`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`VANDA PHARMACEUTICALS INC.,
`
`Plaintiff,
`
`v.
`
`MSN PHARMACEUTICALS INC. and
`MSN LABORATORIES PRIVATE
`LIMITED,
`
`Defendants.
`
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`C.A. No. ____________
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Vanda Pharmaceuticals Inc. (“Vanda”) for its Complaint against
`
`Defendants MSN Pharmaceuticals Inc. (“MSN Pharmaceuticals”) and MSN Laboratories Private
`
`Limited (“MSN Labs”) (collectively, “MSN”) alleges as follows:
`
`I.
`
`THE PARTIES
`
`1.
`
`Plaintiff Vanda is a Delaware corporation with its principal place of
`
`business at 2200 Pennsylvania Ave. NW, Suite 300E, Washington, DC 20037. Vanda is a
`
`pharmaceutical company that focuses on the development and commercialization of new
`
`medicines to address unmet medical needs, including Hetlioz® (tasimelteon oral capsules), for the
`
`treatment of Non-24-Hour Sleep-Wake Disorder (“Non-24”).
`
`2.
`
`On information and belief, MSN Pharmaceuticals is a Delaware
`
`corporation, with its principal place of business 20 Duke Road, Piscataway, New Jersey 08854.
`
`3.
`
`On information and belief, MSN Labs is an Indian private limited company,
`
`having a place of business at MSN House, C-24, Sanathnagar Industrial Estate, Hyderabad,
`
`500018, Telangana, India.
`
`
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 2 of 13 PageID #: 2
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`4.
`
`On information and belief, MSN Pharmaceuticals is a wholly owned
`
`subsidiary of MSN Labs.
`
`5.
`
`On information and belief MSN Pharmaceuticals is the designated U.S.
`
`agent for MSN Labs in accordance with 21 C.F.R. § 314.50(a) in connection with Abbreviated
`
`New Drug Application No. 211654 (the “MSN ANDA”).
`
`6.
`
`On
`
`information and belief, MSN Pharmaceuticals
`
`is a generic
`
`pharmaceutical company that manufactures and distributes generic pharmaceutical products for
`
`sale in the State of Delaware and throughout the United States in concert with MSN Labs.
`
`7.
`
`On information and belief, MSN Pharmaceuticals and MSN Labs acted in
`
`concert to prepare and submit the MSN ANDA.
`
`II.
`
`NATURE OF THE ACTION
`
`8.
`
`This is an action arising under the patent laws of the United States (Title 35,
`
`U.S. Code, §§ 100, et seq.) based upon MSN’s infringement of one or more claims of Vanda’s
`
`U.S. Patent No. 10,829,465 (“the ’465 patent”), which, in relevant part, generally relates to
`
`compositions comprising purified tasimelteon.
`
`9.
`
`Vanda is the holder of approved New Drug Application No. 205677 for
`
`Hetlioz® (tasimelteon) capsules, 20 mg, which was approved by the Food and Drug
`
`Administration (“FDA”) on January 31, 2014, for the treatment of Non-24, a circadian rhythm
`
`sleep disorder.
`
`10.
`
`11.
`
`Tasimelteon is the active ingredient in Hetlioz®.
`
`On information and belief, MSN filed the MSN ANDA under § 505(j) of
`
`the Federal Food, Drug, and Cosmetic Act (the “FFDCA”), to obtain approval to commercially
`
`manufacture and sell generic tasimelteon capsules in its 20 mg strength for the treatment of Non-
`
`24 (“MSN’s ANDA Product”).
`
`2
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`
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 3 of 13 PageID #: 3
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`12.
`
`On information and belief, MSN made and included in its ANDA a
`
`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”) that, in its
`
`opinion and to the best of its knowledge, the ’465 patent is invalid, unenforceable, and/or that
`
`certain claims will not be infringed by MSN’s ANDA Product.
`
`13.
