Case 1:14-cv-01237-GMS Document 1 Filed 09/25/14 Page 1 of 11 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`Civil Action No. ___________
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`)))))
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`)))))))
`
`CEPHALON, INC.
`
`v.
`
`Plaintiff,
`
`AGILA SPECIALTIES INC. f/k/a STRIDES, INC.
`and ONCO THERAPIES LIMITED,
`
`Defendants.
`
`COMPLAINT
`
`Cephalon, Inc. (“Cephalon” or “Plaintiff”) brings this action for patent infringement
`
`against Defendants Agila Specialties Inc. f/k/a Strides, Inc. and Onco Therapies Limited
`
`(collectively “Onco” or “Defendants”).
`
`1.
`
`This is an action by Cephalon against Onco for infringement of United States
`
`Patent No. 8,791,270 (“the ’270 patent”). This action arises out of Onco’s filing of an
`
`Abbreviated New Drug Application (“ANDA”) seeking approval by the United States Food and
`
`Drug Administration (“FDA”) to sell generic versions of TREANDA®, Cephalon’s innovative
`
`treatment for chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, prior to the
`
`expiration of the ’270 patent.
`
`Cephalon, Inc.
`
`THE PARTIES
`
`2.
`
`Plaintiff Cephalon, Inc. is a corporation operating and existing under the laws of
`
`Delaware, with its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355.
`
`1
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`AGILA ET AL - EXHIBIT 1020
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`

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`Case 1:14-cv-01237-GMS Document 1 Filed 09/25/14 Page 2 of 11 PageID #: 2
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`Cephalon is engaged in the business of research, development, manufacture, and sale of
`
`innovative pharmaceutical products throughout the world.
`
`Agila Specialties Inc. and Onco Therapies Limited
`
`3.
`
`On information and belief, Defendant Agila Specialties Inc. f/k/a Strides, Inc. is a
`
`corporation organized and existing under the laws of New Jersey, with its principal place of
`
`business at 201 South Main Street, Suite #3, Lambertville, New Jersey 08530.
`
`4.
`
`On information and belief, Defendant Onco Therapies Limited is a corporation
`
`organized and existing under the laws of India, with its principal place of business at Strides
`
`House, Bilkahalli, Bannerghatta Road, Bangalore, Karnataka India 560076.
`
`5.
`
`On information and belief, both Agila Specialties Inc. f/k/a Strides Inc. and Onco
`
`Therapies Limited submitted, collaborated and/or acted in concert in the preparation or
`
`submission of ANDA No. 204104.
`
`JURISDICTION AND VENUE
`
`Subject Matter Jurisdiction
`
`6.
`
`7.
`
`This action for patent infringement arises under 35 U.S.C. § 271.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a), and the Declaratory Judgment Act, 28 U.S.C §§ 2201 and 2202.
`
`Personal Jurisdiction Over Defendants
`
`8.
`
`On information and belief, this Court has personal jurisdiction over Agila
`
`Specialties Inc. f/k/a Strides, Inc. and Onco Therapies Limited because, among other things, both
`
`defendants market, distribute and/or sell generic drugs throughout the United States and within
`
`the State of Delaware and therefore purposefully avail themselves of the privilege of conducting
`
`activities within the State of Delaware. Defendants have also committed, or aided, abetted,
`
`2
`
`

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`Case 1:14-cv-01237-GMS Document 1 Filed 09/25/14 Page 3 of 11 PageID #: 3
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`contributed to and/or participated in the commission of, the tortious action of patent infringement
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`that has led to foreseeable harm and injury to Cephalon, which manufactures TREANDA®, for
`
`sale and use throughout the United States, including the State of Delaware.
`
`9.
`
`On information and belief, Defendants previously have been sued in this Judicial
`
`District, did not challenge this Court’s exertion of personal jurisdiction over them, and have
`
`availed themselves of this forum by asserting counterclaims for the purpose of litigating a patent
`
`infringement dispute. See Cubist Pharm. Inc. v. Strides Inc. et al., C.A. No. 13-01679 (D. Del.);
`
`Aventis Pharma S.A. et al. v. Strides, Inc. et al., 1:11-cv-01121 (D. Del.); Senju Pharm. Co., Ltd.
`
`et al. v. Strides, Inc. et al., C.A. No. 13-00851 (D. Del.).
`
`10.
`
`On information and belief, this Court also personal jurisdiction over Defendants
`
`because they did not challenge this Court’s exercise of personal jurisdiction over them for
`
`purposes of litigating allegations of patent infringement involving the ANDA that is the subject
`
`matter of this lawsuit. See Cephalon, Inc. v. Agila Specialties Inc. f/k/a Strides, Inc. and Onco
`
`Therapies Limited, C.A. No. 13-2080-GMS.
`
`Venue
`
`11.
`
`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400(b).
`
`The ’270 Patent
`
`BACKGROUND
`
`12.
`
`The ’270 patent, entitled “Bendamustine Pharmaceutical Compositions,” was duly
`
`and lawfully issued on July 29, 2014 to inventors Jason E. Brittain and Joe C. Franklin.
`
`13.
`
`The named inventors of the ’270 patent assigned their rights in the ’270 patent to
`
`Cephalon.
`
`3
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`

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`Case 1:14-cv-01237-GMS Document 1 Filed 09/25/14 Page 4 of 11 PageID #: 4
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`14.
`
`Cephalon is the sole owner by assignment of all rights, title and interest in the
`
`’270 patent.
`
`15.
`
`Shortly after the ’270 patent issued, Cephalon listed the ’270 patent in FDA
`
`publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly
`
`referred to as “the Orange Book” (“Orange Book”), with respect to TREANDA®.
`
`16.
`
`The ’270 patent will expire on January 12, 2026. A true and accurate copy of the
`
`’270 patent is attached hereto as Exhibit A.
`
`The TREANDA® Drug Product
`
`17.
`
`Cephalon researched, developed, applied for and obtained FDA approval to
`
`manufacture, sell, promote and/or market bendamustine hydrochloride products known as
`
`TREANDA®.
`
`18.
`
`Cephalon has been selling, promoting, distributing and marketing TREANDA® in
`
`the United States since 2008.
`
`19.
`
`TREANDA® is indicated to treat chronic lymphocytic leukemia and non-
`
`Hodgkin’s lymphoma.
`
`20.
`
`Cephalon holds New Drug Application No. 22249 and No. 22303 under Section
`
`505(a) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(a), for multiple
`
`TREANDA® products used for treating chronic lymphocytic leukemia and non-Hodgkin’s
`
`lymphoma.
`
`The Onco ANDA
`
`21.
`
`Onco filed with FDA an Abbreviated New Drug Application under 21 U.S.C.
`
`§ 355(j) seeking approval to manufacture, use, offer for sale, sell in and import into the United
`
`States Bendamustine HCl for injection, for intravenous infusion (25 mg and 100 mg) (“Onco’s
`
`4
`
`

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`Case 1:14-cv-01237-GMS Document 1 Filed 09/25/14 Page 5 of 11 PageID #: 5
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`Bendamustine Product”) prior to the expiration of United States Patent No. 8,445,524 (“the ’524
`
`patent”) and United States Patent No. 8,436,190 (“the ’190 patent”).
`
`22.
`
`FDA assigned the ANDA for Onco’s Bendamustine Product the number 204104.
`
`The Ongoing Litigation
`
`23.
`
`In connection with its ANDA, Onco filed with FDA, pursuant to 21 U.S.C.
`
`§ 355(j)(2)(B)(iv), a certification alleging that the claims of other Cephalon patents, United
`
`States Patent No. 8,445,524 (“the ’524 patent”) and United States Patent No. 8,436,190 (“the
`
`’190 patent”), are invalid, unenforceable and/or would not be infringed by the manufacture, use,
`
`importation, sale or offer for sale of Onco’s Bendamustine Product (“Onco’s Paragraph IV
`
`Certification”).
`
`24.
`
`By letter dated November 7, 2013, Onco notified Cephalon that it had filed
`
`ANDA No. 204104 seeking approval to market Onco’s Bendamustine Product prior to the
`
`expiration of the ’524 patent and the ’190 patent (“Onco Notice Letter”).
`
`25.
`
`On December 20, 2013, Cephalon sued Onco for patent infringement of the ’524
`
`patent and the ’190 patent in the District of Delaware. See Cephalon, Inc. v. Agila Specialties
`
`Inc. f/k/a Strides, Inc. and Onco Therapies Limited, C.A. No. 13-2080-GMS. That action was
`
`commenced before the expiration of forty-five days from the date of receipt of the Onco Notice
`
`Letter, which effectively stayed FDA from granting final approval to Onco’s ANDA No. 204104
`
`prior to the expiration of 30 months from the date the Onco Notice Letter was received by
`
`Cephalon.
`
`COUNT I:INFRINGEMENT OF U.S. PATENT NO. 8,791,270 BY ONCO
`
`26.
`
`The allegations of the preceding paragraphs 1–25 are re-alleged and incorporated
`
`herein by reference.
`
`5
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`

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`27.
`
`The ’270 patent issued on July 29, 2014, and Cephalon timely listed the ’270
`
`patent in the Orange Book.
`
`Cephalon notified Onco of the issuance of the ’270 patent before filing this action.
`
`The use of Onco’s Bendamustine Product is covered by one or more claims of the
`
`28.
`
`29.
`
`’270 patent.
`
`30.
`
`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Onco’s Bendamustine Product would infringe one or more claims of the
`
`’270 patent.
`
`31.
`
`Under 35 U.S.C. § 271(e)(2)(A), Onco’s submission to FDA of the Onco ANDA
`
`to obtain approval for Onco’s Bendamustine Product before the expiration of the ’270 patent
`
`constitutes an act of infringement, and if approved, the commercial manufacture, use, offer to
`
`sell, sale, or importation of Onco’s Bendamustine Product containing bendamustine
`
`hydrochloride, would infringe one or more claims of the ’270 patent.
`
`32.
`
`On information and belief, Onco’s Bendamustine Product contains the same
`
`active pharmaceutical ingredient, bendamustine hydrochloride, as that used in Cephalon’s
`
`TREANDA® products and claimed in the ’270 patent.
`
`33.
`
`On information and belief, Onco’s Bendamustine Product is the pharmaceutical
`
`composition of bendamustine hydrochloride, containing less than or equal to 4.0% (area percent
`
`of bendamustine) of bendamustine degradants, recited in one or more claims of the ’270 patent.
`
`34.
`
`On information and belief, Onco’s Bendamustine Product is the pharmaceutical
`
`composition of bendamustine hydrochloride, containing not more than the amount of the HP1
`
`degradant, recited in one or more claims of the ’270 patent.
`
`6
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`

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`35.
`
`On information and belief, Onco’s Bendamustine Product infringes one or more
`
`claims of the ’270 patent.
`
`36.
`
`On information and belief, Onco plans and intends to, and will, infringe the ’270
`
`patent immediately and imminently upon approval of the Onco ANDA.
`
`37.
`
`On information and belief, Onco, under 35 U.S.C. § 271(b), acted in concert,
`
`actively supported, participated in, encouraged, and/or induced the infringement of one or more
`
`claims of the ’270 patent.
`
`38.
`
`On information and belief, Onco plans and intends to, and will, actively induce
`
`infringement of the ’270 patent when the Onco ANDA is approved, and plan and intend to, and
`
`will, do so immediately and imminently upon approval.
`
`39.
`
`On information and belief, Onco knows that Onco’s Bendamustine Product is
`
`especially made or adapted for use in infringing the ’270 patent and that Onco’s Bendamustine
`
`Product is not suitable for substantial non-infringing uses. On information and belief, under 35
`
`U.S.C. § 271(c), Onco plans and intends to, and will, contribute to the infringement of the ’270
`
`patent immediately and imminently upon approval of the Onco ANDA.
`
`40.
`
`The foregoing actions by Onco constitute and/or would constitute infringement of
`
`the ’270 patent, active inducement of infringement of the ’270 patent and/or contribution to the
`
`infringement by others of the ’270 patent.
`
`41.
`
`On information and belief, Onco acted without a reasonable basis for believing
`
`that it would not be liable for infringing the ’270 patent, actively inducing infringement of the
`
`’270 patent and/or contributing to the infringement by others of the ’270 patent.
`
`42.
`
`Cephalon will be substantially and irreparably harmed by Onco’s infringing
`
`activities unless the Court enjoins those activities. Cephalon will have no adequate remedy at
`
`7
`
`

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`Case 1:14-cv-01237-GMS Document 1 Filed 09/25/14 Page 8 of 11 PageID #: 8
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`law if Onco is not enjoined from the commercial manufacture, use, offer to sell, sale in and
`
`importation into the United States of Onco’s Bendamustine Product.
`
`43.
`
`Onco’s activities render this case an exceptional one, and Cephalon is entitled to
`
`an award of its reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`COUNT II: DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 8,791,270 BY ONCO
`
`44.
`
`The allegations of the preceding paragraphs 1–43 are re-alleged and incorporated
`
`herein by reference.
`
`45.
`
`On information and belief, Onco plans to begin manufacturing, marketing, selling,
`
`offering to sell and/or importing Onco’s Bendamustine Product soon after FDA approval of the
`
`Onco ANDA.
`
`46.
`
`Such conduct will constitute direct infringement of one or more claims on the
`
`’270 patent under 35 U.S.C. § 271(a), inducement of infringement of the ’270 patent under 35
`
`U.S.C. § 271(b), and contributory infringement under 35 U.S.C. § 271(c).
`
`47.
`
`Defendants’ infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of the Onco ANDA.
`
`48.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Cephalon and Onco as to liability for the infringement of the
`
`’270 patent. Onco’s actions have created in Cephalon a reasonable apprehension of irreparable
`
`harm and loss resulting from Onco’s threatened imminent actions.
`
`49.
`
`On information and belief, Onco will knowingly and willfully infringe the ’270
`
`patent.
`
`50.
`
`Cephalon will be substantially and irreparably harmed by Onco’s infringing
`
`activities unless the Court enjoins those activities.
`
`8
`
`

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`Case 1:14-cv-01237-GMS Document 1 Filed 09/25/14 Page 9 of 11 PageID #: 9
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Cephalon respectfully requests the following relief:
`
`a.
`
`b.
`
`a judgment that the ’270 patent is valid and enforceable;
`
`a judgment that Onco’s submission of the Onco ANDA No. 204104 was an act of
`
`infringement of one or more claims of the ’270 patent and that the making, using, offering to sell,
`
`selling, marketing, distributing, or importing of Onco’s Bendamustine Product prior to the
`
`expiration of the ’270 patent will infringe, actively induce infringement and/or contribute to the
`
`infringement of one or more claims of the ’270 patent;
`
`c.
`
`an Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
`
`any FDA approval of the Onco ANDA No. 204104 or any product or compound the use of which
`
`infringes the ’270 patent shall be a date that is not earlier than the expiration of the ’270 patent;
`
`d.
`
`an Order pursuant to 35 U.S.C. § 271(e)(4)(B) permanently enjoining Onco and
`
`all persons acting in concert with Onco from commercially manufacturing, using, offering for
`
`sale, selling, marketing, distributing, or importing Onco’s Bendamustine Product, or any product
`
`or compound the use of which infringes the ’270 patent, or inducing or contributing to the
`
`infringement of the ’270 patent, until after the expiration of the ’270 patent;
`
`e.
`
`an Order pursuant to 35 U.S.C. § 283 permanently enjoining Onco and all persons
`
`acting in concert with Onco from commercially manufacturing, using, offering for sale, selling,
`
`marketing, distributing, or importing Onco’s Bendamustine Product, or any product or
`
`compound the use of which infringes the ’270 patent, or inducing or contributing to the
`
`infringement of the ’270 patent, until after the expiration of the ’270 patent;
`
`9
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`

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`Case 1:14-cv-01237-GMS Document 1 Filed 09/25/14 Page 10 of 11 PageID #: 10
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`f.
`
`an Order enjoining Onco and all persons acting in concert with Onco from
`
`seeking, obtaining, or maintaining approval of the Onco ANDA No. 204104 before the
`
`expiration of the ’270 patent;
`
`g.
`
`an award of Cephalon’s damages or other monetary relief to compensate
`
`Cephalon if Onco engages in the commercial manufacture, use, offer to sell, sale or marketing or
`
`distribution in, or importation into the United States of Onco’s Bendamustine Product, or any
`
`product or compound the use of which infringes the ’270 patent, or the inducement or
`
`contribution of the foregoing, prior to the expiration of the ’270 patent in accordance with 35
`
`U.S.C. § 271(e)(4)(C);
`
`h.
`
`an award of Cephalon’s damages or other monetary relief to compensate
`
`Cephalon if Onco engages in the commercial manufacture, use, offer to sell, sale or marketing or
`
`distribution in, or importation into the United States of Onco’s Bendamustine Product, or any
`
`product or compound the use of which infringes the ’270 patent, or the inducement or
`
`contribution of the foregoing, prior to the expiration of the ’270 patent;
`
`i.
`
`a judgment that this is an exceptional case and awarding Cephalon its attorneys’
`
`fees under 35 U.S.C. § 285;
`
`an award of Cephalon’s reasonable costs and expenses in this action; and
`
`an award of any further and additional relief to Cephalon as this Court deems just
`
`j.
`
`k.
`
`and proper.
`
`10
`
`

`
`Case 1:14-cv-01237-GMS Document 1 Filed 09/25/14 Page 11 of 11 PageID #: 11
`
`Dated: September 25, 2014
`
`BAYARD, P.A.
`
`OF COUNSEL:
`David M. Hashmall
`Calvin E. Wingfield Jr.
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`(212) 813-8800
`
`Daryl L. Wiesen
`Emily L. Rapalino
`Nicholas K. Mitrokostas
`Exchange Place
`Boston, MA 02109
`(617) 570-1000
`
`/s/ Stephen B. Brauerman
`Stephen B. Brauerman (sb4952)
`Vanessa R. Tiradentes (vt5398)
`Sara E. Bussiere (sb5725)
`222 Delaware Avenue, Suite 900
`Wilmington, DE 19801
`(302) 655-5000
`sbrauerman@bayardlaw.com
`vtiradentes@bayardlaw.com
`sbussiere@bayardlaw.com
`
`Attorneys for Plaintiff Cephalon, Inc.
`
`11
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`

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`Case 1:14-cv-01237-GMS Document 1-1 Filed 09/25/14 Page 1 of 29 PageID #: 12
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`Case 1:14—cv—01237—GMS Document 1-1 Filed 09/25/14 Page 1 of 29 Page|D #: 12Case 1:14—cv—01237—GMS Document 1-1 Filed 09/25/14 Page 1 of 29 Page|D #: 12
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`EXHIBIT A
`
`
`
`EXHIBIT AEXHIBIT A
`
`

`
`Case 1:14-cv-01237-GMS Document 1-1 Filed 09/25/14 Page 2 of 29 PageID #: 13
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`1111} Patent 1%.:
`{-15} Date 11fPsl:e-nt:
`
`US 3,391,270 B2
`Jul. 29, 2014
`
`1:54)
`
`BENDAI01-1'l_TSTINE UT[Cfl
`C01-PDEHIGNS
`1?]1 Applicant: cephelen, Inc.-. Frazer, PA {US}
`['12]
`Inventors: Jss-in Edward Brlmln, El Cajun. CA
`{US}; Joe Craig F1'11nlIIln, Tulsa, OK
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`We Asians: Cenhamn.Inc~Fra2r-nPA1Us:+
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`(22) Filed:
`Aug. 19, 2013
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`Case 1:14-cv-01237-GMS Document 1-1 Filed 09/25/14 Page 3 of 29 PageID #: 14
`Case l:l4—cv—Ol237—GMS Document 1-1 Filed 09/25/14 Page 3 of 29 Page|D #: 14
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`fi1:u:n Rate Liate ZIIIII3.
`Exv::er1:l
`Deutsehland. 2 pages.
`Flarrberg. d al.. “Low T Vacuum Drying of Siserile
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`
`

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`Case l:l4—cv—Ol237—GMS Document 1-1 Filed 09/25/14 Page 4 of 29 Page|D #: 15
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`US 8,331,231) 32
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`References Clted
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`ein
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