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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`NOVARTIS PHARMACEUTICALS
`CORPORATION,
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`TORRENT PHARMA INC., TORRENT
`PHARMACEUTICALS LTD.,
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`Plaintiff,
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`v.
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`Defendants.
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`C.A. No. _________________
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`COMPLAINT AGAINST
`TORRENT PHARMA INC. AND TORRENT PHARMACEUTICALS LTD.
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`Plaintiff Novartis Pharmaceuticals Corporation (hereinafter “Plaintiff” or “Novartis”), by
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`its attorneys, hereby alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a patent infringement action arising under Title 35 of the United States
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`Code and concerning an Abbreviated New Drug Application (“ANDA”) submitted to the United
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`States Food and Drug Administration (“FDA”) by the above-named defendants seeking FDA
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`approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of
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`sacubitril/valsartan tablets, generic versions of Plaintiff’s ENTRESTO® tablets, 24 mg/26 mg, 49
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`mg/51 mg, and 97 mg/103 mg, prior to the expiration of U.S. Patent No. 11,058,667 (the “’667
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`patent”).
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`PARTIES
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`2.
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`Plaintiff Novartis is a corporation organized and existing under the laws of the
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`State of Delaware, having a principal place of business at One Health Plaza, East Hanover, New
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`Jersey 07936.
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`3.
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`On information and belief, Torrent Pharma Inc. is a corporation organized and
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`existing under the laws of the State of Delaware, having a registered agent for the service of
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`process at Corporation Service Company, 251 Little Falls Drive, Wilmington, Delaware 19808,
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`and having a principal place of business at 150 Allen Road, Suite 102, Basking Ridge, New
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`Jersey 07920. On information and belief, Torrent Pharma Inc. is a wholly-owned subsidiary of
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`Torrent Pharmaceuticals Ltd.
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`4.
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`On information and belief, Torrent Pharmaceuticals Ltd. is a corporation
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`organized and existing under the laws of India, having a principal place of business at Off.
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`Ashram Road, Ahmedabad – 380 009, Gujarat, India.
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`5.
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`On information and belief, Torrent Pharma Inc. develops, manufactures,
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`distributes, sells, and/or imports drug products for the entire United States market and does
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`business in every state including Delaware, either directly or indirectly.
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`6.
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`On information and belief, Torrent Pharmaceuticals Ltd. develops, manufactures,
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`distributes, sells, and/or imports drug products for the entire United States market and does
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`business in every state including Delaware, either directly or indirectly.
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`7.
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`By letter dated November 11, 2021 (“Torrent Notice Letter”), Torrent Pharma
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`Inc. notified Novartis that (i) Torrent Pharma Inc., on behalf of Torrent Pharmaceuticals Ltd.,
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`had submitted to the FDA ANDA No. 213604 for sacubitril/valsartan tablets, 24 mg/26 mg, 49
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`mg/51 mg, and 97 mg/103 mg (“Torrent ANDA Products”), seeking FDA approval to engage in
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`the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA
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`Products in or into the United States, including Delaware, prior to the expiration of the ’667
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`patent, and that (ii) ANDA No. 213604 includes a certification pursuant to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) against the ’667 patent.
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`8.
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`Torrent Pharma Inc. has committed an act of infringement in this judicial district
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`by filing ANDA No. 213604 with the intent to make, use, sell, offer for sale, and/or import the
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`Torrent ANDA Products in or into this judicial district, prior to the expiration of the ’667 patent,
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`an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a
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`Delaware corporation.
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`9.
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`On information and belief, Torrent Pharmaceuticals Ltd. acted in concert with and
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`directed Torrent Pharma Inc. in the preparation and submission of ANDA No. 213604, and, if
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`the ANDA is approved, will direct and act in concert with Torrent Pharma Inc. to engage in the
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`commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA
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`Products in or into the United States, including Delaware, prior to the expiration of the ’667
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`patent.
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`10.
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`Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. have taken the costly,
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`significant step of applying to the FDA for approval to engage in future activities, including the
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`marketing of the Torrent ANDA Products, that will be purposefully directed at Delaware and
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`elsewhere.
