Under the Limited Warranty Program, La Jolla Pharmaceutical Company will issue Replacement Product (as defined herein) for qualifying vials of GIAPREZA, so long as the following Terms and Conditions are met:

Program Term
The Limited Warranty Program shall apply to vials of GIAPREZA administered to the patient between May 1, 2019 and September 30, 2019. La Jolla Pharmaceutical Company may extend, shorten, or modify the term of the GIAPREZA Limited Warranty Program at its sole discretion.

GIAPREZA Limited Warranty Program Eligibility
GIAPREZA Limited Warranty Program Eligibility This Limited Warranty Program shall only apply to vials purchased by an inpatient hospital facility (“Hospital”) from an authorized Distributor for GIAPREZA (“Authorized Distributor”). For our current list of Authorized Distributors, please visit GIAPREZA.com/distribution.

To submit a claim seeking Replacement Product, an authorized representative of Hospital must submit the GIAPREZA Limited Warranty Program Return Form to La Jolla Pharmaceutical Company within thirty (30) days from the date on which GIAPREZA was administered. In order to be eligible for Replacement Product, Hospital must certify the following:

• – GIAPREZA must be administered in a United States hospital between May 1, 2019 and September 30, 2019 in adults being treated for septic or other distributive shock;
• – GIAPREZA was administered for an FDA-approved indication, in accordance with the GIAPREZA prescribing information;
• – At the time of initiation of GIAPREZA, the patient received no more than 0.46 mcg/kg/min of norepinephrine equivalent vasopressor(s);
• – The patient did not meet the following clinical measurement: increase in mean arterial pressure (MAP) by 10 mmHg, or reach a MAP of 65mmHg, within the first three hours of GIAPREZA 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;
• – Hospital will not bill the patient, insurer, or any third party for free Replacement Product received under the GIAPREZA Limited Warranty Program; and
• – Hospital has complied with all other Terms and Conditions of the GIAPREZA Limited Warranty Program

Eligibility of the Limited Warranty Program is not contingent on the institution’s volume of purchases, formulary commitment, or any other requirement tied to the volume or value of referrals generated between La Jolla Pharmaceutical Company and Hospital.

Issuance of Replacement Product
Upon receipt of a completed Product Limited Warranty Return Form and verification of eligibility for the Limited Warranty Program, La Jolla Pharmaceutical Company shall issue a vial(s) of the same NDC of GIAPREZA that was originally purchased by Hospital (“Replacement Product”). Replacement Product shall be shipped to Hospital by La Jolla Pharmaceutical Company’s 3PL (Third-party logistics) at no cost. The replacement vial(s) will include an invoice of replacement product at zero cost. La Jolla Pharmaceutical Company reserves the right to review each request on a claim by claim basis and may deny provider any claim for Replacement Product in the event that any of the Terms and Conditions are not met or followed. In addition, La Jolla Pharmaceutical Company may audit Hospital to confirm compliance with these eligibility requirements.

Sole Remedy
La Jolla Pharmaceutical Company will not provide any refund, rebate, cash, or credit to any individual or entity, including Hospital, for any medical, surgical, or Hospital expense incurred by the patient to whom the Product was administered. ISSUANCE OF REPLACEMENT PRODUCT SHALL BE HOSPITAL’S SOLE REMEDY AND THE SOLE LIABILITY OF LA JOLLA PHARMACEUTICAL COMPANY FOR A BREACH OF THE FOREGOING WARRANTY.

Adverse Events
Please report any Adverse Events, Special Situation Report(s), and/or Product Complaints involving GIAPREZA to the La Jolla Pharmaceutical Company Medical Information Contact Center at:

Telephone: 1-800-651-3861
Fax:1-800-705-4959
Email: medicalinformation@ljpc.com.

Alternatively, you may report the Adverse Events, Special Situation Report(s), and/or Product Complaints directly to the FDA by telephone at 1-800-FDA-1088 or via their website www.fda.gov/medwatch.

Compliance with Law
Hospital shall comply with all applicable federal, state, and local laws and regulations governing its activities related to the 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)). Pursuant to the warranty safe harbor to the Anti-Kickback Statute (42 C.F.R. § 1001.952(g)), Hospital acknowledges that it must fully and accurately disclose and report any price reduction on GIAPREZA provided by La Jolla Pharmaceutical Company to Hospital under the Warranty Program in the applicable cost reporting mechanism or claim for payment filed with Medicare, Medicaid, any other federal or state healthcare programs, or as required by private health insurers. Hospital agrees to provide, upon request by the Secretary of the U.S. Department of Health and Human Services, a State agency, or a private insurer, information regarding the Warranty Program and any Replacement Product provided hereunder. 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 Pharmaceutical Company.