75D30125R73357 0001 Ped FLU.docx

TABLE OF CONTENTS

SECTION B – CONTINUATION OF SF1449

To include age indication and NDC

(Age 0 through 18 years) Min. Order Size: 100 Doses Fed. Excise Tax $0.75 per dose Proposed Quantity and Presentation: Offerors may propose any number of vaccines or presentations of influenza vaccine indicated for children 0 through 18 years of age.

Maximum: 30 Million Doses*

Minimum: 100 Doses

· Delivery Date: Fall 2026: Specific timeline to be proposed

· Deliver To: To be shown on Delivery Orders

* See section B.4.4. for ceiling information

Supplies or Services and prices/cost

1. Background Statement.

The Centers for Disease Control and Prevention (CDC) awards contracts to the manufacturers of pediatric vaccines for the purchase of standard commercial pediatric vaccines. Vaccines are one of the most cost-effective ways to prevent disease and reduce healthcare costs. The Vaccine for Children (VFC) program established pursuant to Section 13631 of the Omnibus Budget Reconciliation Act of 1993 (OBRA ’93), guarantees federal support for the purchase and supply of sufficient quantities of vaccine to the States to cover a defined group of children. The program helps assure the implementation of effective immunization practices and proper use of vaccines to achieve higher immunization coverage. Children (18 years-of-age or younger) who qualify for immunization through the VFC purchase program include those who are (1) Medicaid-eligible, (2) without health insurance, (3) American Indian/Alaska native (as defined in Subsection (h)(3) of the OBRA ’93), or (4) children with health insurance, which does not cover the cost of vaccines, if they receive their immunizations at a Federally-qualified health center or rural health clinic (as defined by the Social Security Act). Health care providers who agree to certain requirements are eligible through the States to receive free vaccine through this VFC purchase program. The establishment of these contracts provides an opportunity to utilize VFC funds and Section 317 vaccine purchase funds to obtain vaccines at prices below those available in the commercial marketplace. In addition, awardees may opt to purchase additional quantities of vaccine under any resulting contract to provide immunizations for children who are not federally vaccine-eligible children using state and local funds.

Offerors for this requirement must be manufacturers of pediatric vaccines in accordance with 42 U.S.C. § 1396s. The term "manufacturer" means any corporation, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities), which manufactures, imports, processes, or distributes under its label any pediatric vaccine. The term "manufacture" means to manufacture, import, process, or distribute a vaccine.

1. Definitions.

OBRA Orders – Vaccine orders under Section 1928(a) (2)(A) of the Social Security Act.

317 Orders – Vaccine orders under Section 317(j) of the Public Health Service Act.

State and Local Orders – Vaccine orders placed by authorized immunization programs using state or local funds in accordance with Section 1928(d)(4)(B) of the Social Security Act.

Manufacturer – As defined in Subsection (h)(4) of the Social Security Act, means any corporation, organization, or institution, whether public or private, which manufactures, imports, processes, or distributes under its label any pediatric vaccine.

Awardees – Includes State health departments and certain local health agencies authorized to order hereunder.

1. Type of Contract.

Indefinite Delivery/Indefinite Quantity (ID/IQ) with Firm-Fixed Price Delivery Orders.

B.4 Fair Opportunity Process for CDC-placed Orders

In accordance with FAR 16.505(a)(6), orders under an IDIQ may be placed using any medium specified in the contract as long as it addresses the requirements of 16.505(a)(7). Delivery Orders for vaccines shall be placed by Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC) in the Vaccine Tracking System (VTrckS). A formal request for delivery order proposal will not occur at the delivery order level or issued on an OF347.

In accordance with 16.505(b)(1) and the broad discretion afforded in developing appropriate order placement procedures [16.505(b)(1)(ii)], delivery orders for vaccines will be placed using a fair opportunity process, which uses the following factors:

1) The vaccines and presentations identified by awardees and healthcare providers as clinically appropriate for their patients;

2) recommendations by state-level medical vaccine advisory committees;

3) and the level of federal and state vaccine funding available to each jurisdiction which incorporates the established IDIQ vaccine prices in the delivery order decision.

4. Combined ceiling for all contracts awarded is 6 million doses or $710,000,000.00, which ever is reached first.

SECTION C – TERMS & CONDITIONS / CONTRACT CLAUSES

C.1. Shelf Life

Expiry for all injectable products shall be no earlier than June 30, 2027.

Expiry for LAIV (live attenuated influenza vaccine) shall be proposed at the longest FDA approved expiry beyond the initial thaw.

C.2. Packaging and Packing Requirements

1. Packaging:

All items shall be packaged in standard commercial manner.

2. Packing:

a. Product shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination. An electronic temperature monitoring device is required with each shipment unless Contractor has obtained prior approval from CDC to use an alternative monitoring method.

b. Contractor will provide the Contracting Officer Representative (COR) with documentation that explains the cause of each temperature excursion and stability data used by the contractor to determine if the cold chain was adversely affected by temperature variance. Upon review of data and recommendation provided, CDC will notify appropriate parties if the vaccine is accepted or rejected.

C.3. Contract Period of Performance

The contract period of performance and the ordering period shall begin on the date of award and shall end February 28, 2027.

C.4. Time of Delivery

Offerors shall propose a delivery schedule. After award of contract, any deviation from proposed schedule will demonstrate reasonably equal treatment with respect to the fulfillment of orders between CDC and the contractor's non-governmental customers.

C.5. Place of Delivery

The Contractor shall be required to deliver vaccines F.O.B. Destination, as directed by delivery orders to the CDC centralized distribution locations currently in Olive Branch, MS, and Clermont, KY.

Vaccine stockpile order(s) shall be delivered to another single location to be determined by CDC.

C.6. Amendment to OBRA Statute

In the event of an amendment of 42 U.S.C. Section 1396(s), any terms of the contract affected by such an amendment will be modified in accordance with the revised statute. The Contracting Officer and the Contractor shall meet to discuss such modifications to the contract before finalization of any changes to the contract.

C.7. Product Licensure

a. The vaccines produced and delivered under this contract shall be manufactured under a current establishment and product license issued by the Food and Drug Administration as indicated below:

b. The Current Good Manufacturing Practice Regulations (CGMPRs) (21CFR Parts 210, 211) will be the standard to be applied for manufacturing, processing, and packing of drugs, chemicals, biologicals, and reagents.

c. The Contractor shall advise the Contracting Officer immediately of any relocation of his prime manufacturing facility or the relocation of any subcontractor’s facility, and if at any time during the life of the contract, the item listed under this contract fails to meet CGMPRs and/or a negative Food and Drug Administration Quality Assurance Evaluation is received; the contract may be terminated, in whole or in part, without further liability to the Government.

C.8. Placement of Orders

a. Vaccine under this contract will be ordered by delivery orders in the Vaccine Tracking System (VTrckS). Orders shall be placed by Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC) on behalf of eligible awardees, or by the awardees. The CDC will provide the contractor with a list of awardees. Each awardee will be identified with a unique identification number in the vaccine ordering system. Orders shall be placed by electronic transfer. In the event of an emergency, (e.g., temporary loss of the IT system) should an order be communicated outside of VTrckS via email or orally, an actual purchase order will be created in VTrckS and transmitted via electronic data interface (EDI) as soon as possible, thereafter. Contractors shall be able to interface with the CDC electronic vaccine ordering system. If unable to interface at the time of award, the vendor shall complete interface implementation by the end of the period of performance of the contract.

b. Orders shall be submitted to the Ordering Address specified in Contract Clauses Paragraph C.3.10, Contractor’s Ordering/Payment Address, and shall contain the following minimum information:

1. Date of order;

2. Contract number and order number;

3. Item description, quantity and unit price;

4. Delivery or performance date;

5. Place of delivery or performance (including consignee);

6. Packaging, packing, and shipping instruction, if any;

7. Accounting and appropriation data;

8. Statement to indicate if partial deliveries are not acceptable; (lack of a statement shall be construed to mean partial deliveries are acceptable and payment shall be made as required elsewhere herein); and

9. Any other pertinent data.

c. The ordering procedures for this vehicle are in accordance with FAR 32.702 and will not create or authorize an obligation in excess of funds available or in advance of appropriations (Anti-Deficiency Act, 31. USC 1341).