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`11.
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`On information and belief, Torrent Pharmaceuticals Ltd. has systematic and
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`continuous contacts with Delaware; has established distribution channels for drug products in
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`Delaware; regularly and continuously conducts business in Delaware, including by selling drug
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`products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates
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`including Torrent Pharma Inc.; has purposefully availed itself of the privilege of doing business
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`in Delaware; and derives substantial revenue from the sale of drug products in Delaware.
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`12.
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`Both Torrent Pharmaceuticals Ltd., the entity identified in the Torrent Notice
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`Letter as having submitted ANDA No. 213604 through Torrent Pharma Inc., and Torrent Pharma
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`Inc. have agreed with Novartis to litigate any patent action(s) concerning ANDA No. 213604 in
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`the District of Delaware, and have agreed, only for the purposes of such action(s), not to
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`challenge personal jurisdiction or venue in the District of Delaware.
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`13.
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`Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. have each availed
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`themselves of the legal protections of the State of Delaware by, among other things, admitting
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`jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for
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`the District of Delaware. See, e.g., Bial-Portela & Ca., et al. v. Torrent Pharms. Ltd., et al., 18-
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`279 (D. Del.); H. Lundbeck A/S, et al. v. Torrent Pharms. Ltd., et al., 18-672 (D. Del.); Novartis
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`Pharms. Corp. v. Alkem Labs. Ltd. et al., C.A. No. 19-1979 (D. Del.); Novartis Pharms. Corp. v.
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`Alkem Labs. Ltd. et al., 21-1330 (D. Del.).
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`JURISDICTION AND VENUE
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`14.
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`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§ 1331, 1338(a), 2201, and 2202.
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`15.
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`This Court has personal jurisdiction over Torrent Pharma Inc. and Torrent
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`Pharmaceuticals Ltd. because, on information and belief, each such Defendant has committed or
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`has aided, abetted, contributed to, or participated in the commission of tortious acts of patent
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`infringement in preparing and submitting ANDA No. 213604 with a certification pursuant to 21
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`U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a
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`Delaware corporation.
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`16.
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`This Court also has personal jurisdiction over Torrent Pharma Inc. and Torrent
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`Pharmaceuticals Ltd. because, on information and belief, each such Defendant, upon approval of
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`ANDA No. 213604, will commit or will aid, abet, contribute to, or participate in future tortious
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`acts of patent infringement permitted under ANDA No. 213604 that will be purposefully directed
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`at Delaware, including the marketing of the Torrent ANDA Products in Delaware, prior to the
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`expiration of the ’667 patent.
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`17.
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`This Court also has personal jurisdiction over Torrent Pharma Inc. and Torrent
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`Pharmaceuticals Ltd. because, on information and belief, each such Defendant’s affiliations with
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`the State of Delaware, including Torrent Pharma Inc.’s incorporation in Delaware, and Torrent
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`Pharmaceuticals Ltd.’s ownership of and actions in concert with Torrent Pharma Inc., are
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`sufficiently continuous and systematic as to render each such Defendant essentially at home in
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`this forum.
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`18.
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`This Court also has personal jurisdiction over Torrent Pharma Inc. and Torrent
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`Pharmaceuticals Ltd. because each has availed itself of the legal protections of the State of
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`Delaware, by admitting jurisdiction and asserting counterclaims in lawsuits filed in the United
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`States District Court for the District of Delaware.
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`19.
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`Both Torrent Pharmaceuticals Ltd., the entity identified in the Torrent Notice
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`Letter as having submitted ANDA No. 213604 in concert with Torrent Pharma Inc., and Torrent
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`Pharma Inc. have agreed not to challenge personal jurisdiction and venue in the District of
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`Delaware with respect to any patent actions concerning ANDA No. 213604. This is an action
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`concerning ANDA No 213604.
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`20.
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`For these reasons, and for other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiction over Defendants.
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`21.
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`Venue is proper in this Court over Torrent Pharma Inc. and Torrent
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`Pharmaceuticals Ltd. because Torrent Pharma Inc. is incorporated in the State of Delaware and
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`therefore resides in this judicial district, and Torrent Pharmaceuticals Ltd. is a foreign entity who
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`may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. §
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`1391(c)(3).
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`THE PATENT-IN-SUIT AND ENTRESTO®
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`22.
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`The ’667 patent, titled “Sacubitril-Valsartan Dosage Regimen for Treating Heart
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`Failure,” was duly and legally issued on July 13, 2021. A true and correct copy of the ’667 patent
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`is attached hereto as Exhibit A.
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`23.
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`Novartis owns the ’667 patent.
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`24.
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`The ’667 patent claims, inter alia, a regimen for treating chronic heart failure with
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`reduced ejection fraction, comprising administering to a human patient in need thereof a twice-
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`daily target dose of 200 mg of (i) sacubitril or a pharmaceutically acceptable salt thereof with (ii)
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`valsartan or a pharmaceutically acceptable salt thereof; wherein (i) and (ii) are provided in a 1:1
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`molar ratio and wherein the twice daily target dose of 200 mg is reached after a titration with a
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`twice daily starting dose of 50 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time
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`followed by a twice daily dose of 100 mg of (i) and (ii) in a 1:1 molar ratio for a specified period
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`of time and wherein the human patient is not taking an ACE inhibitor or an ARB or is taking a
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`low dose of an ACE inhibitor or an ARB before initiating treatment with (i) and (ii).
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`25.
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`Novartis is the holder of New Drug Application (“NDA”) No. 207620 by which
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`the FDA granted approval for the commercial manufacturing, marketing, sale, and use of
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`ENTRESTO® (sacubitril and valsartan) tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.
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`ENTRESTO® currently is indicated to reduce the risk of cardiovascular death and hospitalization
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`for heart failure in adult patients with chronic heart failure, and for the treatment of symptomatic
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`heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one
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`year and older.
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`26.
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`The ENTRESTO® label provides specific instructions for titration for human
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`patients who are not taking an ACE inhibitor or an ARB or taking a low dose of an ACE
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`inhibitor or an ARB before treatment with ENTRESTO® is initiated.
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`27.
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`One or more claims of the ’667 patent cover the use of ENTRESTO®.
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`28.
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`The FDA’s official publication of approved drugs (the “Orange Book”) lists the
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`’667 patent in connection with ENTRESTO®.
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`INFRINGEMENT BY TORRENT OF THE PATENT-IN-SUIT
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`Plaintiff incorporates paragraphs 1 – 28 as if fully set forth herein.
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`On information and belief, Torrent Pharma Inc., on behalf of Torrent
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`29.
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`30.
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`Pharmaceuticals Ltd., submitted to the FDA ANDA No. 213604 under the provisions of 21
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`U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for
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`sale, and/or importation of the Torrent ANDA Products prior to the expiration of the ’667 patent.
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`31.
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`By filing their ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of
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`the Torrent ANDA Products in or into the United States prior to the expiration of the ’667 patent,
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`Torrent Pharma Inc. and/or Torrent Pharmaceuticals Ltd. have committed an act of infringement
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`under 35 U.S.C. § 271(e)(2).
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`32.
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`This action was commenced within 45 days of Plaintiff’s receipt of the Torrent
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`Notice Letter.
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`33.
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`On information and belief, the use of the Torrent ANDA Products in the United
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`States in accordance with and as directed by Torrent’s labeling for those products, if approved,
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`will directly infringe one or more claims of the ’667 patent.
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`34.