`
`Vanda received written notice of MSN’s ANDA and Paragraph IV
`
`Certification as to the ’465 patent on January 21, 2021 (“Notice Letter”), along with an enclosed
`
`statement of MSN’s alleged factual and legal bases for stating that the ’465 patent is invalid,
`
`unenforceable, and/or will not be infringed by MSN’s ANDA Product (“Detailed Statement”).
`
`14. MSN’s Detailed Statement does not provide any factual bases or other
`
`statements alleging that the ’465 patent is unenforceable.
`
`15.
`
`This action is being commenced within 45 days of receipt of MSN’s Notice
`
`Letter.
`
`16. MSN has infringed one or more claims of the ’465 patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by virtue of the filing of the MSN ANDA with a Paragraph IV Certification and
`
`seeking FDA approval of the MSN ANDA prior to the expiration of the ’465 patent or any
`
`extensions thereof.
`
`17. MSN has infringed one or more claims of the ’465 patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by virtue of the filing of the MSN ANDA seeking FDA approval to commercially
`
`manufacture, use, offer for sale, sell, distribute in, or import into the United States generic
`
`tasimelteon for the treatment of Non-24 prior to the expiration of the ’465 patent or any extensions
`
`thereof.
`
`3
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`
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 4 of 13 PageID #: 4
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`III.
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`JURISDICTION
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`18.
`
`This action arises under
`
`the patent
`
`laws of
`
`the United States,
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`35 U.S.C. §§ 100, et seq., and this Court has subject matter jurisdiction over Vanda’s patent
`
`infringement claims under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`19.
`
`This Court has personal jurisdiction over MSN Pharmaceuticals because
`
`MSN Pharmaceuticals is organized under the laws of the State of Delaware.
`
`20.
`
`On information and belief, MSN Pharmaceuticals is registered to conduct
`
`business
`
`within
`
`the
`
`State
`
`of
`
`Delaware
`
`(File
`
`No.
`
`5454849).
`
`See
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`https://icis.corp.delaware.gov/Ecorp/EntitySearch/NameSearch.aspx (accessed on Sept. 23,
`
`2020).
`
`21.
`
`On information and belief, MSN Pharmaceuticals maintains as a registered
`
`agent for service of process United States Corporation Agents, Inc., with an address at 221 North
`
`Broad Street, Suite 3A, Middletown, Delaware 19709.
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`22.
`
`This Court has personal jurisdiction over MSN Labs under Fed. R. Civ. P.
`
`4(k) because, on information and belief, MSN Labs is organized under the laws of India.
`
`23.
`
`This Court has personal jurisdiction over MSN Labs because at least one of
`
`the provisions under Del. Code Ann. tit. 10, § 3104, is satisfied. On information and belief, MSN
`
`Labs satisfies at least § 3104(c)(1) (“[t]ransacts any business or performs any character of work or
`
`service in the State), § 3104(c)(2) (“[c]ontracts to supply services or things in this State”), §
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`3104(c)(3) (“[c]auses tortious injury in the State by an act or omission in this State”), and §
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`3104(c)(4) (“[c]auses tortious injury in the State or outside of the State by an act or omission
`
`outside the State if the person regularly does or solicits business, engages in any other persistent
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`course of conduct in the State or derives substantial revenue from services, or things used or
`
`consumed in the State”).
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`4
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 5 of 13 PageID #: 5
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`24.
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`This Court also has personal jurisdiction over MSN Labs because this suit
`
`arises out of and relates to MSN Labs’s activities, in concert with MSN Pharmaceuticals, that are,
`
`and will be, directed to Delaware. On information and belief, following any FDA approval of the
`
`MSN ANDA, MSN Labs, in concert with MSN Pharmaceuticals, will market and sell MSN’s
`
`ANDA Product that is the subject of the infringement claims in this action in the State of Delaware
`
`and throughout the United States, including in this Judicial District.
`
`25.
