21_75A50126R00001_RFP_0001_RFP File 3 of 3.pdf

PART II – CONTRACT CLAUSES

SECTION I – CONTRACT CLAUSES

THE FOLLOWING GENERAL CLAUSE LISTING(S) WILL BE APPLICABLE TO THE

CONTRACT RESULTING FROM THIS RFP. OFFERORS ARE ENCOURAGED TO REVIEW

THESE CLAUSES AND TO DISCUSS ANY QUESTIONS THEY MAY HAVE ABOUT THEM

PRIOR TO THE CLOSING DATE OF THE RFP.

I.1 FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make the full text available. The full text of a clause may be accessed electronically at:

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide. HHSAR clauses at https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/index.html

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

FAR Clause Clause Title Effective Date

Federal Acquisition Regulation (FAR)

52.202-1 Definitions Jun 2020

52.203-3 Gratuities Apr 1984

52.203-5 Covenant Against Contingent Fees May 2014

52.203-6 Restrictions on Subcontractor Sales to the Government Jun 2020

52.203-7 Anti-Kickback Procedures Jun 2020

52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity May 2014

52.203-10 Price or Fee Adjustment for Illegal or Improper Activity May 2014

52.203-12 Limitation on Payments to Influence Certain Federal Transactions Jun 2020

52.203-13 Contractor Code of Business Ethics and Conduct Nov 2021

52.203-14 Display of Hotline Poster(s) Nov 2021

52.203-16 Preventing Personal Conflicts of Interest Jun 2020

52.203-17 Contractor Employee Whistleblower Rights Nov 2023

52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements – Representation Jan 2017

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements Jan 2017

52.204-5 Women-Owned Business (Other Than Small Business) Oct 2014

52.204-7 System for Award Management-Registration. Nov 2025

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards Nov 2025

52.204-13 System for Award Management Maintenance Nov 2025

52.204-15 Service Contract Reporting Requirement for Indefinite Delivery Contracts Nov 2025

52.204-19 Incorporation by Reference of Representations and Certifications Dec 2014

52.208-90 Nov 2025

Government Supply Sources

52.209-6

Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment, or Voluntarily Excluded Nov 2025

52.209-7 Information Regarding Responsibility Matters Nov 2025

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters Nov 2025

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations Nov 2025

52.210-1 Market Research Jul 2025

52.211-5 Material Requirements Jul 2025

52.213-4 Terms and Conditions – Simplified Acquisitions (Noncommercial) Nov 2025

52.215-2 Audit and Records-Negotiation Nov 2025

52.215-8 Order of Precedence-Uniform Contract Format Nov 2025

52.215-10 Price Reduction for Defective Certified Cost or Pricing Data Aug 2011

52.215-11 Price Reduction for Defective Certified Cost or Pricing Data—Modifications Nov 2025

52.215-12 Subcontractor Certified Cost or Pricing Data Nov 2025

52.215-13 Subcontractor Certified Cost or Pricing Data - Modifications Nov 2025

52.215-14 Integrity of Unit Prices Nov 2021

52.215-15 Pension Adjustments and Asset Reversions Nov 2025

52.215-17 Waiver of Facilities Capital Cost of Money Oct 1997

52.215-18 Reversion or Adjustment of Plans for Postretirement Benefits (PRB) Other Than Pensions Nov 2025

52.215-19 Notification of Ownership Changes Nov 2025

52.215-20 Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data Nov 2025

52.215-21 Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data-Modifications

Nov 2025

52.215-22 Limitations on Pass-Through Charges-Identification of Subcontract Effort Nov 2025

52.215-23 Limitations on Pass-Through Charges Nov 2025

52.216-4 Economic Price Adjustment – Labor and Material Jan 2017

52.216-7 Allowable Cost and Payment Nov 2025

52.216-8 Fixed Fee Jun 2011

52.216-11 Cost Contract – No Fee Apr 1984

52.216-12 Cost-Sharing Contract – No Fee Apr 1984

52.216-27 Single or Multiple Awards Oct 1995

52.217-7 Option for Increased Quantity-Separately Priced Line Item Mar 1989

52.217-8 Option to Extend Services Nov 1999

52.219-8 Utilization of Small Business Concerns Nov 2025

52.219-9 Small Business Subcontracting Plan Nov 2025

52.219-16 Liquidated Damages – Subcontracting Plan Nov 2025

52.219-28 Post-Award Small Business Program Representation Nov 2025

52.222-2 Payment for Overtime Premiums Jul 1990

52.222-3 Convict Labor Jun 2003

52.222-35 Equal Opportunity for Veterans Nov 2025

52.222-36 Equal Opportunity for Workers with Disabilities Nov 2025

52.222-37 Employment Reports on Veterans Nov 2025

52.222-40 Notification of Employee Rights Under the National Labor Relations Act Dec 2010

52.222-50 Combating Trafficking in Persons Nov 2025

52.222-54 Employment Eligibility Verification Nov 2025

52.222-90 Addressing DEI Discrimination by Federal Contractors Apr 2026

52.223-3 Hazardous Material Identification and Material Safety Data- Alt I Nov 2025

52.223-23 Sustainable Products and Services Nov 2025

52.224-1 Privacy Act Notification Apr 1984

52.224-2 Privacy Act Apr 1984

52.224-3 Privacy Training Jan 2017

52.225-1 Buy American Act-Supplies Nov 2025

52.225-8 Duty-Free Entry Oct 2025

52.225-14 Inconsistency between English Version and Translation of Contract. Feb 2000

52.226-7 Drug Free Workplace May 2024

52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving May 2024

52.227-1 Authorization and Consent, Alternate 1 (APR 1984) Jun 2020

52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement Jun 2020

52.227-3 Patent Indemnity Apr 1984

52.227-11 Patent Rights – Ownership by the Contractor May 2014

52.227-14 Rights in Data-General May 2014

52.227-14 Rights in Data-General Alt II Dec 2007

52.227-16 Additional Data Requirements Jun 1987

52.228-7 Insurance – Liability to Third Persons Mar 1996

52.229-3 Federal, State and Local Taxes Feb 2013

52.230-2 Cost Accounting Standards Nov 2025

52.230-3 Disclosure and Consistency of Cost Accounting Practices Nov 2025

52.230-6 Administration of Cost Accounting Standards Nov 2025

52.230-7 Proposal Disclosure – Cost Accounting Practice Changes Apr 2005

52.232-1 Payments Apr 1984

52.232-2 Payments under Fixed-Price Research and Development Contracts Apr 1984

52.232-8 Discounts for Prompt Payment Feb 2002

52.232-9 Limitation on Withholding of Payments Apr 1984

52.232-11 Extras Apr 1984

52.232-17 Interest May 2014

52.232-18 Availability of Funds Apr 1984

52.232-20 Limitation of Cost Nov 2025

52.232-22 Limitation of Funds Nov 2025

52.232-23 Assignment of Claims May 2014

52.232-25 Prompt Payment Jan 2017

52.232-33 Payment by Electronic Funds Transfer-System for Award Management Oct 2018

52.232-39 Unenforceability of Unauthorized Obligations Jun 2013

52.232-40 Providing Accelerated Payments to Small Business Subcontractors Mar 2023

52.233-1 Disputes Nov 2025

52.233-2 Service of Protest Nov 2025

52.233-3 Protest after Award Nov 2025

52.233-4 Applicable Law for Breach of Contract Claim Nov 2025

52.240-91 Security Prohibitions and Exclusions Nov 2025

52.240-93 Basic Safeguarding of Covered Contractor Information Nov 2025

52.242-1 Notice of Intent to Disallow Costs Apr 1984

52.242-2 Production Progress Reports Apr 1991

52.242-3 Penalties for Unallowable Costs Nov 2025

52.242-4 Certification of Final Indirect Costs Jan 1997

52.242-5 Payments to Small Business Subcontractors Jan 2017

52.242-13 Bankruptcy Jul 1995

52.242-14 Suspension of Work Apr 1984

52.242-15 Stop-Work Order, Alternate I Apr 1984

52.242-15 Stop-Work Order Aug 1989

52.243-1 Changes-Fixed-Price Alternate V Apr 1984

52.243-2 Changes-Cost-Reimbursement Alternate V Apr 1984

52.243-6 Change Order Accounting Jul 2025

52.243-7 Notification of Changes Jul 2025

52.244-2 Subcontracts, Alternate I Jun 2020

52.244-5 Competition in Subcontracting Aug 2024

52.244-6 Subcontracts for Commercial Products and Commercial Services (JAN 2025) (DEVIATION FEB 2025) Nov 2025

