Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Compliance Declaration

SPECTRUM PHARMACEUTICALS, INC.’S CORPORATE COMPLIANCE PROGRAM

 

INTRODUCTION

 

Spectrum Pharmaceuticals, Inc.’s Corporate Compliance Program is comprised of the following

elements:

I. WRITTEN POLICIES AND PROCEDURES

II. COMPLIANCE OFFICER AND COMPLIANCE COMMITTEE

III. EFFECTIVE TRAINING AND EDUCATION

IV. EFFECTIVE LINES OF COMMUNICATION

V. INTERNAL MONITORING AND AUDITING

VI. DISCIPLINARY GUIDELINES

VII. CORRECTIVE ACTION PROCEDURES

 

POLICIES ON INTERACTIONS WITH
HEALTHCARE PROFESSIONALS IN CALIFORNIA

Consistent with the requirements of California Health & Safety Code §§ 119400‐119402, Spectrum Pharmaceuticals, Inc. has established an aggregate limit on certain promotional expenditures that may be provided to individual medical and healthcare professionals. Spectrum Pharmaceuticals, Inc. is dedicated to enhancing the practice of medicine and patient care, as well as committed to compliance with applicable federal and state laws and regulations.

Spectrum Pharmaceuticals, Inc. has modified certain policies and procedures that regulate interactions with these medical and health care professionals within the State of California and will review and/or revise its policies as it deems appropriate to meet the requirements of the dynamic legal, regulatory, and commercial environments.

Spectrum Pharmaceuticals, Inc. has set the annual aggregate limit on covered promotional expenditures at $1,500 per covered medical or health care professional for annual periods commencing on December 1, 2018. This limit may be revised by Spectrum Pharmaceuticals, Inc. from time to time. The foregoing limit does not represent any usual, customary, average, or typical amount for medical or health care professionals.

Spectrum Pharmaceuticals, Inc. exempts certain expenditures from this limit based upon a good faith understanding of California Health & Safety Code §§ 119400‐119402 and the PhRMA Code. Such exemptions include:

· Financial support for continuing medical education forums;

· Financial support for health educational scholarships;

· Payments made for legitimate professional services provided by a healthcare or medical

· professional that are provided at the fair market value for the services rendered;

· Items of de minimis value and primarily associated with a healthcare or medical professional or patient’s education; and

· Documents, informational or educational brochures, and other items that inform medical or healthcare professionals about Spectrum Pharmaceuticals, Inc. products, provide scientific and educational data, support medical research and education, or enhance a patient’s understanding or management of a disease state or disorder.

 

ANNUAL DECLARATION OF COMPLIANCE WITH
CALIFORNIA HEALTH & SAFETY CODE §§ 119400 – 119402

Spectrum Pharmaceuticals, Inc. declares, to the best of its knowledge and upon a good faith understanding of applicable statutory requirements, that it has adopted a Comprehensive Compliance Program that satisfies the requirements of California Health & Safety Code §§ 119400‐119402. Additionally, Spectrum Pharmaceuticals, Inc. declares, to the best of its knowledge and upon a good faith understanding of applicable statutory requirements, that it is in full compliance with its Comprehensive Compliance Program and annual aggregate limit.

To ensure continued compliance with the requirements of California Health & Safety Code §§ 119400‐119402 and the Spectrum Pharmaceuticals, Inc. Comprehensive Compliance Program, Spectrum Pharmaceuticals, Inc. will review its compliance program at least annually.

A description of Spectrum Pharmaceuticals, Inc.'s Corporate Compliance Program, including the Company's written declaration of compliance with California Health & Safety Code §§ 119400‐119402 and the Spectrum Pharmaceuticals, Inc. Comprehensive Compliance Program, may be requested by emailing compliance@sppirx.com, or calling Spectrum Pharmaceuticals, Inc.'s toll‐free number at 1‐844‐587‐1660.

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Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

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