A19. Attachment 1_ADR Agreement.docx

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Attached to
FY26-27 Adult Covid-19 Vaccines
Solicitation number
75D30126R73405
Issued by

About this file

This document is an Authorized Distributor of Record (ADR) Agreement template establishing the ongoing relationship between a pharmaceutical manufacturer/supplier and the Centers for Disease Control and Prevention (CDC) under the Prescription Drug Marketing Act (PDMA) of 1988 and implementing federal regulations at 21 CFR Part 203. The agreement designates the CDC as an ADR for the manufacturer's products and requires the manufacturer to identify either their entire product line or specific products (identified by pharmaceutical name, dosage form, strength, and NDC number) for which the CDC is authorized to distribute. The agreement remains valid from the date of dual execution until termination by either party with ninety (90) days written notice and does not abridge, modify, or alter any pre-existing or future distribution agreements between the parties.

The agreement confers only the right to designate the CDC as an ADR and is explicitly not a sales agreement or any other agreement type beyond representing an "ongoing relationship" as defined in federal regulations. Both the CDC Contracting Officer and the Manufacturer/Supplier must execute the agreement with authorized signatures. The document includes an attachment (A-1) for listing specific products by item number, product/brand name, and NDC number, with three vaccine products shown as examples in the template. This ADR designation is relevant to the related FY26-27 Adult Covid-19 Vaccines solicitation for which the CDC is procuring vaccines for the National Center for Immunization and Respiratory Disease's immunization awardees across state and local health departments.

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D-1: Authorized Distributor of Record (ADR) Agreement

AUTHORIZED DISTRIBUTOR OF RECORD (ADR) AGREEMENT

This Agreement hereby represents the ongoing relationship between the supplier named below (“MANUFACTURER / SUPPLIER”) and the Centers for Disease Control and Prevention, herein after referred to as CDC, to establish and designate CDC as an Authorized Distributor of Record (ADR) as set forth in the Prescription Drug Marketing Act (PDMA) of 1988 as well as in the implementing federal regulations found at 21 CFR Part 203. CDC hereafter agrees to comply with all applicable state and federal laws to ensure continued status of this relationship. To further meet the requirements of the PDMA, please forward with the signed agreement an attachment with a list of the specific products that CDC is authorized to distribute or a statement that the CDC is an ADR for the manufacturer’s entire product line. Specific products should be identified by the pharmaceutical / vaccine name, dosage form, and strength of the drug and the NDC number.

Check the box that applies:

__ The Distributor is the ADR for Supplier’s entire product line.

__ The Distributor is the ADR for the products listed on the attachment D-2.

This agreement shall be valid from the date of dual execution until termination by either party on ninety (90) days written notice. This agreement shall not abridge, supplant, modify, or in any way alter any other pre-existing distribution agreement or any future agreements that may, from time to time, be executed in the furtherance of the business relationship between Manufacturer/ Supplier and the CDC.

This agreement confers no rights upon CDC other than to designate CDC as an Authorized Distributor of Record for Manufacturer / Supplier. This agreement is not intended to be, nor shall it be, interpreted as a sales agreement or any other type of agreement other than to represent an “ongoing relationship” within the meaning set forth in 21 CFR Part 203.3(u).

By affixing my signature below, I do hereby acknowledge and represent that I have read this Agreement in its entirety, that I understand its terms, that I am duly authorized to bind my organization to the requirements detailed in the above Agreement and that I agree to ensure that my organization will adhere to such requirement for the duration herein stated.

Authorized Distributor of Record: Centers for Disease Control and Prevention (CDC)

Authorized Signature:________________________________________

Print Name: , U.S. Government Contracting Officer

Date: _________________

Manufacturer / Supplier: _____________________________

Authorized Signature: ________________________________

Print Name: ________________________________________

Date: ______________

ATTACHMENT A-1

LIST OF PRODUCTS

Item No.
Product/Brand Name
NDC
1.
Vaccine
xxxxx-xxxx-xx
2.
Vaccine
xxxxx-xxxx-xx
3.
Vaccine
xxxxx-xxxx-xx

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