SOP 11-06 Rev. A SOP, Sales and Marketing Activities Policy I.
CONFIDENTIAL USA CN Effective: Page 1 of 4
Purpose and Foundational Guidance
This policy is intended to provide sales and marketing personnel employed by or otherwise engaged with LDR guidelines with respect to interacting with health care professionals and to supplement LDR’s other compliance policies, procedures, and related initiatives relative to sales and marketing activities. A health care professional (an “HCP”) is any individual involved in the provision of health care services (directly or indirectly) and/or items to patients, and which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe products of LDR. LDR has adopted the AdvaMed Code of Ethics on Interactions with Health Care Professionals (the “Code”); and the Code, along with this policy, will guide LDR sales and marketing personnel in their interactions with HCPs. The foundation of this policy is to preserve the integrity of the physician-patient relationship. This relationship is based on trust—a trust that is fundamental to the patient because it involves trusting the physician to make decisions that are in the best interest of saving and enhancing the patient’s life. It is important for LDR to interact with HCPs, and those interactions can enhance the physician-patient relationship, but appropriate safeguards in this policy and in the Code ensure that the physician-patient relationship is not compromised. II.
Scope
This policy applies to all LDR officers, directors, and employees, as well as its independent agents and distributors (“LDR Personnel”). It shall govern all interactions with HCPs licensed in the United States. III.
Guidelines for Interactions with Health Care Providers
A. LDR Personnel shall not engage in any conduct or provide any inducement to an HCP that is designed or specifically intended to: (a) reward HCPs or others for ordering products from LDR, or (b) induce HCPs or others to order products from, or generate business for, LDR. B. From time-to-time when there are legitimate needs of the company, LDR may contract with HCPs for personal services, such as design, consulting, or clinical work. In such an event, LDR sales personnel shall not be provided with the specifics of the compensation being provided to any HCP. LDR sales personnel may be provided information on the nature of the services being provided by the HCP. In no circumstance will it be appropriate or acceptable for sales personnel to offer or negotiate the terms of any services contract between LDR and an HCP.
SOP 11-06 Rev. A SOP, Sales and Marketing Activities Policy
CONFIDENTIAL USA CN Effective: Page 2 of 4
C. Excepting HCPs licensed in Vermont, LDR Personnel may engage HCPs in business meetings that involve a meal paid for by the LDR Personnel. However, such meals must be modest in value, occasional in nature, held in a location conducive to the furtherance of the business discussion, and attended only by individuals with a legitimate business interest in the meeting. In determining the modest nature of any such meal, geographic factors will be taken into consideration, as will specifics regarding the nature of the business meal and the number of attendees. The meal shall be subordinate in time to the legitimate business being conducted and should never be part of an entertainment or recreational event. HCPs licensed in Vermont may not be provided meals except while performing services on LDR’s behalf pursuant to a services contract. In order to help guide employees and business partners on the limitations of “modest” meals, LDR has set the following meal limits: Breakfast Lunch Dinner
$30 per head $50 per head $140 per head
The dollar limits set forth above include tax, service charges (“tip”), and alcohol but excludes resort fees or other similar ancillary charges. Except in extenuating circumstances and with the approval of the Compliance Committee, LDR will not reimburse employees for amounts above these limitations. Employees or business partners who show a pattern of exceeding these limits shall be subject to disciplinary action, up to and including termination of employment or termination of any contractual relationship, as applicable. D. LDR Personnel shall not pay for entertainment or recreational events for HCPs. All interactions with HCPs by LDR Personnel shall be professional in nature and focused on legitimate business needs of LDR and/or the exchange of medical and scientific information. E. LDR Personnel shall not provide reimbursement for HCPs to attend meetings where Continuing Medical Education (“CME”) credit is provided, regardless of whether LDR is the sponsor of any such meeting; provided, however, that LDR may provide support for thirdparty meetings in accordance with LDR’s policies related thereto. F. LDR Personnel shall abide by all LDR policies and procedures relating to LDRsponsored sales and promotional meetings and LDR-sponsored training and education meetings as same relate to interactions with HCPs. G. LDR Personnel shall comply with all LDR policies and procedures regarding compliance training, including without limitation, training regarding the health care fraud and
SOP 11-06 Rev. A SOP, Sales and Marketing Activities Policy
CONFIDENTIAL USA CN Effective: Page 3 of 4
abuse laws, internal LDR compliance policies, procedures, and initiatives, and LDR’s Code of Conduct. H. LDR Personnel shall comply with all regulatory and related requirements as they relate to LDR products, including without limitation in the creation and dissemination of marketing materials and other publications. All such materials and publications shall be approved by all appropriate LDR Personnel before dissemination, which personnel necessarily include the LDR regulatory, clinical, and legal departments. I. LDR Personnel shall not provide gifts or other things of value to any HCP without approval of the Compliance Officer. All gifts shall have educational value and a fair market value of $100 or less, excepting anatomical models and textbooks, which may be more than $100. Non-educational branded items such as pens, mugs, and pads of paper are never permitted. Prohibited gifts include gifts provided to celebrate life events or holidays such as flowers, wine, and fruit baskets. J. Without the approval of the Compliance Officer, neither LDR nor LDR Personnel shall provide donations to a charitable organization at the request of an HCP. In addition, without the approval of the Compliance Officer, neither LDR nor LDR Personnel shall provide donations to a charitable organization with whom an HCP or an HCP’s family member is involved as an officer, member of the board of directors, or advisory board. K. LDR Personnel shall only make representations to HCPs or others regarding LDR products that are true and accurate. Additionally, all representations made to HCPs regarding the use of LDR products shall be consistent with and limited to those applications for which each LDR product is cleared or approved. LDR Personnel shall not engage in discussions of off-label usage of any LDR product with any HCP. L. LDR Personnel shall promptly report any product failure or related issues to LDR’s quality department or other appropriate personnel and shall endeavor to assist in the investigation, if requested, of any such product issue. M. Violations of this Policy shall be promptly reported to the Compliance Officer, or, as an alternative, by calling LDR’s Compliance Hotline 1-877-207-9730 or via the internet at https://ldr.alertline.com. N. Any violation of this policy or any federal health care program requirement, rule, regulation, or guideline by any LDR Personnel shall result in disciplinary action including, without limitation, the possibility of termination.
SOP 11-06 Rev. A SOP, Sales and Marketing Activities Policy
CONFIDENTIAL USA CN Effective: Page 4 of 4
ANY FAILURE TO COMPLY WITH THIS POLICY OR ITS SUPPORTING POLICIES WILL BE FULLY INVESTIGATED AND APPROPRIATE ACTION TAKEN. THIS MAY INCLUDE RE-TRAINING, DISCIPLINE, OR OTHER CORRECTIVE ACTION, UP TO AND INCLUDING TERMINATION OF EMPLOYMENT, OR TERMINATION OF A CONTRACT OR BUSINESS RELATIONSHIP WITH LDR BUSINESS ASSOCIATES, DEPENDING ON THE CIRCUMSTANCE.
