RRPV-26-13-BundiVx_RPP_Finalv2.docx

Biomedical Advanced Research and Development Authority (BARDA) Rapid Response Partnership Vehicle (RRPV)

Request for Project Proposals (RPP) Solicitation Number: RRPV 26-13-BundiVx

“Bundibugyo Virus Outbreak Response Vaccines (BundiVx)”

Issue Date: 11 June 2026

Questions Due: 16 June 2026 3 p.m. Eastern

Responses Due: 26 June 2026, by 1 p.m. Eastern

Biomedical Advanced Research and Development Authority (BARDA) Contracts Management & Acquisition (CMA) 400 7th Street, SW, Washington, DC 20024 MedicalCountermeasures.gov

1. Executive Summary

1.1 Rapid Response Partnership Vehicle Consortium

The Rapid Response Partnership Vehicle (RRPV) Consortium is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the Center for the Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services (HHS).

The RRPV will help fortify national health security by developing medical countermeasure products prior to and during a pandemic or public health emergency. The RRPV will focus on the acceleration of products and technology development, regulatory approval, commercialization, and sustainment to address pandemic influenza, emerging infectious diseases, and other biological threats.

Advanced Technology International (ATI) has been awarded an Other Transaction Agreement (OTA) by BARDA to serve as the Consortium Management Firm (CMF) for the RRPV.

RRPV is openly recruiting members to join a broad and diverse biomedical consortium that includes representatives from all organizations who work within stated technical focus areas. For more information on the RRPV mission, refer to the RRPV website at RRPV.org. For entities interested in joining the RRPV Consortium and responding to this solicitation, please visit http://www.rrpv.org/how-to-join.

1.2 Background

Filoviruses, including ebolaviruses and marburgviruses, continue to pose a significant threat to U.S. national health security due to their potential to cause severe hemorrhagic disease, high mortality rates, and rapidly escalating outbreaks. Case fatality rates from past outbreaks range from ~ 25-90%, depending on the species, outbreak setting, and available supportive medical care.

On May 15, 2026, the Ministry of Health of the Democratic Republic of the Congo (DRC) confirmed an outbreak of Ebola virus disease in Ituri Province. On the same day the Africa Centres for Disease Control and Prevention (Africa CDC) specified it was a non-Zaire ebolavirus with, at the time, 46 suspected cases and 65 deaths reported.[footnoteRef:2] The causative agent of the ongoing outbreak has since been identified as Bundibugyo ebolavirus (BDBV) and as of June 10th, 2026, there was a total of 598 confirmed cases and 115 confirmed deaths in DRC as well as 19 confirmed cases and 2 confirmed deaths in Uganda.[footnoteRef:3] [2: https://africacdc.org/news-item/africa-cdc-calls-for-urgent-regional-coordination-meeting-following-ebola-virus-disease-outbreak-in-ituri-province-drc/] [3: https://www.cdc.gov/ebola/situation-summary/index.html]

There are currently no BDBV-specific vaccines licensed or in clinical development that could be leveraged in outbreak response trials.

The only FDA-licensed filovirus vaccine is ERVEBO (Merck), a vesicular stomatitis virus (VSV)-based vaccine indicated for the prevention of disease caused by Zaire ebolavirus (EBOV). A single dose of ERVEBO demonstrated protection during the 2014–2016 West Africa and the 2018 DRC EBOV outbreaks. Additional VSV-based vaccine candidates targeting SUDV and MARV have also demonstrated single-dose protection in nonclinical studies as well as favorable early safety and immunogenicity profiles in Phase 1 clinical studies.

1.3 Purpose

The purpose of this RPP is to advance investigational BDBV vaccine candidates leveraging the VSV vaccine platform, which has demonstrated single dose protection in past EBOV outbreaks.

Work includes manufacturing process development through production of initial current Good Manufacturing Practice (cGMP) Phase 1 clinical trial material (CTM), with a goal of up to 10,000 doses. Early regulatory engagement will inform the critical-path IND-enabling nonclinical. The proposed approach must describe how any available platform efficiencies from prior or ongoing platform development and manufacturing to accelerate the path towards cGMP CTM production and IND submission under the U.S. FDA. Additional activities include a Phase 1 safety and immunogenicity trial as well as options for production of up to 100,000 doses of cGMP CTM.

The end goal of this effort is (1) to produce cGMP CTM and meet regulatory requirements to enable use of investigational candidate(s) in a clinical trial for the ongoing 2026 BDBV outbreak and (2) to identify successful BDBV vaccine candidates for potential further development.

2. Administrative Overview

2.1 RPP Approach

A single-stage approach will be employed with submission of a full technical and cost proposal. Submission of a full technical and cost proposal does not guarantee an award. Invitation to negotiations does not guarantee an award. Submissions that are not invited to negotiations, including the basket (see Section 5.5/5.6 below), will receive notification but may not receive feedback on their offer.

It is expected that there will be one or more qualified respondents that can accomplish the objectives.

At the time of the submission, Offerors must certify on the cover page of their Proposal that, if selected for award, they will abide by the terms and conditions of the latest version of the RRPV Base Agreement. Base Agreements are typically not executed until Offeror is selected for award.

Offerors are advised to check the RRPV website periodically during the proposal preparation period for any changes to the RRPV Base Agreement terms and conditions.

2.2 Order of Precedence

Each proposal selected for award under this RPP will be executed as a Project Award under the RRPV Base Agreement 75A50123D00005. The same provisions as the OTA between the U.S. Government (USG) and ATI (“RRPV Base”) will govern this Base Agreement unless otherwise noted in the Project Award.

2.3 Period of Performance and Funding

2.3.1 Period of Performance

The period of performance should be commensurate with the amount of work proposed. BARDA anticipates the full program Period of Performance to be up to five (5) years from the date of award. Specific dates will be negotiated prior to award of the project agreement.

2.3.2 Funding

The total USG funding amount anticipated to be available is approximately $75M. The USG anticipates making approximately 1-3 awards. Funding may be adjusted based on the Performer’s demonstrated progress and program priorities.

Based on program priorities, the USG may provide additional funds to support continued development and manufacturing.

Funding and estimated number of awards is subject to change and dependent on the proposal(s) received, BARDA priorities, and availability of Federal funds for this program.

2.4 Expected Award Date

The government anticipates the period of performance beginning during fiscal year 2026. The government reserves the right to change the notional period of performance start date through negotiations via the RRPV CMF prior to project award.

2.5 Proprietary Information

The RRPV CMF will oversee submission of proposals submitted in response to this RPP. The RRPV CMF shall take the necessary steps to protect all proprietary information and shall not use such proprietary information for purposes other than proposal evaluation and agreement administration. Please mark all Confidential or Proprietary Information as such. An Offeror’s submission of a proposal under this RPP indicates concurrence with the aforementioned CMF responsibilities.

2.6 Mandatory Eligibility Criteria

To be eligible for consideration Offerors must be RRPV members when their proposal is submitted. Prospective Offerors may join the consortium at www.rrpv.org/how-to-join.

Offerors must meet the following additional mandatory eligibility criteria:

· Proposed approach must use a VSV-based platform technology

· Developer must have development and manufacturing experience with the platform in the context of a filovirus vaccine

· At the time of proposal submission, the developer and proposed Contract Development and Manufacturing Organization (CDMO) partner must already have a demonstrated manufacturing relationship involving the platform technology and the manufacturing system/process proposed for this effort

· Developer must commit to providing material produced to BARDA, or to a BARDA-selected partner, for testing in nonclinical models, nonclinical assays, and/or clinical assays

Failure to meet the mandatory criteria will result in a rejection of the submission without further review.

2.7 Cost Sharing

Cost sharing is defined as the resources expended by the Project Performer on the proposed Statement of Work (SOW). Cost sharing, while not required, is encouraged, if possible, as it leads to stronger leveraging of Government-Performer collaboration. During negotiations cost sharing may be discussed depending on the potential of future commercial applications.

If cost sharing is proposed, then the Offeror shall state the amount that is being proposed and whether the cost sharing is a cash contribution or an in‐kind contribution; provide a description of each cost share item proposed; the proposed dollar amount for each cost share item proposed; and the valuation technique used (e.g., vendor quote, historical cost, labor hours and labor rates, number of trips, etc.).

2.8 Intellectual Property and Data Rights

Intellectual Property (IP) rights for RRPV Project Awards will be defined in the terms of a Project Performer’s Base Agreement. The RRPV CMF reserves the right to assist in the negotiation of IP, royalties, licensing, future development, etc., between the Government and the Project Performers during the entire award period.

The Offeror must comply with the terms and conditions defined in the RRPV Base Agreement regarding Data Rights. It is anticipated that anything delivered under this proposed effort will be delivered to the Government with unlimited data rights as defined in the RRPV Base Agreement unless otherwise specified in Attachment 3, Statement of Work, and agreed to by the Government. All proposed data rights are subject to Government review and approval. Rights in technical data agreed to by the Government will be incorporated into the Project Award.

3 Submissions

3.1 Question and Answer Period

Key dates related to this RPP are provided below. Please submit questions to Ms. Kathy Garee (rrpv-contracts@ati.org). Answers will be posted publicly to the RRPV website.

3.2 General Instructions

Offerors who submit Proposals in response to this RPP must submit by the date on the cover page of this RPP. Proposals received after the time and date specified will not be evaluated.

The Proposal format provided in this RRPV RPP is mandatory and shall reference this RPP number. Offerors are encouraged to contact the Point of Contact (POC), identified herein up until the Proposal submission date/time to clarify requirements.

The Government will evaluate Proposals submitted and will select the Proposal(s) that best meets their current technology priorities using the criteria in Section 5.

All eligible Offerors shall submit Proposals for evaluation according to the criteria set forth in this RPP. Offerors are advised that only ATI, as the RRPV’s CMF, with the approval of the Other Transaction Agreements Officer, is legally authorized to contractually bind or otherwise commit funding for selected Project Awards as result of this RPP.

Offerors may request a current copy of the RRPV Base Agreement terms and conditions by emailing RRPV-contracts@ati.org. Base Agreements are typically not executed until Offeror is selected for award. Offerors are encouraged to contact the Point of Contact (see Section 6), identified herein up until the submission date/time to clarify requirements.

