We expect the best from our people conducting business with, or on behalf of, HEMA Biologics. HEMA Biologics' drive for excellence begins and ends with a commitment to ethical conduct and compliance with law.
The environment in which HEMA Biologics operates is both highly regulated and demanding. Our commitment as individuals to standards that are ethical and fair provides the basis for dealing with our various constituents: the public, customers, and each other.
The HEMA Biologics Code of Conduct ("Code") contains principles and standards to guide our business behavior. Irrespective of any other changes in our business, HEMA Biologics commits to practice the highest standards of business conduct. The Code of Conduct is intended to assist in the fulfillment of our commitment to integrity and to act as the basic guide to our program of compliance with the laws under which we operate.
Concerns or questions about violations of laws, rules, regulations or the Code should be directed to our compliance hotline, 855-247-7800, or if employed by HEMA Biologics you may contact Human Resources.
HEMA Biologics is a specialty biopharmaceutical company focused on the development, manufacture, sales and marketing of specialty biopharmaceutical products. HEMA Biologics employees are committed to applying ethical standards in our dealings with patients, physicians and the community-at- large. As such, HEMA Biologics has developed a Compliance Program as a central component of our commitment to high standards of corporate conduct.
HEMA Biologics' Compliance Officer is charged with overseeing its Compliance Program. The Compliance Officer has direct access to both the CEO and COO and is charged with developing the standards of conduct issued as part of the Compliance Program, directing auditing and monitoring activities, as appropriate, and implementing corrective measures, as necessary.
Comprehensive Compliance Program
The primary purpose of the HEMA Biologics Compliance Program, and that of its affiliated companies, is to communicate and deploy the standards of ethical conduct and to help detect and prevent violations of applicable laws or company policy. The Compliance Program is based on the OIG Compliance Program Guidance for Pharmaceutical Manufacturers ("OIG Guidance") and will address the specific risk areas identified therein, as well as others identified by the Compliance Officer. However, as the OIG Guidance explicitly recognizes, the implementation of a Compliance Program cannot guarantee that all improper employee conduct will be eliminated. Nonetheless, it is HEMA Biologics' expectation that its employees will comply with the Compliance Program.
HEMA Biologics is not a member of the Pharmaceutical and Research Manufacturers of America ("PhRMA"). However, in the states where the PhRMA code has been codified by state law, HEMA Biologics has adopted and does adhere to the tenets of the PhRMA Code on Interactions of Healthcare Professionals ("PhRMA Code"). HEMA Biologics has developed a Code of Conduct, as well as additional policies that have been established in support of the Code of Conduct. The Code of Conduct applies to all HEMA Biologics and affiliated company employees. All of HEMA Biologics' personnel are expected to adhere to the corporate Code of Conduct, the PhRMA Code in states where it is required, and all other applicable compliance policies.
HEMA Biologics will provide effective compliance training for all of its employees on all elements of the Compliance Program as well as on applicable laws and regulations. In addition, the Company will conduct internal auditing and monitoring as necessary to evaluate compliance with company standards.
It is expected that employees will report any compliance-related concerns. As such, a non-retaliation policy is in effect at HEMA Biologics. Employees may report their concerns either anonymously or directly to the Compliance Officer, any manager, or the Human Resources Department.
In the event that HEMA Biologics becomes aware of a violation of law, regulation, or company policy, HEMA Biologics is committed to investigating the matter, and where appropriate, taking disciplinary action, and implementing corrective measures to prevent further such violations.
In accordance with and as explicitly recognized in the OIG Guidance, HEMA Biologics has tailored its Compliance Program to fit its unique environment and size. Additionally, the HEMA Biologics Compliance Program is a living program, involving regular assessments and adjustments to ensure the Program is responsive to the Company's evolving business and associated compliance risks.
Annual California Spending Limit
HEMA Biologics has established annual spending limits as per California Business and Professional Code §119402(d)(1) for certain promotional activities directed toward healthcare professionals in California. This annual dollar limit is $2,000 excluding reasonable payment and reimbursement for legitimate professional services. Spending limits are established as the maximum boundaries for spending, and do not represent a spending "goal" or "average." In most cases, the Company spends significantly less per California physician than the stated spending limit.
Declaration of Compliance with California Law
As part of our ongoing efforts in the area of compliance, HEMA Biologics has developed a Compliance Program that is reasonably designed to prevent and detect violations of law or company policy. To the best of our knowledge, and based on our good faith understanding of the statutory requirements, we have established a Compliance Program that is compliant with the requirements of Cal. Health & Saf Code §§119400- 119402.
In making this Declaration of compliance, HEMA Biologics is not asserting or making any representation that every employee, agent, contractor or partner will always fully comply with its Compliance Program or that HEMA Biologics can prevent individual employees from engaging in improper conduct. While we are routinely reassessing our Compliance Program to improve it, government standards on compliance programs recognize that no program can completely prevent individual employees from improper conduct.
Based upon our good faith understanding of the statutory requirement, and to the best of HEMA Biologics' knowledge, HEMA Biologics declares that, as of the date of this declaration, we are, in all material respects, in compliance with our Compliance Program, as described here, and with California Health & Safety Code §§119400- 119402.
Ensuring ethical and legal conduct is an ongoing company commitment. The Compliance Program is a program that will continue to evolve to meet the company's compliance needs. HEMA Biologics will assess its program as often as necessary, but at least once each year.
Michael Brown, Compliance Officer
July 1, 2022
To obtain a copy of this written declaration please email [email protected] or call toll-free, 1-855-247-7800.
Why We Work with Healthcare Professionals
Working with healthcare professionals (HCPs) allows us to gather and share critical, real-world information, feedback, and insight. This is essential to fulfilling our commitment to develop, license, and market healthcare products that improve lives.
There are three main ways in which HCPs help us gather and share information:
How We Disclose Payments to Healthcare Professionals
The Physician Payments Sunshine Act (the “Sunshine Act”) was enacted by Congress in 2010 to create more transparency around the relationships between pharmaceutical companies and HCPs in the United States. The Sunshine Act requires companies to report to the federal government certain payments and other “transfers of value” made to HCPs and specific teaching hospitals, and further requires those reports be made available to the public. Even without this requirement, HEMA Biologics is generally committed to transparency around our payments and other "transfers of value" to HCPs.
We believe that the requirements of the Sunshine Act, and the transparency the Sunshine Act has created, helps foster trust with patients, healthcare professionals, and government officials and helps reinforce adherence to high ethical standards throughout the industry.
To view HEMA Biologics' disclosure of payments and transfers of value to HCPs and specific teaching hospitals:
The CMS Search Tool will display a summary of HEMA Biologics’ overall payment information. You will also have the ability to search and view more detailed information for payments made to individual HCPs and/or teaching hospitals.
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