A19 D-1 ADR.docx
DOCX document 17 KB Posted
- Attached to
- FY27-28 Adult Flu Vaccines
- Solicitation number
- 75D30126R73517
About this file
This is an Authorized Distributor of Record (ADR) Agreement template that establishes the formal relationship between a pharmaceutical or vaccine manufacturer/supplier and the Centers for Disease Control and Prevention (CDC) as required 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 the supplier's pharmaceutical products or vaccines.
The agreement requires the supplier to specify which products the CDC is authorized to distribute, either by designating the entire product line or by providing a detailed attachment listing specific products identified by pharmaceutical/vaccine name, dosage form, strength, and NDC number. The agreement remains valid from the date of execution by both parties until terminated by either party with ninety (90) days written notice. The document clarifies that this agreement does not constitute a sales agreement or modify any pre-existing distribution agreements, but rather represents an ongoing relationship as defined in federal regulations. Both the CDC Contracting Officer and the Manufacturer/Supplier must sign the agreement, with each party acknowledging they are duly authorized to bind their respective organizations to the terms outlined.
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Other files
| File | Type | Posted |
|---|---|---|
| A19 - 75D30126R73517 0001 - 1449 Solicitation Cover Page 2021 version.pdf | ||
| A19 75D30126R73517 0001 FY27-28 Adult Flu Sol..docx | DOCX document | |
| A19 D-4 Public Disclosure and Publication of Vaccine Pricing.docx | DOCX document | |
| A19 75D30126R73517 FY27-28 Adult Flu Sol..docx | DOCX document | |
| A19 D-2 List of Products.docx | DOCX document | |
| A19 - 75D30126R73517 - 1449 Solicitation Cover Page 2021 version.pdf | ||
| A19 D-3 AI Use Compliance and Risk Management Plan.docx | DOCX document |
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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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