`
`July 20, 2005
`
`Summarv of management guarterlv Visit
`
`July 12-14, 2005
`
`Larry Wood and Stan Rabinovich used the opportunity of the very hot Weather conditions in Israel
`and came for the quarterly visit. This time it was a short trip (2 full days +) but used very efficient.
`We )crformed the lollowino design reviews:
`
`
`
`Edwards Lifesciences P.V.T. Egg/ards Lifesciences v. Boston Scientific Scimed
`
`43 Haeshei Sti P.0.Box 3067 Caesarea BJRFeZQHrQ‘MQI §8§oo°a$mi§189£v§9£+eawazm Y Fax. 972—4-637—3247
`Exhibit 2043 - Part 1
`Page 1 of 43
`PROTECTIVE ORDER MATERIAL
`EDWARDS 01033844
`
`I
`
`Highly Confidential
`
`
`
`
`
`Edwards
`
`
`
`Edwards Lifesciences P.V.T. inwards Lifesciences v. Boston Scientific Scimed
`43 Haeshel St. P.O.Box 3057 Caesarea BJEYRZQEZFQ‘MQI 98%fawtfi1833’9953-ma7-3201 V Fax. 972-4-637-3247
`Exhibit 2043 - Part 1
`Page 2 of 43
`PROTECTIVE ORDER MATERIAL
`EDWARDS 01033845
`
`Highly Confidential
`
`
`
`Edwardé
`
`
`
`Edwards Lifesciences P.V.T. Emlyards Lifesciences v. Boston Scientific Scimed
`43 Haeshei 5x. P.O.Box 3057 Caesarea edfifigé’flifiéi‘éfl gBfiltfanifilggg’Md-GNGZW \f Fax. 972-4-637-3247
`Exhibit 2043 - Part 1
`Page 3 of 43
`PROTECTIVE ORDER MATERIAL
`EDWARDS 01033846
`
`Highly Confidential
`
`
`
`Edwards
`
`
`
`Edwards Lifesciences PIV‘T. ngards Lifesciences v. Boston Scientific Scimed
`
`43 Haeshel St. P.0.Box 3067 Caesarea BJBfiBOfinQOQfiQI §8§od°a¥mfiy83$§9§+6373201 V Fax. 972-4-537-3247
`Exhibit 2043 - Part1
`Page 4 of 43 #
`PROTECTIVE ORDER MATERIAL
`EDWARDS 01033847
`
`
`
`Page 5 of 43
`
`Edwards Lifesciences v. Boston S
` IPR2017-00060 U S Patent 8,992,608
` Exhibit 2043 - Part 1
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 6 of 43
`
`Edwards Lifesciences v. Boston S
` IPR2017-00060 U S Patent 8,992,608
` Exhibit 2043 - Part 1
` PROTECTIVE ORDER MATERIAL
`
`
`
`098€€0LO SCIHVMCEI
`
`|euuapuuoo AIuBgH
`
`Risk evaluation
`
`Edwards
`
`Ida-fa ne.’ Benrcriou
`4:4 ‘1 21105
`
`l
`
`‘V
`M
`
`.
`.
`Edvard; Humane“
`
`Review of feasibility tests
`
`Review of feasibility tests
`
`|___
`
`m m
`
`Detailed product design spec.
`
`Edwards Lifescizncts
`
`Page 7 0f 43
`Exhibit 2043 - Part 1
`
`PROTECTIVE ORDER MATERIAL
`
`1
`__J
`
`Edwards Lifesciences v. Boston Scientific Scimed
`lPR2017-00060 U S Patent 8,992,608
`
`1
`
`
`
`L98€€OLO SCIth/VlClEl
`
`,
`
`W
`
`|euuapuuoo AIufigH
`
`Review of feasibility tests
`
`Review of feasibility tests
`
`
`
`Edward: Likecicncc:
`
`I
`
`Bimini: ljfcsviL-ncm
`
`Review of feasibility tests
`
`Design description - frame
`
`
`
`Review of feasibility tests
`
`Design description - leaflets
`
`Edwards Lifesciences
`
`j
`
`FAwnndslilcscicnau
`
`Edwards Lifesciences v. Boston Scientific Scimed
`lPR2017-00060 U S Patent 8,992,608
`
`Exhibit 2043 - Part 1
`PROTECTIVE ORDER MATERIAL
`
`2
`
`Page 8 0f 43
`
`
`
`ZSSSSOLO SCIHVMCEI
`
`legiuapuugo AIufigH
`
`Design description - Skirt
`
`'
`
`. Regulatory and Clinical plan
`
`Edward! Ufcscituca
`
`>- Customer feedback review
`
`3
`
`; Final prototype manufacturing plan
`
`Labeling and packaging plan
`
`
`
`
`Lil-«uni: Ufcscmuce:
`
`Edwunla Ursiricnma
`
`Ed‘anis Lilcscicncr:
`
`Edwards Lifesciences v. Boston Scientific Scimed
`lPR2017-00060 U 5 Patent 8,992,608
`
`Exhibit 2043 - Part 1
`PROTECTIVE ORDER MATERIAL
`
`3
`
`Page 9 0f 43
`
`___J
`
`
`
`HeIpI'19 patents 15 our li'esNOI‘K, am:
`
`{,0
`
`Edwards Ulcsciencu
`
`€98€€OLO
`
`SCIEVMGE
`
`|eI1uapJuoo AluSIH
`
`Input vs. output checklist
`
`Fd“ards
`
`Activities and timetable
`
`ElIsunhLiI:sciences
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U S Patent 8,992,608
`
`
`
`Page 10 of 43
`Exhlblt 2043- Pan 1
`
`PROTECTIVEORDER MATERIAL
`
`
`
`Concept presentation.
