HHS awards $110.9M contract for Marburg virus immunotherapy development to Mapp Biopharmaceutical

Contract Overview

Contract Amount: $110,877,385 ($110.9M)

Contractor: Mapp Biopharmaceutical, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-28

End Date: 2031-05-01

Contract Duration: 3,137 days

Daily Burn Rate: $35.3K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: THIS COST-PLUS-FIXED-FEE CONTRACT WITH MAPP BIOPHARMACEUTICAL, INC. (MAPP OR CONTRACTOR) IS FOR THE DEVELOPMENT OF MAPP?S THERAPEUTIC INTERVENTION MBP091, AS AN IMMUNOTHERAPY FOR THE TREATMENT OF MARBURG VIRUS INFECTION.

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 $110.9 million to MAPP BIOPHARMACEUTICAL, INC. for work described as: THIS COST-PLUS-FIXED-FEE CONTRACT WITH MAPP BIOPHARMACEUTICAL, INC. (MAPP OR CONTRACTOR) IS FOR THE DEVELOPMENT OF MAPP?S THERAPEUTIC INTERVENTION MBP091, AS AN IMMUNOTHERAPY FOR THE TREATMENT OF MARBURG VIRUS INFECTION. Key points: 1. Contract focuses on a critical public health threat, Marburg virus infection. 2. The contract utilizes a Cost-Plus-Fixed-Fee structure, common for R&D projects. 3. Mapp Biopharmaceutical is the sole awardee, indicating specialized capabilities. 4. The contract duration extends over 9 years, suggesting a long-term development pipeline. 5. Research and Development in Biotechnology is the primary NAICS code. 6. The contract is a Definitive Contract, implying a commitment to a specific outcome. 7. California is the state where the contractor is located.

Value Assessment

Rating: fair

The contract value of $110.9 million for a 9-year R&D project for a novel immunotherapy is difficult to benchmark without more specific cost breakdowns. Cost-Plus-Fixed-Fee contracts can sometimes lead to higher costs if not carefully managed, but they are standard for early-stage research where scope can be uncertain. The fixed fee component provides some cost control for the government. Further analysis would require understanding the specific development milestones and associated costs.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting that multiple vendors had the opportunity to bid. However, the award to a single entity, Mapp Biopharmaceutical, indicates that they were selected as the most qualified offeror for this specialized research and development. The level of competition at the bid stage is not detailed, but the process itself implies a fair opportunity for interested parties.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that can lead to better pricing and innovation. Even with a single awardee, the initial competitive process helps ensure the government is contracting with a capable entity at a reasonable proposed cost.

Public Impact

The primary beneficiaries are individuals at risk of Marburg virus infection, potentially leading to a life-saving treatment. The service delivered is the research and development of a novel immunotherapy. The geographic impact is global, as Marburg virus is a zoonotic disease with international implications. Workforce implications include specialized jobs in biotechnology and pharmaceutical research within California.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns inherent in long-term R&D projects.
Reliance on a single contractor for a critical therapeutic development.
Uncertainty in the success of novel immunotherapy development.

Positive Signals

Focus on a high-priority public health threat.
Contract awarded through full and open competition.
Long-term commitment allows for sustained research effort.

Sector Analysis

This contract falls within the Biotechnology (except Nanobiotechnology) sector, specifically focusing on the development of therapeutic interventions for infectious diseases. The market for infectious disease R&D is significant, driven by emerging threats and the need for advanced medical countermeasures. Comparable spending benchmarks would typically involve other government contracts for vaccine or therapeutic development, often in the billions over their lifecycle, depending on the disease and development stage.

Small Business Impact

The contract data indicates that small business participation (sb) is false, and there is no indication of a small business set-aside (ss). This suggests the contract was not specifically targeted towards small businesses. Subcontracting opportunities for small businesses may exist within Mapp Biopharmaceutical's supply chain, but this is not explicitly detailed in the provided information. The overall impact on the small business ecosystem for this specific contract appears minimal.

Oversight & Accountability

Oversight for this contract would primarily 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, financial reviews, and adherence to the terms of the Cost-Plus-Fixed-Fee agreement. Transparency is typically managed through contract databases and public reporting, though detailed R&D progress may be sensitive. Inspector General jurisdiction would apply to any allegations of fraud, waste, or abuse.