`
`On information and belief, MSN Labs, directly and through its subsidiaries,
`
`affiliates, or agents, including MSN Pharmaceuticals, is in the business of manufacturing generic
`
`pharmaceuticals that it distributes or has distributed in the State of Delaware and throughout the
`
`United States.
`
`26. MSN Pharmaceuticals and MSN Labs, acting in concert, have committed,
`
`or aided, abetted, contributed to, and/or participated in the commission of acts of patent
`
`infringement that will lead to foreseeable harm and injury to Vanda, which manufactures Hetlioz®
`
`for sale and use throughout the United States, including in this Judicial District.
`
`27.
`
`On information and belief, MSN Pharmaceuticals and MSN Labs, acting in
`
`concert, prepared and filed ANDA No. 211654 with the intention of seeking to market generic
`
`tasimelteon nationwide, including within this Judicial District.
`
`28.
`
`On information and belief, MSN plans to market and sell generic
`
`tasimelteon in the State of Delaware, list generic tasimelteon on the State of Delaware’s
`
`prescription drug formulary, and seek Medicaid reimbursement for sales of MSN’s ANDA Product
`
`in the State of Delaware, either directly or through one or more of MSN’s subsidiaries, agents,
`
`and/or alter egos.
`
`5
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 6 of 13 PageID #: 6
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`29.
`
`On information and belief, MSN knows and intends that its proposed
`
`generic tasimelteon product will be distributed and sold in Delaware and will thereby displace
`
`sales of Hetlioz®, causing injury to Vanda. MSN intends to take advantage of its established
`
`channels of distribution in Delaware for the sale of MSN’s ANDA Product.
`
`30.
`
`This Court also has personal jurisdiction over MSN Labs by virtue of, inter
`
`alia, its activities, in concert with MSN Pharmaceuticals (e.g., filing the MSN ANDA seeking
`
`approval to market generic tasimelteon prior to the expiration of the ’465 patent), which were
`
`purposefully directed to the State of Delaware. Vanda is incorporated in Delaware, and thus the
`
`consequences of MSN Labs’s actions were (and will be) suffered in Delaware. MSN Labs knew
`
`or should have known that Vanda is a Delaware corporation and thus MSN Labs knew or should
`
`have known that the consequences of its actions were (and will be) suffered in Delaware.
`
`31.
`
`This Court also has personal jurisdiction over MSN Labs because MSN
`
`Labs’s contacts within this Judicial District are continuous and systematic. On information and
`
`belief, MSN Labs, in concert with MSN Pharmaceuticals, develops, manufactures, seeks approval
`
`for, and sells FDA-approved generic pharmaceutical drugs, which are being marketed, distributed,
`
`and sold in Delaware and throughout the United States. Thus, on information and belief, MSN
`
`Labs does substantial business in Delaware, derives substantial revenue from Delaware, and
`
`engages in other persistent courses of conduct in Delaware. These continuous and systematic
`
`contacts, including, but not limited to, those described above and below, are more than sufficient
`
`for this Court to exercise personal jurisdiction over MSN Labs.
`
`32.
`
`On information and belief, MSN Labs maintains continuous and systematic
`
`contacts with Delaware through its U.S. subsidiary MSN Pharmaceuticals, which is organized
`
`under the laws of the State of Delaware.
`
`6
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`
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 7 of 13 PageID #: 7
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`33.
`
`Furthermore, on information and belief, MSN Pharmaceuticals and MSN
`
`Labs have admitted or consented to, or not contested, the jurisdiction of this Court and/or have
`
`availed themselves of the rights, benefits, and privileges of this Court by asserting claims and
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`counterclaims in prior District of Delaware actions.
`
`IV.
`
`VENUE
`
`34.
`
`Venue is proper in this Judicial District under 28 U.S.C. § 1400(b) with
`
`regard to MSN Pharmaceuticals, because, upon information and belief, MSN Pharmaceuticals
`
`resides in the State of Delaware and therefore MSN’s ANDA submission is sufficiently related to
`
`this District.
`
`35.
