RESPONSIBILITY

Grants


Thank you for your interest in US WorldMeds. As part of our goal to positively change lives through improved healthcare, we are strongly committed to supporting independent medical education activities. The guidelines below have been developed to assist you in preparing medical education grant requests. We look forward to reviewing your application.

If you have questions regarding funding for medical fellowships/scholarships or Investigator-Initiated Trials (IITs), please first contact our Medical Affairs Department at grants@usworldmeds.com

General Guidelines for Medical Education Grant Requests

Support by US WorldMeds of independent medical education activities is limited to only those that fall within the company's specific areas of therapeutic focus:

  • Treatment of motor fluctuations in advanced Parkinson's disease
  • Treatment of non-motor symptoms of Parkinson's disease
  • Botulinum toxin in the use of cervical dystonia, movement disorders, and other areas of unmet need
  • Education on substance use/abuse disorders

Please check back periodically for any updates to current areas of therapeutic focus.

Only fully-completed medical education grant applications will be reviewed, and completing the application does not guarantee approval nor financial support in the entire amount being requested.

The contact person at the requesting organization will be notified within 3 months of receipt of the application with the approval or denial status. Therefore, it is recommended that funding requests be submitted at least 3 months prior to the date of the event, as applicable, to ensure sufficient time for internal review.

If US WorldMeds is able to provide funding for the medical education activity, a Letter of Agreement (provided by US WorldMeds) must be signed by US WorldMeds and the Medical Education Provider.

Any activity for which a grant is awarded is required to be compliant with and adhere to federal and state guidelines and regulations, including, but not limited to, the FDA Final Guidance on Industry-Supported Scientific and Educational Activities, the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, the American Medical Association (AMA) Ethical Guidelines for Gifts to Physicians from Industry, and the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals, where applicable.

All grants are awarded at US WorldMeds' sole discretion. Approval of grant funding is never related to or conditioned upon past prescriptions or purchases of US WorldMeds' products. US WorldMeds does not offer or provide medical education grants to encourage or to reward the prescription, purchase, ordering, or recommending of US WorldMeds products.

Medical Education Grant Request Applications

The completed medical education grant request application should be sent electronically to our Medical Affairs Department at grants@usworldmeds.com A full description of all necessary documents is outlined in the Guidelines for Medical Education Grant Requests.

Contact Information

If you have any questions regarding independent medical education grants, or if you are interested in funding for medical fellowships/scholarships or Investigator-Initiated Trials (IITs), please contact our Medical Affairs Department at grants@usworldmeds.com


Code of Conduct


We expect the best from our people conducting business with, or on behalf of, US WorldMeds. US WorldMeds' drive for excellence begins and ends with a commitment to ethical conduct and compliance with law.

The environment in which US WorldMeds 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 US WorldMeds Code of Conduct ("Code") contains principles and standards to guide our business behavior. Irrespective of any other changes in our business, US WorldMeds 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 US WorldMeds you may contact our Manager, Human Resources.


Comprehensive Compliance Program

(Effective July 1, 2017)

Introduction

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 Compliance Program as a central component of our commitment to high standards of corporate conduct.

Compliance Officer

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 Program

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 the 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 has been codified by state law. 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, 2017
To obtain a copy of this written declaration please email compliance@usworldmeds.com or call toll-free, 1-855-247-7800.