DAl'JEK
`
`GROUP. INC.
`January 13, 1994
`
`G. Karlin Michelson, M.D.
`8610 Sepulveda Btvd.
`Suite 101
`los Angeles, California 90045
`
`Dear Dr. Michelson,
`
`MEDICAl DIVIS,ON
`
`Y.N1. m~ e-::To~s. He......
`/o4EMAilS. 11'1 .;Q1J'
`r3IO'j~:;.nJ
`W.41'S: 18:oJl-07{''.l;I.3J
`;: ....J::; OKHlJ.:l:'.19":'1'l
`
`FAX (3,0) 821 ·5115
`
`It was good to talk wnh you today.
`I am vgry er.thusiastio aboln moving forward
`with the many fusion device concepts. As we had discussed, we would like to
`begin working on the various implant 2nd instrumentation designs. We covered a
`great deal of iniorma1icn in our discussions, so t have lis1ed Some of the things
`we discussed. Please let me know if I missed anything or have misunderstood
`In order to move lonvard wnh the project we discussed the following:
`anything.
`
`1.) You wilt send me (via Fed Ex) today several implants and inlormation on .the
`design. This inl0rma1ion wit! include prior modeling and analysis information on
`the implant as well as regulatory filing information on the 510(k) application by
`KTI en a non-spine application 01 the threaded fusion device technology.
`
`2) You will contact your machinist about manufacturing several sets oj implant
`The machinist will measure tne current
`.and ir1s\rumentation systems.
`instruments, photograph the instruments and forward these to us to allow us to
`begin modeling the complete system We specificaily talked about the following
`
`A.
`
`B.
`
`c.
`
`D.
`
`Primary PlIF InSirt,Jffirtntation . 1 set of instruments'sent alter
`measurement by Inachinist, to allow us to gel started. 3 additional sets of
`primary instruments to be manufactured.
`(Please have your machinist
`send a cost and timing estimate first)
`
`'5rr.o o
`
`D,;.,,'''' h a._ "-
`1(,
`lQrdotic DistractQrs and TreRhineEsize Wmm only) • forward these at
`your earliest convenience. 1don't r8{;aH if we-discussed manufaciure of c.~re"< :i-€--~
`f'!, ~""b
`these, but we should probably make 2 sees (for a total of 3 sets).
`
`Q1her PLiF ,C\ltemalive Insln;menlaJion . We discussed making 2 sets of
`any other alternall'.;es in a single size only (20 mm?). We shoi,lld probably
`discuss an)'thing not already cC\Jemd by ilems A ;and B above.
`1& __
`
`AUF Instrument?lion (20 mm siz.e only) - Manufacture 2 luI! 59tS (for 3 fuil
`sets total), this would incluce the lordoilG wedge distra:;tors, double-barrel
`outer sleeve and appropriate length reamer, oriver, etc.
`
`~~
`
`CONFlDEJ-mAL
`PER p 0. CA TEGOR Y I
`
`Cunlidenllallll!Qrmatiun
`
`THE SPINE SPECIALISTs"',
`
`SDG 34160
`
`MSD 0770109
`
`;2.
`
`MNUV0278500
`
`PX0193-0001
`
`* PLAINTIFF'S
`I
`EXHIBIT
`;;ff,;).;)0
`r4
`/10
`Confidential Information - Patent Prosecution Sensitive
`1107 Estes
`
`Cl«
`zw
`
`C'l
`
`0.
`
`PX0193
`
`WARSAW2007
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00208
`
`Page 1
`
`

`
`E.
`
`F.
`
`G.
`
`1c-,y.;>
`jrr;fU. 'f- ~" ';J
`An1BriQr laWallmolanJ and Instruments (240 X 42L size only) . complete
`the current set (e.g., manuJacture slap hammer) and manufacUre one
`duplicate set {fer a total of 2 compiete sets}.
`
`C\OirvicallmolanI and Ins!rumGnt ~el {Size 16 mm QOIYl· please send this
`set for our review at your earliest corwenlence.
`
`H.Qn·Thr~aQgj Qonl<S1Q.1s (pUSh-in Desigos, Irungated Q/Zsjans, and
`Cervical Fusion Device with FrQnl Siall • Please send me some samples
`of these for our review and records at your earliest convenience.
`
`Dr. Michelson, I think this covers ailihe devices we discussed. Please call me if I
`have missed anything.
`I will look forward to receiving the implants and additional
`information tomorrow,
`I wi!! stay in touch with you as we move forward to this
`project and wi\!
`look forward to hearing irom your machinist regarding 1he
`manufacture of
`the additional
`implant/instrument sets. Also, please do no1
`hesitate to call me at any time. Due to the time difference and our schedules,
`you wiit probably need 10 call me at home at times. My home phone number is
`(901) 681·0243. Please do not hesitate to call me.
`I will talk with you soon.
`Take care.
`
`Sincerely,
`
`f£;~~~-
`
`wrenc r.. Boyd
`anage,
`roduct Development
`
`'v
`
`cc:
`
`Ron Pickard
`John Pafford
`
`Confidentiallntconalion
`
`CONFIDENTIAL
`PER P.O. Cl\TEQORY J
`
`SDG3416I
`
`MSD 0770110
`
`Confidential Information - Patent Prosecution Sensitive
`
`MNUV0278501
`
`PX0193-0002
`
`Page 2
`
`