C.9. Delivery Order Limitations

a. Minimum Order Size: Individual delivery orders issued under this contract must meet the minimum order size as specified within each Contract Line Item Number (See Section B, Continuation of SF 1449). When the Government requires supplies covered by this contract in amounts less than stated above, the Government is not obligated to purchase, nor is the Contractor obligated to furnish those supplies under this contract.

b. Maximum Order: The maximum quantity specified within each Contract Line Item Number (See Section B, Continuation of SF1449) is the maximum number of doses that may be ordered during the contract period of performance. Contractors are advised that the maximum quantity represents their commitment to the Government under their contract.

The Government intends to submit first pre-book orders to Contractors NLT April 15, 2026. Upon receipt of the initial pre-book orders, contractors will have the opportunity to decrease the maximum quantity of each Contract Line Item to initial pre-book quantity plus 30% of the initial pre-book quantity plus planned FY 2026 stockpile purchase. To request this change to the maximum quantity, the contractor shall submit a written request to the Contracting Officer prior to June 2, 2026. The Government will notify Contractors of its commitment to order additional vaccines NLT October 15, 2026.

c. Delivery Orders shipments:

1. Shipments shall be sent with all transaction information necessary to be compliant with applicable Drug Supply Chain Security Act requirements including Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS). Initially, paper documentation or portal access will be acceptable, but EDI messaging between contractors and CDC will transition to allow electronic transmission of information.

2. The Government reserves the right to reject vaccine doses that exceed delivery order requirements. The Government shall notify the Contractor when excess doses have been delivered to distribution sites. The Contractor is responsible for contacting the distribution site to make arrangement for the return of the excess doses and will be responsible for shipping cost associated with their return.

3. Bulk order shipments, when possible, shall consist of

a. One NDC per skid

b. Full skid quantities with same lot number

c. Full case quantities (when total order size allows)

d. Influenza vaccine only, except in the event of an emergency when it is necessary to ship other vaccines together with influenza vaccines.

C.10 Contractor's Ordering/Payment Address

Submission of all orders for Contractor’s vaccines and payment of invoices shall be addressed as referenced below:

C.11. Invoice Submission

1. Invoice submission under this contract will be made as follows:

a. Federal Government: The Contractor shall submit invoices via Electronic Data Interchange (EDI).

b. Awardees: The Contractor shall submit one hard copy of its invoice(s) to the address specified on the delivery order. If mutually acceptable to the Awardee and the Contractor, the Contractor may submit an electronic copy of its invoice(s) to the Awardee by e-mail in lieu of mailing a hard copy.

c. In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Office of Financial Resources is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

d. The Contractor agrees to include the following information on each invoice:

1. Contractor’s name, invoice number, and invoice date;

2. Contract number, or other authorization for delivery of property and/or services;

3. Description, cost or price, and quantity of property and/or services actually delivered or rendered;

4. Shipping and payment terms;

5. Other substantiating documentation or information as required by the contract;

6. Name where practicable, title, phone number, and complete mailing address of responsible official to whom payment is to be sent;

7. NDC and Lot number of vaccine vials/syringes shipped;

8. CDC accounting and appropriation data as described on the delivery order;

9. Electronic Funds Transfer (EFT) and Taxpayer Identification Number (TIN); and

10. Purchase Order (PO) Number and PO Line Item Number.

C.12. Method of Payment

a. Federal Government:

1. The Government will use electronic funds transfer when making payment under this contract IAW FAR Clause 52.232-33, payment by Electronic Funds Transfer - System for Award Management (Oct 2018).

