01-75A50126R00001_RFP_Final.pdf

75A50126R00001

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

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C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

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K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 3304 (a) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

08/17/2026 X

ASPR/DAAPPO/BARDA/DC

ASPR/DAAPO/BARDA/DCMA

US DEPT OF HEALTH & HUMAN SERVICES

CONSITUTION CENTER 400 7th St SW Washington DC 20024

1700 ET 10/30/2026

LAURA E SADDISON

laura.saddison@hhs.gov

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PAGE(S)

LAURA E. SADDISON

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 6/2014)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____120_________ calendar days (60 calendar days unless a different period is inserted

75A50126R00001_RFP_NPIVS-2027

Biomedical Advanced Research and Development Authority (BARDA)

Request for Proposals (RFP) for

Vaccine Medical Countermeasures for Pandemic Influenza

Preparedness and Response

RFP #:75A50126R00001

Issued: August 17, 2026

Initial Questions Due: August 31, 2026 by 12:00 p.m. (EST)

Supplemental Questions Due: September 24, by 12:00 p.m. (EST)

Proposal Responses Due: October 30, 2026 by 5:00 p.m. (EST)

Contracting Officer: Laura Saddison (Laura.Saddison@hhs.gov)

MedicalCountermeasures.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 Sections L of this solicitation.

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

The contract schedule, set forth in SECTIONS B through K, 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 Contractor’s proposal may be included in the resultant contract. The contract schedule is intended to provide the Contractor with information to aid in understanding the likely terms and conditions of any resultant contract.

Questions related to this RFP should be directed via email to Laura Saddison (Laura.Saddison@hhs.gov) and Jill Johnson (Jill.Johnson@hhs.gov). The government will respond to questions at its discretion and as time and resources allow. Questions deemed outside the scope of this RFP will not receive a response.

mailto:Laura.Saddison@hhs.gov mailto:Jill.Johnson@hhs.gov

PART 1 – THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BRIEF DESCRIPTION OF SERVICES AND SUPPLIES

The Center for the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS), has a long-standing Vaccine Medical Countermeasures (MCMs) for Pandemic Influenza Preparedness and Response Program that ensures a constant state of pandemic readiness by enabling the rapid production of influenza vaccines and adjuvants by manufacturers of FDA-licensed vaccines in the event of a public health emergency. As part of this program, BARDA has established pandemic-ready manufacturing and critical enablers for a permanent readiness posture against high threat influenza virus strains through regulatory readiness, vaccine implementation strategies in the event of a public health emergency, and an inventory of vaccine countermeasures, including vaccine seed stocks, bulk antigen and adjuvant, and final container antigen and adjuvant.

Unlike with seasonal influenza vaccines, two doses of adjuvanted pandemic influenza vaccine will likely be required to protect an immunologically naïve population from severe disease (all age groups). This is expected to require at least 330 million regimens (or 660 million doses) to vaccinate the entire U.S. population. Therefore, a strong domestic vaccine manufacturing capability is critical for national security and response to seasonal and pandemic influenza. To support pandemic readiness, it is crucial to have commercially sustainable manufacturing processes that ensure continuous warm-base production capacity that is not solely U.S.

Government (USG)-maintained.

BARDA seeks Contractor(s) to support the continuation of the Vaccine MCMs for Pandemic Influenza Preparedness and Response Program.1 The Contractor(s) must furnish all the necessary services, qualified personnel, materials, supplies, equipment and facilities (U.S.

facilities preferred) not otherwise provided by the USG as needed to provide MCMs, such as vaccines, antigens, and adjuvants, for pandemic preparedness and response or as required in response to a public health emergency; produce antigen and vaccines against influenza virus or other viruses with pandemic potential as required by BARDA; produce antigens, adjuvants, and/or vaccines to support USG efforts to further improve influenza vaccines (for which feasibility data is available); and support rapid regulatory decisions and manufacturing readiness by generating and submitting to FDA all relevant data (e.g., analytical, nonclinical, clinical, and/or chemistry, manufacturing, and controls (CMC)), including data generated during interpandemic periods.

1 https://www.medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/pandemic-vaccines-adjuvants

B.2. PRICES/ COSTS/ PERIOD OF PERFOMRANCE /CONTRACT LINE ITEM NUMBERS

(CLINs) and ACTIVITIES

a. Statement of Work: The Statement of Work (SOW) contained in Section C of the solicitation package delineates the specifics of the supplies or services to be furnished.

b. Offeror should provide pricing for all CLINs and Activities, except those which have

“TBD” or “N/A” in the “Maximum Potential Quantity for the PoP” column. Provide pricing based upon the CLIN, Activity Number, Activity Name, and description in the SOW for the five (5)-year (60-month) base period of performance (PoP), and provide pricing based upon Activity Name and description for the one (1) five-year option period. Note that the Activities in the SOW reflect Base Period numbering (i.e., Activities identified in SOW would be revised in conjunction with any resultant option award with description data unchanged).

c. Price/Cost, e.g., Firm-fixed-price or cost reimbursable, for “TBD” Activities, i.e., Activities

1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017 will be determined as a result of the issuance of a Request for Task Order Response (RTOR) to resultant contract awardee(s).

d. Minimum/Maximum: The Contractor shall be reimbursed by the Government in an amount not less than a total of $50,0000.00 nor more than a total of $ (maximum).

The minimum guarantee is $50,000.00 for the duration of any resultant contract (base + options).

e. Ordering Period: The prices set forth below will cover the ordering period of 120 months from date of award. DATE through DATE.

f. Any material manufactured or data generated under this contract is deliverable to the Government. Upon delivery, inspection, and acceptance of the Activity(-ies) described in SECTION C Statement of Work, and identified in the schedule of pricing below, the Government shall pay to the Contractor the unit price(s) set forth below.

g. At the Contracting Officer’s discretion, offerors may be asked to propose alternative

Activity Contract Types when responding to task order, blanket purchase agreement (BPA), or call order solicitations.

h. Firm-Fixed-Unit-Price (FFUP): The FFUP unit price shall be firm and not subject to adjustment based on offeror’s actual costs of performance. The unit price shall include all direct and indirect labor, materials and supplies, equipment and facilities, travel (if applicable), subcontractor costs, overhead, general and administrative expenses, and profit necessary to perform the work in accordance with the Statement of Work (SOW).

The Government will pay offeror the fixed unit price for each unit actually ordered and accepted. The government does not guarantee that the “Maximum Potential Quantity for the PoP” will be ordered. Payment will be based solely on the number of units ordered and satisfactorily delivered or performed and accepted by the government. Offerors shall propose a single fixed unit price for each FFUP activity. Extended prices will be calculated for evaluation purposes only. Offeror assumes full responsibility for performance costs and resulting profit or loss.

i. Tariffs, Duties, and Trade Remedies: Offerors shall not include any anticipated or speculative tariff, duty, or trade remedy costs in the pricing of any Activity(-ies) other than ACTIVITIES 1018 and 2018.

j. CLIN 1000 BASE PERIOD: _____ (60 months from Base Award)

Activity Activity Name Contract Type UNIT

UNIT

PRICE

MAXIMUM

POTENTIAL

QUANTITY

FOR THE PoP

TOTAL EXTENDED

PRICE

(60-month Base Period)

Candidate Vaccine Virus

(CVV)

FFP EA

CGMP

Influenza Vaccine Master and/or Working Seed Lot(s)

FFP LOT

Influenza Vaccine Research Lot(s)

FFP LOT

CGMP

Influenza Vaccine:

Investigational Lot(s)

FFP LOT

CGMP

Influenza Vaccine:

Commercial Scale Bulk Lot(s)

FFP LOT

CGMP

Adjuvant:

Clinical or Commercial Scale Bulk Lot(s)

FFP LOT

1007A Formulation and Filling:

Antigen

FFUP EA

1007B

Formulation and Filling:

Adjuvant

FFUP EA

1007C

Formulation and Filling:

Co-formulated Antigen and Adjuvant

FFUP EA

1007D

Access to Filling Capacity or Disruption Fee for Commercial Products

FFP EA TBD

1008 Labeling and Packaging FFUP EA

1009A

Storage and Stability:

Commercial Scale Bulk Lots of Antigen

FFUP LOT Per Lot Per Month

1009B

Storage and Stability:

Antigen in Final Container

FFUP

Final Contai ner Per FC Per Month

1009C

Storage and Stability:

Clinical/ Commercial Scale Bulk lots of Adjuvant

FFUP LOT Per Lot Per Month

1009D

Storage and Stability:

Adjuvant in Final Container

FFUP

Final Contai ner Per FC Per Month

1010 Shipping FFP EA TBD

Analytical Laboratory Testing/Assay

FFP EA TBD

1012 Nonclinical Studies FFP Study TBD

1013 Clinical Studies FFP Study TBD

1014 Disposal of Product FFP EA TBD

1015 Emerging Pathogen Cost EA TBD

Validation Activities or Technology Transfer Activities

FFP EA TBD

1017 Manufacturing Enhancements FFP EA TBD

Tariffs, Duties, and Trade Remedies on any

ACTIVITY(-

IES)