3.3 Proposal Submission

Proposals shall be submitted by the date and time specified on the cover page to the following website: www.RRPV.HHS.gov

An RRPV BDR Portal account is required before a response can be submitted. A BDR account can be requested by contacting ATI at RRPV@ati.org. The account request process is simple but may take several days for approval and access. Upon confirmation of a BDR Portal account, offerors will be able to complete their account registration to be able to submit a proposal.

Failure to submit on time for any reason (e.g., due to late registration in BDR Portal) will result in the submission not being considered for award. Respondents will be provided an automated confirmation of successful submission.

Do not submit any classified information in the Proposal submission.

Offerors shall submit files in Microsoft Word, Microsoft Excel, or Adobe Acrobat (PDF – portable and searchable document format) formats as indicated below. ZIP files and other application formats are not acceptable. All files must be print-capable and without a password required. Filenames should contain the appropriate filename extension (.docx, .doc, .xlsx, or .pdf). Filenames should not contain special characters. IOS users must ensure the entire filename and path are free of spaces and special characters. The file should not exceed 10 Megabytes of storage space. Movie and sound file attachments, URL Links, or other additional files, will not be accepted.

Once an Offeror has submitted a Proposal, the Government and the RRPV CMF will not discuss evaluation/status until the evaluation results have been provided to the Offerors.

A receipt confirmation will be provided by email. Offerors may submit, or re‐submit, in advance of the deadline. Neither the Government nor the RRPV CMF will make allowances/exceptions for submission problems encountered by the Offeror using system‐to‐system interfaces. If the Offeror fails to submit the full submission prior to the deadline, the submission will not be accepted. It is the Offeror’s responsibility to ensure a timely and complete submission.

3.4 Preparation Cost

The cost of preparing Proposals in response to this RPP is not considered a direct charge to any resulting award or any other contract.

3.5 Submission Format

Proposals shall reference this RPP number. Each document below (Technical Proposal, Cost Proposal Narrative, Cost Proposal Format, Project Management Plan, and Statement of Work) is mandatory and must each be submitted as separate files and shall remain valid for 180 days unless otherwise specified by the Offeror in the proposal. Offerors are encouraged to contact the RRPV CMF with any questions so that all aspects are clearly understood by both parties. The proposal must include the following:

· Technical Proposal submission (30-page limit, unless noted*) – See Attachment 1: One Word (.docx or .doc) or PDF file for the Technical Proposal. The mandatory template is provided as Attachment 1, and includes mandatory sections for a cover page*, information sheet*, executive summary and minimum eligibility requirements, technical approach, current and pending support, data rights*, and key personnel resumes*.

· Cost Proposal submission (no page limit) – See Attachment 2: One Word (.docx or .doc) or PDF file for Section I: Cost Proposal Narrative is required using the mandatory template. Separately, Section II: Cost Proposal Format is required in Excel (xlsx) format, with working formulas to the maximum extent practicable.

· Statement of Work/Milestone Payment Schedule (no page limit) – See Attachment 3: One Word (.docx or .doc) file. The Offeror is required to provide a detailed SOW/Milestone Payment Schedule using the mandatory template provided as Attachment 3.

· Program/Project Management submission (5-page limit) – See Attachment 4: One Word (.docx or .doc) or PDF file. The Offeror is required to provide details on their proposed approach for Program Management and subcontractor management. Include a listing of key personnel (including proposed consultants) who possess the necessary education, training, and experience to successfully perform the work identified in the technical proposal (Note: key personnel resumes to be included in the technical proposal). A summary of related activities must also be provided for key personnel. An organizational chart for the project with affiliations (who will report to whom).

3.6 Restrictions on Animal and Human Subjects

Project Performers must comply with restrictions and reporting requirements for the use of animal and human subjects, as addressed in further detail in the RRPV Base Agreement. It is anticipated that the Project Award(s) issued under this RPP will require the following:

· The Project Performer shall serve as regulatory product sponsor and be responsible for any regulatory submissions to the US Food and Drug Administration (FDA).

· Support and maintain regulatory submissions throughout life of the project.

· The Project Performer must submit to the Government all regulatory and supporting documentation related to therapeutic development, manufacturing, lot releasing, certificates of analysis, analytical development, stability, nonclinical and clinical testing as well as other related documentation.

· The Project Performer shall cross‐reference any applicable regulatory files, such as Investigational New Drug (IND) applications, Master Files, and Biologics License Applications (BLAs) prior to the conduct of the studies and shall allow cross‐referencing of these documents associated with this effort.

Additional information on the applicable regulatory terms is provided in the RRPV Base Agreement.

4 Technical Requirements

4.1 Introduction

The Offeror shall clearly state how they intend to meet and, if possible, exceed the technical requirements. Responses must include quantitative, data-driven justification and clearly describe how prior platform development enables efficiency, scalability, and reuse.

4.2 Scope

Overall objective. The purpose of this RPP is to advance investigational BDBV vaccine candidates leveraging the VSV platform, which has precedent for single dose protective efficacy in past EBOV outbreaks. The end goals are to (1) produce cGMP CTM and meet regulatory requirements to enable use of investigational BDBV vaccine candidate(s) in the ongoing 2026 BDBV outbreak response trial and to (2) identify successful BDBV vaccine candidates for potential further development. The preference is to support different manufacturing approaches/platforms systems to diversify manufacturing risk.