52.245-1 Government Property Sep 2021

52.245-9 Use and Charges Apr 2012

52.246-2 Inspection of Supplies – Fixed Price Aug 1996

52.246-3 Inspection of Supplies – Cost Reimbursement May 2001

52.246-4 Inspection of Services – Fixed Price Aug 1996

52.246-5 Inspection of Services – Cost Reimbursement Apr 1984

52.246-7 Inspection of Research and Development – Fixed Price Aug 1996

52.246-8 Inspection of Research and Development – Cost Reimbursement May 2001

52.246-9 Inspection of Research and Development (ShortForm) Apr 1984

52.246-15 Certificate of Conformance Apr 1984

52.246-16 Responsibility for Supplies Apr 1984

52.246-23 Limitation of Liability Feb 1997

52.246-25 Limitation of Liability-Services Feb 1997

52.247-29 F.o.b. Origin Feb 2006

52.247-34 F.o.b. Destination Jan 1991

52.247-63 Preference for U.S.-Flag Air Carriers Jan 2025

52.249-2 Termination for Convenience of the Government (Fixed-Price) Apr 2012

52.249-6 Termination (Cost-Reimbursement) May 2004

52.249-8 Default (Fixed-Price Supply and Service) Apr 1984

52.249-9 Default (Fixed-Price Research and Development) Apr 1984

52.249-14 Excusable Delays Apr 1984

52.252-6 Authorized Deviations in Clauses. Nov 2020

52.253-1 Computer Generated Forms Nov 2025

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION

REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

Clause Clause Title Effective Date HHS Acquisition Regulations (HHSAR)

352.203-70 Anti-Lobbying Jun 2026

352.208-70 Printing and Duplication Feb 2026

352.211-1 Public Accommodations and Commercial Facilities Nov 2025

352.211-2 Conference Sponsorship Requests and Conference Materials Disclaimer Nov 2025

352.211-3 Paperwork Reduction Act Nov 2025

352.215-70 Late Proposals and Revisions Dec 2015

352.216-70 Allowable Cost and Payment for Hospitals Mar 2026

352.223-70 Safety and Health Dec 2015

352.224-70 Privacy Act Dec 2015

352.224-71 Confidential Information Dec 2015

352.227-70 Publications and Publicity Dec 2015

352.231-70 Salary Rate Limitation Feb 2026

352.232-71 Electronic Submission of Payment Requests Apr 2026

352.233-71 Litigation and Claims Dec 2015

352.235-71 Protection of Human Subjects Mar 2026

352.235-72 Needle Exchange Mar 2026

352.235-73 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research Mar 2026

352.235-75 Care of Live Vertebrate Animals Mar 2026

352.237-75 Key Personnel Dec 2015

352.239-74 Electronic and Information Technology Accessibility Dec 2015

352.204-70 Prevention and Public Health Fund-Reporting Requirement Dec 2015

352.270-70 Non Discrimination for Conscience Mar 2026

I.2 ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

This contract incorporates the following clauses in full text. FEDERAL ACQUISITION

REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

FAR 52.216-18 Ordering (Aug 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from __________ through ____________ [insert dates].

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

FAR 52.216-19 Order Limitations (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than _____________ [insert dollar figure or quantity], the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor-

(1) Any order for a single item in excess of _____________ [insert dollar figure or quantity];

(2) Any order for a combination of items in excess of ______________ [insert dollar figure or quantity]; or

(3) A series of orders from the same ordering office within _____________ days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within _____ days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

FAR 52.216-22 Indefinite Quantity Alternate II (Nov 2025)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after ______ [insert date after award].

(e) The Government may cancel this contract in whole or in part by providing written notice.