`
`Venue is proper in this Judicial District under 28 U.S.C. § 1391 and
`
`§ 1400(b) with regard to MSN Labs, because, upon information and belief, MSN Labs is
`
`incorporated in India and may be sued in any judicial district in the United States in which MSN
`
`Labs is subject to the Court’s personal jurisdiction.
`
`V.
`
`THE PATENT-IN-SUIT
`
`(U.S. PATENT NO. 10,829,465)
`
`36.
`
`37.
`
`tasimelteon.
`
`The allegations above are incorporated herein by reference.
`
`The ’465 patent covers, generally, compositions comprising purified
`
`38.
`
`As explained in the ’465 patent, “in the synthesis of tasimelteon there are
`
`certain impurities that can be formed as both by-products and degradation products, and that these
`
`impurities can be controlled or reduced to non-detectable or acceptably detectable levels.”
`
`39.
`
`Vanda is the owner of all rights, title, and interest in the ’465 patent, entitled
`
`“Highly Purified Pharmaceutical Grade Tasimelteon.” The USPTO duly and legally issued the
`
`’465 patent on November 10, 2020, to Deepak Phadke, Natalie M. Platt, and Ravi K.
`
`7
`
`
`
`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 8 of 13 PageID #: 8
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`Pandrapragada as inventors, which was assigned to Vanda. A true and correct copy of the ’465
`
`patent is attached to this Complaint as Exhibit A.
`
`40.
`
`The ’465 patent generally claims compositions comprising purified
`
`tasimelteon.
`
`VI.
`
`COUNT I
`
`(INFRINGEMENT OF THE ’465 PATENT)
`
`41.
`
`The allegations above are incorporated herein by reference.
`
`42. MSN filed the MSN ANDA under § 505(j) of the FFDCA to obtain
`
`approval to commercially manufacture, use, offer to sell, and sell generic tasimelteon for the
`
`treatment of Non-24 before the expiration of the ’465 patent and any extensions thereof.
`
`43. MSN’s Notice Letter states that MSN filed the ANDA seeking approval to
`
`manufacture, use, offer to sell, and sell generic tasimelteon in its 20 mg strength for the treatment
`
`of Non-24 before the expiration of the ’465 patent. The Notice Letter represents that an
`
`Amendment to MSN’s ANDA was submitted with a Paragraph IV Certification that the ’465
`
`patent purportedly is invalid, unenforceable, and/or will not be infringed by the commercial
`
`manufacture, use, or sale of MSN’s ANDA Product.
`
`44.
`
`The ’465 patent is listed in FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations for Hetlioz® in its 20 mg strength.
`
`45. MSN thus has actual knowledge of the ’465 patent.
`
`46.
`
`Vanda has the right to enforce the ’465 patent and sue for infringement
`
`thereof.
`
`47.
`
`On information and belief, MSN has made and will continue to make
`
`substantial and meaningful preparations to import into the United States and/or offer to sell, sell,
`
`and/or use within the United States products which are patented by the ’465 patent.
`
`8
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 9 of 13 PageID #: 9
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`48.
`
`On information and belief, MSN’s preparations include, but are not limited
`
`to, the development of MSN’s ANDA Product, systematically attempting to meet the applicable
`
`regulatory requirements for approval of MSN’s ANDA Product, and engaging in litigation to
`
`manufacture, offer to sell, sell, use, and/or import MSN’s ANDA Product prior to the expiration
`
`of the ’465 patent.
`
`49.
`
`On information and belief, MSN intends to use a composition claimed in
`
`the ’465 patent in MSN’s ANDA Product.
`
`50.
`
`On information and belief, the tasimelteon composition in MSN’s ANDA
`
`Product is not materially changed by subsequent process.
`
`51.
`
`On information and belief, a tasimelteon composition of the ’465 patent is
`
`an essential part of MSN’s ANDA Product.
`
`52.
