75A5012R00006 Amendment 001.pdf

(x)

75A50125R00006 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

ASPR-BARDA

Washington DC 20201 Room 640-G 200 Independence Ave., S.W.

ASPR-BARDA

07/14/20250001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

07/12/2025

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

This amendment corrects the Questions due date and Proposal due date.

The cutoff date for all questions on this RFP is July 31, 2025 at 2 PM ET. The due date for all proposal submissions is Aug 26, 2025 at 2PM ET.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

YIFAN YANG

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

Biomedical Advanced Research and Development Authority (BARDA)

Request for Proposals (RFP) for

Marburg Virus and Sudan Ebolavirus Vaccine Licensure and Procurement

RFP #: 75A50125R00006

Amendment 0001

Issued: 14 Jul 2025

Questions Due: 31 Jul 2025

Proposal Responses Due: 26 Aug 2025

Contracting Officer: Yifan Yang – Yifan.yang@hhs.gov

Contract Specialist: Greg Smith – Greg.Smith1@hhs.gov

MedicalCountermeasures.gov mailto:Yifan.yang@hhs.gov mailto:Greg.Smith1@hhs.gov

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any Offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A - Solicitation/Contract Form, accounting, appropriation and general information applicable to the contract award.

If your proposal is not received by the Contracting Officer (CO) or his/her designee at the time and place specified, it will be considered late and handled in accordance with the Federal Acquisition Regulation (FAR), FAR 52.215-1 (Instructions to Offerors – Competitive Acquisition),the Health and Human Services Acquisition Regulation (HHSAR), and HHSAR Clause 352.215-70, “Late Proposals and Revisions” located in Section I of this solicitation.

Potential Offerors must be registered in the System for Award Management (SAM) prior to submittal of a proposal.

The contract schedule, set forth in SECTIONS B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that may be awarded as a result of this solicitation.

The contract cost or price and other contractual provisions unique to the Offeror's proposal may be included in the resultant contract.

The contract schedule is intended to provide the Offeror with information to aid in understanding the likely terms and conditions of any resultant contract.

The cutoff date for all questions on this RFP is July 31, 2025 at 2 PM ET. All questions shall be submitted via e-mail to Yifan.Yang@hhs.gov and Greg.Smith1@hhs.gov. The due date for all proposal submissions is Aug 26, 2025 at 2PM ET. All proposals must be submitted via email to Greg.Smith1@hhs.gov and Yifan.Yang@hhs.gov.

The submission email must include mandatory criteria, business, and technical proposal documents as separate documents.

mailto:Yifan.Yang@hhs.gov mailto:Greg.Smith1@hhs.gov

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The 2014 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies Ebola virus and Marburg virus as high-priority threats as determined by the Department of Homeland Security to present a material threat to national security. Strategies to mitigate the threat of Ebola virus and Marburg virus include the development of vaccines suitable for protection against Ebola and Marburg virus disease respectively. BARDA is seeking vaccines that can be safely and effectively used for the U.S. civilian population in individuals with an elevated risk of exposure to Sudan virus (SUDV) and Marburg virus (MARV).

This acquisition will allow BARDA to invest Project BioShield funds for the advanced development, US Food and Drug Administration (FDA) licensure, procurement, shipping, and vendor managed inventory (VMI) storage of MARV and SUDV monovalent vaccines.

B.1.1. Definitions Dose - means an adult or pediatric therapeutic dose of the pharmaceutical product and not a multi-dose package.

The finished product shall be packaged as single- or multi-unit doses, in approved packaging, to provide for cost-effective product lifecycle value and performance, and to allow for ease of distribution and use during a declared emergency.

Subcontractor - means any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime Contractor or another subcontractor. See, FAR 44.101

Vendor Managed Inventory (“VMI”) storage - means a product that is the subject of one or more orders and is monitored and maintained by the Contractor in Contractor storage facility(s). VMI storage may require Contractor deployment/shipment of product to SNS or other location at the request of US government (USG).

B.2. PRICES/COSTS/PERIOD OF PERFORMANCE

Prices: The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. It is anticipated that the final contract will consist of a base period of performance up to five (5) years and a total contract period of performance (base plus option periods) up to 10 years with the exercise of options.

Period of Performance: This requirement has a five-year base period and five option periods. The total period of performance will not exceed 10 years.

