[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

EXHIBIT 99.1

SECTION A - CMB Approval 2700-0042
- ------------------------------------------------------------------------------------------------------------------------------------
AWARD/CONTRACT | 1. THIS CONTRACT IS RATED ORDER > | RATING | PAGE OF PAGES
| UNDER DPAS (15 CFR 350) | |
| | N/A | 1 32
- ------------------------------------------------------------------------------------------------------------------------------------

2. CONTRACT (Proc. Inst. Ident.) NO. | 3. EFFECTIVE DATE | 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
| |
HHSO100200500001C | November 4, 2004 | ASPHEP0500002
- ------------------------------------------------------------------------------------------------------------------------------------
5. ISSUED BY CODE | | 6. ADMINISTERED BY (if other than item 6) CODE | |
-------------------| ---------------
|
Department of Health and Human Services |
Office of Research and Development Coordination |
Office of Public Health Emergency Preparedness |
200 Independence Avenue, S.W., Room 636G | RFP DHHS-ORDC-04-01
Washington, D.C. 20201 |
- ------------------------------------------------------------------------------------------------------------------------------------
7. NAME AND ADDRESS OF CONTRACTOR (No. street, county, state and ZIP Code) | 8. DELIVERY
| |_| FOB ORIGIN |X| OTHER (See below)
|
VaxGen, Inc. | FOB Destination
1000 Marina Boulevard, Suite 200 | --------------------------------------------
Brisbane, California 94005 | 9. DISCOUNT FOR PROMPT PAYMENT
|
| N/A
| --------------------------------------------
| 10. SUBMIT INVOICES | ITEM
- --------------------------------------------------------------------------------------- |
CODE | FACILITY CODE | ADDRESS SHOWN IN: | Art. G.5.
- ------------------------------------------------------------------------------------------------------------------------------------
11. SHIP TO/MARK FOR CODE | N/A | 12. PAYMENT WILL BE MADE BY CODE | N/A
- ------------------------------------- ------------------- | ----------------------
|
Article F.1. | See Article G.5
- ------------------------------------------------------------------------------------------------------------------------------------
13. AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION: | 14. ACCOUNTING AND APPROPRIATION DATA
|
|_| 10 U.S.C. 2304(c)( ) |_| 41 U.S.C. 253(c)( ) | EIN 1-943236309-AI CAN 1991535 7550140 25.2A
- ------------------------------------------------------------------------------------------------------------------------------------
15A. ITEM NO. | 15B. SUPPLIES/SERVICES | 15C. | 15D. UNIT | 15E. UNIT PRICE | 15F. PRICE
- ------------------------------------------------------------------------------------------------------------------------------------
Title: Acquisition of rPA Anthrax Vaccine for the Strategic |
National Stockpile Period: November 4, 2004 - November 3, 2009 |
Contract Type: IDIQ (Fixed Price Delivery Order and Cost | FY 2005 $877,500,000 for 75 Million doses of rPA Anthrax Vaccine
Reimbursement Task Orders) |
- ------------------------------------------------------------------------------------------------------------------------------------
15G. TOTAL AMOUNT OF CONTRACT > | $877,500,000
- ------------------------------------------------------------------------------------------------------------------------------------
16. TABLE OF CONTENTS
- ------------------------------------------------------------------------------------------------------------------------------------
(v) | SEC. | DESCRIPTION | PAGE(S) | (v) | SEC. | DESCRIPTION | PAGE(S)
- ------------------------------------------------------------------------------------------------------------------------------------
PART I - THE SCHEDULE PART II - CONTRACT CLAUSES
- ------------------------------------------------------------------------------------------------------------------------------------
|X| A SOLICITATION/CONTRACT FORM |X| I CONTRACT CLAUSES
- ------------------------------------------------------------------------------------------------------------------------------------
|X| B SUPPLIES OR SERVICES AND PRICE/COST PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
- ------------------------------------------------------------------------------------------------------------------------------------
|X| C DESCRIPTION/SPECS./WORK STATEMENT |X| J LIST OF ATTACHMENTS
- ------------------------------------------------------------------------------------------------------------------------------------
|X| D PACKAGING AND MARKING PART IV - REPRESENTATIONS AND INSTRUCTIONS
- ------------------------------------------------------------------------------------------------------------------------------------
|X| E INSPECTION AND ACCEPTANCE |X| K REPRESENTATIONS, CERTIFICATIONS AND
OTHER STATEMENTS OF OFFERORS
- ------------------------------------------------------------------------------------------------------------------------------------
|X| F DELIVERIES OR PERFORMANCE
- ------------------------------------------------------------------------------------------------------------------------------------
|X| G CONTRACT ADMINISTRATION DATA |_| L INSTRS., CONDS., AND NOTICES TO OFFERORS
- ------------------------------------------------------------------------------------------------------------------------------------
|X| H SPECIAL CONTRACT REQUIREMENTS |_| M EVALUATION FACTORS FOR AWARD
- ------------------------------------------------------------------------------------------------------------------------------------
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
- ------------------------------------------------------------------------------------------------------------------------------------
17. |X| CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is 18. |_| AWARD (Contractor is not required to sign this
required to sign this document and return 3 copies to document.) Your offer on Solicitation Number _________________
issuing office.) Contractor agrees to furnish and deliver _________, including the additions or changes made by you
all items or perform all the services set forth or otherwise which additions or changes are set forth in full above, is
identified above and on any continuation sheets for the hereby accepted as to the items listed above and on any
consideration stated herein. The rights and obligations of continuation sheets. This award consummates the contract
the parties to this contract shall be subject to and which consists of the following documents: (a) the
governed by the following documents: (a) this Government's solicitation and your offer, and (b) this
award/contract, (b) the solicitation, if any, and (c) such award/contract. No further contractual document is
provisions, representations, certifications, and necessary.
specifications, as are attached or incorporated by reference
herein. (Attachments are listed herein.)
- ------------------------------------------------------------------------------------------------------------------------------------
19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER

Lance K. Gordon Jacqueline C. Holden, Contracting Officer
President and CEO HHS/OS/ORDC
- ------------------------------------------------------------------------------------------------------------------------------------
19B. NAME OF CONTRACTOR 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA 20C. DATE SIGNED

11/4/04 11/4/04
/s/ Lance Gordon /s/ Jacqueline C. Holden
- ------------------------------------------- ---------------------------------------
(Signature of person authorized to sign) (Signature of Contracting officer)
- ------------------------------------------------------------------------------------------------------------------------------------
NSN 7540-01-152-8069 26-107 STANDARD FORM 26 (REV. 4-85)
PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA
FAR (48 CFR) 53.214(a)

1. Contract No. HHSO100200500001C

DETAILED TABLE OF CONTRACT CONTENTS

PART I - THE SCHEDULE

SECTION A -................................................................................................1

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS..........................................................4

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES...............................................4
ARTICLE B.2. PRICES..................................................................................4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS...................................................5
ARTICLE B.4. ADVANCE UNDERSTANDINGS..................................................................6

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT......................................................8

ARTICLE C.1. STATEMENT OF WORK.......................................................................8
ARTICLE C.2. REPORTING REQUIREMENTS..................................................................9
ARTICLE C.3. INVENTION REPORTING REQUIREMENT........................................................10

SECTION D - PACKAGING, MARKING AND SHIPPING...............................................................10

SECTION E - INSPECTION AND ACCEPTANCE.....................................................................10

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. DELIVERIES.............................................................................11
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)........................12

SECTION G - CONTRACT ADMINISTRATION DATA..................................................................12

ARTICLE G.1. PROJECT OFFICER........................................................................12
ARTICLE G.2. KEY PERSONNEL..........................................................................13
ARTICLE G.3. TASK ORDER PROCEDURES..................................................................13
ARTICLE G.4. INDEFINITE DELIVERY CONTRACT PAYMENT METHOD............................................14
ARTICLE G.5. INVOICE SUBMISSION.....................................................................14
ARTICLE G.6. INDIRECT COST RATES....................................................................15
ARTICLE G.7. GOVERNMENT PROPERTY....................................................................15
ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE........................................15
ARTICLE G.9. PAYMENT CONDITIONED ON DELIVERY........................................................16