2. Payments for vaccine purchases will be tracked in the CDC vaccine ordering system.

3. The Government is not liable for payments related to orders submitted by states, cities, or territories.

b. Awardees: By check

c. Vendor: Refunds for CDC shall be submitted as an ACH or credit card payment via Treasury’s Pay.Gov. Each refund shall reference the Purchase Order number(s) and line item(s) of origin if applicable and the information shall be sent to the COR.

C.13. Return Privileges

Return privileges for credit, reimbursement, or exchange do not apply to this contract except vaccines not conforming to the specifications set forth herein.

C.14. Restrictions on Use of Vaccines

Vaccines obtained under this contract shall be used only in children 18 years of age and younger as authorized under Section 1928 of the Social Security Act. Sale of such vaccine to any person or entity or reimbursement of vaccine costs is strictly prohibited. Free distribution of such vaccine is also prohibited, except where such vaccine is administered in the context of Federal and awardee immunization program activities.

C.15. Federal Excise Tax Credit

Negotiated prices for the vaccines included in this Contract may include a Federal Excise Tax (See Continuation of SF 1449 for applicable Contract Line Item Numbers). If for any reason the vaccine is returned (other than for resale) or destroyed, the Contractor shall within 6 months following the date the vaccine is returned or destroyed, file a claim for credit or refund relative to any tax previously paid on such vaccine. The Contractor agrees to credit or refund the amount of such excise tax to the purchaser to the extent that the Contractor receives a credit or refund from the Federal Government. Any such credit or refund to the purchaser is expressly conditioned upon the authorized purchaser providing a written summary of events leading to the request for credit or refund. Even if FET is not applicable to some or all vaccines purchased on the contract, the purchaser shall return all unadministered vaccine to the Contractor for proper disposal, unless destruction of the vaccine renders return impossible. If destruction of the vaccine renders return impossible and is therefore destroyed by the purchaser, the authorized purchaser must provide a written summary of events to the Contractor within 30 days of said destruction.

If a contract is in place with the Contractor at the time when a credit or refund is due, the purchaser may elect to receive vaccine which will be purchased at the current contract price in lieu of a cash payment. Otherwise, the Contractor shall refund the amount due to the purchaser’s account. If a credit or refund is issued by the Contractor for state or local funds, it shall be submitted to the state or local public health entity identified in the request for FET credit. For all Federal Excise Tax refund and other refunds sent to the government, each shall reference the Purchase Order number(s) and line item(s) of origin. Whenever a refund is sent to CDC in response to a return PO, the following documentation shall be included and sent to the COR. This documentation shall include a mapping between the refund number and the return PO numbers and associated PO line item numbers that are covered by the refund. If a credit or refund is issued by the Contractor to the Federal Funds account, it shall contain the Contractor’s DUNS and TIN/EIN and shall be submitted either via EDI (for credit) or as per clause C.12 Method of Payment (for refund).

C.16. Delinquent Delivery Reports

The Contractor shall provide CDC with a weekly electronic listing of all CDC orders that have not been shipped within the agreed upon delivery schedule. The report shall include the following information: order number, date of order, and status of order in number of pending/undelivered doses. The report shall also provide an explanation as to the cause for the delinquent delivery as well as when the vaccine will be delivered. This notification shall not relieve the contractor from meeting its obligations under the contract and shall not limit the Government’s right to seek relief for any breach of contract for failure to perform, including termination for cause.

C.17. Biological Surveillance Data Reports

A. The Contractor shall submit a monthly report of historical sales data for the United States by month and state specifying the name of the vaccine, NDC #, and the total number of doses sold (segregated by CDC and non-CDC sales), in a standardized format acceptable to the Contractor and the CDC. The report shall be submitted electronically to the COR by the 15th of the month. Information related to vaccine sales through CDC contracts is not considered proprietary. CDC acknowledges that those reports pertaining to private sales unrelated to this contract are confidential and proprietary information of the Contractor, and shall not use reports for any purpose other than CDC’s internal tracking and reporting purposes and shall not further disclose such reports without the Contractor’s prior written consent unless required by the law or other Federal authority; provided that, no Contractor authorization shall be required for the CDC to include the data from the Contractor’s report in a report in which aggregated data from multiple Contractors is summarized, so long as, with respect to multi-sourced products, the CDC’s aggregated report does not include any data which could be individually identified as the Contractor’s. In the event that CDC is required by law or other Federal authority to disclose such reports required to be held confidential hereunder, CDC shall notify the Contractor prior to making such disclosure in accordance with law or other Federal authority.

