EX-4.5 4 a45-stiporderforpiftc.htm EX-4.5 a45-stiporderforpiftc
M RKBOFFICE .tJ .S DISTRIGTCOURTATM NGX N . VAFILQD N0? 2 0 2222 s , u L#I'KD 'FY CLERK f' IN THE UNITED STATES DISTW CT COURT FOR THE W ESTERN DISTIU W OF W RGINJA ABINGY ON FEDERAT, TRADE COMMISSION Plaintifil INDIW OR U C. Defendant. civuAcuonuo, l -. 4 o C. t3V 'STIPULATED ORDER FOR PERM ANENT INJUNCTION AND XOUITABLE M OM TARY RELIEF Plaintift the Federal Trade Commlsqion Ccommission' or RFTC'), Eed its Complaint for Permanent Injurtctive and Oier Equitable Relief (stcomplaint') in tbis matter pursuant to Section 13@) of the Federal Trade Commission Act I'SFTC Act'), 15 U.S.C. j 53(1$. Thef Commission and Indivior Inc., by their respective attorneys, have reached an agreement to resolve this case through setlement, and witlmut trial or fnal adjudication of any issue of fact or law, and stipulate to entry of this Stipulated Order for Permancnt Injunction and Other Equitable Monetary Relief ('ïOrder') to resolve a1 maters in dispute in this action. 1 #F Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 1 of 16 Pageid#: 38 Exhibit 4.5


 
FINDINCXN 1. 2. The Court has jurisdiction over the subject matter and 'tlze parties to tlis actlon. Venue for this fnatter is proper iil this Court under 11 U.S.C. û 22 and 28 U.S.C, â 1391@) anb (c), and under Section 13(b) of the IRTC Act, 15 U.S.C. 553(19. The Complaint alleges that Defendant engaged hl unfair metlmdt of competidon Jn violation of Section 5(a) of the FTC Act, 15 U.S.C. jj 45(a), by engaging in anicompetitive activities desia ed to impede competitionâom gendlic equivalents of the 3. brand-name dl'ug Suboxone. 4. This Order does not constitute any evidence against Defendant, nor an admission of : liability or wrongdoing by Defendant in this case or in other lltigavon. Rather, the tenus of this injunction reflect a negotiated compromise, enteted into as a mqans to resolve contested issues withom t'he burdens of litigation. This Order shall not be uscd ln any way, as evidence or otherwise, in any other litigation or proceeding; provided that, nothing in this provision prevents the Commission or Defendant 9om using this Order in any proceeding regarding entbrcement or modifcation of tllis Order or as othmwise rèquired by law. 5. Entry of this Order is in the public interest. STIPULATIONS 1. Defendant and Plaintiff, by and tbrough their counsel, have agreed that entry of this Order fully and fnally resolves a11 issues betweep them adslng 9om the speoG c events iving rise to the allegations descdbed in the Complaint in the indicM ent il Unîted States v. Indivior Inc. ct a1., Case No. 1:19G416 (W.D. Va. Apr. 9, 1019)a and in the 2 <r Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 2 of 16 Pageid#: 39


 
complahts sled infrl re Suboxone, MDL No. 2445 (E.D. Pa.) and State Y lif.çc/avfa, et al v. Indivior Ac., et al., Nc. 2:16-cv-5037 (E.D. Pa.) and precludes 1, rther litlgation between Plaintiff and Defendant on the resolved issues except for the purposes of enforcing or modifying this Order. Plainiffstateslat entry of this Order resoives all of its open antitrust investigations peitaining to Indivlor lnc., to its ultimate parent gndivior PLC), to any company owned (directly or indirectly) by hdivior PLC, or to any afsllated company related to the allegations in the indictment atid complaints referenc:d above. Defendant admits the facts necessary to establish personal and subject materjurisdicion of this Court in this matter. Defendant derlies the charges in the Complaint and disputes that the Commission is 2. entitled to obtain relief 4. Defendant stipulates that it shall cymply with the provisions of this Order pendlng its entry by the Court. 5. Defendant stipulates that it will bear its own costs in this matter and shall not mpke any claims against Plaintif for attomey's fee,s or costs. 6. Defendant waives a1l rights to appeal or othem ise challenge or contest the validity öf tllis Order. Defendant waives any olaim that it may have under the Equal Access to Justice Act, 28 U.S.C. â 2412, concerning the proseoution of tlzis action tbrough the date of this Order, and agrees to bear its own costs and attorney fees in this litigation. The obligations set out below relate solely to business operatiom within the United Stgtes. 3 1 , /@ Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 3 of 16 Pageid#: 40


