GIAPREZA LIMITED WARRANTY PROGRAM TERMS AND CONDITIONS
La Jolla Pharmaceutical Company will replace eligible vials of GIAPREZA free of charge in the event that a patient receiving GIAPREZA does not reach an increase in mean arterial pressure (MAP) of 10 mm Hg, or reach a MAP
of 65 mm Hg, within the ﬁrst three hours of initiation.
This program applies to GIAPREZA vials purchased from an authorized distributor of GIAPREZA (full list of authorized distributors available at https://www.giapreza.com/).
Each replacement requires completion of the GIAPREZA (angiotensin II) Limited Warranty Program Return Form. In order to receive GIAPREZA replacement vials, the hospital must certify the following:
GIAPREZA was administered in a United States hospital between May 1, 2019 and September 30, 2020 in adults being treated for septic or other distributive shock;
The patient receiving GIAPREZA did not reach an increase in MAP of 10 mm Hg, or reach a MAP of 65 mm Hg, within the ﬁrst three hours of initiation;
The healthcare provider overseeing treatment was, at all times, responsible for determining whether a specific treatment, including the administration of GIAPREZA, was medically necessary and clinically appropriate for a particular patient;
The hospital will not bill the patient, insurer, or any third party for vials of GIAPREZA that are replaced under the GIAPREZA (angiotensin II) Limited Warranty Program; and
The hospital has complied with all other Terms and Conditions of the GIAPREZA (angiotensin II) Limited Warranty Program.
Issuance of Replacement Vials
Upon receipt of a completed GIAPREZA (angiotensin II) Limited Warranty Return Form and verification of eligibility for the GIAPREZA (angiotensin II) Limited Warranty Program, La Jolla shall issue a vial of the same NDC of GIAPREZA that was originally purchased by the hospital. The GIAPREZA replacement vials shall be shipped to the hospital by La Jolla’s third-party logistics provider at no cost to the hospital.
The GIAPREZA (angiotensin II) Limited Warranty Program shall apply to vials of GIAPREZA administered between May 1, 2019 and September 30, 2020. La Jolla may extend, shorten, or modify the term of the GIAPREZA Limited Warranty Program any time, for any reason or no reason, at its sole discretion.
You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:
La Jolla Pharmaceutical Company
U.S. Food and Drug Administration
Compliance with Law
The hospital shall comply with all applicable federal, state, and local laws and regulations governing its activities related to the GIAPREZA (angiotensin II) Limited Warranty Program, including without limitation, (i) HIPAA, and state and local privacy and data protection laws; (ii) the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), and analogous state laws; (iii) the Food Drug & Cosmetic Act and regulations promulgated thereunder; and (iv) all Federal healthcare program reporting obligations, including without limitation, the Medicare requirements prohibiting billing for no cost items (42 U.S.C. 1395y(a)(2)). The hospital shall not provide Protected Health Information (PHI), as that term is defined under HIPAA, or information that is considered patient-identifiable under any applicable state laws, to La Jolla.
For questions about the GIAPREZA Limited Warranty Program, please email firstname.lastname@example.org.