Related Government Programs

Biodefense Advanced Research Projects Agency (BARDA) funding
National Institutes of Health (NIH) research grants
Centers for Disease Control and Prevention (CDC) infectious disease programs
Biomedical Advanced Research and Development Authority (BARDA) contracts

Risk Flags

Long contract duration increases exposure to changing research landscapes and potential cost escalation.
Sole awardee may limit options if performance issues arise.
Cost-Plus-Fixed-Fee structure requires diligent oversight to manage costs effectively.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $110.9 million to MAPP BIOPHARMACEUTICAL, INC.. THIS COST-PLUS-FIXED-FEE CONTRACT WITH MAPP BIOPHARMACEUTICAL, INC. (MAPP OR CONTRACTOR) IS FOR THE DEVELOPMENT OF MAPP?S THERAPEUTIC INTERVENTION MBP091, AS AN IMMUNOTHERAPY FOR THE TREATMENT OF MARBURG VIRUS INFECTION.

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 $110.9 million.

What is the period of performance?

Start: 2022-09-28. End: 2031-05-01.

What is Mapp Biopharmaceutical's track record with government contracts, particularly in infectious disease R&D?

Information on Mapp Biopharmaceutical's specific track record with government contracts is not detailed in the provided data. However, the award of this significant Cost-Plus-Fixed-Fee contract by the Department of Health and Human Services (HHS) suggests they possess the necessary qualifications and capabilities to undertake complex research and development in the field of infectious disease therapeutics. Further investigation into federal procurement databases (like SAM.gov or FPDS) would be required to ascertain their history of past performance, prior contract values, and any performance ratings on previous government awards. Understanding their experience with similar therapeutic areas or development phases would provide a clearer picture of their suitability for this Marburg virus project.

How does the $110.9 million cost compare to similar R&D contracts for novel immunotherapies?

Benchmarking the $110.9 million cost for this 9-year contract requires comparing it to similar R&D efforts for novel immunotherapies targeting rare or emerging infectious diseases. Contracts for vaccine and therapeutic development, especially those involving advanced modalities like immunotherapy, can vary widely in cost depending on the stage of development, complexity of the target, and duration. Early-stage research and development contracts, particularly those with a long timeline like this one (over 9 years), can range from tens of millions to hundreds of millions of dollars. Without specific details on the development milestones, preclinical and clinical trial phases included, and the specific scientific approach, a precise comparison is challenging. However, the value appears within a plausible range for a long-term, high-risk R&D endeavor aimed at a critical public health threat.

What are the primary risks associated with this contract, and how are they being mitigated?

The primary risks associated with this contract are inherent in the nature of early-stage, novel immunotherapy research and development. These include scientific risk (the therapy may not prove effective or safe), technical risk (challenges in manufacturing or delivery), and schedule risk (delays in achieving development milestones). Given the Cost-Plus-Fixed-Fee structure, there is also a financial risk of cost overruns if development proves more complex or lengthy than anticipated. Mitigation strategies likely involve rigorous oversight by HHS/ASPR, defined milestones within the contract that trigger payments, and potentially requiring Mapp Biopharmaceutical to meet specific performance metrics. The long contract duration also allows for phased development, enabling adjustments based on research outcomes.

How effective is the Cost-Plus-Fixed-Fee (CPFF) contract type for R&D in emerging infectious diseases?

The Cost-Plus-Fixed-Fee (CPFF) contract type is frequently utilized for research and development (R&D) projects, particularly in areas like emerging infectious diseases where the scope of work and ultimate costs can be uncertain at the outset. This structure allows the government to reimburse the contractor for allowable costs incurred while also providing a fixed fee, which represents the contractor's profit. This provides an incentive for the contractor to control costs, as the fee remains constant regardless of the final cost of performance. For R&D, CPFF is advantageous because it enables the government to fund innovative but potentially unpredictable research without imposing rigid cost ceilings that might stifle creativity or exploration. However, it requires robust government oversight to ensure costs are reasonable and necessary.

What is the historical spending pattern for Marburg virus research or similar biodefense countermeasures by HHS?

Historical spending patterns by HHS on Marburg virus research or similar biodefense countermeasures are not directly available from the provided contract data. However, HHS, through agencies like the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH), has a history of investing significantly in countermeasures for emerging infectious diseases and biothreats. This includes funding for vaccine and therapeutic development for viral hemorrhagic fevers, pandemic influenza, and other high-consequence pathogens. Spending in these areas can fluctuate based on perceived threats, national security priorities, and public health emergencies. The $110.9 million awarded here represents a substantial, long-term investment specifically for Marburg virus immunotherapy, indicating a strategic focus on this particular threat.

Industry Classification

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

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: BAA-18-100-SOL-00003

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 4921 DIRECTORS PLACE STE 100, SAN DIEGO, CA, 92121

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

Financial Breakdown

Contract Ceiling: $299,045,139

Exercised Options: $110,877,385

Current Obligation: $110,877,385

Actual Outlays: $55,498,035

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline