3. HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION

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1 1. PURPOSE It is the goal of UCB, Inc. (UCB) to ensure that its marketing and promotional activities comply with all applicable state and federal laws. In addition, UCB endeavors to conform to pertinent industry guidance, including the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) Guidance to the pharmaceutical industry, and the Accreditation Council for Continuing Medical Education (ACCME) standards for industry support of continuing medical education. This SOP describes the policies and procedures to be followed in initiating, documenting, and obtaining reimbursement for UCB external promotional peer-to-peer programs conducted by health care professionals (HCPs). 2. SCOPE This SOP applies to all external promotional peer-to-peer programs run by, or on behalf of, any UCB business unit. 3. HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION There are no significant hazards or special instructions relating to the arrangements described that need to be detailed in this SOP. 4. RESPONSIBILITIES Professional Education Oversight of third party vendor contracted with UCB who will provide a centralized electronic system through which all peer-to-peer programs are administered. Administration of promotional peer-to-peer programs in collaboration with contracted third party which can include maintenance of speaker contracts/ training forms/ CVs, approval of the final program expenditures, and other related activities required to align with UCB policies. Reviewing all annual program plans and providing operational feedback. Sales and Other Field Employees Scheduling and executing promotional peer-to-peer programs events in accordance with UCB Compliance policies, which includes collaborating with the contracted third party vendor on selection of an appropriate venue(s), providing approved invitations to prospective attendees, attendee pre- registration, properly documenting all program attendees, submission of required final promotional peer-to-peer program Page 1 of 16

2 documentation, and reporting any non-compliant activity within 48 hours of program completion. Compliance Reviewing promotional peer-to-peer program plans and providing approval. Reviewing speaker payment amounts for alignment with established FMV rates. Reviewing sales representative program evaluation forms for activities that did not meet compliance requirements. Identifying specific policy violations and ensuring appropriate follow-up activity to address the violation. Monitoring a sample of promotional peer-to-peer programs and related program management activities including earnings reviews of speakers. Business Unit Bureau Managers Developing annual promotional peer-to-peer program plans and documenting midyear program revisions. Obtaining review and approvals for all promotional peer-to-peer program plans and revisions from the Business Unit Management team (with corresponding Compliance/Legal support), Compliance, and Professional Education Developing a list of recommended speakers based on pre-determined criteria. Developing compensation rates for each speaker consistent with approved fair market value ranges. Maintaining promotional peer-to-peer program content and ensuring timely training of speakers on the Review Committee approved content Collaborating with third party vendor to manage designated components of the promotional peer-to-peer program processes. Medical Affairs Reviewing and approving the qualifications of nominated speakers. Review Committee Reviewing and approving promotional peer-to-peer program content and related materials. Page 2 of 16

3 5. PROCEDURE 5.1 Key Procedural Points In addition to following the procedures set forth in this SOP, promotional peer-to-peer programs must also comply with all UCB policies and procedures governing the engagement of HCPs. Please refer to SOP/Policy: U.S. Compliance - Engaging HCPs, HCIs, and Patients/Caregivers in Fee For Service Arrangements and U.S. Fair Market Value. All promotional peer-to-peer programs shall promote the business objectives of UCB and shall comply with all applicable laws and regulations. UCB will approve only promotional peer-to-peer programs that have an appropriate business purpose and need. UCB is responsible for the content of promotional peer-to-peer programs. All materials used in association with peer-to-peer programs must be approved by the Review Committee. Therefore, speakers must use only UCB-approved slides which must be provided to and presented by speakers in their entirety. UCB will train speakers on how to appropriately respond to unsolicited off-label questions. Promotional peer-to-peer presentations must be consistent with FDA-approved product labeling, maintain fair balance between information on safety and efficacy, be truthful and non-misleading and avoid comparative claims concerning competing products in the absence of substantiated evidence supporting the comparison. Speaker contracts must be signed prior to a speaker participating in speaker training or any promotional peer-to-peer programs. Promotional peer-to-peer program related documentation will be maintained in a central repository under the direction of Professional Education. 5.2 Procedural Requirements for Promotional Peer-to-peer Program Annual Plans Each Business Unit that intends to conduct promotional peer-to-peer programs will create an annual plan for engagement of HCPs. Each plan will contain, at a minimum, the following information: Business/strategic objectives and targets Corresponding types programs needed to achieve the business objectives (e.g., peer to peer, web conference) Number of promotional peer-to-peer programs planned Page 3 of 16

4 Number of speakers and specialties required to satisfy program needs The methodology for determining the appropriate number of speakers must take into account legitimate business needs, including anticipated budget, minimum number of speaking engagements required per speaker and speaker compensation caps Anticipated budget associated with program for the twelve month period Estimated training dates and training activities Compensation range for speakers based on established criteria Each annual plan will be reviewed by Professional Education and approved by the Compliance Department. Significant Modifications to annual plans must be approved by the Compliance Department Request and Approval of Promotional Peer-to-Peer Program All peer-to-peer program requests must be managed through a centralized electronic system which will be overseen by Professional Education but may be administered by an approved third party vendor. Programs must comply with all requirements identified in this and related UCB policies and procedures. Following approval of the annual plan, sales and other field employees will complete a program request form, or comparable third party vendor substitute, for each proposed promotional peer-to-peer program. The program request form will include the following information: The substantive nature of the program including the program type The proposed promotional peer-to-peer program topic, including planned meals and venue Promotional Peer-to-Peer Program Content The UCB Review Committee must approve all promotional peer-to-peer program content, handouts and visual aids (i.e., slides) that are to be used by a UCB speaker for a program. Promotional peer-to-peer presentations must be consistent with the product labeling, maintain fair balance between information on safety and efficacy, be truthful and non-misleading, and avoid comparative claims concerning competing products in the absence of substantial evidence supporting the comparison. Content should clearly indicate that the program is sponsored by UCB and that the speaker has been compensated by UCB. Appropriate disease state awareness content must be presented in the approved format, with a clear break between the presentation of such disease awareness content and product messages. All disease state awareness material must be Page 4 of 16

5 consistent with the approved indication for the product that is the subject of the promotional peer-to-peer program. Promotional peer-to-peer program content will be developed for attendees who are likely to utilize the UCB product within its approved uses, as opposed to attendees who would be likely to use the product significantly for off-label uses Speaker Selection for Promotional Peer-to-Peer Bureau Generally, speaker recommendations will be solicited not more than twice a year. Business Unit Bureau Manager will develop a list of speakers based on predetermined criteria. Nominated speaker(s) requires review and approval by the Medical Affairs Department before the nominee may be selected to participate in the designated UCB promotional peer-to-peer bureau. Speakers must be selected based on their clinical expertise in a particular therapeutic area and/or product category, public speaking skills and previous public speaking experience. Speakers may not be selected, in whole or in part, based on an explicit or implicit understanding, hope, or desire that they will prescribe, purchase, or recommend UCB products as a result of participation in the speaker training or to reward speakers for past business or recommendations. Promotional speaking opportunities may not be marketed or used as a venue for solicitation of referrals for speakers. Professional Education, in coordination with the third party vendor, will verify the speaker s credentials, exclusions and debarment status and obtain approvals of the speaker s CV. Speaker CVs will be routed to Medical Affairs for approval to ensure that the candidate has the appropriate scientific and medical qualifications to deliver the promotional peer-to-peer presentation. A W-9 form will be obtained to report compensation. A background check will be completed to ensure that a candidate is not included on an exclusion or debarment listing. Each speaker must sign a contract using the UCB legally approved template inclusive of all compensation rates. Any changes to the contract language must be reviewed and approved by the Legal Department. Professional Education must receive a signed contract from the speaker before he or she may participate in a UCB speaker training program. Upon approval of a candidate and collection of required documentation, selected speakers must complete a UCB speaker training program (refer to SOP Promotional Peer-to-Peer Speaker Bureau Training) before being included in the bureau. Page 5 of 16

6 The size of the speaker bureau for a product s promotional peer-to-peer program should not exceed the number reasonably needed to conduct the planned number of programs. Annually, or more often if required, speaker utilization will be reviewed to ensure that the appropriate number of speakers are active in the bureau and that each speaker is fulfilling the minimum number of programs to remain an active speaker.. Speakers that do not meet the minimum program requirements will be removed from the program, unless an exception request approved by UCB Compliance. The Business Unit Bureau Managers have discretion in purging speakers based on other criteria (e.g., poor presentation skills, lack of availability, changing business needs). Professional Education will be notified of all changes to the promotional peer-topeer speaker bureau. Speakers not meeting contract requirements lose eligibility for contracting for one year, unless UCB Compliance exception request is granted Speaker Responsibilities Each speaker will be appropriately trained on the program content and their individual responsibilities as a UCB promotional speaker. Training must be completed before a speaker engages in a promotional peer-to-peer program for UCB. Speakers must disclose that they are a paid speaker for UCB and are speaking on behalf of the Company. Speakers are responsible for ensuring that approved indications and all necessary safety and risk information included in materials is appropriately presented during the presentations. Product efficacy and safety information must be presented in the same manner and with comparable prominence. Speakers may never proactively provide off-label information. A speaker may answer an unsolicited off-label question only after the conclusion of a program, in a private manner, consistent with current UCB guidance and training. Extensive questions about off-label uses or questions that the speaker cannot answer should be referred to the Medical Affairs Department Written Agreements All speakers must have an executed speaker agreement on file with Professional Education prior to beginning speaker training. All speaker agreements must include the following: the HCP s name; the term/date of the agreement; Page 6 of 16

7 the requirement that the speaker receive training prior to any speaking engagement; a statement that the HCP s participation as a UCB promotional speaker is not intended as an inducement to, and is in no way contingent upon, the health care professional s future use of UCB products; an acknowledgment that the speaker will disclose to the audience UCB s sponsorship of the program; an acknowledgment that the speaker will use only UCB-approved slide decks, outlines, and informational materials as part of any speaking engagement and that representative will make available the FDA-approved prescribing information for all UCB products that are discussed at a promotional peer-topeer program; and an acknowledgment that the content of all presentations will be consistent with the approved labeling for any products discussed at the promotional peer-topeer program. If the Speaker makes any changes to the Legal-approved template speaker agreement, such changes must be reviewed and approved by Legal before agreeing to or executing the agreement Speaker Compensation and Expenses Compensation All compensation paid to speakers should be based on the pre-determined rate structure set forth in UCB s Fair Market Value Analysis. Any deviations from this rate structure must be documented and approved in advance by Compliance. Please refer to Fair Market Value SOP for more information regarding how to comply with this section. Speakers must have a valid and signed speaker contract in order to receive compensation for speaking. UCB will establish an annual calendar year earning cap on speaker compensation which will be included in the annual program plans. Speakers who have reached the annual cap may not be used until the next calendar year. All speaker fees and other forms of payment for promotional peer-to-peer programs must be paid directly to the party who is contracted to render such services for UCB. Payments may not be made to third-party organizations (corporation or charity) as an alternative to paying the speaker directly. In rare cases, a speaker s terms of employment may require that funds be paid to his employer. UCB will consider these on an exception basis and will require written documentation from the speaker and the employer. If accepted, the speaker contract will be jointly executed with the employer. All earnings Page 7 of 16

8 will be tracked to the speaker for earning cap review and transparency reporting. Payments will be monitored by the third party vendor, who will provide notices to Professional Education and the Business Unit Program Manager when a speaker is approaching the cap based on completed and projected programs. Reimbursement for Program Cancellations Live Events No speaker fee will be paid to a speaker for a program cancelled 72 hours (3 business days) or more prior to the previously scheduled program. A speaker fee is payable to the speaker if the program is cancelled by UCB less than 72 hours (3 business days) prior to the previously scheduled program. On-site Electronic Delivery Programs (e.g., typically web-based events) No speaker fee will be paid to a speaker for a program cancelled 36 hours (1.5 business days) or more prior to the previously scheduled program. Speaker fee is payable to the speaker if the program is cancelled by UCB less than 36 hours (1.5 business days) prior to the previously scheduled program. Reimbursement for Travel/Other Expenses UCB may pay for the reasonable travel, lodging, and meal expenses of speakers as set forth in the Policy for Reimbursement included with each speaker contract. UCB will not pay for the travel, incremental lodging, meals, or other expenses of anyone accompanying a speaker. All expenses are considered reportable transactions Program Venues and Expenses Venue for Promotional Peer-to-peer Programs Peer-to-peer programs must be held in locations that are conducive to the business purpose of the meeting. The venue should not be selected based on the existence or quality of amenities, but rather upon proximity to attendees or transportation, quality and cost of meeting rooms and business support, and other business related factors. Resorts or luxury hotels are not appropriate venues. Recreation and entertainment of any type is strictly prohibited in connection with promotional peer-to-peer programs. Page 8 of 16

9 Meals provided in coordination with a promotional peer-to-peer program should be generally modest by local standards by should not exceed the following limits, inclusive of beverage, tax and tips and any other non-overhead fees: Breakfast: $25 per person Lunch: $50 per person Dinner: $125 per person Additional information regarding venue and meals is set forth in the policy Meals and Gifts for Healthcare Professionals and Customers Peer-to-peer Program Execution and Attendance In order to conduct a promotional peer-to-peer program, the sponsoring employee should have confirmed attendance as follows: Live promotional peer-to-peer programs (on-site/off-site): At least two HCPs must be confirmed to be in attendance at least 96 hours (4 business days) prior to the program. If fewer than two HCPs have been confirmed at least 96 hours prior to the program the program must be cancelled and the speaker notified. If two or more HCPs confirmed prior to the 96 hour program window but the actual number in attendance is fewer than expected, a program may still take place with the reduced attendance and confirmed attendees identified on post-event paperwork as a no-show. On-site electronic delivery programs (e.g., typically teleconference, web conference): Based on the program type, at least one HCP must be confirmed in attendance 48 hours prior to the program. The program must be cancelled and the speaker notified if no attendees are confirmed at least 48 hours prior to the program. UCB sales and promotional personnel must use a sign-in sheet at all programs for confirmed or expected attendees. All attendees, inclusive of UCB employees and speaker, are required to sign in upon arrival. Non-electronic attendance forms must be legible when submitted. HCPs are generally allowed to attend up to 2 programs each year for a product presentation unless significant changes/developments occur with the product label and corresponding promotional peer-to-peer program content, in which case, additional invitations may be issued to refresh the HCP s product education. Page 9 of 16

10 Program Management and Evaluations In the event that a speaker presents unapproved content, fails to present the approved content requested by UCB, proactively discusses off-label information about a UCB product, or fails to follow any other applicable policies, the program sponsor (or other Company employee in attendance) must correct such issues during the Program. The sponsoring employee or other UCB representative should address the audience and clarify the approved uses of the product and explain that UCB does not endorse any off-label use. At the conclusion of the program, the program sponsor or other UCB employee should reiterate the speaker s responsibility to remain on-label during the program. The incident must be reported to Compliance. The speaker s failure to comply with UCB policies should be noted in the program evaluation form completed by the UCB representative Program evaluations will be completed by the UCB employee sponsoring the program for each promotional peer-to-peer event.. These evaluations are internal and speaker payments are not dependent on the results of this evaluation. The evaluations are designed to elicit feedback on the overall quality of the program, the presentation by the speaker, compliance concerns and any other information required by the Business Unit. This evaluation will serve as a certification that the program was held in accordance with all applicable company policies and that the speaker remained on-label and appropriately handled any unsolicited requests for off-label information. In the event that an incident is noted, a notice will immediately be sent to Compliance for review and investigation, as appropriate. Evaluations should be monitored by the Product Teams for program effectiveness and for needed follow-up training with HCP speakers on skills, messaging, and/or compliance. Evaluations will be collected, reviewed and retained by the Professional Education office, or with the third party vendor, with all other program related documentation. If evaluations reveal that a speaker has multiple instances of non-compliance despite having received follow-up training, that speaker may not be used in the future. Page 10 of 16

11 Documentation, Record Maintenance and Retention All records, information and deliverables related to this procedure will be retained for a period of six (6) years or longer if required by applicable law, contract or regulatory requirement. Records related to this procedure will be maintained by the activity owner unless otherwise specifically directed by the Legal Department. For GxP records retention refer to Corporate SOP Retention Periods for GxP Records. Promotional peer-to-peer program documentation will be maintained in a central repository by Professional Education. Professional Education, in conjunction with the third party vendor (where applicable), will maintain a system to document and track promotional peer-topeer program,, including receipt of required documentation and payment of fees and expenses. Speaker fees and expenses will be disclosed as required by federal and state law. HCPs may not condition their agreement to speak on UCB s behalf on the nondisclosure of this information. For all promotional peer-to-peer programs, Professional Education will maintain all contracts, evidence of training and CVs from the speaker and ensure that the speaker has been approved by the Medical Affairs Department. The most current version of the consulting agreement template for promotional peer-to-peer programs should be used and will be maintained by the Legal Department Third Party vendors The UCB standard written agreement for third party vendor services will be used to promote consistency between third party vendors who provide services for UCB promotional peer-to-peer programs. Third party vendors will be contractually required to comply with UCB policies, applicable laws and regulations, and industry guidelines (e.g., PhRMA Code), and UCB will retain the right to audit third party vendor performance upon reasonable request and whenever an issue requiring further inquiry is identified. Third party vendors will execute the administration of promotional peer-to-peer programs in accordance with the terms of their contracts and according to UCB procedures. Third party vendors may substitute their own written or electronic forms that comply with the requirements of this procedure following approval by UCB. UCB will be provided access to all systems and vendor forms with a copy of any required documentation to be retained by Professional Education. a) Third Party Vendor Documentation Professional Education will adhere to the following process to document that third party vendors are compliant with relevant UCB SOPs: Page 11 of 16

12 Maintain a system that tracks and ensures that all third party vendors have an agreement with UCB, except where the third party vendor has been contracted by a co-promotion partner. Certify that all required documents (speaker contracts, speaker CV, speaker invoice, and speaker attendee lists) and payment information have been received by UCB. All information relating to each promotional peer-to-peer program, including aggregate financial information must be tracked in order to ensure the Company is able to comply with applicable laws and regulations. This information is reportable to UCB on a periodic basis and upon reasonable demand. Information that must be tracked includes but is not limited to: Speaker name, identifiers Speaker fees and other expenses Attendee names, addresses, degrees, national prescriber identifier number (if applicable) Meal costs Location of program b) Check Disbursement Process Prior to releasing speaker fees for payment, Professional Education, or third party vendor (where applicable), must receive a signed copy of the speaker invoice, which is included on the speaker expense report, to serve as proof of service delivery. c) Compliance Auditing and Monitoring The Compliance Department shall implement monitoring activities to assess compliance with this SOP. Such monitoring activities shall be revised from time to time as determined by the Compliance Department and will include live monitoring of promotional peer-to-peer program events and training exercises. UCB employees and speakers are required to cooperate fully with the Compliance department in all monitoring and auditing activities. 6. ABBREVIATIONS AND DEFINITIONS Abbreviations and definitions, used in this document, are in accordance with the UCB Glossary. To the extent that these definitions differ from those contained in the UCB Glossary, these definitions will take precedence for the purpose of this policy / procedure. 6.1 Abbreviations FDA Food and Drug Administration HCP Health Care Professional CV Curriculum vitae Page 12 of 16

13 6.2 Definitions Fair Market Value Fair Market Value Analysis Health Care Professional Program Sponsor Third Party Vendor The price, expressed in terms of cash equivalents, at which property would change hands between a hypothetical willing and able buyer and a hypothetical willing and able seller, acting at arm s length in an open and unrestricted market, whether neither is under compulsion to buy or sell and when both have reasonable knowledge of the relevant facts. 1 A centrally managed reference tool consisting of pre-determined rates determined by UCB management to represent FMV compensation for certain types of activities performed by HCPs and HCIs for or on behalf of UCB. The rate structure is based on certain factors such as HCP type (i.e., physician or non-physician), specialty (e.g., primary care practitioner, gastroenterologist, rheumatologist), tier type (i.e., KOL or non-kol), service type (e.g., Advisory Boards, Speaker Training, Research), and program length of time. Any person that is a member of the medical, dental, pharmacy or nursing professions or any other person who, in the course of his or her professional activities, may directly or indirectly prescribe, purchase, supply, recommend, administer or arrange for the use of a medicinal product. The UCB employee who organizes a promotional peer-to-peer program. A company/organization contracted with UCB to perform work/services on behalf of UCB. 7. RELATED DOCUMENTS 7.1 Associated Documents N/A 7.2 References gov , U.S. Fair Market Value sop , Retention Periods for GxP Records sop , Promotional Peer-to-peer Speaker Bureau Training Page 13 of 16

14 sop , U.S. Compliance - Engaging HCPs and HCIs in Fee For Service Arrangements American Society of Appraisers Business Valuation Standards Glossary ; Approved June 2005 Copyright 2005, American Society of Appraisers. 8. LIST OF APPENDICES N/A 9. SOP HISTORY Supersedes SOP(s) (SOP number and version) UCBCOM-SOP sop v1.0 sop v2.0 sop v3.0 sop v4.0 sop v5.0 Migration into MIKADO Periodic revision Changes Removed fr-tmpl as an Associated Document. Will be maintained in the Legal dept. Updated due to changing business requirements. Removed last responsibility for Professional Education (no tracking of earnings, done by Compliance) Retired the annual plan review and approval form (sop-af ). Revised 4 th bullet under section to reflect changing speaker responsibilities. Changed cancellation term to 96 hours. Updated the following sections to reflect changes in business requirements: Section 4.0 Requirements, added: third party vendor to Professional Education and Sales and Other Field Employees Section 5.2.1, removed: Earning cap for each speaker and minimum number of programs required. Removed from last paragraph: the Business Unit Management team, Legal and Professional Education before being provided to. Section 5.2.7, added information for Reimbursement for Program Cancellations. Section 5.2.9, modified to reflect current practice. Section (b), removed: a list of attendee printed names and signatures, the program evaluation and. Page 14 of 16

15 Supersedes SOP(s) (SOP number and version) sop v6.0 Changes Changed Title from Promotional Speaker Programs to Section 6.0 updated definition for HCP Replaced speaker with peer-to-peer throughout the document. Page 15 of 16

16 DOCUMENT APPROVAL ELECTRONIC SIGNATURES Signed by Meaning of Signature Server Date (dd-mmm-yyyy HH:mm:ss TZ) GRAVES Mark Subject Matter Expert Approval 14-Aug :23:20 CEST JEFFORDS SCHENCK Jan Author Approval 19-Aug :53:07 CEST HELLING Douglas Legal Approval 21-Aug :19:33 CEST DAVIS Clive Management Approval 22-Aug :02:48 CEST DHALLA Anisa Subject Matter Expert Approval 09-Sep :15:41 CEST Page 16 of 16