B.2.1. BASE PERIOD CLINs

CLINs Anticipated Period of Performance

CLIN Type Quantity • Supplies/Services Go, No-Go Criteria

2025-2030 (Base Period)

0001 Cost Plus Fixed Fee

NA • CMC activities needed to establish GMP manufacture of a MARV vaccine;

• Production of MARV PPQ lots

NA, made upon award

B.2.2. OPTION CLINs

CLINs Anticipated Period of Performance

CLIN Type Quantity Supplies/Services Go, No-Go Criteria

2025-2030 (Option 1)

0002 Cost Plus Fixed Fee

NA • If not already established or funded to do so, tech transfer to establish domestic BDS manufacturing and F/F capability for a MARV and SUDV vaccine respectively

BARDA concurrence on plan for establishing domestic manufacturing and F/F capability for both MARV and SUDV vaccines respectively

2026-2031 (Option 2)

0003 Cost Plus Fixed Fee

NA • CMC activities needed to establish GMP manufacture of a SUDV vaccine;

• Production of SUDV PPQ lots

SUDV vaccine process characterization and robustness complete or BARDA concurrence on an establishment plan for future SUDV vaccine GMP manufacturing activities

2026-2031 (Option 3)

0004 Cost Plus Fixed Fee

NA • Nonclinical efficacy and immunogenicity studies to support FDA licensure for a MARV vaccine;

• Assay development as required for both humoral and cellular immune response

MARV PPQ lots released and FDA concurrence with licensure pathway

2026 – 2031 (Option 4)

0005 Cost Plus Fixed Fee

NA • Nonclinical efficacy and immunogenicity studies to support FDA licensure for a SUDV vaccine;

• Assay development as required for both humoral and cellular immune response

SUDV PPQ lots released and FDA concurrence on licensure pathway

2026 – 2031 (Option 5)

0006 Cost Plus Fixed Fee

NA • Clinical Studies required for demonstration of safety to support product approval of a MARV vaccine, regulatory activities, and remainder of activities needed for development and licensure of MARV vaccine (expectations include statistically powered Safety and Immunogenicity studies in both US and Africa and lot to lot consistency study);

• BLA preparation and submission

MARV PPQ lots released and FDA concurrence on licensure pathway

2027-2032 (Option 6)

0007 Cost Plus Fixed Fee

NA • Clinical Studies required for demonstration of safety to support product approval of a SUDV vaccine, regulatory activities and remainder of activities needed for development and licensure of SUDV vaccine (expectations include statistically powered Safety and Immunogenicity studies in both US and Africa and lot to lot consistency study);

• BLA preparation and submission

SUDV PPQ lots released and FDA concurrence on licensure pathway

2030-2035 (Option 7)

0008 Cost Plus Fixed Fee

NA • Support for clinical demonstration of efficacy through ring vaccination intervention during filovirus MARV outbreak;

• Outbreak response should include delivery of vaccine, protocol preparation and cooperation with local authorities

BARDA concurrence of need for MARV outbreak support

2030-2035 (Option 8)

0009 Cost Plus Fixed Fee

NA • Support for clinical demonstration of efficacy through ring vaccination intervention during filovirus SUDV outbreak;

• Outbreak response should include delivery of vaccine, protocol preparation and cooperation with local authorities

BARDA concurrence of need for SUDV outbreak support

2030-2035 (Option 9)

0010 Cost Plus Fixed Fee

NA • Post marketing studies for a MARV vaccine including preparation and execution of shelf-life extension or post-expiry testing, label expansion for pediatrics, and immune compromised trial (FDA requirements as specified)

MARV vaccine achieves FDA licensure

2030-2035 (Option 10)

0011 Cost Plus Fixed Fee

NA • Post marketing studies for a SUDV vaccine including preparation and execution of shelf-life extension or post-expiry testing, label expansion for pediatrics, and immune compromised trial (FDA requirements as specified)

SUDV vaccine achieves FDA licensure

2027-2032 (Option 11)

0012 Firm Fixed Price

100,000 pre-licensed doses

• Acquisition of 100,000 new or previously manufactured MARV vaccine doses ready for clinical deployment;

• Delivery to SNS or VMI storage, within continental US, until end of contract

BARDA discretion and availability of funds

2027-2032 (Option 12)

0013 Firm Fixed Price

100,000 pre-licensed doses

• Acquisition of 100,000 new or previously manufactured SUDV vaccine doses ready for clinical deployment.

• Delivery to SNS or VMI storage, within continental US, until end of contract

BARDA discretion and availability of funds

2028-2033 (Option 13)

0014 Firm Fixed Price

100,000 pre-licensed doses

• Additional procurement and storage of drug product (100,000 doses, pre-licensure) for a MARV vaccine;

• Delivery to SNS or VMI storage, within continental US, until end of contract

2028-2033 (Option 14)

0015 Firm Fixed Price

100,000 pre-licensed doses

• Additional procurement and storage of drug product (100,000 doses, pre-licensure) for a SUDV vaccine;

• Delivery to SNS or VMI storage, within continental US, until end of contract

2029-2034 (Option 15)

0016 Firm Fixed Price

100,000 pre-licensed doses

• Additional procurement and storage of drug product (100,000 doses, pre-licensure) for a MARV vaccine;

• Delivery to SNS or VMI storage, within continental US, until end of contract

BARDA discretion and availability of funds

2029-2034 (Option 16)

0017 Firm Fixed Price

100,000 pre-licensed doses

• Additional procurement and storage of drug product (100,000 doses, pre-licensure) for a SUDV vaccine;

• Delivery to SNS or VMI storage, within continental US, until end of contract

(Option 17)

0018 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses of a MARV vaccine;

• Delivery to SNS or VMI storage, within continental US, until expiry or end of contract

(Option 18)

0019 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses of a SUDV vaccine;

• Delivery to SNS or VMI storage, within continental US, until expiry or end of contract

(Option 19)

0020 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses of a MARV vaccine;

• Delivery to SNS or VMI storage, within continental US, until expiry or end of contract

(Option 20)

0021 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses of a SUDV vaccine;

• Delivery to SNS or VMI storage, within continental US, until expiry or end of contract

(Option 21)

0022 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses of a MARV vaccine;

• Delivery to SNS or VMI storage until expiry or end of contract

(Option 22)

0023 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses of a SUDV vaccine;

• Delivery to SNS or VMI storage, within continental US, until expiry or end of contract

(Option 23)

0024 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses of a MARV vaccine;

• Delivery to SNS or VMI storage, within continental US, until expiry or end of contract

(Option 24)

0025 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses of a SUDV vaccine;

• Delivery to SNS or VMI storage, within continental US, until expiry or end of contract

(Option 25)

0026 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses for a MARV vaccine;

• Delivery to SNS or VMI storage, within continental US, until expiry or end of contract

(Option 26)

0027 Firm Fixed Price

100,000 licensed doses

• Procurement of 100,000 licensed doses of a SUDV vaccine;

• Delivery to SNS or VMI storage, within continental US, until expiry or end of contract

B.2.3. PBS Contract Authority: 42 USC 247d-6b(c) and (g), the Project BioShield Act of 2004.

B.2.4. Multi-Year Contract: Multi-year Project BioShield (PBS) contract means a contract for the purchase of supplies or services for more than one, but not more than ten, program years. A multi-year contract may provide that performance under the contract during the option periods and subsequent years of the contract is contingent upon the appropriation of funds, and (if it does so provide) may provide for a cancellation payment to be made to the contractor if appropriations are not made. The key distinguishing difference between multi-year contracts and multiple year contracts is that multi-year contracts, defined in the statutes cited at 17.101, buy more than one year’s requirement (of a product or service) without establishing and having to exercise an option for each program year after the first.

B.2.5. Type of Contract: The Contracting Officer has determined this to be a hybrid Cost Plus Fixed Fee (CPFF) and Firm-Fixed Priced (FFP) contract type.

B.3. ADVANCE UNDERSTANDINGS

The final contract may contain advance understandings between the Government and the Offeror. Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost will be included in this Section if the Contracting Officer has granted his/her approval prior to contract award.

B.3.1. Delivery in this case will refer to final release of final drug product for storage as VMI or SNS delivery as requested by BARDA.

B.3.2. At least sixty calendar days prior to expiration of this Contract, the Contractor shall notify the USG in writing of the amount and the stock-keeping unit (SKU) type of all remaining products being maintained in VMI by the Contractor on behalf of the USG.

B.3.3. The Contractor shall negotiate and enter into a Quality Agreement with HHS, BARDA, and other USG groups as needed, no later than ninety calendar days after Contract award. This Quality Agreement shall outline the responsibilities of both the Contractor and the USG (i.e., ASPR) for product shipping, receiving, and storage. These documents shall be drafted and signed by all parties prior to the transport and storage of the product.

a. Person-in-Plant With seven (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a person-in-plant in the Contractor’s or Subcontractor’s facility, who shall be subject to the Contractor’s or Subcontractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s or Subcontractor’s facility. The Government’s representative shall be provided reasonable access, during normal business hours, to the production areas being utilized in performance on the Contract. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor’s or subcontractor’s plant.

An article substantially similar to this Person-in-Plant article shall be incorporated into any subcontract for experimental or manufacturing work.

b. Security A security plan with proposal submission is required for this effort. See Attachments #13 & #14.

c. Subcontracts Prior written consent from the Contracting Officer in the form of Contracting Officer Authorization (COA) is required for any subcontract that:

• Is of the cost-reimbursement type; or

• Is of the fixed price type and exceeds $250,000 or 5% of the contract, whichever is less.

The Contracting Officer shall request appropriate supporting documentation in order to review and determine authorization, pursuant with FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, the Contractor shall provide a copy of the signed, executed subcontract and consulting agreement to the Contracting Officer within ten (10) calendar days.

Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions set forth in this Section.

d. Overtime Compensation No overtime (premium) compensation is authorized under the subject contract.

e. Sharing of contract deliverables within United States Government (USG) In an effort to build a robust medical countermeasure pipeline through increased collaboration, the Government may share technical deliverables with Government entities responsible for Medical Countermeasure Development.

In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration, BARDA may share technical deliverables and test results created in the performance of this Contract with colleagues within the Integrated Portfolio.

This advanced understanding does not authorize the Government to share financial information outside of the United States Government, except as required by law. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data – General, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables.

f. Approval of Human and Animal Protocols The Contractor shall submit all human and animal protocols and human informed consent documents as referenced under this Contract to the COR for review and approval prior to seeking other approvals (Institutional Review Board, Human Use Committee, Institutional Animal Care and Use Committee) unless the contractor already had such approvals prior to contract award. The Government requires no fewer than ten (10) business days to perform a review. The Contractor shall take this review time into account and submit protocols as early as possible to avoid delays. The Government’s comments and feedback shall be addressed prior to approval. The Contracting Officer’s Representative (COR) will review and provide approval of protocols. Human informed consents shall also be submitted and reviewed with any human protocol.

g. Rights in Data The contract will incorporate the FAR Clause 52.227-14, Rights in Data—General. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables. The contract will also include FAR Clause 52.227-16 Additional Data Requirements.

h. Invoice Submission During End of Fiscal Year The government will not accept invoices for processing from Sep 6th through Oct 5th because of end of year fiscal requirements. Any invoices received from September 6th through October 5th will be canceled and returned to the Contractor for resubmission beginning on October 6th.

i. Travel Costs

a) Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract during the Base Period (CLIN 0001) shall not exceed $XXX (to be determined at the time of award) without the prior written approval of the Contracting Officer. Costs must be consistent with Federal Acquisition Regulations (FAR) 52.247-63 – Preference for U.S. Air Flag carriers.

b) The Contactor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulation (FAR) 31.2 – Contracts with Commercial Organizations, Sub-Section 31.205- 46, Travel Costs.

c) If foreign travel is necessary, a Contracting Officer Authorization (COA) will be required. Expenditures for foreign travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed the amount specified in each approved COA, without the prior written approval of the Contracting Officer. Foreign travel must be billed separately from domestic travel.

Requests for foreign travel must be submitted at least four weeks in advance and shall contain the following:

a). Meeting(s) and place(s) to be visited, with costs and dates; name(s) and title(s) of Contractor personnel to travel and their functions in the contract project;

b). Contract purposes to be served by the travel;

c). How travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of BARDA contract funds;

d). How such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and e). What additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project.

B.4. PROVISIONS TO APPLICABLE COSTS

This section prohibits or restricts the use of contract funds which includes the following items (costs unallowable unless otherwise approved by the Contracting Officer):

a) Acquisition, by purchase or lease, of any interest in real property;

b) Rearrangement or alteration of facilities;

c) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value;

d) Accountable Government Property;

e) Overtime;

f) General scientific meetings/conferences;

g) Travel costs including foreign travel;

h) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);

i) Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000.00;

j) Refreshments and Meal Expenditures;

k) Promotional Items;

l) Printing.

While BARDA can support all activities in support of FDA regulatory filings, we cannot pay the fees requires for those filings. In other words, funds should no ever go from one USG agency (BARDA) to another (FDA).

SECTION C – DESCRIPTION/SPECIFICATIONS

C.1. STATEMENT OF OBJECTIVES

BACKGROUND AND PURPOSE

1. Background and Purpose

This request for proposals (RFP) is for the advanced development, licensure, and procurement of monovalent vaccines against Marburg virus (MARV) and Sudan virus (SUDV) respectively. Furthermore, this RFP will also support late-stage development and Phase 4 Post-Marketing commitments/requirements required by the Food and Drug Administration (FDA) for products approved under the traditional, animal rule, or accelerated pathways.

Filoviruses are known to cause severe health consequences, including death, in humans. Infections with Ebola virus (EBOV), Sudan virus (SUDV), and Marburg virus (MARV) can lead to case fatality rates of up to 90%. The West Africa outbreak of EBOV during 2014-2015 resulted in 28,646 confirmed, probable, and suspected cases, with 11,323 reported deaths. Several individuals were transported back to the US for treatment, and four confirmed cases were treated in the US, underscoring the urgent need for MCMs for filoviruses to be developed, manufactured, and procured to protect the US population. While there is a licensed vaccine against EBOV, there are currently no FDA-licensed vaccines or therapeutics for SUDV and MARV. The immediate need for MARV and SUDV vaccines has been emphasized by recent outbreaks, including the SUDV outbreak in 2022 that resulted in 141 confirmed cases and 55 deaths. Additionally, a MARV outbreak in 2024 led to 66 confirmed cases and 15 deaths.

