompt Payment
	FAR52.232-9

	 	Apr 1984
	 	Limitation on Withholding of Payments
	FAR52.232-17

	 	Jun 1996
	 	Interest (Over $100,000)
	FAR52.232-23

	 	Jan 1986
	 	Assignment of Claims
	FAR52.232-25

	 	Jun 1997
	 	Prompt Payment
	FAR52.232-34

	 	May 1999
	 	Payment by Electronic Funds Transfer-Other Than
Central Contractor Registration
	FAR52.233-1

	 	Dec 1998
	 	Disputes
	FAR52.233-3

	 	Aug 1996
	 	Protest After Award
	FAR52.242-1

	 	Apr 1984
	 	Notice of Intent to Disallow Costs
	FAR52.242-13

	 	Jul 1995
	 	Bankruptcy (Over $100,000)
	FAR52.243-3

	 	Aug 1987
	 	Changes — Time-and-Materials and Labor-Hours
	FAR52.244-2

	 	Aug 1998
	 	Subcontracts
	FAR52.245-5

	 	Jan 1986
	 	Government Property (Cost-Reimbursement, Time and
Material, or Labor-Hour Contract)
	FAR52.245-6

	 	Sep 1996
	 	Termination (Cost-Reimbursement), Alternate IV (Sep
1996)
	FAR52.249-14

	 	Apr 1984
	 	Excusable Delays
	FAR52.253-1

	 	Jan 1991
	 	Computer Generated Forms
	HHSAR352.202-1

	 	Apr 1984
	 	Definitions
	HHSAR352.228-7

	 	Dec 1991
	 	Insurance — Liability to Third Persons
	HHSAR352.232-9

	 	Apr 1984
	 	Withholding of Contract Payments
	HHSAR352.233-70

	 	Apr 1984
	 	Litigation and Claims
	HHSAR352.242-71

	 	Apr 1984
	 	Final Decisions on Audit Findings
	HHSAR352.270-5

	 	Apr 1984
	 	Key Personnel
	HHSAR352.270-6

	 	Jul 1991
	 	Publication and Publicity
	HHSAR352.270-7

	 	Apr 1984
	 	Paperwork Reduction Act
	 
	 	 	 	 

					
	A-TEK, Inc.
	 	Attachment 3 — Page 3 of 4
	 	Subcontract No. S2040823-1

 

 

NOTE: All HHSAR clause can be reviewed in full text at
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1999_register&docid=fr08ja99-34

ADDITIONAL CONTRACT CLAUSES INCORPORATED BY REFERENCE

	 	 	 	 	 
	CLAUSE NO.	 	CLAUSE TITLE	 	DATE
	52.204-02

	 	Security Requirements
	 	Aug 1996
	52.217-08

	 	Option to Extend Services
	 	Nov 1999
	52.223-5

	 	Pollution Prevention and Right-To-Know Information
	 	Apr 1998
	52.224-01

	 	Privacy Act Notification
	 	Apr 1984
	52.224-02

	 	Privacy Act
	 	Apr 1984
	52.225-08

	 	Duty Free Entry
	 	Feb 2000
	52.225-16

	 	Sanctioned European Union for Country Services
	 	Feb 2000
	52.227-19

	 	Commercial computer Software Restricted Rights
	 	Jun 1987
	52.228-05

	 	Insurance-Work on a Government Installation
	 	Apr 1984
	52.232-22

	 	Limitation of Funds
	 	Apr 1984
	52.237-02

	 	Protection of Government Buildings, Equipment and
Vegetation
	 	Apr 1984
	52.237-03

	 	Continuity of Services
	 	Jan 1991
	52.239-1

	 	Privacy of Security Safeguards
	 	Aug 1996
	 
	 	 	 	 

					
	A-TEK, Inc.
	 	Attachment 3 — Page 4 of 4
	 	Subcontract No. S2040823-1

 

 

	 	 	 
	To:
	 	 
	 

	 	Virtual Alert, Inc.
	 

	 	7748 Herschell Avenue
	 

	 	LaJolla, CA 92038

			
	Attention:	 	[***]

[***]

SUBCONTRACT

MODIFICATION NO. 01

SUBCONTRACT NUMBER: S2040823-1

Date: 10/29/04

	 	 	 
	 
	 	 
	 
	 	 
	Ship To:
	 

	 	Department of Homeland Security
	 

	 	Science and Technology Directorate
	 

	 	245 Murray Drive, Building 410
	 

	 	Washington, DC 20528
	 

	 	 
	 

	 	Attention: Dr. Peter Estacio (202) 254-6073
	 

	 	Fax: (202) 254-6169; E-mail: Peter.Estacio@dhs.gov

	 	 	 	 	 	 	 
	Project No.

1410-000
	 	Program Manager

Richard Basch
	 	Performance Period

08/23/04-02/04/05
	 	Payment Terms

5 days after Government pay

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Qty	 	Item	 	Description	 	Unit Price	 	Total
	 	 	 	 	 	 	 	 	 
	 	 	 	 	The purpose of this Modification is to incorporate Work Assignments (WA) #1, #2, #3, and #4 and re-allocate base
period funding on a WA basis.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Additionally, all corresponding areas of the Subcontract that are affected are also modified accordingly.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	WA funding allocated to date are as follows:	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	0001 - Total Base Period Funding	 	$[***]	 	 	 	 	 	 
	 	 	 	 	less travel reserved for A-TEK Program Management Executive Staff	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	0001 - Total Base Period Funding	 	$[***]	 	 	 	 	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	WA 01	 	Contract Team Core Management Staffing & Administrative Support	 	$[***]	 	 	 	 
	 	 	WA 02	 	[***] Staffing and Information Systems Management	 	$[***]	 	 	 	 
	 	 	WA 03	 	2004 Syndromic Surveillance Conference	 	$[***]	 	 	 	 
	 	 	WA 04	 	BioWatch Training, Consequence Management & Signal Interpretation	 	$[***]	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	$[***]	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Total Remaining Funding to be allocated by WA	 	$[***]	 	 	 	 	 	 
	MODIFICATION
NOTES:
	 	 	 	 	 	 	 	TOTAL	 	[***]	 	 

	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1	 	The total value of the subcontract is modified as follows:	 	[***]	 	 	 	 	 	 	 	 
	 	 	     less travel for A-TEK Management	 	[***]	 	 	 	 	 	 	 	 
	 

	 	 	 	                    NEW TOTAL
	 	[***]	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	2	 	The following sections of the subcontract have been modified to accomplish the above:	 	 	 	 	 	 
	 	 	     - B — Supplies/Services and Price/Cost	 	 	 	 	 	 	 	 	 	 
	 	 	     - B.1. Schedule of Items	 	 	 	 	 	 	 	 	 	 
	 	 	     - C. Statement of Work	 	 	 	 	 	 	 	 	 	 
	 	 	     - F. Deliveries or Performance	 	 	 	 	 	 	 	 	 	 
	 	 	     - F.1. Effective Period of the Subcontract	 	 	 	 	 	 	 	 	 	 
	 	 	     - F.2. Place of Performance	 	 	 	 	 	 	 	 	 	 
	 	 	     - F.3. Deliverables	 	 	 	 	 	 	 	 	 	 
	 	 	     - H.11. Key Personnel	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	3	 	All other references to “Task Order” are hereby replaced by “Work Assignment.”	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	4	 	All other Terms, Conditions, Provisions and Clauses remain unchanged.	 	 	 	 	 	 

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

 

A-TEK, Inc.

By: /s/ Debbie Rieger

Name: Debbie Rieger

Title: President

Date: 11/08/04

Virtual Alert, Inc.

By: /s/ Dan Lintz

Name: Dan Lintz

Title: CEO

Date: 11-3-04

Page 1 of 4

1. Section B SUPPLIES/SERVICES AND PRICE/COST, to include B.1 SCHEDULE OF ITEMS and B.1.1.
through B.1.9, is hereby deleted in its entirety is and replaced with the following, with changed
text in blue:

B. — SUPPLIES/SERVICES AND PRICE/COST

The Subcontractor, acting as an independent contractor and not as an agent of the Government, shall
furnish all materials, personnel, facilities, support and management necessary to provide the
supplies and services as set forth below as defined in (1) the Statement of Work (SOW) entitled
“BioWatch Staffing, Communication, and Laboratory Data Integration” dated 07/19/04, incorporated as
Attachment 1 to this subcontract; (2) the technical proposal submitted to DHS 09 August
2004, incorporated as Attachment 2 to this subcontract; and any and all Work Assignments
added to the subcontract by Modification.

B.1 Schedule of Items

On a Time and Material-(T&M) type Work Assignment basis, the Subcontractor shall provide a full
range of supplies and services as specified and in accordance with the SOW. Base Period pricing is
set forth below by Work Assignment (WA). Option Year pricing has been calculated using the Base
Period times 2 and escalated [***]% per year. Pricing shall be detailed and provided with the
corresponding subcontract exercising each Option Year and the corresponding WAs.

T&M rates are inclusive of all labor, fringe, overhead, G&A, taxes, insurance and profit.
Materials and travel shall be invoiced at cost and supported by receipts for all material costs
exceeding $25. Travel shall be reimbursed in accordance with Section H.10 herein.

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

					
	A-TEK, Inc.
	 	Modification 01 Pg 2
	 	Subcontract No. S2040823-1

 

 

	 	 	 	 	 	 	 
	Work	 	 	 	Period of	 	 
	Assignment	 	Description	 	Performance	 	Funded Value
	WA 01

	 	Contract Team Core Management
Staffing and Administrative
Support
	 	08/20/04 — 02/28/05
	 	[***]
	WA 02

	 	New York City Staffing and
Information Systems Management
	 	08/20/04 — 02/28/05
	 	[***]
	WA 03

	 	2004 Syndromic Conference and Work
	 	08/20/04 — 02/28/05
	 	[***]
	WA 04

	 	BioWatch Training, Consequence
Management and Signal
Interpretation
	 	08/20/04 — 02/28/05
	 	[***]
	 

	 	 	 	 	 	 
	 

	 	 	 	TOTAL
	 	[***]

	 	 	 	 	 	 	 
	The total funding available for this subcontract is -

	 	[***].	 	 	 	 
	The total amount allocated by WA is -

	 	[***]	 	 	 	 
	 	 	 
	The total amount remaining to be allocated to WAs is -

	 	 	 	 	 	[***]
	 
	 	 	 	 	 	 
	The total unfunded value of Option Year 1 if exercised is -

	 	 	 	[***]	 	 
	The total unfunded value of Option Year 2 if exercised is -

	 	 	 	[***]	 	 

Option Year values are subject to change based on the resultant value of the DHS exercised
options to A-TEK.

A breakdown of each WA is provided within each separately issued WA document. Additional work for
any given WA will be incorporated by subcontract modification as WAs are provided by DHS.

2. Section C STATEMENT OF WORK is hereby modified with the following changed text in blue:

C. — STATEMENT OF WORK

This Subcontract hereby incorporates the full Statement of Work (SOW) entitled “BioWatch Staffing,
Communication, and Laboratory Data Integration” dated 07/19/04, incorporated as Attachment
1 to this subcontract, the technical proposal submitted to DHS 09 August 2004, incorporated as
Attachment 2 to this Subcontract

3. Section F DELIVERIES OR PERFORMANCE is hereby modified with the following changed text in
blue: 

F. DELIVERIES OR PERFORMANCE

The Subcontractor shall, through A-TEK, comply with the requirements defined in the Statement of
Work (SOW) entitled “BioWatch Staffing, Communication, and Laboratory Data Integration” dated
07/19/04, incorporated as Attachment 1 to this subcontract; the technical proposal
submitted to DHS 09 August 2004, incorporated as Attachment 2 to this subcontract, all
requirements added by each Work Assignment made a part of this Subcontract, and Section F of the
Prime CIO-SP2 Contract found in full text at http://nitaac.nih.gov.

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

					
	A-TEK, Inc.
	 	Modification 01 Pg 3
	 	Subcontract No. S2040823-1

 

 

4. Section F.1 EFFECTIVE PERIOD OF THE SUBCONTRACT is hereby modified to add the following
text in blue: 

Each individual Work Assignment will include the period of performance specific to that WA.

5. Section F.2 PLACE OF PERFORMANCE is hereby modified to add the following text in blue: 

Each individual Work Assignment will designate the place of performance specific to that WA.

6. Section F.3 DELIVERABLES is hereby modified to add the following text in blue: 

Each individual Work Assignment will designate deliverables specific to that WA.

7. Section H.11 KEY PERSONNEL is hereby modified to add the following text in blue: 

Each individual Work Assignment will designate Key Personnel specific to that WA.

Additionally, the following Key Personnel are further identified as follows:

[***]

- - - END OF MODIFICATION 01 - - -

[***] = Certain information on this page has been
omitted and filed separately with the Commission. Confidential
treatment has been requested with respect to the omitted
portions.

 

 

					
	A-TEK, Inc.
	 	Modification 01 Pg 4
	 	Subcontract No. S2040823-1

 

 

	 	 	 
	To:
	 	 
	 

	 	Virtual Alert, Inc.
	 

	 	7748 Herschell Avenue
	 

	 	LaJolla, CA 92038

			
	Attention:	 	[***]

[***]

SUBCONTRACT

MODIFICATION NO. 02

SUBCONTRACT Number: S2040823-1

Date: 11/15/04

	 	 	 
	 
	 	 
	 
	 	 
	Ship To:
	 

	 	Department of Homeland Security
	 

	 	Science and Technology Directorate
	 

	 	245 Murray Drive
	 

	 	Building 410
	 

	 	Washington, DC 20528
	 

	 	 
	 

	 	Attention: Dr. Peter Estacio (202) 254-6073
	 

	 	Fax: (202) 254-6169; E-mail: Peter.Estacio@dhs.gov

	 	 	 	 	 	 	 
	Project No.

1410-000
	 	Program Manager

Richard Basch
	 	Performance Period

08/20/04 — 02/28/06
	 	Payment Terms

5 days after Government pay

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Qty	 	Item	 	Description	 	Unit Price	 	Total
	 	 	 	 	 	 	 	 	 
	 	 	 	 	The purpose of this Modification is to revise the Base Period and Option Year periods of performance, collapsing the
Base period and Option Year 1 together as the total 18 month Base period, rename Option Year 2 now to be Option Year 1,
and clarify the Period of Performance start and end dates.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	The requirement for receipts for travel costs has changed from $25 to $75.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Additionally, all corresponding areas of the Subcontract that are affected are also modified accordingly.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	0001a – Total Base Period FUNDED
	 	 	 	[***]	 	 	 	 
	 

	 	 	 	0001b – Total Base Period UNFUNDED
	 	 	 	[***]	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	0001 – Total Base Period VALUE (Ceiling)     08/20/04 – 02/28/06
	 	 	 	[***]	 	 	 	 
	 
	 	 	 	 	 	 	 
	 

	 	 	 	0002 – Total Option Year 1 Period UNFUNDED     03/28/06 – 02/28/07
	 	 	 	[***]	 	 	 	 
	 
	 	 	 	 	 	 	 
	 

	 	 	 	Total Subcontract Award Amount remains unchanged:
	 	 	 	[***]	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	MODIFICATION NOTES:	 	 	 	 	 	TOTAL	 	$[***]
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	1	 	The following sections of the subcontract have been modified to accomplish the above:	 	 	 	 	 	 
	 	 	     B.1. Schedule of Items	 	 	 	 	 	 
	 	 	     F.1. Effective Period of the Subcontract	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	2	 	All other Terms, Conditions, Provisions and Clauses remain unchanged.	 	 	 	 	 	 

 

A-TEK, Inc.

By: /s/ Debbie Rieger

Name: Debbie Rieger

Title: President

Date: 11/15/04

Virtual Alert, Inc.

By: /s/ Chris Popov

Name: Chris Popov

Title: Director

Date: Nov 16, 2004

Page 1 of 2

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

1. Section B.1 SCHEDULE OF ITEMS, is hereby modified as follows, with changed text in
blue:

 B.1 Schedule of Items

third (3rd) paragraph, second (2nd) sentence –

Materials and travel shall be invoiced at cost and supported by receipts for all material costs
exceeding $75. Travel shall be reimbursed in accordance with Section H.10 herein.

Sixth (6th) paragraph, -

	 	 	 	 	 	 	 	 	 
	The total FUNDED value of the Base Year is
	 	 	 	 	 	 	[***]	 
	The total UNFUNDED value of the Base Year is -
	 	 	 	 	 	 	[***]	 
	 
	 	 	 	 	 	 	 	 
	The total unfunded value of the Option Year 1 if exercised is -
	 	 	[***]	 	 	 	 	 

4. Section F.1 EFFECTIVE PERIOD OF THE SUBCONTRACT is hereby modified with the following
changed text in blue:

F.1 Effective Period of the Subcontract

This Subcontract shall remain in effect from 08/20/04 through 02/28/06, with one (1) Option with
periods of performance as set forth below, in accordance with the DHS Order to Prime Contractor:

	 	•	 	Base Period: 08/20/04 — 02/28/06
	 	•	 	Option Year: 03/01/06 — 02/28/07

Options shall be executed and funded by Modification when the corresponding Modifications are
issued under the Prime Contract.

Each individual Work Assignment will include the period of performance specific to that WA.

- -
- END OF MODIFICATION 02 - - -

[***] = Certain information on this page has been omitted
and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.

 

 

	 	 	 
	To:
	 	 
	 

	 	Virtual Alert, Inc.
	 

	 	7748 Herschell Avenue
	 

	 	LaJolla, CA 92038

			
	Attention:	 	[***]

[***]

SUBCONTRACT

MODIFICATION NO. 03

SUBCONTRACT Number: S2040823-1

Date: 11/24/04

	 	 	 
	 
	 	 
	 
	 	 
	Ship To:
	 

	 	Department of Homeland Security
	 

	 	Science and Technology Directorate
	 

	 	245 Murray Drive
	 

	 	Building 410
	 

	 	Washington, DC 20528
	 

	 	 
	 

	 	Attention: Dr. Peter Estacio (202) 254-6073
	 

	 	Fax: (202) 254-6169; E-mail: Peter.Estacio@dha.gov

	 	 	 	 	 	 	 
	Project No.

