UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WATSON LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS, INC.,
`Patent Owner.
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`
`
`
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`
`
`Case No. IPR2017-01622
`Patent No. 9,339,507
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`PETITIONER’S REPLY IN SUPPORT OF PETITION FOR INTER
`PARTES REVIEW OF U.S. PATENT NO. 9,339,507
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313-1450
`Submitted Electronically via the Patent Review Processing System
`
`

`

`PETITIONER’S EXHIBIT LIST
`
`
`
`1003
`
`1004
`
`1005
`
`Exhibit Description
`1001
`U.S. Patent No. 9,339,507
`1002
`Declaration of Maureen D. Donovan in Support of the Petition for
`Inter Partes Review of U.S. Patent No. 9,339,507
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`(“Chaudry”)
`Hossein Ardeschi Ghofrani, Robert Voswinckel, et al., “Neue
`Therapieoptionen in der Behandlung der pulmonalarteriellen
`Hypertonie,” Hertz, 30,4 (June 2005): 296-302 (“Ghofrani”)
`Opti-Neb-ir® Operating Instructions, Model ON-100/2 (2005)
`RESERVED
`Venta-Neb-ir® A-I-C-I Operating Instructions, Model VN-100/4
`Annexes to Commission Decision C(2005)3436 of 05 September
`2005, http://ec.europa.eu/health/documents/community-
`register/2005/2005090510259/anx_10259_en.pdf (Annex III –
`Ventavis® Labelling and Package Leaflet)
`U.S. Patent No. 6,606,989 (“Brand ’989”)
`Amendment and Reply Accompanying RCE filed in 12/591,200 (Jul.
`2, 2013) (with accompanying Declaration of Lewis Rubin, M.D.)
`WO 93/00951 to Patton
`Declaration of Scott Bennett, Ph.D.
`Affidavit of Christopher Butler, June 15, 2017
`Affidavit of Christopher Butler, June 16, 2017
`RESERVED
`RESERVED
`U.S. Patent No. 6,521,212 (“Cloutier ’212”)
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`1993
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`(“Purewal EP ’777”)
`U.S. Patent No. 4,895,719 (“Radhakrishnan ’719”)
`
`1012
`1013
`1014
`1015
`1016
`1017
`1018
`1019
`1020
`1021
`
`1006
`1007
`1008
`1009
`
`1010
`1011
`
`1022
`1023
`
`1024
`
`i
`
`

`

`1025
`1026
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`1032
`
`1033
`
`1034
`1035
`
`1036
`
`1037
`
`1038
`
`1039
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`1040
`
`U.S. Patent No. 5,153,222 (“Tadepalli ’222”)
`U.S. Patent No. 6,357,671 (“Cewers ’671”)
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`272_Remodulin.cfm (“Remodulin® Approval Package”)
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`https://www.ptcommunity.com/news/2003-09-22-000000/european-
`agency-approves-ventavis-primary-pulmonary-hypertension
`EU Community Register of Medicinal Products, Homepage,
`http://ec.europa.eu/health/documents/community-
`register/html/index_en.htm
`EMEA Scientific Discussion, Ventavis® (2004),
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`Muller et al., “Use of Inhaled Iloprost in a Case of Pulmonary
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`Anesthesiology 743-747 (2003)
`
`ii
`
`

`

`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
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`
`1049
`
`1050
`
`1051
`
`Mueller et al., “Inhaled Iloprost in the Management of Pulmonary
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`21 Eur. J. Anaesthesiology (suppl. 33) 2-36 (2004)
`Commission Decision C(2005)3436 of 05 September 2005,
`http://ec.europa.eu/health/documents/community-
`register/2005/2005090510259/dec_10259_en.pdf
`EU Community Register of Medicinal Products for Human Use,
`Ventavis, http://ec.europa.eu/health/documents/community-
`register/html/h255.htm#
`Summary of Community Decisions, Official Journal of the European
`Union (Oct. 28, 2005) http://eur-lex.europa.eu/legal-
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`vasodilator in severe pulmonary hypertension,” 25 European Heart
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`register/register_faq_2015.pdf
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`Council of 31 March 2004, http://eur-lex.europa.eu/LexUriServ/
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`Register of Commission Documents, European Union,
`https://ec.europa.eu/transparency/regdoc/index.cfm?fuseaction=home
`
`iii
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`

