A19 Authorized Distributor of Record (ADR) Agreement.docx

DOCX document 23 KB Posted

Attached to
FY25 Vaccines for Children Federal contract opportunity
Solicitation number
75D30125R00065
Issued by
Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

About this file

This is an Authorized Distributor of Record (ADR) Agreement that establishes the Centers for Disease Control and Prevention (CDC) as an authorized distributor under the Prescription Drug Marketing Act (PDMA) of 1988. The agreement allows CDC to distribute either a manufacturer's entire product line or specific products listed in Attachment A-1, which includes vaccines identified by name, dosage form, strength, and NDC number.

The agreement is related to solicitation 75D30125R00065 for the FY25 Vaccines for Children (VFC) program, which provides pediatric vaccines to eligible children 18 years or younger who are Medicaid-eligible, uninsured, American Indian/Alaska native, or have insurance that doesn't cover vaccines when receiving immunizations at qualified health centers. The program enables CDC to purchase vaccines at below-market prices from manufacturers, who must meet the definition under 42 U.S.C. 1396s as entities that manufacture, import, process, or distribute pediatric vaccines.

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Other files for this federal contract opportunity

Other files attached to FY25 Vaccines for Children, newest first.
File Type Posted
A19 Solicitation - 75D30125R00065.pdf PDF
A19 Solicitation - 75D30125R00065.pdf PDF
A19 Vaccine Order Limitation Chart.docx DOCX document
A19 Solicitation - 75D30125R00065.pdf PDF

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Text version

Attachment 2: 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 A-1.

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: David Dombeck, 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

File details come from the government source that posted it. Updated .