This FAQ document is intended solely for U.S. Medical Education Grants.

Transcription

1 This FAQ dcument is intended slely fr U.S. Medical Educatin Grants. Changes in UCB US plicy r guidance will be updated in this dcument, s please review it befre each request. Fr infrmatin and assistance navigating the registratin and applicatin screens, please refer t the sftware system instructins/ FAQs at Revised April 2018 UCB cnsiders educatinal grants fr independent accredited and nn-accredited prgrams that fster increased understanding f scientific, clinical, and healthcare issues that cntribute t the enhancement f patient care. All prgrams must be nn-prmtinal in nature and shuld be fcused n healthcare prfessinals, patients, and/r caregivers. UCB requires that educatinal requests be submitted at least 60 days prir t the prgram start date. All funds are paid by electrnic funds transfer nly (n checks). Please review this dcument carefully as it cntains infrmatin and guidance nt cntained within the medical educatin Grant applicatin at The FAQs are divided int the fllwing sectins: General Medical Educatin Grant and UCB Plicy Infrmatin Registratin The Applicatin The Request Prcess Appendix A: UCB s Educatinal Supprt Agreement UCB Medical Educatin Grant FAQs 1

2 General Medical Educatin Grant and UCB Plicy Infrmatin UCB U.S. will cnsider requests that meet the fllwing criteria: Funds must be used t supprt scientific and educatinal activities that fster increased understanding f scientific, clinical, and healthcare issues that cntribute t the enhancement f patient care. T the extent cnsistent with PhRMA Cde guidelines, financial supprt may be cnsidered in supprt f fellws, residents r students t attend certain educatinal r scientific cnferences. Funds may nt be prvided directly t individuals but must be given t an academic r training institutin that independently selects the recipients f funds. UCB Educatinal Grants may nt be used t supprt the general educatinal r research activities f HCPs in training, nr their stipends r salaries. Any meals r refreshments prvided t attendees shuld be mdest and served buffet-style r as a bxed meal. UCB U.S. will generally NOT supprt expenses that include any reprtable transfer f value as defined by the Physician Payment Sunshine Act. What if I plan t pay fr a reprtable item frm a surce ther than the UCB grant? Yu must be specific as t the surce f funding fr all items. Fr example, please specify if attendee meals are paid frm registratin fees r frm the hsting rganizatin s wn funds. It is nt acceptable t indicate that anther cmmercial supprter will pay fr a reprtable item. UCB culd still be respnsible fr partial reprting and will be required t cllect this infrmatin fr a final evaluatin. Hw d I knw if these US FAQs and guidelines pertain t my request? If any f the applicant rganizatins (requesting rganizatin, accredited prvider r payee) is based in the U.S. r the educatinal prgram is t take place in the U.S., yur request must be evaluated by the UCB U.S. ffice and fllw all applicable laws and regulatins. Wh can request an educatinal grant? Independent medical educatin grant requests may be submitted frm rganizatins such as hspitals, medical assciatins/scieties, medical schls, medical educatin cmpanies and patient rganizatins t UCB Medical Educatin Grant FAQs 2

3 supprt scientific and educatinal activities that fster increased understanding f scientific, clinical, and healthcare issues that cntribute t the enhancement f patient care. Grants may nt be prvided t individuals (e.g. healthcare prfessinals) r private practice grups. Educatinal grant funds must be used slely fr legitimate expenses related t the educatin f healthcare prfessinals, patients r caregivers. Des UCB issue Calls fr Grants r Requests fr Prpsals? UCB des ccasinally issue Requests fr Prpsals (RFPs). RFPs will be psted in the Grant sectin at UCB s U.S. Funding page and may be psted t the ACEHP and/r SACME websites as well. Hw is my educatinal grant request evaluated? A cmmittee reviews every request. UCB carefully cnsiders all requests and must chse between many excellent prpsals when selecting prgrams t fund. While UCB wuld like t be able t supprt many mre prgrams, we simply cannt supprt them all. Criteria fr supprt include, but are nt limited t: Educatinal value Alignment with UCB s medical educatin bjectives Target audience Prgram csts Cmpliance with internal and external regulatins Availability f funds Merit f all requests already funded as well as thse under cnsideratin at the time f review Other supprt prvided t an rganizatin Accreditatin status (healthcare prfessinal educatin nly) Overdue recnciliatin and/r refund Can I mdify the Letter f Agreement r prvide my rganizatin s Agreement fr UCB signature? N. UCB will nt sign any Agreement frm yur rganizatin and will nt mdify the UCB Agreement. All grants supprted by UCB must abide by the Agreement issued by UCB. See Appendix A fr the UCB Educatinal Supprt Agreement (als knwn as Letter f Agreement). Hw and when d I receive payment? UCB medical educatin grants are paid by electrnic funds transfer nly (n checks). We will btain r verify the banking details if yur request is apprved. Payment can be expected within apprximately 30 days f receipt r cnfirmatin f the banking details. Hw shuld I acknwledge UCB s supprt fr my prgram? Please acknwledge that the prgram is supprted by UCB, Inc. Nte that accrding ACCME Standards fr Cmmercial Supprt, the acknwledgment f cmmercial supprt cannt cntain the crprate lg f an ACCME-defined cmmercial interest. UCB Medical Educatin Grant FAQs 3