In 2006, the Department of Homeland Security (DHS) determined that Ebola viruses and MARV are material threats to national health security. The threat of filovirus agents being used as biological/bioterror weapons led the DHS to issue a Material Threat Determination (MTD) based on its Material Threat Assessment (MTA) for Ebola viruses and MARV.

In July 2014, Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) issued the "Product-Specific Requirements for Medical Countermeasures for Marburg and Ebola Virus Diseases". The document defines the product requirements for both post-exposure prophylaxis (PEP) and therapeutic treatment of infections caused by an intentional large-scale release of an Ebola virus or MARV.

The resulting product(s) produced would be procured using Project BioShield (PBS) funds. In the event of a declared emergency prior to licensure of the vaccine by the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Review (CBER), it is anticipated that the investigational product(s) may be administered under an Emergency Use Authorization (EUA) held by the CDC or BARDA. The United States Government (USG) desires vaccines that can meet the PHEMCE product requirements for MCM against MARV and SUDV exposure.

This RFP will also support the necessary late-stage development to achieve licensure of the product(s) being procured.

2. Scope: The USG is seeking to support the advanced development and licensure of a monovalent MARV and a monovalent SUDV vaccine respectively. Additionally, USG is seeking to procure and maintain up to 500,000 licensed regimens of monovalent vaccines against MARV and SUDV respectively. Additionally, USG may procure up to 300,000 doses prelicensure of MARV and SUDV monovalent vaccines. The vaccines shall either be delivered to the Strategic National Stockpile (SNS) or maintained as vendor-managed inventory (VMI) storage through the end of the contract as determined by BARDA and the Contracting Officer. The regimen shall be provided as Final Drug Product (FDP). The USG is seeking vaccines held by the SNS or VMI storage that may be administered under an Emergency Use Authorization (EUA) if an emergency is declared in response to a future outbreak.

The scope of the base period and options 2-8 will include late-stage development activities necessary, and required by the U.S. FDA, to support product licensure. Option 1 should support the necessary activities to tech transfer and establish domestic BDS manufacturing and fill/finish capability for a MARV and SUDV vaccine. Under Option 1, the Offeror shall propose a plan to have the BDS manufacturing for both vaccines at a single domestic manufacturer and the fill/finish of both vaccines at a single domestic facility for their proposal to this RFP.

Additional options (options 9-10) will include Phase 4 Post-Marketing Commitments.

Finally, options 11-16 will include procurement of MARV and SUDV doses prelicensure and options 17-26 include procurement of MARV and SUDV doses after FDA licensure.

The Contractor shall provide, as part of the Contract, a VMI storage program for the specified product in which the Contractor shall monitor and maintain, as specified in an inventory management plan, required inventory levels and product shelf-life. The Contractor shall provide availability of shipments 24 hours a day, 7 days a week, 365 days a year and shall be able to deploy as requested pursuant to the Contract. The VMI storage provided by the Contractor shall include a plan to provide the USG with an accurate inventory of the product as well as Contractor storage location(s) should the USG have an immediate need for the product to be released from VMI storage in an emergency situation. The Contractor’s plan to provide access to the product as needed by the USG and the Quality Agreement with the Administration for Strategic Preparedness and Response (ASPR) shall align with the USG’s specific product use during a mass casualty incident. In order to meet the above objectives, the Contractor shall have evidence that the labeling, storage, distribution and transport programs are secure and controlled.

The statement of objectives are outlined in the following four sections that the Offeror(s) shall address in their proposal:

Section 3: Program Management and Risk Mitigation Objectives (CLINs 1-11) Section 4: Late-Stage Product Development Objectives (CLINs 1-9) Section 5: Post-Marketing Commitments and/or Requirements (CLINs 10 and 11) Section 6: Procurement, Storage, or Delivery of Product Objectives (CLINs 12-27)

3. Program Management and Risk Mitigation Objectives The Offeror is directed towards details provided in Section F for items below.

3.1. Program and Risk Management Objectives

3.1.1. The Offeror shall submit program/risk management documents as described in Section F.3.2.E and F.4.

3.1.2. The Offeror shall develop and maintain a risk mitigation plan that is acceptable to the CO and COR. This shall include a risk matrix per Attachment 11.

3.1.3. The Offeror shall provide a security plan which is associated with all aspects of manufacture of product, process, storage, and inventory of the FDP. The Security Plan shall include all sites within the supply chain, including proposed shipping carriers. For those sites/carriers that are not defined at the time of award or are added during the period of performance, individualized Security Plans shall be provided to the USG prior to inclusion of sites/carriers into the supply chain. BARDA’s Program Protection Office will be authorized to review and approve Security Plans and will conduct annual audits / site visits to ensure a reliable product is delivered to the USG. Security requirements and a template for a Security Plan are included in Attachments 13 and 14, respectively.

