Form 1 DRAFT PPA Addendum (FINAL REVISED)

Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau

OMB No. 0915-0327; Expiration Date: XX/XX/20XX

Pharmaceutical Pricing Agreement

ADDENDUM

Between

The secretary of health and human services

(hereinafter referred to as the “Secretary”)

and

The Manufacturer

Identified in “Signatures” Section of this Addendum

(hereinafter referred to as the “Manufacturer”)

This is an Addendum to the Pharmaceutical Pricing Agreement (the “Agreement”) between the Secretary and the Manufacturer. The following terms are hereby incorporated as part of the Agreement:

1. Manufacturer shall furnish the Secretary with reports, on a quarterly basis, that include the price of each covered outpatient drug that is subject to the Agreement, that according to the manufacturer, represents the maximum price that covered entities may permissibly be required to pay for the drug (referred to in this addendum as the “ceiling price”).

2. Manufacturer shall offer each covered entity covered outpatient drugs for purchase at or below the applicable ceiling price, if such drug is made available to any other purchaser at any price.

Signatures

FOR THE SECRETARY OF HEALTH AND HUMAN SERVICES

By: _____________________________________ Date: ___________

Title: Associate Administrator, Healthcare Systems Bureau

Health Resources and Services Administration

ACCEPTED FOR THE MANUFACTURER

By: __________________________________ Date: ___________ (Signature)

Printed Name: ___________________________ Title: ________________________

Phone Number: _________________________ Email Address: ______________________

Name of Manufacturer: ______________________________________________________

Manufacturer Address: ______________________________________________________

______________________________________________________

______________________________________________________

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-0327. Public reporting burden for this collection of information is estimated to average 0.5 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10C-03I, Rockville, Maryland, 20857.