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
USWM, LLC, is a specialty biopharmaceutical company focused on the development, manufacture, sales and marketing of specialty biopharmaceutical products. US WorldMeds 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.
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.
Michael Brown, Compliance Officer
July 1, 2021
To obtain a copy of this written declaration please email firstname.lastname@example.org or call toll-free, 1-855-247-7800.
USWM, LLC FCOI Policy
Version Date: 12 November 2021
APPLIES TO: All USWM employees and External Partners involved in the design, conduct or reporting of PHS Funded Research programs for which USWM is the recipient Institution.
PURPOSE: Under this policy, USWM (the “Institution”) strives to ensure that all work performed under Government Awards meets the highest standard of integrity and is free of any real or perceived conflicts of interest that could bias the design, conduct or reporting of research. As USWM must comply with government regulations when making expenditures with Government Awards, this policy governs the disclosure of individual financial interests and the management and reporting of individual financial conflicts of interest in Government Awards, specifically PHS Funded Research. It is intended to comply with the requirements of federal regulations, including , but not limited to, the conflict of interest regulations of the U.S. Department of Health and Human Services Public Health Service (“the PHS FCOI Rules”) as found in 42 CFR Part 50 Part F (titled Promoting Objectivity in Research) and 45 CFR Part 94 (titled Responsible Prospective Contractors) and the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of Interest Rules”).
Compliance Officer: The designated Institutional official responsible for managing the conflict of interest process for PHS Funded Research, including solicitation and review of Investigator disclosures of SFIs.
External Partner: Any Investigator, not directly employed by USWM, including individual consultants, subcontractors, or those employed by other Institutions party to PHS Funded Research for which USWM is the award recipient through an agreement with USWM including subrecipients such as consortium members, sub-awardees, vendors, and contractors.
FCOI Management Plan: The document specifying the actions to be taken to manage a Financial Conflict of Interest.
Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of a PHS research study or other government funded project.
Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of USWM, which may include, but is not limited to: research, research consultation, teaching, professional practice, institutional and committee memberships, and service on panels such as Institutional Review Boards, Data and Safety Monitoring Boards, or advisory boards.
Investigator: The project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
PHS Funded Research: PHS funded grants and cost reimbursement contracts including research grants or contracts, and other types of government financial assistance (e.g., cooperative agreements, loans, loan guarantees, property, donated supplies, and direct appropriations) that USWM receives directly from government agencies or indirectly from pass through entities. (PHS Funded Research does not include procurement contracts, payments for health care services provided under government health care programs (e.g., Medicare, Medicaid) or Medical Education and Research Costs (MERC)).
Public Health Service (PHS): a division of the Department of Health and Human Services, consisting of the following agencies: Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).
Relevant Family Members: An Investigator’s spouse, domestic partner, or dependent children.
Remuneration: Salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorships).
Senior/Key Personnel: The PD/PI and any other person identified as senior/key personnel by USWM in the grant application, progress report, or any other report submitted to the PHS by USWM.
Significant Financial Interest (SFI):
- A financial interest consisting of one or more of the following interests of the Investigator or their Relevant Family Member that reasonably appears related to the Investigator’s Institutional Responsibilities: (i) the value of any remuneration received from a public entity in twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000, or when the Investigator or their Relevant Family Member holds any equity interest (e.g., stock, stock option, or other ownership interest): or (ii) the value of any remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or their immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or (iii) intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests.
- Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities. The disclosure will include, at a minimum, the following details (i) the purpose of the trip, (ii) the identity of the sponsor/organizer, (iii) the destination and the (iv) the trip duration. (This disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.)
- A significant financial interest does not include the following:
- Salary, royalties, or other remuneration paid by USWM to the Investigator if the Investigator is currently employed or otherwise appointed by USWM;
- Any ownership interest (e.g., stock, stock options) in USWM held by the Investigator;
- Intellectual property rights assigned to USWM and agreements to share in royalties related to such rights;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; and
- Income from service on advisory committees or review panels for a federal, state, or local government agency, or an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
- For employees of an External Partner of USWM (e.g., a contract research or manufacturing organization, analytical lab, or other specialty service provider under agreement with USWM to perform specific fee for service activities related to PHS funded research), salary, royalties, equity or other remuneration paid by the External Partner to individual employees named as Investigators for USWM’s PHS funded research.
POLICY: It is the policy of USWM to comply with the Financial Conflict of Interest Rules (“FCOI Rules”) to ensure that the work performed for PHS Funded Research is carried out in a manner that is free from any bias which may result from financial conflicts of interest.
The following applies to USWM employee Investigators and External Partner Investigators employed at Institutions without FCOI policies involved in PHS Funded Research for which USWM is the recipient.
The contract between External Partner Investigators and USWM must contain language requiring compliance with USWM’s FCOI Policy .
Disclosure of SFI: Investigators must disclose any Significant Financial Interests (SFI) related to the Investigator’s institutional responsibilities that meet or exceed the regulatory definition of SFI to USWM. Investigators must complete or update a disclosure survey at least annually during the period of the PHS Funded Research award period and must disclose any new SFI’s within thirty days of discovering or acquiring a new SFI. Investigators also must ensure that the disclosure survey is completed or updated no later than the time of application for an initial PHS Funded Research project. If USWM determines that an SFI constitutes a Financial Conflict of Interest (“FCOI”), USWM will establish and monitor an FCOI Management Plan (“FMP”) to manage or eliminate the conflict of interest. The USWM Compliance Officer will be the designated official responsible for managing the conflict of interest process for PHS Funded Research. No PHS Funded Research funds may be expended unless the Compliance Officer has determined that no FCOI exists or that any FCOI is manageable in accordance with the terms of an FMP that has been adopted and implemented in accordance with the procedures set forth in this policy.
Duty to Cooperate: If the Compliance Officer requests additional information from an Investigator to assess whether a SFI constitutes a Financial Conflict of Interest, (including but not limited to documents relating to the SFI), the Investigator must cooperate with the request. If a FMP is implemented in connection with a SFI, the Investigator must comply with the FMP. Compliance with the requirements of this policy is a condition of employment with USWM for employed Investigators and a condition of participating in PHS Funded Research projects as an External Partner. Failure to comply may result in appropriate sanctions.
Training: All Investigators will be informed of the Institution’s FCOI policy, the Investigator’s disclosure responsibilities, and the applicable federal regulations upon becoming an Investigator for USWM. Investigators will be required to complete FCOI training (i) prior to engaging in research related to PHS Funded Research, (ii) when this policy is revised to alter the responsibilities of an Investigator; (iii) at least every four years; and (v) if an Investigator is found to be not in compliance with the policy or management plan.
FCOI training can either be completed using the NIH FCOI tutorial at: grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm or CITI COI training found at: about.citiprogram.org/en/homepage/ .
FCOI training must be documented by submitting a valid certificate from the listed online programs to the USWM Compliance Officer at email@example.com.
The following applies to External Partner Investigators employed by Institutions with their own FCOI policies:
Any individual or organization acting as a consultant, subcontractor, or subrecipient (“External Partner”) to USWM on a PHS-funded award must either: (1) have a FCOI policy that meets the requirements of the PHS FCOI Rules or (2) follow USWM’s FCOI policy. External Partners with their own policy will certify that (I) their policy meets the requirements of the PHS FCOI Rules and (ii) that the External Partner Investigator is compliant with the Institution’s FCOI policy in response to a written request from the USWM Compliance Officer prior to their inclusion as an Investigator in any application for PHS Funded Research. Upon a PHS Funded Research award and prior to the performance of any services related to PHS Funded Research, the External Partner Investigator’s contract with USWM will be executed with language requiring compliance with the External Partner Institution’s FCOI Policy, including, without limitation, timely reporting of FCOI in order for USWM to meet its FCOI reporting obligations to the PHS awarding entity, and the requirement of the Institution to cooperate with USWM to develop or oversee an FMP when determined necessary.
PUBLIC POSTING OF POLICY and FCOIs: Information concerning identified FCOIs held by Senior/Key personnel will be made publicly accessible. The publicly accessible information will be updated at least annually, within 60 days of a newly identified FCOI, and will remain available for three years from the date the information was most recently updated.
REPORTING OF FCOI: Before the expenditure of any funds under a PHS-funded project and within sixty days of subsequently identifying a Financial Conflict of Interest, the Compliance Officer will report all Financial Conflicts of Interest that have not been eliminated to the PHS awarding component and will ensure that an appropriate FMP has been implemented. The report will include the elements required under the PHS FCOI Rules. For subsequently identified FCOI’s, the Compliance Officer will conduct a retrospective review to determine whether the PHS funded project was affected by the financial conflict of interest, and if bias is found, will submit a mitigation report to the PHS awarding component. The Compliance Officer also will provide an annual FCOI report that addresses the status of any previously reported FCOIs and FMPs related to an ongoing PHS-funded project.
- Before the application for any PHS Funded Research, Investigators must have on file with USWM 1) a valid FCOI training certificate with USWM or written confirmation that the Investigator's Institution has an FCOI policy which complies with the FCOI Rules and 2) a disclosure of Significant Financial Interests.
- Prior to expenditure of funds for the PHS Funded Research, the Compliance Officer will (i) review all Investigator SFI disclosures; (ii) collect additional information from the disclosing individual and/or from other individuals who possess relevant information, if necessary, to understand the nature of the SFI, (iii) determine whether the SFI are related to the individual’s research responsibilities at USWM and therefore represent FCOI requiring an FMP. In conducting this review, the Compliance Officer may consider factors such as the value of the SFI, if the SFI could be affected by the PHS-funded research, is an entity whose financial interest could be affected by the PHS-funded research, and/or how the SFI could affect the Investigator's ability to objectively contribute to PHS Funded Research.
- Prior to expenditure of funds for the PHS Funded Research, the Compliance Officer will (i) review all Investigator SFI disclosures; (ii) collect additional information from the disclosing individual and/or from other individuals who possess relevant information, if necessary, to understand the nature of the SFI, (iii) determine whether the SFI are related to the individual’s research responsibilities at USWM and therefore represent FCOI requiring an FMP. In conducting this review, the Compliance Officer may consider factors such as the value of the SFI, if the SFI could be affected by the PHS-funded research, is an entity whose financial interest could be affected by the PHS-funded research, and/or how the SFI could affect the Investigator’s ability to objectively contribute to PHS Funded Research.
- If the Compliance Officer determines that an FCOI exists, the Compliance Officer will:
- prepare the Public Financial Conflict of Interest Disclosure Form, including the following information, for reported FCOIs such that it can be made publicly available upon request:
- Project/Contract number
- Investigator’s name
- Investigator’s title and role with respect to the research project
- Name of the entity in which the relevant SFI is held
- Nature of the relevant SFI (e.g., equity, consulting fees, travel, reimbursement, honoraria, etc.)
- Approximate dollar value of the relevant SFI (dollar ranges are permissible: $5,000-$9,999; $10,000-$19,999; etc.); and
When an Investigator is new to participating in the PHS Funded Research, the above will be completed within 60 days.
- The Compliance Officer will request updated SFI or FCOI disclosures from all Investigators and Subrecipient Institutions, respectively, on an annual basis during the relevant funding period for a PHS Funded Research project. In addition, Investigators are responsible for reporting any new SFIs for themselves and Relevant Family Members, including any sponsored travel (for the Investigator only), within 30 days of acquiring the new SFI or the dates of such travel. In the event of sponsored travel, the Investigator must disclose the purpose of the trip; the name of the entity that paid for the travel; the travel destination; the duration of the trip; the dates of the travel; and if known, the approximate value of the travel.
- The Compliance Officer will review SFI disclosures annually and within 30 days of each new report of SFI. If the Compliance Officer determines a FCOI exists, the steps outlined in item 3 are required.
- Each Investigator under an FMP must comply fully and promptly with the FMP, and each person identified in the FMP as having responsibility for monitoring compliance with the FMP must carefully and fully monitor that compliance.