The cancellation will take effect 30 calendar days after the contractor receives the notice of cancellation. No further orders may be issued against the contract, but orders already awarded will be completed unless a termination action is taken against the contractor.

(f) The Contractor may request to cancel this contract by submitting a written cancellation request to the contracting officer. The cancellation will take effect 90 calendar days after the Government receives the cancellation request, unless the contracting officer informs the contractor, before cancellation is effective, that cancellation is not approved. A contractor who requests cancellation is not eligible for the minimum guarantee. If cancelled, no further orders may be issued against the contract, but orders already awarded will be completed unless a termination action is taken against the order.

FAR 52.216-27 Single or Multiple Awards (Oct 1995)

The Government may elect to award a single delivery order contract or task order contract or to award multiple delivery order contracts or task order contracts for the same or similar supplies or services to two or more sources under this solicitation.

FAR 52.216-32 Task-Order and Delivery-Order Ombudsman (Sept 2019)

(a) In accordance with 41 U.S.C. 4106(g), the Agency has designated the following task-order and delivery-order Ombudsman for this contract. The Ombudsman must review complaints from the Contractor concerning all task-order and delivery-order actions for this contract and ensure the Contractor is afforded a fair opportunity for consideration in the award of orders, consistent with the procedures in the contract. [https://www.hhs.gov/grants-contracts/grants-business-contacts/competition-advocates/index.html]

(b) Consulting an ombudsman does not alter or postpone the timeline for any other process (e.g., protests).

(c) Before consulting with the Ombudsman, the Contractor is encouraged to first address complaints with the Contracting Officer for resolution. When requested by the Contractor, the Ombudsman may keep the identity of the concerned party or entity confidential, unless prohibited by law or agency procedure.

FAR 52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days before the contract expires.

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a)The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b)If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c)The total duration of this contract, including the exercise of any options under this clause, shall not exceed 126 months.

FAR 52.237-3 Continuity of Services (Jan 1991)

(a)The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or another contractor, may continue them. The Contractor agrees to-

(1) Furnish phase-in training; and

(2) Exercise its best efforts and cooperation to effect an orderly and efficient transition to a successor.

(b)The Contractor shall, upon the Contracting Officer’s written notice,

(1) furnish phase-in, phase-out services for up to 90 days after this contract expires and

(2) negotiate in good faith a plan with a successor to determine the nature and extent of phase-in, phase-out services required. The plan shall specify a training program and a date for transferring responsibilities for each division of work described in the plan and shall be subject to the Contracting Officer’s approval. The Contractor shall provide sufficient experienced personnel during the phase-in, phase-out period to ensure that the services called for by this contract are maintained at the required level of proficiency.

(c)The Contractor shall allow as many personnel as practicable to remain on the job to help the successor maintain the continuity and consistency of the services required by this contract. The Contractor also shall disclose necessary personnel records and allow the successor to conduct on-site interviews with these employees. If selected employees are agreeable to the change, the Contractor shall release them at a mutually agreeable date and negotiate transfer of their earned fringe benefits to the successor.

(d)The Contractor shall be reimbursed for all reasonable phase-in, phase-out costs (i.e., costs incurred within the agreed period after contract expiration that result from phase-in, phase-out operations) and a fee (profit) not to exceed a pro rata portion of the fee (profit) under this contract.

HHSAR 352.204-75 Supply Chain Risk Assessment During Contract Performance (Oct 2024) (Deviation)

(a) Definitions. As used in this clause—

Contract means as defined in FAR 2.101.

Foreign person means as defined in 31 CFR 800.224.

Mission-critical acquisition means the acquisition of products, materials, information, or services that are identified as—

(1) Contract support or development services for HHS or OpDiv/StaffDiv research and development;

(2) Contract support or development services for HHS or OpDiv/StaffDiv Financial databases and services;

(3) Contract support services that require utilization or sharing of HHS or OpDiv/StaffDiv Intellectual property;

(4) Contract services supporting HHS or OpDiv/StaffDiv continuity of operations (COOP) mission essential functions;

(5) Contract support services or development initiatives for HHS or OpDiv/StaffDiv critical infrastructure;

(6) An HHS or OpDiv/StaffDiv high-value/dollar acquisition; or

(7) Other acquisitions for critical assets or services as identified by OpDiv/StaffDiv leadership.