4. Late-stage Product Development Objectives

4.1. General Product Development Objectives

4.1.1. The Offeror shall provide draft Target Product Profiles (TPPs) which will be further developed through discussion and negotiation with BARDA and/or FDA.

4.1.2. The monovalent vaccines shall individually have the intention for an indication for protection against disease caused by MARV and SUDV respectively. Single dose regimen is a priority for both vaccines. Single dose vial presentation preferred.

4.1.3. The vaccines shall have the intention for an indication for use in healthy adults (Ages 18-65).

4.1.4. The vaccines shall have a minimum of four years stability at the intended storage temperature.

4.1.5. The vaccines shall be able to be manufactured at a scale capable of meeting the USG requirements for stockpiling. Please see the quantities of vaccine regimens noted in Section 6.

4.2. Regulatory Objectives

4.2.1. The Offeror shall submit a Quality Management System (QMS) plan and a regulatory master plan for obtaining product licensure as directed and approved by the COR and CO. The plan shall include risk evaluation and address outstanding items identified by FDA (toxicology, nonclinical and clinical studies, and manufacturing activities).

4.2.2. The Offeror shall maintain and update, as required by the FDA, all required regulatory documentation (investigator brochure, regulatory binder, etc.), that will be used to support use under EUA and/or licensure.

4.2.3. The Offeror shall obtain FDA concurrence on the regulatory pathway to licensure (i.e. traditional approval, accelerated approval, or Animal Rule).

4.2.4. The Offeror shall conduct all necessary activities and meetings with the FDA to support preparation and submission of a Biologics License Application (BLA) to the FDA.

4.2.5. The Offeror shall re-label investigational product (upon licensure) to be consistent with the licensed product, in accordance with regulatory requirements from the FDA.

4.2.6. The Offeror shall develop a Phase 4 post-marketing plan that shall continue monitoring for safety and efficacy in anticipation of FDA guidance for post-marketing commitments.

4.3. Nonclinical Objectives

If not already completed or funded to do so, the Offeror shall perform nonclinical studies required for IND application submission in suitable model(s) to demonstrate safety (e.g., toxicology, biodistribution, etc.), immunogenicity, and efficacy against MARV and SUDV that support clinical trials. Nonclinical study data shall support FDA licensure of the monovalent vaccines against MARV and SUDV under the regulatory pathway that received FDA concurrence. Additionally, the Offeror should support preparation of required documentation as required by FDA for the approved regulatory pathway. If not already completed or funded to do so, the Offeror should complete assay development needed to support both nonclinical and clinical studies needed for licensure.

4.3.1. The Offeror shall conduct any FDA required nonclinical efficacy and immunogenicity studies to support FDA licensure.

4.3.2. The Offeror shall conduct any FDA required toxicity studies to support FDA licensure if not already funded to do so or already completed.

4.3.3. The Offeror should include assay development as required by FDA for approved regulatory pathway if not already completed or funded to do so.

4.4. Clinical Objectives

The Offeror(s) shall demonstrate that the monovalent vaccines against MARV and SUDV are safe in human clinical trials and immunogenic as measured by immunological assays required for demonstration of safety to support product approval. Human safety and immunogenicity studies shall be adequate to support FDA licensure of the vaccines against MARV and SUDV. Additionally, the Offeror shall plan for support for clinical demonstration of efficacy through vaccination intervention during a MARV or SUDV outbreak. Additionally, the Offeror should plan for support for outbreak response to include but not limited to the delivery of vaccine, protocol preparation and cooperation with local authorities.

4.4.1. The Offeror shall complete any remaining Phase 3 clinical studies, as required by FDA for licensure under the approved regulatory pathway and evaluate critical biological outcomes using validated or qualified assays as directed by the BARDA/FDA. This may include but is not limited to: statistically powered Safety and Immunogenicity studies in both US and Africa and lot to lot consistency studies for both MARV and SUDV vaccines.

4.4.2. The Offeror shall demonstrate correlation between clinical and nonclinical studies if warranted by the regulatory path per BARDA/FDA guidance.

4.4.3. The Offeror shall include additional plans for support outbreakefficacy studies (one per vaccine) for the event that an outbreak of MARV or SUDV occurs.

4.5. Chemistry, Manufacturing, Control (CMC) Objectives

CMC activities needed to establish GMP manufacture and release of monovalent vaccines against MARV and

SUDV.

4.5.1. The Offeror shall provide a Manufacturing Plan that includes a facility regulatory compliance plan addressing cGMP standards, description of the manufacturing facility quality assurance, and regulatory acceptance including quality systems, validation master plan and regulatory milestones for MARV and SUDV vaccines.

