A19. 75D30126R73405 Adult Covid Solicitation.docx

75D301-26-R-73405

TABLE OF CONTENTS

SECTION B - CONTINUATION OF SF1449

CLIN

COVID-19 Adult Vaccines

PoP: 06/01/2026 – 05/31/2027

Firm Fixed Price Line

1.0

Each

B.1. Background

The Centers for Disease Control and Prevention (CDC) awards one or more Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts for the purchase of standard commercial adult vaccines.

Vaccines are one of the most cost-effective ways to prevent disease and reduce healthcare costs. The establishment of these contracts provides opportunity to utilize Section 317 vaccine purchase funds to obtain vaccines at prices below those available in the commercial marketplace. These funds provide vaccines for state and local health departments to use in populations at greatest risk for under vaccination and disease. The 317 program, as established under Section 317(j) of the Public Health Service Act, works to ensure that adults receive appropriate immunization by partnering with healthcare providers in the public and private sectors. The program helps assure the implementation of effective immunization practices and proper use of vaccines to achieve higher immunization coverage. The vaccines awarded under these contracts will be purchased for the National Center for Immunization and Respiratory Disease’s (NCIRD’s) immunization awardees (the fifty state health departments, several large city programs, and current and former U.S. Territories) to support adult immunization programs as provided under Section 317(j) of the Public Health Service Act. In addition, awardees may opt to purchase additional quantities of vaccine for adults under any resulting contract using state and local funds.

While the primary intention for the contracts is to procure vaccines for the 2026-2027 season, the government also has a requirement to be able to purchase vaccines for the 2025-2026 season, before vaccine becomes available for the 2026-2027 season.

B.2. Definitions:

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.

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

B.3. Type of Contract

Indefinite Delivery Indefinite Quantity contract with Firm-Fixed-Price delivery orders.

B.4 Fair Opportunity Process for CDC-placed Orders

In accordance with Revolutionary FAR Overhaul (RFO) 16.504-5(e), orders under an IDIQ may be placed using any medium specified in the contract as long as it addresses the requirements of RFO 16.506(b). 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 RFO 16.507-2 and the broad discretion afforded in developing appropriate order placement procedures [RFO 16.507-2(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 $892,363,500.00.

B.5 Vaccine Order Limitation Chart

Item Description To include age indication & NDC

(incl. FET) Total Estimated Cost (incl. FET)

1. COVID-19 Vaccine - Adult (age 19 years and older)

Min. Order Size: 100 Doses Fed. Excise Tax: $0.75 per dose Maximum: 10 Million Doses

Minimum: 100 Doses

Proposed Quantity and Presentation: Offerors may propose any number of vaccines or presentations of licensed COVID-19 vaccines indicated for persons aged 19 and older.

Provide dose Maximum and cost for:

· 2025-2026 season vaccine

· 2026-2027 season vaccine

SECTION C - CONTRACT CLAUSES

C.1. Shelf Life

Vaccine provided under this contract shall have a minimum 12-month shelf life remaining upon delivery to the consignee.

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 shall begin on the date of award and shall end 12 months later (CDC will provide the Contractor with official end date at time of award).

C.4. Time of Delivery

Delivery of vaccine and required documentation is required to be made at destination within 15 working days after receipt of electronic, written, or telephonic order (telephone orders to be confirmed in writing). The required documentation includes the packing list, EDI, and DSCSA documentation. Shipments delivered with incorrect or missing packing list, EDI, or DSCSA documentation will be quarantined and considered not ready to be received into inventory until the discrepancy is resolved. Days during which vaccine is in quarantine at CDC's depots count toward the 15 working day requirement.

C.5. Place of Delivery The contractor is required to deliver all vaccines F.O.B. destination

For refrigerated and frozen vaccines, the Contractor shall be required to deliver vaccines as directed by delivery orders to the CDC centralized distribution locations currently in Olive Branch, MS and Clermont, KY.

For ultra-cold vaccines, the contractor shall be required to deliver ultra-cold vaccines F.O.B. destination as directed by delivery orders.

In addition, shipments to five CDC Occupational Health Clinic locations may be requested by the CDC.

C.6. 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 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.7. Placement of Orders

a. Vaccines under this contract will be ordered by delivery orders in the Vaccine Tracking System (VTrckS). Orders shall be placed by 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. No orders will be placed by CDC until contractors are able to interface with the CDC electronic vaccine ordering system.

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 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.8. 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 CDC under their contract.

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

C.9. Maximum Contract Price

The contract unit prices shall be no higher than the manufacturer’s current Federal Ceiling Price (FCP) as established by the manufacturer and the Department of Veterans Affairs. These FCPs are reviewed and recalculated annually and are normally established as an annual FCP on or about January 1st of each year. If during the contract period, the FCP for any vaccine is reduced to a price lower than the contract unit price, the Contractor, whether distributor or manufacturer, shall in turn reduce the CDC’s contract unit price. The procedure for making such changes to the contract shall be as follows:

(1) The Contractor shall notify the Contracting Officer within 10 business days of the effective date of the establishment of the FCP which is lower than the contract unit price; any price reduction to be applied after a new FCP is established shall be retroactive to the date the new FCP is established. Contractors shall provide a credit if necessary for any orders placed prior to establishment of the new FCP at a higher price.

(2) The Contracting Officer shall issue a bilateral modification upon receipt of this notification. In addition, in accordance with Section 317(l) (2) of the Public Health Service Act, authorized states may purchase vaccines at the same contract prices given to the CDC.

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 RFO 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 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 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 solely for purposes of serving persons aged 19 years and older. 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 to the following address as per clause C.12., Method of Payment (for refund).

C.16. Delinquent Delivery Report

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(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

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

o 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).

o Safety Data Sheet (SDS) o Healthcare Distribution Alliance (HDA) form, and o 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; or

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. New FDA Product License/Authorization

Manufacturers who receive a new FDA product license for a vaccine 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. New FDA licensed products added to this contract must comply with Clause C.25., Price Changes.

C.24. ACIP Approved Product

When a new vaccine product is recommended by the ACIP, 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.25., Price Changes.

CDC is only able to contract for COVD-19 vaccines that have a Biologic License Application (BLA) approval issued by the U.S. Food and Drug Administration. The COVID-19 vaccines offered to CDC at the time of contract award which will have a BLA approval are anticipated to not be the same products that manufacturers will offer for the 2026-2027 season and that CDC awardees will order for that season. Product changes between contract award and the availability of 2026-2027 vaccines may include:

(a) a potential update to the vaccine composition and/or strain composition of COVID-19 vaccines;

(b) presentation changes;

(c) assignment of new NDCs and labels.

These changes may occur independent of one another or multiple changes may occur simultaneously as new or updated products or presentations become available.

Once a new or updated product or presentation is recommended by the ACIP, the parties shall discuss any impact of the new product to CDC’s immunization program and this contract. It is CDC’s intent to offer the recommended COVID-19 vaccines for the 2026-2027 season for inclusion in its routine programs. To that end, the parties intend to negotiate and execute a bilateral contract modification when it becomes necessary to add or change the COVID-19 vaccine products on this contract.

If a new or updated product or presentation replaces a product(s) currently on the contract, the new product may be added to the contract with a maximum quantity that is of an equivalent monetary value to the maximum quantity of the product being replaced. The replaced product would simultaneously be removed from the contract. This action would be made through a bilateral contract modification. In negotiating contract changes, the parties shall consider the manufacturing lead time required by the contractor to make new products available for awardee ordering. Any contract terms related to the manufacturing lead time for new products, including updates on minimum shelf life remaining on delivery to the consignee, shall be incorporated by bilateral contract modification. Both parties recognize that uncertainties about vaccine composition and presentation will potentially continue to exist in future seasons. It is CDC’s intent to establish COVID-19 vaccines in its routine immunization program such that CDC’s awardees have access to the same products that the manufacturers sell to commercial customers, in accordance with current immunization recommendations.

Both parties agree to work collaboratively and maintain open communication during the ordering period of this contract to meet this goal.

C.25. 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 Aug 2025) Nov 2025

(Deviation) (RFO Sep 2025) Nov 2025

(Deviation)(RFO Aug 2025) Nov 2025

HHSAR Clauses Incorporated by Reference

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

52.252-2 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)

52.216-18 Ordering. (Deviation) (RFO Aug 2025)

(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 06/1/2026 through 5/31/2027.

(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. (Deviation) (RFO Aug 2025)

(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 Aug 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. (Deviation) (RFO Aug 2025)

(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. 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.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the 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, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, 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

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)

CDCG.02 Contracting Officer's Representative (COR) Jul 2017

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.

In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer, immediately or as soon as possible, in a letter or e-mail separate of any required report(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Contract changes shall be made only by the Contracting Officer through properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the COR delegation memorandum upon request.

CDCG.03 Contracting Officer Jul 1999

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that contained in an authorized modification to this contract, duly issued by the Contracting Officer, received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

CDCG.07 Payment by Electronic Funds Transfer Feb 2018

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232- 33, Payment by Electronic Funds Transfer –System for Award Management, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In the case that EFT information is not within the System of Award Management, FAR 52.232-34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Office of Financial Resources at 678-475-4510.

(c) In cases where the contractor has previously provided such information, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed or sent via facsimile after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention Office of Financial Resources (OFR)

P.O. Box 15580 Atlanta, GA 30333 Or – Fax copy to 404-638-5342

CDCH.14 Records Management Obligations (Jun 2020)

A. Applicability

The following applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes 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.

The term Federal record:

1. includes Centers for Disease Control and Prevention (CDC) records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their CDC contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. 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. chs. 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 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), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all 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. CDC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of CDC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to the Contracting Officer and the Contracting Officer’s Representative. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate 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 the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity.