`
`
`
`John E. Flaherty
`Cynthia S. Betz
`McCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry St.
`Newark, New Jersey 07102
`(973) 622-4444
`jflaherty@mccarter.com
`cbetz@mccarter.com
`
`OF COUNSEL:
`Mark N. Reiter (pro hac vice forthcoming)
`Philip Spear (pro hac vice forthcoming)
`GIBSON, DUNN & CRUTCHER LLP
`2001 Ross Avenue #2100
`Dallas, Texas 75201
`(214) 698-3369
`mreiter@gibsondunn.com
`pspear@gibsondunn.com
`
`David Glandorf (pro hac vice forthcoming)
`GIBSON, DUNN & CRUTCHER LLP
`1801 California Street, Suite 4200
`Denver, CO 80202-2642
`Tel.: (303) 298-5726
`dglandorf@gibsondunn.com
`Attorneys for Plaintiff
`Merck Sharp & Dohme LLC
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`MERCK SHARP & DOHME LLC,
`
`
`
`
`Plaintiff,
`
` Civil Action No. ___________________
`
`v.
`
`GLAND PHARMA LIMITED,
`
`
`
`
`
`
`
`
`
`Defendant.
`
`Electronically Filed
`
`
`
`
`
`
`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 2 of 13 PageID: 2
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`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Merck Sharp & Dohme LLC (“Merck” or “Plaintiff”), by and through its
`
`undersigned attorneys, hereby files this Complaint for Patent Infringement against Defendant
`
`Gland Pharma Limited (“Gland” or “Defendant”) and alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement of U.S. Patent Nos. 9,023,790 (the “’790
`
`Patent”) and 9,358,297 (the “’297 Patent”) arising under the patent laws of the United States,
`
`Title 35, United States Code, § 100 et seq., and, in particular, under 35 U.S.C. § 271(e). Gland
`
`notified Merck pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) (the “Notice Letter”) that Gland is the
`
`owner of Abbreviated New Drug Application (“ANDA”) No. 217553, (the “Gland ANDA”),
`
`which Gland filed or caused to be filed under 21 U.S.C. § 355(j) with the United States Food and
`
`Drug Administration (“FDA”) for approval to engage in the commercial manufacture, use or sale
`
`of a generic version of Merck’s NOXAFIL® (posaconazole) intravenous (infusion) solution, 300
`
`mg/16.7 mL (18 mg/mL), which is sold in the United States. The Gland posaconazole
`
`intravenous solution product described in the Gland ANDA is referred to herein as the “Generic
`
`Posaconazole IV Solution Product.”
`
`THE PARTIES
`
`2.
`
`Plaintiff Merck is a corporation organized and existing under the laws of the State
`
`of New Jersey, having a principal place of business at 126 E Lincoln Ave Rahway, NJ, 07065-
`
`4607. Merck is a global, research-driven pharmaceutical company that discovers, develops,
`
`manufactures and markets a broad range of innovative products to improve health. Merck Sharp
`
`& Dohme LLC is the surviving entity after a merger with Merck Sharp & Dohme Corp., which
`
`was the previous owner of Merck’s NOXAFIL® product and the patents and NDA covering the
`
`
`
`
`
`1
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`
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`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 3 of 13 PageID: 3
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`
`
`same.
`
`3.
`
`On information and belief, Defendant Gland is a corporation organized and
`
`existing under the laws of India, with a place of business at Survey No. 143-148, 150 & 151
`
`Near Gandimaisamma ‘X’ Roads D.P. Pally, Dundigal Gandimaisamma Mandal Medchal-
`
`Malkjgiri District, Hyderabad, Telangana, 500043 India. On information and belief Gland is in
`
`the business of, among other things, manufacturing, promoting, marketing, selling, offering for
`
`sale, using, distributing, and importing into the United States, generic versions of branded
`
`pharmaceutical drugs for the U.S. market.
`
`JURISDICTION AND VENUE
`
`4.
`
`5.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1338(a).
