A19 D-1 ADR Pediatric.docx
DOCX document 17 KB Posted
- Attached to
- FY27-28 Pediatric Flu Vaccines
- Solicitation number
- 75D30126R73518
About this file
This is an Authorized Distributor of Record (ADR) Agreement template establishing the ongoing relationship between a 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 authorized distributor for pharmaceutical and vaccine products, with the manufacturer/supplier required to submit either a complete product line authorization or a specific attachment listing authorized products identified by pharmaceutical/vaccine name, dosage form, strength, and NDC number. The agreement remains valid from the date of dual execution until either party provides ninety (90) days written notice of termination and does not modify, alter, or abridge any pre-existing or future distribution agreements between the parties.
This template is not intended to serve as a sales agreement but rather to formalize the "ongoing relationship" designation required under federal pharmaceutical distribution regulations. Both the CDC Contracting Officer and the Manufacturer/Supplier must execute the agreement by signature, printed name, and date. The agreement requires the signing parties to acknowledge they have read and understand the terms and are duly authorized to bind their respective organizations to the specified requirements for the duration of the agreement.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| A19 - 75D30126R73518 0001 1449 Solicitation Cover Page.pdf | ||
| A19 75D30126R73518 0001 FY27-28 Peditatric Flu Sol..docx | DOCX document | |
| A19 D-3 AI Use Compliance Risk Management Plan.docx | DOCX document | |
| A19 D-4 Public Disclosure and Publication of Vaccine Pricing.docx | DOCX document | |
| A19 75D30126R73518 FY27-28 Peditatric Flu Sol..docx | DOCX document | |
| A19 D-2 List of Products.docx | DOCX document | |
| A19 - 75D30126R73406 - 1449 Solicitation Cover Page 2021 version.pdf |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
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: ______________
File details come from the government source that posted it. Updated .