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75A50126C00004

Definitive Contract

Overview

Government Description
Late-stage development, FDA marketing authorization, procurement, and stockpile of antibiotics for the treatment of drug-resistant secondary bacterial infections and/or the treatment or pep of infections caused by biothreat pathogens. Includes advancing antibiotics for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and bloodstream infections (BSI), as well as post-exposure prophylaxis and/or treatment of biothreat pathogens. Activities involve domestic drug substance manufacturing and fill/finish drug product manufacturing, with vendors required to have existing domestic capabilities or a plan to onshore manufacturing. Work may be performed at responder facilities or subcontracted to commercial laboratories, contract research organizations, or contract manufacturing organizations.
Awardee
Place of Performance
Florham Park, NJ 7932 United States
Pricing
Cost Plus Fixed Fee
Set Aside
None
Extent Competed
Full And Open Competition
Est. Average FTE
240
Shionogi was awarded Definitive Contract 75A50126C00004 (75A501-26-C-00004) for Late-Stage Antibiotic Development, FDA Authorization, Procurement, and Stockpile (HABP/VABP, BSI, PEP, Biothreat Pathogens) worth up to $481,678,318 by the HHS Office of the Assistant Secretary for Preparedness and Response in April 2026. The contract has a duration of 10 years and was awarded through solicitation Pre Solicitation - Antibiotic for Treatment of Bacterial Pneumonia or Bloodstream Infections full & open with NAICS 541714 and PSC AN13 via direct negotiation acquisition procedures with 1 bid received. As of today, the Definitive Contract has a total reported backlog of $362,517,627.

Status
(Open)

Last Modified 4/6/26
Period of Performance
4/6/26
Start Date
3/10/36
Current End Date
3/10/36
Potential End Date
0% Complete

Obligations and Backlog
$119.2M
Total Obligated
$119.2M
Current Award
$481.7M
Potential Award
25% Funded
$0.0
Funded Backlog
$362.5M
Total Backlog

Award Hierarchy

Definitive Contract

75A50126C00004

Subcontracts

0

Activity Timeline

Interactive chart of timeline of amendments to 75A50126C00004

Opportunity Lifecycle

Procurement history for 75A50126C00004

People

Suggested agency contacts for 75A50126C00004

Competition

Number of Bidders
1
Solicitation Procedures
Negotiated Proposal/Quote
Evaluated Preference
None
Performance Based Acquisition
Yes
Commercial Item Acquisition
Commercial Item Procedures Not Used
Simplified Procedures for Commercial Items
No

Other Categorizations

Subcontracting Plan
Plan Not Required
Cost Accounting Standards
Yes
Business Size Determination
Large Business
Awardee UEI
V8H8DT6RCHW6
Awardee CAGE
37UN1
Agency Detail
Awarding Office
75A501 BARDA - ASPR / DAAPPO / BARDA DCMA
Funding Office
75A501
Created By
hhsveronicastroud
Last Modified By
hhseringreninger1
Approved By
hhseringreninger1

Legislative

Legislative Mandates
None Applicable
Performance District
NJ-11
Senators
Robert Menendez
Cory Booker
Representative
Mikie Sherrill
Modified: 4/6/26