SECTION H - SPECIAL CONTRACT REQUIREMENTS.................................................................16

ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOP............................16
ARTICLE H.2. RESTRICTION FROM USE OF HUMAN SUBJECTS.................................................16
ARTICLE H.3. NEEDLE EXCHANGE........................................................................16
ARTICLE H.4. PRIVACY ACT............................................................................16
ARTICLE H.5. ANIMAL WELFARE.........................................................................17
ARTICLE H.6. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS........................................17
ARTICLE H.7. PUBLICATION AND PUBLICITY..............................................................17
ARTICLE H.8. PRESS RELEASES.........................................................................17
ARTICLE H.9. TASK ORDERDELIVERY ORDER CONTRACT OMBUDSMAN............................................17
ARTICLE H.10. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE....................................18
ARTICLE H.11. ANTI -LOBBYING........................................................................18
ARTICLE H.12. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS.....................18
ARTICLE H.13. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES.......................19

Contract No. HHSO100200500001C

SECTION I -...............................................................................................19

ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED FIXED PRICE SUPPLY CONTRACT...........................20
ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED FIXED PRICE SUPPLY CONTRACT...........................22
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES.....................................................26
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES............................................................26
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT..................................27

PART III......................................................................................................29

SECTION J - LIST OF ATTACHMENTS...........................................................................29

1. Statement of Work
2. Invoice Instructions for Fixed-Price Contracts
3. Inclusion Enrollment Report
4. Privacy Act System of Records
5. Safety and Health
6. Research Patient Care Costs

PART IV.......................................................................................................30

SECTION K - REPRESENTATIONS AND CERTIFICATIONS.........................................................30

1. Representations and Certifications...............................................................30
2. Human Subjects Assurance Identification Number...................................................30
3. Animal Welfare Assurance Number..................................................................30

Contract No. HHSO100200500001C

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this contract is for the Acquisition of rPA Anthrax Vaccine for
the Strategic National Stockpile.

ARTICLE B.2. PRICES

a. The contractor shall be reimbursed by the Government in an amount not more
than a total of $877,500,000 for 75 Million doses of rPA Anthrax Vaccine
(maximum) for successful performance of this contract (Requirements 1, 2,
3, 4a), b), c) and d), 5, 6, 7 and 10). Exclusive of this amount are the
following items for which future task orders may be issued:

Task Order Requirement 4(e) - Phase 4 Post-Marketing Studies - $28,014,355
($5,503,096 for set-up costs within 6 months of award)
Task Order Requirement 8 - Maintaining a Warm Base - $29,431,920
Task Order Requirement 9 - Clinical Trails in Special Populations -
$11,514,308
Security Recommendations not to exceed [ * ]
Anticipated PPI in Year 3 of the contract not to exceed [ * ]

FUNDED CONTRACT AMOUNTS

Description of item to be ordered Total Funded Amount
--------------------------------- -------------------

75 Million Doses of rPA Anthrax Vaccine $877,500,000

b. The prices set forth in this ARTICLE B.2. will cover the contract period
October 29, 2004 through October 28, 2009

c. Upon delivery and acceptance of the items described in SECTION C of this
contract and identified in the schedule of charges below, the Government
shall pay to the contractor the unit prices set forth below:

Description of item to be ordered Unit Price % of Total Fixed Price to be paid Total Cost
--------------------------------- ---------- --------------------------------- ----------

75 Million Doses of rPA Anthrax Vaccine $10.06 85.98% $754,500,000.00
Upon Delivery to the SNS
GUP BLA Supplement 0.35 2.99% $ 26,250,000.00
PEP BLA Supplement 0.35 2.99% $ 26,250,000.00
18 month Real Time Stability 0.94 8.03% $ 70,500,000.00
------ ---- ---------------
Total $11.70 100% $877,500,000.00

d. Payment Schedule

The Contractor will submit invoices for finished rPA vaccine furnished in
accordance with the following:

i. Invoices for the Base Amount of $10.06 per dose will be submitted
monthly upon collection of the relevant lots of usable product from
the manufacturer's facility. A lot is defined as approximately [ * ]
doses of rPA vaccine in pre-filled syringes. Should the Government
choose to delay or defer shipment of released FDP to the SNS
site(s), the Government agrees to accept the vaccine while in the
Contractor's possession and make timely payment of the FDP invoice.

ii. A price supplement of $0.35 per dose will be applied when the BLA
approval for General Use Prophylaxis (GUP) is achieved. Once
achieved, Contractor will submit an invoice to retroactively apply
the price supplement to doses already delivered under IND. Invoices
for future deliveries will include the base price plus the price
supplement.

Contract No. HHSO100200500001C

iii. A price supplement of $0.35 per dose will be applied when the BLA
approval for Post Exposure Prophylaxis (PEP) is achieved. Once
achieved, Contractor will submit an invoice to retroactively apply
the price supplement to doses already delivered under IND. Invoices
for future deliveries will include the base price plus the price
supplement.

iv. A price supplement of $0.94 per dose will be applied when the
milestone of demonstrating 18 month real time stability in prefilled
syringes is achieved. Once achieved, Contractor will submit an
invoice to retroactively apply the price supplement to doses already
delivered under IND. Invoices for future deliveries will include the
base price plus the price supplement.

2. Delivery Order No. 1 is hereby incorporated in this contract as follows:

1) Date of Order - November 4, 2004

2) Contract No. HHSO100200500001C

3) Description - 75 Million doses of rPA Anthrax Vaccine

4) Delivery Schedule - as set forth in Article F.1.

5) Place of Delivery - as set forth in Article F.1.

6) Packing - as set forth in Section D

7) Accounting & Appropriation Data - see Block 14 of Contract Face Page

8) Method of Payment - See Article B.2.d.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

(These provisions apply only to the Cost Plus Fixed Fee components of this
contract; i.e., Requirements 4(e), 8 and 9)

a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE,
incorporated in this contract, unless authorized in writing by the
Contracting Officer, the costs of the following items or activities shall
be unallowable as direct costs:

(1) Acquisition, by purchase or lease, of any interest in real property;

(2) Special rearrangement or alteration of facilities;

(3) Purchase or lease of any item of general purpose office furniture or
office equipment regardless of dollar value. (General purpose
equipment is defined as any items of personal property which are
usable for purposes other than research, such as office equipment
and furnishings, pocket calculators, etc.);

(4) Travel to attend general scientific meetings;

(5) Foreign travel;

(6) Consultant costs;

(7) Subcontracts;

(8) Patient care costs;

(9) Accountable Government property (defined as both real and personal
property with an acquisition cost of $1,000 or more and a life
expectancy of more than two years) and "sensitive items" (defined
and listed in the Contractor's Guide for Control of Government
Property), 1990, regardless of acquisition value.

Contract No. HHSO100200500001C

b. Travel Costs

(1) Domestic Travel

(a) Total expenditures for travel (transportation, lodging,
subsistence, and incidental expenses) incurred in direct
performance of this contract shall not exceed $8,126 without
the prior written approval of the Contracting Officer.

(b) The Contractor shall invoice and be reimbursed for all travel
costs in accordance with Federal Acquisition Regulations (FAR)
31.205-46.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

1. Storage and Shipment of Final Drug Product

a. Contractor will provide adequate Final Drug Product (FDP) storage
capacity for up to [ * ] including the estimated [ * ] required for
QC testing and QA release. If testing should take longer than the
estimated [ * ] to fulfill FDA/CBER requirements, it will be the
responsibility of VaxGen to cover the additional storage costs.
Should the Government require FDP storage in excess of [ * ], the
Government will provide 6 months notice to VaxGen of such a
requirement, unless mutually agreed to otherwise, and the Government
will be responsible for all costs associated with such additional
storage.

b. Prior to initial shipment of product to the SNS, the following
process shall be followed:

i. Contractor shall submit a letter summarizing each study that
has relevance to defining the product as usable.

ii. Usable product must meet specifications as per footnote 2 of
the Statement of Work and as per Section 7 of the advanced
understandings below.

iii. The Project Officer will notify Contractor when transfer of
product is acceptable for purposes of this advance
understanding.

c. Upon Contractor issuance of a FDP Certificate of Analysis, and
Contractor release of each FDP lot, Contractor will arrange for
shipment to the Government's SNS site via the Government's selected
shipping contractor. All shipments will be FOB manufacturer's
facility.

d. For licensed product subject to FDA lot release requirements,
Contractor will provide Sponsor lot release of product for transport
to the SNS and will make arrangements for quarantined storage of
inventory until such time as FDA lot release is provided. Upon FDA
release, product will then be moved into the general inventory and
available for immediate deployment. Should any lot having received
Sponsor lot release and for which payment has been rendered fail to
receive FDA lot release, Contractor agrees to replace the failed lot
at no cost to the Government, FOB manufacturer's facility.