4.5.2. The Offeror shall complete any remaining manufacturing and quality control activities needed to support FDA licensure for both MARV and SUDV vaccines.

4.5.3. The Offeror shall conduct long term stability studies on Bulk Drug Substance (BDS) and final drug product (FDP) to extend expiry dating with a goal of at least five years for MARV and SUDV vaccines after initial licensure.

4.5.4. The Offeror shall demonstrate capability and compliance or plans for all required CMC activities for both MARV and SUDV vaccines. These include but are not limited to those listed below:

4.5.4.1. BDS and FDP, process, facilities, and equipment validation, analytical methods and assays qualification/validation appropriate for product characterization and product release, including tests for the identity, purity, potency, and for demonstrating stability of the BDS and FDP to support FDA licensure.

4.5.4.2. Identify a stable source and availability of reagents and reference standards for these assays required; execute product stability testing plans as evidenced by available data towards the intended product stability.

4.5.4.3. Develop and maintain documentations such as those describing quality control (QC) and quality assurance (QA) monitoring plan, and manufacturing process, facility information, product storage and monitoring inventory systems, process flow for personnel, material and waste disposal.

4.5.4.4. Packaging of FDP to provide for the most cost-effective product life-cycle value and performance, and to allow for ease of distribution and use during a declared public health emergency.

4.5.4.5. Activities for PAI readiness as needed or required.

4.5.5. For Option 1, the Offeror shall submit a plan to have both the MARV and SUDV vaccine manufactured by a single domestic US manufacturer and have the fill/finish of both the MARV and SUDV vaccine done at a single US domestic facility.

4.5.6. The Offeror shall complete onshoring manufacturing of BDS to a domestic CMO if not already funded to do so and BDS is not already manufactured within the US.

4.5.7. The Offeror shall complete onshoring of fill/finish (F/F) manufacturing of FDP (formulation/fill/finish (F/F)) to a domestic CMO if not already funded to do so and F/F of FDP is not already done within the US.

5. Post-Marketing Commitments and/or Requirements (Option CLIN 0010 and CLIN 0011):

5.1. The Offeror shall commit to comply with Post-Marketing Commitments and/or Requirements (PMCR) as specified by the FDA for both MARV and SUDV vaccines. Cost estimates may be based on tentative plans in place prior to direction from the FDA. Based on guidance from the FDA, select items from section 4 of the Statement of Objectives may be moved to the PMCR section.

6. Additional Procurement (Option CLINs 0012-0027):

The estimate to be procured for option CLINs 0012 through 0027 is up to an additional 800,000 regimens for each vaccine (MARV and SUDV vaccines), in accordance with all federal, and state and local regulations. The source of transportation used by the Offeror for the delivery of product must meet USG security requirements. Product will either be maintained as VMI storage until end of contract or be delivered to the SNS in a manner consistent with FDA guidance for EUA of Medical Products, under section 564 of the Federal Food, Drug, and Cosmetic Act, which was amended by the Project BioShield Act of 2004 and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. However, the USG has the sole discretion to determine the amount of product to be procured based on requirements and availability of funds. These efforts include manufacturing, stability testing, and storage. Please propose price per dose tables for both VMI storage (which includes possible deployment/shipping of product from VMI storage to SNS or other location at request of USG) and delivery to the SNS. All VMI storage must be located within the continental US.

The Offeror shall maintain cGMP compliance and quality control of MARV and SUDV doses when stored in VMI. The Offeror shall maintain cGMP compliance and quality control of vaccine doses at all stages of shipping.

The VMI storage program shall include storage, holding, inventory management, quality control, secure safe keeping, and possible deployment/shipping of product (shipping product out from VMI storage to SNS or other location). An inventory management plan shall include a plan to provide the USG with an accurate inventory of product as well as location(s) should USG have an immediate need for product in an emergency situation. While a strategy for deployment/shipping of product shall be provided as an example in the Offeror's product delivery plan, the Quality Agreement with ASPR that includes product delivery as needed by the government shall be negotiated after award to align with the USG’s specific product use during a mass casualty event. Descriptions of product transfer will be specified in a Quality Agreement between HHS/ASPR and the Offeror.

6.1. CLIN 00012 shall support procurement, storage, and shipping of up to 100,000 doses of a MARV vaccine prior to licensure of the vaccine by the FDA.

6.2. CLIN 00013 shall support procurement, storage, and shipping of up to 100,000 doses of a SUDV vaccine prior to licensure of the vaccine by the FDA.

6.3. CLIN 00014 shall support procurement, storage, and shipping of up to 100,000 doses of a MARV vaccine prior to licensure of the vaccine by the FDA.

