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`EXHIBIT 21
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`TO THE DECLARATION OF BRIAN J.
`NISBET IN SUPPORT OF DEFENDANTS’
`OPPOSITION TO NUVASIVE’S MOTION
`FOR PARTIAL SUMMARY JUDGMENT
`AND MOTION TO EXCLUDE
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`NIMALKA R. WICKRAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`DAVID P. DALKE (SBN: 218161)
`ddalke@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`GEORGE C. LOMBARDI (Pro Hac Vice)
`glombardi@winston.com
`BRIAN J. NISBET (Pro Hac Vice)
`bnisbet@winston.com
`SARANYA RAGHAVAN (Pro Hac Vice)
`sraghavan@winston.com
`WINSTON & STRAWN LLP
`35 West Wacker Drive
`Chicago, IL 60601-9703
`Telephone: (312) 558-5600
`Facsimile: (312) 558-5700
`
`CORINNE STONE HOCKMAN (Pro Hac Vice)
`chockman@winston.com
`WINSTON & STRAWN LLP
`800 Capitol Street, Suite 2400
`Houston, TX 77002-2925
`Telephone: (713) 651-2600
`Facsimile:
`(713) 651-2700
`
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.
`
`
`
`UNITED STATES DISTRICT COURT
`
`SOUTHERN DISTRICT OF CALIFORNIA
`
`SAN DIEGO DIVISION
`
`
`
`
`
`Plaintiff,
`
`Case No. 3:18-CV-00347-CAB-MDD
`NUVASIVE, INC., a Delaware
`
`corporation,
`[Assigned to Courtroom 4C – Honorable
`
`Cathy Ann Bencivengo]
`
`
`[Magistrate: Hon. Mitchell D. Dembin]
`v.
`
`
`DEFENDANTS’ AMENDED
`ALPHATEC HOLDINGS, INC., a
`RESPONSE TO PLAINTIFF
`Delaware corporation and
`NUVASIVE, INC.’S FIFTH SET OF
`ALPHATEC SPINE, INC., a
`INTERROGATORIES (NO. 23)
`California corporation,
`
`
`Complaint filed: February 13, 2018
`Defendants.
`
`DEFENDANTS’ AMENDED RESPONSE TO PLAINTIFF NUVASIVE, INC.’S
`CASE NO. 3:18-CV-00347-CAB-MDD
`FIFTH SET OF INTERROGATORIES (NO. 23)
`
`
`
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`EXHIBIT 21 - PAGE 364
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`14. Defendants’ responses are subject to all objections as to competence,
`relevance, materiality, and admissibility. Defendants reserve the right to make all such
`
`objections at trial.
`OBJECTIONS TO PLAINTIFF’S DEFINITIONS AND INSTRUCTIONS
`1.
`Defendants incorporate by reference their objections to Plaintiff’s
`definitions and instructions as contained in Defendants’ Responses to Plaintiff’s First
`Set of Interrogatories (Nos. 1-10) and Defendants’ Responses to Plaintiff’s First Set of
`Requests for Production (Nos. 1-41).
`SPECIFIC OBJECTIONS AND RESPONSES
`Subject to the General Objections, all of which are hereby incorporated by
`reference as though set forth fully within each and every response to below, Defendants
`respond specifically to Plaintiff’s Interrogatories as follows:
`INTERROGATORY NO. 23:
`If Alphatec contends it does not willfully infringe the ’334 and ’156 implant
`patents, identify in detail all legal and factual bases for Alphatec’s contention that
`Alphatec does not willfully infringe.
`RESPONSE TO INTERROGATORY NO. 23:
`In addition to the General Objections, Defendants object to this Interrogatory to
`the extent it calls for a legal conclusion and attempts to shift the burden of proof of
`willful infringement to Defendants. Defendants further object to this Interrogatory as
`vague, ambiguous, overbroad, unduly burdensome, and as failing to describe the
`requested information with reasonable particularity to the extent that it requires
`Defendants to “identify in detail all legal and factual bases.” Defendants further object
`to this Interrogatory to the extent it seeks information protected from discovery by the
`attorney-client privilege, the work product doctrine, or any other privilege or immunity.
`Defendants further object to this Interrogatory as seeking disclosure of private,
`confidential, trade secret, proprietary, or commercially and competitively sensitive
`information, the disclosure of which would result in substantial competitive injury to
`4
`DEFENDANTS’ AMENDED RESPONSE TO PLAINTIFF NUVASIVE, INC.’S
`CASE NO. 3:18-CV-00347-CAB-MDD
`FIFTH SET OF INTERROGATORIES (NO. 23)
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`EXHIBIT 21 - PAGE 365
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`proffered evidence or further contentions from NuVasive.
`FIRST AMENDED RESPONSE TO INTERROGATORY NO. 23:
`
`Subject to and without waiving the foregoing General and Specific Objections,
`Defendants supplements its response as follows:
`Alphatec denies that it willfully infringes the ’334 and ’156 patents because it
`does not infringe the ’334 and ’156 patents.
`For at least the reasons discussed in response to Interrogatory No. 1, there can be
`no infringement of the ’334 and ’156 patents.
`Even to the extent Alphatec is found to infringe the ’334 and ’156 patents, there
`is no evidence that such infringement was willful, wanton, malicious, bad-faith,
`deliberate, consciously wrongful, flagrant, or characteristic of a pirate. See Halo Elecs.,
`Inc. v. Pulse Elecs., Inc., 136 S. Ct. 1923, 1932 (2016). First, it is undisputed that
`Alphatec’s product development team was under direct and specific guidance not to
`copy any competitor’s intellectual property, largely due to a major lawsuit between
`Medtronic and NuVasive involving each other’s retractors and implants used in a lateral
`procedure. Costabile Dep. Tr. 67:24–68:21. Second, Alphatec had a good faith reason
`to believe that the ’334 patent and ’156 patent were invalid before, during, and after the
`development of the Accused Products.
`For years, Alphatec monitored the various public litigations and post-grant
`proceedings before the Patent Office that cast substantial doubt over the validity of
`NuVasive’s patent portfolio. Among these proceedings, Alphatec monitored, before,
`during, and after the development of the Battalion Implant (“Battalion”), Medtronic’s
`challenge to the validity of the ’334 and ’156 patents in Warsaw Orthopedic, Inc. v.
`NuVasive Inc., No. 3:12-cv-02738.
`Warsaw and Medtronic filed suit against NuVasive in August 2012. In March
`2013, NuVasive asserted that Medtronic infringed the ’334 and ’156 patents. In
`response, Medtronic initiated IPRs against the ’334 and ’156 patents in October 2013,
`both of which the PTAB instituted in February 2014. After the Patent Office decided
`7
`DEFENDANTS’ AMENDED RESPONSE TO PLAINTIFF NUVASIVE, INC.’S
`CASE NO. 3:18-CV-00347-CAB-MDD
`FIFTH SET OF INTERROGATORIES (NO. 23)
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`EXHIBIT 21 - PAGE 366
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`to examine the validity of the ’156 patent and the ’334 patent, Alphatec started official
`development of its LLIF system in July 2014 and first developed the prototypes of
`
`Battalion in August 2014. See Response to Interrogatory No. 2.
`In February 2015, the PTAB issued Final Written Decisions for the ’334 and ’156
`patent IPRs. There, the PTAB invalidated claims 1–5, 10, 11, 14–17, and 19–28 of the
`’334 patent and claims 1–14, 19–20, and 23–27 of the ’156 patent. The Final Written
`Decisions found all challenged claims of the ’156 patent and all but one of the
`challenged claims of the ’334 patent invalid as obvious over several prior art references.
`Throughout 2015, after the ’156 patent and ’334 patent had been invalidated, Alphatec
`continued to develop the Battalion in order to bring it to market. In October 2015,
`Alphatec finalized its design of Battalion. Response to Interrogatory No. 2. Later that
`year, in December 2015, Alphatec had a validation lab with a production equivalent
`product for the Battalion. Id. And, in April 2016, Alphatec submitted the Battalion
`510(k) to the FDA, which cleared the Battalion in September 2016. Id.
`It was not until November and December 2016 – after the FDA cleared
`Alphatec’s Battalion product – that the Federal Circuit issued its decision regarding
`NuVasive’s appeal of the PTAB’s findings for the ’334 and ’156 IPRs. The Federal
`Circuit affirmed the majority of the PTAB’s invalidity findings with respect to the ’334
`patent, but vacated and remanded the PTAB’s decision relating to claims 16 and 17 of
`the ’334 patent due to procedural violations, and vacated the PTAB’s decision relating
`to the ’156 patent on very narrow findings regarding the sufficiency of the PTAB’s
`analysis showing a motivation to combine prior art references. The Federal Circuit
`however did not disturb the PTAB’s findings concerning the disclosures of the prior art
`references obviating the ’156 patent and ’334 patent. Though the Federal Circuit
`returned to the ’156 patent and the ’334 patent PTAB to address these narrow issues,
`the validity of the claims of the ’334 and ’156 remained in substantial doubt.
`In early 2017, Alphatec had its first sale and surgery with the Battalion and
`announced the launch of Battalion in April 2017. The ’334 and ’156 IPRs were
`8
`DEFENDANTS’ AMENDED RESPONSE TO PLAINTIFF NUVASIVE, INC.’S
`CASE NO. 3:18-CV-00347-CAB-MDD
`FIFTH SET OF INTERROGATORIES (NO. 23)
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`EXHIBIT 21 - PAGE 367
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`terminated in May 2017 pursuant to the settlement of Warsaw Orthopedic, Inc. v.
`NuVasive, Inc. without the PTAB completing its analysis of the invalidity of the claims
`
`of the ’156 and ’334 patents. As such, Alphatec continued to believe that that there
`was substantial doubt surrounding the validity of these claims and Alphatec had a good
`faith basis to believe the ’334 patent and the ’156 patent were invalid.
`In addition to those involving the ’334 patent and ’156 patent, Alphatec
`monitored other litigations and post-grant proceedings involving related NuVasive
`patents that cast further doubt on the validity of NuVasive’s patent portfolio.
`For example, in Medtronic Sofamor Danek USA, Inc. v. Nuvasive, Inc., No. 3:08-
`cv-01512, Medtronic filed suit against NuVasive asserting that NuVasive infringed,
`among others, U.S. Patent No. 5,860,973, which had claims direct towards a spinal
`implant, and U.S. Patent No. 6,945,933, which had claims directed to a spinal access
`system. In September 2011, the trial for Phase I of this litigation concluded with the
`jury finding both of these patents valid and infringed by NuVasive. The Federal Circuit
`affirmed the jury verdict with respect to validity and infringement of the ’973 and ’933
`patents. Alphatec closely monitored this litigation. Alphatec noted that in February
`2015, during the development of Battalion, Medtronic’s ’973 patent expired. And, in
`January 2016, Alphatec entered nonexclusive patent license agreement with Warsaw
`Orthopedic for the ’933 patent. ATEC_LLIF000262386.
`
`In the same suit, NuVasive counterclaimed that Medtronic infringed U.S. Patent
`Nos. 7,207,949 (related to U.S. Patent No. 8,355,780) and 7,582,058 (related to U.S.
`Patent No. 9,833,227). The claims of these patents were directed to systems and
`methods for accessing a spine surgical site. But in June 2009, Medtronic filed request
`for inter partes reexamination of the ’949 patent (Application No. 95/001,202). In
`August 2009, the PTAB granted the request. After back and forth between the parties,
`the Examiner rejected claims 2, 8, and 12–14 of the ’949 patent which were directed to
`“[a] system for accessing a surgical target site,” and claims 16–27 and 29–38 of the ’949
`patent which were directed to “[a] method of accessing a spinal target site.” In
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`DEFENDANTS’ AMENDED RESPONSE TO PLAINTIFF NUVASIVE, INC.’S
`CASE NO. 3:18-CV-00347-CAB-MDD
`FIFTH SET OF INTERROGATORIES (NO. 23)
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`EXHIBIT 21 - PAGE 368
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`September 2014, the PTAB affirmed rejection of the claims of the ’949 patent.
`In October 2009, Medtronic filed a request for inter partes reexamination of the
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`’058 patent (Application No. 95/001,247). After initial arguments and discussion
`between the parties, the examiner withdrew the grounds of rejection in its short Right
`of Appeal Notice. In March 2013, during the appeal of the ’058 patent reexamination,
`the PTAB invalidated claims 1, 2, and 4–8 of the ’058 patent (Application No.
`95/001,247) which were directed to “[a] method of accessing a surgical target site.”
`Medtronic presented another strong invalidity challenge to NuVasive access
`patents in Warsaw Orthopedic, Inc. v. NuVasive Inc., No. 3:12-cv-02738.
`In October 2013, Medtronic filed two IPRs for U.S. Patent No. 8,192,356 (related
`to U.S. Patent No. 9,833,227) seeking review of claims 21, 22, 24–26, 30, and 33–37.
`In April 2014, the PTAB instituted review. Then in April 2015, The PTAB invalidated
`claims 21, 22, 24, 30, and 33-37 which were directed to “[a] system for accessing a
`spinal disc of a lumbar spine through an operative corridor.”
`Also, in October 2013, Medtronic filed IPR for U.S. Patent No. 8,016,767
`(related to U.S. Patent No. 8,355,780) seeking review of claims 1, 2, 4, 5, 10, 15, 17,
`and 18. In April 2014, the PTAB instituted review as to all claims sought for the ’767
`patent. And, in April 2015, the PTAB invalidated claims 1, 2, 4, 5, 10, 15, 17, and 18
`of the ’767 patent, which were directed to “[a] method of accessing a surgical target
`site.”
`
`Additionally, Alphatec monitored NuVasive, Inc. v. Globus Medical, Inc., No
`1:10-cv-00849. In October 2010, NuVasive filed suit against Globus alleging that
`Globus was infringing, among others, U.S. Patent No. 7,691,057 (related to U.S. Patent
`Nos. 8,439,832 and 8,753,270). In February 2012, Globus filed a request for inter
`partes reexamination of the ’057 patent (Application No. 95/001,888). The Examiner
`ordered reexamination of claims 17–22 and 24–27, which were directed to “[a] method
`of accessing a surgical target site within a spine.” In April 2012, the Patent Office filed
`a decision granting the request for inter partes reexamination of the ’057 patent. After
`10
`DEFENDANTS’ AMENDED RESPONSE TO PLAINTIFF NUVASIVE, INC.’S
`CASE NO. 3:18-CV-00347-CAB-MDD
`FIFTH SET OF INTERROGATORIES (NO. 23)
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`EXHIBIT 21 - PAGE 369
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`additional back and forth between the parties, the Examiner withdrew the grounds of
`rejection in its short Right of Appeal Notice. In July 2014, the PTAB reversed the
`
`Examiner in the inter partes reexamination of the ’057 patent finding that claims 17–
`22 and 24–27 to be unpatentable. In November 2018, the Federal Circuit vacated and
`remanded the PTAB’s obvious determination for ’057 patent on very narrow grounds
`related to secondary considerations.
`Accordingly, these proceedings raised questions regarding NuVasive’s patent
`portfolio as it related to access and implant patents. The proceedings were well known
`and disclosed by NuVasive in their public financial filings. See e.g. NuVasive 2013
`Annual Report (Form 10-K), 21–22, 31 (Mar. 3, 2014); NuVasive 2014 Annual Report
`(Form 10-K), 22–23, 33–34 (Feb. 25, 2015); NuVasive 2015 Annual Report (Form 10-
`K), 25–26 (Feb. 11, 2016); NuVasive 2016 Annual Report (Form 10-K), 105–106 (Feb.
`9, 2017). And all of this litigation, both before district courts and before the Patent
`Office, was widely publicized by multiple sources and well known across the industry
`including within Alphatec. See e.g., ATEC_LLIF000970732–747.
`Furthermore, after the commencement of the instant suit in February 2018,
`Alphatec presented a strong invalidity case for the ’334 and ’156 patents. For example,
`in July 2018, the Court, in its Order Denying Motion for Preliminary Injunction, noted
`that Alphatec raised a substantial question as to the validity of claim 1 of the ’156 patent.
`Doc. No. 94 at 10. Alphatec also filed petitions for IPRs challenging all asserted claims
`of the ’334 and ’156 patents in December 2018 and January 2019. The Court stayed
`litigation of the ’334 and ’156 patents as a result of Alphatec’s IPRs. In July 2019, the
`PTAB instituted Alphatec’s IPRs for all asserted claims of the ’334 and ’156 patents.
`The PTAB’s institution of both IPRs further supports Alphatec’s good faith belief that
`the ’334 and ’156 patents were and are invalid.
` It was against this backdrop of multiple challenges to NuVasive’s patent
`portfolio when Alphatec began developing the Transcend Implant (“Transcend”).
`Official development of Alphatec’s Transcend began in or about September 2018, after
`11
`DEFENDANTS’ AMENDED RESPONSE TO PLAINTIFF NUVASIVE, INC.’S
`CASE NO. 3:18-CV-00347-CAB-MDD
`FIFTH SET OF INTERROGATORIES (NO. 23)
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`EXHIBIT 21 - PAGE 370
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`the Court in the instant case stated Alphatec raised a substantial question as to the
`validity of claim 1 of the ’156 patent. Doc. No. 94 at 10. Alphatec decided expand its
`
`lateral implant offerings to include a Titanium implant (IdentiTi) to address surgeons
`asking for Titanium implants, over PEEK implants, due to the bone’s affinity for
`titanium. Alphatec decided to add an equivalent PEEK version of the IdentiTi for
`surgeons who chose to continue using PEEK implants, and developed the Transcend.
`The Transcend implant was designed to match the dimensions of Alphatec’s IdentiTi
`implant. Alphatec had a validation lab for Transcend in September 2019. And the
`Transcend launched commercially in October 2019.
`Alphatec maintains that the asserted claims of the ’334 and ’156 patents are
`invalid under at least 35 U.S.C. § 112, ¶ 2 and 35 U.S.C. § 102(b).
`Moreover, in the first quarter of 2016, NuVasive was contemplating an
`acquisition of Alphatec. During this period, NuVasive representatives met with
`representatives from Alphatec. In the course of those meetings, and through the
`diligence process, Alphatec representatives presented business highlights—and
`NuVasive became aware of—containing explicit information regarding Alphatec’s
`product pipeline, including Battalion Ti-coated interbodies, information regarding
`Battalion’s full U.S. launch, Alphatec’s Squadron retractor, Alphatec’s LLIF product
`offerings, LLIF interbody, and information stating that Alphatec planned to develop and
`release a “next generation” LLIF interbody in 2018. E.g. NUVA_ATEC0318805 at
`0318823–24, 0318826, 0318829; NUVA_ATEC0318771; NUVA_ATEC0318760;
`NUVA_ATEC0319014. NuVasive did not tell Alphatec that it believed Alphatec’s
`implant offerings might infringe the ’156 patent and the ’334 patent. Alphatec relied
`on NuVasive’s silence throughout that time period when it expended significant time
`and resources to launch its lateral products.
`Also, since learning of the ’334 and ’156 patents, Alphatec has introduced a
`suitable, non-infringing alternative to the Accused Products. Specifically, Alphatec
`commercially launched its IdentiTi line of implants in 2019. The IdentiTi Interbody
`12
`DEFENDANTS’ AMENDED RESPONSE TO PLAINTIFF NUVASIVE, INC.’S
`CASE NO. 3:18-CV-00347-CAB-MDD
`FIFTH SET OF INTERROGATORIES (NO. 23)
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`EXHIBIT 21 - PAGE 371
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`Implant System allows Alphatec to address the broader market of surgeons who prefer
`titanium over PEEK. Alphatec began alpha evaluations of the various IdentiTi implants
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`in August 2018.
`Alphatec notes that NuVasive bears the burden to show that willful infringement
`applies. Defendants reserve the right to supplement this response in response to any
`proffered evidence or further contentions from NuVasive.
`
`
`
`
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`
`
`Dated: November 3, 2020
`
`
`
`WINSTON & STRAWN LLP
`
`
`By: /s/ Nimalka R. Wickramasekera
`Nimalka R. Wickramasekera
`George C. Lombardi
`Brian J. Nisbet
`David P. Dalke
`Saranya Raghavan
`Corinne Stone Hockman
`Attorneys for Defendants
`ALPHATEC HOLDINGS, INC. AND
`ALPHATEC SPINE, INC.
`
`
`
`
`
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`DEFENDANTS’ AMENDED RESPONSE TO PLAINTIFF NUVASIVE, INC.’S
`FIFTH SET OF INTERROGATORIES (NO. 23)
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`CASE NO. 3:18-CV-00347-CAB-MDD
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`EXHIBIT 21 - PAGE 372
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`CERTIFICATE OF SERVICE
`United States District Court for the Southern District of California
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`Case No. 3:18-CV-00347-CAB-MDD
`I am a resident of the State of Illinois, over the age of eighteen years, and not a
`party to the within action. My business address is Winston & Strawn LLP, 35 W.
`Wacker Drive Chicago, IL 60601-9703. On November 3, 2020, I served the following
`document:
`DEFENDANTS’ RESPONSE TO PLAINTIFF NUVASIVE, INC.’S FIFTH SET
`OF INTERROGATORIES (NO. 23)
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`by electronically transmitting copy(ies) of the document(s) listed above via
`email to the addressees as set forth below, in accordance with the parties’
`agreement to be served electronically pursuant to Fed. R. Civ. P. 5, or
`Local Rule of Court, or court order. No error messages were received after
`said transmission.
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`SEE ATTACHED SERVICE LIST
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`I declare under penalty of perjury under the laws of the United States of America
`that the above is true and correct.
`Signed: /s/ Greg Skogg_
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`Greg Skogg
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`Dated: November 3, 2020
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`CERTIFICATE OF SERVICE
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`CASE NO. 3:18-CV-00347-CAB-MDD
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`EXHIBIT 21 - PAGE 373
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`Case 3:18-cv-00347-CAB-MDD Document 307-22 Filed 02/16/21 PageID.30041 Page 12 of
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`SERVICE LIST
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`Paul D. Tripodi II, Esq.
`Erik Carlson
`Wilson Sonsini Goodrich & Rosati P.C.
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`Telephone: (323) 210-2900
`Facsimile: (866) 974-7329
`Email: ptripodi@wsgr.com
`Email: ecarlson@wsgr.com
`Email: nuva/atec@wsgr.com
`Email: NUVA_ATEC-IP@list.wsgr.com
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`Wendy L. Devine, Esq.
`Wilson Sonsini Goodrich & Rosati P.C.
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, CA 94105
`Telephone: (415) 947-2000
`Facsimile: (415) 947-2099
`Email: wdevine@wsgr.com
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`Natalie J. Morgan, Esq.
`Christina Elizabeth Dashe, Esq.
`Wilson Sonsini Goodrich & Rosati P.C.
`12235 El Camino Real, Suite 200
`San Diego, CA 92130
`Telephone: (858) 350-2363
`Facsimile: (858) 350-2399
`Email: nmorgan@wsgr.com
`Email: cdashe@wsgr.com
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`Sara L. Tolbert, Esq.
`Wilson Sonsini Goodrich & Rosati P.C.
`650 Page Mill Road
`Palo Alto, CA 94304
`Telephone: (650) 493-9300
`Facsimile: (650) 565-5100
`Email: stolbert@wsgr.com
`Hilgers Graben PLLC
`Michael T. Hilgers (Pro Hac Vice)
`mhilgers@hilgersgraben.com
`J. Bub Windle (Pro Hac Vice)
`bwindle@hilgersgraben.com
`Trenton T. Tanner (Pro Hac Vice)
`ttanner@hilgersgraben.com
`575 Fallbrook Blvd, Suite 202
`Lincoln, NE 68521
`Telephone: 402-260-2106
`Fax: 402-413-1880
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`CERTIFICATE OF SERVICE
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`CASE NO. 3:18-CV-00347-CAB-MDD
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`EXHIBIT 21 - PAGE 374
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`Case 3:18-cv-00347-CAB-MDD Document 307-22 Filed 02/16/21 PageID.30042 Page 13 of
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`Andrew R. Graben (Pro Hac Vice)
`agraben@hilgersgraben.com
`10000 N. Central Expy, Suite 400
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`Dallas, TX 75231
`Telephone: 214-842-6828
`Fax: 402-413-1880
`Attorneys for Plaintiff NuVasive, Inc.
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`CERTIFICATE OF SERVICE
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`CASE NO. 3:18-CV-00347-CAB-MDD
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`EXHIBIT 21 - PAGE 375
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