Obalon Co-op Advertising Program Guidelines

Transcription

1 Obaln C-p Advertising Prgram Guidelines The Obaln lgtype, brand name and assciated trademarks are valuable assets. They help cnsumers identify ur prducts and services. The apprpriate use f cnsistent imagery and themes depicting cnfidence, apprpriate weight lss and success will supprt the brand-building effrts at yur practice. The fllwing guidelines have been develped t ensure an understanding f this C-p Advertising Prgram ( Prgram ). If yu have any questins regarding the cntents f these guidelines, including cmpliance with specific requirements, please immediately cntact yur Practice Develpment Manager ( PDM ). I. Prgram Eligibility Obaln may prvide yu a c-p advertising allwance that meets certain requirements that may be utlined during an Obaln-spnsred prmtin. The amunt f yur c-p allwance is determined by yur eligibility based n current prgram. Please discuss these eligibility details with yur Executive Accunt Manager (EAM) and/r Practice Develpment Manager (PDM). In rder t receive c-p advertising reimbursement yu must adhere t all brand guidelines and btain prir apprvals frm Obaln when required. Hwever, n prir apprval is necessary when an accunt uses any final materials prduced by Obaln. Obaln reserves the right t audit yur cmpliance with these guidelines. II. Allwable Expenses In general, nearly any media that strngly identifies the accunt with the brand may be allwed. The term media refers t bradcast, replicate and distribute print materials r purchased advertising space. Media cmmissins are allwed nly fr media planning and ther activities directly related t the placement f print, TV, radi and nline media. Any materials that vilate any f the prvisins set frth in these guidelines are nt allwed and may cnstitute vilatin f federal, state and/r lcal law r regulatin. A. Reimbursable Expenses Online banner ads, pay per click and ther SEM media including agency fees fr media buying supprt marketing prgrams Scial media (agency supprt csts nly) Bradcast r cable televisin advertising including media cmmissins Spnsrship f lcal TV r radi shws Radi advertising Print advertising such as lcal magazine, newspaper r newspaper inserts Direct mail, including printing and pstage Billbards Public bus billbards and ads Public bench ads 2018 Obaln Therapeutics Inc.

2 Stadium r arena signage B. Nn-Reimbursable Expenses: Csts fr creative writing, design r ther prductin csts assciated with the creatin f advertisements Csts f ffering rebates, credit and prmtins Any advertisements r merchandising that displays cmpetitive items Any nline effrts directed t a landing page r website hme page displaying cmpetitive prducts Creative design and assciated csts fr any advertising whether print, bradcast r nline are nt allwed. Assciatin dues and publicatin subscriptin r cntributin expenses Items nt assciated with the prmtin f the brand III. Material Guidelines Fr accunt-prduced materials Obaln and Obaln-related cntent must represent greater than 50% f the advertisement and must cmply with all legal/regulatry requirements discussed belw Website/Micrsite Obaln lg clearly and prminently featured n hme page Messaging and language is n-label and cnsistent with that f Obaln.cm Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Cntent must be accurate and nn-misleading Advertisement shuld be targeted t avid audiences that are nt age apprpriate fr the prduct message Online Obaln lg prminently shwn n banner ads Cpy-nly based ads must include the use f the Obaln brand name Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Cntent must be accurate and nn-misleading Advertisement shuld be targeted t avid audiences that are nt age apprpriate fr the prduct message Mbile Obaln lg clearly and prminently shwn n visual ads Cpy-nly based ads must include the use f the Obaln brand name Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Cntent must be accurate and nn-misleading 2018 Obaln Therapeutics Inc.

3 Advertisement shuld be targeted t avid audiences that are nt age apprpriate fr the prduct message Scial Media Twitter and like feeds must mentin Obaln name Facebk page must clearly and prminently feature Obaln lg Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Nte that if this is nt pssible given characterlimited frmats, the advertisement des nt cmply with the legal requirements utlined belw and may nt be undertaken Cntent must be accurate and nn-misleading Advertisement shuld be targeted t avid audiences that are nt age apprpriate fr the prduct message TV/Vide Obaln lg clearly and prminently shwn Audible mentin f Obaln name Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Cntent must be accurate and nn-misleading Advertisement shuld be targeted t avid audiences that are nt age apprpriate fr the prduct message Radi Audible mentin f Obaln name n less than 2x in a 30-secnd spt and 3x in a 60-secnd spt Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Cntent must be accurate and nn-misleading TV and Radi Prgram Spnsrships Audible mentin f Obaln name Any visual materials featuring accunt must include the Obaln lg clearly and prminently shwn Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Cntent must be accurate and nn-misleading Advertisement shuld be targeted t avid audiences that are nt age apprpriate fr the prduct message Print Obaln lg prminently shwn Lg must be n smaller than the size f the accunt s lg Lgs within the text r bdy f an ad r lgs appearing in phtgraphs including thse depicting imagery are nt cnsidered sufficient use 2018 Obaln Therapeutics Inc.

4 Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Cntent must be accurate and nn-misleading Advertisement shuld be targeted t avid audiences that are nt age apprpriate fr the prduct message Billbards Obaln lg prminently shwn Lg must be n smaller than the size f the accunt s lg Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Cntent must be accurate and nn-misleading Testimnials Must be pre-apprved by Obaln and meet all the belw criteria regarding testimnials Individuals giving testimnials have prvided Obalnapprved cnsent release frms Safety/risk infrmatin is fairly balanced, as a whle, with benefit infrmatin Cntent must be accurate and nn-misleading Endrsements shuld accurately reflect the pinins, findings, beliefs r experience f the endrser Advertisement shuld be targeted t avid audiences that are nt age apprpriate fr the prduct message General Advertising nt specifically cvered by these guidelines shuld have prir apprval frm Obaln Advertising paid fr, in whle r in part, thrugh c-p advertising cannt include cmpetitive items r claims r ther brand names. (Exceptin: practice websites may include all brands serviced) Cntent must be accurate and nn-misleading Advertisement shuld be targeted t avid audiences that are nt age apprpriate fr the prduct message IV. Additinal Legal/Regulatry Guidelines Alng with the abve prvisins, yur ads must als meet legal and regulatry requirements, including as applicable prir Obaln apprval f advertisement cntent. T be eligible fr c-p advertising, fllw these guidelines, always be truthful and avid ptential misrepresentatin and miscmmunicatin abut Obaln prducts and yur services. Obaln will never cndne nr supprt in any way any materials that vilate federal, state r lcal laws r regulatins Obaln Therapeutics Inc.

5 A. Prduct Price in Advertising When mentining price in the advertising, accunts must abide by Obaln s Minimum Advertising Pricing (MAP). B. Special Offers When yu are advertising a special price, be sure t include language similar t the fllwing: Fr a limited time nly. Call fr details. While supplies last. A discunt is an additinal cst t prmte a sale. When advertising discunts and rebates, yu shuld nt raise yur price t cver an advertised discunt r rebate. C. Advertising Ethics When creating yur Obaln advertising, yu must always display gd business ethics the disparagement f cmpetitrs will nt be tlerated. Yur cmmunicatins must meet regulatins set frth by the Federal Trade Cmmissin (FTC), the Fd and Drug Administratin (FDA), media utlets, as well as ther required federal, state and lcal laws. Accunts shuld prmte their businesses in a straightfrward, factual fashin. All advertisements must cntain a brief statement f the prduct s intended use and relevant warnings, precautins, side effects and cntraindicatins. 21 U.S.C. 352(r). Mrever, all advertisements cntaining prduct claims must be apprpriately balanced with prduct safety and risk infrmatin, and must nt be false r misleading in any way. 21 U.S.C. 352(q). Otherwise, advertisements may vilate federal law. 21 U.S.C. 352(a). D. Reimbursement/Payment Upn apprval t mve frward with the c-p advertisement(s), the accunt will submit all receipts and dcumentatin ( submissin ) t their PDM cnfirming the advertisement meets all Obaln guidelines. At that pint, Obaln will prcess payment, matching dllar fr dllar up t the eligible amunt and reimburse the practice accrdingly. Payment will be in the frm f a check sent via U.S. Pstal Service t the accunt fr receipt within 6-8 weeks after the submissin. Accunts chsing t d nline advertising thrugh Obaln s chsen vendr will nt have t prvide a submissin. They can directly pay the vendr the apprpriate amunt and Obaln will match, dllar fr dllar up t the eligible amunt, and pay the vendr directly. Any reimbursement and/r payment presuppses that the requisite Obaln apprvals have been made fr each piece f advertising material submitted. E. Practitiner/Practice Nn-Endrsement Participatin in this prgram, including receipt f any reimbursement/payment is in n way an endrsement by Obaln f the practitiner and/r practice and any services prvided and may nt be used as such in any advertising materials in any way. Obaln des nt endrse any practitiner r practice fr any reasn, including but nt limited t the quality f service r any specific practitiner/practice reputatin Obaln Therapeutics Inc.

6 F. Apprvals All advertisements must be apprved by Obaln s Medical-Legal Review (MLR) prcess prir t disseminatin and use. Advertisements using ne f ur Obaln-apprved templates may nt require apprval frm Obaln, prvided that n ther mdificatins, changes r additins are made. All ther advertising must be submitted t yur Obaln Practice Develpment Manager (PDM) fr apprval prir t launching. G. Testimnials Testimnial advertisements are heavily regulated by the FTC. 15 U.S.C. 45; 16 CFR Part 255. The fllwing criteria shuld be fllwed fr all testimnial endrsements: Must reflect nly hnest pinins, findings, beliefs r experiences f the endrser, wh must be a bna fide user f the prduct at the time the endrsement was given May nly cntinue t utilize endrsement s lng as endrser remains a bna fide user f the prduct Need nt be phrased in the exact wrds f the endrser, unless the advertisement affirmatively represents thse exact wrds Must nt be edited in a manner that wuld make them false, misleading r unsubstantiated Must disclse material cnnectins between Obaln, the endrser and the physician and/r practice, as applicable H. Cnsistency with FDA-Apprved Labeling All advertisement cntent must nt cntain any claim r statement regarding the prduct that represents r implies that the prduct is safe and effective in any way, ppulatin r use that is nt apprved r cleared by the FDA. FDA Draft Guidance fr Industry: Medical Prduct Cmmunicatins That Are Cnsistent With the FDA-Required Labeling Questins and Answers Guidance fr Industry, (Jan. 2017). Such statements, express r implied, in written, ral, bradcast r therwise, are unlawful and misbrand the prduct. I. Safety/Risk Language Requirements The fllwing safety/risk infrmatin is required t be included n all advertisements: The Obaln Balln System is intended fr adults with a bdy mass index (BMI) f 30 t 40 kg/m2 (30 t 50 punds verweight) willing t fllw a diet and exercise prgram. All Obaln ballns must be remved in 6 mnths. Patients with prir weight lss surgeries are nt eligible. The mst cmmn side effects reprted were mild abdminal pain and nausea which typically reslved within tw weeks. Yu must take daily acid-blcking medicine prescribed by yur dctr. Fr full Imprtant Safety Infrmatin g t r call yur dctr Obaln Therapeutics Inc.

7 J. Benefit and Safety/Risk Statement Requirements Presentatin f safety/risk infrmatin is very imprtant and heavily regulated by FDA. FDA law requires that advertisements be (1) cnsistent with the FDA-apprved label, (2) cntain a brief statement f the prduct s intended use and relevant warnings, precautins, side effects and cntraindicatins, (3) be apprpriately balanced with prduct safety and risk infrmatin, and (4)must nt be false r misleading in any way. 21 U.S.C. 352(a),(q),(r). Benefit and safety/risk statement requirements must be viewed as a whle, and the net impressin f the advertisement must cntain apprpriately balanced prduct safety/risk infrmatin. FDA Draft Guidance fr Industry: Presenting Risk Infrmatin in Prescriptin Drug and Medical Device Prmtin, (May 2009). The fllwing factrs must be cnsidered: Benefit infrmatin must nt minimize r dwnplay safety/risk infrmatin The ttal amunt f benefit infrmatin shuld nt exceed that f safety/risk infrmatin The lcatin f safety/risk infrmatin must nt be any harder t find than that f benefit infrmatin The clr/cntrast between text and backgrund shuld nt highlight the benefit infrmatin mre than the safety/risk infrmatin The fnt size t be used fr the safety/risk infrmatin shuld be n smaller than the smallest fnt size used in the advertisement Audi presentatin f safety/risk infrmatin shuld be played in a manner (i.e., speed, ludness, pitch) similar t that f the benefit infrmatin 2018 Obaln Therapeutics Inc.