US WorldMeds, LLC ("US WorldMeds"), and its wholly-owned subsidiary, Solstice Neurosciences, LLC ("Solstice"), is a specialty biopharmaceutical company focused on the development, manufacture, sales and marketing of specialty biopharmaceutical products. US WorldMeds and Solstice employees are committed to applying ethical standards in our dealings with patients, physicians and the community-at-large. As such, US WorldMeds has developed a comprehensive Compliance Program as a central component of our commitment to high standards of corporate conduct.
US WorldMeds' 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 Plan
The primary purpose of the US WorldMeds 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 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 US WorldMeds' expectation that its employees will comply with the Compliance Program.
US WorldMeds has developed a Code of Conduct, as well as additional policies that have been established in support of that Code of Conduct. The Code of Conduct applies to all US WorldMeds and affiliated company employees. While US WorldMeds is not a member of the Pharmaceutical and Research Manufacturers of America ("PhRMA"), US WorldMeds has adopted and does adhere to the tenets of the PhRMA Code on Interactions with Healthcare Professionals (the "PhRMA Code") in the states where it is required. All of US WorldMeds' 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.
US WorldMeds 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 US WorldMeds. Employees may report their concerns either anonymously or directly to the Compliance Officer, any manager, or the Human Resources Department.
In the event that US WorldMeds becomes aware of a violation of law, regulation, or company policy, US WorldMeds 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, US WorldMeds has tailored its Compliance Program to fit its unique environment and size. Additionally, the US WorldMeds 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
US WorldMeds 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.
California Senate Bill No. 1765 Declaration
As part of our ongoing efforts in the area of compliance, US WorldMeds 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, US WorldMeds is not asserting or making any representation that every employee, agent, contractor or partner will always fully comply with its Compliance Program or that US WorldMeds 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 US WorldMeds' knowledge, US WorldMeds 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. US WorldMeds will assess its program as often as necessary, but at least once each year.
US WorldMeds, LLC
Amy Yuda, Compliance Officer
July 1, 2016
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