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`On information and belief, the Torrent ANDA Products, to be approved, must
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`contain instructions for practicing a regimen for the treatment of chronic heart failure with
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`reduced ejection faction comprising administering to a human patient in need thereof a twice-
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`daily target dose of 200 mg of (i) sacubitril or a pharmaceutically acceptable salt thereof with (ii)
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`valsartan or a pharmaceutically acceptable salt thereof; wherein (i) and (ii) are provided in a 1:1
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`molar ratio and wherein the twice daily target dose of 200 mg is reached after a titration with a
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`twice daily starting dose of 50 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time
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`followed by a twice daily dose of 100 mg of (i) and (ii) in a 1:1 molar ratio for a specified period
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`of time and wherein the human patient is not taking an ACE inhibitor or an ARB or is taking a
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`low dose of an ACE inhibitor or an ARB before initiating treatment with (i) and (ii), which
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`administration will constitute direct infringement of one or more claims of the ’667 patent. On
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`information and belief, if the Torrent ANDA Products are approved, physicians, other medical
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`providers, caregivers and/or patients following said instructions will directly infringe one or
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`more claims of the ’667 patent. On information and belief, if the Torrent ANDA Products are
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`approved, Torrent Pharma Inc. and/or Torrent Pharmaceuticals Ltd. will actively encourage,
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`recommend, or promote this infringement with knowledge of the ’667 patent, and with
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`knowledge and intent that their acts will induce infringement of one or more claims of the ’667
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`patent.
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`35.
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`On information and belief, if the Torrent ANDA Products are approved, Torrent
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`Pharma Inc. and/or Torrent Pharmaceuticals Ltd. will commercially manufacture, sell, offer for
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`sale, and/or import those products, which must be specifically labeled for use in a regimen for
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`the treatment of chronic heart failure with reduced ejection fraction comprising administering to
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`a human patient in need thereof a twice-daily target dose of 200 mg of (i) sacubitril or a
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`pharmaceutically acceptable salt thereof with (ii) valsartan or a pharmaceutically acceptable salt
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`thereof; wherein (i) and (ii) are provided in a 1:1 molar ratio and wherein the twice daily target
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`dose of 200 mg is reached after a titration with a twice daily starting dose of 50 mg of (i) and (ii)
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`in a 1:1 molar ratio for a specified period of time followed by a twice daily dose of 100 mg of (i)
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`and (ii) in a 1:1 molar ratio for a specified period of time and wherein the human patient is taking
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`neither an ACE inhibitor nor an ARB or is taking a low dose of an ACE inhibitor or an ARB
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`before initiating treatment with (i) and (ii), as recited in one or more claims of the ’667 patent.
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`On information and belief, if the Torrent ANDA Products are approved, those products will
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`constitute a material part of a regimen for the treatment of chronic heart failure with reduced
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`ejection fraction comprising administering to a human patient in need thereof a twice-daily target
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`dose of 200 mg of (i) sacubitril or a pharmaceutically acceptable salt thereof with (ii) valsartan or
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`a pharmaceutically acceptable salt thereof; wherein (i) and (ii) are provided in a 1:1 molar ratio
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`and wherein the twice daily target dose of 200 mg is reached after a titration with a twice daily
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`starting dose of 50 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time followed
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`by a twice daily dose of 100 mg of (i) and (ii) in a 1:1 molar ratio for a specified period of time
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`and wherein the human patient is not taking an ACE inhibitor or an ARB or is taking a low dose
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`of an ACE inhibitor or an ARB before initiating treatment with (i) and (ii), as recited in one or
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`more claims of the ’667 patent. On information and belief, if the Torrent ANDA Products are
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`approved, physicians, caregivers and/or patients following the approved instructions in the
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`Torrent ANDA Products will directly infringe one or more claims of the ’667 patent. On
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`information and belief, if the Torrent ANDA Products are approved, Torrent Pharma Inc. and/or
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`Torrent Pharmaceuticals Ltd. will contributorily infringe one or more claims of the ’667 patent
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`and will do so with knowledge of the ’667 patent, and that the Torrent ANDA Products are
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`especially made or especially adapted for use in infringing one or more claims of the ’667 patent
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`and are not suitable for substantial non-infringing use.
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`36.
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`Plaintiff will be substantially and irreparably damaged by Torrent Pharma Inc.’s
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`and Torrent Pharmaceuticals Ltd.’s infringement of the ’667 patent.
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`37.
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`Plaintiff is entitled to the relief provided by 35 U.S.C. § 271(e)(4) and 35 U.S.C.