Office of National Security (ONS) means the HHS office responsible for the management, oversight, policy, guidance, and implementation of the HHS Enterprise Supply Chain Risk Management (E-SCRM) Program, including the conducting of supply chain risk assessments.

State-owned enterprise means a legal entity that is created by a government in order to partake in commercial activities on the government's behalf. A state-owned enterprise or government-owned enterprise is a business enterprise where the government or state has significant control through full, majority, or significant minority ownership.

Supply chain risk means the potential for harm or compromise that arises as a result of security risks from suppliers, their supply chains, and their products, materials, information, or services. Supply chain risks include exposures, threats, and vulnerabilities associated with the products and services traversing the supply chain as well as the exposures, threats, and vulnerabilities to the supply chain.

Supply chain risk assessment means a systematic examination of supply chain risks, likelihoods of their occurrence, and potential impacts.

Supply chain risk management (SCRM) means a systematic process for managing risk to the integrity, trustworthiness, and authenticity of products, materials, information, and services within the supply chain. It addresses the activities of foreign and other adversaries aimed at compromising the supply chain, which may include the introduction of counterfeit or malicious items into the supply chain. It is conducted through identification of threats, vulnerabilities, and consequences throughout the supply chain and development of mitigation strategies to address the respective risks presented by the supplier, the supplied products, materials, information, and services, or the supply chain at any point during the life cycle.

(b) Supply chain risk assessment. The Office of National Security (ONS) or delegated designee may perform a supply chain risk assessment of the Contractor. In performing the supply chain risk assessment, the Government may consider public and non-public information relating to the Contractor’s supply chain.

(c) Updated information and representations. If requested by the Contracting Officer, or if there are any changes to the information or representations the Contractor has submitted prior to award or during contract performance, the Contractor must submit to the Contracting Officer the information and representations in paragraphs (d) or (e).

(d) Required information submittal. The Contractor shall provide the following information for products, materials, information, or services provided during contract performance:

(1) Description of the type of products, materials, information, or services provided.

(2) Vendor and manufacturer’s company, if applicable, including name and address.

(3) If known, vendor’s and manufacturer’s web site, and the Commercial and Government Entity (CAGE) code and Unique Entity Identifier (UEI).

(e) Representations. The Contractor represents that—

(1) It [ ] does, [ ] does not have any foreign ownership, outside of retail shareholders, who control more than 10% of the company’s total shares. If yes, identify the legal name of the owning organization/individual and their country of affiliation.

(2) It [ ] does, [ ] does not have any of the following business affiliations with foreign entities: technology development partnerships, strategic partnerships, joint ventures, foreign subsidiaries, grants from a foreign entity. If yes, identify the legal name of the organization, its foreign address, and the nature of the relationship.

(3) It [ ] does, [ ] does not have any foreign governments, or state-owned enterprises that have investments or ownership interest in the company. If yes, identify the foreign government, the ownership stake percentage, and the nature of the relationship.

(4) The company leadership (C-Suite executives, Board members, etc.) [ ] does, [ ] does not have any substantial ties to foreign countries, including being citizens of a foreign country, graduates of a foreign university, or investments in a foreign country. If yes, identify the individual, the nature of the tie, and the country they are tied to.

(5) It [ ] has, [ ] has not violated export controls or the Foreign Corrupt Practices Act within 5 years. If yes, enter the event, the date, and any remediation the company committed after the event.

(6) It [ ] has, [ ] has not been prohibited from doing business with the government of the US or any of its administrative subdivisions to include agencies, states, territories or municipalities. If yes, enter the event, the date, and any remediation the company committed after the event.

(7) It [ ] has, [ ] has not been prohibited from doing business with any foreign governments or subdivisions thereof. If yes, enter the event, the date, and any remediation the company committed after the event.

(8) It [ ] has had, [ ] has not had affiliations with any entities prohibited (e.g.

Huawei, see SAM.gov “exclusions” page for additional information regarding prohibited entities) from doing business with the government of the US or any of its administrative subdivisions to include agencies, states, territories or municipalities? If yes, enter the event, the date, and any remediation the company committed after the event.