Cost EA TBD

1019 Standard Data Reporting NSP Monthl y N/A Not

Separately Priced (NSP)

1020 Additional Reporting NSP Report N/A Not Separately

Total Estimated Dollar Amount – Base Period (60 Months)

k. CLIN 2000 OPTION PERIOD 1: _____ (60 months from the exercise of Option Period 1)

Activity Activity Name Contract Type UNIT UNIT

PRICE

MAXIMUM

POTENTIAL

QUANTITY FOR

THE PoP

TOTAL EXTENDED

PRICE

(60-month Option Period 1)

Candidate Vaccine Virus

(CVV)

FFP EA

CGMP

Influenza Vaccine Master and/or Working Seed Lot(s)

FFP LOT

Influenza Vaccine Research Lot(s)

FFP LOT

CGMP

Influenza Vaccine:

Investigational Lot(s)

FFP LOT

CGMP

Influenza Vaccine:

Commercial Scale Bulk Lot(s)

FFP LOT

CGMP

Adjuvant:

Clinical or Commercial Scale Bulk Lot(s)

FFP LOT

2007A Formulation and Filling:

Antigen

FFUP EA

2007B

Formulation and Filling:

Adjuvant

FFUP EA

2007C

Formulation and Filling:

Co-formulated Antigen and Adjuvant-

FFUP EA

2007D

Access to Filling Capacity or Disruption Fee for Commercial Products

FFP EA TBD

2008 Labeling and Packaging FFUP EA

2009A

Storage and Stability:

Commercial Scale Bulk Lots of Antigen

FFUP

LOT Per Lot Per Month

2009B

Storage and Stability:

Antigen in Final Container

FFUP

Final Contai ner Per FC Per Month

2009C

Storage and Stability:

Clinical/ Commercial Scale Bulk lots of Adjuvant

FFUP LOT Per Lot Per Month

2009D

Storage and Stability:

Adjuvant in Final Container

FFUP

Final Contai ner Per FC Per Month

2010 Shipping FFP EA TBD

Analytical Laboratory Testing/Assay

FFP EA TBD

2012 Nonclinical Studies FFP Study TBD

2013 Clinical Studies FFP Study TBD

2014 Disposal of Product FFP EA TBD

2015 Emerging Pathogen Cost EA TBD

Validation Activities or Technology Transfer Activities

FFP EA TBD

2017 Manufacturing Enhancements FFP EA TBD

Tariffs, Duties, and Trade Remedies on any

ACTIVITY(-

IES)

Cost EA TBD

2019 Standard Data Reporting NSP Monthl y N/A Not

Separately

2020 Additional Reporting NSP Report N/A Not Separately

Total Estimated Dollar Amount – Option Period 1 (60 Months)

Total Contract Value (Base + Option Period 1): _________________

B.3. CONTRACT TYPE/TASK ORDER TYPES

This RFP seeks to award multiple Indefinite-Delivery, Indefinite-Quantity (IDIQ) contracts with services and supplies obtained through the issuance of firm-fixed price (FFP), firm-fixed-unit-price (FFUP), cost reimbursable (Cost), and/or hybrid task orders and delivery orders.

During the ordering period of the IDIQ, authorized officials assigned to the IDIQ may order, and the Offeror shall provide supplies and services at the negotiated unit price.

In accordance with FAR 16.504-5(h)(2) contracting officers may establish one or more Blanket Purchase Agreements (BPAs) to fill repetitive needs for supplies or services under this IDIQ contract.

B.4. PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT ("PREP ACT")

COVERAGE

The Federal Government may not use, or authorize the use of, any products or materials provided under this agreement from Recipient's domestic manufacturing capacity unless such use occurs in the United States and is protected from liability under a declaration issued under the Public Readiness and Emergency Preparedness Act, 42 U.S.C. § 247d-6d.

Exceptions to this include activities related to the following:

• Analytical studies conducted in whole or in part outside the United States that do not involve using materials in humans.

• Clinical trials conducted in whole or in part outside the United States in which the sponsor maintains clinical trial insurance for injuries to study participants.

• Uses for which Recipient provides its written consent by signing a Material Transfer Agreement, Technology Transfer and Evaluation Agreement, Clinical Trial Agreement, or similar authorizing use of materials outside of the United States.

B.5. ADVANCE UNDERSTANDINGS

The final contract contains 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. Although BARDA provides descriptions of certain legal requirements, the contractor is responsible for confirming those requirements and complying with them.

B.5.1 Vendor Production Facilities

1. List the manufacturing sites and lines available for each of the manufacturing phases, including validation status of each site and line.

2. Indicate whether the site and line will be available to BARDA in the event of a public health emergency.

3. Include as an attachment a current blueprint of the facilities (or a reasonable facsimile). Clearly indicate the sites and lines for each manufacturing phase and include their capacities and capabilities as appropriate (Attachment 3).

4. The manufacturing facility locations must be reported within Activity 1019 and Activity 2019 as part of Standard Data Reporting.

Vendor Production Facilities: Bulk Production

Bulk

Manufacturing Process

Validated Bulk Manufacturing Site (Address)

Validated Bulk Manufacturing

Line #

Final Bulk Container Type (Carboy, Bottle, Bag, etc.)

and Size

Final Bulk Container Target Fill Volume

Maximum Dose Quantity Can

Produce in 180 days

Antigen Only Adjuvant Only

Co-formulated Antigen + Adjuvant

Other (please indicate)

Vendor Production Facilities: Formulation, Fill-Finish

Validated Formulation

Site (Address)

Validated Fill Finish

Site (Address)

Validated Fill Finish

Line #

Final Fill Presentation Type

(MDV, SDV, PFS,

sprayer, etc.) and

Size

Final Fill Presentation

Target Fill Volume

Maximum Dose

Quantity Fill Finish Line Can

Produce in 180 days

Line(s) used for other

Commercial Products?

(Yes/No)

Antigen Only Adjuvant Only

Co-formulated Antigen + Adjuvant

Other (please indicate)

B.5.2 Potency Reagent Production and Calibration

List the roles and responsibilities in terms of potency reagent production and calibration activities within the interpandemic period, noting any differences for pandemic response, for each manufacturing platform.

Partner Responsibilities

BARDA

1. Select virus strains for CVV preparation and/or bulk vaccine antigen manufacturing

2. Coordinate potency reagent production and calibration through working with CBER and manufacturer

CBER

1. Prepare antigens for sheep antiserum production as needed

2. Immunize sheep and collect/lyophilize antisera

3. Lyophilize reference antigens for manufacturer as needed

4. Calibrate primary liquid standard (PLS) provided by manufacturer

5. Calibrate lyophilized antisera generated by CBER and lyophilized reference antigen provided by manufacturer (or reference antigen provided by manufacturer and lyophilized by CBER).

6. Ship calibrated lyophilized antisera and lyophilized reference antigen to manufacturer for release and stability testing

Manufacturer (specify manufacturing process)

1. Generate PLS and lyophilized reference antigen and ship to CBER for calibration (Reference antigen may also be lyophilized by CBER).

2. In-house release testing of bulk vaccine antigen and fill/finished antigen or vaccine using CBER calibrated antisera and reference antigens.

B.5.3 Analytical Laboratory Assays

Provide a table of pricing for common analytical assays used for potency, alternative potency, release, stability testing, etc. Examples include single radial immunodiffusion (SRID), high-performance liquid chromatography (HPLC), sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), immunoblot (Western blot), mass spectrometry, etc. Typical real time and accelerated stability testing time points at appropriate temperatures should be included. Indicate the location (e.g., in-house versus outsourced) where the most common testing is performed. Responses to TBD and unpriced Activities will rely on these tables to evaluate proposed costs.

B.5.4 Schedule of Labor Category Hourly Rates for TBD ACTIVITIES:

Provide a table of manufacturing, QA, QC, clinical, regulatory, process development, etc. position titles, description of the education levels attained, years of relevant experience, and hourly rates. Responses to TBD and unpriced Activities will rely on these tables to evaluate proposed costs. The table below is for example purposes only:

Position Description Hourly Rate

QA or Manufacturing -1 B, 3+ years entry level role $

QA or Manufacturing -2 B, 3+ years $

QA or Manufacturing-Manager B, 6+ years; $

QA or Manufacturing-Director B, 10+ years, M 5+ years $

QA or Manufacturing-Vice President B, 20+ years, M 10+ years $

Technician-1 H, 6+ years $

H: High School; B: Bachelor; M: Master; D: Doctor

*Overtime Compensation is not unauthorized under the subject contract.