6.4. CLIN 00015 shall support procurement, storage, and shipping of up to 100,000 doses of a SUDV vaccine prior to licensure of the vaccine by the FDA.

6.5. CLIN 00016 shall support procurement, storage, and shipping of up to 100,000 doses of a MARV vaccine prior to licensure of the vaccine by the FDA.

6.6. CLIN 00017 shall support procurement, storage, and shipping of up to 100,000 doses of a SUDV vaccine prior to licensure of the vaccine by the FDA.

6.7. CLIN 00018 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a MARV vaccine.

6.8. CLIN 00019 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a SUDV vaccine.

6.9. CLIN 00020 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a MARV vaccine.

6.10. CLIN 00021 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a SUDV vaccine.

6.11. CLIN 00022 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a MARV vaccine.

6.12. CLIN 00023 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a SUDV vaccine.

6.13. CLIN 00024 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a MARV vaccine.

6.14. CLIN 00025 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a SUDV vaccine.

6.15. CLIN 00026 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a MARV vaccine.

6.16. CLIN 00027 shall support procurement, storage, and shipping of up to 100,000 licensed doses of a SUDV vaccine.

C.2. PRODUCT REQUIREMENTS

This product shall be held in VMI storage (if not shipped to the SNS), until such time it is requested by the USG for emergency use and transferred to USG custody.

If the need for product release/deployment/shipment arises, the authorization procedures in Notification of Release of Product shall be followed.

In the event the USG requires deployment/shipment of all or any portion of the required inventory level, the USG shall then provide the Contractor with a CO or designee’s Notification of Release of Product reflecting the quantity and product(s) released/deployed.

Descriptions of material transfer will be specified in a Quality Agreement between HHS ASPR and the Contractor.

The finished product shall be packaged as a single dose to provide for cost-effective product lifecycle value and performance, and to allow for ease of distribution and use during a declared emergency.

Option periods will be exercised in accordance with the period of performance specified in Article B.2.1. The Government may choose to exercise or to not exercise an option. The Contractor shall be notified IAW FAR 52.217- 9, if the Government intends to exercise an option.

C.2.1. VMI Storage requirements Within 15-days before the first delivery to VMI storage or SNS, the Contractor shall provide a listing of the names, titles and telephone numbers (non-emergency and emergency) of its key personnel who should be contacted for USG visits, inventory status, and access to and/or deployment/shipment of product, and a simulated deployment of the product, during normal and after business hours. The Contractor shall notify by telephone and provide the CO and COR in writing any future updates or changes to the listing within 24 hours of making the update or change.

At the discretion of the USG and independent of quality testing conducted by the Contractor, the USG reserves the right to conduct inspections and collect samples of product that is intended to be held in VMI storage by the Contractor at the manufacturing facility(s), satellite sites, or under VMI storage.

The Contractor shall allow announced and unannounced visits to its VMI storage facility(s) by HHS personnel for the purpose of inspection and review of the required product inventory levels. Quality assessments of Contractor’s facility and quality systems may undergo an initial qualification audit. The CO will provide the Contractor with a minimum of a 48-hour advance notice of any announced visits. A Quality Assessment agenda shall be provided prior to the assessment date. Upon completion of the assessment, HHS shall provide to the Contractor a written Quality Assessment Report summarizing all findings and recommendations. The Contractor shall provide a written response addressing each finding/recommendation within 30 calendar days from the date report is received by the Contractor. The Contractor shall provide additional information and/or clarification regarding the assessment findings as requested by HHS. HHS will limit visits to no more than 2 per year, per facility, provided that each visit is uneventful, and the Contractor’s performance has been satisfactory. All visits, announced and unannounced, will be limited to normal weekday business hours and non-federal holidays.

The Contractor shall be responsible to notify the CO and COR within 24-hours after any notice of inspection and unscheduled inspections or actions by regulatory agencies, other enforcement agencies (e.g., FDA, DEA, OSHA), and third-party contractors that may involve and/or impact USG purchased products in VMI storage. The USG shall be permitted to delegate at least two persons to observe the inspection. The notifications should be sent electronically to the CO, COR or other officials as designated by the CO.

The Contractor shall provide the USG with a plan of proposed corrective actions no later than fifteen business days from the USG’s identification of problems regarding storage, inventory management, or other discrepancies identified through scheduled or non-scheduled storage sites visits. Contractor shall make all mutually agreed upon changes pursuant to such agreements as soon as possible.

In the event of a drug recall on any product(s) under this Contract and to the extent it may affect the safety, efficacy or continued supply of the Product(s) covered under this Contract, the recall of product(s) other than those that are covered under this Contract that are manufactured by or at the facilities of the manufacturer of the product(s) covered under this Contract, Contractor shall notify the CO, COR and/or other officials…