 
1. 2. DEFG ITIONS 'tcommission'' memzs the United States Federal Trade Commissioh. 'tlndivior'' or 'Defendant' mennn hdivlor lnc., lndivior PLQ and anyl-oint venture, subsidiary, division, Foup, or ao liate Controlled currently or in the future by Indivior. $6505:)(2) Application' means an applcation fled with the Unhed States Food and Drug Administraitm pursuant to Section 50541942) of the Federal Food, Dnlg and Cosmytic Act, 21 U.S.C, j 355($(2). 3. 4. SWNDA'' means Abbreviated New Dmg Appllcation ilçd with the United States Food and Dt'ug Administration pursuant to Scction 505(j) of the Federal Food, Dmg and Cosmetic Act, 21 U.S.C. û 3551 . 'W uthorized œ neric'' means a Drug Produot that is manufactured pursuant to an NDA and M arketed in the United States under a name other than the proplietary name identifed in the NDA. 5. 6- tritizen Petitlon'' means a public request tllat the FDA issue, amend, or zevoke a regulation or ordtr or take or regain 1om taldng any other form of administmtive acuon pursuant to 21 C.F.R. 5 10.30. ''Commerce'' has the same defzlition it has in 15 U.S.C. û 44, Gconlrol'' or Ctcontrolled'' means tlw hplding of more than 50% of the commpn vofhg stock or ordinary shares in, or the right to appoint more than 50% of the directors of, or atïy other arrangement resulting hl the dghi to direct the management ofi tle said 7. 8. comoration, compqny, partnership, joint vçnmre, or enity. 4 Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 4 of 16 Pageid#: 41


 
9. 'Direct Cost'' means the variable costs incurred to produce or sell an Original Dmg Product or Follow-on Dzug Product, including the costs of ingredients and manufacfnring, as well as the costs of marketing that product. The term Direct Cost does not include any allocation of overhead costas, administrative costs, research and development costs, or any other Gxed costs. 10. çdDrtzg Product' means a fnished dosage fonn (e.g., tablet, capsule, solution, or patch) as j y xsa Axox oz 5(s(b)(ydefned in 1 C.F.R, â 314.3(b), approved under a singe , , Applicaion, and available by presoription, that contains a dnzg substance, generaly, but not necessarily, in association with one or more other ingredients. Notwitbgtandiàg the foregoing, the term Drug Product, as used in tlis Order, shall not include producz that are predominantly purchased over-the-c-otmter ($rTC'') in the Uzlited States. 'tBffective Pdce'' means the net price paid by a payor, on a monthly basiz, for apafent's course of keatment with a Drug Product, taking into account a11 discounts, reftmds, reimbursements, mzd rebates. 12. 'l'he ç'Escrow Account'' is the escrow açcount establishcd by the Resolution Areement (desned below). 13. 'TDA' means tho U.S. Food and Drag Adrninistation. 14. fTolow-on Drug Product' means a Drug Product a) for wïoh Defendant has submitted an 'NDA, conkols an approved NDA, or has the right to distdbute in the United States; b) that contains an active inpedient 1at is (l) the same as an active ingredient in a previously approved Original Drug Product, or (ii) an isomer, salt form variant, or metabolite of an active invedient in a previously approved Original Dmg Produd; and c) 5 Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 5 of 16 Pageid#: 42


 
that treats the same condition or targets the same patient population as the previously approved Original Drug Product. No> ithstanding the foregoing, for purposes of this Order, the term Followaon Dm g Product shall not hclude an Authorized Generic version of the Original Drug Product, 15. . ttM arket,'' ttM arketeda'' or SsM arketlng'' means the promodon, offering for sale, sale, or distibution of a Drug Product. 16. CNDA'' means a New Dnzg Appllcation fled with the United States Food and Drug Administration pursuant to Section 505@) of the Federal Food, Dlug and Cosmetic Act, 21 U.S.C. j 35599, including a11 changes or supplements thereto that do not result in the submission of a new NDA. 17, 'r riginal Dnlg Product'' means a Drug Product that is M arketed in the United States and fûr which Defendant contols the NDA or has the zight to distdbute in the United States. 18. çdperson' means any individual, partnership, joint venmre, lrm, corporation, associatlon, trust, unincorporated organization, or other business, and any subsidiaries, divisions, groups, or affiliates thereoft 19. The tdResolution Agreemept'' is the agreement entered into between Indivior and the United States Department of Jusdce. Thls Resolution Agreement, among other terms, (i) cals upon Indivior to Rnd an Escrow Account and (ii) desir ates $10 million of the Rmounts to be paid into tlze .& crow Account as money that will then be paid to FTC. 20. ççsaleable Expiration Date'' means 6 months before a Drug Product's expiration date. k 21. ç'Stattls Quo Period' means a pedod beginning the day Defendant begins Marketing a Folow-on Drug Product in the United States and ends on the earlier of (i) 6 months after 6 3ê Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 6 of 16 Pageid#: 43


 
a Third Pa14y begins Marketing a Dag Product approved under an ANDA or 505.1b)(2) Application fol' whioh the Odginal Dmg Product is the reference listed drqg, or (i) 3. years alor the day. Defendant or a licensee of Defendant begins Marlceting the Follow-on Drug Product in the United States. For clari.ty, if a Third Party begatl M arketing a Drug Product as described in (i) of thls definition six months o1. more before Defendant begins M arketing a F. ollow-on D 1ug Product in the United States, then there is no applicable Status Quo Period, and thq restdcdons of Pqmgraph 1I.C do not apply: 22. t'Subloçadet' .means the buprenorphine extended-releab: injection Drug Product thatis tlw subject of NDA 209819 and is sold in the posage strengths of 100mg and 300mg. 23, ûelxird Party' means any Person other than Defendant. ORDER 1. PROHIBITED AG IVITY: CITIZEN PETITION PROCESS IT IS ORDKRRD that if Defendant lil0s a Citizen Petitionx Defendant shall simultanepusly disclose to both the FDA and the Com. mission: A. A l1 stud. ies ald data on which the Citizen Petition relies; and B. M 1 studies and data within' jhe lmowledge' or possessien of Defdndant that address the validity or strength of one or more of the material contentions in the Citizen Petition. Defendant shall provide such disclosure to the Commission b.y sending en eledronic, copy of the disclpsure submission to the Comjliance Division of the Bureau of Competition of tle FTC at bccomplianceo fk.zov. Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 7 of 16 Pageid#: 44


 
11. PROHDXTED ACTM TY: PRODUCT SW ITCO G CONDUCT IT IS FURTHER ORDERED that: Defendant shall provide a notiûcatiôn to the Plaintiff 30 calendar dgys aler Defendant files an NDA for a Follow-on Dlxg Product in the United States. T his notifcation shal A. be sent by electrbnic transmission to the Compliance Division of the Bureau of Competition of the IRTC at btcomnlianceaûc.aov and shall inolude, fttter alia, the folowing infolnnation: ($) a reference to ttlq Qrder, (i) the NDA number for fhe Folow- on Drug Prnduci, and (ii) the associated 0. riginal Drug'product aqd NDA number under which it is approved. B. Defendant shall provide a second notiication six months befoze the date specifed for FDA approval of the Follow-on Drug Prgduct under the Presoziption Drug User Fee Aot. This notifcation shall reference this Order and the previous notiscation 'submitted under Patagraph II.A. above for the Follow-oh Drug Product. Def, end. anfs vsh. all .sublpk the following doouments and.infol-mation with the notifcation: Documents suffcient to show tho company's pricing plans for the Origlnal Drug Product and Pollow-on Dnlg Product; Documents sufûoient to show the forecasted sales for thù OriginalDlug Product and Follow-on Drugproduct; Transcdpt of any of the Defendant'', investor calls dming the prior twelve months that discuss the Follow-on Dnzg Product; A statem ent of all claimed benefits of the Follow-on Dnlg Product compared to the Original Drug Product; and, 8 Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 8 of 16 Pageid#: 45


 
A statelnent of whether Defendant intends to materially alter the terms on which it sells the Original Drug Product and, if so, identifoation of these terms, and a11 reasons for materiàlly altering them . Defendant shall deliver this notifcajion and. thç required. documents to the Assistant Director of the Compliance Diviàion of the Buryau of Coppetidon of the FTC, either through electronio transmission to bccomplianceaûc.sqov or hand-delivery to the FTC, If, on the date when Defendant or its licensee begins Marketing a Follow-oh Drug Pmduct in the United States', A Third Party has submited an ANDA or 505(b)(2) Application for whioh the Odginal Dl'ug Product is the reference tisted drug, then during the Status Quo Period, Defbndant shal be prohibited from: Destroying inventoly or withdrawing from tlle market any strength or fgrmulation of the associated Oliginal Drug Productiprovf#ct however, Defendant may destroy Drug Prodùct that has passed its Saleable Expiration Date. Failing to fill orders for the Original Dnlg Product on the sqm e terms and conditions (except for those terms and conditions relating to Effectiv: Price, which are addressed below in Parapaph 11.C.3) within the same time frame and. with the yame convbnience as are' orders for tl.1ç Followxon Dru'g Product. For the: avôidance of doubt this clause does not prohibit Defendaàt'from offering different term s or conditions for a given Oliginal Dnzg Product or Follow-on Dl-ug Ptoduct to different customers, so long as çach custom er is offered the sam e 9 KN Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 9 of 16 Pageid#: 46


