A19 75D30126R73518 FY27-28 Peditatric Flu Sol..docx

TABLE OF CONTENTS

SECTION B - CONTINUATION OF SF1449

Period of Performance: 12/31/2026-02/28/2028 Firm Fixed Price

B.1 Background 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.

B.2. 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.

B.3 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.

In accordance with RFO 16.507-2 and the broad discretion afforded in developing appropriate order placement procedures [RFO 16.505(a)(2)], 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 maximum value for all contracts is: $850,000,000.00.

B.4 Estimated Contract Data Reserved B.5 Purchase of Vaccines The combined, aggregate maximum ceiling value for all contracts awarded under this multiple-award IDIQ is $850,000,000.00. The maximum ceiling value of this contract is to be determined (TBD). Upon mutual agreement of the Government and contractor, the maximum ceiling value of this contract may be adjusted via modification so long as the combined, aggregate maximum ceiling value of all contracts is not exceeded. The minimum guarantee is 100 doses per vaccine at $__. The total funded amount of this contract is $__ which represents the Governments maximum potential liability if delivery orders are executed in VTrckS for the full funded amount. Funds for unplaced delivery orders may be de-obligated unilaterally by the Government.

B.6 Minimum and Maximum Order Limitations

(Incl. FET) Maximum Extended Price (Incl. FET)

(age 0 through 18) (To include age indication and NDC) Min. Order Size: 100 Doses Fed. Excise Tax $0.75 per dose Max: 30 Mil Doses Min: 100 Doses

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.

· Delivery Date: Fall 2027: Specific timeline to be proposed

· Delivery To: To be shown on delivery orders

SECTION C – TERMS & CONDITIONS / CONTRACT CLAUSES

C.1. Shelf Life

Expiry for all injectable products shall be no earlier than June 30, 2028.

Expiry for Live attenuated influenza vaccine (LAIV)) shall be proposed at the longest Food and Drug Administration (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, 2028.

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.

As applicable, 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) (21 CFR 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 its 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.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 RFO 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 potential commitment to the Government under their contract.

The Government intends to provide Contractors with initial pre-book quantities NLT April 15, 2027. The planned FY 2027 stockpile purchase quantity will be provided separately subsequent to the initial pre-book quantities. The planned FY 2027 stockpile purchase quantity does not constitute a binding order, commitment, or obligation by the Government to purchase such quantity unless and until an authorized order is issued in accordance with the terms and conditions of the contract. Upon receipt of the planned FY 2027 stockpile purchase quantity, a Contractor may request a reduction in the maximum quantity for each applicable Contract Line Item Number (CLIN) to an amount equal to the initial pre-book quantity, plus the planned stockpile purchase quantity and 30 percent of the initial pre-book quantity. Any such request shall be submitted in writing to the Contracting Officer prior to June 1, 2027. The Government will notify Contractors of its commitment to order additional vaccine quantities NLT October 15, 2027.

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 RFO 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 a copy of this referenced 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 RFO Clause 52.212-4(d), 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.

FAR Clauses Incorporated by Reference

(Deviation) (RFO Apr 2026) Nov 2025

(Deviation) (RFO Apr 2026) Nov 2025

(Deviation)(RFO Nov 2025) Nov 2025

HHSAR Clauses Incorporated by Reference 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/ https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/hhsar (End of clause)

HHSAR 352.203-70 ANTI-LOBBYING (JUN 2026) (RFO DEVIATION)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor must not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or

(c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in paragraphs (a), (b), and (c) of this clause include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

(End of clause)

HHSAR 352.204-72 Records Management (Feb 2024) (DEVIATION)

(a) Applicability. This clause applies to contracts that include Federal records, as defined in paragraph (b).

(b) Definition. As used in this clause— Federal record means all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. See 44 U.S.C. 3301.

(1) The term Federal record—

(i) Includes HHS records;

(ii) Does not include personal materials;

(iii) Applies to records created, received, or maintained by Contractors pursuant to their contract; and

(iv) May include deliverables and documentation associated with deliverables.

(2) Recorded information means all traditional forms of records, regardless of physical form or characteristics, including information created, manipulated, communicated, or stored in digital or electronic form. (See 44 U.S.C. 3301.)

(3) Personal materials means documentary materials belonging to an individual that are not used to conduct agency business. Personal files are excluded from the definition of Federal records and are not owned by the Government. (See 36 CFR 1220.18.)

(c) Requirements.

(1) The Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chapters 21, 29, 31, 33), NARA regulations at 36 CFR chapter XII subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all Federal records, regardless of form or characteristics, mode of transmission, or state of completion.

(2) In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), and the Privacy Act of 1974 (5 U.S.C. 552a), and must be managed and scheduled for disposition only as permitted by statute or regulation.

(3) In accordance with 36 CFR 1222.32, the Contractor shall maintain all Federal records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

(4) The Contractor is responsible for preventing the alienation or unauthorized destruction of Federal records, including all forms of mutilation. Federal records may not be removed from the legal custody of HHS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Contracting Officer. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. The Contractor shall report to the Contracting Officer any unlawful or accidental removal, defacing, alteration, or destruction of Federal records.

(5) The Contractor shall immediately notify the Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that appropriate personnel are trained to adhere to these contract requirements, and that applicable, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of information, data, documentary material, Federal records and/or equipment is properly protected. The Contractor shall not remove Federal Records from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Contracting Officer. When information, data, documentary material, Federal records and/or equipment are no longer required, it shall be returned to HHS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or as otherwise directed by the Contracting Officer. Destruction of Federal records is expressly prohibited unless in accordance with paragraph (c)(4).

(6) The Contractor shall only use Government information technology equipment for purposes specifically authorized by the contract and in accordance with HHS policy.

(7) The Contractor shall not create or maintain any Federal records containing any non-public HHS information that are not specifically authorized by the contract.

(8) The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

(9) All Contractor employees assigned to this contract handle Federal records are required to take HHS-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

(d) Subcontract flowdown. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract.

(End of Clause)

HHSAR 352.208-70 PRINTING AND DUPLICATION (FEB 2026) (RFO DEVIATION)

(a) Unless otherwise specified in this contract, no printing by the Contractor or any subcontractor is authorized under this contract. All printing required must be performed by the Government Printing Office except as authorized by the Contracting Officer. The Contractor must submit camera-ready copies to the Contracting Officer's Representative (COR). The terms “printing” and “duplicating/copying” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing.

(b) If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 production units of only one page, or less than 25,000 production units in aggregate of multiple pages for the use of a department or agency. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10 3⁄4 by 14 1⁄4 inches. This page limit applies to each printing requirement and not for all printing requirements under the entire contract.

(c) Approval for all printing, as well as duplicating/copying in excess of the stated limits, must be obtained from the COR who will consult with the designated publishing services office and provide direction to the contractor. The cost of any unauthorized printing or duplicating/copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed.

(End of clause)

Amendment to Clause:

Paragraph (d) of 52.212-4, Changes:

Notwithstanding FAR Clause 52.212-4(d), 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 52.216-18 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 12/31/2026 through 02/28/2028.

(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 combination of items in excess of maximum value of the contract; or

(3) A series of orders from the same ordering office within 365 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 30 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.

(End of clause)

52.216-22 Indefinite Quantity. (Deviation) (RFO 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 ordering period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order, which may include order options to be exercised after the ordering period of this contract but before the end of the period of performance of the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order, including options exercised, to the same extent as if the order were completed during the contract's ordering period; provided that the Contractor shall not be required to make any deliveries under this contract after 15 working days beyond the expiration date.

(End of clause)

52.216-32 Task-Order and Delivery-Order Ombudsman. (Sep 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. See CDC clause CDCH.15 for Ombudsman POC information.

(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.

(End of clause)

Additional Regulation or Supplement Clauses Incorporated by Full Text 352.239-79 Information and Communication Technology Accessibility (Deviation) (FEB 2024)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contractor order must comply with the Revised 508Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section- 508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility- checklists/index. html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards.