Exhibit 10.1

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

N/A

PAGE OF PAGES

1

6

2. AMENDMENT/MODIFICATION NO.

Modification #01

3. EFFECTIVE DATE

See block 16c

4. REQUISITION/PURC

N/A

5. PROJECT NO. (If applicable)

N/A

6. ISSUED BY
Department of Health and Human Services
Office of Research and Development Coordination
Office of Public Health Emergency Preparedness
200 Independence Avenue, SW, Room 636G

Washington, DC 20201

CODE

 

7. ADMINISTERED BY (If other than Item 6)

 

 

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State, and Zip Code)

 

VaxGen, Inc.

1000 Marina Boulevard, Suite 200

Brisbane, CA 94005-1841

 

x

 

9A. AMENDMENT OF SOLICITATION NO.

 

 

9B. DATED (SEE ITEM 11)

 

x

 

10A. MODIFICATION OF CONTRACT/ORDER NO. Contract No. HHSO100200500001C

 

 

 

CODE:

 

 

FACILITY CODE:

10B. DATED (SEE ITEM 13)

November 4, 2004

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

o The above numbered solicitation is amended as set forth in Item 14. The hour
and date specified for receipt of Offers o is extended, o is not extended.

 

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods:
(a) By completing Items 8 and 15, and returning _______ copies of the amendment;
(b) By acknowledging receipt of this amendment on each copy of the offer
submitted; or (c) By separate letter or telegram which includes a reference to
the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this
amendment, you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If Required)

NA

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE
CONTRACT/ORDER NO., AS DESCRIBED IN ITEM 14.

 

x

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify Authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

o

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH
IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103 (b).

 

o

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

 

 

o

D. OTHER (Specify type of modification and authority)

 

E. IMPORTANT: Contractor

x

is NOT

o

is required to sign this document and return

 

copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings,
including solicitation/contract subject matter where feasible)

 

PURPOSE: To purpose of this modification is to modify Articles B.2., B.4., C.3.,
F.1., G.2., G.5., H.3, H.8., and H.11.

TOTAL FIXED PRICE DELIVERY ORDER $877,500,000 for 75 Million does of rPA Anthrax
Vaccine

EXPIRATION DATE: October 31, 2012 (Changed)

CONTRACT TYPE: IDIQ Fixed Price Delivery Order and Cost-reimbursement Task
Orders)

 

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

 

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Sharon M. Kraft, Contracting Officer

HHS/OS/ORDC

15B. CONTRACTOR/OFFEROR

15C. DATE

SIGNED

16B. UNITED STATES OF AMERICA

 

BY /s/ Sharon M. Kraft____________

16C. DATE SIGNED

(Signature of person authorized to sign)

 

(Signature of Contracting Officer)

5/5/06

 

NSN 7540-01-152-8070

OMB No. 0990-0115

STANDARD FORM 30 (REV. 10-83)
FAR (48 CFR) 53.243

 

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ARTICLE B.2. PRICES - paragraph b. is revised to read as follows:

b. The prices set forth in the ARTICLE B.2. will cover the contract period
November 4, 2004 through October 31, 2012.

ARTICLE B.4. ADVANCE UNDERSTANDINGS - paragraph 14. is added to read as follows:

14. The Contractor shall complete all work in accordance with the Statement of
Work and the contract milestones set forth below:

Milestones

Contract Completion Date

1. Release BDS for Clinical Use:

a. [ * ]

b. [ * ]

1. July 13, 2006

a. [ * ]

b. [ * ]

2. Release DP for Clinical Use:

a. [ * ]

b. [ * ]

2. November 9, 2006

a. [ * ]

b. [ * ]

3. Demonstrate Adequate Vaccine Stability to Support Clinical Use:

a. [ * ]

b. [ * ]

3. November 9, 2006

 

a. [ * ]

b. [ * ]

4. Initiate BDS Process Validation:

a. [ * ]

b. [ * ]

c. [ * ]

d. [ * ]

e. [ * ]

f. [ * ]

g. [ * ]

h. [ * ]

4. October 13, 2006

a. [ * ]

b. [ * ]

c. [ * ]

d. [ * ]

e. [ * ]

f. [ * ]

g. [ * ]

h. [ * ]

5. Initiate DP Process Validation/Consistency Lots:

a. [ * ]

b. [ * ]

c. [ * ]

d. [ * ]

e. [ * ]

 

5. June 29, 2007

a. [ * ]

b. [ * ]

c. [ * ]

d. [ * ]

e. [ * ]

6. Initiate Next Clinical Trial:

a. [ * ]

b. [ * ]

c. [ * ]

d. [ * ]

e. [ * ]

 

6. November 13, 2006

a. [ * ]

b. [ * ]

c. [ * ]

d. [ * ]

e. [ * ]

 

[ * ] = 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.

 

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Modification #01

 

 

 

 

7. FDP Consistency Lot Doses Released for Use:

a. [ * ]

b. [ * ]

7. October 18, 2007

a. [ * ]

b. [ * ]

8. Demonstrate Human Safety and Immunogenicity (VAX023):

a. [ * ]

8. October 19, 2007

9. Demonstrate 18 month real time FDP Stability

9. April 1, 2009

10. Demonstrate Animal efficacy to Support EUA or

Contingency Use:

a. Conduct successful pivotal PEP animal efficacy study using vaccine produced
and tested using validated procedures, and submit report to CBER and DHHS

10. August 10, 2008

11. Demonstrate Human Safety and Immunogenicity to Support

EUA or Contingency Use:

a. Confirm safety and immunogenicity of chosen vaccine dose and formulation
using consistency lots

11. October 10, 2008

12. IND Amendment to Support EUA or Contingency Use:

a. [ * ]

b. [ * ]

c. [ * ]

12. November 7, 2008

a. [ * ]

b. [ * ]

c. [ * ]

13. Complete Delivery of 25 M Doses into SNS Per Article

F.1.(a)

 

13. October 25, 2009

14. Complete Delivery of 50 M Doses into SNS Per Article F.1.(a)

 

14. June 27, 2010

15. Complete Delivery of 75 M Doses into SNS Per Article F.1.(a)

 

15. February 7, 2011

16. Submit BLA to Support Post-Exposure Prophylaxis

Indication:

a. [ * ]

b. [ * ]

c. [ * ]

16. July 13, 2010

a. [ * ]

b. [ * ]

c. [ * ]

17. Submit BLA to Support Pre-Exposure Prophylaxis Indication:

a. [ * ]

b. [ * ]

c. [ * ]

17. February 18, 2011

a. [ * ]

b. [ * ]

c. [ * ]

 

ARTICLE C.3. INVENTION REPORTING REQUIREMENTS-is modified to read as follows:

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:

 

[ * ] = 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.

 

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Contract No. HHS0100200500001C

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Modification #01

 

 

Contracting Officer

ORDC, OPHEP, DHHS

6700-B Rockledge Drive, MSC 7612

Room 4119

Bethesda, MD 20892 -7612

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.

ARTICLE F.1. DELIVERIES-paragraphs (a) and b. are amended to read as follows:

(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 by October 25, 2009,
delivery of 50 million doses by June 27, 2010 and 75 million doses by February
7, 2011.

 

b.

The above items shall be addressed and delivered to:

 

Addressee
Project Officer

ORDC, OPHEP, DHHS
200 Independence Avenue, S.W.
Room 624D

Washington, DC 20201

 

Contracting Officer

ORDC, OPHEP, DHHS
6700-B Rockledge Drive, MSC 7612
Room 4119
Bethesda, MD 20892-7612

Deliverable Item No.
(1) and (2) and
(a) - (f) set forth above

 

 

 

 

(1) and (2)

Quantity

(3)

 

 

 

 

 

(1)

 

ARTICLE G.2. KEY PERSONNEL-is amended to read as follows:

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.5. INVOICE SUBMISSION-is amended to read as follows:

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

[ * ] = 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.

 

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Contract No. HHS0100200500001C

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Modification #01

 

 

following directions for the submission of invoices must be followed to meet the
requirements of a “proper” invoice, pursuant to FAR 32.9.

(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. HHS0100200500001C

 

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

 

Contracting Officer

ORDC, OPHEP, DHHS

6700-B Rockledge Drive, MSC 7612

Room 4119

Bethesda, MD 20892-7612

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

ARTICLE H.3. NEEDLE EXCHANGE -paragraph b. is hereby modified as follows:

b. Public Law and Section No.

Fiscal Year

Period Covered

P.L. 108-447, Title V -

 

General Provisions, Section 505

2005

10/01/04 – 09/30/05

ARTICLE H.8. PRESS RELEASES -paragraph b. is hereby modified as follows:

b. Public Law and Section No.

Fiscal Year

Period Covered

P.L. 108-447, Title V -

 

General Provisions, Section 506

2005

10/01/04 – 09/30/05

ARTICLE H.11. ANTI-LOBBYING -paragraph c. is hereby modified as follows:

c. Public Law and Section No.

Fiscal Year

Period Covered

for a., above: P.L. 108-447,

Title V - General Provisions,

 

Section 503a

2005

10/1/04 – 9/30/05

 

 

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Contract No. HHS0100200500001C

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Modification #01

 

 

 

for b., above, P.L. 108-447,

Title V - General Provisions,

 

Section 503b

2005

10/1/04 -9/30/05

 

No other terms or conditions are changed by this modification.

 

 

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