`
`On information and belief, a tasimelteon composition of the ’465 patent in
`
`MSN’s ANDA Product is not a trivial or non-essential component of another product.
`
`53.
`
`On information and belief, MSN’s ANDA Product is covered by one or
`
`more claims of the ’465 patent.
`
`54.
`
`On information and belief, MSN’s ANDA Product is not a staple article of
`
`commerce and has no substantial uses that do not infringe at least claim 1 of the ’465 patent.
`
`55. MSN has
`
`infringed and will
`
`infringe
`
`the
`
`’465 patent under
`
`35 U.S.C. § 271(e)(2)(A) by virtue of its submission of the MSN ANDA, and any amendments
`
`and/or supplements thereto, to FDA seeking to obtain approval for generic tasimelteon covered by
`
`one or more claims of the ’465 patent, prior to the expiration of the ’465 patent.
`
`56.
`
`The commercial manufacture, use, offer to sell, sale, distribution, or
`
`importation of products under the MSN ANDA would infringe directly or contribute to or induce
`
`9
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 10 of 13 PageID #: 10
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`the infringement of one or more claims of the ’465 patent, including at least claim 1 under 35
`
`U.S.C. § 271(a), (b), (c), and/or (g).
`
`57.
`
`On information and belief, MSN will induce others to infringe and/or
`
`contribute to the infringement of at least claim 1 of the ’465 patent under 35 U.S.C. § 271(b) and/or
`
`(c) by, among other things, actively and knowingly aiding and abetting others to infringe,
`
`including, but not limited to the manufacturer of MSN’s ANDA products, or its Active
`
`Pharmaceutical Ingredient (“API”), or other subsequence purchasers, distributors, or users thereof,
`
`which manufacture constitutes direct infringement of at least claim 1 of the ’465 patent.
`
`58.
`
`On information and belief, MSN will induce others to infringe and/or
`
`contribute to the infringement of at least claim 1 of the ’465 patent under § 271(b) and/or (c) by
`
`making, using, selling, offering to sell, and/or importing MSN’s ANDA Product and/or the API
`
`thereof.
`
`59.
`
`On information and belief, subsequent purchasers, distributors or users
`
`thereof will also directly infringe at least claim 1 of the ’465 patent.
`
`60.
`
`On information and belief MSN will infringe at least claim 1 of the ’465
`
`patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell, or using MSN’s ANDA
`
`Product or the API for MSN’s ANDA Product.
`
`61.
`
`On information and belief, MSN’s ANDA Product and/or the API for
`
`MSN’s ANDA Product is not materially changed by subsequent process.
`
`62.
`
`On information and belief, MSN’s ANDA Product and the API for MSN’s
`
`ANDA Product are not a trivial or non-essential component of another product.
`
`10
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`
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 11 of 13 PageID #: 11
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`63.
`
`Vanda seeks entry of an order requiring that MSN amend its Paragraph IV
`
`Certification in the MSN ANDA to a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(III)
`
`(“Paragraph III Certification”) as provided in 21 C.F.R. § 314.94(a)(12)(viii)(A).
`
`64.
`
`Vanda seeks entry of an order declaring that MSN has infringed the ’465
`
`patent by virtue of submitting its ANDA pursuant to 35 U.S.C. § 271(e)(2)(A).
`
`65.
`
`Vanda seeks entry of an order pursuant to 35 U.S.C. § 271(e)(4), including
`
`an order of this Court that the effective date of any FDA approval of the MSN ANDA be a date
`
`that is not earlier than the expiration of the ’465 patent or any later expiration of exclusivity for
`
`the ’465 patent to which Vanda becomes entitled.
`
`66.
`
`Vanda will be irreparably harmed if MSN is not enjoined from infringing
`
`or actively inducing or contributing to infringement of one or more claims of the ’465 patent.
`
`Pursuant to 35 U.S.C. § 283, Vanda is entitled to a permanent injunction against further
`
`infringement. Vanda does not have an adequate remedy at law.
`
`67.
`
`On information and belief, MSN’s statement of the factual and legal bases
`
`for its opinion regarding the invalidity and noninfringement of the ’465 patent is devoid of an
`
`objective good faith basis in either the facts or the law. This case is exceptional and Vanda is
`
`entitled to attorneys’ fees pursuant to 35 U.S.C. § 285.
`
`68.
`
`To the extent MSN commercializes its product, Vanda will also be entitled
`
`to damages under 35 U.S.C. § 284.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Vanda respectfully requests that this Court enter judgment in its
`
`favor against MSN and grant the following relief:
`
`A.
`
` an adjudication that MSN has infringed directly, contributed to, or induced
`
`the infringement of one or more claims of the ’465 patent under 35 U.S.C. § 271(e)(2)(A) by
`
`11
`
`
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 12 of 13 PageID #: 12
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`submitting to FDA the MSN ANDA to obtain approval for the commercial manufacture, use, offer
`
`for sale, sale, distribution in, or importation into the United States of generic tasimelteon for the
`
`treatment of Non-24 before the expiration of the ’465 patent;
`
`B.
`
`a declaration that MSN will infringe directly, contribute to, or induce the
`
`infringement of one or more claims of the ’465 patent under 35 U.S.C. § 271(a), (b), (c) and/or (g)
`
`if it markets, manufactures, uses, offers for sale, sells, distributes in, or imports into the United
`
`States generic tasimelteon for the treatment of Non-24 before the expiration of the ’465 patent;
`
`C.
`
`an order requiring that MSN amend its Paragraph IV Certification to a
`
`Paragraph III Certification as provided in 21 C.F.R. § 314.94(a)(12)(viii)(A);
`
`D.
`
`an order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
`
`date of any FDA approval of the MSN ANDA for generic tasimelteon be a date that is not earlier
`
`than the date of the expiration of the ’465 patent or any later period of exclusivity to which Vanda
`
`is or may become entitled;
`
`E.
`
`a permanent injunction enjoining MSN, its officers, agents, servants,
`
`employees, attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or
`
`participation with any of them from infringing the ’465 patent, or contributing to or inducing
`
`anyone to do the same, including the manufacture, use, offer to sell, sale, distribution, or
`
`importation of any current or future versions of the product described in the MSN ANDA;
`
`F.
`
`an order enjoining MSN, its officers, agents, servants, employees, attorneys,
`
`affiliates, divisions, subsidiaries, and those persons in active concert or participation with any of
`
`them from infringing the ’465 patent, or contributing to or inducing anyone to do the same,
`
`including the manufacture, use, offer to sell, sale, distribution, or importation of any current or
`
`future versions of the product described in the MSN ANDA;
`
`12
`
`
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`Case 1:21-cv-00283-UNA Document 1 Filed 02/24/21 Page 13 of 13 PageID #: 13
`
`G.
`
`an assessment of pre-judgment and post-judgment interest and costs against
`
`MSN, together with an award of such interest and costs, in accordance with 35 U.S.C. § 284;
`
`H.
`
`an award to Vanda of its attorneys’ fees incurred in connection with this
`
`lawsuit pursuant to 35 U.S.C. § 285; and
`
`I.
`
`such other and further relief as this Court may deem just and proper.
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Derek J. Fahnestock
`
`Karen Jacobs (#2881)
`Derek J. Fahnestock (#4705)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`kjacobs@morrisnichols.com
`dfahnestock@morrisnichols.com
`
`Attorneys for Plaintiff
`Vanda Pharmaceuticals Inc.
`
`OF COUNSEL:
`
`Nicholas Groombridge
`Eric Alan Stone
`Josephine Young
`Daniel J. Klein
`Jennifer Rea Deneault
`Michael F. Milea
`PAUL, WEISS, RIFKIND, WHARTON
`& GARRISON LLP
`1285 Avenue of the Americas
`New York, NY 10019
`(212) 373-3000
`
`February 24, 2021
`
`13
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