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`§ 283, including an order of this Court that the effective date of any approval of ANDA No.
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`213604 be a date that is no earlier than May 9, 2036, the expiration of the ’667 patent, or a date
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`no earlier than the expiry of any other patent extension or exclusivity to which Plaintiff is
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`entitled, and an award of damages for any commercial sale or use of the Torrent ANDA Products
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`and any act committed by Torrent Pharma Inc. and/or Torrent Pharmaceuticals Ltd. with respect
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`to the subject matter claimed in the ’667 patent, which act is not within the limited exclusions of
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`35 U.S.C. § 271(e)(1).
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`38.
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`On information and belief, Torrent Pharma Inc. and/or Torrent Pharmaceuticals
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`Ltd. have taken and continue to take active steps towards the commercial manufacture, use, sale,
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`offer for sale, and/or importation of the Torrent ANDA Products, including seeking approval of
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`those products under ANDA No. 213604.
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`39.
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`There is a substantial and immediate controversy between Plaintiff and Torrent
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`Pharma Inc. and Torrent Pharmaceuticals Ltd. concerning the ’667 patent. Plaintiff is entitled to
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`declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that the use of the Torrent ANDA
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`Products will directly infringe one or more claims of the ’667 patent and Torrent Pharma Inc.
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`and/or Torrent Pharmaceuticals Ltd. will induce infringement of and/or contributorily infringe
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`one or more claims of the ’667 patent.
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`PRAYER FOR RELIEF
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`
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`WHEREFORE, Plaintiff prays that this Court grant the following relief:
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`40.
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`Judgment that defendants Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd.
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`have infringed one or more claims of the ’667 patent by filing ANDA No. 213604;
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`41.
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`A permanent injunction restraining and enjoining defendants Torrent Pharma Inc.
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`and Torrent Pharmaceuticals Ltd. and their officers, agents, attorneys, and employees, and those
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`acting in privity or concert with them, from engaging in the commercial manufacture, use, sale,
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`or offer for sale in the United States, or importation into the United States, of the Torrent ANDA
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`Products prior to the expiration of the ’667 patent, inclusive of any extensions and additional
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`periods of exclusivity;
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`42.
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`An order that the effective date of any approval of ANDA No. 213604 be a date
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`that is not earlier than the expiration date of the ’667 patent, inclusive of any extensions and
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`additional periods of exclusivity;
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`43.
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`Declaratory judgment that the use of the Torrent ANDA Products will directly
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`infringe one or more claims of the ’667 patent;
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`44.
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`Declaratory judgment that the commercial manufacture, sale, offer for sale, and/or
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`importation of the Torrent ANDA Products will induce infringement of and/or contributorily
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`infringe one or more claims of the ’667 patent;
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`45.
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`Damages or other monetary relief from defendants Torrent Pharma Inc. and
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`Torrent Pharmaceuticals Ltd. for the infringement, inducement of infringement and contributory
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`infringement of the ’667 patent;
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`46.
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`A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and
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`an award of attorney’s fees;
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`47.
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`Plaintiff’s costs and expenses in this action; and
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`48.
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`Such other and further relief as the Court may deem just and proper.
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`
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`MCCARTER & ENGLISH, LLP
`
`By: /s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`
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`
`
`Attorneys for Plaintiff Novartis
`Pharmaceuticals Corporation
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`
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`
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`Dated: December 22, 2021
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`
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`
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`OF COUNSEL:
`
`Nicholas N. Kallas
`Christina Schwarz
`Christopher E. Loh
`Susanne L. Flanders
`Jared L. Stringham
`Shannon K. Clark
`Laura K. Fishwick
`Gregory J. Manas
`VENABLE LLP
`1290 Avenue of the Americas
`New York, New York 10104
`(212) 218-2100
`nkallas@venable.com
`cschwarz@venable.com
`cloh@venable.com
`slflanders@venable.com
`jlstringham@venable.com
`skclark@venable.com
`lfishwick@venable.com
`gjmanas@venable.com
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