B.5.5 Fair Product Pricing

a. If, at any time prior to, or during, the base term and any exercised options of this contract, Contractor enters into any agreement with a Covered Nation under which the Covered Nation commits to purchase (i) the same or a lesser volume of Product than the U.S. Government commits to purchase (ii) at a price lower than the price the U.S. Government is obligated to pay for Product under this contract, Contractor shall provide notice of such lower price to the U.S. Government within 30 days of the execution of the Contractor-Covered Nation agreement and the U.S. Government may elect, at its discretion, to receive the benefit of this provision and purchase the Product at that lower price.

b. Upon any such election by the U.S. Government, this contract shall be deemed to have been amended and modified such that, from the date on which the lower priced Product are first supplied or delivered to the applicable Covered Nation (the “Amended Pricing Effective Date”), the U.S. Government will receive that lower price for Product for which Contractor has not invoiced the U.S. Government following that Amended Pricing Effective Date.

c. Any price reductions provided hereunder are not intended as an inducement or reward for any procurement or purchasing decisions by the U.S. Government of any Contractor product.

d. For purposes of this section, “Covered Nation” shall mean a nation that is a high-income country as defined by the World Bank and “Product” shall mean one dose of Contractor’s product that is the subject of this contract.

e. The USG shall not be entitled to the price of Product purchased by a Covered Nation for purposes of donation or resale by the Covered Nation to non-governmental organizations, intergovernmental organizations, or “lower-income” or “lower middle-income countries” as those terms are defined by the World Bank as of the date of the effective date of agreement between Contractor and the Covered Nation.

f. For clarity, if Contractor enters into an agreement with more than one nation, a multinational organization, or a multilateral organization, and a Covered Nation receives Product under such an agreement or benefits from the price under such an agreement, the Parties agree that the relevant volume for purposes of this contract shall be the total Product volume specified in such agreement and not the Product volume any one Covered Nation receives.

B.5.6 Donation of Excess Product

a. In the event the Government determines that doses of Product funded under the contract are no longer needed by the Government, the Government may donate, either directly or through a nongovernmental organization or intergovernmental organization, remaining doses to any "lower income" or "lower middle-income countries", as those terms are defined by the World Bank as of the date of donation (“Donee Nation”), that: (1) (a) has an active marketing approval in place for use of Product at the time of donation or, (b) if no marketing approval is in place, has an active regulatory authorization. Prior to any donation, the USG shall use reasonable efforts to promote Donee Nations’ compliance with Product Handling Guidance (Attachment 1).

b. The Government shall notify Contractor prior to any planned donation to a Donee Nation. Contractor agrees to work with the Government in good faith to ensure all applicable regulatory submissions, import/export permits, and other requirements for donation are completed in advance of shipment to the extent that donation is authorized under Paragraph “a” above. Nothing in this Paragraph shall require the Contractor to seek regulatory approval in any particular country.

c. Contractor will be responsible for shipment of Product to the receiving Donee Nation;

provided, however, Contractor shall have no obligation to repackage or relabel the product already purchased by the USG for delivery to the U.S. market and provided further that Contractor shall only be responsible for shipment of the product to one reasonable location within the receiving Donee Nation, or as otherwise agreed between the Parties. Contractor shall be responsible for the cost of shipping.

d. The parties acknowledge that Article B.4 regarding PREP Act coverage does not apply to the provision of any product under this paragraph to a Donee Nation. The USG makes no representations as to PREP Act coverage thereto.

B.5.7 Sharing of contract deliverables within United States Government (USG)

Subject to the data rights provisions of FAR 52.227-14 and 52.227-14 Alt. II, 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 War (DOW), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), BARDA may share technical deliverables and test results created in the performance of this Contract with the United States Government and entities within the Integrated Portfolio. This advance understanding does not authorize the Government to share financial or technical information, technical deliverables, or any other data outside of the United States Government. 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.

B.5.8 Dissemination of Information

Performance under this contract may require the Contractor to access non-public data and information proprietary to a U.S. Government agency, another U.S. Government Contractor or of such nature that its dissemination or use other than as specified in the work statement would be harmful to the interests of the U.S. Government or others. Neither the Contractor, nor Contractor personnel, shall divulge nor release data nor information relating to product delivery timing or sites that is developed or obtained under performance of this contract, except upon written approval of the Contracting Officer (CO) which the Contracting Officer will provide in accordance with other Government policies and/or guidance. The Contractor shall not use, disclose, or reproduce proprietary data that bears a restrictive legend, other than as specified in this contract, or any information at all regarding this agency. The Contractor shall comply with all applicable Government requirements for protection of non-public Government or third-party information. Unauthorized disclosure of nonpublic information is prohibited by the Government’s rules. Unauthorized disclosure may result in termination of the contract, replacement of a Contractor employee, or other appropriate redress.