The project supports manufacturing process development through to production of cGMP Phase 1 CTM (target: up to 10,000 doses); critical path IND-enabling activities to support a Phase 1 trial; a Phase 1 clinical trial; additional manufacturing of up to 100,000 doses of CTM; regulatory engagements and submissions; and necessary logistical support (e.g., dose and sample shipping for outbreak response).

4.3 Performance Objectives and Supporting Technical Justification and Plans

Offerors are encouraged to address the following areas, as applicable to the proposed effort, and may provide any additional technical or other information they deem pertinent.

· Platform technology

· Provide a technical description of the platform technology, including details of the platform backbone/viral vector engineering and formulation

· Nonclinical

· Describe the nonclinical efficacy and immunogenicity data generated using the platform for BDBV and any other filoviruses; data supporting rapid onset of single-dose protection is a priority

· Describe the relevant nonclinical safety data generated by the Offeror for the platform

· Clinical

· Describe the clinical safety, immunogenicity, and efficacy data generated using the platform for filoviruses; data supporting rapid onset of immunogenicity and/or protection following a single dose is a priority

· Describe the overall clinical safety database generated with the platform

· Manufacturing

· Describe the Offeror’s manufacturing experience with the platform for filoviruses

· Describe the manufacturing expression system and process proposed for use under this RPP

· Provide details on the manufacturing partner and facility (developer-owned or CDMO partner(s)

· Describe the joint experience of the Offeror with the manufacturing facility/CDMO for the manufacturing expression system and process proposed for use under this RPP

· Note the mandatory criteria in Section 2.6: at the time of proposal submission, the developer (i.e., Performer) and the proposed Contract Development and Manufacturing Organization (CDMO) partner must already have a demonstrated manufacturing relationship involving the platform technology and the manufacturing system/process proposed for this effort

· Leveraging platform efficiencies

· Describe any FDA feedback previously received regarding nonclinical, clinical, or platform-based efficiencies that could be leveraged to accelerate development of the proposed candidate

· Describe the Offeror’s manufacturing plan for production of cGMP CTM.

· Describe the steady-state manufacturing process and timelines

· Describe the planned accelerated manufacturing process, projected timelines, key critical-path activities, and assumptions required to achieve accelerated production.

· Targets are

· Up to 10,000 doses of CTM (Section 4.4, Task 1b)

· Up to 100,000 doses of CTM (Section 4.4, Task 2)

· The stated dose targets represent an ideal for the associated Task. Based on the proposed platform and manufacturing process/system, describe the number of doses reasonably anticipated to be produced under each task/subtask and provide the technical justification that supports the estimates. Capture this in the proposed work.

· Regulatory and development plan

· Propose a regulatory strategy and development plan to achieve U.S. FDA approval of a Phase 1 IND application. The proposal must describe the Offeror’s risk management approach, the extent to which efficiencies from past platform development and manufacturing activities can be leveraged, and any appropriate regulatory flexibilities that may be used. The regulatory strategy and accelerated development plan shall focus on production of stage-appropriate cGMP CTM, in line with project tasks, and supporting critical-path nonclinical and clinical studies anticipated to enable use of CTM in an outbreak response trial.

4.4 Project Tasks

All work described below must be included in the proposal and planned for execution. However, pursuant to the mandatory eligibility criteria in Section 2.6, Offerors must commit to providing any materials produced under this effort to BARDA or a BARDA-designated third party. BARDA anticipates potential coordination with partner organizations, as appropriate, to conduct critical-path nonclinical and other supporting studies and to facilitate the potential use of cGMP CTM in outbreak clinical trials conducted in affected countries.

As appropriate, the Performer may be required to engage with international regulatory authorities, local ministries of health, and relevant ethics committees to support the use of investigational CTM in clinical trials conducted in countries affected by the 2026 BDBV outbreak.

All tasks must account for necessary regulatory engagement and submissions.

1 Manufacturing through cGMP Phase 1 CTM

· Task 1a. Process development to engineering run (Base)

· Conduct any necessary process development work through production of an engineering run at scale

· Conduct analytical assay development and testing to support product release and stability studies

· Regulatory

· Conduct early regulatory engagement with the U.S. FDA to identify manufacturing and nonclinical critical-path activities necessary to support submission of a Phase 1 IND

· Prepare and submit all regulatory documentation required to support the proposed activities, and conduct any necessary regulatory interactions and submissions

· Task 1b. Production of Phase 1 cGMP CTM (target: up to 10,000 doses) (Option)

· Production of up to 10,000 doses of Phase 1 cGMP CTM

· Conduct any analytical development and testing to support release

· Conduct stability studies

· Conduct stage appropriate process, facilities, equipment and analytical qualification

· Support preparation of any regulatory documentation, engagement, and submissions required

· Include any logistical support activities (e.g., labelling, shipping, storage, etc.) both for the Phase 1 and for potential shipment of doses for use in an outbreak clinical trial in countries affected by the 2026 BDBV outbreak

2 Task 2. IND-enabling nonclinical activities (Option).

· Conduct all critical path nonclinical activities required for submission of a Phase 1 IND under the U.S. FDA and achieve safe-to-proceed status

· Propose all nonclinical activities that could reasonably be required to support successful submission a Phase 1 IND under the U.S. FDA. Note that if awarded, the specific nonclinical activities to be conducted will be finalized as informed by FDA feedback received through a pre-IND meeting or other regulatory interactions.

· Note that while all work shall be proposed and planned, per the mandatory eligibility criteria (Section 2.6), Offerors must commit to providing any material produced to BARDA, or a BARDA-selected third party. BARDA anticipates possible coordination with other partner organizations to conduct nonclinical/in vitro studies.

· Prepare and submit all regulatory documentation required to support the proposed activities, and conduct any necessary regulatory interactions and submissions

3 Task 3. Phase 1 clinical trial (Option). Plan and execute a Phase 1 study under a U.S. FDA IND. The Propose a placebo-controlled Phase 1 study design and provide a proposed draft protocol synopsis; the final study design will be determined in future discussion with BARDA.

· The Phase 1 study design should consider an initial interim analysis of the safety, tolerability, and rapid immunogenicity profile of the single-dose investigational vaccine from the perspective of future potential use for reactive deployment in an outbreak setting. Given the anticipated use scenario, the principal immunologic objective is to characterize the kinetics of early immune responses associated with rapid onset of protection following a single vaccination to inform decision-making for potential outbreak trial use. Endpoints related to durability of response should be accounted for in exploratory endpoints.

· Conduct all necessary activities, including but not limited to:

· Conduct trial readiness and execution activities.

· Propose a plan to accelerate study recruitment and enrollment

· Conduct immunogenicity assays

· Conduct safety and immunogenicity analysis

· Produce interim and final Clinical Study Report

· Prepare and submit all regulatory documentation required to support the proposed activities, and conduct any necessary regulatory interactions and submissions

4 Task 4. Manufacturing up to 100,000 doses of CTM.

· Include two separate options as: Task 4a (option) and Task 4b (option) that each account for manufacturing of up to 100,000 doses.

· For both options include

· Conduct of any analytical development and testing to support release and stability studies

· Any logistical support activities (e.g., labelling, shipping, storage, etc.)

5 Task 5. Outbreak trial support (Option).

· Shipping of clinical immune samples from outbreak clinical, sample storage, and any other required support functions, to enable testing in immune assays developed under the BARDA-funded development program.

· Incorporation of clinical safety data into the Performer’s safety database for the platform

4.4 Performance Requirements

Preparation, submission, and maintenance of nonclinical and clinical documentation for regulatory filings (pre-IND/IND) to support regulatory strategies aimed at obtaining FDA approval.

4.5 Deliverables

Over the course of this project, Awardee is required to provide the deliverables in Attachment 3 Section 4.0 of this RPP.

4.6 Special Requirements

· Export Control: The Project Awardee will be expected to be knowledgeable of and comply with any applicable U.S. Export Laws.

· Security and Classified Data: The security classification level for this effort will be Unclassified. If Controlled Unclassified Information is provided or must be generated under this agreement, it will be subject to the safeguarding provisions and reporting requirements of the RRPV Base Agreement and/or Project Award.

5 Proposal Selection/Evaluation

5.1 Gain-of-Function Research

In accordance with Executive Order 14292 “Improving the Safety and Security of Biological Research,” BARDA does not support gain-of-function research or research involving the manipulation of pathogens that may result in a gain of function.

For purposes of this RPP, gain-of-function research is defined as scientific research on an infectious agent or toxin that has the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility.

Covered research activities include those that could result in significant societal consequences and that seek or achieve one or more of the following outcomes:

· Enhancing the harmful consequences of an agent or toxin

· Disrupting beneficial immunological responses or reducing the effectiveness of immunizations

· Conferring resistance to clinically or agriculturally useful prophylactic or therapeutic interventions, or enabling evasion of detection methodologies

· Increasing the stability, transmissibility, or dissemination potential of an agent or toxin

· Altering the host range or tropism of an agent or toxin

· Enhancing the susceptibility of a human population to an agent or toxin

· Generating or reconstituting an eradicated or extinct agent or toxin

Proposals will be evaluated by BARDA for the appropriate use of strains in proposed studies, in addition to all other evaluation factors. Proposals that include gain-of-function research will be considered unacceptable and will not be eligible for award.

5.2 Compliance Screening

The RRPV CMF will conduct a preliminary screening of submitted Proposals to ensure compliance with the RPP requirements. As part of the preliminary screening process, the RRPV CMF will request additional information from proposals that do not meet the requirements of the RPP. If requirements remain not met, a proposal may be eliminated from the competition. The Government reserves the right to request additional information or eliminate proposals that do not meet these requirements from further consideration.

5.3 Proposal Evaluation Process

An initial review will assess alignment to mandatory criteria; if determined acceptable further review will be conducted as described.

Following the preliminary screening, the Government sponsor will perform source selection using the evaluation factors detailed below. The Government will conduct an evaluation of all qualified Proposals.

Qualified Proposals will be evaluated by a panel of subject matter experts (SMEs) who will make recommendations to a Source Selection Authority.