1410-000
	 	Program Manager

Richard Basch
	 	Performance Period

08/20/04-02/28/06
	 	Payment Terms

5 days after Government pay

	 	 	 	 	 	 	 	 	 	 	 
	Qty	 	Item	 	Description	 	Unit Price	 	Total
	 	 	 	 	 	 	 	 	 
	 

	 	 	 	The purpose of this Modification is to revise the due dates for the
deliverables Surge Capacity Staffing Plan and Operations and
Enhancement Review Committee.	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	Additionally, all corresponding areas of the Subcontract that are
affected are also modified accordingly.	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	MODIFICATION NOTES:	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	1	 	The following section of the subcontract has been modified to accomplish the above:	 	 	 	 	 	 
	 	 	     F.3. Deliverables	 	TOTAL	 	$	0.00	 
	 
	 	 	 	 	 	 	 	 	 	 
	2	 	All other Terms, Conditions, Provisions and Clauses remain unchanged.	 	 	 	 	 	 

 

A-TEK, Inc.

By: /s/ Debbie Rieger

Name: Debbie Rieger

Title: President

Date: 11/24/04

Virtual Alert, Inc.

By: /s/ Chris Popov

Name: Chris Popov

Title: Director

Date: Nov 29, 2004

Page 1 of 2

[***] = Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions

 

 

1. Section F.3 Deliverables is hereby modified as follows, with changed text in blue:

F.3 Deliverables

The due dates for the following deliverables are revised as follows:

	 	 	 	 	 
	SOW

Task Number
	 	Deliverable

Title
	 	New

Due Date
	 
	 	 
	 	 
	3

7
	 	Surge Capacity Staffing Plan

Operations and Enhancement Review Committee
	 	Within 120 days of award

Within 150 days of award

2. Section C STATEMENT OF WORK is hereby modified as follows, with changed text in blue:

Paragraph 9. Deliverables/Delivery Schedule 

The due dates for the following deliverables are revised as follows:

	 	 	 	 	 
	SOW

Task Number
	 	Deliverable

Title
	 	New

Due Date
	 
	 	 
	 	 
	3

7
	 	Surge Capacity Staffing Plan

Operations and Enhancement Review Committee
	 	Within 120 days of award

Within 150 days of award

This modification results in no change to the funded amounts of this subcontract.

- -
- END OF MODIFICATION 03 - - -

 

 

					
	A-TEK, Inc.
	 	Modification 03 Pg 2
	 	Subcontract No. S2040823-1exv10w13

 

DISTRIBUTOR AGREEMENT

     THIS DISTRIBUTOR AGREEMENT (this “Agreement”) is made effective as of the 24th day of October,
2005 by and between (i) ReGen Biologics, Inc., a Delaware corporation (“MANUFACTURER”), having its
principal place of business located at 509 Commerce Street, East Wing, Franklin Lakes, New Jersey
07417, U.S.A., and (ii) XMedica, a company organized and existing under the laws of Italy, having
its principal place of business located at Via Francesco Olgiati, 26 , Milan 20143, Italy
(“DISTRIBUTOR”).

RECITALS

     A. MANUFACTURER developed, designed, manufactures, markets, distributes, sells and supplies a
collagen meniscus implant and certain other products listed on Schedule A attached hereto
(collectively, the “Products”).

     B. DISTRIBUTOR possesses expertise in the promotion, marketing, distribution, sale and supply
of products similar to the Products and is knowledgeable of the market for the Products in the
Territory (as hereinafter defined).

     C. DISTRIBUTOR desires to promote, market, distribute, sell and supply the Products in the
Territory on an exclusive basis in accordance with the terms and provisions of this Agreement.

     D. MANUFACTURER is willing to grant to DISTRIBUTOR the right to promote, market, distribute,
sell and supply the Products, and to use MANUFACTURER’s trademarks, trade names and copyrights for
such purposes, in the Territory on an exclusive basis in accordance with the terms in this
Agreement.

     E. The parties hereto desire to set forth herein the terms and provisions of their agreements
and understandings.

     NOW, THEREFORE, in consideration of the foregoing, of the mutual promises herein set forth and
of other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties hereto, intending legally to be bound, hereby agree as follows:

1. DEFINITIONS.

     1.1. Agreed-Upon Marketing Expenses. The term “Agreed-Upon Marketing Expenses” shall
have the meaning given to such term in Section 2.8 hereof.

     1.2. Confidential Information. The term “Confidential Information” shall have the
meaning given to such term in Section 5.5 hereof.

     1.3. Copyrights. The term “Copyrights” shall mean all MANUFACTURER designs,
advertising materials and other copyrightable works as may from time to time be specifically
designated by MANUFACTURER in writing as Copyrights to be licensed to DISTRIBUTOR under this
Agreement.

 

 

     1.4. Customer. The term “Customer” shall mean any person or entity which purchases the
Products for its own use and not for resale to another person or entity, whether such purchase for
use is from the DISTRIBUTOR or any of its Dealers.

     1.5. Dealer. The term “Dealer” shall mean any person or entity appointed by
DISTRIBUTOR to promote, market, distribute, sell and supply the Products in the Territory to
Customers pursuant to a dealer agreement consistent with the terms and provisions of this
Agreement.

     1.6. Defect. The term “Defect” shall mean any material failure of the Product to
conform to the applicable specifications for the Product, as set forth on Schedule B, at
the time of its shipment by the MANUFACTURER.

     1.7. Marks. The term “Marks” shall mean the trademarks “ReGen Biologics,” “CMI,”
“Collagen Meniscus Implant,” “SharpShooter” and all other names, marks and symbols as may from time
to time be specifically designated by MANUFACTURER in writing as Marks to be licensed to
DISTRIBUTOR under this Agreement.

     1.8. Quota. The term “Quota” shall have the meaning given to such term in Section 2.4
hereof.

     1.9. Term. The term “Term” shall have the meaning given to such term in Section 7.1
hereof.

     1.10. Territory. The term “Territory” shall mean the countries and/or regions listed
in Schedule C attached hereto and made a part hereof.

2. APPOINTMENT.

     2.1. Appointment.

          (a) MANUFACTURER hereby grants to DISTRIBUTOR the right, in accordance with the provisions of
this Agreement and further described on Schedule A, to market, distribute, sell and supply the
Products to Customers and Dealers located in the Territory in accordance with the terms and
provisions of this Agreement. MANUFACTURER reserves the right to appoint other distributors in the
Territory to market, distribute, sell and supply products other than the Products during the Term
of this Agreement.

          (b) DISTRIBUTOR agrees not to, directly or indirectly, export or otherwise make available the
Products to any Customer or Dealer for resale outside of the Territory or under circumstances which
reasonably indicate that a Customer or Dealer will sell Products outside the Territory.

          (c) DISTRIBUTOR agrees, at its expense, to obtain all approvals of any governmental authority
or “standards association” in the Territory necessary for the importation, sale or distribution of
the Products in the Territory and to provide MANUFACTURER with evidence thereof.

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          (d) DISTRIBUTOR shall display and use the Marks and the Copyrights, and shall permit and
authorize the same to be displayed or used, only as expressly permitted under Article 5 hereof or
otherwise with the prior written consent of MANUFACTURER.

          (e) DISTRIBUTOR agrees to conduct its business as an independent contractor under its own name
only. DISTRIBUTOR acknowledges and agrees that it is not an employee, co-venturer or agent of
MANUFACTURER and has no right or authority to make any representation to such effect. Neither
DISTRIBUTOR nor its employees, agents or dealers shall assume, create or enter into any obligation,
agreement or commitment of any kind on behalf of MANUFACTURER.

          (f) DISTRIBUTOR shall not make any representations, warranties or covenants to any third party
with respect to the Products except in accordance with the terms of this Agreement and such Product
information as MANUFACTURER provides to DISTRIBUTOR in writing from time to time.

     2.2. Experience. DISTRIBUTOR represents and warrants to MANUFACTURER that it is an
experienced distributor of products similar to the Products and that it is capable, as of the
effective date of this Agreement, and shall remain capable at all times thereafter, of performing
each of its obligations hereunder without assistance from MANUFACTURER (except as specifically
provided for herein) or any third party other than its Dealers.