2. Security Requirements and Associated Costs

a. The Government may issue separate contract modifications to fund
improvements that may be needed at Contractor's or subcontractor's
sites in order to provide levels of security beyond those required
for routine, commercial pharmaceutical production. VaxGen will
provide proposals for funding for such improvements and upon receipt
of a contract modification, will implement security measures in
accordance with the Government's specifications and schedules.

b. It is understood and agreed that documentation will be submitted to
support vehicular access control to the manufacturing site [ * ] via
gates operated by card key with closed circuit television (CCTV)
surveillance. Cost to implement vehicular access will not exceed
[ * ]

Contract No. HHSO100200500001C

c. It is understood and agreed that documentation will be submitted to
support [ * ] requirements. Cost to support [ * ] will not exceed
[ * ]

d. DHHS or its designee will review and approve all proposed security
improvements funded by the Government under cost reimbursement
arrangements prior to implementation.

3. Economic Price Adjustment - [ * ]

a. Manufacture of the fixed price product required includes [ * ] In
accordance with standard industry practice, [ * ]. The contractor
certifies that this contract does not include amounts to cover such
adjustments beyond the [ * ] of contract performance.

b. [ * ]

c. Promptly after the Contracting Officer receives the notice and data
referred to in the previous paragraph of this clause, the
Contracting Officer and the Contractor shall negotiate a price
adjustment in the contract unit prices and its effective date. The
Contractor shall continue performance pending agreement on, or
determination of, an adjustment and its effective date. The
Contractor shall submit a separate invoice for the adjustment amount
applicable to doses previously shipped, if any, and the unit price
will be adjusted to reflect the change applicable to undelivered
product.

d. Any price adjustment under this clause is subject to the following
limitations:

i. Any adjustment shall be limited to [ * ] but not to exceed [ *
]. There shall be no adjustment for supplies or services for
which the production cost is not affected.

ii. No adjustment shall apply to supplies that are delivered
before the effective date of the adjustment.

iii. It is understood and agreed that documentation will be
submitted to support the anticipated [ * ].

4. This contract is awarded under solicitation RFP-DHHS-ORDC-04-01. This
solicitation sought a minimum quantity of rPA anthrax vaccine of 25
million doses and a maximum quantity of 75 million doses. In its response,
Contractor offered [ * ] pricing scenarios based on volume. [ * ] This
volume-based pricing reflects cost efficiencies anticipated for production
at higher volumes and the need for a lower unit margin at higher volumes
to provide the required return.

5. Pursuant to FAR 52.244-2 and 52.244-2 (ALT II), award of the following
agreements shall not proceed without the prior written approval of the
Contracting Officer upon review of the draft agreements:

[ * ]

Upon written approval of each draft agreement, a copy of the signed,
approved agreement shall be provided to the Contracting Officer

6. The following Alternate Proposals proposed by Contractor will not be
funded under this contract:

[ * ]

7. Notwithstanding the definition of usable product set forth at footnote 2
of the Statement of Work, Contractor understands the definition of usable
product as originally stated in the RFP and is working towards obtaining
sufficient data to establish the final formulation for use under a
contingency-use protocol. For clarity, usable product must be derived from
a validated manufacturing process, including that of the final
formulation, in which there is a high degree of confidence, as determined
by the FDA/CBER, that all manufactured units from successive lots will
meet acceptable product specifications. A minimum of 3 consistency lots
(replicate process runs) must be manufactured at commercial scale to
demonstrate reproducibility and provide an accurate measure of variability
among successive runs. Sufficient safety (nonclinical and clinical) and
efficacy data (nonclinical and clinical serology) shall be submitted to
Contractor's

Contract No. HHSO100200500001C

IND prior to delivery of vaccine to the SNS to support use of
investigational vaccine by the US Government under a Post-Exposure
Contingency Use IND protocol (used concurrently with antibiotics). These
data will be the basis for FDA/CBER review and concurrence that the
vaccine meets the definition of usability for Post-Exposure Contingency
Use. All FDP to be shipped to the SNS will be manufactured using a
validated process demonstrated by comprehensive and satisfactory
in-process and release testing. In addition, an ongoing stability program
will be in place using stability indicating assays that have been agreed
upon by FDA/CBER. The product must meet stability specifications to the
satisfaction of FDA/CBER prior to entry into the stockpile. The acceptance
of the product for inclusion in the SNS for emergency purposes will be
based upon review of ongoing data and mutual agreement with FDA/CBER,
ORDC, and CDC, in consultation with Contractor, that the above usability
criteria have been met.

8. Contractor has included the cost of the following in its fixed price per
dose of $11.70:

a. Product Liability and Clinical Trial Insurance

b. Packaging and ancillaries including safety needles, alcohol swabs,
package inserts and informed consent forms

c. The cost of monitoring vaccine while stored at the SNS storage sites

9. It is understood and agreed that ORDC may attend meetings between
Contractor and FDA for "informational purposes only" and ORDC will be
provided with copies of correspondence and regulatory submissions to FDA.

10. Indemnification: The contractor is required to obtain clinical trial
insurance. If the contractor is not able to obtain sufficient insurance
coverage for activities under the contract, and the contractor desires
indemnification pursuant to Public Law No. 85-804 from the USG, the
Contractor shall submit a request to DHHS for indemnification by the USG.
The Contractor's Request for Indemnification shall provide all information
and documentation as required by FAR 50.403-l(a) (Indemnification
Requests). The Contracting Officer may extend the deadline for submission
of indemnification requests. Except for clinical trials, the USG will
agree that vaccines delivered to the SNS will not be used until
indemnification has been approved.

11. SAFETY Act: As a requirement of indemnification, the contractor is
required to request liability protection under the terms of the SAFETY
Act.

12. Product Approval as Required by Project Bioshield Act of 2004

Pursuant to Section 42 U.S.C. 247d-6b(c)(7)(C)(ii)(V) of the Public Health
Service Act, the Statement of Work contains requirements with respect to
the approval, clearance, or licensing of the product from the Secretary.
Timetables for the development of data and other information to support
such approval, clearance, or licensing are included in the contractor's
proposal (including Section 7 titled "Schedule and Master Gantt Chart" of
the Final Proposal Revision, dated September 21, 2004) and are
incorporated into the contract pursuant to Article C.1.a.

13. For the purposes of this contract, the term General Use Prophylaxis means
Pre-Exposure Prophylaxis.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, material,
equipment, and facilities, not otherwise provided by the Government as
needed to perform the Statement of Work, SECTION J, ATTACHMENT 1, dated
November 4, 2004, attached hereto and made a part of this contract. [ * ]
Substantive deviations, as determined by the Government, if any, from the
technical plan which could affect the probability of technical or
programmatic success of this contract will be recommended by the
contractor but must be approved by the government's Contracting Officer in
advance of implementation.

Contract No. HHSO100200500001C

ARTICLE C.2. REPORTING REQUIREMENTS

Technical Reports

In addition to those reports required by the other terms of this contract, the
Contractor shall prepare and submit the following reports in the manner stated
below and in accordance with ARTICLE F.1. DELIVERIES of this contract:

The Contractor(s) shall submit to the Contracting Officer and to the Project
Officer technical progress reports covering the work accomplished during each
reporting period. These reports are subject to the technical inspection and
requests for clarification by the Project Officer. These shall be brief and
factual and prepared in accordance with the following format:

(1) Monthly Technical Progress Reports: On the fifteenth of each month for
the previous calendar month, the Contractor shall submit a Monthly
Technical Progress Report to the Project Officer and the Contracting
Officer. A monthly report will not be required for the period when the
final report is due. The Contractor shall submit one copy of the Monthly
Progress Report electronically via e-mail. Any attachments to the e-mail
report shall be submitted in Microsoft Word or WordPerfect 9 or compatible
version. Such reports shall include the following specific information:

a. The contract number and title, the period of performance being
reported, the contractor's name and address, the author(s), and the
date of submission;

b. Section I - An introduction covering the purpose and scope of the
contract effort;

c. Section II - The report shall detail, document, and summarize the
results of work done during the period covered. This shall include
the information listed below that is applicable for the performance
period during the month being reported. Also to be included is a
summary of work planned for the next reporting period.