This process may involve the use of contractors as SME consultants or reviewers. Where appropriate, the USG will employ non‐disclosure agreements to protect information contained in the RPP as outlined in Section 2.9. An Offeror’s submission of a Proposal under this RPP indicates concurrence with the aforementioned use of contractors and SMEs.

Evaluation of proposals will be based on an independent, comprehensive review and assessment of the work proposed against stated preferred characteristics, technical requirements, source selection criteria, and evaluation factors. The Government will evaluate each proposal against the evaluation factors detailed below and assign adjectival ratings to the non‐cost/price factor(s) as discussed below. The Offeror shall clearly state how it intends to meet and, if possible, exceed the RPP requirements. Mere acknowledgement or restatement of a RPP requirement is not acceptable, unless specifically stated otherwise.

The Government will evaluate each Proposal against the evaluation factors detailed below and assign one of the following adjectival ratings in order to determine the best value to the Government.

· Outstanding

· Good

· Acceptable

· Marginal

· Unacceptable

Once an Offeror has submitted a Proposal, the Government and the RRPV CMF will not discuss evaluation/status until the evaluation results have been provided to the Offerors.

5.4 Evaluation Factors

The Government will evaluate the information provided in each Offeror’s Proposal to determine which Proposal(s) provide(s) the best value to the Government. Non-Cost/Non-Price Evaluation factors are listed in descending order of importance. Non-Cost/Non-Price factors are more important than Cost/Price, collectively and individually. A determination on best value to the Government will be based on the following criteria:

Factor 1 ‐ Technical Approach: This factor evaluates the relevancy, thoroughness, completeness, and feasibility of the proposed approach in relation to the following subfactors:

a. General Technical Approach including ability of proposal to meet all requirements as outlined in this RPP.

b. Accelerated Development and Manufacturing Approach including proposed plan to leverage any efficiencies provided by prior platform work and any additional manufacturing efficiencies; joint developer/CDMO experience manufacturing the platform for filoviruses; joint developer/CDMO; demonstration of active and successful manufacturing of the platform technology at developer’s with a Contract Development and Manufacturing Organization (CDMO) partner with the propose manufacturing system/process

c. Clinical approach plan to assess safety and immunogenicity as aligned to safety and rapid onset to protection demonstration and exploratory endpoints plan for durability of response

Factor 2 ‐ Relevant Corporate and Capabilities Experience: This factor evaluates the offeror’s demonstrated corporate experience and capabilities experience as well as the technical and program management experience of the proposed team to perform the proposed work. The Government may also consider information in Contractor Performance Assessment Reporting System (CPARS), and the Federal Awardee Performance and Integrity Information System (FAPIIS) or similar systems. Demonstrated capability of the Performer’s own manufacturing facility or proposed CDMO partner(s) will also be considered.

Factor 3 ‐ Program Management Approach: This factor evaluates the quality, thoroughness, completeness and feasibility of the proposed Program Management approach in relation to the following subfactors:

a. Key Personnel & Personnel Management

b. Contract/Subcontract Management

Factor 4 ‐ Cost/Price: (See Section 5.5 below): Assessment of the cost of the project to determine i) whether the project cost is within the available funding limits, and ii) the ability and/or likelihood of the offeror to successfully execute the proposed project within the financial resources proposed.

5.5 Cost/Price Evaluation

If a proposal is selected for award, the RRPV CMF will evaluate the estimated cost proposed by the Offeror for performing all requirements outlined in this RPP. Evaluation will include analysis of the proposed cost together with all supporting information. The RRPV CMF may request additional information or clarification as necessary. The RRPV CMF will assess the reasonableness and completeness of the cost estimates and then provide a formal assessment to the Government. The Government will review this assessment and make the final determination that the project value is fair and reasonable, subject to final Government negotiations.

Proposals will be evaluated using the understanding of cost realism, reasonableness and completeness as outlined below:

1. Realism. Proposals will be evaluated to determine if Costs are realistic for the work to be performed, reflect a clear understanding of the requirements, and are consistent with the various elements of the Offeror's schedule proposal.

Estimates are “realistic” when they are neither excessive nor insufficient for the effort to be accomplished. Estimates must also be realistic for each phase of the proposed project when compared to the total proposed cost.

The RRPV CMF will make a determination by directly comparing proposed costs with comparable current and historical data, evaluator experience, available estimates, etc. Proposed estimates will be compared with the corresponding technical proposals for consistency.

1. Reasonableness. The Offeror’s cost proposal will be evaluated to determine if it is reasonable. For a price to be reasonable, it must represent a price to the Government that a prudent person would pay in the conduct of competitive business. Normally, price reasonableness is established through cost and price analysis.

To be considered reasonable, the Offeror’s cost estimate should be developed from applicable historic cost data. The Offeror should show that sound, rational judgment was used in deriving and applying cost methodologies. Appropriate narrative explanation and justification should be provided for critical cost elements. The overall estimate should be presented in a coherent, organized and systematic manner.

Costs provided shall be clearly attributable to activities or materials as described by the Offeror. Costs should be broken down in the Cost Proposal Format. An optional template is located on the Members-Only RRPV website.

1. Completeness. The RRPV CMF will evaluate whether the proposal clearly and thoroughly documents the rationale supporting the proposed cost and is compliant with the requirements of the solicitation.

The proposal should clearly and thoroughly document the cost/price information supporting the proposed cost in sufficient detail and depth. The RRPV CMF will evaluate whether the Offeror’s cost proposal is complete with respect to the work proposed. The RRPV CMF will consider substantiation of proposed cost (i.e., supporting data and estimating rationale) for all elements.

Rate and pricing information is required to properly perform the cost analysis of the proposal. If the Offeror is unwilling to provide this information in a timely manner, its proposal will be lacking information that is required to properly evaluate the proposal, and the proposal may not be selected for award.

5.6 Best Value

The Government will conduct the source selection based on the evaluation criteria and ratings listed above. The overall award decision will be based upon a Best Value determination by considering and comparing factors in addition to cost or price. Funding recommendations depend on various factors and programmatic relevance. Based on the evaluation of the Technical Approach, Relevant Experience, and Cost/Price, the Government reserves the right to negotiate and request changes to any or all parts of the SOW. Offerors will have the opportunity to concur with the requested changes, propose further changes and revise cost proposals as necessary.

5.7 Evaluation Results

Following the evaluation of proposals, the Source Selection Authority may recommend the following for the CMF’s consideration:

0. Select the proposal (or some portion of the proposal) for award;

0. Place the proposal in the Basket; or

0. Reject the proposal (will not be considered for award and will not be placed in the Basket)

The Government does not guarantee a minimum or maximum number of awards resulting from this solicitation.

5.8 Basket Provision

The electronic “Basket” is an innovative acquisition tool. Proposals rated as Acceptable through Outstanding, but not immediately selected for award may be placed in the Basket for 2 years from the date of RPP close and eligible for award during that time. Proposals rated as below Acceptable will not be placed in the Basket and will not be eligible for future award. If awarding from the Basket, the Government reserves the right to award whichever proposal best meets its needs.

5.9 Points of Contact

Questions related to this RPP should be directed to Ms. Kathy Garee (rrpv‐contracts@ati.org).

All technical questions must be submitted by 12pm ET on June 5, 2026, to allow for a Government response. The Government will respond to questions at its discretion. All questions and responses will be posted to the RRPV Solicitation webpage (https://www.rrpv.org/opportunities/). Individualized responses or discussions will not be provided to ensure fairness to all Offerors.

Attachment 1 – Technical Proposal Template

General Instructions The Technical Proposal must address the technical requirements described in the RPP in sufficient detail to permit evaluation from a technical perspective in accordance with the evaluation factors set forth in the RPP. The Technical Proposal shall be single‐spaced, single‐sided, and 8.5 x 11 inches, and 12‐point font. Smaller type may be used in figures and tables but must be clearly legible. Margins on all sides (top, bottom, left, and right) should be at least 1 inch. Offerors are strongly encouraged to use pictures and graphics to succinctly represent proposed ideas, organization, etc.

The Technical Proposal shall be limited to 30 pages (unless otherwise noted below). Pages in excess of this limitation may not be considered. Offerors are advised that the number of pages should be commensurate with the degree of complexity of the proposed effort. It is expected, and encouraged, that less complex, less expensive proposals will be significantly less than 30 pages in length.

To ensure Technical Proposals receive proper consideration, the Technical Proposal format shown below is mandatory. If there are any items which are not applicable to a specific proposal, include the section topic in the proposal with a short explanation as to why it is not applicable.

1. Cover Page*

2. RRPV Member Organization Information Sheet*

3. Executive Summary & Minimum Eligibility Criteria

4. Technical Approach

5. Current & Pending Support

6. Data Rights*

7. Resumes of Key Personnel* (each not to exceed 3 pages)

* Sections marked with an asterisk (*) are excluded from the page limitation.

Technical Proposal Cover Page

[Name of Offeror] [Address of Offeror]

RRPV 26-13-BundiVx

[Proposal Title]

[Offeror] certifies that, if selected for award, the Offeror will abide by the terms and conditions of the RRPV Base Agreement.

[Offeror] certifies that this Proposal is valid for 180 days from the close of the applicable RPP, unless otherwise stated.

[As detailed in Section 2.5 of the Request for Project Proposals, Offerors are to include a proprietary data disclosure statement/legend if proprietary data is included.

Sample:

This Proposal includes data that shall not be disclosed outside the RRPV Consortium Management Firm and the Government. It shall not be duplicated, used, or disclosed, in whole or in part, for any purpose other than proposal evaluation and agreement administration. The data subject to this restriction is (clearly identify) and contained on pages (insert page numbers).

1. Member Information Sheet If an item is not applicable, then that section should be listed as “not applicable.”

OFFEROR NAME:

ALL PLACES OF PERFORMANCE:

TITLE OF PROPOSED EFFORT:

UEI # (if applicable):

CAGE CODE (if applicable):

SMALL BUSINESS (YES/NO):

CONFLICT OF INTEREST (YES/NO):

TOTAL COST OF PROPOSAL:

PROPOSED PERIOD OF PERFORMANCE IN MONTHS:

PREFERRED PAYMENT METHOD (FFP, CPFF, Cost Reimbursable (CR), CR/COST SHARE):

REQUESTED USE OF GOVERNMENT RESOURCES, PROPERTY, LABS, ETC. (YES/NO):

PROPOSED USE OF ANIMAL SUBJECTS (YES/NO):

PROPOSED USE OF HUMAN SUBJECT (YES/NO):

PROPOSED USE OF HUMAN SPECIMEN MATERIAL (YES/NO):

PROPOSED USE OF HUMAN FETAL TISSUE (YES/NO):

PROPOSED USE OF LIVE VERTABRATE ANIMALS (YES/NO):

PROPOSED USE OF SELECT BIOLOGICAL AGENTS OR TOXINS (YES/NO):

CONTRACT/NEGOTIATION CONTACT (NAME, ADDRESS, PHONE, EMAIL):

TECHNICAL/PRINCIPAL INVESTIGATOR CONTACT (NAME, ADDRESS, PHONE, EMAIL):

COGNIZANT RATE AUDIT AGENCY OFFICE (IF KNOWN, INCLUDE POC, ADDRESS, PHONE #, E‐MAIL):

2. Executive Summary & Minimum Eligibility Requirements [The Executive Summary allows Offerors to present briefly and concisely the important aspects of their proposals to evaluators. The summary should present an organized progression of the work to be accomplished, without the technical details, such that the reader can grasp the core concepts of the proposed project.]

[This section must address how the Offeror currently satisfies each aspect of the following minimum eligibility requirements. Proposals will be reviewed to confirm minimum criteria are met.]

1. Offerors must be RRPV members when the proposal is submitted. As mentioned above, prospective Offerors may join the consortium at www.rrpv.org/how‐to‐join.

2. Developer must have development and manufacturing experience with the platform in the context of a filovirus vaccine.

3. At the time of proposal submission, the developer and proposed Contract Development and Manufacturing Organization (CDMO) partner must already have a demonstrated manufacturing relationship involving the platform technology and the manufacturing system/process proposed for this effort

4. Developer must commit to providing material produced to BARDA, or to a BARDA-selected partner, for testing in nonclinical models, nonclinical assays, and/or clinical assays

3. Technical Approach [Provide sufficient technical detail and analysis to support the technical solution being proposed for the project. Clearly identify the core of the intended approach. It is not effective simply to address a variety of possible solutions to the technology problems. Include citation to each Deliverable identified in the Statement of Work throughout the Technical Approach (e.g. (1.1)). Provide the following information:]

1. Background: [Describe the problem that the proposal is addressing.]

2. Approach: [Describe your approach to solving the problem, broken out by Phase as outlined in Section 4 (Technical Requirements) of the RPP. Include relevant background data about your approach. Include the current status of your approach.]

3. Objectives: [Specify the objectives of the proposed effort.]

4. Past Experience: [Describe relative corporate and capabilities past experience, as well as the technical and management experience of the proposed team, to perform the proposed work. Past experience should be recent, relevant and similar in size and scope to offeror’s proposed effort.]

5. Technical Strategy: [Describe the proposed methodology, including development and manufacturing approach, in sufficient detail to show a clear course of action.]

6. Manufacturing: [Include the following information as part of the technical approach. Manufacturing activities must be described in sufficient detail to assess technical feasibility, manufacturing readiness, scalability, regulatory compliance, and the ability to produce cGMP Clinical Trial Material (CTM) within the proposed timelines. The manufacturing approach must address all applicable regulatory requirements and industry standards, including current cGMP regulations, relevant FDA guidance documents, ICH quality guidelines, and demonstrate suitability to support Phase 1 IND submission and outbreak-response deployment.]

· Manufacturing Experience: Describe the Offeror’s prior experience developing and manufacturing filovirus vaccines using the proposed platform technology. Summarize relevant experience with process development, technology transfer, engineering runs, cGMP manufacturing, clinical material production, and regulatory submissions. Describe how prior platform knowledge will be leveraged to reduce manufacturing, quality, and regulatory risk.

· Manufacturing Partner and Facility: Identify the proposed manufacturing facility or CDMO partner(s), including facility location, capabilities, cGMP status, relevant inspection history, and manufacturing scale. Describe the manufacturing expression system and process proposed for use under this RPP. Describe the joint experience of the Offeror and the proposed facility/CDMO with the same platform technology, expression system, and manufacturing process. The proposal must demonstrate that, at the time of submission, the developer and proposed CDMO already have a manufacturing relationship involving the proposed platform and manufacturing system/process.

· Manufacturing Process and Readiness: Provide an overview of the proposed manufacturing process from starting materials through final drug product, including upstream, downstream, formulation, and fill-finish, as applicable. Describe current process maturity, remaining process development needs, critical process parameters, critical quality attributes, in-process controls, and key assumptions required to proceed to engineering and cGMP production.

· Process Development Through Engineering Run: Describe the process development activities, analytical assay development, scale-up parameters as applicable, testing, and engineering run strategy proposed to support cGMP manufacturing readiness. Include engineering run objectives, scale, success criteria, and how results will inform cGMP production.

· cGMP CTM Production: Describe the phase-appropriate manufacturing plan for Phase 1 cGMP CTM, including the steady-state process, projected timelines, batch size, yield assumptions, release testing, stability testing, and logistical support. Separately describe the accelerated manufacturing approach, projected timelines, critical-path activities, and assumptions needed to produce CTM.