UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MEDTRONIC, INC.
`Petitioner
`
`v.
`
`NUVASIVE, INC.
`Patent Owner
`
`
`Patent Number: 8,361,156 B2
`Issue Date: January 29, 2013
`
`
`Case No. IPR2013-00506
`
`______________________________________________________
`
`
`DECLARATION OF PATRICK MILES
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`
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`
`
`
`
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`
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`
`
`1
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`NUVASIVE 2030
`Medtronic, Inc. v. NuVasive, Inc.
`IPR2013-00506
`
`

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`patents assigned to NuVasive, many of which are related to NuVasive’s XLIF solution,
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`including lateral surgical method and systems.
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`spinal fusion procedures using the CoRoent XL interbody implants and other interbody
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`fusion implants, and I understand the design constraints and difficulties associated with
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`developing a new interbody fusion implant, especially one particularly suited for lateral,
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`trans-psoas lumbar surgeries.
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`I submit this declaration in support of NuVasive’s Patent Owner Response to
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`the inter partes review related to US. Patent No. 8,187,334 (“the ’334 patent”).
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`My testimony is based on my education and experience in the spinal
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`orthopedics field, including my work experience at Sofamor Danek from 1996 to 1999 and at
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`the competitive landscape, and my personal knowledge and involvement in certain events.
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`The development of the XLIF solution at NuVasive began in 2001. The XLlF
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`systems and procedure were initially released at the North American Spine Society Annual
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`Meeting in late 2003. Our commercialization efforts continued after the 2003 NASS meeting
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`into 2004. The CoRoent XL family of interbody implants, used in XLlF procedures and
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`inserted into the spine from a direct lateral, retroperitoneal, transpsoas approach to the
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`lumbar spine, was commercially launched at NASS in 2004. The CoRoent XL implants
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`were the first commercially available lumbar interbody implants having a length greater than
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`transpsoas approach to the lumbar spine.
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`Initially, NuVasive’s XLIF solution was met with substantial skepticism within
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`the spinal orthopedics community, including concern over the size of our implants. During
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`those early years, we put substantial resources into training the spinal community to
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`overcome that skepticism and show the spinal community that the XLIF solution was indeed
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`a safe and effective solution for spinal fusion especially in the lower lumbar region. We
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`have continued to improve the XLIF solution, specifically expanding its usability to treat a
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`wider array of spinal issues. Eventually, NuVasive’s success led to competitors in the
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`marketplace, the first of those being Medtronic Sofamor Danek with its “DLIF” surgical
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`technique and its Clydesdale lateral implants in the 2006/2007 timeframe—years after
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`NuVasive pioneered the market for lateral, trans-psoas interbody fusion surgeries with the
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`CoRoent XL implant. NuVasive currently has a patent infringement lawsuit pending in U.S.
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`District Court against Medtronic, accusing its DLIF system, including its Clydesdale
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`implants, of infringing NuVasive patents. Additional competitors have also entered the
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`market with lateral fusion solutions that incorporate many of the important innovations
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`developed by NuVasive. Those other companies include, among others, Globus Medical,
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`Inc. with its Lateral Lumbar lnterbody Fusion (“LLIF”) solution and transcontinental interbody
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`implants introduced in the 2010 timeframe. See id. NuVasive also has a patent
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`See Appendix A, p. 7. The above information from Petitioner Medtronic confirms my
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`understanding that NuVasive pioneered the market for lateral, trans-psoas interbody fusion
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`surgeries with the CoRoent XL implant and that NuVasive was dominant participant in this
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`market for such lateral, trans-psoas interbody fusion implants for at least years 2004-2008.
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`See Appendix A, p. 7. Moreover, since 2008, based upon my knowledge and experience in
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`product marketing and development for spine surgery, I believe that in all of the years since
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`NuVasive pioneered the market for lateral, trans-psoas interbody fusion surgeries with the
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`CoRoent XL implant (2004 through 2013), NuVasive was, and continues to be, the
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`dominant participant in this market for such lateral, trans-psoas interbody fusion implants.
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`See also Appendix A, p. 17 (showing that Petitioner Medtronic’s projections for years 2009-
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`2013 correctly predicted that NuVasive’s CoRoent XL implant for NuVasive’s XLlF solution
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`would continue to be the market leader for interbody revenue).
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`Additionally, the above information above information from Petitioner
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`Medtronic confirms the fact that the “lnterbody Revenue” for NuVasive’s CoRoent XL
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`implant for NuVasive’s XLlF solution accelerated rapidly (refer to p. 7 of Appendix A). For
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`example, after NuVasive pioneered the market for lateral, trans-psoas interbody fusion
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`surgeries with the CoRoent XL implant, NuVasive’s revenues associated with CoRoent XL
`
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`implants in 2006 was more than 295% greater than those from 2005 (the first full year of
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`sales).
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`2007 was more than 302% greater than those from 2006. Or, taking a longer view of the
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`growth in revenue associated with CoRoent XL implants, NuVasive’s revenues associated
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`with CoRoent XL implants in 2013 was more than 3,900% greater than those from 2005.
`In
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`sum, in the years since NuVasive pioneered the market for lateral, trans-psoas interbody
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`fusion surgeries with the CoRoent XL implant, the total CoRoent XL implant revenues from
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`2005 through 2013 totaled hundreds of millions of dollars, which (based upon my
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`knowledge and experience in product marketing and development for spine surgery) is
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`considered to be a tremendous commercial success and which i believe to be greater than
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`any other competitor lateral, trans-psoas interbody implant in this market (e.g., Medtronic
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`Clydesdale implant, Globus Transcontinental implant, and others).
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`11.
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`l hereby declare that all statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to be true; and
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`further that these statements were made with the knowledge that willful false statements
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`and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of
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`the Title 18 of the United States Code and that such willful false statements may jeopardize
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`the validity of the application or any patents issued thereon.
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`Dated: May 21, 2014
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`<5
`By: ; 3
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`Patrick Miles
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`APPENDIX A (MILES DECLARATION)
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`DLIF Marketing Plan
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`DLIF IS FOR EVERY SURGEON.
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`Confidential Information - Patent Prosecution Sensitive
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`Page 2
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`MNUV0188194
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`PX1056-OOO1
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`Outline
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`|.
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`Executive Summary
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`ll. Current Environment
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`Ill. Market Plan
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`Mission
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`Objectives
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`Strategies
`Tactics
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`IV.
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`Impact for the Future
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`air IS FOR EVERY SURGEON
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`Confidential Information — Patent Prosecution Sensitive
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`11
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`Page 3
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`2
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`{:LIF Math-Ivy Plan
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`Discuss all competitors entering the arena
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`PX1056—0002
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`Executive Summary
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`The lateral market is here to stay and XLIF is negatively impacting
`MDT minimally invaswe growth and share
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`Our DLIF objectives to reverse this trend are to increase the % of.
`territories sellin% DLIF to 40% 23% today by end of FY11 and
`complete 30,00 DLIF levels( ,500 today by end of FY12
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`'
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`To meet these objectives. we must execute on strategies of:
`1} Product Pipeline, 2) Training, and 3) Messaging
`Product: Execute time efficient launch of_la_te_r_a|
`late, begin shift to _
`Innovation With launch of flEi'gfiQ, unleash Innovative mw_impLan_t desrgn
`Training: Continue focus on effective surgeon and sales training
`Messaging: Expand awareness of DLIF and entire minimally invasive
`platform across AL]. stakeholders as a company
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`DLIF is one piece of the fastest growin platform at MSB (b5200M in
`CY08 for just minimally invasive fusionl)J
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`am
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`PX1056—0003
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`MNUVO188196
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`Product
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`Drive 40"
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`of sales
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`force to soil C-iycieso’aie ‘-.\
`by end of FY 'E 'i
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`Perform 30,000 DLiF
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`Confidential Information - Patent Prosecution Sensitive
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`Page 5
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`1 3
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`PX1 056-0004
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`Messaging" T)
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`Current Environment
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`5-
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`GLIF marital-cg Pian
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`Eltf IS FOR EVERY SURGEON
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`Confidential Information — Patent Prosecution Sensitive
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`Page 6
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`14
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`PX1056-0005
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`MNUVO188198
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`5
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````aabcdcefcghijklmnogpq rsDtEuFvuwxyz {||} CDusF~ nog€‚ƒ„‚…<†‡‡ˆ ‰† Š‹ ŒŽ|‘‘ ’“@”’• –>;< —˜ ™š›œžŸž  u¡ED ¢£¤¥¦£§¨ ©ª«¬¬­®¯°±;==;>‹ˆ nog>=>† ²£¢¢³´³¨¦£¥¦£§¨µŸž ŸŒž ¶·¸¹º»¼½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ÛÜÝÞßàááâãã
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`
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`Page 7
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`15
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`Market Financials to Date
`
`10.5
`
`101
`
`CY06
`
`Major
`Initiatives
`
`4.4
`
`CY07
`
`Clydesdale Launch
`
`NIM Eclipse Launch
`
`am
`
`äääääääääåæçèéêëèìíîèÜïð ñyòóò ÔÙôõÙÕö÷ jø ùEøEFwE~úûñ üÄÃÀ¾à ü½ýÀÃÀ½¾À¾þ ØÖÿô ôõÙÕ ÌÐÊÌ hu¡FùCrrÊÌÐ ôõØÖØÖö×
`ÌÓÏÍÊ ÊÌÐ

ÌÌËÓÍÐ  hijk ôõØÖØÖö× ÕÇÂþÀ½¾ÄÅÅÜïð  yÏÑÒÐ ÎÏÒÑËúûñ ôÕ õØöÖÕÖÙC wsDE~ ½¿¶·¸¹º»ÐÊÎÌ ×ØÖÿÕÊÒÍÑ Ó hE!"ÍÓ#ÊËÓÏÍ Ä$ÄÀÅÄ%ż½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ÛÜÝÞßàáá&''
`
`13% MDT Share
`
`CYOS
`
`F‘I"OE RTM Tlaining
`
`Strategic Product Addition
`Clydesdale SIZE Extensmn
`Longitude Launched
`
`MNUVO188200
`
`7
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`our IS FOR E‘.ER'\" S'LIFGEDN
`
`New MedEd Strategy Implemented
`
`NIM & Patient Positioning incorporated
`
`Clydesdale Downclass
`
`Sales Trainings
`
`Regional Sales Meetings
`
`Advanced DLIF Trainings held regionally
`
`New Tech Rep focus product
`
`NIM rep alignment
`
`Captured ~18% of market share since launch
`
`High Def Animation available
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`Confidential Information - Patent Prosecution Sensitive
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`Page 8
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`16
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`PX1056-0007
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`16
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`Lateral Market Dynamics
`
`1.
`
`Innovative minimally invasive approach
`
`— Nuvasive pioneered the approach
`
`— Strategic focus top MIS competitor
`
`2. Driving minimally invasive fusion market
`
`EI'IJF I-E. FDR BERT SURGEON
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`NOO()*+,(-.()/////////////////012345360 789:9;; <<<<<<<<<<¼½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ÛÜÝÞßàáá&'â
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`2005
`2005
`3
`131.5
`3109.4 3
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`E19 $13.9 E
`
`2001'
`161.
`531
`
`S
`f.
`
`2008
`202.3
`WEE
`
`"
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`Confidential Information — Patent Prosecution Sensitive
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`Page 9
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`PX1056—0008
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`-
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`2006
`54.1%
`7.6%
`
`2007
`46.1‘.‘
`152%
`
`2003
`41
`21.8%
`
`MNUV0188201
`
`8
`
`17
`
`

`

`Market Plan
`
`EILSF IS FOR EVERY SURGEON
`
`'3
`
`I’JLIF Hamel-"g: Pian
`
`=>?@?A®?B¼½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ÛÜÝÞßàáá&'&
`
`Confidential Information — Patent Prosecution Sensitive
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`Page 10
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`18
`
`MNUV0188202
`
`9
`
`PX1056-0009
`
`18
`
`

`

`Leverage the exciting & innovative DLIF
`technology as a key growth driver for Medtronic's
`entire minimally invasive platform.
`
`EIUF IS FOR E'rE'fi'r' SLIRGEDH
`
`“1
`
`a'Z‘LIF flannel-'29 Plan
`
`Cabcdcefcg¼½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ñúDEFGHHIFJ KL
`
`Confidential Information — Patent Prosecution Sensitive
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`Page 11
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`19
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`PX1056-OO10
`
`MNUVO188203 10
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`19
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`

`

`cdMgng))*NOPQQRSTUTUTUTUT VWXYZ[ \]^_¼½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ÛÜÝÞßàáá&'`
`
`
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`Page 12
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`20
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`PRODUCT PIPEL'N E
`
`Balance cadence of iterative and
`DISRUPTIVE technology
`
`TRAINING
`
`MESSAGING
`
`Etf Is FOR EVERY SURGEON
`
`abcc¼½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ñúDEFGHHIFd Ke
`
`Develop best-in-class sales and
`surgeon training outlets along the
`entire learning CONTINUUM
`
`Create AWARENESS of the Medtronic
`DLIF offering 8. the strength of the
`complete solution
`
`‘2
`
`OLIF h‘ar'ua’rlm-g Plan
`
`Confidential Information — Patent Prosecution Sensitive
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`Page 13
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`PX1056—OD12
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`MNUV0188205 12
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`21
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`

`fghhijgklmnopÀÅÄýÇý õôÕ®qÙÕrstuvswx¶¶ºyz·»ºo{|}~gʀÓÊËÌ ‚ƒ„…†‡ˆ ‰ÄÃÂÇÄŊõÙÕ ‹ŒŽ ̏ːyxW õÖّ’ð ¢¥“¦”•r}~uÖÀ¾þý õÖöØÖö ÄÃÙÕnf—f˜™±®qš›œ€ž¾À¿ÂŸ%À ½ÅÄÇ ¡¢££ ¤¥¦yº§y·¥º ¨©ª «¬­®¯°±²³´µ¶g· ¸g¹º»»º¼yº¸ ÌÐÊÌ ½¾¿ÀÁÂÃ姻zż ‘’ð ýöÕ٠ǽÆÂÇÃý وȄƒƒÃ½ ÉÑÏÍÐÓÌÎÌ  Ç½ÆÂÇÃÊËÌ ¶g·¸g¹ º»»º¼yº¸m{ÍÎÏÐÑÖØÒÕ ¡¢££ ¤¥¦yº§y·¥º ›œ€¼½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ñúDEFGHHIFÓ KÔ
`
`
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`Page 14
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`22
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`

`Training
`
`Develop best in ctass saies and surgeon training outiets
`aiong the entire learning curve CONTINUUM
`
`lance. Learning Modules on DLIF procedure and lip-stint:
`~ .1] DLIF iechniaues
`rrILI drw'e of DUF sales iools}
`
`n,~'a|e.Mernuhi5 for imme diale Iralning needs
`mphca
`n; etc
`
`' a Tech Reps
`— The.
`_ I: wrrksmp wiih an
`
`Complete
`
`— Month 3
`
`alfs WIN“- _=ary Green lo discuss current trend: and nit-dates
`
`Ongoing
`
`EMF IS FOR E‘Efi'r' SLIRGEDo-J
`
`äääääää ÕÖ×Ö×Ö×ÖØØØØÙØ ÚxÛxÛxÛxÛÚ¼½¾¿ÀÁ¾ÃÀÄŠƾ¿½ÇÈÄÃÀ½¾ ÉÊËÌÍËÉÎÏÐÌÑÒËÓÏÍ ÔÕÖ×ØÙØÚÕ ÜÝÞßàáââãàä Kå
`
`. 1| [or DLIF L. 5?.
`a focused DLIF l
`
`m; fol HIM reps
`
`m flLIF N-
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`Confidential Information - Patent Prosecution Sensitive
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`Page 15
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`23
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`PX1056—0014
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`MNUV0188207 14
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`23
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`

`

`Messaging
`
`Create AWARENESS of the Medtronic DLIF offering and
`the strength of the complete soiution
`
`Surgeon-For.
`I.
`a: EILIF pourrz-al am-emssng campaign
`
`pun ecm'n
`‘: El {HI melena is
`
`Jan '10
`
`540.000
`(Budgeted)
`
`Eltf IS FOR E‘I'Efi'r' SURGEON
`
`WÔ?@AB=B?A?B==?ææ çèèéèêëëìë íííííííííííîïðñòóôðõòö÷ øðñïùúöõòïð ûüýþÿýû þ ý ÿ 
`
`

 ÜÝÞßàáââãàâ K
`
`Communication Plan
`, EiLiF .a
`sheet um: quunerry
`
`15
`
`{aLIF l'.*n--.el-r-§ Pier!
`
`Nov '13!)
`
`Confidential Information - Patent Prosecution Sensitive
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`24
`
`Page 16
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`PX1056—OD15
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`MNUV0188208 15
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`24
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`

`Impact for the Future
`
`1'1
`
`SLIF reariwlmg Pian
`
`Eltf IS FOR EVERY SURGEON
`
` 9îïðñòóôðõòö÷ øðñïùúöõòïð ûüýþÿýû þ ý ÿ 
`
`

 ÜÝÞßàáââãà K
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`Confidential Information — Patent Prosecution Sensitive
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`Page 17
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`25
`
`PX1056-0016
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`MNUVO188209 16
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`25
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`

`

`Elf IS FOR EVERY sLIRGECM.
`
`Financials for the Future
`
`3
`
`.N m
`
`Ea
`
`”in3
`I:
`a:)
`a:
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`1-:
`
`o E.
`
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`E
`
`CY12
`
`Clyiiesdaie ||
`
`Sensor Retrador
`
`26
`
`PX1056-OD17
`
`MNUV0188210 17
`
`CY11
`
`ME MD
`
`-
`.
`Awareness Campaign
`
`Economic.- Marketing
`
`'45-
`les Tr
`EILIF
`Update
`.
`I'-ianonai
`Cus.tom Training Oops
`
`1'.'
`
`OLIF i.’a.t'-.almg Pian
`
` !*")îïðñòóôðõòö÷ øðñïùúöõòïð ûüýþÿýû þ ý ÿ 
`
`

 ÜÝÞß#áââãá# K$
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`Confidential Information - Patent Prosecution Sensitive
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`Page 18
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`26
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`

`

`Lateral approach falls out of favor
`
`Compiex constructs become frowned
`upon by hospital administration
`
`implant pricing seriously impacted by
`health care reform
`
`NUVA beats to the punch on retractor,
`implant. or other technology
`
`iii
`
`fiLlF Mantel-'1‘; Pier!
`
`Confidential Information — Patent Prosecution Sensitive
`
`MNUV01882’I‘I 18
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`Page 19
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`27
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`PX1056—OD18
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`— DLIF continues to be positioned as
`one piece of the MIS puzzle
`— Clinical evidence to position is key
`
`— implant stratification becomes key to
`maintain pricing for onei'two level
`— Clinical and economic evidence to
`justify construct benefit is needed
`
`— implant stratification again key to
`hold premium at key accounts
`— Clinical evidence to position is key
`
`— Create surgeon advisory board to
`meet regularly and stay ahead of
`where DLIF can take us.
`— Maintain focus on where DLIF works
`for us in the MIS portfolio and
`continue to innovate in this area
`
`EMF IS FOR E‘Efi'r' SURGECN
`
`%ò% KKKKKK &'()(' *+îïðñòóôðõòö÷ øðñïùúöõòïð ûüýþÿýû þ ý ÿ 
`
`

 ÜÝÞß#áââãáá ,-
`
`27
`
`

`

`Quad:
`
`Questions?
`
`Confidential Information — Patent Prosecution Sensitive
`
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`Page 20
`
`îïðñòóôðõòö÷ øðñïùúöõòïð ûüýþÿýû þ ý ÿ 
`
`

 ÜÝÞßàáââãáã ,.
`
`MNUVO188212 19
`
`28
`
`PX1056-OD19
`
`28
`
`