`
`Be:
`
`David Brumfield
`Brad Estes
`
`CONFlDt:NTfAL
`?ER 1'0. CA-:-EGORY I
`
`SDG 34162
`
`CDnl!oenUa! Information
`
`MSD OT70111
`
`Confidential Information - Patent Prosecution Sensitive
`
`MNUV0278502
`
`PX0193-0003
`
`Page 3
`
`

`
`D\NL!Z
`
`Q.~OUP. INC.
`January 14, 1>194
`
`G. Karlin Michelson. M.D.
`8610 Sepulvwa Blvd.
`Suile 101
`Los Ang;lles, Califomia 90045
`
`Dear ()(. Michelson,
`
`:»'ilr~RE<:~J:IlCM
`",,·f)~V$..fM :)t'l:)1
`lSOl1.J')8.,')t:::J
`..,....l$ tlOOt~"...),.:U
`--Ul:::'O'~ :s3:I'.:Jt;l?
`
`FAX 310 &21-51' 5
`
`tn {onow-up to our discussion today about manutaeture of the vanous \ostrument
`S<its, MIa are 1M vanous items we dlscussed:
`
`1. PUF Set 3 S<I1S of 65 insls per set at $3.000 per set
`(Timing approximalely 3 weeks)
`
`Tctal $9.0c0
`
`2. Lordolic DlstraC10rs Size 16 mm
`
`Lordotio dislr_C10rs
`inn<lr Sleeve
`Trephille
`Cap Oliver
`Rotary Knife
`
`$loo@
`S35@
`S IS{] @
`$ 150@
`$2OO@
`
`3 sets 101al al $600 per se1
`
`Total $1.000
`
`3. AUF Inslrumemation (Size 13 mm and 20 mm)
`
`Wedge Dislraetofs
`OUler Shotgun Slea'ffi
`DrilVreamer
`Jrnat SIe!Jva
`Dri'ierCap
`Siapper/puller
`Rings
`Tap
`Implant Driver
`
`$125
`$1.50
`$150
`$125
`$225
`$250
`$J()
`$150
`$250
`
`2Qmm Sat
`6@
`i@
`1@
`1@
`
`16mm Se1
`6@
`1 @
`1@
`1@
`1@
`1'<)
`2@
`1@
`1@
`
`Per Sel
`
`$2210
`
`$1485
`
`Need three complete sets at $3.695 per
`
`Totai $11.085
`
`THE SPINE SPEClAUST=
`
`Confidential InformlltiOTl
`
`MSD 1331704
`
`Confidential Information - Patent Prosecution Sensitive
`
`MNUV0278503
`
`PX0193-0004
`
`Page 4
`
`

`
`4. Ar,terior lateral lnstrumentatiOfl (240 x 42l)
`
`Dislractor 6, 8,10,12,14 mm
`Slap Hammer
`Driver CaD
`Implant O'river
`Other
`
`$1600 total
`$275 @
`$225 @
`$275 @
`$175 @
`
`Total per set is $2750 and we can use some components from !he eXisting sat
`
`Total npprox. $4,500
`
`Overall, it looks Ilke it adds up as tonows:
`
`L PUF lnstrumentation (3 Sets Manufactured)
`
`$9,COO
`
`2. LordoUc -Distraetars and irephine (3 Se1s)
`
`3. AUF ln~rumems (3 Sets Size 18 and 20 mm)
`
`4. Ariterior Laterallnsts. (2 Sets Total)
`
`$11.085
`
`$4,500
`
`Dr. Michelson, please let me know if this agrees with your notes from our
`conversation. Please have your machinist send me a wrinen quotation for these
`items and I will cut a purchase order. Call me if you have any items to discuss.
`Talk with you soon.
`
`Sincerely,
`
`'t" ~ -
`(awrenca;
`
`~/Manager, Product Development
`
`cc:
`
`John Pafford
`David Brumfield
`Brad Estes
`
`Confidenti:ll Information
`
`MSD 1331705
`
`Confidential Information - Patent Prosecution Sensitive
`
`MNUV0278504
`
`PX0193-0005
`
`Page 5