- The Institution will disclose the FCOI and FMP to the PHS awarding entity (i) before the expenditure of any federal funds; (ii) within 60 days of identification of an Investigator who is newly participating in the project; (iii) within 60 days for new, or newly identified, FCOIs for existing Investigators; (iv) at least annually; and (v) after a retrospective review to update a previously submitted report if new information is discovered following completion of the review.
- USWM will promptly notify the PHS awarding entity if:
- Bias is found with the design, conduct, or reporting of the PHS Funded Research, including a Mitigation Report to explain what actions have been or will be taken to mitigate the effects of bias in accordance the regulation. The report will include the Institution name, name of investigator with the FCOI, nature of the SFI(s), and value of the SFI(s).
- An Investigator fails to comply with the Institution’s FCOI policy or an FCOI management plan appears to have biased the design, conduct, or reporting of the PHS Funded Research. Corrective action will be undertaken by USWM for cases of such noncompliance.
- the date of creation;
- the date of termination or completion of the Government Award and submission of the final expenditure report for the Government Award identified in the disclosure statement; or
- the date of final resolution of any investigation, audit, or similar action involving the records.
FAILURE TO COMPLY: Failure to comply with USWM's FCOI policy includes failing to submit a required disclosure, providing false information, omitting required information, failing to maintain confidentiality, failure to carry out duties prescribed by these policies, and refusal or failure to comply with an FMP adopted under these policies. A failure to comply with these policies may result in a decision by the Compliance Officer to employ any or all of the following disciplinary actions: (1) require retraining on FCOI policies (2) suspend, all or in part, the Investigator’s activities related to PHS Funded Research , (3) require permanent replacement of the non-compliant Investigator's responsibilities for the PHS Funded Research, (4) suspend eligibility of the individual to be included as an Investigator for future USWM PHS Funded Research initiatives, and/or termination of employment. NOTE: In addition, USWM will comply with federal financial conflict of interest requirements regarding non-compliance retrospective review and corrective actions).
If the Institution determines that noncompliance has occurred due to (i) failure of the Investigator to disclose an SFI that is determined to constitute an FCOI; (ii) failure of the Institution to review of manage such an FCOI; or (iii) failure of the Investigator to comply with the financial conflict of interest management plan, the Institution will complete a retrospective review within 120 days of the determination of noncompliance. The retrospective review will document at minimum the following: project number, project title, PD/PI or contact PD/PI , name of Investigator with the FCOI, name of the entity with which the Investigator has an FCOI, reason(s) for the retrospective review, methodology of the retrospective review, findings of the review, and conclusions of the review.
If the Department of Health and Human Services determines that an Institution’s PHS-funded research project involving clinical research intended to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by the Institution as required by the regulations, the Institution shall require the Investigator involved to 1) disclose the FCOI in each public presentation of the results and 2) request an addendum to any previously published presentations.
USWM Compliance Officer
4441 Springdale Drive
Louisville, KY 40241
Payments to Physicians
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:
- Research and Development
HCPs, hospitals, and research institutions collaborate with US WorldMeds and others to research the safety and effectiveness of new medicines and treatment options, develop new uses for existing medicines, and conduct in-depth studies of how medicines may help patients.
- Professional Advising and Consulting
Input, advice, and feedback from HCPs is not only critical to advancing our research and development activities, but also helps us better understand treatment landscapes and the needs of patients and healthcare providers. Consulting relationships help ensure we’re developing medicines that are safe and effective, and that meet the needs of the patients we serve.
- Expert-Led Forums
US WorldMeds engages knowledgeable, experienced HCPs to assist with educating their peers, other professionals, patients, and caregivers about health conditions, treatment landscapes, and, when appropriate, our products.
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, US WorldMeds 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 US WorldMeds' disclosure of payments and transfers of value to HCPs and specific teaching hospitals:
- Go to https://openpaymentsdata.cms.gov
- Click in the “Search Physician, Teaching Hospital, or Company by Name” field
- Type in “USWM, LLC” or any part thereof and click "Search"
- Select “USWM, LLC” by clicking on it in the Search Results
The CMS Search Tool will display a summary of US WorldMeds’ 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.