4 What d I d if my prgram has changed? Yu are required t ntify UCB at grants@ucb.cm. This requirement is als utlined in the UCB Agreement. If the change is minr, such as a shrt delay in the launch date r end date f yur prgram, the change may nt necessitate full cmmittee apprval. If the lcatin r scpe f yur prgram has changed frm the riginal request, yur change request will require full cmmittee review and apprval. If changes are significantly different frm the riginal request, yu may be asked t submit a new applicatin. Sufficient time fr UCB review f change requests will vary depending n vlume and the time f year, but we typically require at least 30 days. I have funds left ver after cmpletin f my prgram. May I apply these t anther prgram? N. UCB funds may nly be used fr the specific activity(ies) utlined and apprved in the riginal grant request. Even if the prgram is a recurring ne, funds can nly be used fr the riginal activities during the specified timeframe utlined in the applicatin. This directive is included in the UCB Agreement. Where can I return unused funds? Checks shuld be made ut t UCB r UCB, Inc. and may be mailed t: UCB Grants Office 1950 Lake Park Drive Smyrna, GA S that we are able t credit yur funds crrectly, please include the request ID n the check r accmpanying crrespndence. Registratin Please nte that befre submitting yur first request at everyne must register as a new user. All required fields (fields with an asterisk*) must be cmpleted. Registratin at allws yu t submit funding requests n behalf f an rganizatin. Basic requirements fr registratin include the registrant s cntact infrmatin as well as the rganizatin infrmatin. Additinal details are required during the applicatin prcess and may be different fr each funding type. UCB Medical Educatin Grant FAQs 4

5 Refer t the FAQ Dcument and Request Instructins system-specific dcuments at fr mre infrmatin and assistance navigating the registratin and applicatin screens. The Applicatin All required fields (fields with an asterisk*) must be cmpleted in rder t Submit the request. A minimum f the Request Title field must be cmpleted in rder t Save and cntinue yur applicatin at a later time. Sme applicatin fields cntain help tips. Click n a field heading, and if a help tip exists, it will appear in a bx t the left f the applicatin. Fr example, if yu click n the heading, Request Title, yu will receive the instructin Describe yur request in a few wrds in a bx n the left side f the applicatin. The rganizatin requesting r applying fr funding may be different frm the accredited prvider r the rganizatin t be paid. Yu will have the pprtunity t prvide details regarding the accredited prvider and payee rganizatin, if different. Yu shuld be prepared t enter all cntact persns and rganizatin details, including phne numbers, addresses and VAT r IRS Tax ID numbers, if applicable. Yu are able t view all pages f the applicatin withut cmpletin f the prir page. Fr instance, if yu wuld like t view the fields yu will need t answer in the Activity Details sectin, yu may jump ahead t view that tab withut cmpletin f prir fields/tabs. Additinal infrmatin fr select applicatin fields RFP (Request fr Prpsal) Number This is nly applicable if yu are respnding t a specific RFP. Therapeutic Area and Indicatin(s) - Using the drp dwn menu, select the general therapeutic area (e.g. immunlgy) that best represents the main fcus f yur educatinal activity. The Indicatin field will then display. Yu may select all applicable indicatins. Yu shuld visit UCB s U.S. Funding page t review the therapeutic areas f interest specific t the U.S. prir t submitting yur applicatin. Prgram Start Date - Enter the estimated start date f yur educatinal activity. Prgram End Date - Enter the date yur prgram will be cmpleted, r fr enduring materials, enter the date f expiratin, whichever is the latest date. UCB Medical Educatin Grant FAQs 5

6 Are yu requesting funding frm ther supprters? If yu are requesting funding frm ther pharmaceutical/cmmercial supprters in additin t UCB, please indicate this here. If nt, simply enter n. Learning Objectives and Needs Assessment infrmatin is entered directly int the applicatin frm. Nte that see attached is nt an acceptable entry. Yu will have the pprtunity t uplad supprting dcumentatin later in the applicatin; hwever, supprting dcuments shuld nt serve as a substitute fr the cmpletin f these fields. Intended Educatinal Outcme Level t be Measured Outcmes level expected t be achieved is required fr prfessinal educatin activities in the United States. Levels are based n Mre s utcmes framewrk fr evaluating medical educatin impact. Patient r caregiver educatin des nt require an utcme measurement. Activity Detail Infrmatin This sectin includes infrmatin abut the educatin delivery frmat and intended audience. Yu shuld cmplete the applicatin data fr each type f educatinal prgram included in yur prgram request. The prgram/activity categries are: On-site/in-persn Live activity Live internet activity (such as a live interactive webinar) Enduring internet material Other enduring material (nt delivered via internet) Example: If yu are requesting funding fr a live sympsium and a live webcast, yu shuld cmplete the applicatin fields fr the tw separate frmats, On-site/in-persn Live activity and Live internet activity. Example: If yu are requesting funding fr tw live meetings in tw different cities, yu shuld cmplete the applicatin fields fr tw separate On-site/in-persn Live activity frmats. Yu need t cmplete a line item fr city #1 and its venue and expected audience and anther line item fr city #2 and its venue and expected audience. Budget - The applicatin cntains a detailed line item budget template which shuld be cmpleted fr yur ttal prgram budget. Nte that see attached and uplading a budget dcument is nt acceptable. UCB des nt recmmend that educatinal activities take place at resrts r five star htels. Educatin shuld remain the primary fcus f the prgram, with assciated csts being mdest and reasnable fr the lcatin. Budget - Line Item Optins Management Fees Accunt & Activity Management, Audience Generatin/Activity Marketing, Cntent Develpment, Educatinal Effectiveness Measurements, Peer Review Cst Meeting Lgistics AV/ Equipment Rental & Labr, DDR (Delegate Daily Rate), Meeting Rm(s), Onsite Meeting Supprt, Telecnference Fees UCB Medical Educatin Grant FAQs 6

7 Prductin and Shipping Printing and Prductin, Shipping and Pstage Faculty and Staff travel Faculty Airfare, Faculty Htel, Faculty Mileage Reimbursement, Faculty Transprtatin, Staff Airfare, Staff Htel, Staff Transprtatin, Transprtatin fees Accreditatin Fees Accreditatin Fees, Assciatin Fees, Certificate Fees Meal Expenses Breakfast, Lunch, Dinner, Breaks/snacks, Fd & Beverages UCB is fllwing the meal guidance in the Physician Payment Sunshine Act. Any meals r refreshments prvided t attendees shuld be presented buffet-style r as a bxed meal. Specify the meal presentatin in the Cmments field f the line item budget. Failure t specify the meal presentatin details in the Cmments field may result in autmatic denial f yur request. In accrdance with PhRMA Cde, meals shuld be mdest with assciated csts being reasnable fr the lcatin. If apprpriate, yu may want t itemize catering fees/taxes r clarify if thse fees are included in the Cst Per Meal line item expense. This may alleviate questins frm UCB in the case that yur budgeted meal expenses appear high. Hnraria Fees Chair, C-Chair, Peer Reviewer, Speaker Request fr Supprt Yu may enter either the amunt requested frm UCB as a whle number r percentage. The requested amunt may nt exceed the ttal budget. Attachments Sme supprting dcumentatin is required in additin t the applicatin, and yu may als attach supplementary dcuments. The fllwing attachments are required: Letter f Request n letterhead Prgram agenda/verview W-9 (name and tax ID n W9 must match Payee data in applicatin) Accreditatin certificate(if yur prgram is accredited) Yu may als uplad ther supprting dcumentatin, hwever, please keep the number f supprting dcuments t a minimum. Als nte that see attached is nt an acceptable respnse in the applicatin fields. Refer t the FAQ Dcument and Request Instructins system-specific dcuments at fr mre infrmatin and assistance navigating the registratin and applicatin screens. UCB Medical Educatin Grant FAQs 7

8 Educatinal Supprt Agreement, als knwn as Letter f Agreement (LOA) UCB utilizes Adbe EchSign t send and btain electrnic signatures n the LOA. If yur request is apprved, the cntacts in the applicatin will receive a ntificatin frm the UCB erequest system. All cntacts will als receive an frm EchSign.cm with a direct link t the LOA and instructins t e-sign it. If the recipient is nt the prper signatry, there is an ptin t delegate and send the LOA t anther recipient. Once all parties have e-signed the LOA, EchSign autmatically s the fully executed LOA t all. Use f Adbe EchSign eliminates the need t lg in t erequest fr LOA access. As previusly stated in a sectin abve, UCB will nt sign any Agreement frm anther rganizatin and will nt mdify the UCB Agreement. All grants supprted by UCB must abide by the Agreement issued by UCB. The Request Prcess Hw will I knw that my request was successfully submitted r if it is apprved? All crrespndence related t yur grant request will be sent t the address prvided in the applicatin. ntificatins are sent when yu submit the request, if additinal infrmatin is required, and when the request is apprved r denied. The Requestr and Accredited Prvider (if applicable) identified in the applicatin are ntified when the request is apprved r denied. If the request is apprved, the Payee cntact identified in the applicatin is ntified as well. Be sure the address is valid and is entered crrectly. If yu d nt receive an autmated ntificatin upn submissin f a request, check yur spam settings t ensure UCB erequest cmmunicatins are nt mistakenly filtered by yur spam filter. Hw lng will it take fr UCB t review my medical educatin request? UCB requires at least 60 days t review and respnd t grant requests. Wh can I cntact fr questins r t ask abut the status f a request? UCB requires at least 60 days t review and respnd t grant requests. Yu will be ntified f the decisin via , but yu may als lg in at t review the status f yur request. See belw fr status definitins: Incmplete Yu have nt cmpleted and submitted the request applicatin. Pending Recnciliatin Once yur request has been prcessed, the status changes t Pending Recnciliatin. Hwever, the recnciliatin is nt due until 90 days after the end date in the applicatin. Submitted Yur request has been submitted and is pending review by UCB. Recnciliatin Submitted Yur recnciliatin was successfully submitted and is pending UCB review. UCB Medical Educatin Grant FAQs 8

9 Under Review Yur request is under review by UCB. Recnciliatin Cmplete UCB has reviewed yur recnciliatin and yur request is nw clsed. Additinal Infrmatin Required An has been sent t the requestr fr additinal infrmatin needed fr review f yur request. Pending Refund A refund is due t UCB. Additinal Inf Resubmitted Yu have submitted the requested additinal infrmatin and it is under review by UCB. Refund Cmplete Yur refund was submitted t UCB and yur request is nw clsed. Cntract/LOA Sent Yur request was apprved and the Letter f Agreement r Cntract (depending n yur Cuntry) has been ed fr yur acceptance. Withdrawn by Requestr The request was withdrawn r canceled by the Requestr. Cntract/LOA Executed The Letter f Agreement r Cntract (depending n yur Cuntry) has been signed and yur request is pending payment. Declined Yur request was declined by UCB and ntificatin was ed t the requestr. Hw is my request reviewed and funding determined? UCB cnsiders many factrs in determining which prgrams t supprt including, but nt limited t, the scientific quality f the prgram, the educatinal need, budget and audience reach. UCB des prefer accredited medical educatin ptins fr healthcare prfessinals. Please nte that we cannt discuss specific details regarding funding decisins. What is an Additinal Infrmatin request and hw much time d I have fr cmpletin? A request fr Additinal Infrmatin is made when clarificatin r mre infrmatin is required in rder t cnsider yur grant request. The request will be sent via . UCB will nly review yur applicatin nce all necessary infrmatin is received. Des previus supprt f my activity by UCB guarantee future supprt? N. Each request submitted t UCB will be evaluated based n its individual merit. Please d nt cnsider any request apprved until yu receive written cnfirmatin and the supprt Agreement has been executed by all parties. Can I edit my applicatin after submissin? N. Be sure t review yur applicatin befre clicking submit, as yu will nt be able t edit the request further unless yu cntact grants@ucb.cm. UCB Medical Educatin Grant FAQs 9

10 Will my lcal UCB representative be able t assist me with the applicatin prcess r keep me apprised f my applicatin status? N. Only the erequest/grants department may assist yu with yur request. N questins r crrespndence shuld be directed t any ther UCB persnnel. Can I find ut exactly why my request was denied? N. We regret that we cannt discuss specific details regarding this decisin. UCB carefully reviews all requests and must chse between many excellent prpsals when selecting prgrams t fund. While UCB wuld like t be able t supprt many mre prgrams, we simply cannt supprt them all. Criteria fr supprt include, but are nt limited t: Educatinal value Alignment with UCB s medical educatin bjectives Target audience Prgram csts Cmpliance with internal and external regulatins Availability f funds Merit f all requests already funded as well as thse under cnsideratin at the time f review. Other supprt prvided t an rganizatin Accreditatin status (healthcare prfessinal educatin nly) Overdue recnciliatin and/r refund What are sme cmmn reasns fr delay in the review prcess? Vague agenda Questinable r unclear budget items Cnflicting infrmatin within the applicatin Increase in vlume f requests received by UCB at certain times f year Hw and when d I receive payment? UCB medical educatin grants are paid by electrnic funds transfer nly (n checks). We will btain r verify the banking details if yur request is apprved. Payment can be expected within 30 days f receipt r cnfirmatin f the banking details. What is recnciliatin? At the cnclusin f the funded prgram, recipients are required t submit infrmatin regarding the audience reach, an itemized budget reflecting the use f funds, and any ther infrmatin t verify the grant award was used as intended. Recnciliatin must be cmpleted within 90 days after the end date listed in the applicatin unless therwise cmmunicated. Yu will receive a recnciliatin reminder apprximately ne business day after the end date with instructins fr cmpleting the Recnciliatin. Fr prgrams invlving ptential transfers f value t cvered recipients (as defined in Open Payments), reprting f csts will be requested prir t full recnciliatin. A data cllectin template will be prvided t yu. Educatin prvider shall prvide a refund t UCB if the ttal mnies received frm external supprters exceeds the ttal prgram budget by $ r mre, and the amunt prvided by UCB is $ r mre. UCB Medical Educatin Grant FAQs 10

11 The refund shall be calculated as fllws: ttal mnies received frm external supprters minus ttal prgram budget multiplied by the percent f UCB s cntributin t the ttal mnies prvided (e.g., ttal mnies received ($50,000.00) minus ttal prgram budget ($48,500.00) equals $1,500.00, multiplied by the percent f UCB s cntributin t the ttal mnies prvided (40%) equals $ refund t UCB. Nte: If yu d nt cmplete the recnciliatin within 90 calendar days f the activity end date, yu and pssibly yur entire rganizatin may be prevented frm submitting any additinal grant requests until the recnciliatin is prperly cmpleted. If additinal time is required, please cntact grants@ucb.cm. UCB Medical Educatin Grant FAQs 11

12 Appendix A EDUCATIONAL SUPPORT AGREEMENT THIS AGREEMENT is made as f [Date the Crdinatr/VT generates LOA] by and between [Applicant rganizatin name] ( the Requestr ), [Educatin Prvider rganizatin name] ( the Educatin Prvider ), [Payee rganizatin name] ( the Payee ), and UCB, Inc., having its principal place f business at 1950 Lake Park Drive, Smyrna, Gergia ( UCB ). WHEREAS, UCB desires t prvide supprt fr the independent scientific and educatinal activity t be cnducted by the Educatin Prvider referenced within this Agreement (the Prgram ) by means f an unrestricted educatinal grant as described herein (the Grant ); WHEREAS, the prvisin f this Grant is cnsistent with internal UCB plicies and laws which cnfrm with applicable industry guidelines, including the Pharmaceutical Research and Manufacturers f America (PhRMA) Cde n Interactins with Healthcare Prfessinals, the U.S. Department f Health and Human Services Office f the Inspectr General (OIG) guidance t the pharmaceutical industry, applicable standards fr industry supprt f cntinuing medical educatin such as the Accreditatin Cuncil fr Cntinuing Medical Educatin (ACCME) standards and FDA s 1997 Guidance fr Industry: Industry Supprted Scientific and Educatinal Activities; NOW, THEREFORE, in cnsideratin f the premises and mutual cvenants herein cntained, the Parties agree as fllws: 1. Definitins As used in this Agreement, the fllwing capitalized terms, whether used in the singular r plural frm, have the meanings set frth in this Sectin 1 r as defined elsewhere in this Agreement. 1.1 "Effective Date" means the date n which this Agreement becmes effective. 1.2 Original Grant Submissin means the nline applicatin and its attachments submitted via the nline UCB prtal. 1.3 "Party" means UCB, the Educatin Prvider, Requestr, and the Payee as the cntext requires. "Parties" means UCB, the Educatin Prvider, Requestr, and the Payee. 1.4 Prgram means the independent scientific and educatinal activity t be cnducted by the Educatin Prvider, as laid in the Original Grant Submissin, and referenced within this Agreement. 12

13 1.5 UCB Prduct Infrmatin refers t any materials r infrmatin cntaining a UCB prduct r brand lg r trademark, r ther infrmatin identifying a UCB prduct r brand. 2. Scpe f Agreement 2.1 The terms and cnditins f this Agreement will gvern the verall cnduct f the Parties regarding the prvisin f the Grant by UCB t the party cnducting the Prgram, as prvided fr in the Original Grant Submissin. 2.2 The full terms f the Prgram are set frth in the Original Grant Submissin, and by reference t the Prgram, are fully incrprated int this Agreement. 2.3 If there are any incnsistencies between this Agreement and any external cmmunicatins, understandings, r representatins between the Parties regarding the Prgram r the Grant, this Agreement will cntrl. 3. Prgram Purpse 3.1 The Prgram is fr nn-prmtinal scientific and educatinal purpses nly, and is nt intended and may nt be used t prmte UCB prducts, directly r indirectly. The Prgram must be free f UCB s influence and cntrl, and will be designed and prduced independently f UCB. 4. Prgram Descriptin 4.1 This sectin prvides an verview f the Prgram t be cnducted by the Educatin Prvider pursuant t this Agreement. The full terms and scpe f the Prgram is included in the Original Grant Submissin. 4.2 Prgram Overview: a. Prgram Title f Independent Educatinal Activity: [Request Title] b. Grant Amunt: [$Amunt apprved by review cmmittee] c. Grant ID: [Request Tracking Number] d. Prgram Date: [Prgram Start Date] [Prgram End Date] 5. Prgram Changes 13

14 5.1 All changes, mdificatins, r amendments t the Prgram must be apprved by the UCB Grant Review Cmmittee, and frmally requested by electrnic submissin t grants@ucb.cm in advance f the scpe change. 5.2 Any changes, mdificatins, r amendments t the Prgram nt frmally requested by electrnic submissin t grants@ucb.cm and apprved by the UCB Grant Review Cmmittee shall be vid and f n effect. 6. Funding 6.1 UCB agrees t award [Payee rganizatin name] with an unrestricted Grant in the amunt f [$amunt apprved by review cmmittee] fr funding f the Prgram. UCB will nt instruct, influence r cause any funds t be directed twards any specific prgram expense. 6.2 N ther funds frm UCB will be paid t the Prgram directr, faculty, r thers invlved with the Prgram (e.g., additinal hnraria, extra scial events) in furtherance f the Prgram. 6.3 Educatin Prvider will use the Grant slely fr the Prgram. Any Grant funds nt used t supprt the Prgram in accrdance with the terms and cnditins f this Agreement must be prmptly refunded t UCB within thirty (30) days. 6.4 At the cnclusin f the Prgram, Educatin Prvider within 90 days f prgram event date(s) will prvide UCB with a recnciliatin f actual expenses vs. estimated expenses. Educatin Prvider shall prvide a refund t UCB if the ttal mnies received frm external supprters exceeds the ttal prgram budget by $ r mre, and the amunt prvided by UCB is $ r mre. The refund shall be calculated as fllws: ttal mnies received frm external supprters minus ttal prgram budget multiplied by the percent f UCB s cntributin t the ttal mnies prvided (e.g., ttal mnies received ($50,000.00) minus ttal prgram budget ($48,500.00) equals $1,500.00, multiplied by the percent f UCB s cntributin t the ttal mnies prvided (40%) equals $ refund t UCB. 6.5 Fr live events, the Grant will nt be used t subsidize the cst f travel, ldging, registratin fees, hnraria, r persnal expenses fr attendees r their spuses, r fr meals r scial events/entertainment ther than thse mdest meals r events intended t facilitate discussin and held as part f the Prgram in rms/venues that facilitate scientific/educatinal discussin. 6.6 If the Grant is specifically designated as schlarship funding fr medical residents r fellws t attend a majr medical and scientific sympsium, hwever, there is a narrw exceptin. Such schlarship funding may be used by the Educatin Prvider t underwrite reasnable travel and ldging expenses 14

15 fr such medical resident attendees subject t the American Medical Assciatin (AMA) and PhRMA guidelines. 7. Independence f the Prgram 7.1 Educatin Prvider is respnsible fr cntrl f the Prgram's cntent, quality and scientific integrity. Educatin Prvider and its partners and agents will nt seek r permit UCB r its agents t script r influence the develpment f the Prgram cntent directly r indirectly. UCB and its agents will nt attempt t script r influence the Prgram cntent. 7.2 Educatin Prvider shall nt use any UCB-Branded Infrmatin within the Prgram, and shall nt prvide any UCB-Branded Infrmatin within any assciated Prgram materials. 7.3 Educatin Prvider is respnsible fr the selectin f speakers, presenters, mderatrs and audience members and shall nt permit UCB t influence r cntrl such selectin prcesses. 7.4 Educatin Prvider represents that it will cmply with current FDA guidance and regulatins pertaining t the distinctins between prmtinal and educatinal activities (including, but nt limited t, FDA's guidance n industry-supprted scientific and educatinal activities) and verifies that the Prgram shall at all times be administered s as t remain an independent educatinal activity and t cmply with all applicable laws, regulatins and the terms f this Agreement. 8. Independence f Grant Slicitatin 8.1 Educatin Prvider and UCB warrant and represent that UCB's supprt f the Prgram is nt tied t, a reward fr, r an inducement fr Educatin Prvider's (r Prgram faculty's) past, present r future ability t generate business fr UCB and that the Grant was requested by Educatin Prvider and paid by UCB slely n the basis f the anticipated scientific and educatinal value f the Prgram. 9. Relatinships between Accredited Prvider and UCB 9.1 Educatin Prvider represents that there are n legal, business r ther relatinship(s) between Educatin Prvider and UCB r between UCB and Educatin Prvider's Educatinal Partners r agents that culd cmprmise the independent, educatinal nature f the Prgram r hinder Educatin Prvider's ability t cmply with the terms f this Agreement. In additin, Educatin Prvider represents that neither it, nr any f its emplyees, is invlved in any sales r marketing f UCB prducts. 10. Objectivity and Balance 15

16 10.1 Educatin Prvider will make every effrt t ensure that data regarding UCB's prducts (r cmpeting prducts), if presented, are bjectively selected and presented, with bth favrable and unfavrable infrmatin, and a balanced discussin f prevailing infrmatin n the prduct(s) and/r alternate treatments. The theme f the Prgram will nt fcus n a single UCB prduct (r a cmpeting prduct), except when the existing treatment ptins are s limited as t preclude meaningful discussin f alternative therapies. Educatin Prvider will make every effrt t ensure that all data presented in the Prgram are accurate, reliable, balanced, bjective, nn-misleading and scientifically sund. Data presented must be sufficiently cmplete t allw critical analysis by the audience. Any knwn limitatins r uncertainty respecting the data shuld be fully disclsed and data frm nging research shuld be represented as nt yet cnclusive. If an interim analysis f an nging study is presented r referred t, the limitatins f such data must be disclsed. 11. Cmpliance Requirements 11.1 Educatin Prvider agrees t cmply with the applicable accreditatin standards (such as the Accreditatin Cuncil fr Cntinuing Medical Educatin (ACCME) Standards fr Cmmercial Supprt f Cntinuing Medical Educatin) and shall see that its Educatinal Partners, faculty, speakers and mderatrs als abide by such standards. The Educatin Prvider must als cmply with the Patient Prtectin and Affrdable Care Act (Sunshine r Open Payments) Act f Educatin Prvider will be required t reprt faculty and attendee related transfers f value t UCB as a part f prgram recnciliatin if UCB determines that a reprtable transfer f value has ccurred Accredited Prvider agrees t cnduct the Prgram cnsistent with the PhRMA Cde n Interactins with Health Care Prfessinals (including, but nt limited t, ensuring that any health care prviders wh may receive remuneratin in cnnectin with the Prgram will receive nly fair market value fr their actual services). 12. Audit and Inspectin Rights 12.1 As part f its rutine cmpliance mnitring, UCB reserves the right t attend the Prgram and t audit the Prgram and its materials and recrds at any time t assess the cmpliance f the Prgram. UCB r its designee shall have the right t access all persnnel, materials, and recrds pertaining t the Prgram in any frm r lcatin (including lcatins wned and perated by a third party) as may be reasnably necessary t enable UCB t evaluate cmpliance with this Agreement. Any such audit shall be cnducted during rdinary business hurs and upn seven (7) business days ntice r sner if such audit is fr cause. 13. Disclsures 13.1 Financial Relatinships. Educatin Prvider will ensure disclsure t the audience f: (i) UCB's funding (i.e., the Grant); (ii) any financial r ther significant relatinship between Educatin Prvider and UCB, and between ther Prgram rganizers and UCB; and (iii) any financial r ther significant relatinship between UCB and any individual speakers, faculty r mderatrs f the Prgram. 16

17 13.2 Transparency. The Parties acknwledge and agree that UCB reserves the right t publicly disclse all medical and/r educatin grants that it supprts in the U.S. The reprt may include but is nt limited t the names f all Parties t this Agreement, the amunt f the Grant, any financial relatinships that UCB may have with faculty, speakers r rganizers as well as the title, purpse and ttal budget f the Prgram Unapprved Uses. Educatin Prvider will ensure that wherever the Prgram invlves discussin f uses f a drug that are nt apprved fr use by the United States Fd and Drug Administratin, prper disclsure f this unapprved status is made. 14. Ancillary Prmtinal Activities 14.1 N prmtinal activities will be permitted in the same rm as the Prgram. N prduct advertisements will be permitted in the Prgram rm. Prmtinal activities may take place nly in an area set up fr cmmercial exhibits that is separate frm and nt in the bligatry path t the Prgram area. 15. Use f Third Party Accredited Prviders 15.1 If Educatin Prvider chses t use the services f a third party educatinal prvider, at all times Educatin Prvider agrees t remain in cntrl f all substantive aspects f the Prgram, and that the third party educatinal prvider's rle shall be limited t administrative and lgistical supprt under the Educatin Prvider's directin. Educatin Prvider is ultimately respnsible fr the Prgram and shall ensure that any and all third party prviders cmply with this Agreement. 16. Term and Terminatin 16.1 This Agreement is effective as f the Effective Date, and will terminate n [Prgram End Date] (the 'Terminatin Date') Terminatin Withut Cause. Either party may unilaterally terminate this Agreement, with r withut cause, by delivering advance written ntice t the ther party heret in accrdance with Sectin In the event this Agreement is terminated withut cause, full refund f the funding f the Prgram must be returned t UCB within sixty (60) days Terminatin with Cause. In the event that any party shall be in default f any f its bligatins under this Agreement, including an inability t perfrm the Prgram, generally, the defaulting party shall ntify the nn-defaulting party f the default within thirty (30) days in accrdance with Sectin As an exceptin t the thirty (30) day ntice perid, in the event that the defaulting party becmes aware f the default prir t the Prgram Start Date, the defaulting party must infrm the nn-defaulting party f the 17

18 default befre the Prgram Start Date in accrdance with Sectin In the event that UCB is the nndefaulting party, UCB reserves the right t terminate the Prgram and request a refund f the funding as deemed apprpriate by the UCB Grant Review Cmmittee Extensin f Term. The Parties may mutually cnsent t an extended term f this Agreement by means f a frmal request by electrnic submissin t grants@ucb.cm. 17. General 17.1 Entire Agreement/Assignability. This Agreement cnstitutes the entire and nly agreement between the Parties relating t the Prgram, and all prir negtiatins, representatins, agreements and understandings are superseded hereby. N agreements amending, altering r supplementing the terms heref may be made except by means f a written dcument signed by the duly authrized representatives f the Parties Binding Effect; Assignment. Accredited Prvider may nt assign, subcntract, r therwise delegate its, his, r her rights r bligatins under this Agreement withut UCB's express prir written cnsent. Subject t the freging, this Agreement will be binding upn and inure t the benefit f the Parties and their respective heirs, legal representatives, successrs, and assigns Applicable Law. This Agreement will be cnstrued and enfrced in accrdance with the laws f the State f Gergia, United States f America, withut regard t any chice r cnflict f laws, rule r principle that wuld result in the applicatin f the laws f any ther jurisdictin Severability. If any prvisin f this Agreement will be fund by a curt f cmpetent jurisdictin t be vid, invalid r unenfrceable, the same will either be refrmed t cmply with applicable law r stricken if nt s cnfrmable, s as nt t affect the validity r enfrceability f this Agreement Ntices. Any ntice r cmmunicatin required r permitted t be given hereunder shall be submitted and signed by authrized persnnel t the party s address submitted within the Original Grant Submissin. In the event that ntice is t be sent t UCB, the ntice shall be directed t grants@ucb.cm. The parties expressly cnsent and agree this agreement shall be electrnically signed. The parties agree the electrnic signatures appearing n this agreement shall be treated fr purpses f validity, enfrce ability as well as admissibility, the same as hand written signatures. 18