B.5.9 Sharing Research Data

BARDA endorses the sharing of final research data to serve health. This contract is expected to generate research data that must be shared with the public and other researchers.

BARDA recognizes that data sharing may be complicated or limited, in some cases, by institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-published documentation on the Health Information Privacy at http://www.hhs.gov/ocr/privacy/index.html). The rights and privacy of people who participate in BARDA-funded research must be protected at all times; thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.

B.5.10 Dissemination of False or Deliberately Misleading Information

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

B.5.11 Rights of Refusal

The Government’s rights to data first developed in the performance of this Contract, the Government’s limited rights to preexisting data used during the development effort under this Contract and the Government’s rights to use Subject Inventions developed under this Contract shall survive any transfer of such title to a Subject Invention any third party. The Government may either exercise or waive this first right of refusal in writing and submit to the Contractor within ninety (90) calendar days of the initial notification to the Government of the Contractor’s intent to conduct any such transfer of title to a Subject Invention. This Article shall not apply to transfers of title to technology created with the use of funding obtained outside of this Contract.

B.5.12 Person in Plant

Upon request from BARDA, 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, of 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 http://www.hhs.gov/ocr/privacy/index.html manner, or to any extent not authorized by law, any information coming to him/her in the course of employment or official duties, while stationed in a contractor or subcontractor plant.

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

B.5.13 Notification of Critical Programmatic Concerns, Risks, or Potential Risks

Contractor shall communicate to BARDA and document all critical programmatic concerns, issues, or probable risks that have or are likely to significantly impact project schedule or cost. Incidents that present liability to the project even without schedule impact, must also be reported.

· Contractor must notify BARDA within 48 hours of activity or incident or within 24 hours for a security related activity or incident.

· Email or telephone with written follow-up to CO and COR.

· Additional updates due to COR and CO within 48 hours of additional developments.

· Contractor shall submit within five (5) business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues.

· If corrective action is deemed necessary, Contractor must address in writing, its consideration of concerns raised by BARDA within five (5) business days of receiving such concern(s).

B.5.14 Conflict of Interest

Prior to commencement of any work, the Contractor and subcontractors agree to notify the CO promptly that, to the best of their knowledge and belief, no actual or potential conflict of interest exists or to identify to the CO any actual or potential conflict of interest the Contractor or subcontractors may have. In emergency situations, however, work may begin but notification shall be made within five (5) business days. The Contractor and subcontractors agree that if an actual or potential organizational conflict of interest is identified during performance, the Contractor and subcontractors shall promptly make a full disclosure in writing to the CO; this disclosure shall include a description of actions which the Contractor and subcontractors have taken or proposes to take, after consultation with the CO, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor and subcontractors shall continue performance until notified by the CO of any contrary action to be taken. Remedies include termination of this contract for convenience, in whole or in part, if the CO deems such termination necessary to avoid an organizational conflict of interest. If the Contractor or subcontractors were aware of a potential organizational conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the CO, BARDA may terminate the contract for default, debar the Contractor or subcontractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

B.5.15 Organizational Conflict of Interest

a. General: For the purpose of this provision/clause, “Consultant” is defined as a company, firm, LLC, sole proprietor, joint venture member, independent contractor, subcontractor, affiliate, or similar entity that is not an employee of the Contractor.

b. Disclosure: The Contractor must report contacts with Consultants who are paid to furnish advice, information, direction, or assistance to the Contractor or any subcontractor in support of the preparation or submission of the Contractor’s business or technical proposal. The report must include the following information:

i. The name, title, and contact information for the Consultant, including the name and contact information for his/her company/firm/etc.

ii. The name, title, and contact information for a Contractor’s point of contact, including the name and contact information for the prime contractor if the consulting services were received by a subcontractor.

iii. The nature of the consulting services received. The contractor must perform a Conflict of Interest (COI) check prior to using any consultant.

c. Resolution: The responsible Contracting Officer will review the Contractor’s disclosure to determine whether an actual or appearance of a conflict of interest exists based on the information disclosed by the Contractor and/or from other sources. The framework for the Contracting Officer’s review will be FAR Subpart 9.5, Organizational and Consultant Conflicts of Interest. If an actual or appearance of a conflict of interest exists, the Contracting officer will take action which may include, but is not limited to, requesting a mitigation plan from the Contractor.

