`571-272-7822
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`Paper No. 9
`December 1, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
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`v.
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`GENENTECH, INC.,
`Patent Owner.
`____________
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`Case IPR2017-01959
`Patent 7,371,379 B1
`____________
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`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`PAULRAJ, Administrative Patent Judge.
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`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
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`IPR2017-01959
`Patent 7,371,379 B1
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`I.
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`INTRODUCTION
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`On August 25, 2017, Samsung Bioepis Co., LTD (“Bioepis”) filed a
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`Petition, seeking an inter partes review of claims 1–3, 5, 7, 9–11, 16–28, and
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`30–40 of U.S. Patent No. 7,371,379 B1 (Ex. 1001, “the ’379 patent”). Paper
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`2 (“Pet.”). Genentech, Inc. (“Patent Owner”) has waived its right to file a
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`Preliminary response to the Petition. Ex. 3001. Along with the Petition,
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`Bioepis also filed a Motion for Joinder to join this proceeding with
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`IPR2017-00805. Paper 1 (“Mot.”). Patent Owner opposes the Motion.
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`Paper 7.
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`As explained further below, we institute trial on the same grounds as
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`instituted in IPR2017-00805 and grant Petitioner’s Motion for Joinder.
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`II. DISCUSSION
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`In IPR2017-00805, Hospira, Inc. (“Hospira”) challenged claims 1–3,
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`5, 7, 9–11, 16–28, and 30–40 of the ’379 patent as obvious under 35 U.S.C.
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`§ 103(a) over the combination of the Herceptin Label,1 Baselga ’96,2 Pegram
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`’98,3 and the Knowledge of a Person of Ordinary Skill in the Art. On July
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`27, 2017, we instituted trial to review the patentability of those claims.
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`Hospira, Inc. v. Genentech, Inc., IPR2017-00805, Paper 13.
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`1 Genentech, Inc, Herceptin® Trastuzumab, Sept. 1998 (hereinafter “Herceptin
`Label” (Ex. 1008).
`2 Jose Baselga, Phase ll Study of Weekly Intravenous Recombinant Humanized
`Anti-p185HER2 Monoclonal Antibody in Patients With HER2/neu-Overexpressing
`Metastatic Breast Cancer, 14 JOURNAL OF CLINICAL ONCOLOGY 737–744 (1996)
`(hereinafter “Baselga ’96”) (Ex. 1013).
`3 Mark D. Pegram, Phase ll Study of Receptor-Enhanced Chemosensitivity Using
`Recombinant Humanized Anti-p185HER21neu Monoclonal Antibody Plus Cisplatin in
`Patients With HER2/neu-Overexpressing Metastatic Breast Cancer Refractory to
`Chemotherapy Treatment, 16 JOURNAL OF CLINICAL ONCOLOGY 2659–71 (1998)
`(hereinafter “Pegram ’98”) (Ex. 1014).
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`IPR2017-01959
`Patent 7,371,379 B1
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`The Petition in this case is substantively identical to the one in
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`IPR2017-00805. Compare IPR2017-00805, Paper 1 with IPR2017-01959,
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`Paper 2. For the same reasons stated in our Decision on Institution in
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`IPR2017-00805, we institute trial in this proceeding on the same ground.
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`See IPR2017-00805, Paper 13.
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`Having determined that institution is appropriate, we now turn to
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`Bioepis’s Motion for Joinder. Under the statute, “[i]f the Director institutes
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`an inter partes review, the Director, in his or her discretion, may join as a
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`party to that inter partes review any person who properly files a petition
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`under section 311.” 35 U.S.C. § 315(c). When determining whether to
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`grant a motion for joinder we consider factors such as timing and impact of
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`joinder on the trial schedule, cost, discovery, and potential simplification of
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`briefing. Kyocera Corp. v. SoftView, LLC, Case IPR2013-00004, slip op. at
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`4 (PTAB Apr. 24, 2013) (Paper 15).
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`Under the circumstances of this case, we determine that joinder is
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`appropriate. Bioepis filed the Petition and Motion for Joinder in the present
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`proceeding within one month after we instituted trial in IPR2017-00805.
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`See 37 C.F.R. § 42.122(b). Bioepis represents that the Petition in this case is
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`“essentially a copy of the Hospira Petition, including a ground that is
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`substantially identical to that presented in the Hospira Petition in IPR2017-
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`00805.” Mot. 1. According to Bioepis, the Petition “relies solely on the
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`same prior art analysis and expert testimony submitted by Hospira.” Id. at 3.
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`Bioepis asserts that it “anticipates participating in the proceeding in a limited
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`‘understudy’ capacity,” unless Hospira is terminated as a party. Id. at 2, 5;
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`see also id. at 6 (agreeing that, “as long as Hospira remains a party . . . the
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`Board may order petitioners to consolidate filings, and limit Bioepis to . . .
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`IPR2017-01959
`Patent 7,371,379 B1
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`[an] understudy role”). As a result, Bioepis avers that joinder will “create no
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`additional burden for the Board, Genentech, or Hospira,” “have no impact
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`on the trial schedule of IPR2017-00805,” and result in no prejudice to either
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`Genentech or Hospira. Id. at 1–3.
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`Genentech argues that “Bioepis offers no real assurances that its role
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`will be so limited as to prevent prejudice to Patent Owner.” Paper 7, 1.
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`Genentech asks us to impose certain conditions on Bioepis, including: (1) as
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`long as Hospira remains a party to IPR2017-00805, Bioepis “has no right to
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`its own briefing or oral argument;” (2) Bioepis may “proceed based solely
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`on the arguments and evidence presented and maintained by Hospira;” (3)
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`no additional discovery is permitted by Bioepis, and Bioepis may not ask
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`any questions during deposition; (4) Bioepis may not alter the Hospira IRP
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`trial schedule, and (5) “Bioepis acknowledges that the estoppel provisions of
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`35 U.S.C. § 315(e) will be applicable to it even if it remains in a
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`circumscribed secondary role.” Id. at 2–3.
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`We find certain conditions Genentech proposes overly restrictive. For
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`example, although Bioepis anticipates taking an understudy role in this
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`proceeding, it may unexpectedly “strongly disagrees” with a position
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`adopted (or repudiated) by Hospira after the filing of Hospira Petition. See
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`Mot. 6. Under those circumstances, this panel may wish to entertain
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`requests for additional briefing, additional discovery, or an opportunity for
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`Bioepis to ask questions at a deposition. See 37 C.F.R. § 42.5 (authorizing
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`the panel “may determine a proper course of conduct in a proceeding”). In
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`addition, to the extent we grant its Motion for Joinder, Bioepis becomes a
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`“petitioner” in the IPR2017-00805 proceeding. Patent Owner does not cite
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`to, nor are we aware of, any authority suggesting that a passive role in an
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`IPR2017-01959
`Patent 7,371,379 B1
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`IPR proceeding insulates a petitioner from the estoppel provision of
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`§ 315(e). Rather, the provision vests as a matter of law such that Bioepis’s
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`formal acknowledgement of § 315(e) is irrelevant.
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`Where, as in the present case, a party seeks to take a secondary role in
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`an on-going IPR, joinder promotes economy and efficiency, thereby
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`reducing the burden on the Patent Owner and on the limited resources of the
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`Board, as compared to distinct, parallel proceedings. See 37 C.F.R.
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`§ 42.1(b) (instructing that an inter partes review must be conducted to
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`“secure the just, speedy, and inexpensive resolution”).
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`In view of the foregoing, we find that joinder based upon the
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`conditions stated by Bioepis’s in its Motion for Joinder will have little or no
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`impact on the timing, cost, or presentation of the trial on the instituted
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`ground. Discovery and briefing will be simplified if the proceedings are
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`joined. Having considered Bioepis’s Motion in light of Genentech’s
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`response, the Motion is granted.
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`III. ORDER
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`Accordingly, it is
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`ORDERED that trial is instituted in IPR2017-01959 to determine
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`whether claims 1–3, 5, 7, 9–11, 16–28, and 30–40 of the ’379 patent would
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`have been obvious over the combination of the Herceptin Label, Baselga
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`’96, Pegram ’98, and the Knowledge of a Person of Ordinary Skill in the
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`Art;
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`FURTHER ORDERED that Bioepis’s Motion for Joinder with is
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`granted;
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`FURTHER ORDERED that IPR2017-01959 is terminated and joined
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`to IPR2017-00805, pursuant to 37 C.F.R. §§ 42.72, 42.122, based on the
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`IPR2017-01959
`Patent 7,371,379 B1
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`conditions discussed above, specifically, absent leave of the Board, Bioepis
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`shall maintain an understudy role with respect Hospira, coordinate filings
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`with Hospira, not submit separate substantive filings, not participate
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`substantively in oral argument, and not actively participate in deposition
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`questioning except with the assent of all parties;
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`FURTHER ORDERED that the Scheduling Order in place for
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`IPR2017-00805 shall govern the joined proceedings;
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`FURTHER ORDERED that all future filings in the joined proceeding
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`are to be made only in IPR2017-00805;
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`FURTHER ORDERED that the case caption in IPR2017-00805 for all
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`further submissions shall be changed to add Bioepis as a named Petitioner
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`after Hospira, and to indicate by footnote the joinder of IPR2017-01959 to
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`that proceeding, as indicated in the attached form of caption;
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`FURTHER ORDERED that a copy of this Decision shall be entered
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`into the record of IPR2017-00805.
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`IPR2017-01959
`Patent 7,371,379 B1
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`Sample Case Caption
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`HOSPIRA, INC., and
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioners,
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`v.
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`GENENTECH, INC,
`Patent Owner.
`____________
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`Case IPR2017-008051
`Patent 6,627,196 B1
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`____________
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`1 Case IPR2017-01959 has been joined with this proceeding.
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`IPR2017-01959
`Patent 7,371,379 B1
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`FOR PETITIONER BIOEPIS:
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`Dimitrios Drivas
`ddrivas@whitecase.com
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`Scott Weingaertner
`sweingaertner@whitecase.com
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`FOR PATENT OWNER:
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`David Cavanaugh
`david.cavanaugh@wilmerhale.com
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`Owen Allen
`owen.allen@wilmerhale.com
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`Adam Brausa
`abrausa@durietangri.com
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`FOR PETITIONER HOSPIRA (IPR2017-00805):
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`Amanda Hollis
`amanda.hollis@kirkland.com
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`Stefan Miller
`Stefan.Miller@kirkland.com
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`Karen Younkins
`karen.younkins@kirkland.com
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