1. Assessment of problems and recommendations related to scale up
to full production capacity, including raw material
procurement status;

2. Quality control testing and purity;

3. FDA inspections and consultation results or recommendations;

4. Storage and stability studies for expiration date results
(real time and accelerated);

5. Security assessment, problems and recommendations;

6. Clinical trial study progress, results and final reports;

7. Progress and completed reports of effectiveness studies
performed in animals that were designed with consultation from
the USG and FDA/CBER.

8. Quality control potency assessment;

9. Inventory report of total number of vaccine syringes in
storage during the month, to include: lot number, expiration
date, and bulk quantity (if applicable);

10. Quantity of out-of-date vaccines, assessment and
recommendations to replacement vaccine orders to maintain
required stockpile quantities;

11. Physical storage facility and stability assessments, problems
encountered and recommended solutions, etc.;

12. Overall project assessment, problems encountered and
recommended solutions, etc.

Contract No. HHSO100200500001C

c. Section III - An explanation of any difference between planned
progress and actual progress, why the differences have occurred,
and, if behind planned progress, what corrective steps are planned.
The project plan and schedule, with accompanying Gantt chart, will
be updated in each Monthly Report and compared to the locked project
baseline. The updated Microsoft Project computer file must also be
provided to the Project Officer.

(2) Final Report - 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.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11 including, but
not limited to, the invention disclosure report, the confirmatory license, and
the government support certification, shall be directed to the Contracting
Officer. In addition, one copy of an annual utilization report, and a copy of
the final invention statement, shall be submitted to the Contracting Officer.
The final invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted to
the Contracting Officer on the expiration date of the contract at the following
address:

Contracting Officer
ORDC, OPHEP, DHHS
200 Independence Avenue, S.W.
Room 636G
Washington, D.C. 20201

If no invention is disclosed or no activity has occurred on a previously
disclosed invention during the applicable reporting period, a negative report
shall be submitted to the Contracting Officer at the address listed above.

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and
shipped in accordance with [ * ]. At a minimum, all deliverables shall be marked
with the contract number and contractor name. The Contractor shall guarantee
that all required materials shall be delivered in immediate usable and
acceptable condition. In accordance with Section B.4.1.d.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform
inspection and acceptance of materials and services to be provided.

b. For the purpose of this ARTICLE, the Project Officer is the authorized
representative of the Contracting Officer.

c. Initial Inspection and acceptance will be performed by USG personnel at
the time of transfer of product in accordance with the SNS Transportation
Protocol. Further inspection will occur at the time of placement of
product into SNS storage.

d. This contract incorporates the following clauses by reference, with the
same force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available.

FAR Clause 52.246-2, INSPECTION OF SUPPLIES - FIXED PRICE (AUGUST 1996)

FAR Clause 52.246-5, INSPECTION OF SERVICES - COST REIMBURSEMENT (APRIL
1984)

FAR Clause No. 52.246-16, RESPONSIBILITY FOR SUPPLIES (APRIL 1984).

10.

Contract No. HHSO100200500001C

e. Acceptance of usable product into the stockpile shall not be deemed as
satisfying the requirements for: 1) licensure for PEP and GUP indications
or 2) 18-month FDP stability milestone.

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon
performance of the work described in Article C.1. and upon delivery and
acceptance by the Contracting Officer, or the duly authorized representative, of
the following items in accordance with the stated delivery schedule:

a. The items specified below as described in SECTION C, ARTICLE C.1. will be
required to be delivered F.O.B. Destination as set forth in FAR 52.247-35,
F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in
accordance with and by the dates specified below and any specifications
stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of the contract:

Item Description Delivery Schedule
---- ----------- -----------------

(1) Monthly Technical Progress Report Fifteenth of each month for
previous month

(2) Final Report On or before contract expiration
date

In addition, the following items shall be delivered:

(a). 75 million single-dose units of rPA anthrax vaccine packaged in
pre-filled syringes with safety needles to be delivered to the SNS
accompanied by sufficient safety (clinical and nonclinical) and
efficacy (nonclinical) data to support use under a "Post- Exposure
Contingency Use" IND protocol (concurrently with antibiotics) with
25 million doses to be delivered within 2 years of contract award
date, delivery of 50 million doses by May, 2007, and 75 million
doses by December, 2007.

(b). An FDA approval letter for the BLA and accompanying issuance of a
license for rPA anthrax vaccine for the clinical indication of
pre-exposure prophylaxis use for those doses of vaccine in the SNS.

(c). An FDA approval letter for the BLA supplement for rPA anthrax
vaccine for the clinical indication of post-exposure prophylaxis use
concurrently with antibiotics.

(d). Evidence, including a summary of salient results, of an ongoing
Quality Control/Quality Assurance Program for the monitoring of SNS
stored product and ongoing stability testing of the retained lots of
product in SNS over the life of the contract or the expiration date
of the vaccine, or until vaccine is used, whichever comes first.

(e). Submission of final study reports as evidence of completion for
special population trials, including pediatric and geriatric
populations.

(f). One (1) lot of Bulk Drug Substance per year to maintain cGMP
capacity (warm base) for the production of rPA anthrax vaccine for
the life of the contract.

b. The above items shall be addressed and delivered to:

11.

Contract No. HHSO100200500001C

Addressee Deliverable Item No. Quantity
--------- -------------------- --------

Project Officer (1) and (2) and (3)
ORDC, OPHEP, DHHS (a) - (f) set forth above
6610 Rockledge Drive
Room 5107, MSC 6604
Bethesda, Maryland 20892-6604

Contracting Officer (1) and (2) (1)
ORDC, OPHEP, DHHS
200 Independence Avenue, S.W.
Room 636G
Washington, D.C. 20201

ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (AUGUST 1989) and FAR 52.242-15 ALTERNATE I
(APRIL 1984)

52.242- 17, Government Delay of Work (APRIL 1984)

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. PROJECT OFFICER

The following Project Officer will represent the Government for the purpose of
this contract:

[ * ]
Senior Project Officer/Microbiologist
ORDC, OPHEP, DHHS
6610 Rockledge Drive
Room 5107, MSC 6604
Bethesda, Maryland 20892-6604

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.

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.

The Contracting Officer hereby delegates the Project Officer as the Contracting
Officer's authorized representative responsible for signing software license
agreements issued as a result of this contract.

The Government may unilaterally change its Project Officer designation.

12.

Contract No. HHSO100200500001C

ARTICLE G.2. KEY PERSONNEL

Pursuant to the Key Personnel clause incorporated in Section I of this contract,
the following individual is considered to be essential to the work being
performed hereunder:

Name Title
[ * ] [ * ]

ARTICLE G.3. TASK ORDER PROCEDURES

This Article does not apply to the Task Order issued under Article B.2.e.

In providing items under the contract, the following procedures/shall apply to
the award of the D/TOR. All work required under the contract shall be authorized
through the execution of a bilateral order. Each order will obligate the
necessary funds to complete the required order and will include the work
statement of the D/TOR as an attachment. An order may be issued at any time
within the contract period. A D/TOR shall, at a minimum, include a Statement of
Work, evaluation factors, specific reporting requirements, deliverables and task
schedule, the relevant importance of technical and cost factors, and any special
instructions.