(9) It [ ] has, [ ] has not been suspended or debarred at any point while doing business with the U.S. Government or any of its administrative subdivisions to include agencies, states, territories or municipalities. If yes, enter the event, the date, and details below.

(10) It [ ] has previously filed for or is currently in, [ ] has not previously filed for or is not currently in bankruptcy in the last 10 years. If yes, enter the event, the date, and details below.

(11) It [ ] was or is currently in, [ ] was not or is not currently in litigation in the last 10 years. If yes, enter the event, the date, and details below.

(f) Supply chain risk determination. Findings from the supply chain risk assessment will be considered in connection with a determination of the Contractor’s eligibility to continue performance on the contract. The Government reserves the right to limit the disclosure of information to the Offeror regarding the risk in accordance with all applicable laws or regulations.

(g) Mitigation plans. Any mitigation plans and amendments determined necessary and to be implemented and sustained during contract performance will be incorporated into the contract.

(h) Subcontracts. The Contractor shall include the substance of this clause, including the information and representations in paragraphs (d) and (e), and this paragraph (h), in subcontracts with persons or entities involved the development or delivery of any mission-critical products, materials, information, or services. The Contractor shall submit all subcontractor information and representations with its proposal for any additional mission-critical products, materials, information, or services during performance of the contract.

PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J – LIST OF ATTACHMENTS

All attachments are located at the end of Section M and are incorporated into this RFP:

J.1. SOLICITATION ATTACHMENTS:

The following Attachments are provided with this Solicitation:

1. Product Handling Guidance Donee Nations

2. ASPR Security Requirements

3. Vendor Production Facilities.xlsx

4. Agent Request Form

5. BARDA Dose Tracker Template.xlsx

6. HHS Protection of Human Subjects (https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/index.html)

7. Breakdown of Proposed Costs.xlsx

8. Summary of Related Activities

9. ACH Vendor/ Miscellaneous Payment Enrollment Form

10. SF-LLL, Disclosure of Lobbying Activities

11. SF-LLL, Disclosure of Lobbying Activities Instructions

12. HHS Subcontracting Plan Template

13. Risk Mitigation Plan/Matrix Template

14. Past Performance Questionnaire

15. RFP Contractor Q&A Template

16. Bill of Materials (BOM) Template

17. Manufacturing Plan

18. Business and Supply Continuity Plans (BCP SCP)

19. Surge Manufacturing and Supply Chain Readiness Assessment

20. BARDA Responses to Contractor Question No’s 1-5.xlsx

PART IV – REPRESENTATIONS AND INSTRUCTIONS

SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST:

1. Go to the System for Award Management (SAM) and complete the online Representations and Certifications. System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Contracting officers will not consider these representations when making award decisions or enforcing requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

The SAM website can be accessed at: https://www.sam.gov.

2. Complete and INCLUDE as part of your BUSINESS PROPOSAL: SECTION K –

REPRESENTATIONS AND CERTIFICATIONS

If you are unable to access any documents electronically, you may request a copy from the Contracting Officer identified on the cover page of this solicitation.

K.1. PRODUCT LICENSURE

1. The influenza antigens, vaccines, and adjuvants purchased, stored, and shipped under this contract must be manufactured under a current establishment and product licensure issued by the FDA. Offeror must indicate number below:

i. Name of Vaccine (as applicable):

ii. License Number(s) (as applicable):

2. The Contractor agrees to comply with CGMP guidelines (21 CFR Parts 210-211, 600) for manufacturing, processing, and packing of drugs, chemicals, biologicals, and reagents.

K.2. FAR 52.203-2 CERTIFICATE OF INDEPENDENT PRICE DETERMINATION (APR

1985)

K.3. INCORPORATION BY REFERENCE OF FAR 52.203-11 CERTIFICATION AND

DISCLOSURE REGARDING PAYMENTS TO INFLUENCE CERTAIN FEDERAL

TRANSACTIONS (SEPT 2024)

K.4. FAR 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (Nov 2025)

(a) (1) The Offeror certifies, to the best of its knowledge and belief, that—

(i) The Offeror and/or any of its Principals—

(A) Are □ are not □ presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;

(B) Have □ have not □, within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) contract or subcontract; violation of Federal or State antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property (if offeror checks "have", the offeror shall also see 52.209-7, if included in this solicitation);

(C) Are □ are not □ presently indicted for, or otherwise criminally or civilly charged by a governmental entity with, commission of any of the offenses enumerated in paragraph (a)(1)(i)(B) of this provision; and

(D) Have □, have not □, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds the threshold at 9.104-5(a)(2) for which the liability remains unsatisfied. Federal taxes are considered delinquent if both of the following criteria apply:

(1) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if a pending administrative or judicial challenge remains. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.

(2) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded.

(ii) The Offeror has □ has not □, within a 3-year period preceding this offer, had one or more contracts terminated for default by any Federal agency.

(2) "Principal," for the purposes of this certification, means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The Offeror shall provide immediate written notice to the Contracting Officer if, at any time prior to contract award, the Offeror learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.

(c) A certification that any of the items in paragraph (a) of this provision exists will not necessarily result in withholding of an award under this solicitation. However, the Government will consider the certification in connection with a determination of the Offeror's responsibility. Failure of the Offeror to furnish a certification or provide such additional information as requested by the Contracting Officer may render the Offeror non-responsible.

(d) This provision does not require establishment of a system of records in order to render, in good faith, the certification required by paragraph (a). The knowledge and information of an Offeror is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings.

(e) The certification in paragraph (a) of this provision is a material representation of fact upon which reliance was placed when making award. If the Government later determines that the Offeror knowingly rendered an erroneous certification, in addition to other remedies available to the Government, the Contracting Officer may terminate the contract resulting from this solicitation for default.

K.5. FAR 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (Nov 2025)

(a) Definitions. As used in this provision—

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000 means—

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror □ has □ does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked "has" in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in–

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of

$100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in

(c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management, which can be accessed via https://www.sam.gov (see 52.204-7).

K.6. FAR 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (Nov 2025)

(a) The Government will not enter into a contract with any corporation that—

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that–

(1) It is □ is not □ a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is □ is not □ a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

(End of provision)

K.7. FAR 52.209-13 Violation of Arms Control Treaties or Agreements-Certification (Nov 2025)

(a) This provision does not apply to acquisitions at or below the simplified acquisition threshold or to acquisitions of commercial products and commercial services as defined in Federal Acquisition Regulation 2.101.

(b) Certification. [Offeror shall check either (1) or (2).]

__ (1) The Offeror certifies that–

(i) It does not engage and has not engaged in any activity that contributed to or was a significant factor in the President's or Secretary of State's determination that a foreign country is in violation of its obligations undertaken in any arms control, nonproliferation, or disarmament agreement to which the United States is a party, or is not adhering to its arms control, nonproliferation, or disarmament commitments in which the United States is a participating state.

The determinations are described in the most recent unclassified annual report provided to Congress pursuant to section 403 of the Arms Control and Disarmament Act (22 U.S.C. 2593a).

The report is available at https://www.state.gov/bureaus-offices/under-secretary-for-arms-control-and-international-security-affairs/bureau-of-arms-control-verification-and-compliance/; and

(ii) No entity owned or controlled by the Offeror has engaged in any activity that contributed to or was a significant factor in the President's or Secretary of State's determination that a foreign country is in violation of its obligations undertaken in any arms control, nonproliferation, or disarmament agreement to which the United States is a party, or is not adhering to its arms control, nonproliferation, or disarmament commitments in which the United States is a participating state. The determinations are described in the most recent unclassified annual report provided to Congress pursuant to section 403 of the Arms Control and Disarmament Act (22 U.S.C. 2593a). The report is available at https://www.state.gov/bureaus-offices/under-secretary-for-arms-control-and-international-security-affairs/bureau-of-arms-control-verification-and-compliance/; or

__ (2) The Offeror is providing separate information with its offer in accordance with paragraph

(d)(2) of this provision.