B. Data Reports to Manufacturers The Government will submit monthly reports of all vaccine data specifying doses by project, zip code, and NDC # in a standardized format. For all vaccines except direct ship vaccines, the Government shall provide distribution data. Because the Government does not distribute direct ship vaccines, purchase data will be provided. The reports shall be submitted electronically to the Contractor by the 15th of the month for the previous month. The Government shall also provide the Contractor with an annual Vaccine Tracking System (VTrckS) spend plan for each awardee and an annual providers list during the first quarter of the fiscal year.

C.18. Prohibitions on Inducements

The Contractor is expressly prohibited from offering, providing, or arranging inducements of any kind to providers or authorized purchasers ordering vaccine under this contract for the purpose of obtaining orders for vaccine. Examples of such inducements include, but are not limited to entertainment, meals, and free or reduced prices for syringes, vaccines, or other medical products or supplies. If the Contractor has entered into similar agreements with the authorized purchasers which offer inducements relative to its commercial business, these agreements must be clear that they do not apply to purchases made under the CDC Federal contracts.

C.19. Contract Changes

Notwithstanding FAR Clause 52.212-4(c), Changes, the parties hereby agree that modifications for funding and other administrative changes (e.g., changes to CDC accounting data) that do not affect the terms and conditions of the contract may be made unilaterally by the CDC.

C.20. Vaccine specific information – Images, SDS, HDA, PI, and NDC Mapping Template

Upon contract award, for all new vaccines, the Contractor agrees to provide the following to the COR:

· Camera-ready vaccine product images in .pdf format and written authorization for CDC to use the images. (CDC will use the images to illustrate the Contractor’s products on the CDC vaccine ordering system and for inclusion in CDC provider training materials.)

· Safety Data Sheet (SDS)

· Healthcare Distribution Alliance (HDA) form, and

· Package Insert (PI)

Additionally, Contractor agrees to provide updated product images, SDSs, HDA forms, and PIs

a. if these items change or new NDCs are added during the course of the contract, and

b. for existing vaccines if requested.

2. For each vaccine available on this contract (new and previously offered), Contractor shall complete the information in the template below. If there is more than one component/NDC within the unit of use, each component NDC should be listed separately along with component name.

*Temperature Range Definitions: Ambient CRT = 20 to 25℃; Refrigerated = 2 to 8℃; Frozen = -50 to -15℃; Ultra Cold = -90 to -60℃

Ultra Cold

* Ambient CRT; Refrigerated; Frozen;

Ultra Cold

C.21. Advance Notice of Supply Issues

The Contractor agrees to provide advance notification to COR and the CDC Contracting Officer of any supply issue which may result in the Contractor’s failure to deliver vaccine within the agreed upon delivery schedule specified in the contract. This notification shall be given as soon as the Contractor becomes aware of the scope of the problem that may impede the timely delivery of vaccine. This notification shall not relieve the Contractor from meeting its obligations under the contract and shall not limit the Government’s right to seek relief for any breach of contract for failure to perform, including termination for cause. Furthermore, any deviation from the delivery schedule due to a vaccine supply issue will demonstrate reasonably equal treatment with respect to the fulfillment of orders between CDC and the non-government customers.

C.22. Authorized Distributor of Record (ADR) Agreements

In accordance with the Prescription Drug Marketing Act (PDMA) of 1998, it is requested that all suppliers provide a written statement included as an attachment in Section D of this solicitation, which designates the CDC as the ADR for all vaccines subject to distribution under this contract.

C.23. Use of VFC Provider Lists and Distribution of Material

a. Contractors are prohibited from utilizing VFC providers lists obtained from any source for any mailing or other communication with VFC providers, except as approved in writing by the CDC COR. In addition, contractors are prohibited from otherwise communicating with VFC providers regarding the VFC program, except as approved in writing by the CDC COR. To the extent that Contractors have established relationships with VFC providers or authorized purchasers under this contract that are independent from the VFC program, communications related to such independent relationships are not covered by this provision and do not require CDC consent.

b. Contractors are prohibited from providing names and/or addresses of VFC providers to any third party, except as needed to comply with the terms of this contract, in which cases the CDC COR shall be notified in writing.

c. Any Contractor that ships vaccine directly to VFC providers is prohibited from inserting any promotional or other material that is promotional in nature for any product that the Contractor produces, into shipping containers for vaccine purchased under this contract, except for material related to use of the vaccine as approved in writing by the CDC COR. Additionally, any shipping container inserts that are required, such as handling instructions or educational materials, should not contain any promotional material as part of its content.

C.24. New FDA Product License

Manufacturers who receive a new FDA product license for a vaccine already included within the scope of a VFC resolution may have the new product added to its contract by modification if it is determined that adding the product is in the best interest of the Government. Such new products must be consistent with VFC formulary schedules (regarding periodicity and dosage regimens) as established for the vaccines by the Advisory Committee on Immunization Practices (ACIP). New FDA licensed products added to this contract must comply with Clause C.26. Price Changes, below.

C.25. ACIP Approved Product

When a new vaccine product is approved by the ACIP for inclusion in the VFC Formulary, the Manufacturer of such product may have the new product added to its contract by modification if it is determined that adding the product is in the best interest of the Government. This would include new vaccines, new indications or new formulations for existing products, or new dosing regimens for an existing product. New ACIP Approved Products added to this contract must comply with Clause C.26. Price Changes, below.

C.26. Price Changes

All price change effective dates shall be approved by the CDC Contracting Officer and shall occur on the first day of the following month in VTrckS.

Solicitation No. 75D301-25-R-73357 0001

FAR Clauses Incorporated by Reference

Responsibility Matters Oct 2018

HHSAR Clauses Incorporated by Reference

Amendment to Clause:

Paragraph (c) of 52.212-4, Changes:

Notwithstanding FAR Clause 52.212-4(c), Changes, the parties hereby agree that modifications for funding and other administrative changes (e.g., changes to CDC accounting data) that do not affect the terms and conditions of the contract may be made unilaterally by the CDC.

FAR Clauses Incorporated by Full Text

52.252-2 Clauses Incorporated by Reference.

Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/ (End of clause)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services. (Deviation Feb 2025)

(a)The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1)52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2)52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(3)52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4)52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5)52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b)The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.] _X_ (1)52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

_X_ (2)52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509)).

__ (3)52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4)52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

_X_ (5)52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (6)[Reserved].

__ (7)52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8)52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (9)52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

__ (10)52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) ( Pub. L. 115–390, title II).

_X_ (11) (i)52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

__ (ii)Alternate I (Dec 2023) of 52.204-30.

_X_ (12)52.209-6, Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (Jan 2025) ( 31 U.S.C. 6101 note).

_X_ (13)52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

__ (14)[Reserved].

__ (15)52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) ( 15 U.S.C. 657a).

__ (16)52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (17)[Reserved] __ (18) (i)52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii)Alternate I (Mar 2020) of 52.219-6.

__ (19) (i)52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii)Alternate I (Mar 2020) of 52.219-7.

_X_ (20)52.219-8, Utilization of Small Business Concerns (Jan 2025)( 15 U.S.C. 637(d)(2) and (3)).

_X_ (21) (i)52.219-9, Small Business Subcontracting Plan (Jan 2025) ( 15 U.S.C. 637(d)(4)).

__ (ii)Alternate I (Nov 2016) of 52.219-9.

_X_ (iii)Alternate II (Nov 2016) of 52.219-9.

__ (iv)Alternate III (Jun 2020) of 52.219-9.

__ (v)Alternate IV (Jan 2025) of 52.219-9.

__ (22) (i)52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

__ (ii)Alternate I (Mar 2020) of 52.219-13.

__ (23)52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 657s).

_X_ (24)52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

__ (25)52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) (15 U.S.C. 657f).

_X_ (26) (i)52.219-28, Post award Small Business Program Representation (Jan 2025) (15 U.S.C. 632(a)(2)).

__ (ii)Alternate I (Mar 2020) of 52.219-28.

__ (27)52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

__ (28)52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) (15 U.S.C. 637(m)).

__ (29)52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

__ (30)52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15 U.S.C. 637(a)(17)).

_X_ (31)52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (32)52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2025)( E.O. 13126).

__ (33)52.222-21, Prohibition of Segregated Facilities (Apr 2015).

__ (34) (i)52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

__ (ii)Alternate I (Feb 1999) of 52.222-26.

_X_ (35) (i)52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (ii)Alternate I (Jul 2014) of 52.222-35.

_X_ (36) (i)52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C. 793).

__ (ii)Alternate I (Jul 2014) of 52.222-36.

_X_ (37)52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

_X_ (38)52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (39) (i)52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii)Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (40)52.222-54, Employment Eligibility Verification (Jan 2025) ( Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (41) (i)52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii)Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (42)52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (43)52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (44)52.223-20, Aerosols (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (45)52.223-21, Foams (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (46)52.223-23, Sustainable Products and Services (Deviation FEB 2025) ( E.O. 14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

__ (47) (i)52.224-3 Privacy Training (Jan 2017) ( 5 U.S.C. 552 a).

__ (ii)Alternate I (Jan 2017) of 52.224-3.

__ (48) (i)52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

__ (ii)Alternate I (Oct 2022) of 52.225-1.

__ (49) (i)52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii)Alternate I [Reserved].

__ (iii)Alternate II (Jan 2025) of 52.225-3.

__ (iv)Alternate III (Feb 2024) of 52.225-3.

__ (v)Alternate IV (Oct 2022) of 52.225-3.

_X_ (50)52.225-5, Trade Agreements (NOV 2023) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (51)52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52)52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

__ (53)52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (54)52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

_X_ (55)52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ( E.O. 13513).

__ (56)52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (57)52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

__ (58)52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

_X_ (59)52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

_X_ (60)52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (61)52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

_X_ (62)52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

__ (63)52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

__ (64)52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (65) (i)52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

__ (ii)Alternate I (Apr 2003) of 52.247-64.

__ (iii)Alternate II (Nov 2021) of 52.247-64.

(c)The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.] __ (1)52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).

__ (2)52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3)52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4)52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

__ (5)52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

__ (6)52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

__ (7)52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

__ (8)52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

__ (9)52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792).

__ (10)52.247-69, Reporting Requirement for U.S.-Flag Air Carriers Regarding Training to Prevent Human Trafficking (Jan 2025) ( 49 U.S.C. 40118(g)).

(d)Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1)The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2)The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3)As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1)Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1), in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i)52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509).

(ii)52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712).

(iii)52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iv)52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(v)52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(vi)52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

(vii) (A)52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

(B)Alternate I (Dec 2023) of 52.204–30.

(viii)52.219-8, Utilization of Small Business Concerns (Jan 2025) ( 15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(ix)52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(x)52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

(xi)52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

(xii)52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(xiii)52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

(xiv)52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xv)52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter 67).

(xvi) (A)52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O 13627).

(B)Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xvii)52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(xviii)52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xix)52.222-54, Employment Eligibility Verification (Jan 2025) ( E.O. 12989).

(xx)52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xxi)52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xxii) (A)52.224-3, Privacy Training (Jan 2017) ( 5 U.S.C. 552a).

(B)Alternate I (Jan 2017) of 52.224-3.

(xxiii)52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

(xxiv)52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxv)52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxvi)52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

(xxvii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2)While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

52.216-18 Ordering. Aug 2020

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 the effective date of the contract through the expiration date of the contract.

(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.

(End of clause)

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 100 doses, 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 the maximums stated in the vaccines order limitations chart;

(2) Any order for a…