A19 Solicitation - 75D30126R73375 Pg 2-31 Version 5.docx

TABLE OF CONTENTS

SECTION B - CONTINUATION OF SF1449

CLIN

Vaccines for Children (VFC)

PoP: 4/01/2026 – 3/31/2027

Firm Fixed Price Line

1.0

Each

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 13631of 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. (S)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. 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 FAR 16.506(a), orders must be within the scope, issued within the specified ordering period, and be within the maximum value of the contract.as long as it addresses the requirements of 16.506(b). Delivery Orders for vaccines shall be placed by 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 16.507-2(a)(2) the contracting officer has broad discretion afforded in developing appropriate order placement procedures. 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 $13,361,773,853.93.

75D301-26-R-73375

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 Ordering Period The contract period of performance and the ordering period shall begin on the date of award and shall end 12- months later.

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, Electronic Data Interchange (EDI), and Drug Supply Chain Security Act (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 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.

The Contractor shall be required to deliver frozen vaccines F.O.B. destination as directed by delivery orders.

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 (CGMPR's) (21CFR Parts210, 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 their 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 CGMPR's 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 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 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.

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

C.9. Delivery Order Limitations

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

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

a. One NDC per skid;

b. Full skid quantities with same lot number;

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

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:

Ordering Address

Payment Address

C.11. Method of Payment

a. Federal Government:

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

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

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

b. Vendor: If a refund is due, the vendor shall submit an ACH or credit card payment via Treasury's Pay.Gov.

c. Awardees: By check.

C.12. 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.13. 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.14. 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 undistributed vaccine to the Contractor for proper disposal, unless destruction of the vaccine renders return impossible. If destruction of the vaccine renders returns 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 are fund is sent to CDC in response to a return PO, the following documentation shall be included with the check and sent to the COR. This documentation shall include a mapping between the refund 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.11 Method of Payment (for refund).

C.15. 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.16. 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. There port 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. There ports 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.17. 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.18. 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.19. 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:

a. 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.)

b. Safety Data Sheet (SDS)

c. Healthcare Distribution Alliance (HDA)form, and

d. 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,

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.

Unit of Sale (Box/Carton)

Unit of Use (Vial/Syringe)

NDC (5-4-2 format)

Brand Name/Trade Name

Description/Presentation

NDC (5-4-2 format)

C.20. 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 begiven 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.21. 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 02 of this solicitation, which designates the CDC as the ADR for all vaccines subject to distribution under this contract.

C.22. 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.23. New FDA Product License Manufacturers who receive a new FDA product license for a vaccine already included with 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.25, Price Changes, below.

C.24. 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.25, Price Changes, below.

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 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 4/1/2026 through 3/31/2027.

(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.15 Agency Ombudsman Aug 2022

CDC is committed to ensuring fair opportunity for all offerors submitting proposals for competitive task/delivery orders issued against existing Indefinite Delivery Indefinite Quantity contracts in accordance with FAR 16.505. Offerors/Contractors may protest task/delivery order awards of any amount on the grounds that the order increases the scope, period, or maximum value of the contract under which the order was issued. These complaints may be lodged at the agency level or protested with the General Accountability Office (GAO).

Additionally, in accordance with FAR 16.505(a)(10)(i), protests of task/delivery orders valued in excess of $10,000,000.00 should be filed directly with the GAO in following the procedures at FAR 33.104.

In accordance with FAR 16.505(b)(5), CDC has designated an agency Task/Delivery Order Ombudsman who is responsible for reviewing the complaints from contractors on the task/delivery order process. The Ombudsman's responsibility is to review complaints and ensure that all contractors are afforded a fair opportunity to be considered, consistent with procedures in the contract. The Contract Ombudsman is independent of the contracting office. The process for handling complaints under the Ombudsman is as follows:

(a) The written complaint must include all the information required for agency protests in FAR 33.103 and must be sent to:

Centers for Disease Control and Prevention Attn: Terrance Perry Agency Ombudsman District @ Chamblee, Bldg. 2877, Mailstop- TW-3 Atlanta, GA 30341 Email: eax4@cdc.gov

Complaints must be submitted to the Agency Ombudsman no later than 10 days after the basis of the protest is known or should have been known, whichever is earlier.

(b) The Ombudsman will contact the complainant by phone, to assure full understanding of the issues raised in the protest. This contact will be made within 2 business days of the receipt of the protests by the Ombudsman. Since there is only one individual serving as the agency Task/Delivery Order Ombudsman, there may be protests received when the Ombudsman is in a travel or leave status. In that instance, the Ombudsman will begin action on the complaint immediately upon return to the office.

CDCH.23 Evaluation of Contractor Performance Utilizing CPARS Aug 2021

In accordance with FAR 42.15, Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Contractor Performance Assessment Reporting System (CPARS). CDC utilizes this web-based system to prepare and report contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

SECTION D – CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS

D-1. VACCINE ORDER LIMITATION CHART

To include NDC

Min. Shelf Life: 12 Months Fed. Excise Tax: N/A Maximum: 50K Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $2.25 per dose Maximum: 6.5M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $3.75 per dose Maximum: 5.38M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $3.00 per dose Maximum: 3.5M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $3.75 per dose Maximum: 7.5M Doses

Minimum. 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $4.50 per dose Maximum: 3M Doses

Minimum. 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 4M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 8.5M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $1.50 per dose Maximum: 100K Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 7.7M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 8M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 9M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $2.25 per dose Maximum: 8M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $3.00 per dose Maximum: 3.4M Doses

Minimum: 10 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 2.5M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 6.5M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 750K Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 125K Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 13M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: N/A Maximum: 350K Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 2.5M Doses

Minimum: 100 Doses

Min. Shelf Life: 12 Months Fed. Excise Tax: $0.75 per dose Maximum: 7M Doses

Minimum: 100 Doses