`

`1052
`
`1053
`
`1054
`1055
`1056
`1057
`1058
`
`1059
`1060
`
`1061
`
`1062
`
`1063
`1064
`1065
`1066
`1067
`1068
`1069
`1070
`1071
`1072
`1073
`1074
`1075
`1076
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`Regulation (EC) No. 1049/2001 of the European Parliament and of the
`Council of 30 May 2001,
`http://www.europarl.europa.eu/RegData/PDF/r1049_en.pdf
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`https://ec.europa.eu/transparency/regdoc/index.cfm?fuseaction=
`list&n=10&adv=0&coteId=&year=2005&number=
`3436&version=ALL&dateFrom=&dateTo=
`&serviceId=&documentType=&title=&titleLanguage=&titleSearch=
`EXACT&sortBy=NUMBER&sortOrder=DESC (search result for
`document search of Commission reference number ‘3436’ for year
`‘2005’)
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`Declaration of DeForest McDuff, Ph.D.
`U.S. Patent No. 9,358,240
`U.S. Patent No. 6,756,033
`Amendment and Reply filed in 13/469,854 (Jan. 4, 2013) (with
`accompanying Declaration of Lewis Rubin, M.D.)
`Reply in 13/469,854 (June 13, 2014)
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`Adcirca, FDA Label, 5/2017
`Adempas, FDA Label, 10/2016
`Bayer, Annual Report, 2014
`Bayer, Annual Report, 2015
`
`iv
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`

`

`1078
`1079
`
`1080
`1081
`1082
`1083
`1084
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`1085
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`Economics of the Biopharmaceuticals Industry, New York: Oxford
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`
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`
`viii
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`

`

`Petitioner submits this reply to address two issues raised in Patent Owner’s
`
`Preliminary Response (“POPR”) (Paper No. 5): (1) the timeliness of the Petition;
`
`and (2) the prior art status of Ghofrani (Ex. 1005). Prior authorization for this
`
`submission was provided by email from the Board on November 2, 2017.
`
`A. The Petition Was Timely Filed.
`
`Patent Owner asserts that the Petition was untimely because Petitioner was
`
`served with a motion to amend its complaint attaching as an exhibit a proposed
`
`amended complaint on June 17, 2016. POPR, 14-15. Patent Owner is incorrect as
`
`the Board has previously found when confronted with this identical issue. See TRW
`
`Automotive US LLC v. Magna Elecs, Inc., IPR2014-293, Paper 18 at 10-11 (PTAB
`
`June 27, 2014). Attaching a proposed amended complaint to a motion seeking leave
`
`of court to file an amended complaint is not service with the amended complaint
`
`itself. Section 315(b), therefore, was not triggered until the Court authorized and
`
`Patent Owner filed the amended complaint. This happened on June 21, 2016. Prior
`
`to that date, no “complaint alleging infringement of the patent” involved in this
`
`proceeding had been served under any reasonable interpretation of the Federal Rules
`
`of Civil Procedure.
`
`Patent Owner’s position is contrary to the Federal Rules of Civil Procedure,
`
`which the Board looks to in determining issues related to service of a complaint. See
`
`Macauto U.S.A. v. BOS GmbH & KG, IPR2012-00004, Paper 18 (P.T.A.B. Jan. 24,
`
`1
`
`

