HHS awards $164M contract for botulinum neurotoxin countermeasure development to MAPP Biopharmaceutical

Contract Overview

Contract Amount: $16,413,163 ($16.4M)

Contractor: Mapp Biopharmaceutical, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2020-09-30

End Date: 2026-06-30

Contract Duration: 2,099 days

Daily Burn Rate: $7.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: DEVELOPMENT OF A PAN-BOTULINUM NEUROTOXIN MEDICAL COUNTERMEASURE

Place of Performance

Location: SAN DIEGO, SAN DIEGO County, CALIFORNIA, 92121

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $16.4 million to MAPP BIOPHARMACEUTICAL, INC. for work described as: DEVELOPMENT OF A PAN-BOTULINUM NEUROTOXIN MEDICAL COUNTERMEASURE Key points: 1. Contract focuses on critical biodefense research and development. 2. Competition was full and open, suggesting a robust market. 3. Contract type is Cost Plus Fixed Fee, common for R&D. 4. Performance period is extensive, spanning nearly 7 years. 5. The North American Industry Classification System (NAICS) code indicates a focus on biotechnology research. 6. The contract is a definitive contract, implying a single award. 7. The Small Business Administration (SBA) status is not applicable, suggesting no specific set-aside.

Value Assessment

Rating: fair

Benchmarking the value of this contract is challenging due to its specialized R&D nature and the specific target (pan-botulinum neurotoxin). The Cost Plus Fixed Fee (CPFF) structure is typical for research where costs are uncertain, but it can lead to less price certainty than fixed-price contracts. Without comparable contract data for similar biodefense countermeasure development, a precise value-for-money assessment is difficult. The total award amount of $164.1 million over nearly seven years suggests a significant investment in a high-priority area.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple qualified vendors had the opportunity to bid. This process is designed to foster competition and potentially drive down costs or improve the quality of proposals. The specific number of bidders is not provided, but the 'full and open' designation suggests a competitive environment was sought.

Taxpayer Impact: A full and open competition generally benefits taxpayers by increasing the likelihood of receiving the best value through a competitive bidding process, rather than potentially overpaying in a sole-source or limited competition scenario.

Public Impact

The primary beneficiaries are the U.S. population, through enhanced preparedness against botulinum toxin threats. The service delivered is the research and development of a novel medical countermeasure. The geographic impact is national, focusing on public health security. Workforce implications include specialized jobs in biotechnology and pharmaceutical research within California.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost uncertainty inherent in R&D contracts can lead to budget overruns.
The long performance period increases the risk of scope creep or changing technological landscapes.
Reliance on a single contractor for this critical countermeasure development could pose a risk if performance falters.

Positive Signals

Focus on a critical biodefense capability addresses a significant public health threat.
Full and open competition suggests a potentially strong pool of qualified offerors.
The extensive duration allows for thorough research and development cycles.

Sector Analysis

This contract falls within the Biotechnology (except Nanobiotechnology) Research and Development sector, a critical area for national security and public health. The market for biodefense countermeasures is specialized, often driven by government funding and specific threat assessments. Comparable spending benchmarks are difficult to establish due to the unique nature of developing broad-spectrum neurotoxin treatments, but significant government investment is typical for such advanced R&D projects.

Small Business Impact

The data indicates that this contract was not set aside for small businesses (ss: false, sb: false). Therefore, there are no direct subcontracting implications or specific impacts on the small business ecosystem stemming from a small business set-aside. The prime contractor, MAPP Biopharmaceutical, Inc., is likely a mid-to-large-sized entity capable of undertaking complex R&D.

Oversight & Accountability

Oversight for this contract would typically fall under the Department of Health and Human Services (HHS), specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). Mechanisms likely include regular progress reports, milestone reviews, and financial audits. Transparency is generally maintained through contract award databases, though specific R&D details may be sensitive. Inspector General jurisdiction would apply for investigations into fraud, waste, or abuse.

Related Government Programs

Biodefense Medical Countermeasures
National Biodefense Strategy
Advanced Research Projects Agency for Health (ARPA-H)
Strategic National Stockpile
Botulinum Toxin Research

Risk Flags

R&D Cost Overruns
Long-term Project Viability
Technological Obsolescence
Contractor Performance Risk

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $16.4 million to MAPP BIOPHARMACEUTICAL, INC.. DEVELOPMENT OF A PAN-BOTULINUM NEUROTOXIN MEDICAL COUNTERMEASURE

Who is the contractor on this award?

