JOFOC_Seqiris_H5N8_P C_Study_Redacted.pdf

Class Justification for Other than Full and Open Competition see FAR 2.101 and 3.104 "

1. Identification of the agency and contracting activity.

Agency: United States Department of Health and Human Services (HHS) Office of the Secretary Assistant Secretary for Preparedness and Response (ASPR)

Sponsoring organization:

Contracting Officer:

Contracting Officer's Rep:

Biomedical Advanced Research and Development Authority (BARDA), Influenza Division (ID)

2. Nature and/or description of the action being approved.

In accordance with FAR Subparts 6.302-1 under Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, this justification seeks authority to approve the utilization ofNovartis as a sole source contractor to perform H5N8 physical chemical compatibility (PC) study.

3. Description of the supplies or sentices required to meet the agency's needs (including the estimated value).

Project Title. Physical chemical compatibility study of H5N8 vaccine

Project Description. The objective of this requirement is to assess the compatibility of A/Influenza H5N8 pandemic vaccine

This will involve "use time stability" studies where vaccines and adjuvant are mixed and held at room temperature for up to 24 hours to support a targeted 8 hours use time

Requirement type.

0 Research & development (R&D) 0 R & D support services 1::&:1 Support services (non-R&D) 0 Supplies/equipment

0 Information technology (IT) 0 Construction 0 Architect-engineer (A & E) services D Design-build D Other (specify): _______ _

Type of action.

l&l New requirement 0 Follow-on 0 Other (specify):

Proposed contract/order type.

1:&1 Firm-fixed-price 0 Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): ___ _ 0 Cost-plus-fixed-fee 0 Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ____ _ 0 Time and materials 0 Indefmite delivery/Indefinite Quantity 0 Other (specify): ---=--- 0 Completion Form 0 Term form

Acquisition identification number. TBD

Total estimated dollar value and performance/delivery period.

The total estimated dollar value for the contract is for physical chemical compatibility of H5N8 vaccine The performance/delivery period for this activity is estimated to be 2 months from the issuance of a new contract.

4. Identification of the statutory authority permitting an exception to fair opportunity and supporting rational and the supporting rationale including a demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the exception cited.

a. Identification of the statutory authority permitting an exception to fair opportunity.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c) (1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

When the supplies or services required by the agency are available from only one responsible source, or, for DoD, NASA, and the Coast Guard, from only one or a limjted number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

b. Name and address of the proposed contractor(s).

Size of Contractor: Large Business

Novartis 75 Sidney Street, Mailstop 172J Cambridge, MA 02139

c. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Novartis has been awarded several contracts since 2005 to suppo1t advanced development for cell based influenza vaccine, for antigen sparing strategy, for pre-pandemic preparedness and response through vaccine stockpile contracts. In addition, Novartis has conducted several PC studies with H5Nl and H7N9 vaccine to support clinical studies.

Novartis is the only manufacturer of influenza vaccines under contract for "Acquisition of MCMs for Pandemic Influenza Preparedness and Response" used in clinical studies sponsored by NIH. Novartis has exclusive access to the regulatory documentation required for PC study.

Novartis is the only company on contract ready to conduct PC study. The other contractors under contract would need to expend significant time, resources and effmi to manufacture, formulate/fill

The costs to achieve this objective are significantly higher than the value of this award.

5. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

Because HHS is currently under contract with Novartis and other influenza vaccine manufacturers to do similar activities as those contemplated in this justification, HHS has significant historical and current cost data available for it to determine the cost to be fair and reasonable.

6. Any other facts supporting the justification.

None.

7. A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

A unique property of this exemption request is the prior experience in conducting PC study Currently, only Novartis is qualified at this time to respond to PC study and satisfying all needs for the timely accomplishment of the PC study based on prior experiences as mentioned above.

8. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government's minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official

Project Officer

Head of the Sponsoring

Program Office

Name & Title

9. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Officia l

Contracting Officer

Name & Title

10. Chief of the Contracting Office and Head of the Contracting Activity signature(s). .{; 1-1/) U f-<.

Date

Official Name & Title Si~nature Date Chief of the Contracting N!A Gv[;'-

Office (Acting) ~ t-OJ

Head of the Contracting I Activity

11. Competition Advocate signature. I Official Name & Title Signature Date

Competition 4 ·1-:to& Advocate ~ 'c ~