`

`2013) (looking to Fed. R. Civ. P. 4(d) to determine bar date); The Scotts Co. LLC v.
`
`Encap, LLC, IPR2013-00110, Paper 12 (Jul. 3, 2013) (same). Rule 15(a)(2) allows
`
`for an amended complaint “with the opposing party’s written consent or the court’s
`
`leave” and Rule 15(a)(3) requires a party to respond to an amended complaint
`
`“within 14 days after service of the amended pleading.” Where, as here, a party
`
`seeks leave to amend under Rule 15, that leaves “the matter in the court’s hands to
`
`decide” and “an actual ‘complaint’ within the meaning of § 315(b)” does not exist
`
`until it is “granted by the Court.” TRW, 2014-293, Paper 18 at 9-11.
`
`Attaching a proposed amended complaint to a motion for leave to amend does
`
`not constitute “service” that triggers the 14 day response period under Fed R. Civ.
`
`P. 15(a)(3). Nor does it constitute service under § 315(b) as another panel of the
`
`Board has already concluded. See TRW, at 11 (“[W]e conclude that on December
`
`20, 2012, Patent Owner served Petitioner with a Motion for Leave to file its Second
`
`Amended Complaint, but Petitioner was not ‘served with a complaint’ alleging
`
`infringement of the . . . patents for the purposes of § 315(b).”). Here, once the Court
`
`allowed the amended complaint (Ex. 1165, D.I. 48), Patent Owner filed it the same
`
`day (Ex. 1166, D.I. 49). Because that happened on June 21, 2016, that date is when
`
`Petitioner was served with a complaint for purposes of Fed. R. Civ. P. 15(a)(3) and
`
`35 U.S.C. § 315(b). TRW, at 9.
`
`Tellingly, Patent Owner cites TRW to support its cause. That decision rejected
`
`2
`
`