(c) Procedures for reviewing the annual unclassified report (see paragraph (b)(1) of this provision). For clarity, references to the report in this section refer to the entirety of the annual unclassified report, including any separate reports that are incorporated by reference into the annual unclassified report.

(1) Check the table of contents of the annual unclassified report and the country section headings of the reports incorporated by reference to identify the foreign countries listed there. Determine whether the Offeror or any person owned or controlled by the Offeror may have engaged in any activity related to one or more of such foreign countries.

(2) If such activity might have occurred, review all findings in the report associated with those foreign countries to determine whether or not each such foreign country was determined to be in violation of its obligations undertaken in an arms control, nonproliferation, or disarmament agreement to which the United States is a party, or to be not adhering to its arms control, nonproliferation, or disarmament commitments in which the United States is a participating state. For clarity, in the annual report an explicit certification of non-compliance is equivalent to a determination of violation. However, the following statements in the annual report are not equivalent to a determination of violation:

(i) An inability to certify compliance.

(ii) An inability to conclude compliance.

(iii) A statement about compliance concerns.

(3) If so, determine whether the Offeror or any person owned or controlled by the Offeror has engaged in any activity that contributed to or is a significant factor in the determination in the report that one or more of these foreign countries is in violation of its obligations undertaken in an arms control, nonproliferation, or disarmament agreement to which the United States is a party, or is not adhering to its arms control, nonproliferation, or disarmament commitments in which the United States is a participating state. Review the narrative for any such findings reflecting a determination of violation or non-adherence related to those foreign countries in the report, including the finding itself, and to the extent necessary, the conduct giving rise to the compliance or adherence concerns, the analysis of compliance or adherence concerns, and efforts to resolve compliance or adherence concerns.

(4) The Offeror may submit any questions with regard to this report by email to NDAA1290Cert@state.gov. To the extent feasible, the Department of State will respond to such email inquiries within 3 business days.

(d) Do not submit an offer unless—

(1) A certification is provided in paragraph (b)(1) of this provision and submitted with the offer; or

(2) In accordance with paragraph (b)(2) of this provision, the Offeror provides with its offer information that the President of the United States has

(i) Waived application under 22 U.S.C. 2593e(d) or (e); or

(ii) Determined under 22 U.S.C. 2593e(g)(2) that the entity has ceased all activities for which measures were imposed under 22 U.S.C. 2593e(b).

(e) Remedies. The certification in paragraph (b)(1) of this provision is a material representation of fact upon which reliance was placed when making award. If the Government later determines that the Offeror knowingly submitted a false certification, in addition to other remedies available to the Government, such as suspension or debarment, the Contracting Officer may terminate any contract resulting from the false certification.

K.8. FAR 52.215-6 PLACE OF PERFORMANCE (Nov 2025)

(a) The offeror or respondent, in the performance of any contract resulting from this request for proposals, □ intends, □ does not intend [check applicable block] to use one or more plants or facilities located at a different address from the address of the offeror or respondent as indicated in this proposal or response to request for information.

(b) If the offeror or respondent checks "intends" in paragraph (a) of this provision, it shall insert in the following spaces the required information:

Place of Performance (Street Address, City, State, County, ZIP Code)

Name and Address of Owner and Operator of the Plant or Facility if Other than Offeror or Respondent

K.9. FAR 52.219-1 SMALL BUSINESS PROGRAM REPRESENTATIONS (Nov 2025)

(a) Definitions. As used in this provision-

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business concern eligible under the WOSB Program.

HUBZone small business concern means a small business concern that meets the requirements described in 13 CFR 126.200, is certified by the Small Business Administration (SBA) and designated by SBA as a HUBZone small business concern in the Small Business Search (SBS) ( 13

CFR 126.103).

Service-disabled veteran-owned small business (SDVOSB) concern eligible under the SDVOSB Program means an SDVOSB concern that is designated in the System for Award Management (SAM) as certified by the Small Business Administration (SBA) in accordance with 13 CFR 128.300.

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph (b) of this provision.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern means a small business concern that-

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by one or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States, and

(2) The management and daily business operations of which are controlled (as defined at 13 CFR 124.106) by individuals who meet the criteria in paragraph (1) of this definition.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127) means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United…