B.5.16 Institutional Responsibility Regarding Conflicting Interests of Investigators

The Contractor shall comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that investigators (defined as the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded under BARDA contracts) will not be biased by any conflicting financial interest.

As required by 45 CFR Part 94, the Contractor shall, at a minimum:

a. Maintain a written, enforceable policy on conflict of interest that complies with 45

CFR Part 94 and inform each investigator of the policy, the investigator’s reporting responsibilities, and the applicable regulations. The Contractor must take reasonable steps to ensure that investigators working as collaborators or subcontractors comply with the regulations.

b. Designate an official(s) to solicit and review financial disclosure statements from each investigator participating in BARDA-funded research. Based on established guidelines consistent with the regulations, the designated official(s) must determine whether a conflict of interest exists, and if so, determine what actions should be taken to manage, reduce, or eliminate such conflict. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the BARDA-funded research. The Contractor may require the management of other conflicting financial interests in addition to those described in this paragraph, as it deems appropriate. Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interests are included in 45 CFR Part 94, under Management of Conflicting Interests.

c. Require all financial disclosures to be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.

d. Maintain records, identifiable to each award, of all financial disclosures and all actions taken by the Contractor with respect to each conflicting interest 3 years after final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.

e. Establish adequate enforcement mechanisms and provide for sanctions where appropriate.

If a conflict of interest is identified, the Contractor shall report to the Contracting Officer, the existence of the conflicting interest found. This report shall be made and the conflicting interest managed, reduced, or eliminated, at least on a temporary basis, within sixty (60) days of that identification.

If the failure of an investigator to comply with the conflict of interest policy has biased the design, conduct, or reporting of the BARDA-funded research, the Contractor must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will take appropriate action or refer the matter to the Contractor for further action, which may include directions to the Contractor on how to maintain appropriate objectivity in the funded research.

The Contracting Officer may at any time inquire into the Contractor’s procedures and actions regarding conflicts of interests in BARDA-funded research, including a review of all records pertinent to compliance with 45 CFR Part 94. The Contracting Officer may require submission of the records or review them on site. On the basis of this review, the Contracting Officer may decide that a particular conflict of interest will bias the objectivity of the BARDA-funded research to such an extent that further corrective action is needed or that the Contractor has not managed, reduced, or eliminated the conflict of interest. The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.

If the Contracting Officer determines that BARDA-funded clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an investigator with a conflict of interest that was not disclosed or managed, the Contractor must require disclosure of the conflict of interest in each public presentation of the results of the research.

B.5.17 The Offeror will be responsible for maintaining Government Property in accordance with FAR 52.245-1.

B.5.18 Invoices: Cost and Personnel Reporting, Variance from the Negotiated Budget

Invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

b. The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

i. Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

ii. Fringe Benefits - Cite rate and amount

iii. Overhead - Cite rate and amount

iv. Materials & Supplies - Include detailed breakdown when total amount is over

$1,000.

v. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite

Course of Action (COA), if appropriate. List separately domestic travel, general scientific meeting travel, and foreign travel.

vi. Consultant Fees - Identify individuals and amounts.

vii. Subcontracts - Attach subcontractor invoice(s).

viii. Equipment - Cite authorization and amount.

ix. General and Administrative (G&A) - Cite rate and amount.

x. Total Cost

xi. Fixed Fee

xii. Total Cost-Plus-Fixed-Fee (CPFF)

B.5.19 Registration with the Select Agent Program for Work Involving the Possession, Use, and/or Transfer of Select Biological Agents or Toxins

Work involving select biological agents or toxins shall not be conducted under this contract until the Contractor and any affected subcontractor(s) are granted a certificate of registration or are authorized to work with the applicable select agents.

For prime or subcontract awards to international institutions who possess, use, and/or transfer Select Agents under this contract, the institution must complete registration with the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS) or the Animal and Plant Health Inspection Services (APHIS), U.S.

Department of Agriculture (USDA), as applicable, before performing work involving Select Agents, in accordance with 42 CFR 73. No Government funds can be used for work involving Select Agents, as defined in 42 CFR 73, if the final registration certificate is denied.

For prime or subcontract awards to foreign institutions who possess, use, and/or transfer Select Agents under this contract, the institution must provide information satisfactory to the Government that a process equivalent to that described in 42 CFR 73 (https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=8a4be60456973b5ec6bef5dfeaffd49a&r=PART&n=42y1.0.1.6.