Within the time allowed for proposal preparation Contractors shall submit their
proposal in response to D/TOR, which shall include, but not necessarily be
limited to the following information:

i. A statement of the contractor's clear understanding of the order
requirements;

ii. A statement of technical and managerial resources and expertise the
contractor can provide to satisfy the requirement;

iii. An approach to perform the work;

iv. Resumes with identification of the actual personnel proposed for the
work;

v. A schedule of performance (preferably in MS Project) identifying
major milestones, deliverables and task data, and activity
completion; and

vi. An itemization of all costs necessary to complete the work. At a
level deemed practical by the Contractor, proposal budget will be
linked to associated CWP and schedule activities.

The Government will evaluate proposals and conduct negotiations as necessary.

The Contracting Officer is the only individual authorized to issue a D/TOR or
award a Delivery/Task Order under the contract. Unless specifically authorized
by the Contracting Officer, the contractor shall not commence work on a
requirement until an order has been fully executed. It is anticipated that
orders will be awarded within 30 calendar days from receipt of proposals. Each
order shall, at a minimum, contain the following information:

o Date of order

o Contract number and delivery/task order numbers sequentially; (e.g.,
DHHS-ORDC-04-1234, Order No. 01,02, 03, etc).

o Description of services, and estimated costs.

o Performance period.

13.

Contract No. HHSO100200500001C

o Name and address of sponsoring office.

o Name of Contracting Officer's technical representative;

o Place of performance.

o Packaging, packing, and shipping instructions, if any.

o Accounting and appropriation data.

o Pricing Arrangements

FAR 16.501-2(c) states that indefinite quantity contracts may
provide for any appropriate cost or pricing arrangement under Part
16. Therefore, firm fixed price, cost reimbursement, time and
materials, and labor-hour arrangements may be used.

o Any other pertinent information.

No protest under FAR 16.505(a)(8) Subpart 33.1 is authorized in connection with
the issuance or proposed issuance of a delivery/task order under the contract
except for a protest on the grounds that the order increases the scope, period,
or maximum value of the contract. Orders awarded under the contract are not
subject to the competition requirements of FAR Part 6.

vii. The Ombudsman for this delivery/task order contract is [ * ].
Correspondence from awardees may be forwarded to the address set
forth in Article H.9. of the contract.

ARTICLE G.4. INDEFINITE DELIVERY CONTRACT PAYMENT METHOD

To initiate and receive prompt payment, the Contractor shall comply with the
following procedure:

a. A Record of Call Number or Task/Delivery Order Number shall be given to
you at the time the order is placed. The Contractor is cautioned not to
accept an order unless one of these numbers is issued.

b. Invoices shall be submitted to the address indicated in ARTICLE G.5.
INVOICE INSTRUCTIONS of this contract. Invoices shall cite the Contract
Number and the Record of Call Number or Task/Delivery Order Number for
each order for which payment is being requested. See ARTICLE G.5. INVOICE
INSTRUCTIONS for more information about submission of a proper invoice.

ARTICLE G.5. INVOICE SUBMISSION

a. Invoice Instruction for Fixed-Price Type Contracts, and for
Cost-Reimbursement Type Contracts are attached and made part of this
contract. The invoice instructions and the following directions for the
submission of invoices must be followed to meet the requirements of a
"proper" invoice, pursuant to FAR 32.9.

b. (1) Invoices shall be submitted as follows:

(a) To be considered a "proper" invoice in accordance with FAR
32.9, Prompt Payment, each invoice shall clearly identify the
contract number that appears on the face page of the contract
as follows:

Contract No. HHSO100200500001C

(b) An original and two copies to the following designated billing
office:

14.

Contract No. HHSO100200500001C

Contracting Officer
ORDC, OPHEP, DHHS
200 Independence Avenue, S.W.
Room 636G
Washington, D.C. 20201

(2) Inquiries regarding payment of invoices should be directed to the
designated billing office, (202) 401-3693.

ARTICLE G.6. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)
Clause 52.216-7(d)(2), Allowable Cost and Payment incorporated by reference in
this contract in Part II, Section I, the cognizant Contracting Officer
representative responsible for negotiating provisional and/or final indirect
cost rates is identified as follows:

Director, Division of Financial Advisory Services
Office of Acquisition Management and Policy
National Institutes of Health
6100 Building, Room 6B05
6100 EXECUTIVE BLVD MSC-7540
BETHESDA, MD 20892-7540

These rates are hereby incorporated without further action of the Contracting
Officer.

ARTICLE G.7. 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 DHHS Publication, Contractor's Guide for Control of
Government Property, 1990, which is incorporated into this contract by
reference. 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 DHHS Publication,
Contractor's Guide for Control of Government Property, 1990 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.

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of contractor performance will be prepared
on this contract in accordance with FAR 42.15. The final performance
evaluation will be prepared at the time of completion of work. In addition
to the final evaluation, interim evaluations will be prepared annually to
coincide with the anniversary date of the contract.

Interim and final evaluations will be provided to the Contractor as soon
as practicable after completion of the evaluation. The Contractor will be
permitted thirty days to review the document and to submit additional
information or a rebutting statement. If agreement cannot be reached
between the parties, the matter will be referred to an individual one
level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, contractor responses, and review comments, if
any, will be retained as part of the contract file, and may be used to
support future award decisions.

15.

Contract No. HHSO100200500001C

ARTICLE G.9. PAYMENT CONDITIONED ON DELIVERY

Pursuant to 3 19F-2(c)(7)(c)(ii)(l) of the Public Health Service Act, no payment
will be made until delivery has been made of a portion, acceptable to the
Secretary, of the total number of units under contract. For purposes of this
contract such portion is agreed to be one lot as defined in Article B.2.d.
Delivery is defined as set forth in Article F.1. and in the applicable clauses.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
PROJECTS

The primary purpose of the Public Health Service (PHs) is to support and advance
independent research within the scientific community. PHS has established
effective, time tested and well recognized procedures for stimulating and
supporting this independent research by selecting from multitudes of
applications those research projects most worth of support within the
constraints of its appropriations. The reimbursement through the indirect cost
mechanism of independent research and development costs not incidental to
product improvement would circumvent this competitive process.

To ensure that all research and development projects receive similar and equal
consideration, all organizations may compete for direct funding of independent
research and development projects they consider worthy of support by submitting
those projects to the appropriate Public Health Service grant office for review.
Since these projects may be submitted for direct funding, the Contractor agrees
that no costs for any independent research and development project, including
all applicable indirect costs, will be claimed under this contract.

ARTICLE H.2. RESTRICTION FROM USE OF HUMAN SUBJECTS

NOTICE: UNDER GOVERNING REGULATIONS, FEDERAL FUNDS ADMINISTERED BY THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES SHALL NOT BE EXPENDED FOR RESEARCH
INVOLVING HUMAN SUBJECTS, AND INDIVIDUALS SHALL NOT BE ENROLLED IN SUCH
RESEARCH, WITHOUT PRIOR APPROVAL BY THE OFFICE FOR HUMAN RESEARCH PROTECTIONS
(OHRP) OF AN ASSURANCE TO COMPLY WITH THE REQUIREMENTS OF 45 CFR 46 TO PROTECT
HUMAN RESEARCH SUBJECTS. THIS RESTRICTION APPLIES TO ALL COLLABORATING SITES
WITHOUT OHRP-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN, AND COMPLIANCE
MUST BE ENSURED BY THE AWARDEE.

PRISONERS SHALL NOT BE ENROLLED IN ANY HHS RESEARCH ACTIVITIES UNTIL ALL
REQUIREMENTS OF HHS REGULATIONS AT 45 CFR PART 46, SUBPART C HAVE BEEN MET. IF A
RESEARCH SUBJECT BECOMES A PRISONER DURING THE PERIOD OF THIS CONTRACT, 45 CFR
PART 46, SUBPART C WILL APPLY TO RESEARCH INVOLVING THAT INDIVIDUAL.

ARTICLE H.3. NEEDLE EXCHANGE

a. Pursuant to Public Law(s) cited in paragraph b., below, 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.

b. Public Law and Section No. Fiscal Year Period Covered

P.L.***

***(This requirement is pending passage of the applicable Public Law for
Fiscal Year 2005)

ARTICLE H.4. PRIVACY ACT

This procurement action requires the Contractor to do one or more of the
following: design, develop, or operate a system of records on individuals to
accomplish an agency function in accordance with the Privacy Act of 1974, Public
Law 93-579,

16.