     2.3. Duties of DISTRIBUTOR. DISTRIBUTOR agrees to fulfill the following
responsibilities hereunder:

          (a) Use its best efforts to promote, market, distribute, sell and supply the Products in the
Territory in compliance with this Agreement;

          (b) Promote the sale of the Products by engaging in advertising, promotional and public
relations activities intended to maximize consumer awareness of, interest in and demand for the
Products;

          (c) Utilize its best efforts to meet demand for Products by maintaining inventory adequate to
ship Products for sale within 24 hours after receipt of an order therefor;

          (d) Cooperate with MANUFACTURER to provide MANUFACTURER with relevant and appropriate
information to prepare labels to be used in the packaging of the Products to be delivered to
DISTRIBUTOR;

          (e) Appoint and support qualified Dealers in the territory;

          (f) Keep adequate records of Product sales by DISTRIBUTOR and its Dealers with regard to
traceability, making such records available for inspection, and such other data as MANUFACTURER may
reasonably request from time to time;

          (g) Provide methods and means of handling, storing, and delivering product that prevent damage
or deterioration;

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          (h) Employ and maintain an adequate number of experienced sales and marketing personnel;

          (i) Train Customers and surgeons using the Product, either through MANUFACTURER or a trainer
certified by MANUFACTURER, in accordance with the standards and guidelines provided and updated
from time to time by MANUFACTURER in writing, as MANUFACTURER shall determine in its sole
discretion, as necessary to ensure expertise regarding the Products;

          (j) Require all sales and marketing personnel, and Dealers and their respective sales and
marketing personnel, to participate in the training programs conducted by MANUFACTURER pursuant to
Section 2.8 hereof;

          (k) Advise MANUFACTURER immediately of any disputes between DISTRIBUTOR and any Customer or
Dealer, and any legal notices or actions relating to the Products or this Agreement; and

          (l) Advise MANUFACTURER of all material laws, rules and regulations of the Territory,
including any new interpretations thereof, relating to importing, promoting, marketing,
distributing and selling the Products in the Territory.

     2.4. Standard of Performance. As a material inducement for MANUFACTURER to enter into
this Agreement with DISTRIBUTOR, DISTRIBUTOR agrees to meet or exceed the sales quota(s) (the
“Quotas”) described in Schedule D attached hereto, as such Schedule D shall be
revised from time to time, which MANUFACTURER and DISTRIBUTOR agree are fair and reasonable.
Notwithstanding any provision of this Agreement, if DISTRIBUTOR fails to attain any Quota, then
MANUFACTURER shall have the right to terminate this Agreement in accordance with the provisions of
Section 7.2 hereof.

     2.5. Time Restriction on Sales and Use. Notwithstanding any other provision hereof,
in no event shall DISTRIBUTOR sell or supply any Product to any Dealer, Customer or other person on
or after the expiration date (“Expiration Date”) which shall not be less than eighteen (18) months
after the date of shipment of such Product by MANUFACTURER, and DISTRIBUTOR agrees to require all
Dealers and Customers, and their respective agents and representatives, not to sell or supply any
Product to any Customer or other person or use any Product on or after the Expiration Date.

     2.6. Reporting Defects. DISTRIBUTOR agrees to promptly inspect all Products for
Defects and shall notify MANUFACTURER of any such Defects in writing within ten (10) days of
receipt thereof. Should DISTRIBUTOR fail to give such notice of Defects that it becomes aware of,
or with due care should have become aware of, or fail to obtain an extension from MANUFACTURER, the
Products shall be deemed to be accepted by the DISTRIBUTOR. DISTRIBUTOR shall also be obligated to
accept the return of any Product from any surgeon who becomes aware of any Defect in such Product
and DISTRIBUTOR shall notify MANUFACTURER of any such Defects in writing within ten (10) days of
receipt thereof. In the event that DISTRIBUTOR notifies MANUFACTURER in writing of any Defect
pursuant hereto, MANUFACTURER shall be obligated to replace such Product or refund the purchase

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price in full to the DISTRIBUTOR. MANUFACTURER reserves the right to investigate any Defects
or other warranty claims to determine whether such claim is proper, including without limitation an
inspection of the Product in question, and DISTRIBUTOR shall cooperate with any such investigation.

     2.7. Annual, Quarterly and Other Reports.

          (a) On or before November 30th of each calendar year during the Term of this Agreement,
DISTRIBUTOR agrees to prepare and to submit to MANUFACTURER an annual report, setting forth in
adequate detail for the next calendar year (i) DISTRIBUTOR’s plans for marketing, sales and other
efforts and the number of its personnel to be assigned during such calendar year to the performance
of DISTRIBUTOR’s duties under this Agreement (ii) a forecast of projected sales for such calendar
year and (iii) the projected marketing and training expenses related to the Product for such year
presented on a monthly basis.

          (b) No later than fifteen (15) days after the end of each calendar quarter during the Term of
this Agreement, DISTRIBUTOR shall submit to MANUFACTURER in writing a quarterly report in
reasonable detail showing (i) the aggregate sales of the Product for such quarter in units, U.S.
dollars and in EUR (ii) the number of surgeries performed by each Hospital (Customer) and the date
since the last surgery for each Hospital (Customer) was performed, (iii) the number and names of
Customers and surgeons trained by the DISTRIBUTOR, (iv) an attestation stating that all surgeons
performing the CMI procedure are in compliance with the MANUFACTURER’S then current training
standards in accordance with section 2.3 (h) of this Agreement and (v) the marketing and training
expenses actually incurred by DISTRIBUTOR in carrying out its obligations hereunder.

          (c) DISTRIBUTOR shall submit to MANUFACTURER copies of any market research reports relating to
Product sales and competition which the DISTRIBUTOR commissions or otherwise obtains, except as
prohibited by copyright or similar laws (in which case DISTRIBUTOR will simply inform MANUFACTURER
of the existence of such information and where it may be obtained). To the extent the foregoing
information is contained in plans or reports which contain information about other products or
markets, DISTRIBUTOR may submit to MANUFACTURER only those excerpts from such plans or reports
which relate to the Product sales and competition.

     2.8. Duties of Manufacturer.

          (a) MANUFACTURER agrees to fulfill the following responsibilities hereunder: (i) ship the
Products to Distributor in accordance with the terms and conditions hereof, (ii) fulfill the
responsibilities under the warranties made and delivered with the Products, and (iii) provide
training to DISTRIBUTOR, Customers and surgeons in support of DISTRIBUTOR’s responsibilities set
forth in Section 2.3 hereof.

          (b) MANUFACTURER shall review each annual report provided by DISTRIBUTOR pursuant to Section
2.7 and, by written notice delivered to DISTRIBUTOR within 90 days of the receipt of such annual
report, shall approve in its discretion all or such portion of the projected marketing and training
expenses related to the Product for such year as

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MANUFACTURER deems necessary or appropriate (such expenses approved by the MANUFACTURER to be
referred to herein as “Agreed-Upon Marketing Expenses”).

          (c) MANUFACTURER shall make Dr. William Rodkey or other qualified personnel designated by
MANUFACTURER (collectively, “Trainers”) available to provide training sessions to DISTRIBUTOR, its
employees, Customers, surgeons and Dealers, and their respective employees and other agents, as
applicable, during the Term of this Agreement, as follows: (a) at least twice in calendar year
2005, (b) at least four times in calendar year 2006, (c) at least four times in each successive
year for the remainder of the Term (or a prorated number of times if earlier terminated). Each of
the training sessions shall consist of an in-person visit by a Trainer for at least [two (2) days
or (six (6) hours per day)]. The substance and format of such sessions shall be determined the
Trainer in his or her reasonable discretion. DISTRIBUTOR shall pay for or reimburse MANUFACTURER
for all costs (including travel, meals and hotel) related to the Trainer’s training sessions
provided pursuant to this Section 2.8, provided that if the Trainer is in or will be traveling to
Europe for purposes unrelated to such training sessions, DISTRIBUTOR will pay only the incremental
costs related to such training sessions, such as the airfare from such point within Europe and
expenses for hotel, meals and local transportation incurred in connection with such training
sessions. DISTRIBUTOR shall also supply, pay for or reimburse MANUFACTURER for all supplies and
materials required by the Trainer for such training sessions.

3. PRICE AND PAYMENT TERMS.

     3.1. Price. Subject to and in accordance with the terms and conditions hereof,
MANUFACTURER shall supply the Products to DISTRIBUTOR at the prices specified in Schedule A
attached hereto, as amended by MANUFACTURER from time to time in accordance therewith.

     3.2. Payment Terms.

          (a) DISTRIBUTOR shall promptly pay to MANUFACTURER all amounts due to MANUFACTURER under this
Article 3 in accordance with Schedule A attached hereto.

          (b) All amounts payable to MANUFACTURER shall be paid within thirty (30) days of invoice at
MANUFACTURER’s principal place of business in U.S. Dollars or as the parties shall otherwise agree
in writing from time to time. Interest thereon shall accrue on amounts due hereunder to
MANUFACTURER at the rate of one and one-half percent (1-1/2%) per month or the maximum rate
otherwise permitted by applicable law, whichever shall be lower, and be payable from the due date
thereof until paid in full. In the event that there shall be imposed by the central bank or
similar governing body in the Territory any restrictions preventing payment of funds due to
MANUFACTURER hereunder, and DISTRIBUTOR shall not otherwise remit amounts due to MANUFACTURER
hereunder by a means acceptable to MANUFACTURER, MANUFACTURER may, in its discretion, terminate
this Agreement pursuant to Section 7.2 hereof and instruct DISTRIBUTOR to deposit such funds in a
banking institution located within the Territory in accordance with MANUFACTURER’s instructions.