61) for U.S. institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds before using these funds for any work directly involving the Select Agents. The Contractor must provide information addressing the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations, and policies equivalent to 42 CFR 73. The Government will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part 73. When requested by the contracting officer, the Contractor shall provide key information delineating any laws, regulations, policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of Select Agents.

This includes summaries of safety, security, and training plans, and applicable laws, regulations, and policies. For the purpose of security risk assessments, the Contractor must provide the names of all individuals at the foreign institution who will have access to the Select Agents and procedures for ensuring that only approved and appropriate individuals have access to Select Agents under the contract.

No BARDA funds may be used for a restricted experiment with a Select Agent or Toxin at either a domestic or a foreign institution without written approval from the Contracting Officer.

Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins as well as information about the registration process, can be obtained on the Select Agent Program Web site at https://www.selectagents.gov/sat/list.htm

B.5.20 Animal Welfare

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy).

The PHS policy can be accessed at: https://olaw.nih.gov/policies-laws/phs-policy.htm.

Animal studies will not begin until the Contractor’s or subcontractor’s IACUC provide final approval of the study protocol.

B.5.21 Information on Compliance with Animal Care Requirements

Registration with the U.S. Department of Agriculture (USDA) is required to use regulated species of animals for biomedical purposes. USDA is responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et. seq.), https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act.

The PHS Policy is administered by the OLAW https://olaw.nih.gov/. An essential requirement of the PHS Policy (https://olaw.nih.gov/policies-laws/phs-policy.htm) is that every institution using live vertebrate animals must obtain an approved assurance from OLAW before they can receive funding from any component of the U.S. Public Health Service. If the Contractor does not have an assurance and will be utilizing a subcontractor to perform the animal work, then the Contractor and subcontractor must have an Inter- Institutional Assurance in place to allow the Contractor to utilize the assurance of the subcontractor to meet the Government's requirements for assurance. The request for this negotiation of this assurance must be submitted to OLAW by the Government on behalf of the Contractor.

The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals https://nap.nationalacademies.org/catalog/12910/guide-for-the-care-and-use-of-laboratory-animals-eighth and that they comply with the regulations (9 CFR, Subchapter A) https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act issued by the USDA under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects. Compliance with the USDA regulations is an absolute requirement of this Policy.

The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) http://www.aaalac.org is a professional organization that inspects and evaluates programs of animal care for institutions at their request. Those that meet the high standards are given the accredited status. As of the 2015 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC. While AAALAC accreditation is not required to conduct biomedical research, it is highly desirable. AAALAC uses the Guide as https://www.selectagents.gov/sat/list.htm https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act their primary evaluation tool. They also use the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. It is published by the Federation of Animal Science Societies https://www.fass.org.

B.5.22 Approval of Required Assurance by Law

Under governing regulations, federal funds that are administered by the Department of Health and Human Services, BARDA shall not be expended by the Contractor for research involving live vertebrate animals, nor shall live vertebrate animals be involved in research activities by the Contractor under this award unless a satisfactory assurance of compliance with 7 U.S.C. 2136 and 9 CFR Sections 2.25-2.28 is submitted by Recipient 30 days prior to commencing research involving live vertebrate animals and approved by the Office of Laboratory Animal Welfare (OLAW). Each performance site (if any) must also assure compliance with 7 U.S.C. 2136 and 9 CFR Sections 2.25-2.28 with the following restriction:

Only activities that do not directly involve live vertebrate animals (i.e., are clearly severable and independent from those activities that do involve live vertebrate animals) may be conducted by individual performance sites pending OLAW approval of their respective assurance of compliance with 7 U.S.C. 2136 and 9 CFR Sections 2.25-2.28. Additional information regarding OLAW may be obtained at https://olaw.nih.gov/policies-laws/phs-policy.htm.

B.5.23 Clinical Terms of Award

Efforts performed under this contract, whether performed domestically, OCONUS, or Tribal Nations or jurisdictions must be conducted ethically and in accordance with U.S Food and Drug Administration (FDA) guidance and all applicable laws, directives, and regulations which includes the following:

• Electronic Records; Electronic Signatures (21 CFR Part 11)

• Regulatory Hearing Before the Food and Drug Administration (21 CFR Part

16)

• Protection of Human Subjects (21 CFR Part 50)

• Financial Disclosure by…