NOI_MF59T.pdf

NOTICE OF INTENT

Solicitation Number:

Intent-2018-MF59T

Notice Type:

Special Notice

Synopsis Date:

May 24, 2018

Notice of Intent to Use Other Than Full and Open Competition

Action Code: Notice of Intent to Sole Source

Agency: Department of Health and Human Services

Office: Office of Secretary, Assistant Secretary for Preparedness and Response (ASPR), Office of

Acquisition Management, Contracts and Grants (AMCG) on behalf of Biomedical

Advanced Research and Development Authority (BARDA)

Location: 200 C Street, O’Neil House Office Building, Washington, DC 20515

The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Office of Acquisitions Management, Contracts & Grants (AMCG), and Office of the

Biomedical Advanced Research and Development Authority (BARDA), intend to use other than full and open competition to award a sole source contract to Seqirus, Inc. to generate stability and leachable/extractable (L/E) data on HHS owned bulk MF59 manufactured in 2009 currently being stored at

UPS facility in Lousiville, KY. Additionally, to acquire data to establish the need to continue stability testing for the maintenance long-term stored product or dispose.

This notice of intent to award a sole source contract will be posted for 15 calendar days to verify that no other sources can meet this requirement given only one responsible source and no other supplies or services will satisfy the Government requirements. The Government seeks to avoid substantial duplication of cost and extensive time that is not expected to be recovered through competition. Testing the product in-house at Seqirus is more advantageous and timely for the Government to mitigate risk of transporting the product for testing from another source and to eliminate additional cost. This 15 calendar day notice shall expire on June 8th, 2018 at 12:00 PM Eastern Time (ET).

If no credible responses to the intent to sole source are received, the Government intends to negotiate a firm fixed price purchase order to Seqirus, Inc. The proposed contract action will support services for which the Government intends to solicit and negotiate with only one source under the authority of the Federal Acquisition Regulation (FAR) 6.302-1 entitled “Only one reasonable source and no other supplies or services will satisfy agency requirements”. This notice of intent is not a request for competitive proposals.

Interested parties may identify their interest and capability to respond to this requirement by submitting in writing their name, address, telephone number, email, and a statement regarding capability to provide the specified requirement. Responses shall be limited to ten (10) pages or less, including all attachments. Interested parties will be considered only if they respond to this notice with clear and convincing evidence that competition would be advantageous to the Government, would not be cost or time prohibitive. All capability statements, proposals, or quotes received prior to June 8th, 2018 at

12:00 PM ET will be considered by the Government. The Government will not be responsible for any costs incurred by responding to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

Anticipated Award Date and Period of Performance:

The Government anticipates an award date in FY2018. The estimated period of performance is 90 days from date of award.

Delivery Schedule:

The delivery schedule of the bulk MF59 testing and final report will be established during contract negotiations.

Contract Type:

The Government proposes the award of firm-fixed price purchase order for the procurement of MF59 testing and final report.

Estimated award amount:

The total estimated dollar value for this procurement is $42,247.

Background:

The National Strategy for Pandemic Influenza (2005) describes the activities to be undertaken before a pandemic to ensure preparedness. The strategy seeks to “established domestic production capacity and stockpile of countermeasures to ensure sufficient vaccine to vaccinate frontline personnel and at risk-populations.” One of the goals in the Implementation Plan for the National Strategy for Pandemic

Influenza (2006) is the “establishment and maintenance of stockpiles of pre-pandemic vaccine adequate to immunize 20 million persons against influenza viruses that pose a pandemic threat.” Since 2005, the government has purchased millions of doses of influenza pre-pandemic vaccines and adjuvants and placed them on stability with routine product monitoring. In 2009 to prepare and respond to the H1N1 pandemic HHS acquired 87M doses of MF59. The MF59 was under a stability program, ended in 2014.

In 2015 CSL acquired Novartis which became Seqirus, Inc. and the new Seqirus management made a business decision to limit the use and testing of MF59 to a maximum of 5 years from date of manufacture in order to avoid risk to their commercial product. Therefore the MF59 bulk lots owned by HHS have not been tested for stability since 2015 and it is not possible to assess the quality of the long-term stored

MF59 adjuvant unless stability testing is conducted.

This SSN is focused on support to generate stability and leachable/extractable (L/E) data on HHS owned bulk MF59 manufactured in 2009 currently being stored at UPS facility in Lousiville, KY and to generate a final report.

Seqirus possesses an adjuvant technology (MF59), unique to Seqirus, which has clearly shown effectiveness in combination with influenza pre-pandemic vaccine antigen. This effectiveness is shown by a number of parameters, including: the 6-12 fold antigen sparing (6-12 fold reduced antigen concentration) effect, and an enhanced immune response (higher amounts of antibody, longer duration of antibody presence after vaccination, and greater cross-reactivity against different vaccine strains). The

MF59 adjuvanted vaccine is considered safe and well-tolerated and has been administered in million people. HHS acquired million doses of MF59 adjuvant during the H1N1 pandemic and has been stored and under stability program until 2015, when Seqirus decided not to continue stability testing of the

MF59 adjuvant (shelf life of max 5 years). Seqirus is currently in possession of the product; therefore it’s more advantageous to the Government to have the testing done in-house. Due to the high value of the adjuvant it is critical to test the stability of the adjuvant as soon as possible and Seqirus have carried on

MF59 stability testing for many years with established and validated methods in a short time.

Contracting Office Address:

Office of the Assistant Secretary for Preparedness & Response (ASPR)

Department of Health and Human Services

200 C Street

O’Neill House Office Building

Washington, District of Columbia

20515 United States

Place of Performance:

Seqirus, Inc.

475 Green Oaks Parkway

Holly Springs, NC 27540

Primary Point of

Contact:

Sherica Teshome

Contracting Officer

Sheirca.Teshome@hhs.gov

Phone: 202-205-5919

Secondary Point of Contact:

Kyle Roberts

Contract Officer

Kyle.Roberts@hhs.gov

Phone: (202) 260-0747 mailto:Sheirca.Teshome@hhs.gov mailto:Kyle.Roberts@hhs.gov