Contract No. HHSO100200500001C

December 31, 1974 (5 USC 552a) and applicable agency regulations. Violation of
the Act may involve the imposition of criminal penalties.

The Privacy Act System of Records applicable to this project is Number
(Pending). This document will be incorporated into this contract as an
Attachment in a future modification.

NOTE: Clinical Trials cannot be initiated until the Systems Notice has been
published and approval is received from the Contracting Officer.

ARTICLE H.5. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance
with the Public Health Service Policy on Humane Care and Use of Laboratory
Animals. This policy may be accessed at
http://grants1.nih.gov/grants/olaw/references/phspol.htm

ARTICLE H.6. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS

UNDER GOVERNING POLICY, FEDERAL FUNDS ADMINISTERED BY THE PUBLIC HEALTH SERVICE
(PHs) SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING LIVE VERTEBRATE ANIMALS
WITHOUT PRIOR APPROVAL BY THE OFFICE FOR LABORATORY ANIMAL WELFARE (OLAW), OF AN
ASSURANCE TO COMPLY WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY
ANIMALS. THIS RESTRICTION APPLIES TO ALL PERFORMANCE SITES WITHOUT OLAW-APPROVED
ASSURANCES, WHETHER DOMESTIC OR FOREIGN.

ARTICLE H.7. PUBLICATION AND PUBLICITY

The contractor shall acknowledge the support of the Department of Health and
Human Services 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 Department of Health and Human Services under Contract No.
HHSO100200500001C."

ARTICLE H.8. PRESS RELEASES

a. Pursuant to Public Law(s) cited in paragraph b., below, 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: (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.

b. Public Law and Section No. Fiscal Year Period Covered

P.L.***

***(This requirement is pending passage of the applicable Public Law for
Fiscal Year 2005)

ARTICLE H.9. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

In accordance with FAR 16.505(b)(5), the following individual has been
designated as the DHHS Ombudsman for task order and delivery order contracts:

17.

Contract No. HHSO100200500001C

[ * ]
HHS Office of Acquisition Management and Policy
Room 336-E, Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20201
Telephone: 202-690-8554
Fax: 202-690-6902

ARTICLE H.10. 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 and the
mailing address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

ARTICLE H.11. ANTI -LOBBYING

a. Pursuant to Public Law(s) cited in paragraph c., below, contract funds
shall only be used for normal and recognized executive-legislative
relationships. Contract funds shall not be used, for publicity or
propaganda purposes; or 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 legislature, except in presentation to the Congress
or any State legislature itself.

b. Contract funds shall not be used to pay salary or expenses of the
contractor or any agent acting for the contractor, related to any activity
designed to influence legislation or appropriations pending before the
Congress or any State legislature.

c. Public Law and Section No. Fiscal Year Period Covered

P.L.***

***(This requirement is pending passage of the applicable Public Law for
Fiscal Year 2005)

ARTICLE H.12. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

Work involving select biological agents or toxins shall not be conducted under
this contract until the contractor and any affected subcontractor(s) are granted
a certificate of registration or are authorized to work with the applicable
agents.

For prime or subcontract awards to domestic institutions who possess, use,
and/or transfer Select Agents under this contract, the institution must complete
registration with the Centers for Disease Control and Prevention (CDC),
Department of Health and Human Services (DHHS) or the Animal and Plant Health
Inspection Services (APHIS), U.S. Department of Agriculture (USDA), as
applicable, 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.

18.

Contract No. HHSO100200500001C

For prime or subcontract awards to foreign institutions who possess, use, and/or
transfer Select Agents under this contract, the institution must provide
information satisfactory to the DHHS that a process equivalent to that described
in 42 CFR 73 (http://www.cdc.gov/od/sap/docs/42cfr73.pdf) for U.S. institutions
is in place and will be administered on behalf of all Select Agent work
sponsored by these funds before using these funds for any work directly
involving the Select Agents. The contractor must provide information addressing
the following key elements appropriate for the foreign institution: safety,
security, training, procedures for ensuring that only approved/appropriate
individuals have access to the Select Agents, and any applicable laws,
regulations and policies equivalent to 42 CFR 73. An DHHS-chaired committee of
U.S. federal employees (including representatives of DHHS grants/contracts and
scientific program management, CDC, Department of Justice and other federal
intelligence agencies, and Department of State) will assess the policies and
procedures for comparability to the U.S. requirements described in 42 CFR Part
73. When requested by the contracting officer, the contractor should provide key
information delineating any laws, regulations, policies, and procedures
applicable to the foreign institution for the safe and secure possession, use,
and transfer of Select Agents. This includes concise summaries of safety,
security, and training plans, and applicable laws, regulations, and policies.
For the purpose of security risk assessments, the contractor must provide the
names of all individuals at the foreign institution who will have access to the
Select Agents and procedures for ensuring that only approved and appropriate
individuals have access to Select Agents under the contract.

Listings of HHS select agents and toxins, biologic agents and toxins, and
overlap agents or toxins as well as information about the registration process,
can be obtained on the Select Agent Program Web site at
http://www.cdc.gov/od/sap/

ARTICLE H.13. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The contractor acknowledges that U.S. Executive Orders and Laws, including but
not limited to E.O.13224 and P.L.107-56, prohibit transactions with, and the
provision 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.

19.

Contract No. HHSO100200500001C

ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED FIXED PRICE SUPPLY CONTRACT - FAR
52.252- 2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

THESE CLAUSES ARE APPLICABLE TO STATEMENT OF WORK REQUIREMENTS 1,2,3,4a), b), c)
and d), 5, 6, 7 and 10.

This contract incorporates one or more 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.arnet.gov/far/.

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CHAPTER 1) CLAUSES

FAR
CLAUSE NO. DATE TITLE
- ---------- ---- -----

52.202-1 Jul 2004 Definitions

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

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

52.203-6 Jul 1995 Restrictions on Subcontractor Sales to the Government (Over $100,000)

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

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

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

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

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

52.204-7 Oct 2003 Central Contractor Registration

52.209-6 Jul 1995 Protecting the Government's Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment (Over $25,000)

52.211-5 Aug 2000 Material Requirements

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

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

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

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

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

52.215-15 Jan 2004 Pension Adjustments and Asset Reversions

20.

Contract No. HHSO100200500001C

52.215-18 Oct 1997 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than
Pensions

52.215-19 Oct 1997 Notification of Ownership Changes

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

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

52.219-9 Jan 2002 Small Business Subcontracting Plan (Over $500,000)

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

52.222-19 Jun 2004 Child Labor--Cooperation with Authorities and Remedies

52.222-20 Dec 1996 Walsh-Healey Public Contracts Act

52.222-26 Apr 2002 Equal Opportunity

52.222-35 Dec 2001 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans

52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities

52.222-37 Dec 2001 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans

52.223-6 May 2001 Drug-Free Workplace

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

52.225-1 Jun 2003 Buy American Act - Supplies

52.225-13 Dec 2003 Restrictions on Certain Foreign Purchases

52.227-1 Jul 1995 Authorization and Consent

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

52.227-3 Apr 1984 Patent Indemnity

52.229-3 Apr 2003 Federal, State and Local Taxes (Over $100,000)

52.232-1 Apr 1984 Payments

52.232-8 Feb 2002 Discounts for Prompt Payment

52.232-9 Apr 1984 Limitation on Withholding of Payments

52.232-11 Apr 1984 Extras

21.

Contract No. HHSO100200500001C

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

52.232-23 Jan 1986 Assignment of Claims

52.232-25 Oct 2003 Prompt Payment

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

52.233-1 Jul 2002 Disputes

52.233-3 Aug 1996 Protest After Award

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

52.243-1 Aug 1987 Changes - Fixed-Price

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

52.245-2 May 2004 Government Property (Fixed-Price Contracts)

52.249-2 Sep 1996 Termination for the Convenience of the Government (Fixed-Price)

52.249-8 Apr 1984 Default (Fixed-Price Supply and Service)(Over $100,000)

52.253-1 Jan 1991 Computer Generated Forms

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES

HHSAR
CLAUSE NO. DATE TITLE
- ---------- ---- -----

352.202-1 Jan 2001 Definitions

352.232-9 Apr 1984 Withholding of Contract Payments

352.270-4 Jan 2001 Pricing of Adjustments

352.270-6 Jul 1991 Publications and Publicity

352.270-7 Jan 2001 Paperwork Reduction Act

End of GENERAL CLAUSES FOR A NEGOTIATED FIXED PRICE SUPPLY CONTRACT - Rev.
07/2004.

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

THESE CLAUSES ARE APPLICABLE TO STATEMENT OF WORK REQUIREMENTS 4e), 8 and 9.

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.arnet.gov/far/.

22.

Contract No. HHSO100200500001C

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CHAPTER 1) CLAUSES

FAR
CLAUSE NO. DATE TITLE
- ---------- ---- -----

52.202-1 Jul 2004 Definitions

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

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

52.203-6 Jul 1995 Restrictions on Subcontractor Sales to the Government (Over $100,000)

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

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

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

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

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

52.204-7 Oct 2003 Central Contractor Registration

52.209-6 Jul 1995 Protecting the Government's Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment (Over $25,000)

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

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

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

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

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

52.215-15 Jan 2004 Pension Adjustments and Asset Reversions

52.215-18 Oct 1997 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than
Pensions

52.215-19 Oct 1997 Notification of Ownership Changes

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

52.216-7 Dec 2002 Allowable Cost and Payment

52.216-8 Mar 1997 Fixed Fee

23.

Contract No. HHSO100200500001C

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

52.219-9 Jan 2002 Small Business Subcontracting Plan (Over $500,000)

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

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.)

52.222-3 Jun 2003 Convict Labor

52.222-26 Apr 2002 Equal Opportunity

52.222-35 Dec 2001 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans

52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities

52.222-37 Dec 2001 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans

52.223-6 May 2001 Drug-Free Workplace

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

52.225-1 Jun 2003 Buy American Act - Supplies

52.225-13 Dec 2003 Restrictions on Certain Foreign Purchases

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

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

52.227-11 Jun 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.

52.227-14 Jun 1987 Rights in Data - General

52.232-9 Apr 1984 Limitation on Withholding of Payments

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

52.232-20 Apr 1984 Limitation of Cost

52.232-23 Jan 1986 Assignment of Claims

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

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

52.233-1 Jul 2002 Disputes

24.

Contract No. HHSO100200500001C

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

52.242-1 Apr 1984 Notice of Intent to Disallow Costs

52.242-3 May 2001 Penalties for Unallowable Costs (Over $500,000)

52.242-4 Jan 1997 Certification of Final Indirect Costs

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

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

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.

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

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

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

52.249-6 Sep 1996 Termination (Cost-Reimbursement)

52.249-14 Apr 1984 Excusable Delays

52.253-1 Jan 1991 Computer Generated Forms

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES:

HHSAR
CLAUSE NO. DATE TITLE
- ---------- ---- -----

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

352.216-72 Oct 1990 Additional Cost Principles

352.228-7 Dec 1991 Insurance - Liability to Third Persons

352.232-9 Apr 1984 Withholding of Contract Payments

352.233-70 Apr 1984 Litigation and Claims

352.242-71 Apr 1984 Final Decisions on Audit Findings

352.270-5 Apr 1984 Key Personnel

352.270-6 Jul 1991 Publications and Publicity

352.270-7 Jan 2001 Paperwork Reduction Act

25.

Contract No. HHSO100200500001C

End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT - Rev. 07/2004.

ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

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

ALTERNATE IV (OCTOBER 1997) of FAR Clause 52.215-21, REQUIREMENTS FOR COST OR
PRICING DATA OR INFORMATION OTHER THAN COST OR PRICING DATA--MODIFICATIONS
(OCTOBER 1997) is added.

FAR Clause 52.232-20 LIMITATION OF COST, is deleted in its entirety and FAR
Clause 52.232-22, LIMITATION OF FUNDS 9APRIL 1984) is substituted therefor.
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.

ARTICLE 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.

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

(1) FAR 52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER
1997).

(2) FAR 52.216-18, Ordering (OCTOBER 1995)

"(a) .... Such orders may be issued from October 29, 2004 through
contract expiration date"

(3) FAR 52.216-22, Indefinite Quantity (OCTOBER 1995).

"(d) ... the Contractor shall not be required to make any
deliveries under this contract after contract expiration date"

(4) FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone
Small Business Concerns (JANUARY 1999).

"(c) Waiver of evaluation preference.....

{ } Offeror elects to waive the evaluation preference."

(5) FAR 52.224-1, Privacy Act Notification (APRIL 1984).

(6) FAR 52.224-2, Privacy Act (APRIL 1984).

(7) FAR 52.227-14, Rights in Data - General (JUNE 1987).

(8) FAR 52.242-3, Penalties for Unallowable Costs (MAY 2001).

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CHAPTER 3) CLAUSES:

(1) HHSAR 352.223-70, Safety and Health (JANUARY 2001). This clause is
provided in full text in SECTION J - ATTACHMENTS.

26.

Contract No. HHSO100200500001C

(2) HHSAR 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.

(3) HHSAR 352.270-9, Care of Live Vertebrate Animals (JANUARY 2001).

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

This contract incorporates the following clauses in full text.

FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES:

a. FAR Clause 52.216-19, ORDER LIMITATIONS (OCTOBER 1995)

(a) Minimum Order. When the Government requires supplies or services
covered by this contract in an amount of less than 25,000,000 doses
of rPA Anthrax vaccine, the Government is not obligated to purchase,
nor is the Contractor obligated to furnish, those supplies or
services under the contract.

(b) Maximum Order. The Contractor is not obligated to honor--

(2) Any order for a single item in excess of 75,000,000 doses of
rPA Anthrax vaccine .

(3) Any order for a combination of items in excess of 75,000,000
doses of rPA Anthrax vaccine ; or

(4) A series of orders from the same ordering office within 30days
that together call for quantities exceeding the limitation in
subparagraph (1) or (2) above.

(c) If this is a requirements contract (i.e., includes the Requirements
clause at subsection 52.216-21 of the Federal Acquisition Regulation
(FAR)), the Government is not required to order a part of any one
requirement from the Contractor if that requirement exceeds the
maximum-order limitations in paragraph (b) above.

(d) Notwithstanding paragraphs (b) and (c) above, the Contractor shall
honor any order exceeding the maximum order limitations in paragraph
(b), unless that order (or orders) is returned to the ordering
office within 30days after issuance, with written notice stating the
Contractor's intent not to ship the item (or items) called for and
the reasons. Upon receiving this notice, the Government may acquire
the supplies or services from another source.

b. FAR Clause 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS (JULY 2004)

(a) Definitions. As used in this clause--

Commercial item, has the meaning contained in Federal Acquisition
Regulation 52.202-1, Definitions.

Subcontract, includes a transfer of commercial items between
divisions, subsidiaries, or affiliates of the Contractor or
subcontractor at any tier.

(b) To the maximum extent practicable, the Contractor shall incorporate,
and require its subcontractors at all tiers to incorporate,
commercial items or nondevelopmental items as components of items to
be supplied under this contract.

27.

Contract No. HHSO100200500001C

(i) 52.219-8, Utilization of Small Business Concerns (MAY
2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts
that offer further subcontracting opportunities. If the
subcontract (except subcontracts to small business
concerns) exceeds $500,000 ($1,000,000 for construction
of any public facility), the subcontractor must include
52.219-8 in lower tier subcontracts that offer
subcontracting opportunities.

(ii) 52.222-26, Equal Opportunity (APR 2002) (E.O.11246).

(iii) 52.222-35, Equal Opportunity for Special Disabled
Veterans, Veterans of the Vietnam Era, and Other
Eligible Veterans (DEC 2001) (38 U.S.C. 4212(a)).

(iv) 52.222-36, Affirmative Action for Workers with
Disabilities (JUN 1998) (29 U.S.C. 793).

(v) 52.247-64, Preference for Privately Owned U.S. Flag
Commercial Vessels (APR 2003) (46 U.S.C. Appx 1241 and
10 U.S.C. 2631) (flow down required in accordance with
paragraph (d) of FAR clause 52.247-64).

(2) While not required, the Contractor may flow down to
subcontracts for commercial items a minimal number of
additional clauses necessary to satisfy its contractual
obligations.

(d) The Contractor shall include the terms of this clause, including
this paragraph (d), in subcontracts awarded under this contract.

28.

Contract No. HHSO100200500001C

PART III

SECTION J - LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract

1. Statement of Work, November 4,2004, 5 pages.

2. Invoice Instructions for Fixed-Price Contracts, 1 page.

3. Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page.

4. Privacy Act System of Records, Number (PENDING)

5. Safety and Health, HHSAR Clause 352.223-70, (1/01), 1 page.

6. Research Patient Care Costs, 1 page.

29.

Contract No. HHSO100200500001C

PART IV

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

1. Representations and Certifications, dated October 22, 2004.

2. Human Subjects Assurance Identification Number FWA00001083.

3. Animal Welfare Assurance Number (To be obtained after contract award).

END of the SCHEDULE

(CONTRACT)

30.

Contract No. HHSO100200500001C

STATEMENT OF WORK

Acquisition of Licensed Recombinant Protective Antigen

Anthrax vaccine for the Strategic National Stockpile

[ * ]

2.) Specific Technical Requirements

[ * ]

Statement of Work ATTACHMENT 1
(11/04/04) Page 2

Contract No. HHSO100200500001C

Development and Licensure of rPA Anthrax Vaccine:

Requirement 1 - Vaccine Production and cGMP Compliance

[ * ]

Requirement 2 - Stability Testing of Finished Vaccine

[ * ]

Requirement 3 - Design of Safety and Efficacy Studies

[ * ]

Requirement 4 - Conduct Safety and Efficacy Studies

[ * ]

Requirement 5 - Regulatory Submissions

[ * ]

Requirement 6 - Shipment to SNS and Storage

[ * ]

Requirement 7 - Disposition of Vaccine Inventory

[ * ]

Requirement 8 - Maintaining a "Warm Base"

[ * ]

Requirement 9 - Clinical Trials in Special Populations

[ * ]

Requirement 10 - Security of Contract Operations

[ * ]

3.) Meetings and Conferences

[ * ]

Statement of Work ATTACHMENT 1
(11/04/04) Page 2

Contract No. HHSO100200500001C

INVOICE INSTRUCTIONS FOR FIXED-PRICE CONTRACTS.

General The contractor shall submit vouchers or invoices as prescribed herein.

Format Standard Form 1034, Public Voucher for Purchases and Services Other Than
Personal, and Standard Form 1035, Public Voucher for Purchases and Services
Other than Personal--Continuation Sheet, or the payee's letterhead or
self-designed form should be used to submit claims for reimbursement.

Number of Copies As indicated in the Invoice Submission Clause in the contract.

Frequency Invoices submitted in accordance with the Payment Clause shall be
submitted upon delivery of goods or services unless otherwise authorized by the
contracting officer.

Preparation and Itemization of the Invoice The invoice shall be prepared in ink
or typewriter as follows:

(a) Designated Billing Office and address

(b) Invoice Number

(d) Both the contract number and the ADB number (which appears in the
upper left hand corner of the face page of the contract), and date

(e) Payee's name and address. Show the contractor's name ( as it appears
in the contract), correct address, and the title and phone number of
the responsible official to whom payment is to be sent. When an
approved assignment has been made by the contractor, or a different
payee has been designated, then insert the name and address of the
payee instead of the contractor.

(f) Description of goods or services, quantity, unit price, (where
appropriate), and total amount.

(g) Charges for freight or express shipments other than F.O.B.
destination. (If shipped by freight or express and charges are more
than $25, attach prepaid bill.)

(h) Equipment If there is a contract clause authorizing the purchase of
any item of equipment, the final invoice must contain a statement
indicating that no item of equipment was purchased or include a
completed NIH Form entitled, "Report of Government Owned, Contractor
Held Property."

Currency All DHHS contracts are expressed in United States dollars. Where
payments are made in a currency other than United States dollars, billings on
the contract shall be expressed, and payment by the United States Government
shall be made, in that other currency at amounts coincident with actual costs
incurred. Currency fluctuations may not be a basis of gain or loss to the
contractor. Notwithstanding the above, the total of all invoices paid under this
contract may not exceed the United States dollars authorized.

ATTACHMENT 2

Contract No. HHSO100200500001C

PRIVACY ACT SYSTEM OF RECORDS

**** THE PRIVACY ACT SYSTEM OF RECORDS WILL BE ADDED TO THE CONTRACT IN A FUTURE
MODIFICATION. ****

Privacy Act System of Records ATTACHMENT 3
( / / ) 1

Contract No. HHSO100200500001C

HHSAR 352.223-70 SAFETY AND HEALTH (JANUARY 2001)

(a) To help ensure the protection of the life and health of all persons, and
to help prevent damage to property, the Contractor shall comply with all
Federal, State and local laws and regulations applicable to the work being
performed under this contract. These laws are implemented and/or enforced
by the Environmental Protection Agency, Occupational Safety and Health
Administration and other agencies at the Federal, State and local levels
(Federal, State and local regulatory/enforcement agencies).

(b) Further, the Contractor shall take or cause to be taken additional safety
measures as the Contracting Officer in conjunction with the project or
other appropriate officer, determines to be reasonably necessary. If
compliance with these additional safety measures results in an increase or
decrease in the cost or time required for performance of any part of work
under this contract, an equitable adjustment will be made in accordance
with the applicable "Changes" Clause set forth in this contract.

(c) The Contractor shall maintain an accurate record of, and promptly report
to the Contracting Officer, all accidents or incidents resulting in the
exposure of persons to toxic substances, hazardous materials or hazardous
operations; the injury or death of any person; and/or damage to property
incidental to work performed under the contract and all violations for ---
which the Contractor has been cited by any Federal, State or local
regulatory/enforcement agency. The report shall include a copy of the
notice of violation and the findings of any inquiry or inspection, and an
analysis addressing the impact these violations may have on the work
remaining to be performed. The report shall also state the required
action(s), if any, to be taken to correct any violation(s) noted by the
Federal, State or local regulatory/enforcement agency and the time frame
allowed by the agency to accomplish the necessary corrective action.

(d) If the Contractor fails or refuses to comply promptly with the Federal,
State or local regulatory/enforcement agency's directive(s) regarding any
violation(s) and prescribed corrective action(s), the Contracting Officer
may issue an order stopping all or part of the work until satisfactory
corrective action (as approved by the Federal, State or local
regulatory/enforcement agencies) has been taken and documented to the
Contracting Officer. No part of the time lost due to any stop work order
shall be subject to a claim for extension of time or costs or damages by
the Contractor.

(e) The Contractor shall insert the substance of this clause in each
subcontract involving toxic substances, hazardous materials, or
operations. Compliance with the provisions of this clause by
subcontractors will be the responsibility of the Contractor.

(End of clause)

Safety and Health Clause ATTACHMENT 5
HHSAR 352.223-70, (1/01) 1

Contract No. HHSO100200500001C

RESEARCH PATIENT CARE COSTS

(a) Research patient care costs are the costs of routine and ancillary
services provided to patients participating in research programs described
in this contract.

(b) Patient care costs shall be computed in a manner consistent with the
principles and procedures used by the Medicare Program for determining the
part of Medicare reimbursement based on reasonable costs. The Diagnostic
Related Group (DRG) prospective reimbursement method used to determine the
remaining portion of Medicare reimbursement shall not be used to determine
patient care costs. Patient care rates or amounts shall be established by
the Secretary of HHS or his duly authorized representative.

(c) Prior to submitting an invoice for patient care costs under this contract,
the contractor must make every reasonable effort to obtain third party
payment, where third party payors (including Government agencies) are
authorized or are under a legal obligation to pay all or a portion of the
charges incurred under this contract for patient care.

(d) The contractor must maintain adequate procedures to identify those
research patients participating in this contract who are eligible for
third party reimbursement.

(e) Only those charges not recoverable from third party payors or patients and
which are consistent with the terms and conditions of the contract are
chargeable to this contract.

ATTACHMENT 6