 
terms and conditions for tle Odginal Dnlg Product as for the Follow-on Dl'ug Product, Offering an Effective Price for the associated OriA al Drug Product to any C'ustomer that is highcr than the Bffective Price Defendant offers to that Customer 3. for tlïe Follow-on Dmg Prcduct; Provîden however, tltis prohibition does not apply (a) if the Effective Pdce of thè Orignal Drug Product is not increased by more than tlle corresponding increase in the presoription drug price component of the Consumer Price Index at any time dudng the eighteen months prior to introduction of the Follow-on Dlug Pmduct or during the Status Quo Pedod; or (b) if the difference in Bffective Price is athibutable Folely to a difference in the Dh'ect Costs of the producl. Deleting the National Dlug Code for the associated Original Drug Product âom tho Natlonal Drag Data File; Providen however, that Defendant shall have no obligations tmder this Paragrâph 4, 11.C with respect to an Orighal Drug Product: (a) for which the associated Follow-on Drug is no longer Marketed in the United Statœ, or (b) that the FDA has determined should no longer be Marketed in the United States because of safety concernA. Defendant may recall and deskoy prôducts consistem with 21 C.F.R. Part 7, Subpart C; may take reasonable steps to proteot safety in the event of manufacmdng defects; and may take any action that is requested by FDA; 10 Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 10 of 16 Pageid#: 47


 
Providedfurther. for clcrïfy, this Paragraph 11.C doe,s not apply to Sublocade because any relevant Status Quo Pedod with respect to.that Dl'ug Product has endtd. EQUITM LE MONETM W RELIEF IT IS FURTHER ORDERED that: Judgment in the amount of ten milion dolars ($10,000,000) is entered in favor of 111. A. Plaintiff against Defendant as equitable monetary relief. At the time specifed by the Resolution Agreement FTC shall be paid (and Defendant shall provide a11 necessary consen/ so that FTC is paid) $10 mlllion 9om tlte Escrow Account. Defendant is not obligated to furnish any other funds to satisfy thejudgment B. entered as descdbed in parapaph 111.A above. Notwithstanding any other provision ûf this Order: A11 money paid to Plaintiffpursuant to this Order may be depositùd into a fund administered by Plaintif or its designee to be used fo4 equitable relie: inoluding consumer redress and other equitable relief Plaintiff determines to be reasonably related to Defendant's aleged violative practices and lnjuly and any attendant expenses for the administration of such fund. Plaintiffshall dm osit any money not used for such eqlzitable relief in the U.S. Treasuty Any interest enrned on amotmts deposited into the fund will remain in the fund and become part of the fund. D. W iM n 10 business days of entry of the Order, Defendant shall submit its Taxpayer Identifcation Number (Employer Identifcation Number) to Plaintiff. Defendant shall have no lights to challenge any actions Plaintiff or its representatives may take pursuant to this Parap aph H1. of the Order. Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 11 of 16 Pageid#: 48


 
The pûymenty provided for herein are provided for the purposes of settlement only, are remedial, and are neithelt a.p.enalty nor a fne. The $10 million that the FTC shall be paid tltough this Order is intendeito be, tti the extent practicable (ts set out in Section HI.C pf this Order), Sfrestitution' wiëin tNe meaning of 26 U.S.C. j 1624942). In colmection with this payliwnt, FTC shal cûmply with any a/plicable statutory or regulatory reporting requirements. IV. NOTIFICATION REQUIXEMENT IT IS FURTHER ORDERED that Defendant shall notify the.dommissioh withih 30 calendm' days of s'tarting to M arket, either directly or through. 'g licçnsee, Dlug Products in tlw United States by: A. Receiving FDA approval to M arket a Dt-ug Product in the United States; Acquiring Control of a Person jhat has FDA approval to M arket a Drug Pkoduct in the United States; or C. Acquiring or l.icensing a Dl'ug Pmduct. thét, at. the time' pf such acqulsif. on, 'has FDA approval to be Marketed in the United States. Defendant shall provide such notifcation to the Commiésion by sending an electrorjio copy of the notifcation t: the Colppliance Division of the Bureau of Competition of the FTC at bccompliançc@ûc.gov q/ Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 12 of 16 Pageid#: 49


