A19 - Attachment 1 - ADR Agreement.docx
DOCX document 23 KB Posted
- Attached to
- Vaccines for Adults FY26-27
- Solicitation number
- 75D30126R73406
About this file
This is an Authorized Distributor of Record (ADR) Agreement template establishing the legal framework for the relationship between a vaccine manufacturer/supplier and the Centers for Disease Control and Prevention (CDC). The agreement designates the CDC as an ADR in compliance with the Prescription Drug Marketing Act (PDMA) of 1988 and implementing regulations under 21 CFR Part 203. The agreement requires the supplier to identify either that the CDC is an ADR for the manufacturer's entire product line or to provide a list of specific products (identified by pharmaceutical/vaccine name, dosage form, strength, and NDC number) for which the CDC holds ADR status.
The agreement remains valid from the date of dual execution until termination by either party with ninety days' written notice. It is explicitly limited to establishing an ongoing distribution relationship and does not constitute a sales agreement or alter any pre-existing or future distribution agreements between the parties. The CDC is identified as the Authorized Distributor of Record, and the agreement requires authorized signatures from both the CDC Contracting Officer and the Manufacturer/Supplier, along with printed names and dates. This template is intended for use in connection with the CDC's procurement of adult vaccines under the Section 317 immunization program for state and local health departments.
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Other files
| File | Type | Posted |
|---|---|---|
| A19 - Attachment 2 - List of Products.docx | DOCX document | |
| A19 - 75D30126R73406 Adult Vaccine Solicitation Pg 2-34.docx | DOCX document | |
| A19 - 75D30126R73406 - 1449 Solicitation Cover Page.pdf |
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Text version
Attachment D-1:
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: ______________
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