Document:

exv10w3

 

EXHIBIT 10.3

HANOVER COMPRESSOR COMPANY

Schedule of Compensation for Non-Employee Directors

(Effective May 8, 2007)

	 	 	 
	 
	Annual Retainer

	 	$30,000 (all directors)
	 
	Committee Chairman Annual Retainer

	 	(Committee Chair Retainer excludes the chairman of the board)
	 
	Audit Committee

	 	$15,000 
	 
	Compensation Committee

	 	$15,000 
	 
	Finance Committee

	 	$10,000 
	 
	Governance Committee

	 	$10,000 
	 
	Chairman of the Board Annual Retainer

	 	$120,000 
	 
	Attendance Fee

	 	$1,500 paid for all in-person and telephonic board and
committee meetings (excludes the chairman of the board).
	 
	Restricted Stock

	 	Time-vested restricted stock valued on the date of grant at
approximately $105,000, for all directors excluding the
chairman of the board, and approximately $150,000, for the
chairman of the board. The grant is subject to the terms of
2006 Stock Incentive Plan, as amended, and vests at the rate of one-third per year over
a three-year period, subject however, to immediate vesting
in the event of a change in control other than the change of
control that will occur in connection with the previously
announced entry into a Agreement and Plan of Merger, dated
February 5, 2007, among Hanover Compressor Company,
Universal Compression Holdings, Inc., Iliad Holdings, Inc.,
Hector Sub, Inc. and Ulysses Sub, Inc. (the “Merger”).
	 

	 	 

Directors are required to hold the shares until they cease
to serve as a director (except to the extent necessary to
meet the associated tax obligation).
	 
	Reimbursement of Travel Expenses

	 	100% of travel and other expenses while on company business.
	 

In addition, the board approved the grant of a cash performance award of $105,000 that is
payable and contingent upon the successful consummation of the Merger. The award was granted only
to the six directors who will retire from the Hanover board of directors and who have not been
nominated to serve on the board of Iliad Holdings, Inc. upon the consummation of the Merger
(the “Retiring Directors”). The Retiring Directors will forfeit their respective May 8, 2007
restricted stock grants upon consummation of the Merger. The board further approved the grant of
21,000 shares of restricted stock to Gordon T. Hall, Chairman of the Board, to acknowledge Mr.
Hall’s critical role in negotiating certain aspects of the Merger and his future role in ensuring a
successful integration post-Merger. This grant is subject to the same
terms as described in “Restricted Stock” above.exv10w15

 

Exhibit 10.15

	PAGE            OF PAGES
AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350) RATING 1 | 29
——  ——  ——  —
2. CONTRACT (Proc. Inst. Ident.) NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
HHSO100200700031C            January 17, 2007 ASPHEP070051 1/12/07
——  ——  —
5. ISSUED BY CODE |
HHS/OS/OPHEP/OPHEMC 330 Independence Ave, SW,
Rm G640 Washington, DC 20201 6. ADMINISTERED BY (If other than Item 5) CODE |
——  —
7. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
IOMAI Corporation
20 Firstfield Road Gaithersburg, MD 20878 DUNS 00-443-1065 8. DELIVERY
CODE FACILITY CODE  ̈ FOB ORIGIN ý OTHER (See below)
——  —
9. DISCOUNT FOR PROMPT PAYMENT
N/A
—
10. SUBMIT INVOICES            ITEM
(4 copies unless other- 5
wise specified) TO THE -
ADDRESS SHOWN IN
—
11. SHIP TO/MARK FOR CODE | 12. PAYMENT WILL BE MADE BY CODE |
See Paragraph D.1. See Article G.4.
——  —
14. ACCOUNTING AND APPROPRIATION DATA
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: CAN 1993157; APPROPRIATION 75X0140
C. 253(c) O.C. 25210; AMOUNT $14,454,914.00
——  —
15a. ITEM No. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
——  ——  ——  ——  ——  —
SEE SECTION B
15G. TOTAL AMOUNT OF CONTRACT $128,511,517
——  —
16. TABLE OF CONTENTS
—
(X) SEC            DESCRIPTION            PAGE(S) (X)
SEC            DESCRIPTION            PAGE(S)
——  ——  ——  ——  ——  ——  ——  —
PART I — THE SCHEDULE            PART II — CONTRACT CLAUSES
——  —
X A            SOLICITATION/CONTRACT FORM 1 X I            CONTRACT CLAUSES 21
——  ——  ——  ——  ——  ——  ——  —
X B            SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III — LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
——  ——  ——  ——  —
X C            DESCRIPTION/SPECS./WORK STATEMENT 4 X J            LIST OF ATTACHMENTS 28
——  ——  ——  ——  ——  ——  ——  —
X D            PACKAGING AND MARKING 9 PART IV — REPRESENTATIONS AND INSTRUCTIONS
——  ——  ——  ——  —
;  REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS 29
——  ——  ——  ——  ——  ——  ——  —
X F            DELIVERIES OF PERFORMANCE 11
——  ——  ——  —
X G            CONTRACT ADMINISTRATION DATA 13 L            INSTRS., CONDS., AND NOTICES TO OFFERORS
——  ——  ——  ——  ——  —
X H            SPECIAL CONTRACT REQUIREMENTS 16 M            EVALUATION FACTORS FOR AWARD
——  ——  ——  ——  ——  —
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
—
17. ý CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return 2 copies to
issuing office.) Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified
above and on any continuation sheets for the consideration stated herein. The rights and obligations of the parties to this
contract shall be subject to and governed by the following documents: (a) this award/contract, (b) this solicitation, if any, and 18.  ̈ AWARD (Contractor is not required to sign this
document.) Your offer on Solicitation Number , including the additions or changes made by you which
(c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein. additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any
condition sheets. This award consummates the contract which
(Attachments are listed herein.) consists of the following documents : (a) the Government’s solicitation and your offer, and (b) this award/contract. No further contractual document is necessary.
——  —
19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER
Stanley C. Erck, President & CEO            Schuyler T. Eldridge
——  —
19B. NAME OF CONTRACTOR 20B. UNITED STATES OF AMERICA
BY /s/ Stanley C. Erck BY /s/ Schuyler T. Eldridge
——  19C. DATE SIGNED ——  20C. DATE SIGNED
(Signature of person authorized to sign) 12/21/2006 (Signature of Contracting Officer) 01/17/07
——  ——  ——  —
AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 26 (REV. 12/2002)
Previous edition is usable

 

 

SECTION B—SUPPLIES OR SERVICES AND PRICES/COSTS

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This project from the Department of Health and Human Services (HHS) through the Office of Public
Health Emergency Medical Countermeasures (OPHEMC) within the Office of Public Health Emergency
Preparedness (OPHEP) provides incremental multi-year funding for cost-reimbursable contracts for
the development of antigen sparing approaches and products used as or with pandemic influenza
vaccines leading towards U.S.-licensure from U.S.-based manufacturing sites for products not
readily available at the onset of an influenza pandemic. The approach may include adjuvants, other
biologicals, or medical delivery devices that when used with pre-pandemic and pandemic influenza
vaccines afford enhanced immunogenicity (fewer immunizations) and/or an antigen sparing effects
(less antigen utilization). The objective of this project is to stretch the domestic influenza
vaccine supply in the event of an influenza pandemic.

B.2. HHSAR 352.232-74 Estimated Cost and Fixed Fee — Incrementally Funded Contract (Apr 1984)

(a) It is estimated that the total cost to the Government for full performance of this contract
will be $128,511,517, of which the sum of $[***] represents the estimated reimbursable
costs and $[***] represents the fixed-fee.

(b) Total funds currently available for payment and allotted to this contract are
$14,454,917, of which $[***] represents the estimated reimbursable costs and $[***]
represents the fixed-fee. For further provisions on funding, see the Limitation of Funds clause.

(c) It is estimated that the amount currently allotted will cover performance through March 31,
2008.

(d) The Contracting Officer may allot additional funds to the contract without the concurrence of
the Contractor

B3. Cancellation Ceiling

(a) This clause does not apply when the contract is fully funded.

(b) The total funding in B.2 (c) includes an amount that covers the cancellation charge described
in FAR 52.217-2, Cancellation Under Multi-year Contracts. The cancellation charge shall not exceed
100% of total funding under B.2 (b) above (insert dollar amount or express as a percentage
of total funding under B.2 (b).

B.4. CONTRACT LINE ITEM NUMBERS (CLINS)

	 	 	 	 	 	 	 	 	 	 	 
	ITEM	 	SUPPLIES / SERVICES	 	QTY/UNIT	 	EST. COST	 	FIXED FEE	 	TOTAL EST. CPFF
	0001

	 	Product Development Plan

(milestone 1)
	 	1 Job
	 	$[***]
	 	$[***]
	 	$[***]
	 
	 	 	 	 	 	 	 	 	 	 
	0002

	 	Non-Clinical Development,

 Clinical Development, and

Regulatory Licensure Plans

(milestone 2)
	 	1 Job
	 	$[***]
	 	$[***]
	 	$[***]

 

			
	[***]	  =  	Portions of this exhibit have been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the Commission.

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 2 of 29

 

 

	 	 	 	 	 	 	 	 	 	 	 
	ITEM	 	SUPPLIES / SERVICES	 	QTY/UNIT	 	EST. COST	 	FIXED FEE	 	TOTAL EST. CPFF
	0001

	 	Product Development Plan

(milestone 1)
	 	1 Job
	 	$[***]
	 	$[***]
	 	$[***]
	 
	 	 	 	 	 	 	 	 	 	 
	0002

	 	Non-Clinical Development,

Clinical Development, and

Regulatory Licensure Plans

(milestone 2)
	 	1 Job
	 	$[***]
	 	$[***]
	 	$[***]
	 
	 	 	 	 	 	 	 	 	 	 
	0003

	 	Production Plan

(milestone 3)
	 	1 Job
	 	$[***]
	 	$[***]
	 	$[***]
	 
	 	 	 	 	 	 	 	 	 	 
	0004

	 	Contractor Defined Milestones

(milestone 4); See milestone 4 of

the Statement of Work for key

elements
	 	1 Job
	 	$[***]
	 	$[***]
	 	$[***]
	 
	 	 	 	 	 	 	 	 	 	 
	0005

	 	Technical Progress Reports and

Executive Summary
	 	12 reports

per year
	 	$[***]
	 	$[***]
	 	$[***]
	 
	 	 	 	 	 	 	 	 	 	 
	0006

	 	Final Report
	 	1 report
	 	$[***]
	 	$[***]
	 	$[***]

 

			
	[***]	  =  	Portions of this exhibit have been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with the Commission.

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 3 of 29

 

 

SECTION C — DESCRIPTION/SPECIFICATIONS

C.1. BACKGROUND/STATEMENT OF WORK

Purpose

     The purpose of this contract is to support advanced stage development of enhanced immunity
and/or antigen-sparing strategies for pandemic influenza vaccination leading toward submission of
a U.S. licensure application and development of required industrial capacity to support
implementation of the antigen sparing strategy with pandemic influenza vaccine at full production
capacity at or before the onset of a pandemic. Incremental multi-year funding for this
cost-reimbursement contract is provided to your organization to support this effort. Ultimately,
these antigen-sparing influenza vaccines or products shall be produced at one or more Food and
Drug Administration (FDA)-licensed manufacturing facilities and shall provide sufficient surge
capacity to contribute substantially to U.S. and ideally global vaccine needs during an influenza
pandemic.

Objectives

Using intellectual property to which the company has unencumbered and documented access and
documents “freedom to operate,” the contractor shall accomplish the following objectives
associated with advanced development of a pandemic influenza vaccine antigen-sparing technology:

a) Conduct preclinical and clinical testing to assess the safety, immunogenicity and
efficacy, as required by the FDA of the antigen-sparing strategy, and to define the type and
magnitude of the antigen sparing effect for monovalent influenza vaccine against novel
influenza strains (i.e., H5N1 or other subtypes not currently circulating among people) that
are considered to have pandemic potential. Monovalent vaccines against novel influenza
strains may be manufactured by the Contractor or subcontractor at a facility in compliance
with current Good Manufacturing Practices (cGMP) guidelines and current World Health
Organization (WHO) biosafety guidelines for pandemic influenza vaccine manufacturing. (2005).

b) Develop a preclinical and clinical manufacturing and testing plan with the supportive
regulatory development plan that will lead to submission of a licensure application. The
contractor should seek guidance from the FDA on the clinical development plan for their
antigen-sparing products and should indicate where necessary that the clinical development
plan reflects FDA’s guidance.

c) Develop a plan to manufacture the antigen-sparing pandemic influenza vaccine or products
in a licensed facility based in the U.S. or, for a product with long-term stability that is
suitable for stockpiling at an FDA-licensed facility in the U.S. or at a foreign site with a
capacity to support rapid stockpile purchases commensurate with U.S. pandemic influenza
vaccine needs.

Activities that may be supported by this contract shall include product toxicology studies in
animals, clinical lot manufacturing including consistency lots for usage as or with pandemic
influenza vaccines, clinical evaluation studies of the antigen-sparing strategy for safety and
immunogenicity, process and manufacturing scale up development, product lot release assay
development and process validation; product-dedicated manufacturing equipment; facility concept
design and facility validation. USG support shall not be provided for building a manufacturing
facility or purchasing an existing facility.

Additional information

This advanced development contract is milestone-driven and funding is expected to occur in
phases. Periodic assessments of progress will be conducted by DHHS. Continuation of effort
on initial and subsequent milestones and associated funding will be based on contractor
performance, timeliness and quality of deliverables, availability of other antigen sparing
strategies and products deemed more advantageous to the USG, and consultations between the
contractor, DHHS, and interagency

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 4 of 29

 

 

working group members. This paragraph does not limit the Government’s rights under contract
clauses that include, but are not limited to, FAR 52.217-2, Cancellation Under Multi-year
contracts, and 52.249-6, Termination (Cost-Reimbursement).

Statement of Work

     Independently and not as an agent of the government, the contractor shall furnish all
the necessary services, qualified personnel, materials, equipment, and facilities not otherwise
provided by the government as needed to perform the work described below.

     The contract will include a Contractor Work Plan (CWP) that describes the activities to be
performed and a single Gantt chart to include all activities described in the CWP with a
time-phased and task-linked budget. The level of detail contained in the CWP and the
corresponding Gantt chart will be sufficient to facilitate management and execution of the
contract.

Milestones

	I.	 	Milestone 1: Within three (3) months of contract award, the Contractor shall provide
to the HHS for review and acceptance a milestone-driven Product Development Plan for
development of antigen sparing pandemic influenza vaccine or related products. This plan
shall include: a) pre-clinical studies, as needed, to support clinical testing; b) process
development and scale up manufacturing of monovalent pandemic influenza vaccine product or
use with this vaccine to novel influenza viruses; c) clinical and consistency lot
manufacturing for FDA product licensure, d) general clinical development plan including
development and validation of clinical sample assays (see Milestone 2); e) product lot
release assay development and validation, and f) regulatory master plan for product licensure
(see Milestone 2). Pandemic monovalent influenza vaccine used in these studies may be
produced by the Contractor or a corporate partner.

	II.	 	Milestone 2: Within six (6) months of contract award, the Contractor shall submit to
HHS for review and acceptance complete milestone-driven Non-Clinical Development,
Clinical Development, and Regulatory Licensure Plans to initiate vaccine and/or device
development, pre-clinical studies, or clinical studies, as appropriate based on the current
stage of development and as outlined in the development, testing, and manufacturing plan.

	 	A.	 	A pre-clinical testing plan that is integrated with the clinical
testing and manufacturing plans using the most current and available information
including consultation with Center for Biologics Evaluation and Research (CBER) at
FDA.
	 
	 	B.	 	A clinical testing plan that is integrated with the pre-clinical
testing and manufacturing plans using the most current and available information
including consultation with FDA CBER. Clinical trials performed as a result of this
contract shall include any of Phase I, Phase 2, and Phase 3 trials, as needed to
achieve U.S. licensure. Trials should include children, adults, and the elderly, as
needed, to support licensure for both low and high-risk populations. Given the
duration, cost, and importance of clinical trials, the schedule for each clinical
trial should clearly indicate key outcomes, populations, study sites and
collaborators, analytic strategy, sample size, timelines, and other key components.
Studies should be done using monovalent influenza vaccine to a novel influenza strain
with and without the product providing enhanced immunity and/or antigen-sparing
effect.
	 
	 	C.	 	A regulatory plan that is integrated with all products and clinical
testing and manufacturing activities using the most current and available information
including consultation with FDA CBER.

	III.	 	Milestone 3: Within twelve (12) months of contract award, the Contractor shall
provide the USG

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 5 of 29

 

 

	 	 	with one or more of the following, as appropriate for the antigen sparing product(s) being
developed:

	 	A.	 	A Production Plan to produce at least 150 million doses of the
monovalent antigen sparing pandemic influenza vaccine within a 6 month period.
	 
	 	B.	 	If the antigen sparing strategy relies on a non-vaccine product that is not
suitable for long term stockpiling, the Contractor must provide a Production
Plan to produce at least 150 million units within 6 months or requiring no more
than 1-month lead time before the first units are produced of the product at a
licensed or licensable U.S.-based facility.
	 
	 	C.	 	If the antigen sparing strategy uses a delivery device that is suitable for
long term stockpiling, the Contractor must provide a Production Plan to
produce and make available to the U.S. Government first within a 6 month
manufacturing period at a U.S.-licensed facility and at reasonable cost, a quantity
commensurate with delivery of at least 150 million vaccine doses.
	 
	 	D.	 	A Production Plan shall contain the concept architectural and
mechanical engineering descriptions, drawings of functional areas, and flow diagrams
of personnel, product, raw materials, and waste for the manufacturing facilities and
ancillary product testing laboratories. Major product related equipment should be
indicated in the description and drawings that would permit vaccine or product
production for pandemic purposes as levels and timeframes indicated above.

	 	 	The manufacturing facility and production processes shall be maintained in compliance with
current Good Manufacturing Practices (cGMP) for all manufacturing operations and current
Good Laboratory Practices (cGLP) for testing laboratories, as applicable. Ability to meet
standards for Biosafety Level (BSL) 2 + and 3 as described in WHO biosafety guidelines for
pandemic influenza vaccine manufacturing may be necessary, if the Contractor will be
handling and testing highly pathogenic avian influenza viruses or derivatives to generate
pandemic influenza vaccines.

	IV.	 	Milestone 4: Contactor defined milestones. The Contractor shall provide a work
breakdown structure including comprehensive and integrated timelines (Gantt chart) and
major milestones to complete the remaining the scope of work as relevant given the stage of
vaccine and/or device development and evaluation toward product licensure. The Contractor
shall propose milestones at which time data will be presented summarizing results of prior
activities and new plans and protocols that will be submitted for review and approval in
order to guide all subsequent activities. Potential milestones may include FDA acceptance
of an IND application, production of an investigational lot of vaccine and/or delivery
system, validation of facilities, systems, and equipment, validation of QC lot release
product methods, validation of manufacturing processes, stability study programs,
consistency lot manufacturing, completion of a clinical trial and progress to a new phase
of vaccine evaluation, submission of a licensure application, an option for additional
clinical studies of pandemic vaccines etc.

[END OF STATEMENT OF WORK]

Meetings and conferences:

The Contractor shall participate in regular meetings to coordinate and oversee the contract effort
as directed by the Project Officer. Such meetings may include, but are not limited to, meetings of
all Contractors and subcontractors to discuss clinical manufacturing progress, product development,
product assay development, scale up manufacturing development, clinical sample assays development,
preclinical/clinical study designs and regulatory issues,; meetings with individual contractors and
other HHS officials to

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 6 of 29

 

 

discuss the technical, regulatory, and ethical aspects of the program; and meetings with technical
consultants to discuss technical data provided by the Contractor. Monthly teleconferences with the
Contractor and subcontractors with HHS officials will be held at times and dates to be determined
to review technical and product development progress.

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 7 of 29

 

 

C.2. REPORTING REQUIREMENTS

In addition to those reports required by other terms of this contract, the Contractor(s) shall
submit to the Contracting Officer and the Project Officer technical progress reports covering the
work accomplished during each reporting period on a periodical basis as set forth below and as
may be otherwise established by the Project Officer as circumstances require. These reports are
subject to the technical inspection and requests for clarification by the Project Officer. These
reports shall be brief and factual and prepared in accordance with the following format:

	I.	 	Technical Progress Reports: On the fifteenth of each month for the previous calendar month or
within fifteen days past the achievement of prescribed project milestones, the Contractor
shall submit to the Project Officer and the Contracting Officer. The frequency of Technical
Progress Reporting will be determined by the Contracting Officer and Project Officer after
contract award. The format and type of Technical Progress Report and Executive Summary will
be provided by the Project Officer. Technical Progress Reports will include project timelines
and milestones and summaries of product manufacturing, testing, and clinical evaluation. A
Technical Progress Report will not be required for the period when the Final Report is due.
The Contractor shall submit one copy of the Technical Progress Report electronically via
e-mail. Any attachments to the e-mail report shall be submitted in Microsoft Word or Word
Perfect, Microsoft Excel, Microsoft Project Manger, and/or Adobe Acrobat PDF files. Such
reports shall include the following specific information:

	 	A.	 	Title page containing Technical Progress Report, the contract number and
title, the period of performance or milestone being reported, the contractor’s name,
address, and other contact information, the author(s), and the date of submission;
	 
	 	B.	 	Introduction/Background — An introduction covering the purpose and scope of
the contract effort;
	 
	 	C.	 	Progress — The report shall detail, document, and summarize the results of
work performed, test results, and milestones achieved during the period covered. Also
to be included is a summary of work planned for the next reporting period;
	 
	 	D.	 	Issues — Issues resolved, new issues, and outstanding issues are enumerated
with options and recommendations for resolution. An explanation of any difference
between planned progress and actual progress, why the differences have occurred, and,
if project activity is delinquent, then what corrective steps are planned. Revised
timelines are provided.
	 
	 	E.	 	Invoices — Summary of any invoices submitted during the reporting period.
	 
	 	F.	 	Action Items — Summary table of activities or tasks to be accomplished by a
certain date and by whom.
	 
	 	G.	 	Distribution List — A list of persons receiving the Technical Progress report

	 
	 	H.	 	Attachments — Results on the project are provided as attachments

	II.	 	The Executive Summary, which shall accompany each Technical Progress Report, will be
formatted in Microsoft Power Point presentations and include the following:

	 	A.	 	Title page containing Executive Title, the contract number and title, the
period of performance or milestone being reported, the contractor’s name and the date
of submission;
	 
	 	B.	 	Project Progress presented as milestone events, test results, tasks, and
other activities achieved during the reporting period as talking point bullets;
	 
	 	C.	 	Project Issues presented headings and each item as a talking point bullet.

	III.	 	Final Reports — By the expiration date of the contract, the Contractor shall submit a
comprehensive Final Report that shall detail, document, and summarize the results of the
entire contract work. The report shall explain comprehensively the results achieved. A draft
Final Report will be submitted to the Project Officer for review and revision, then the
original, four copies, and an electronic file containing the Final Report with revisions shall
be submitted to the Project Officer for distribution to the Contracting Officer and the
Program.

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 8 of 29

 

 

SECTION D—PACKAGING, MARKING AND SHIPPING

D.1. SHIPPING

I. Method of Delivery

Unless otherwise specified by the Contracting Officer or the Contracting Officer’s representative,
delivery of items, to be furnished to the government under this contract (including invoices),
shall be made by first class mail.

II. Addressees — For all contract deliverables.

	 	 	 
	Project Officer

	 	Contracting Officer
	HHS/OPHEP/OPHEMC

	 	HHS/OPHEP/OPHEMC
	300 Independence Avenue SW

	 	300 Independence Avenue SW
	Room G640

	 	Room G640
	Washington, D.C. 20201

	 	Washington, D.C. 20201

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 9 of 29

 

 

SECTION E—INSPECTION AND ACCEPTANCE

The Contracting Officer or the duly authorized representative will inspect and accept materials and
services to be delivered under the contract. Contractor inspector is hereby noted, as the Project
Officer and place of inspection will be the contractor’s facilities. In addition, the following
clause is incorporated by reference:

FAR Clause No.52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT FORM) (APR 1984)

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 10 of 29

 

 

SECTION F—DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The period of performance of this contract is from the date of contract award to 60 months after
contract award.

Delivery will be required F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION,
WITHIN CONSIGNEE’S PREMISES (APR 1984).

F.2. Technical Report Requirements

	 	 	 	 	 	 	 
	Item	 	Deliverable	 	Quantity	 	Due Date
	1.

	 	Technical Progress Report
	 	Original — C.O.

2 Copies — P.O.

1 Electronic Copy — P.O.
	 	1st
Report due
on/before February
15, 2007;
thereafter, due
on/before the
15th of
the month or
milestone following
each reporting
period. Not due
when Final is due.
	 
	 	 	 	 	 	 
	2.

	 	Executive Summary
	 	Original — C.O.

2 Copies — P.O.

1 Electronic Copy — P.O.
	 	1st
Report due
on/before February
15, 2007;
thereafter, due
on/before the
15th of
the month following
each anniversary
date of the
contract. Not due
when Final is due.
	 
	 	 	 	 	 	 
	3.

	 	Final Report
	 	Original — C.O.

2 Copies — P.O.

1 Electronic Copy — P.O.
	 	Due on/before the
completion date of
the contract.

F.3. Contract Deliverables

	 	 	 	 	 	 	 
	Milestones	 	Deliverable	 	Quantity	 	Due Date
	1.

	 	Product Development Plan

(milestone 1)
	 	Original — C.O.

2 Copies — P.O. 

1 Electronic Copy — P.O.
	 	Three (3) months
after contract
award.
	 
	 	 	 	 	 	 
	2.

	 	Non-Clinical Development,
Clinical Development, and
Regulatory Licensure Plans
(milestone 2)
	 	Original — C.O.

2 Copies — P.O.

1 Electronic Copy — P.O.
	 	Within Six (6)
months after
contract award.
	 
	 	 	 	 	 	 
	3.

	 	Production Plan (milestone 3)
	 	Original — C.O.

2 Copies — P.O.

1 Electronic Copy — P.O.
	 	Within Twelve (12)
months after
contract award.
	 
	 	 	 	 	 	 
	4.

	 	Contractor Defined

Milestones (milestone 4)
	 	Original — C.O.

2 Copies — P.O.

1 Electronic Copy — P.O.
	 	Performance of
Contractor defined
Milestones within
60 months after
contract award.

 
	 	 	 
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	 	Page 11 of 29

 

 

F.4. STOP WORK ORDER

The following clause is incorporated by reference:

FAR CLAUSE 52.242-15, STOP WORK ORDER (AUG 1989) with ALTERNATE I (APR 1984)

	 	 	 
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	 	Page 12 of 29

 

 

SECTION G.—CONTRACT ADMINISTRATION DATA

G.1. CONTRACTING OFFICER

1) The Contracting Officer is the only individual who can legally commit the Government to the
expenditure of public funds. No person other than the Contracting Officer can make any changes to
the terms, conditions, general provisions or other stipulations of this contract.

2) The Contracting Officer is the only person with authority to act as agent of the Government
under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any
changes in the statement of work; (2) modify or extend the period of performance; (3) change the
delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the
performance of this contract; or (5) otherwise change any terms and conditions of this contract.

3) No information, other than that which may be contained in an authorized modification to this
contract, duly issued by the Contracting Officer, which may be received from any person employed by
the United States Government, or otherwise, shall be considered grounds for deviation from any
stipulation of this contract.

G.2. PROJECT OFFICER

The Government’s Project Officer(s) will be identified by modification upon contract execution.

The Project Officer is responsible for: (1) monitoring the Contractor’s technical progress,
including the surveillance and assessment of performance and recommending to the Contracting
Officer changes in requirements; (2) interpreting the statement of work and any other technical
performance requirements; (3) performing technical evaluation as required; (4) performing technical
inspections and acceptances required by this contract; and (5) assisting in the resolution of
technical problems encountered during performance.

G.3. KEY PERSONNEL

Pursuant to HHSAR Clause 352.270-5, Key Personnel, incorporated in Section I of this contract, the
following individuals are considered to be essential to the work being performed hereunder:

	 	 	 
	Name	 	Title
	Gregory M. Glenn, M.D

	 	Principal Investigator
	Denise G. Courbron, MS, PMP

	 	Project Manager
	Larry R. Ellingsworth, Ph.D

	 	Vice President, Research
	Diane Epperson, Ph.D

	 	Manager, Preclinical Immunology
	Sarah Alcott Frech, D.V.M.., M.P.H

	 	Vice President, Clinical Development
	Mervyn L. Hamer

	 	Vice President, Operations
	Kimber L. Poffenberger, Ph.D.

	 	Vice President, Regulatory Affairs
	Robert Seid, Ph.D.

	 	Vice President, Formulation
	Jeffrey L. Wells

	 	Director, Quality Systems

	 	 	 
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	 	Page 13 of 29

 

 

Prior to diverting any of the specified individuals to other programs, the Contractor shall notify
the Contracting Officer reasonably in advance and shall submit justification (including proposed
substitutions) in sufficient detail to permit evaluation of the impact on the program. No
diversion shall be made by the Contractor without the written consent of the Contracting Officer;
provided, that the Contracting Officer may ratify in writing such diversion and such ratification
shall constitute the consent of the Contracting Officer. The contract may be modified from time to
time during the course of the contract to either add or delete personnel, as appropriate.

G. 4. INVOICE SUBMISSION

Invoices will be submitted monthly in accordance with “Invoice/Financing Request Instructions”
attached to this contract.

G. 5. CONTRACT FINANCIAL REPORT

Financial reports will be submitted to the address specified in Block 7 of face page of the
contract. Normally, reports are due quarterly. Examples of the cost elements to be reported
include the following:

Expenditure Category

	 	1.	 	Direct Labor

	 	a.	 	Principal Investigator
	 
	 	b.	 	Co-Principal Investigator

	 	2.	 	Personnel — Other
	 
	 	3.	 	Fringe Benefits
	 
	 	4.	 	Materials/Supplies
	 
	 	5.	 	Travel
	 
	 	6.	 	Consultant Costs
	 
	 	7.	 	Subcontract Costs
	 
	 	8.	 	Other Direct Costs
	 
	 	9.	 	Clinical Trials Costs
	 
	 	10.	 	Indirect Cost
	 
	 	11.	 	Fee
	 
	 	12.	 	Total Cost

G. 6. INDIRECT COST RATES

Profit making organizations will negotiate provisional and/or final indirect cost rates with their
cognizant Government Audit Agency.

G. 7. POST AWARD EVALUATION OF PAST PERFORMANCE

Interim and final evaluations of contractor performance shall be conducted on this contract in
accordance with FAR 42.15. The final performance evaluation shall be completed at the time of
completion of work. Interim and final evaluations will be submitted to the Contractor as soon as
practicable. The Contractor will be permitted thirty days to review the document and to submit
additional information or a rebutting statement.

G.8. GOVERNMENT PROPERTY

	a.	 	In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I
of this contract, the Contractor shall comply with the provisions of HHS Publication,
“Contractor’s Guide for Control of Government Property,” which is incorporated into this contract

	 	 	 
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	 	Page 14 of 29

 

 

	 	 	by reference. This document can be accessed at:
http://www.knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm. Among
other issues, this publication provides a summary of the Contractor’s responsibilities
regarding purchasing authorizations and inventory and reporting requirements under the
contract. A copy of this publication is available upon request to the Contracts Property
Administrator.

	b.	 	Notwithstanding the provisions outlined in the HHS Publication, “Contractor’s Guide for
Control of Government Property,” which is incorporated in this contract in paragraph a. above,
the contractor shall use the form entitled, “Report of Government Owned, Contractor Held
Property” for performing annual inventories required under this contract. This form is
included as an attachment in SECTION J of this contract.

	 	 	 
	Contract No. HHSO100200700031C

	 	Page 15 of 29

 

 

SECTION H—SPECIAL CONTRACT REQUIREMENTS

H. 1. HUMAN SUBJECTS

Research involving human subjects shall not be conducted under this contract until the protocol
developed in Milestone 2 has been approved by DHHS, written notice of such approval has been
provided by the Contracting Officer, and the Contractor has provided to the Contracting Officer a
properly completed Optional Form 310 certifying Internal Review Board (IRB) review and approval of
the protocol. The human subject certification can be met by submission of the Contractor’s self
designated form, provided that it contains the information required by the Optional Form 310.

H. 2. HUMAN MATERIALS

It is understood that the acquisition and supply of all human specimen material (including fetal
material) used under this contract will be obtained by the Contractor in full compliance with
applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United
States and that no undue inducements, monetary or otherwise, will be offered to any person to
influence their donation of human material.

H. 3. ANIMAL WELFARE ASSURANCE

The Contractor shall obtain, prior to the start of any work under this contract, an approved Animal
Welfare Assurance from the Office of Protection from Research Risks (OPRR), Office of the Director,
NIH, as required by Section I-43-30 of the Public Health Service Policy on Humane Care and Use of
Laboratory Animals. The Contractor shall maintain such assurance for the duration of this contract,
and any subcontractors performing work under this contract involving the use of animals shall also
obtain and maintain an approved Animal Welfare Assurance.

H. 4. CONFIDENTIALITY OF INFORMATION

The following information is covered by HHSAR 352.224-70, confidentiality of Information (APR
1984):

                         Data obtained from
human subjects

H. 5. REVIEW AND APPROVAL

The Contractor shall not release any reports, manuscripts, press releases, or abstracts about the
work being performed under this contract without written approval in advance from the Government.

H. 6. IDENTIFICATION AND DISPOSITION OF DATA

The Contractor will be required to provide certain data generated under this contract to the
Department of Health and Human Services (DHHS). DHHS reserves the right to review any other data
determined by DHHS to be relevant to this contract. The contractor shall keep copies of all data
required by the Food and Drug Administration (FDA) relevant to this contract for the time specified
by the FDA.

H. 7. EPA ENERGY STAR REQUIREMENTS

In compliance with Executive Order 12845 (requiring Agencies to purchase energy efficient computer
equipment) all microcomputers, including personal computers, monitors, and printers that are
purchased using Government funds in performance of a contract shall be equipped with or meet the
energy efficient low-power standby feature as defined by the EPA Energy Star program unless the
equipment always meets

	 	 	 
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	 	Page 16 of 29

 

 

EPA Energy Star efficiency levels. The microcomputer, as configured with all components, must be
Energy Star compliant.

This low-power feature must already be activated when the computer equipment is delivered to the
agency and be of equivalent functionality of similar power managed models. If the equipment will be
used on a local area network, the vendor must provide equipment that is fully compatible with the
network environment. In addition, the equipment will run commercial off-the-shelf software both
before and after recovery from its energy conservation mode.

H.8. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in DHHS
funded programs is encouraged to report such matters to the HHS Inspector General’s Office in
writing or on the Inspector General’s Hotline. The toll-free number is 1-800-HHS-TIPS
(1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is
Htips@os.dhhs.gov.

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, DC 20026

H.9. ACKNOWLEDGMENT OF FEDERAL FUNDING

	A.	 	Section 507 of P.L. 104-208 mandates that contractors funded with Federal dollars, in whole
or in part, acknowledge Federal funding when issuing statements, press releases, requests for
proposals, bid solicitations and other documents. Contractors are required to state (1) the
percentage and dollar amounts of the total program or project costs financed with Federal
money, and (2) the percentage and dollar amount of the total costs financed by nongovernmental
sources.

This requirement is in addition to the continuing requirement to provide an acknowledgment of
support and disclaimer on any publication reporting the results of a contract funded activity.

	B.	 	Publication and Publicity

The Contractor shall acknowledge the support of the Department of Health and Human Service,
Office of Public Health Emergency Preparedness, Office of Research and Development Coordination
whenever publicizing the work under this contract in any media by including an acknowledgment
substantially as follows:

“This project has been funded in whole or in part with Federal funds from the Office of Public
Health Emergency Preparedness, Office of Public Health Emergency Medical Countermeasures, under
Contract No. HHSO100200700031C.

H.10. NEEDLE EXCHANGE

Pursuant to Section 505 of Public Law 105-78, contract funds shall not be used to carry out any
program of distributing sterile needles or syringes for the hypodermic injection of any illegal
drug. Section 505, however, is subject to the condition stated in Section 506. Specifically,
Section 506 states that after March 31, 1998, a program for exchanging needles and syringes for
used hypodermic needles and syringes may be carried out in a community if: (1) the Secretary of
Health and Human Services determines that exchange projects are effective in preventing the spread
of HIV and do not encourage the use of illegal drugs; and (2)

	 	 	 
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	 	Page 17 of 29

 

 

the project is operated in accordance with criteria established by the Secretary for preventing the
spread of HIV and for ensuring that the project does not encourage the use of illegal drugs.

H.11 PRESS RELEASES

Pursuant to Section 508 of Public Law 105-78, the contractor shall clearly state, when issuing
statements, press releases, requests for proposals, bid solicitations and other documents
describing projects or programs funded in whole or in part with Federal money that: (1) the
percentage of the total costs of the program or project which will be financed with Federal money;
(2) the dollar amount of Federal funds for the project or program; and (3) the percentage and
dollar amount of the total costs of the project or program that will be financed by nongovernmental
sources.

H.12. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to
Executive Order 13224 and Public Law 107-56, prohibit transactions with, and the provisions of
resources and support to, individuals and organizations associated with terrorism. It is the legal
responsibility of the contractor to ensure compliance with these Executive Orders and Laws. This
clause must be included in all subcontracts issued under this contract.

H.13. MANUFACTURING STANDARDS

The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR Parts 210-211) will be the
standard to be applied for manufacturing, processing and packing of this therapeutic product.

If at any time during the life of the contract, the Contractor fails to comply with cGMP in
the manufacturing, processing and packaging of this therapeutic product and such failure results in
a material adverse effect on the safety, purity or potency of this therapeutic product (a material
failure) as identified by CBER and CDER, the Contractor shall have thirty (30) calendar days from
the time such material failure is identified to cure such material failure. If the Contractor
fails to take such an action within the thirty (30) calendar day period, then the contract may be
terminated.

The USG reserves the right to inspect the contractor’s facilities for cGMP compliance. HHS will
audit manufacturing, testing and other relevant sites. Focus areas will include manufacturing,
quality systems and regulatory affairs relative to the contract milestone activities within six (6)
months of contract award. Any deficiencies observed in the audit will require remediation. Within
three (3) months, a time-plan for remediation must be in place and remediation shall be complete
within 12 months of award.

	 	 	 
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	 	Page 18 of 29

 

 

H.14. ANTI-LOBBYING PROVISIONS

The contractor is hereby notified of the restrictions on the use of Department of Health and Human
Service’s funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United States Code (Public Law 101-121, effective 12/23/89), among other
things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or
cooperative agreement from using appropriated funds (other than profits from a federal contract) to
pay any person for influencing or attempting to influence an officer or employee of any agency, a
Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in
connection with any of the following covered Federal actions; the awarding of any Federal contract;
the making of any Federal grant; the making of any Federal loan; the entering into of any
cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative
agreement. For additional information of prohibitions against lobbying activities see FAR Subpart
3.8 and FAR Clause 52.203-12.

In addition, the current Department of Health and Human Services Appropriations Act provides that
no part of any appropriation contained in this Act shall be used, other than for normal and
recognized executive-legislative relationships, for publicity or propaganda purposes, for the
preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or
video presentation designed to support, or defeat legislation pending before the Congress, or any
State or Local legislature except in presentation to the Congress, or any State or Local
legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part
of any appropriation contained in this Act shall be used to pay the salary or expenses of any
contract or grant recipient, or agent acting for such recipient, related to any activity designed
to influence legislation or appropriations pending before the Congress, or and State or Local
legislature.

H.15. POSSESSION, USE AND TRANSFER OF SELECTED BIOLOGICAL AGENTS OR TOXINS

The contractor shall not conduct work involving select agents or toxins under this contract until
it and any associated subcontractor(s) comply with the following:

For prime or subcontract awards to domestic institutions that possess, use, and/or transfer Select
Agents under this contract, the institution must comply with the provisions of 42 CFR part 73, 7
CFR part 331, and/or 9 CFR part 121
(http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf), as required,
before using DHHS funds for research involving Select Agents. No DHHS funds can be used for
research involving Select Agents if the final registration certificate is denied.

For prime or subcontract awards to foreign institutions that possess, use, and/or transfer Select
Agents under this contract, before using DHHS funds for any work directly involving the Select
Agents, the foreign institution must provide information satisfactory to the DHHS that safety,
security, and training standards equivalent to those described in 42 CFR part 73, 7 CFR part 331,
and/or 9 CFR part 121 at:

(http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf)

are in place and will be administered on behalf of all Select Agent work sponsored by these funds.
The process for making this determination includes inspection of the foreign laboratory facility
by an HHS representative. During this inspection, the foreign institution must provide the
following information: concise summaries of safety, security, and training plans; names of
individuals at the foreign institution who will have access to the Select Agents and procedures
for ensuring that only approved and appropriate individuals, in accordance with institution
procedures, will have access to the Select Agents under the contract; and copies of or links to
any applicable laws, regulations, policies, and procedures applicable to that institution for the
safe and secure possession, use, and/or transfer of select agents. An DHHS-chaired committee of
U.S. federal employees (including representatives of select DHHS grants/contracts and

			
	 	 	 
	Contract No. HHSO100200700031C
	 	Page 19 of 29

 

 

scientific program management, CDC, Department of Justice and other federal intelligence agencies,
and Department of State) will ultimately assess the results of the laboratory facility inspection,
and the regulations, policies, and procedures of the foreign institution for equivalence to the
U.S. requirements described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121
(http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf). The committee
will provide recommendations to the OPHEMC Director, DHHS. The Director (or designee) will make
the approval decision and notify the Contracting Officer. The Contracting Officer will inform the
prime contractor of the approval status of the foreign institution. No DHHS funds can be used for
research involving Select Agents at a foreign institution until DHHS grants this approval.

Listings of HHS select agents and toxins, and overlap select agents or toxins as well as
information about the registration process for domestic institutions, are available on the Select
Agent Program Web site at http://www.cdc.gov/od/sap/ and
http://www.cdc.gov/od/sap/docs/salist.pdf. Listings of USDA select agents and toxins as
well as information about the registration process for domestic institutions are available on the
APHIS/USDA website at:

http://www.aphis.usda.gov/programs/ag_selectagent/index.html; and

http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html.

For foreign institutions, see the NIAID Select Agent Award information:

http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm

			
	 	 	 
	Contract No. HHSO100200700031C
	 	Page 20 of 29

 

 

PART II – CONTRACT CLAUSES

SECTION I — CONTRACT CLAUSES

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT — FAR
52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if
they were given in full text. Upon request, the Contracting Officer will make their full text
available. Also, the full text of a clause may be accessed electronically at this address:
http://www.acquisition.gov/comp/far/index.html.

I.1. GENERAL CLAUSES

General Clauses for a Cost-Reimbursement Research and Development Contract

	 	 	 	 	 	 	 
	FAR

	 	52.202-1
	 	Jul 2004
	 	Definitions
	FAR

	 	52.203-3
	 	Apr 1984
	 	Gratuities (Over $100,000)
	FAR

	 	52.203-5
	 	Apr 1984
	 	Covenant Against Contingent Fees (Over $100,000)
	FAR

	 	52.203-6
	 	Sep 2006
	 	Restrictions on Subcontractor Sales to the Government (Over $100,000)
	FAR

	 	52.203-7
	 	Jul 1995
	 	Anti-Kickback Procedures (Over $100,000)
	FAR

	 	52.203-8
	 	Jan 1997
	 	Cancellation, Rescission, and Recovery of Funds for Illegal or
Improper Activity (Over $100,000)
	FAR

	 	52.203-10
	 	Jan 1997
	 	Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
	FAR

	 	52.203-12
	 	Sep 2003
	 	Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
	FAR

	 	52.204-4
	 	Aug 2000
	 	Printed or Copied Double-Sided on Recycled Paper (Over $100,000)
	FAR

	 	52.204-7
	 	Oct 2003
	 	Central Contractor Registration
	FAR

	 	52.209-6
	 	Sep 2006
	 	Protecting the Government’s Interests When Subcontracting With
Contractors Debarred, Suspended, or Proposed for Debarment
(Over $25,000)
	FAR

	 	52.215-2
	 	Jun 1999
	 	Audit and Records — Negotiation (Over $100,000)
	FAR

	 	52.215-8
	 	Oct 1997
	 	Order of Precedence — Uniform Contract Format
	FAR

	 	52.215-10
	 	Oct 1997
	 	Price Reduction for Defective Cost or Pricing Data
	FAR

	 	52.215-12
	 	Oct 1997
	 	Subcontractor Cost or Pricing Data (Over $500,000)
	FAR

	 	52.215-14
	 	Oct 1997
	 	Integrity of Unit Prices (Over $100,000)

			
	 	 	 
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	 	Page 21 of 29

 

 

	 	 	 	 	 	 	 
	FAR

	 	52.215-15
	 	Oct 2004
	 	Pension Adjustments and Asset Reversions
	FAR

	 	52.215-18
	 	Jul 2005
	 	Reversion or Adjustment of Plans for Post-Retirement
Benefits (PRB) other than Pensions
	FAR

	 	52.215-19
	 	Oct 1997
	 	Notification of Ownership Changes
	FAR

	 	52.215-21
	 	Oct 1997
	 	Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data – Modifications
	FAR

	 	52.216-7
	 	Dec 2002
	 	Allowable Cost and Payment
	FAR

	 	52.216-8
	 	Mar 1997
	 	Fixed Fee
	FAR

	 	52.217-2
	 	Oct 1997
	 	Cancellation Under Multi-Year Contracts
	FAR

	 	52.219-8
	 	May 2004
	 	Utilization of Small Business Concerns (Over $100,000)
	FAR

	 	52.219-9
	 	Sep 2006
	 	Small Business Subcontracting Plan (Over $500,000)
	FAR

	 	52.219-16
	 	Jan 1999
	 	Liquidated Damages — Subcontracting Plan (Over $500,000)
	FAR

	 	52.222-2
	 	Jul 1990
	 	Payment for Overtime Premium (Over $100,000) (Note: The
dollar amount in paragraph (a) of this clause is $0
unless otherwise specified in the contract.)
	FAR

	 	52.222-3
	 	Jun 2003
	 	Convict Labor
	FAR

	 	52.222-21
	 	Feb 1999
	 	Prohibition of Segregated Facilities
	FAR

	 	52.222-26
	 	Apr 2002
	 	Equal Opportunity
	FAR

	 	52.222-35
	 	Sep 2006
	 	Equal Opportunity for Special Disabled Veterans,
Veterans of the Vietnam Era, and Other Eligible
Veterans
	FAR

	 	52.222-36
	 	Jun 1998
	 	Affirmative Action for Workers with Disabilities
	FAR

	 	52.222-37
	 	Sep 2006
	 	Employment Reports on Special Disabled Veterans,
Veterans of the Vietnam Era, and Other Eligible
Veterans
	FAR

	 	52.223-6
	 	May 2001
	 	Drug-Free Workplace
	FAR

	 	52.223-14
	 	Aug 2003
	 	Toxic Chemical Release Reporting (Over $100,000)
	FAR

	 	52.225-1
	 	Jun 2003
	 	Buy American Act – Supplies
	FAR

	 	52.225-13
	 	Feb 2006
	 	Restrictions on Certain Foreign Purchases
	FAR

	 	52.227-1
	 	Jul 1995
	 	Authorization and Consent, Alternate I (Apr 1984)
	FAR

	 	52.227-2
	 	Aug 1996
	 	Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000)
	FAR

	 	52.227-11
	 	Jan 1997
	 	Patent Rights — Retention by the Contractor (Short
Form) (Note: In accordance with FAR 27.303(a)(2),
paragraph (f) is modified to include the requirements
in FAR 27.303(a)(2)(i) through (iv). The frequency of
reporting in (i) is annual.

			
	 	 	 
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	 	Page 22 of 29

 

 

	 	 	 	 	 	 	 
	FAR

	 	52.227-14
	 	Jun 1987
	 	Rights in Data – General
	FAR

	 	52.232-9
	 	Apr 1984
	 	Limitation on Withholding of Payments
	FAR

	 	52.232-17
	 	Jun 1996
	 	Interest (Over $100,000)
	FAR

	 	52.232-18
	 	Apr1984
	 	Availability of Funds
	FAR

	 	52.232-20
	 	Apr 1984
	 	Limitation of Cost (applies when contract is fully funded)
	FAR

	 	52.232-22
	 	Apr 1984
	 	Limitation of Funds (applies when contract is incrementally funded)
	FAR

	 	52.232-23
	 	Jan 1986
	 	Assignment of Claims
	FAR

	 	52.232-25
	 	Oct 2003
	 	Prompt Payment, Alternate I (Feb 2002)
	FAR

	 	52.232-33
	 	Oct 2003
	 	Payment by Electronic Funds Transfer—Central Contractor Registration
	FAR

	 	52.233-1
	 	Jul 2002
	 	Disputes
	FAR

	 	52.233-3
	 	Aug 1996
	 	Protest After Award, Alternate I (Jun 1985)
	FAR

	 	52.233-4
	 	Oct 2004
	 	Applicable Law for Breach of Contract Claim
	FAR

	 	52.242-1
	 	Apr 1984
	 	Notice of Intent to Disallow Costs
	FAR

	 	52.242-3
	 	May 2001
	 	Penalties for Unallowable Costs (Over $650,000)
	FAR

	 	52.242-4
	 	Jan 1997
	 	Certification of Final Indirect Costs
	FAR

	 	52.242-13
	 	Jul 1995
	 	Bankruptcy (Over $100,000)
	FAR

	 	52.243-2
	 	Aug 1987
	 	Changes — Cost Reimbursement, Alternate V (Apr 1984)
	FAR

	 	52.244-2
	 	Aug 1998
	 	Subcontracts, Alternate II (Aug 1998) *If written consent to
subcontract is required, the identified subcontracts are listed in
ARTICLE B, Advance Understandings.
	FAR

	 	52.244-5
	 	Dec 1996
	 	Competition in Subcontracting (Over $100,000)
	FAR

	 	52.244-6
	 	Sep 2006
	 	Subcontracts for Commercial Items
	FAR

	 	52.245-5
	 	May 2004
	 	Government Property (Cost-Reimbursement, Time and Material, or
Labor-Hour Contract)
	FAR

	 	52.246-23
	 	Feb 1997
	 	Limitation of Liability (Over $100,000)
	FAR

	 	52.246-25
	 	Feb 1997
	 	Limitation of Liability — Services
	FAR

	 	52.249-6
	 	May 2004
	 	Termination (Cost-Reimbursement)
	FAR

	 	52.249-14
	 	Apr 1984
	 	Excusable Delays

			
	 	 	 
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	FAR

	 	52.253-1
	 	Jan 1991
	 	Computer Generated Forms
	HHSAR

	 	352.202-1
	 	Jan 2001
	 	Definitions — with Alternate paragraph (h) (Jan 2001)
	HHSAR

	 	352.216-72
	 	 Oct 1990
	 	Additional Cost Principles
	HHSAR

	 	352.228-7
	 	Dec 1991
	 	Insurance — Liability to Third Persons
	HHSAR

	 	352.232-9
	 	Apr 1984
	 	Withholding of Contract Payments
	HHSAR

	 	352.233-70
	 	 Apr 1984
	 	Litigation and Claims
	HHSAR

	 	352.242-71
	 	 Apr 1984
	 	Final Decisions on Audit Findings
	HHSAR

	 	352.270-5
	 	Apr 1984
	 	Key Personnel
	HHSAR

	 	352.270-6
	 	Jul 1991
	 	Publications and Publicity
	HHSAR

	 	352.270-7
	 	Jan 2001
	 	Paperwork Reduction Act

I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES

ARTICLE I.1. of this SECTION is hereby modified as follows:

FAR Clauses 52.219-9, Small Business Subcontracting Plan (September 2006), and 52.219-16,
Liquidated Damages—Subcontracting Plan (January 1999) are deleted in their entirety.

FAR Clause 52.232-20, Limitation of Cost, is deleted in its entirety and FAR Clause 52.232-22,
Limitation of Funds (APRIL 1984) is substituted therefore. [Note: When this contract is fully
funded, FAR Clause 52.232-22, Limitation of Funds will no longer apply and FAR Clause 52.232-20,
Limitation of Cost will become applicable.]

I.3. ADDITIONAL CONTRACT CLAUSES

This contract incorporates the following clauses by reference, with the same force and effect, as
if they were given in full text. Upon request, the contracting officer will make their full text
available.

52.215-17 Waiver of Facilities Capital Cost of Money (October 1997)

52.243-2, Changes—Cost Reimbursement (August 1987)

I.4 Additional Contract Clauses of SECTION I – Added in full text

52.222-39 Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004)

(a) Definition. As used in this clause—

“United States” means the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana
Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.

