Tax ID Number:20 ###-###-#### DUNS Number:082804936

The purpose of this modification is to increase the estimated cost of the contract from

$[***] by $[***] to $[***]. The estimated fixed fee remains unchanged at

$[***]. The total estimated cost and fixed fee of the contract is increased by

$3,700,000 from $24,081,404 to $27,781,404. Additionally, Articles B.2, B.3, C.1, G.3 and Section J - Attachment 1 are modified as outlined in the supplemental pages to this modification and the Statement of Work dated September 14, 2018 is amended to incorporate the data dated 7/30/2019 covering WBS 1.1.10, WBS 1.5.10, WBS 1.5.11.

 

TOTAL FUNDS ALLOTED TO DATE:$27,781,404 (Changed)

Continued ...

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

 

 

NAME OF OFFEROR OR CONTRACTOR

ALTIMMUNE, INC. 1305044

 

NSN 7540-01-152-8067OPTIONAL FORM 336 (4-86)

Sponsored by GSA FAR (48 CFR) 53.110

 

 

 

 

Beginning with the effective date of this modification, the Government and contractor mutually agree as follows:

 

1)Revise ARTICLE B.2 - Estimated Cost and Fixed Fee as follows:

 

 

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

paid subject to the Allowable Cost and Payment and Fixed Fee Clauses.

 

 

 

 

2)Revise ARTICLE B.3 – Option Prices as follows:

 

ARTICLE B.3. OPTION PRICES

The starting date of the period of performances for CLIN 0002 (Option 1) through CLIN 0008 (Option 7) are revised from January 1, 2021 to March 31, 2021.

 

 

 

ARTICLE C.1. STATEMENT OF WORK

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 dated September 14, 2018 (including additional activities WBS 1.1.10, 1.5.10 and 1.5.11) set forth in SECTION J-List of Attachments, attached hereto and made a part of the contract.

 

4)SECTION J (LIST OF ATTACHMENTS)

 

Attachment 1 (Statement of Work dated September 14, 2018) is revised to incorporate NasoShield Post-Investigation Phase 1b Trial & Non-Clinical Studies WBS 1.1.10, 1.5.10, 1.5.11 dated July 30, 2019. (16 pages)

 

5)ARTICLE G.3 KEY PERSONNEL

 

Article G.3 is deleted and replaced with the following:

 

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

 

 

 

The key personnel specified in this contract are considered to be essential to work performance. At least thirty (30) business days prior to diverting any of the specified individuals to other programs or contracts, including, where practicable, an instance when an individual must be replaced as a result of leaving the employ of the Contractor, the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer.

 

 

Revised Statement of Work:

 

Broad Agency Announcement (BAA) for the Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures for BARDA

 

 

 

CBRN-BAA-13-100-SOL-00013

Development of a Single-Dose Intranasal Vaccine for Post-Exposure Prophylaxis of Inhalation Anthrax

Topic Area of Interest Number 1: Vaccines

 

Contractual Statement of Work

September 14, 2018

PREAMBLE

 

Independently and not as an agency of the Government, the Contractor shall be required to furnish to The Government all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work submitted in response to the BARDA Broad Agency Announcement (BAA) CBRN-BAA-13- 100-SOL-00013.

The Government reserves the right to modify the milestones, progress, schedule, budget or deliverables to add or delete deliverables, process or schedules if the need arises. Because of the nature of this research and development (R&D) contract and the complexities inherent in this and prior programs, at designated milestones the Government will evaluate whether work should be redirected, removed, or whether schedule or budget adjustments should be made. The Government reserves the right to change the product, process, schedule or events to add or delete part or all these elements as the need arises.

 

Overall Objectives and Scope

 

The overall objective of this contract is to advance the development of AdVAV as a novel, intranasally administered vaccine for use in protection against anthrax infection. The scope of work for this contract includes pre-clinical, clinical and manufacturing development activities that fall into the following areas: nonclinical efficacy studies; clinical activities; manufacturing activities; and all associated regulatory, quality assurance, management and administrative activities. The development effort for AdVAV will progress in specific stages that cover the base performance segment and the option segments as specified in this contract. The Contractor must complete specific tasks required in the base work segment before the Government will exercise any or all the option segments. The scope of work includes the following tasks integral to the successful completion of CLIN 0001 (Base segment) and CLIN 0002 through CLIN 0008 (Option segments).

 

 

1.[***]

1.3.1[***]

1.3.2[***]

1.3.3[***]

1.3.4[***]

2.[***]

3.[***]

4.[***]

5.[***]

5.2.1[***]

6.[***]

7.[***]

8.[***]

9.[***]

9.1.4[***]

 

NasoShield Post-Investigation Phase 1b Trial & Non-

Clinical Studies SOW dated July 30, 2019

 

[***]

 

 

(WBS 1.1.10): [***]

 

[***]

 

(WBS 1.5.10): [***]

 

[***]

 

(WBS 1.5.11): [***]

[***]

 

Activities & Deliverables

 

[***]

 

END OF MODIFICATION 06 of HHSO100201600008C