`
`This Court has personal jurisdiction over Gland by virtue of its presence in New
`
`Jersey, having conducted business in New Jersey, having availed itself of the rights and benefits
`
`of New Jersey law such that it should reasonably anticipate being haled into court in this judicial
`
`district, and having engaged in systematic and continuous contacts with the State of New Jersey
`
`through the marketing and sales of generic drug products within this judicial district, through the
`
`receipt of revenue from the sales and marketing of generic drug products within this judicial
`
`district, and through its pursuit of regulatory approval for its Generic Posaconazole IV Solution
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`Product to market and sell its Generic Posaconazole IV Solution Product, if approved, in this
`
`judicial district and to residents of this judicial district, and having sent or caused to have sent the
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`Notice Letter to Merck in New Jersey, prompting the filing of this lawsuit.
`
`6.
`
`According to Gland, it has filed 139 ANDAs in the United States and has had 100
`
`approved. See Gland Pharma Limited 2021-2022 Annual Report, pg. 35 available at
`
`https://glandpharma.com/images/Annual_Report_2021-22_(Double_Page).pdf. Gland’s website
`
`
`
`
`
`2
`
`
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`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 4 of 13 PageID: 4
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`
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`further states that Gland has “a global footprint across 60 countries, including the United States.”
`
`See Home, available at https://glandpharma.com/ (last visited September 8, 2022):
`
`
`7.
`
`Although this Court has personal jurisdiction over Gland for at least the reasons
`
`set forth above, in the absence of such personal jurisdiction in any single state, a foreign entity
`
`such as Gland is subject to jurisdiction throughout the United States. See Fed. R. Civ. P. 4(k)(2);
`
`Merial Ltd. v. Cipla Ltd., 681 F.3d 1283, 1293–94 (Fed. Cir. 2012).
`
`8.
`
`Upon information and belief, Gland has previously submitted to the jurisdiction of
`
`this Court and has further previously availed itself of this Court by asserting counterclaims in at
`
`least the following actions: Fresenius Kabi Deutschland GmbH et al v. Gland Pharma Limited,
`
`No. 3:20-cv-12347 (D.N.J.) (Sept. 4, 2020); Merck Sharp & Dohme B.V. et al v. Gland Pharma
`
`Limited, No. 2:20-cv-02750 (D.N.J.) (Mar. 12, 2020); Chiesi USA Inc. et al v. Gland Pharma
`
`Limited, No. 2:19-cv-18565 (D.N.J.) (Sept. 30, 2019); Medicure Int’l, Inc. v. Gland Pharma
`
`Limited, No. 2:18-cv-16246 (D.N.J.) (Nov. 16, 2018).
`
`9.
`
`Venue is proper as to Gland in this judicial district under 28 U.S.C. § 1391(c)(3)
`
`because Gland is a foreign entity who may be sued in any judicial district. See In re HTC Corp.,
`
`889 F.3d 1349, 1357 (Fed. Cir. 2018).
`
`
`
`
`
`3
`
`
`
`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 5 of 13 PageID: 5
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`
`
`NOXAFIL®
`
`10. Merck is the holder of New Drug Application (“NDA”) N205596 for the
`
`manufacture and sale of posaconazole intravenous solution, which Merck markets and sells
`
`under the registered trademark NOXAFIL® (“NOXAFIL® for Injection”). NOXAFIL® for
`
`Injection is approved for the prophylaxis of invasive fungal infections in high risk patients.
`
`11.
`
`NOXAFIL® for Injection is an embodiment of one or more claims of the ’790
`
`Patent and the ’297 Patent (collectively, the “Patents-in-Suit”). The Patents-in-Suit are listed in
`
`the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange
`
`Book”) for NOXAFIL®.
`
`PATENTS-IN-SUIT
`
`12.
`
`The ’790 Patent, entitled “Posaconazole Intravenous Solution Formulations
`
`Stabilized by Substituted β-Cyclodextrin,” was duly and legally issued by the USPTO on May 5,
`
`2015. The Orange Book lists the expiration date of the ’790 Patent as July 4, 2031. Merck is the
`
`owner of all title, right and interest in and to the ’790 Patent by assignment. A copy of the ’790
`
`Patent is attached as Exhibit A.
`
`13.
`
`The ’297 Patent, entitled “Posaconazole Intravenous Solution Formulations
`
`Stabilized by Substituted β-Cyclodextrin” was duly and legally issued by the USPTO on June 7,
`
`2016. The Orange Book lists the expiration date of the ’297 Patent as June 24, 2031. Merck is
`
`the owner of all title, right and interest in and to the ’297 Patent by assignment. A copy of the
`
`’297 Patent is attached as Exhibit B.
`
`GLAND’S ANDA
`
`14.
`
`Gland filed or caused to be filed the Gland ANDA with the FDA, seeking FDA
`
`approval to market and sell within the United States the Generic Posaconazole IV Solution
`
`Product before the expiration of the Patents-in-Suit.
`
`
`
`
`
`4
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`
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`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 6 of 13 PageID: 6
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`
`
`15.
`
`On information and belief, the Gland ANDA identified Merck’s NOXAFIL® for
`
`Injection product and included a written certification, as required by 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV), alleging that the claims of the Patents-in-Suit are invalid or otherwise
`
`will not be infringed by the Generic Posaconazole IV Solution Product.
`
`16.
`
`On or about August 1, 2022, Merck received the Notice Letter from Gland, dated
`
`July 29, 2022, stating that pursuant to § 505(j)(2)(B)(ii) of the Federal Food Drug and Cosmetic
`
`Act, 21 U.S.C. § 355(j)(2)(B)(ii), Gland had submitted the Gland ANDA to the FDA.
`
`17.
`
`In its letter to Merck, Gland stated its allegation that the claims of the Patents-in-
`
`Suit are invalid.
`
`18.
`
`Gland does not contest that at least the pharmaceutical composition claims of the
`
`’790 and ’297 Patents would be infringed by the manufacture, use, or sale of the Generic
`
`Posaconazole IV Solution Product, unless those claims are found to be invalid.
`
`19.
`
`By filing or causing to be filed the Gland ANDA, Gland necessarily represented
`
`to the FDA that the Generic Posaconazole IV Solution Product has the same active ingredient as
`
`NOXAFIL® for Injection, has the same method of administration, dosage form, and strength as
`
`NOXAFIL® for Injection and is bioequivalent to NOXAFIL® for Injection.
`
`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 9,023,790
`
`20. Merck incorporates by reference Paragraphs 1–19 of this Complaint as if fully set
`
`forth herein.
`
`21.
`
`By filing or causing to be filed the Gland ANDA with the FDA under 21 U.S.C. §
`
`355(j) to obtain approval to engage in the commercial manufacture, use or sale of the Generic
`
`Posaconazole IV Solution Product before the expiration of the ’790 Patent, Gland committed an
`
`act of infringement under 35 U.S.C. § 271(e)(2).
`
`
`
`
`
`5
`
`
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`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 7 of 13 PageID: 7
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`
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`22.
`
`If Gland commercially makes, uses, offers to sell or sells the Generic
`
`Posaconazole IV Solution Product within the United States, or imports the Generic Posaconazole
`
`IV Solution Product into the United States, or induces or contributes to any such conduct during
`
`the term of the ’790 Patent, Gland would further infringe at least one claim of the ’790 Patent
`
`under 35 U.S.C. §§ 271(a), (b), and/or (c).
`
`23.
`
`Gland’s commercial manufacture, use, offer to sell, or sale of the Generic
`
`Posaconazole IV Solution Product within the United States, or importation of the Generic
`
`Posaconazole IV Solution Product into the United States, during the term of the ’790 Patent,
`
`would infringe at least one claim of the ’790 Patent.
`
`24.
`
`Upon approval of the Gland ANDA, and the commercial marketing of the
`
`Generic Posaconazole IV Solution Product, Gland would actively induce and/or contribute to
`
`infringement of at least one claim of the ’790 Patent. At least in light of the prescribing
`
`instructions Gland proposes to provide in connection with the Generic Posaconazole IV Solution
`
`Product, Gland will induce health care professionals, resellers, pharmacies, and end users of the
`
`Generic Posaconazole IV Solution Product to directly infringe one or more claims of the ’790
`
`Patent. Gland will encourage acts of direct infringement with knowledge of the ’790 Patent and
`
`knowledge that it is encouraging infringement.
`
`25.
`
`Gland had actual and constructive knowledge of the ’790 Patent prior to filing the
`
`Gland ANDA and was aware that the filing of the Gland ANDA with the request for FDA
`
`approval before the expiration of the ’790 Patent would constitute an act of infringement of the
`
`’790 Patent.
`
`
`
`
`
`6
`
`
`
`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 8 of 13 PageID: 8
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`
`
`26. Merck will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoined by this Court. Merck has no adequate
`
`remedy at law.
`
`COUNT II FOR INFRINGEMENT OF U.S. PATENT NO. 9,358,297
`
`27. Merck incorporates by reference Paragraphs 1–26 of this Complaint as if fully set
`
`forth herein.
`
`28.
`
`By filing or causing to be filed the Gland ANDA with the FDA under 21 U.S.C. §
`
`355(j) to obtain approval to engage in the commercial manufacture, use or sale of the Generic
`
`Posaconazole IV Solution Product before the expiration of the ’297 Patent, Gland committed an
`
`act of infringement under 35 U.S.C. § 271(e)(2).
`
`29.
`
`If Gland commercially makes, uses, offers to sell or sells the Generic
`
`Posaconazole IV Solution Product within the United States, or imports the Generic Posaconazole
`
`IV Solution Product into the United States, or induces or contributes to any such conduct during
`
`the term of the ’297 Patent, Gland would further infringe at least one claim of the ’297 Patent
`
`under 35 U.S.C. §§ 271(a), (b), and/or (c).
`
`30.
`
`Gland’s commercial manufacture, use, offer to sell, or sale of the Generic
`
`Posaconazole IV Solution Product within the United States, or importation of the Generic
`
`Posaconazole IV Solution Product into the United States, during the term of the ’297 Patent,
`
`would infringe at least one claim of the ’297 Patent.
`
`31.
`
`Upon approval of the Gland ANDA, and the commercial marketing of the
`
`Generic Posaconazole IV Solution Product, Gland would actively induce and/or contribute to
`
`infringement of at least one claim of the ’297 Patent. At least in light of the prescribing
`
`instructions Gland proposes to provide in connection with the Generic Posaconazole IV Solution
`
`
`
`
`
`7
`
`
`
`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 9 of 13 PageID: 9
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`
`
`Product, Gland will induce health care professionals, resellers, pharmacies, and end users of the
`
`Generic Posaconazole IV Solution Product to directly infringe one or more claims of the ’297
`
`Patent. Gland will encourage acts of direct infringement with knowledge of the ’297 Patent and
`
`knowledge that it is encouraging infringement.
`
`32.
`
`Gland had actual and constructive knowledge of the ’297 Patent prior to filing the
`
`Gland ANDA and was aware that the filing of the Gland ANDA with the request for FDA
`
`approval before the expiration of the ’297 Patent would constitute an act of infringement of the
`
`’297 Patent.
`
`33. Merck will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoined by this Court. Merck has no adequate
`
`remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff prays for judgment in its favor and against Defendant and
`
`respectfully requests the following relief:
`
`A.
`
`A judgment that Defendant has infringed one or more claims of the ’790
`
`Patent under 35 U.S.C. § 271(e)(2) by submitting the Gland ANDA;
`
`B.
`
`A judgment that Defendant has infringed one or more claims of the ’297
`
`Patent under 35 U.S.C. § 271(e)(2) by submitting the Gland ANDA;
`
`C.
`
`A judgment, pursuant to 35 U.S.C. § 271(e)(4)(B), preliminarily and
`
`permanently enjoining Defendant, its officers, agents, servants, employees, parents, subsidiaries,
`
`divisions, affiliates, from making, using, selling, offering to sell, or importing any product that
`
`infringes the ’790 Patent, including the product described in the Gland ANDA, prior to the
`
`expiration of the ’790 Patent, including any extensions;
`
`
`
`
`
`8
`
`
`
`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 10 of 13 PageID: 10
`
`
`
`D.
`
`A judgment, pursuant to 35 U.S.C. § 271(e)(4)(B), preliminarily and
`
`permanently enjoining Defendant, its officers, agents, servants, employees, parents, subsidiaries,
`
`divisions, affiliates, from making, using, selling, offering to sell, or importing any product that
`
`infringes the ’297 Patent, including the product described in the Gland ANDA, prior to the
`
`expiration of the ’297 Patent, including any extensions;
`
`E.
`
`A judgment declaring that making, using, selling, offering to sell, or
`
`importing the product described in the Gland ANDA, or inducing or contributing to such
`
`conduct, would constitute infringement of the ’790 Patent by Defendant pursuant to 35 U.S.C.
`
`§ 271;
`
`F.
`
`A judgment declaring that making, using, selling, offering to sell, or
`
`importing the product described in the Gland ANDA, or inducing or contributing to such
`
`conduct, would constitute infringement of the ’297 Patent by Defendant pursuant to 35 U.S.C.
`
`§ 271;
`
`G.
`
`A judgment ordering that, pursuant to 35 U.S.C. § 271(e)(4)(A), the
`
`effective date of any approval of the Gland ANDA be a date that is not earlier than the expiration
`
`of the ’790 Patent or any later expiration of exclusivity to which Plaintiff is or becomes entitled;
`
`H.
`
`A judgment ordering that, pursuant to 35 U.S.C. § 271(e)(4)(A), the
`
`effective date of any approval of the Gland ANDA be a date that is not earlier than the expiration
`
`of the ’297 Patent or any later expiration of exclusivity to which Plaintiff is or becomes entitled;
`
`I.
`
`If Defendant, its officers, agents, servants, employees, parents,
`
`subsidiaries, divisions, affiliates, and those persons in active concert or participation with any of
`
`them commercially manufactures, uses, offers to sell, sells or imports the product described in
`
`the Gland ANDA prior to the expiration of the ’790 Patent or any later expiration of exclusivity
`
`
`
`
`
`9
`
`
`
`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 11 of 13 PageID: 11
`
`
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`to which Plaintiff is or becomes entitled, a judgment awarding Plaintiff monetary relief, together
`
`with interest;
`
`J.
`
`If Defendant, its officers, agents, servants, employees, parents,
`
`subsidiaries, divisions, affiliates, or those persons in active concert or participation with any of
`
`them commercially manufactures, uses, offers to sell, sells or imports the product described in
`
`the Gland ANDA prior to the expiration of the ’297 Patent or any later expiration of exclusivity
`
`to which Plaintiff is or becomes entitled, a judgment awarding Plaintiff monetary relief, together
`
`with interest;
`
`K.
`
`A declaration that this case is exceptional within the meaning of 35 U.S.C.
`
`§ 285 and awarding reasonable attorneys’ fees, costs and disbursement incurred as a result of this
`
`action; and
`
`L.
`
`Such other and further relief as the Court deems just and proper.
`
`
`
`
`
`
`
`* * *
`
`10
`
`
`
`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 12 of 13 PageID: 12
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`
`
`Dated: September 8, 2022.
`
`
`
`
`OF COUNSEL:
`
`Mark N. Reiter (pro hac vice forthcoming)
`Philip Spear (pro hac vice forthcoming)
`GIBSON, DUNN & CRUTCHER LLP
`2001 Ross Avenue #2100
`Dallas, TX 75201-6912
`(214) 698-3100
`mreiter@gibsondunn.com
`pspear@gibsondunn.com
`
`David Glandorf (pro hac vice forthcoming)
`GIBSON, DUNN & CRUTCHER LLP
`1801 California Street
`Denver, CO 80202-2642
`(303) 298-5726
`dglandorf@gibsondunn.com
`
`
`
`
`
`
`
`
`COUNSEL OF RECORD:
`
` /s/ John E. Flaherty
`John E. Flaherty
`Cynthia S. Betz
`McCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry St.
`Newark, New Jersey 07102
`(973) 622-4444
`jflaherty@mccarter.com
`cbetz@mccarter.com
`
`
`Attorneys for Plaintiff
`Merck Sharp & Dohme LLC
`
`
`
`
`
`
`
`
`
`
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`Case 2:22-cv-05461-JXN Document 1 Filed 09/08/22 Page 13 of 13 PageID: 13
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`
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`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`Pursuant to Local Civil Rule 11.2, I hereby certify that the matter in controversy is not the
`
`subject of any other action pending in any court, or of any pending arbitration or administrative
`
`proceeding.
`
`
`
`
`
`By: /s/ John E. Flaherty
`John E. Flaherty
`
`
`
`
`
`
`
`
`
`CERTIFICATION PURSUANT TO L. CIV. R. 201.1(d)
`
`Pursuant to Local Civil Rule 201.1, I hereby certify the above-captioned matter is not
`
`subject to compulsory arbitration in that, inter alia, the Plaintiff seeks non-monetary injunctive
`
`relief and the amount in controversy exceeds the $150,000 threshold of interest and costs and any
`
`claim for punitive damages.
`
`
`
`
`
`
`
`
`
` By: /s/ John E. Flaherty
`John E. Flaherty
`
`
`
`
`