`

`the very argument Patent Owner advances. Despite Patent Owner’s efforts to
`
`distinguish TRW, the relevant facts stand on all fours. In both, the Board is
`
`confronted with the same question: does service of a proposed amended complaint
`
`attached to a motion to amend constitute service of a complaint under § 315(b)?
`
`TRW unequivocally found it does not. TRW, at 10-11. Patent Owner’s discussion
`
`of ancillary dicta in TRW, POPR at 18-19, does nothing to distinguish its clear
`
`holding on the identical question now before the Board. Patent Owner’s argument
`
`that Petitioner “was aware of and conceded its status as a defendant” prior to June
`
`21, 2016 is of no moment. (POPR at 15.) The statute requires service of a complaint,
`
`not notice. Like in TRW, the Petition here was timely.
`
`B. Ghofrani Is Prior Art By Another.
`
`The authors of Ghofrani differ from the named inventors. Ghofrani has five
`
`authors, two of whom are inventors, Drs. Seeger and Voswinckel, and three who are
`
`not, Drs. Ghofrani, Grimminger and Reichenberger. (Ex. 1005.) In addition to Drs.
`
`Seeger and Voswinckel, the patent at issue names five additional inventors:
`
`Olschewski, Roscigno, Rubin, Schmehl and Sterritt. (Ex. 1001.) Recognizing this
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`disparity in inventive entities, Patent Owner submitted substantively identical
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`declarations from Drs. Ghofrani, Grimminger and Reichenberger. (Exs. 2026, 2027,
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`and 2028.) In those declarations, the non-inventor authors declared that they had
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`nothing to do with the section of Ghofrani relied on by Petitioner related to inhaled
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`3
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`treprostinil. (E.g., Ex. 2026 ¶ 5.) They say instead that Dr. Ghofrani was involved
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`in the section of the paper discussing phosphodiesterase inhibitors (PDEs) and Drs.
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`Grimminger and Reichenberger were involved in the section of the paper discussing
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`endothelin A receptor antagonists (ERAs). (E.g., Ex. 2026 ¶¶ 4, 6.)1
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` While the declarations suggest that Drs. Ghofrani, Grimminger, and
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`Reichenberger were not involved in aspects of the paper germane to the patentability
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`challenge lodged in the Petition, other evidence of record casts doubt on their
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`recollections. Indeed, other evidence of record shows that the declarants were
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`involved in studies of inhaled treprostinil, such as the study described in Ghofrani,
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`contrary to their declarations. For example, the Voswinckel, et al. reference (Ex
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`1003) includes a discussion that is solely limited to a study involving inhaled
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`treprostinil. (Id. at 7.) Drs. Ghofrani, Grimminger and Reichenberger are all authors
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`on Voswinckel. (Id.) Indeed, the Voswinckel reference appears to describe the same
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`work disclosed in Ghofrani. Both studies were conducted in Geisen, Germany,
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`included 17 patients with severe pulmonary hypertension, and resulted in pulmonary
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`selective vasodilation following inhaled administration of treprostinil. (Ex. 1003 at
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`7, Ex. 1005 at 3.)2 Similarly, an earlier Voswinckel, et al. reference (Ex 1046)
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`(Voswinckel II) solely discussing inhaled treprostinil in the treatment of pulomary
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`1 Patent Owner did not submit a declaration from any of the inventors declaring
`that the work described in Ghofrani was the inventors’ own work.
`2 There is no discussion of PDEs or ERAs in the Voswinckel reference.
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`4
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`hypertension (with no discussion of PDEs or ERAs) also includes Drs. Ghofrani and
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`Reichenberger as co-authors. That reference is even cited in Ghofrani, (Ex. 1005 at
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`n. 6), and in it, the authors—including Drs. Ghofrani and Reichenberger—expressly
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`state that “we investigated the acute hemodynamic response to inhaled treprostinil.”
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`(Ex. 1046 at 5) (emphasis added).
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`A printed publication is prima facie prior art under 102(a) when its
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`“authorship differs in any way from the inventive entity unless it is stated within the
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`publication itself that the publication is describing the applicant’s work.” MPEP
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`2132.01; see also In re Katz, 687 F.2d 450, 455 (C.C.P.A. 1982); Cognex Corp. v.
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`Microscan Sys., Inc., No. 13 CIV. 2027, 2013 WL 5550092, at *2 (S.D.N.Y. Sept.
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`30, 2013). Ghofrani contains no such statement. Instead, it cites to an article co-
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`authored by Ghofrani and Reichenberger that expressly says they were involved in
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`studies involving inhaled treprostinil, contrary to their declarations.
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`These inconsistencies between the uncorroborated declarations and other
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`evidence of record demonstrate that at the very least there is a factual dispute as to
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`whether Ghofrani was “by another.” Petitioner expects that a fully developed record
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`on the matter will allow it to show Ghofrani is prior art to the challenged claims. See
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`37 CFR 42.108(c); see also Emerachem Holdings, LLC v. Volkswagen Group of
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`Am., Inc., -- F.3d --, 2017 WL 2587462, at*3-5 (Fed. Cir. Jun. 15, 2017) (holding
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`uncorroborated declarations insufficient to prove prior art was inventors’ own work).
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`5
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`Dated: November 9, 2017
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`Respectfully submitted,
`
`/Michael K. Nutter/
`Michael K. Nutter, Lead Counsel
`Reg. No. 44,979
`Andrew R. Sommer, Back-Up Counsel
`Reg. No. 53,932
`Kurt A. Mathas, Back-Up Counsel
`WINSTON & STRAWN LLP
`
`6
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Petitioner’s Reply in
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`Support of Petition For Inter Pares Review of U.S. Patent No. 9,339,507 is
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`being served on November 9, 2017, by filing this document through the PTAB
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`E2E System as well as delivering a copy via email to the following counsel for the
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`Patent Owner:
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`Stephen B. Maebius – Lead Counsel
`Email: smaebius@foley.com
`George Quillin
`Email: gquillin@foley.com
`UT507-IPR@foley.com
`FOLEY & LARDNER LLP
`
`Shaun R. Snader
`Email: ssnader@unither.com
`UNITED THERAPEUTICS CORP.
`
`Douglas Carsten
`Email: dcarsten@wsgr.com
`Richard Torczon
`Email: rtorczon@wsgr.com
`Robert Delafield
`Email: bdelafield@wsgr.com
`Veronica Ascarrunz
`Email: vascarrunz@wsgr.com
`WILSON, SONSINI, GOODRICH & ROSATI
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`7
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`
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`Dated: November 9, 2017
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`Respectfully submitted,
`
`/Michael K. Nutter/
`Michael K. Nutter, Lead Counsel
`Reg. No. 44,979
`Andrew R. Sommer, Back-Up Counsel
`Reg. No. 53,932
`Kurt A. Mathas, Back-Up Counsel
`WINSTON & STRAWN LLP
`
`8
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`