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          (c) Notwithstanding any provision of this Agreement, MANUFACTURER may terminate this
Agreement, immediately upon prior written notice, in the event that DISTRIBUTOR fails to pay to
MANUFACTURER all amounts due hereunder within the time specified herein and in Schedule A
attached hereto.

4. PRODUCT ORDERS.

     4.1. General Provisions.

          (a) Each purchase order for a Product shall be firm and, subject to the terms and conditions
hereof, MANUFACTURER shall use its best efforts to fill such purchase order in accordance with its
terms at its principal place of business. DISTRIBUTOR shall place orders in writing or,
notwithstanding Section 9.2, by email, which shall set forth, at a minimum, an identification of
the Product ordered, the quantity of such Product ordered, shipping instructions, shipping address
and the requested ship date. Notwithstanding the foregoing, MANUFACTURER shall be permitted to
ship the quantity of the Product ordered at any time during the 90-day period after the date of the
order for the Product. In the event that MANUFACTURER does not fill a firm purchase order by
DISTRIBUTOR for any Product, in whole or in part, the sole and exclusive remedy or consequence of
DISTRIBUTOR is as set forth on Schedule D hereto.

          (b) Purchase orders for a Product may not be cancelled by DISTRIBUTOR.

          (c) In the event that DISTRIBUTOR shall, at any time, be in arrears on payments owing to
MANUFACTURER or otherwise in material breach of this Agreement, MANUFACTURER may, immediately upon
written notice to DISTRIBUTOR, decline to continue the performance of this Agreement with
DISTRIBUTOR, and such action by MANUFACTURER shall not give rise to any cause or claim of breach of
contract or other liability against MANUFACTURER.

          (d) All shipments shall be made with shipping, insurance and handling charges prepaid by
MANUFACTURER, all of which shall be added to MANUFACTURER’s invoice to DISTRIBUTOR. All risk of
loss shall pass to DISTRIBUTOR upon delivery to the shipper. Products shall be packed and shipped
by MANUFACTURER to DISTRIBUTOR in accordance with MANUFACTURER’s standard procedures, unless
DISTRIBUTOR has expressly made a special request for shipping in which case MANUFACTURER shall use
commercially reasonable efforts to honor such request. MANUFACTURER shall not bear any liability
arising or resulting from any delays in the delivery of the Products to DISTRIBUTOR or to Dealer or
Customer.

          (e) MANUFACTURER reserves the right at any time to make changes to the Product at any time and
from time to time in its sole discretion.

          (f) Any order submitted by DISTRIBUTOR which contains terms different from, or in addition to,
those contained in this Agreement shall be deemed governed by the terms of this Agreement. Any
such different or additional terms shall be deemed to be deleted from

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such order unless otherwise specifically approved in writing by an authorized officer of
MANUFACTURER.

     4.2. Taxes and Other Charges. DISTRIBUTOR agrees to pay, collect and remit on the
dates when they are due all import duties, value-added, sales, and other taxes, tariffs, duties,
fees and assessments imposed by any governmental agency within the Territory in respect of the
Products (other than income or similar withholding taxes imposed upon amounts remitted to
MANUFACTURER). DISTRIBUTOR agrees to indemnify and hold MANUFACTURER harmless against any such
liabilities.

     4.3. Import Requirements. Other than obtaining the governmental authorizations and
approvals set forth on Schedule E, all of which shall be MANUFACTURER’s sole responsibility
hereunder, DISTRIBUTOR agrees to obtain at its expense all necessary customs, import and other
governmental authorizations and approvals in the Territory (including, without limitation, foreign
exchange) with respect to this Agreement and delivery of the Products to DISTRIBUTOR.
MANUFACTURER’s obligations under this Agreement shall be expressly subject to the grant and
effectiveness of all such authorizations and approvals.

     4.4. Export Requirements. MANUFACTURER and DISTRIBUTOR agree to comply fully with all
applicable U.S. export laws, regulations and orders and to adopt such policies and procedures as
may be required thereby. MANUFACTURER’s obligations under this Agreement shall be expressly
subject to the grant and effectiveness of all necessary U.S. export authorizations and approvals.

     4.5. Foreign Corrupt Practices Act. DISTRIBUTOR hereby agrees that it shall not, and
shall refrain from any acts that would cause MANUFACTURER to, violate the United States Foreign
Corrupt Practices Act. DISTRIBUTOR hereby agrees to indemnify and hold harmless MANUFACTURER from
any breach of this Section 4.5.

     4.6. Warranty. MANUFACTURER warrants that the Products shall be free of Defects at
the time of its shipment by the MANUFACTURER. Such warranty shall survive until the Expiration
Date. If any Product is determined by MANUFACTURER to have any Defects, then MANUFACTURER’s
obligation under this warranty shall be to replace as soon as practicable any such defective items
at MANUFACTURER’s expense, exclusive of delivery costs to and from the MANUFACTURER, or, at
MANUFACTURER’S option, provide a refund with respect to any such defective Product. THE FOREGOING
WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE
IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, WHETHER IMPOSED BY
CONTRACT, STATUTE, COURSE OF DEALING, CUSTOM OR USAGE OR OTHERWISE. MANUFACTURER shall have no
responsibility for any Product that has been modified, repaired, or subjected to misuse or neglect.
Notwithstanding any provision of this Agreement, MANUFACTURER shall not be liable under this
Agreement or otherwise for any special, incidental, consequential, punitive, lost profit or similar
damages, and shall not in any event be liable to DISTRIBUTOR or any Customer or Dealer thereof for
an amount in excess of amounts paid by DISTRIBUTOR to MANUFACTURER hereunder. The provisions in
this Section 4.6, Section 4.1(a) and the indemnity in Section 4.7 constitute the sole

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and exclusive remedy of DISTRIBUTOR for breach of the representations, warranties and
covenants contained herein.

     4.7. MANUFACTURER Indemnification. Subject to the terms and conditions hereof,
MANUFACTURER agrees to defend, indemnify and hold DISTRIBUTOR, its subsidiaries, affiliates and
agents harmless from and against any and all third party claims of loss, liability, costs and
expenses (including reasonable legal fees and costs) arising out of any Defect in the Product.

     4.8. Goodwill. DISTRIBUTOR acknowledges and agrees that all goodwill created or
otherwise associated with the promotion, marketing, distribution and sale of the Products in the
Territory during or following the Term of this Agreement shall accrue directly to the benefit of,
MANUFACTURER and shall be the sole and exclusive property of MANUFACTURER.

5. MARKS, COPYRIGHTS AND OTHER INTELLECTUAL PROPERTY MATTERS.

     5.1. Scope of Use. MANUFACTURER hereby grants to DISTRIBUTOR a no-cost,
non-exclusive, limited license to use the Marks and the Copyrights solely for purposes of
performing its duties and obligations under this Agreement. DISTRIBUTOR hereby acknowledges
MANUFACTURER’s ownership of all right, title and interest in the Marks and the Copyrights.
DISTRIBUTOR further acknowledges that it shall acquire no interest in the Marks or the Copyrights
by virtue of this Agreement or the performance by DISTRIBUTOR of its duties and obligations
hereunder. Further, all use of the Marks and the Copyrights by DISTRIBUTOR shall be solely in the
interest of and on behalf of MANUFACTURER. DISTRIBUTOR acknowledges that it shall not use the name
“ReGen Biologics” or any similar name as part of its corporate and/or trade name. MANUFACTURER
makes no warranty, express or implied, as to the use or validity of the Marks or the Copyrights in
the Territory. MANUFACTURER reserves the right to approve all advertising and marketing materials
of DISTRIBUTOR to ensure that the Marks and the Copyrights are properly used by DISTRIBUTOR. The
limited license granted to DISTRIBUTOR under this Section 5.1 shall continue only during the Term
of this Agreement. Upon termination or expiration of this Agreement, DISTRIBUTOR shall cease all
use, including as part of DISTRIBUTOR’s corporate and/or trade name, of the Marks and the
Copyrights, or variants sounding like or appearing to be similar thereto in any manner whatsoever.

     5.2. Notification of Infringing Uses. DISTRIBUTOR agrees to report promptly to
MANUFACTURER any use in the Territory by any third party of the Marks, the Copyrights or any marks
or trade or product names identical or similar to the Marks or the Copyrights, and agrees to assist
MANUFACTURER at MANUFACTURER’s expense in enforcing such rights in the Territory. DISTRIBUTOR
acknowledges that MANUFACTURER shall, in its discretion, have the sole right to bring, or to
authorize DISTRIBUTOR to bring in MANUFACTURER’s name, a legal action or suit to enjoin such use
and, in such event, DISTRIBUTOR agrees to cooperate fully with MANUFACTURER in connection
therewith.

     5.3. Manufacture Prohibited. Under no circumstances shall DISTRIBUTOR authorize or
directly or indirectly participate in the manufacture of any Products or, without

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MANUFACTURER’s prior written consent, the creation of any advertising materials which
incorporate or use in any way the Marks or the Copyrights.

     5.4. Conflicts. DISTRIBUTOR covenants and agrees that, during the Term hereof, except
with the express prior written consent of MANUFACTURER, neither the DISTRIBUTOR nor any of
DISTRIBUTOR’s affiliates shall for any reason whatsoever, directly or indirectly, for the
DISTRIBUTOR or on behalf of or in conjunction with any other person, through a relative or as a
member of a partnership, or as an executive, employee, stockholder, owner, investor, joint
venturer, officer or director of a corporation or in a position of managerial capacity, whether as
an employee, independent contractor, consultant or advisor, or as an agent, associate or consultant
of any person, promote, market, distribute, sell or supply any implant for growing tissue in the
meniscus of the knee or otherwise interfere with any actual or prospective client or customer of
the MANUFACTURER or any of its affiliates. If, however, DISTRIBUTOR decides to do so, DISTRIBUTOR
agrees that, in advance of accepting such work, DISTRIBUTOR will promptly notify MANUFACTURER in
writing, specifying the organization for which DISTRIBUTOR proposes to work, and will promptly
provide information sufficient to allow MANUFACTURER to determine if such work would conflict with
(i) the terms of this Agreement, including the terms of this Section 5.4, (ii) the interests of the
MANUFACTURER or (iii) further work which the MANUFACTURER might request of DISTRIBUTOR. If the
MANUFACTURER determines that such work conflicts with any of the foregoing, the MANUFACTURER
reserves the right to terminate this Agreement immediately by providing written notice to
DISTRIBUTOR.

     5.5. Treatment of Information.

          (a) DISTRIBUTOR acknowledges that, as a result of DISTRIBUTOR’s engagement by the
MANUFACTURER, DISTRIBUTOR will develop, have access to and use confidential information and
materials of the MANUFACTURER which is of a special and unique nature and value. For purposes of
this Agreement, the term “Confidential Information” shall include, but not be limited to, the
MANUFACTURER’s financial information, customer lists, designs, computer programs, manuals, works of
authorship, copyrights, inventions, patents, know-how, discoveries, trade secrets and other
intellectual property rights. DISTRIBUTOR further acknowledges that any information and materials
received by the MANUFACTURER from third parties (including, without limitation, customers and
clients of the MANUFACTURER) in confidence (or subject to non-disclosure or similar covenants)
shall be deemed to be Confidential Information. As a material inducement to the MANUFACTURER to
engage (or to continue to engage) DISTRIBUTOR and to compensate DISTRIBUTOR hereunder, DISTRIBUTOR
covenants and agrees not to, except with the prior written consent of the MANUFACTURER, directly or
indirectly, disclose, transfer or use, for any purpose whatsoever, any such Confidential
Information other than for the purposes required by this Agreement.

          (b) Disclosure of Confidential Information shall not be prohibited if such disclosure is
directly pursuant to a valid and existing court order; provided, however, that (i) DISTRIBUTOR
shall first have given prompt notice to the MANUFACTURER of any such possible or prospective order
and (ii) the MANUFACTURER shall have been afforded a

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reasonable opportunity to prevent or limit any such disclosure at MANUFACTURER’s sole cost and
expense.

          (c) For purposes of this Agreement, Confidential Information shall not include information
which is or becomes available to the public through no fault of DISTRIBUTOR, is disclosed to
DISTRIBUTOR by a third party under no obligation to keep such information confidential, or is
independently developed without reference to any Confidential Information.

          (d) DISTRIBUTOR covenants and agrees that all right, title and interest in any Confidential
Information shall be and shall remain the exclusive property of the MANUFACTURER. DISTRIBUTOR
agrees immediately to disclose to the MANUFACTURER all Confidential Information developed in whole
or in part by DISTRIBUTOR in connection with any services provided by DISTRIBUTOR hereunder and to
assign to the MANUFACTURER any right, title or interest DISTRIBUTOR may have in such Confidential
Information. DISTRIBUTOR agrees to execute any instruments and to do all other things reasonably
requested by the MANUFACTURER (both during and after DISTRIBUTOR’s engagement by the MANUFACTURER)
in order to vest more fully in the MANUFACTURER all ownership rights in those items transferred by
DISTRIBUTOR to the MANUFACTURER.

          (e) DISTRIBUTOR understands and agrees that the MANUFACTURER shall suffer irreparable harm in
the event that DISTRIBUTOR breaches any of DISTRIBUTOR’s obligations under Section 5.4 or this
Section 5.5 of the Agreement and that monetary damages shall be inadequate to compensate the
MANUFACTURER for such breach. Accordingly, DISTRIBUTOR agrees that, in the event of a breach or
threatened breach by DISTRIBUTOR of any of the provisions of Section 5.4 or this Section 5.5, the
MANUFACTURER, in addition to and not in limitation of any other rights, remedies or damages
available to the MANUFACTURER at law or in equity, shall be entitled to a temporary restraining
order, preliminary injunction, permanent injunction or other specific performance in order to
prevent or to restrain any such breach by DISTRIBUTOR, or by any or all of DISTRIBUTOR’s partners,
co-venturers, employers, employees, servants, agents and other representatives and any and all
persons directly or indirectly acting for, on behalf of or with DISTRIBUTOR.

          (f) All notes, data, tapes, reference items, sketches, drawings, memoranda, records and other
materials in any way relating to any of the information referred to in Section 5.5 hereof
(including, without limitation, any Confidential Information) or to the MANUFACTURER’s business
shall belong exclusively to the MANUFACTURER and DISTRIBUTOR agrees to turn over to the
MANUFACTURER all copies of such materials in DISTRIBUTOR’s possession or under DISTRIBUTOR’s
control at the request of the MANUFACTURER or, in the absence of such a request, upon the
termination or expiration of DISTRIBUTOR’s obligation to provide any services hereunder.

          (g) DISTRIBUTOR agrees that the breach or alleged breach by the MANUFACTURER of (i) any
covenant contained in this Agreement or any other agreement between the MANUFACTURER and
DISTRIBUTOR or (ii) any obligation owed to DISTRIBUTOR by the MANUFACTURER, shall not affect the
validity or enforceability of the covenants and agreements of DISTRIBUTOR set forth in Section 5.4
or this Section 5.5.

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          (h) DISTRIBUTOR represents and warrants that neither DISTRIBUTOR nor any of DISTRIBUTOR’s
partners, employees, assistants, agents or other representatives is bound by any fiduciary duty,
contract or any other pre-existing obligation which is in conflict or in any way inconsistent with
the provisions of this Agreement. DISTRIBUTOR represents and warrants that DISTRIBUTOR’s
performance of all the terms of this Agreement will not breach any agreement to keep in confidence
proprietary information acquired by DISTRIBUTOR in confidence or in trust prior to commencement of
this Agreement. DISTRIBUTOR warrants that DISTRIBUTOR has the right to disclose and/or or use all
ideas, processes, techniques and other information, if any, which DISTRIBUTOR has gained from third
parties, and which DISTRIBUTOR discloses to the MANUFACTURER or uses in the course of performance
of this Agreement, without liability to such third parties. Notwithstanding the foregoing,
DISTRIBUTOR agrees that DISTRIBUTOR shall not bundle with or incorporate into any deliveries
provided to the MANUFACTURER herewith any confidential or proprietary third party products, ideas,
processes, or other techniques. DISTRIBUTOR represents and warrants that DISTRIBUTOR has not
granted and will not grant any rights or licenses to any intellectual property or technology that
would conflict with DISTRIBUTOR’s obligations under this Agreement. DISTRIBUTOR will not knowingly
infringe upon any copyright, patent, trade secret or other property right of any former client,
employer or third party in the performance of the services required by this Agreement.

6. REGULATORY MATTERS.

     6.1. Regulatory Compliance. Other than obtaining the governmental authorizations and
approvals set forth on Schedule E, DISTRIBUTOR shall comply with all health registration
laws, regulations and orders of any government entity within the Territory and with all other
governmental requirements relating to the promotion, marketing, distribution, sale and supply of
the Product in the Territory. DISTRIBUTOR shall provide all information in its possession as
necessary for MANUFACTURER to comply with its regulatory or other governmental reporting
requirements.

     6.2. Reports. DISTRIBUTOR shall keep MANUFACTURER fully informed of any governmental
activities and plans which potentially or actually affect the sale of the Product in the Territory.

     6.3. Complaints and Adverse Incident Reporting. DISTRIBUTOR shall advise
MANUFACTURER, by telephone or facsimile, within such time as is required by any regulatory body
with jurisdiction over the Product in the Territory after it becomes aware of any complaints or
adverse incidents from the use of the Product. DISTRIBUTOR shall provide MANUFACTURER with a
written report delivered by confirmed facsimile of any reported complaints or adverse incidents,
stating the full facts known to it, including but not limited to customer name, address, telephone
number and lot or serial number, as appropriate.

     6.4. Product Recalls and Advisory Notices. MANUFACTURER and DISTRIBUTOR each shall
notify the other promptly if the Product is alleged or proven to be the subject of a recall, market
withdrawal, correction, or advisory notice, if either party believes a recall, market withdrawal,
correction, or advisory notice may be advisable. The parties shall cooperate in the handling and
disposition of any such recall, market withdrawal, correction, or advisory notice.

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Each party shall maintain records of all sales of the Product and Dealers and Customers
sufficient to adequately administer a recall, market withdrawal, correction, or advisory notice for
a period of five (5) years after termination or expiration of this Agreement.

     6.5. Authorized Representative. DISTRIBUTOR shall act as the Authorized
Representative for the MANUFACTURER or its European subsidiary in accordance with Schedule F to
this Agreement. MANUFACTURER at its sole discretion may at any time elect to transfer these
responsibilities to its subsidiary or other representative and therefore release the DISTRIBUTOR
from any future obligations herein.

7. TERM; TERMINATION.

     7.1. Term of Agreement. The term of this Agreement (including any extensions hereof,
the “Term”) shall commence as of the effective date hereof and shall continue until terminated at
11:59 p.m. U.S. Eastern Time on December 31, 2007; provided, however, this
Agreement shall be renewed as of the anniversary date each year for an additional one year period
from such date if the MANUFACTURER notifies the DISTRIBUTOR in writing of such renewal, such notice
to be delivered at least sixty (60) days prior to the end of the then-current Term;
provided, further, however, DISTRIBUTOR shall have the right to accept or
reject such renewal by delivering written notice thereof to MANUFACTURER at least thirty (30) days
prior to the end of the then current Term. In the event no notice from DISTRIBUTOR is received by
MANUFACTURER, the renewal shall be deemed accepted by DISTRIBUTOR. Any dealer agreement entered
into between DISTRIBUTOR and any Dealer shall specify a term not exceeding the Term of this
Agreement.

     7.2. Termination by MANUFACTURER. Notwithstanding the provisions of Section 7.1
hereof, MANUFACTURER may terminate this Agreement immediately at any time after the occurrence of
any of the following events:

          (a) DISTRIBUTOR fails to attain any of the Quotas referred to in Section 2.4 hereof and
specified in Schedule D attached hereto and MANUFACTURER has given DISTRIBUTOR thirty (30)
days’ written notice of such failure;

          (b) DISTRIBUTOR fails to make timely payment to MANUFACTURER of any amount payable to
MANUFACTURER in accordance with Section 3.2(c) hereof and such failure continues for ten (10) days
after written notice to DISTRIBUTOR by MANUFACTURER;

          (c) MANUFACTURER has given thirty (30) days’ prior written notice to DISTRIBUTOR of such
termination, for any reason or no reason; if such termination notice is delivered on or before
December 31, 2007, DISTRIBUTOR shall deliver a final report to MANUFACTURER showing the marketing
and training expenses actually incurred by DISTRIBUTOR in carrying out its obligations hereunder
through the date of the termination notice. On or before the thirtieth (30th) day after
receiving such final report from DISTRIBUTOR, MANUFACTURER shall pay DISTRIBUTOR an amount equal to
fifty percent (50%) of the Agreed-Upon Marketing Expenses actually incurred by DISTRIBUTOR in

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carrying out its obligations hereunder for a period of up to 24 months through the date of the
termination notice;

          (d) (i) DISTRIBUTOR has been liquidated or dissolved or has discontinued its business; (ii) a
trustee or receiver is appointed for the DISTRIBUTOR or for all or a substantial part of its
assets; (iii) the DISTRIBUTOR makes a general assignment for the benefit of creditors; (iv) the
DISTRIBUTOR files or is the subject of any insolvency proceeding, petition in bankruptcy or similar
proceeding (whether such petition or proceeding shall be pursued in a court of law or equity),
which in the case of an involuntary bankruptcy, remains undismissed or unstayed for thirty (30)
days; (v) the DISTRIBUTOR becomes insolvent or the DISTRIBUTOR at any time fails generally to pay
its debts as such debts become due; or (vi) any governmental agency or bankruptcy court or other
court of competent jurisdiction assumes custody or control of the whole or any part of the assets
of the DISTRIBUTOR;

          (e) Without the prior written approval of MANUFACTURER, DISTRIBUTOR enters into an agreement
effecting a Change of Control of DISTRIBUTOR. For purposes of this Agreement, a “Change of
Control” shall be deemed to have occurred if (i) any person (as such term is used in Sections 13(d)
and 14(d) of the Securities Exchange Act of 1934 (the “Exchange Act”)), who is not, as of the date
of this Agreement, a “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act), directly
or indirectly, of securities of the DISTRIBUTOR representing fifty percent (50%) or more of the
combined voting power of the DISTRIBUTOR’s then outstanding securities, becomes, after the date of
this Agreement, such a beneficial owner, (ii) the stockholders of the DISTRIBUTOR approve a merger,
consolidation or similar business combination involving the DISTRIBUTOR, or (iii) the stockholders
of the DISTRIBUTOR approve a plan of liquidation or dissolution of the DISTRIBUTOR or the sale or
disposition by the DISTRIBUTOR of all or substantially all of the DISTRIBUTOR’s assets;

          (f) The central bank or similar governing body in the Territory imposes restrictions
preventing DISTRIBUTOR from payment of funds payable to MANUFACTURER hereunder, and no alternative
acceptable to MANUFACTURER to effectuate payment to MANUFACTURER is available; or

          (g) DISTRIBUTOR breaches or violates any material provision of this Agreement and fails to
cure same (to the extent such breach or violation is capable of cure) within thirty (30) days’
written notice from MANUFACTURER thereof.

     7.3. Termination by DISTRIBUTOR. Notwithstanding the provisions of Section 7.1
hereof, DISTRIBUTOR may terminate this Agreement at any time after the occurrence of any of the
following events:

          (a) MANUFACTURER breaches or violates any material provision of this Agreement and fails to
cure same (to the extent such breach or violation is capable of cure) within thirty (30) days’
written notice from DISTRIBUTOR thereof; or

          (b) (i) MANUFACTURER is liquidated or dissolved or discontinues its business; (ii) a trustee
or receiver is appointed for the MANUFACTURER or for all or a substantial part of its assets; (iii)
the MANUFACTURER makes a general assignment for the

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benefit of creditors; (iv) the MANUFACTURER files or is the subject of any insolvency
proceeding, petition in bankruptcy or similar proceeding (whether such petition or proceeding shall
be pursued in a court of law or equity), which in the case of an involuntary bankruptcy, remains
undismissed or unstayed for thirty (30) days; (v) the MANUFACTURER is or becomes insolvent or the
MANUFACTURER any time fails generally to pay its debts as such debts become due; or (vi) any
governmental agency or bankruptcy court or other court of competent jurisdiction assumes custody or
control of the whole or any part of the assets of the MANUFACTURER;

     7.4. Actions Following Termination.

          (a) In the event of the termination of this Agreement or the expiration of the Term hereof,
DISTRIBUTOR shall promptly (i) account for and pay to MANUFACTURER upon demand all amounts then
owing to MANUFACTURER pursuant to the terms hereof and (ii) cease holding itself out as a
DISTRIBUTOR of MANUFACTURER. At the election of the MANUFACTURER, any inventory of Products in
DISTRIBUTOR’s possession shall be returned in exchange for a full refund by MANUFACTURER or a
credit against any amounts owed to MANUFACTURER by DISTRIBUTOR.

          (b) In the event of the termination of this Agreement or the expiration of the Term hereof,
all of DISTRIBUTOR’s rights hereunder to promote, market, distribute, sell and supply the Products
and to use the Marks and Copyrights shall automatically terminate.

          (c) In the event of the termination of this Agreement or the expiration of the Term hereof,
MANUFACTURER shall be entitled, without liability to DISTRIBUTOR, but shall not be obligated, to
deal, directly or through its authorized distributors, dealers and representatives, with Dealers
and Customers.

          (d) Following any such termination or expiration, DISTRIBUTOR agrees to cooperate fully with
MANUFACTURER and its authorized representatives and promptly to provide all information relating to
the promotion, marketing, distribution, sale and supply of the Products.

     7.5. Continuing Obligations. No termination or expiration of this Agreement shall in
any way affect the continuing obligations of DISTRIBUTOR under Article 5 hereof or this Article 7.
DISTRIBUTOR agrees that each of the provisions of this Article 7 is reasonable and further agrees
not to contest the validity or enforceability thereof by way of wrongful termination proceedings or
otherwise.

     7.6. Liability on Termination. MANUFACTURER shall not be liable to DISTRIBUTOR by
reason of the termination or expiration of this Agreement in accordance with its terms, or the
failure to renew or extend this Agreement, in whole or in part. MANUFACTURER shall not have any
obligation (statutory or otherwise) to compensate, indemnify or reimburse DISTRIBUTOR, for any
claims, indemnities, liabilities or damages attributable to DISTRIBUTOR’s loss of future profits,
or losses attributable to any expenditure, investment, lease or other commitment of DISTRIBUTOR of
any nature whatsoever (whether financial, employment or otherwise) incurred by DISTRIBUTOR in
connection with the

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performance of its duties and obligations under this Agreement. DISTRIBUTOR hereby agrees to
indemnify and hold MANUFACTURER harmless from and against all claims of the employees and agents of
DISTRIBUTOR for compensation or severance, disability or national insurance, social security or
similar payments.

     7.7. DISTRIBUTOR Indemnification. DISTRIBUTOR agrees to defend, indemnify and hold
MANUFACTURER, its subsidiaries, affiliates and agents harmless from and against any and all claims
of loss, liability, costs and expenses (including reasonable legal fees and costs) arising out of
(i) any misrepresentations by DISTRIBUTOR or its employees, dealers and agents with respect to the
Products or its or their relationship to MANUFACTURER, (ii) any material breach or violation by
DISTRIBUTOR of this Agreement or (iii) any negligent, wrongful or intentional acts or omissions on
the part of DISTRIBUTOR or its employees dealers and agents.

8. REPRESENTATIONS AND WARRANTIES.

     8.1. General Representations and Warranties. On the date hereof, each party hereto
represents and warrants to the other party hereto as follows:

          (a) Authorization. Such party is duly organized, validly existing and in good
standing under the laws of the jurisdiction of its organization. Such party has full power and
authority to execute, deliver and perform the terms and provisions of this Agreement and to
consummate the transactions contemplated hereby. All corporate action of such party necessary for
the execution and delivery of this Agreement and the consummation of the transactions contemplated
herein has been duly taken. This Agreement has been duly and validly executed and delivered by
such party and constitutes a legal, valid and binding obligation enforceable against such party in
accordance with its terms.

          (b) No Violation. Neither the execution, delivery or performance of this Agreement
nor the consummation of the transactions contemplated hereby by such party do or will: (a)
violate, or constitute a default under, any license, permit or agreement to which such party is a
party or subject, or by which such party is bound; or (b) violate the certificate of incorporation,
bylaws or other organizational documents of such party or violate any statute or law or any
judgment, decree, order, regulation or rule of any court or governmental agency or body by which
such party is bound.

          (c) Consents. No consent, approval, waiver, authorization or order of, or
registration or filing with, any court or governmental agency or body or other third party is
required in connection with the execution, delivery or performance by such party of this Agreement
or the consummation by such party of the transactions contemplated hereby.

          (d) Litigation. There is no action, suit, arbitration, mediation, proceeding, claim
or investigation pending against such party (or against any officer, director, employee or agent
thereof in their capacity as such or relating to their employment, services or relationship with
such party) before any governmental authority or arbitrator, nor, to such party’s knowledge, has
any such action, suit, arbitration, mediation, proceeding, claim or investigation been

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threatened, in each case that may adversely affect, contest or challenge such party’s
authority, right or ability to perform such party’s obligations under this Agreement.

9. GENERAL PROVISIONS.

     9.1. Assignability. Except as specifically provided in Section 2 hereof, DISTRIBUTOR
shall not sell, assign, transfer, convey, delegate or encumber its duties and obligations
hereunder, or any rights or interests hereunder, and DISTRIBUTOR shall not suffer or permit any
assignment or transfer or encumbrance thereof, whether voluntary, by operation of law or otherwise,
without the prior written consent of MANUFACTURER.

     9.2. Notices. All notices, requests, reports, submissions and other communications
permitted or required to be given under this Agreement shall be in writing in the English language,
and shall be deemed to have been duly delivered or given upon personal delivery to the party to be
notified (or upon the date of attempted delivery where delivery is refused), or five days after
deposit with the United States Postal Service, by registered or certified mail, or one day after
deposit with next day air courier, with postage and fees prepaid, or on the same day of any
facsimile transmission (with confirmation), in each case if such notice or other communication is
addressed to the party entitled thereto at the address indicated for such party set forth below (or
at such other address as such party may designate by ten (10) days’ advance written notice to the
other parties to this Agreement):

          If to MANUFACTURER:

ReGen Biologics, Inc.

509 Commerce Street, East Wing

Franklin Lakes, New Jersey 07417

U.S.A.

Fax: +12016515141

Attention: Mr. Brion Umidi

          If to DISTRIBUTOR:

XMedica s.r.l.

Via Francesco Olgiati, 26

20143 Milano

Italy

Fax: +39289159084 

Attention: Mr. Paolo Curradini

     9.3. Transfer of Agreement: MANUFACTURER may at any time at its own decision with
prior written notice to DISTRIBUTOR transfer this agreement and all duties and obligations
hereunder to a European subsidiary.

     9.4. No Implied Waivers. The failure of either party to exercise any right or option
it is granted herein, or to require the performance by the other party hereto of any provision of
this Agreement, or the waiver by either party of any breach of this Agreement, shall not prevent a

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subsequent exercise or enforcement of such provisions or be deemed a waiver of any subsequent
breach of the same or any other provision of this Agreement.

     9.5. Modification or Amendment. Except by MANUFACTURER to the extent and in the
manner specified in this Agreement, any modification or amendment of any provision of this
Agreement must be in writing and bear the signature of the duly authorized representatives of both
parties.

     9.6. Language. The language of this Agreement is expressly stipulated to be the
English language. In the event that this Agreement shall be translated into one or more other
languages, the English language version of this Agreement shall be the governing version for
purposes of interpreting and enforcing this Agreement.

     9.7. Publicity. Neither party shall publicize or disclose to any third party the
terms or provisions of this Agreement, or the discussions relating thereto, without the prior
written consent of a duly authorized officer of the other party, provided that MANUFACTURER may
disclose such information as required or advisable under law (including, without limitation, any
requirements of federal securities law or regulations) or in accordance with the rules and
regulations governing the Nasdaq stock market or other exchange, quotation or trading system to the
extent applicable.

     9.8. Arbitration. Any dispute between the parties under this Agreement which cannot
be resolved after good-faith negotiation between the parties shall be submitted to arbitration
under the Commercial Arbitration Rules of the American Arbitration Association (the “AAA”). The
arbitrator or arbitrators shall be chosen by mutual agreement of the parties in accordance with AAA
rules. The arbitration proceedings shall take place in the State of New Jersey, U.S.A. The
arbitrator(s) shall apply United States law to all issues in dispute, in accordance with Section
9.8 hereof. The language of all arbitration proceedings hereunder shall be English. The findings
of the arbitrator(s) shall be final and binding on the parties.

     9.9. Law Governing Agreement. The validity of this Agreement and the rights,
obligations and relations of the parties hereunder shall be construed and determined under and in
accordance with the laws of the State of New Jersey, U.S.A. without regard to the conflicts of laws
principles thereof. The parties agree that all matters concerning this Agreement, including the
enforcement of any decision of an arbitration, shall be determined by the federal or state courts
residing in the State of New Jersey, and consent to jurisdiction of such courts and service of
process by mail or other means of hard copy delivery, such as fax, is hereby granted by the
parties. To the extent otherwise applicable, the parties hereby agree that the United Nations
Convention on the Sale of Goods shall not apply.

     9.10. Severability. Whenever possible, each provision of this Agreement shall be
interpreted in such manner as to be effective and valid under applicable law, but if any provision
of this Agreement is held to be invalid, illegal or unenforceable in any respect under any
applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability shall
not affect any other provision or any other jurisdiction, but this Agreement shall be reformed,
construed and enforced in such jurisdiction as if such invalid, illegal or unenforceable provision
had never been contained herein.

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     9.11. Financial Review. During the Term hereof and 6 months after its termination,
MANUFACTURER shall have the right, directly or through any of its agents or representatives, upon
reasonable prior written notice to DISTRIBUTOR, to conduct an audit and review of DISTRIBUTORS
business related to this agreement at DISTRIBUTOR’s principal business offices of DISTRIBUTOR’s
books and records relating hereto, including without limitation, working papers, and to make copies
thereof at MANUFACTURER’s expense. If the results of such an audit and review shall disclose a
deficiency in amounts payable by DISTRIBUTOR to MANUFACTURER in excess of five percent (5%) of the
amounts actually paid or reported as being payable to MANUFACTURER hereunder for any period which
is so reviewed, then DISTRIBUTOR shall promptly reimburse MANUFACTURER for the entire cost of such
an audit and review, including, but not limited to, professional fees and travel and lodging
expenses.

     9.12. Complete Agreement. This Agreement, including the schedules attached hereto,
sets forth the entire agreement between the parties hereto with respect to the subject matter
hereof and merges, supersedes and replaces any and every other agreement, proposal, negotiation or
communication, written or oral, which may have existed between MANUFACTURER and DISTRIBUTOR with
respect to the subject matter hereof.

[Signatures on next page.]

-19-

 

     IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly
authorized representatives as of the day and year first above written.

	 	 	 	 	 	 	 
	 	 	MANUFACTURER:  
	 
	 	 	 	 	 	 
	 	 	REGEN BIOLOGICS, INC.
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Brion D. Umidi	 	 
	 	 	 	 	 
	 

	 	 	 	Name:	 	 Brion D. Umidi
	 

	 	 	 	 	 	 
	 

	 	 	 	Title:	 	Sr. Vice President and Chief
Financial Officer
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	DISTRIBUTOR:
	 
	 	 	 	 	 	 
	 	 	XMEDICA s.rl.
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Paolo Curradini	 	 
	 	 	 	 	 
	 

	 	 	 	Name:	 	Paolo Curradini
	 

	 	 	 	 	 	 
	 

	 	 	 	Title:	 	Chief Executive Officer
	 

	 	 	 	 	 	 

-20-

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