(b) Except as provided in paragraph (e) of this clause, during the term of this contract, the
Contractor shall post a notice, in the form of a poster, informing employees of their rights
concerning union membership and payment of union dues and fees, in conspicuous places in and about
all its plants and offices, including all places where notices to employees are customarily posted.
The notice shall include the following information (except that the information pertaining to
National Labor Relations Board shall not be included

			
	 	 	 
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in notices posted in the plants or offices of carriers subject to the Railway Labor Act, as amended
(45 U.S.C. 151-188)).

Notice to Employees

Under Federal law, employees cannot be required to join a union or maintain membership in a union
in order to retain their jobs. Under certain conditions, the law permits a union and an employer to
enter into a union-security agreement requiring employees to pay uniform periodic dues and
initiation fees. However, employees who are not union members can object to the use of their
payments for certain purposes and can only be required to pay their share of union costs relating
to collective bargaining, contract administration, and grievance adjustment.

If you do not want to pay that portion of dues or fees used to support activities not related to
collective bargaining, contract administration, or grievance adjustment, you are entitled to an
appropriate reduction in your payment. If you believe that you have been required to pay dues or
fees used in part to support activities not related to collective bargaining, contract
administration, or grievance adjustment, you may be entitled to a refund and to an appropriate
reduction in future payments.

For further information concerning your rights, you may wish to contact the National Labor
Relations Board (NLRB) either at one of its Regional offices or at the following address or toll
free number:

National Labor Relations Board

Division of Information

1099 14th Street, N.W.

Washington, DC 20570

1-866-667-6572

1-866-316-6572 (TTY)

To locate the nearest NLRB office, see NLRB’s website at
http://www.nlrb.gov.

(c) The Contractor shall comply with all provisions of Executive Order 13201 of February 17, 2001,
and related implementing regulations at 29 CFR Part 470, and orders of the Secretary of Labor.

(d) In the event that the Contractor does not comply with any of the requirements set forth in
paragraphs (b), (c), or (g), the Secretary may direct that this contract be cancelled, terminated,
or suspended in whole or in part, and declare the Contractor ineligible for further Government
contracts in accordance with procedures at 29 CFR Part 470, Subpart B—Compliance Evaluations,
Complaint Investigations and Enforcement Procedures. Such other sanctions or remedies may be
imposed as are provided by 29 CFR Part 470, which implements Executive Order 13201, or as are
otherwise provided by law.

(e) The requirement to post the employee notice in paragraph (b) does not apply to—

 (1) Contractors and subcontractors that employ fewer than 15 persons;

 (2) Contractor establishments or construction work sites where no union has been formally
recognized by the Contractor or certified as the exclusive bargaining representative of the
Contractor’s employees;

 (3) Contractor establishments or construction work sites located in a jurisdiction named in the
definition of the United States in which the law of that jurisdiction forbids enforcement of
union-security agreements;

 (4) Contractor facilities where upon the written request of the Contractor, the Department of Labor
Deputy Assistant Secretary for Labor-Management Programs has waived the posting requirements with
respect to any of the Contractor’s facilities if the Deputy Assistant Secretary finds that the
Contractor has demonstrated that—

 (i) The facility is in all respects separate and distinct from activities of the Contractor related
to the performance of a contract; and

 (ii) Such a waiver will not interfere with or impede the effectuation of the Executive order; or

 (5) Work outside the United States that does not involve the recruitment or employment of workers
within the United States.

 (f) The Department of Labor publishes the official employee notice in two variations; one for
contractors covered by the Railway Labor Act and a second for all other contractors. The Contractor
shall—

 (1) Obtain the required employee notice poster from the Division of Interpretations and Standards,
Office of Labor-Management Standards, U.S. Department of Labor, 200 Constitution Avenue, NW, Room
N-5605, Washington, DC 20210, or from any field office of the Department’s Office of
Labor-Management Standards or Office of Federal Contract Compliance Programs;

			
	 	 	 
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(2) Download a copy of the poster from the Office of Labor-Management Standards website at
http://www.olms.dol.gov; or

(3) Reproduce and use exact duplicate copies of the Department of Labor’s official poster.

 (g) The Contractor shall include the substance of this clause in every subcontract or purchase
order that exceeds the simplified acquisition threshold, entered into in connection with this
contract, unless exempted by the Department of Labor Deputy Assistant Secretary for
Labor-Management Programs on account of special circumstances in the national interest under
authority of 29 CFR 470.3(c). For indefinite quantity subcontracts, the Contractor shall include
the substance of this clause if the value of orders in any calendar year of the subcontract is
expected to exceed the simplified acquisition threshold. Pursuant to 29 CFR Part 470, Subpart
B—Compliance Evaluations, Complaint Investigations and Enforcement Procedures, the Secretary of
Labor may direct the Contractor to take such action in the enforcement of these regulations,
including the imposition of sanctions for noncompliance with respect to any such subcontract or
purchase order. If the Contractor becomes involved in litigation with a subcontractor or vendor, or
is threatened with such involvement, as a result of such direction, the Contractor may request the
United States, through the Secretary of Labor, to enter into such litigation to protect the
interests of the United States.

52.227-14, Rights in Data Alternate II (June 1987)

     (g)(2) Notwithstanding paragraph (g)(1) of this clause, the contract may identify and
specify the delivery of limited rights data, or the Contracting Officer may require by written
request the delivery of limited rights data that has been withheld or would otherwise be
withholdable. If delivery of such data is so required, the Contractor may affix the following
“Limited Rights Notice” to the data and the Government will thereafter treat the data, subject
to the provisions of paragraphs (e) and (f) of this clause, in accordance with such Notice:

Limited Rights Notice (June 1987)

	 	(a)	 	These data are submitted with limited rights under Government Contract No.
HHSO10020070031C and subcontracts. These data may be reproduced and used by the
Government with the express limitation that they will not, without written permission
of the Contractor, be used for purposes of manufacture nor disclosed outside the
Government; except that the Government may disclose these data outside the Government
for the following purposes, if any; provided that the Government makes such disclosure
subject to prohibition against further use and disclosure:

(i) Use (except for manufacture) by support service contractors.

	 	(b)	 	This Notice shall be marked on any reproduction of these data, in whole or in
part.

(End of Clause)

I. 5. Department of Health and Human Services Acquisition Regulations (HHSAR)

(48 CFR Chapter 3) Clauses: Full text of these clauses can be found at

http://www.dhhs.gov/oamp/dap/hhsar.html/

352.223-70, Safety and Health (January 2001)

352.224-70, Confidentiality of Information (April 1984)

352.270-5, Key Personnel (April 1984)

			
	 	 	 
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	 	Page 26 of 29

 

 

352.270-8, Protection of Human Subjects (January 2001)

Note: The Office for Human Research Protections (OHRP), Office of the Secretary (OS), Department
of Health and Human Services (DHHS) is the office responsible for oversight of the Protection of
Human Subjects and should replace Office for Protection from Research Risks (OPRR), National
Institutes of Health (NIH) wherever it appears in this clause.

352.270-9, Care of Live Vertebrate Animals (January 2001)

			
	 	 	 
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PART III — LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J — LIST OF ATTACHMENTS

Invoice/Financing Request Instructions (1 page)

Report of Government owned Contractor held property (1 page)

Contractor defined milestones (December 20, 2006, 3 pages)

			
	 	 	 
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	 	Page 28 of 29

 

 

SECTION K – REPRSENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

Annual Representations and Certifications completed and located at the Online Representations and
Certifications Application (ORCA) website. [This includes the changes if any identified in
paragraph (b) of the FAR provision 52.204-8, Annual Representations and Certifications, contained
in the contractor’s proposal.]

			
	 	 	 
	Contract No. HHSO100200700031C
	 	Page 29 of 29

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