The obligated recipient is MAPP BIOPHARMACEUTICAL, INC..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $16.4 million.

What is the period of performance?

Start: 2020-09-30. End: 2026-06-30.

What is the specific scientific approach MAPP Biopharmaceutical will use to develop a pan-botulinum neurotoxin medical countermeasure?

The provided data does not detail the specific scientific approach MAPP Biopharmaceutical will employ. Developing a 'pan-botulinum' countermeasure implies targeting multiple types of botulinum neurotoxins (A-G) simultaneously, which is a significant scientific challenge. This could involve strategies such as developing broad-spectrum antibodies, novel small molecules that inhibit toxin activity, or other advanced biotechnological methods. The contract's NAICS code (541714) confirms the focus is on Biotechnology Research and Development. Further details on the technical approach would likely be found in the proposal documents or subsequent technical reports, which are not publicly available in this dataset.

How does the $164.1 million award compare to historical spending on similar biodefense R&D contracts?

Direct comparison of the $164.1 million award to historical spending on 'pan-botulinum neurotoxin' countermeasures is difficult as such specific programs are rare due to the complexity and cost. However, significant government investments in biodefense R&D are common. For instance, contracts for vaccine development, broad-spectrum antiviral research, or other advanced medical countermeasures against biological threats often run into hundreds of millions of dollars over several years. The duration of this contract (nearly 7 years) and its specialized nature suggest the funding level is commensurate with the ambitious goals of developing a novel, broad-acting countermeasure against a serious threat.

What are the key performance indicators (KPIs) or milestones for this contract?

The provided data does not specify the Key Performance Indicators (KPIs) or milestones for this contract. However, for a research and development contract of this nature, KPIs would typically include achieving specific scientific objectives, successful completion of preclinical studies (e.g., in vitro and animal models), demonstration of efficacy and safety, progression through regulatory pathways, and potentially the development of manufacturing processes. The Cost Plus Fixed Fee (CPFF) contract structure often ties payments to the achievement of defined milestones, which are crucial for tracking progress and managing taxpayer investment.

What is the track record of MAPP Biopharmaceutical, Inc. in developing medical countermeasures, particularly for biodefense applications?

Information regarding MAPP Biopharmaceutical, Inc.'s specific track record in developing medical countermeasures, especially for biodefense applications, is not included in the provided data. A comprehensive assessment would require reviewing their past performance on government contracts, publications, patents, and any previously developed or licensed products. Their success in winning this significant contract under full and open competition suggests they possess relevant capabilities and experience deemed sufficient by the Department of Health and Human Services (HHS) to undertake this complex research and development effort.

What are the potential risks associated with the Cost Plus Fixed Fee (CPFF) contract type for this project?

The Cost Plus Fixed Fee (CPFF) contract type, while common for R&D where costs are uncertain, carries inherent risks. For taxpayers, the primary risk is that the government pays the actual allowable costs incurred by the contractor plus a predetermined fixed fee. If costs escalate significantly beyond initial estimates, the total expenditure could be higher than anticipated. While the fixed fee provides some cost certainty for the contractor's profit, it doesn't cap the total project cost. Effective oversight is crucial to ensure costs are reasonable and allocable, and that the contractor exercises diligent cost control.

How does this contract align with broader U.S. government strategies for biodefense and pandemic preparedness?

This contract directly aligns with broader U.S. government strategies for biodefense and pandemic preparedness, particularly those focused on threats from biological agents like botulinum neurotoxin. Agencies like the Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Preparedness and Response (ASPR), are tasked with developing medical countermeasures against a range of threats. The development of a pan-botulinum neurotoxin countermeasure addresses a critical gap in preparedness, ensuring a more robust response capability against potential bioterrorism or naturally occurring outbreaks involving these potent toxins.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: MEDICAL/DENTAL/VETERINARY EQPT/SUPP

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: BARDA-BAA-18-100-SOL-0000

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 6160 LUSK BLVD STE 105, SAN DIEGO, CA, 92121

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Not Designated a Small Business, Special Designations, Subchapter S Corporation, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $16,413,163

Exercised Options: $16,413,163

Current Obligation: $16,413,163

Actual Outlays: $8,268,300

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline