Solicitation - 75D30125R00116 - COVID 19 Pediatric.docx

Supplies or Services and Prices/Cost Section B

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.

CDC seeks to award contracts for all U.S-licensed or authorized COVID-19 brands with a pediatric indication. 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. 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 16.505(a)(6), orders under an IDIQ may be placed using any medium specified in the contract as long as it addresses the requirements of 16.505(a)(7). Delivery Orders for vaccines shall be placed by Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC) in the Vaccine Tracking System (VTrckS). A formal request for delivery order proposal will not occur at the delivery order level or issued on an OF347.

75D30125R00116

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

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

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

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

B.5. Vaccine Order Chart:

Please see the vaccines order limitations chart in section J.

CLIN

This requirement is for the award of one or more indefinite delivery / indefinite quantity contract(s) to purchase COVID-19 Pediatric Vaccines.

Product Product Service Code: 6505 Is Performance Based Payment: No

1.0

Each

Notes

1. Proposed Quantity and Presentation: Offerors may propose any number of vaccines or presentations of Emergency Use Authorizations (EUA) and/or Biologics License Application (BLA) COVID-19 vaccines indicated for children 0 through 18 years of age.

Description/Specifications/Statement of Work

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 shall begin on the date of award and shall end 12 months later (CDC will provide 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 For refrigerated and frozen vaccines, 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 Aurora, CO, and Clermont, KY.

For ultra-cold vaccines, the contractor shall provide delivery options for both of the following:

(1) bulk delivery of vaccines F.O.B. destination, as directed by delivery orders to the CDC centralized distribution locations currently in Olive Branch, MS, and Aurora, CO, and/or Clermont, KY; and

(2) drop ship delivery of vaccines F.O.B. destination as directed by delivery orders to provider locations.

In addition, vaccine stockpile order(s) shall be delivered to additional location(s) 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/Authorization

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

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

c. The Contractor shall advise the Contracting Officer immediately of any relocation of his prime manufacturing facility or the relocation of any subcontractor’s facility, and if at any time during the life of the contract, the item listed under this contract fails to meet 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, (i.e., 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.12, Contractor’s Ordering/Payment Address, and shall contain the following minimum information:

1. Date of order;

2. Contract number and order number;

3. Item description, quantity and unit price;

4. Delivery or performance date;

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

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

7. Accounting and appropriation data;

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

9. Any other pertinent data.

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

C.9. Delivery Order Limitations

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

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

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) and other required data. 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. COVID-19 vaccine only, except in the event of an emergency when it is necessary to ship other vaccines together with COVID-19 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. Method of Payment

a. Federal Government:

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

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

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

b. Awardees: By check

c. Vendor: Refunds for CDC shall be submitted as an ACH or credit card payment via Treasury’s Pay.Gov.

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 (FET); 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.14 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. 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.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(c), Changes, the parties hereby agree that modifications for funding and other administrative changes (e.g., changes to CDC accounting data) that do not affect the terms and conditions of the contract may be made unilaterally by the CDC.

C.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:

· 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.

NDC (5-4-2

format)

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 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.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 in Section D 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/Authorization

Manufacturers who receive a new FDA product license/authorization 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/authorized products added to this contract must comply with Clause C.30. 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.30. Price Changes, below.

CDC is only able to contract for COVD-19 vaccines that have a Biologic License Application (BLA) approval or an Emergency Use Authorization (EUA) 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/EUA are anticipated to not be the same products that manufacturers will offer for the 2025-2026 season and that CDC awardees will order. Product changes between contract award and the start of awardee ordering 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 approved by the ACIP for inclusion in the VFC Formulary, 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 current, recommended COVID-19 vaccines for the 2025-2026 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 the seasons following commercialization of COVID-19 vaccines. 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.

Inspection and Acceptance FAR Clauses Incorporated by Reference

Date

Deliveries or Performance Destination

CLIN Delivery Schedule Ship To Address

FoB Details

0001 1.0 Each Delivery Period

01 JUN 2025

31 MAY

Ship To McKesson Specialty Distribution 8745 Forest Hill Irene Rd Olive Branch, MS 38654 United States

FAR Clauses Incorporated by Reference

Date

Contract Administration Data FAR Clauses Incorporated by Full Text

52.216-32 | Task-Order and Delivery-Order Ombudsman. Sep 2019 52.216-32 Task-Order and Delivery-Order Ombudsman.

As prescribed in 16.506(j), insert the following clause:

TASK-ORDER AND DELIVERY-ORDER OMBUDSMAN (SEPT 2019)

(a) In accordance with 41 U.S.C. 4106(g), the Agency has designated the following task-order and delivery-order Ombudsman for this contract. The Ombudsman must review complaints from the Contractor concerning all task-order and delivery-order actions for this contract and ensure the Contractor is afforded a fair opportunity for consideration in the award of orders, consistent with the procedures in the contract.See CDC clause CDC0_H046 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 CDCG.01 | Invoice Submission Mar 2021

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 liew 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.

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

Special Contract Requirements Additional Regulation or Supplement Clauses Incorporated by Full Text 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: Kem Williams, Agency Ombudsman District @ Chamblee, Bldg 2877, Mailstop-TW-3 Atlanta, GA 30341 Email: knw9@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.

Contract Clauses Amendment to Clause:

Paragraph (c) of 52.212-4, Changes:

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

FAR Clauses Incorporated by Reference

Date

Content Paper.

May 2011

and Video Services or Equipment.

Nov 2021

Responsibility Matters Oct 2018

Additional Regulation or Supplement Clauses Incorporated by ReferenceNumber Title Effective Date 352.203-70 | Anti-Lobbying Dec 2015 352.232-71 | Electronic submission of payment requests Dec 2015

FAR Clauses Incorporated by Full Text

52.212-5 DEV | Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services JAN 2025 DEVIATION FEB 2025 (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

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

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

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

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

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

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

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

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

[Contracting Officer check as appropriate.]

X(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) (41 U.S.C. 4704 and 10 U.S. C. 4655).

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

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

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

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

(6) [Reserved].

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

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

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

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

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

(ii) Alternate I (DEC 2023) of 52.204-30.

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

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

(14) [Reserved].

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

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

(17) [Reserved]

(18) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

(ii) Alternate I (MAR 2020) of 52.219-6.

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

(ii) Alternate I (MAR 2020) of 52.219-7.

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

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

(ii) Alternate I (NOV 2016) of 52.219-9.

X(iii) Alternate II (NOV 2016) of 52.219-9.

(iv) Alternate III (JUN 2020) of 52.219-9.

(v) Alternate IV (JAN 2025) of 52.219-9.

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

(ii) Alternate I (MAR 2020) of 52.219-13.

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

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

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

X (26) (i) 52.219-28, Postaward Small Business Program Rerepresentation (JAN 2025) (15 U.S.C. 632(a)(2)).

(ii) Alternate I (MAR 2020) of 52.219-28.

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

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

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

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

X (31) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

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

(33) [Reserved]

(34) [Reserved]

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

(ii) Alternate I (JUL 2014) of 52.222-35.

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

(ii) Alternate I (JUL 2014) of 52.222-36.

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

X(38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

(E.O. 13496).

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

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

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

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

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

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

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

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

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

(46) 52.223-23, Sustainable Products and Services (MAY 2024)(DEVIATION FEB 2025)(7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

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

(ii) Alternate I (JAN 2017) of 52.224-3.

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

(ii) Alternate I (OCT 2022) of 52.225-1.

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

(ii) Alternate I [Reserved].

(iii) Alternate II (JAN 2025) of 52.225-3.

(iv) Alternate III (FEB 2024) of 52.225-3.

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

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