 
V. REPORTING REQUIREMENTS IT IS FURTHER ORPERED that: Defendant shall submit'to Plaintiff a velifed writtqn repm't withi'n 60 balendar dayà aier the date this Order is entered, one year aher thc date this Order is entered, and anriually for 9 years thereaher, setting forth. in detail thè mannet ând fol-m in which Defeàtlant has A. complied and is complying with this Order. Defendant shall submit each,. report required under thk Paravaph to 1he Secretac ofthe Commission and shall send alï electronic copy of eac'h mport to the Uompliance Di. vision of the Bureau of Competition of the FTC ft bcconoliance@. Xc.qov. B. VI. CHANGE OF CORPOM TE CONTROL 1'r IS FUIITHER ORDERED that A. Defendant shall notify Plaihtiff at leaqt 30 calendar days plior to: 1 An roposed dissolu'tion of Indiviof, lr2.9. y p Any proposed acquisition, merger, or consolidatlon of Indivior Inc-; dr 3. Any other èhange in Defendant, ibcluding, but not limited toy assignment and the creation, sale or dlssolution of sub sidiariew if such change might affeot the compliance obligations atising out bfthis Order. B. Nb informatioh cr documertts obtained.by the means provididjn'thls Pragraph W . shall be divulged by ïhefommission to any person öthùr tlan an authotized represenlative of 'the Commission, except in the course of ij legal proceeding regrding enforeement of the Order, or as othenvise required by law. Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 13 of 16 Pageid#: 50


 
0 . ACCESS TO INFORM ATION IT IS FURTHER ORDERED that: A. For the purpose of determlning or securing compliance with this Order or fadlitating consumer redress pcsuant to this order, and subjeot to any Iegaly recogizt; privilege or any applicable privacy laws ànd regulations, Defendant shall, upon reasonable notice and in response to a written request by FTC staff: Provide the FTC wlth documents and other dectronically storcd infonnation ht Defendant's posscssion, custody, or contzol, that are relevant to compliancc or consumer rtdress under the Orderk and 2. Pennit Commission staffto interview ofûcers, directors, or employees öf Defendant, who may have counsel (representfng the Defendant, the indlvidual, or both) present, regarding maters that are relevant to compliance or consnmer redress under the Order. B. No informaEon or documents obtained by the means provided in this Parapapll VH. shall be divulged by the Commission to mly person other than an authorized representative of th. e Commissioh, except in the course of a legal proceeding regarding enforccment of tlle Order, or as othem iso required by law. W 11. M TENTION OF JURISDICTION IT IS FURTHER OIZDEQRD that this Court shaz rdainjurisdiction of this mater for purposes of construcuon, modifcation, and enforcenwnt of this Order. 11' Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 14 of 16 Pageid#: 51


 
Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 15 of 16 Pageid#: 15 15 IX. EXPIRATION OF THE ORDER IT IS FURTHER ORDERED that this order shall expire 10 years after the date it is entered. X. DISMISSAL AND COSTS IT IS FURTHER ORDERED that this action shall be dismissed with prejudice and each party shall bear its own costs. SO ORDERED this 20 day of Nov. 2020 United States District Judge [illegible]________


 
Case 1:20-cv-00036-JPJ-PMS Document 5 Filed 11/20/20 Page 16 of 16 Pageid#: 16 16 MARKUS SO STIPULATED AND AGREED: FOR PLAINTIFF FEDERAL TRADE COMMISSION: Digitally signed by :: MARKUS MEIER MEIER Date: 2020.01.23 • 15:23:17 -04'00' .Date: Iuly 23, 2020 Markus H. Meier Assistant Director Health Care Division Bureau of Competition Federal Trade Commission FOR INDIVIOR INC: /s/ Javier Rodriguez Date: 7/24/20 Javier Rodriguez Chief Legal Officer /s/ Jennifer S. DeGraw Date: 7/24/20 Jennifer S. DeGraw Gentry Locke Rakes & Moore /s/ Jonathan Berman Date: 7/24/20 Jonathan Berman JONES DAY