`
`Detailed product design spec. including
`design changes.
`Risk evaluation.
`
`Review of feasibility tests.
`
`Quality plan.
`Customer feedback review.
`
`Edwards Life sciatica
`
`Review
`
`Yair Spanier
`llJuiy 1305
`
`Risk evaluation
`
`> Content
`
`Final regulatory and clinical plan.
`
`Final prototype manufacturing plan.
`
`Labeling and packaging plan.
`
`Program budget and timetable.
`Selection of subcontractors.
`
`Verification of Input checklist versus output
`checklist.
`
`['11st Die 3( Sauce:
`
`Edumia LJIIJ :cicncc:
`
`Design specifications
`
` l
`
`Edwnnls Likscicnccé
`
`Highly Confidential
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U 5 Patent 8,992,608
`Exhibit 2043 - Part 1
`
`'“ ' 'fiRO‘I‘EC‘rIVE ORDER MATERIAL
`
`Page 1 1 of 43
`EDWARDS 01033854
`
`
`
`Feasibilitv tests nertormed:
`
`Summary of feasibility tests
`
`Edwards Lil‘- scirnccs
`
`Feasibility tests results
`
`Feasibility tests results —
`size 8- position
`
` Edwards [chsn'cntrs
`
`Feasibility tests results -
`steady flow
`
`_
`
`’
`
`3
`
`Feasibility tests results —
`Pulsatile flow
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`lPR2017-00060 U 5 Patent 8,992,608
`Exhibit 2043 - Part 1
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`Page 12 of 43
`EDWARDS 01033855
`
`
`
`.. 'Additional verification tests
`required
`
`" { Feasibility tests results —
`Animal cases
`
`
`
`Edwards Madame:
`
`Edisriis Ulrs-zlvncré
`
`
`
`Feasibility tests results -
`Animal cases
`
`Eduan'is Lilcwcnrcs
`
`Edwards Liftmcncr 4
`
`Highly Confidential
`
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060 U 5 Patent 8,992,608
`Exhibit 2043 - Part 1
`PROTECTIVE ORDER MATERIAL
`
`Page 13 of 43
`EDWARDS 01033856
`
`
`
`Quality plan
`
`Customer feedback review
`
`Edwards Lift scirnws
`
`Final regulatory and clinical plan
`
`Final prototype manufacturing plan
`
`
`
`Edl'lflb bicscii‘nm
`
`Edwards lgfcsrirnrr:
`
`Labeling and packaging plan
`
`Selection of subcontractors
`
`Edamls Ufa-3i Bruits
`
`Edna}.- LJL- scienccs
`
`Edwards Lifesciences v. Boston Scientific Scimed
`lPR2017-00060 U 5 Patent 8,992,608
`
`4
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033857
`
`
`
`Design input vs. Design output
`
`Verification of input checklist versus
`output checklist
`
`liduanla Likwienu:
`
`Eduard: Llfcsncuccs
`
`I
`
`Schedule
`
`Edum'sLilcu-icncra
`
`Edwstda Lifcmcnccs
`
`‘
`
`I
`
`
`
`hdwards
`
`Helping patients is our life‘s wofik. and w
`
`Edwurd: Lik wicucca
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U S Patent 8,992,608
`
`
`Highly Confidential
`
`______Fxhibit 2043 - Part 1
`PROTEéTli/E ORDER MATERIAL
`
`5
`
`Page 15 of 43
`EDWARDS 01033858
`
`
`
`Objectives
`
`Strategy((.cont )
`
`
`
`w-H. .-
`Ed‘uls Lilcwicneg
`
`Edwards
`
`Elwinis [.irrfl‘ifllru
`
`Edwunis Lil‘c:~cciznc
`.,..... m“.
`
`Strategy (cont)
`
`“a 3 '1 smencqs
`
`L—___._____
`Highly Confidential
`
`Edwards Lifesciences v. Boston S
`
`lPR2017-00060 U 5 Patent 8,992,608
`Exhibit 2043- Part 1
`
`PROTECTIVE ORDER MATERIAL
`
`Page 16 of 43
`EDWARDS 01033859
`
`
`
`Schedule
`
`Budget (estimation)
`
`a IJltsczi-nurs.
`. N...”
`
`r..—<- u...“
`Edwards Lilrsrirnogs
`
`
`
`Thank you!
`
`Edwards
`Helping patients is our life's work, and
`
`00 W
`
`r.......~..~.y
`Edumi: UlcsriL-ricgi
`
`
`
`Edwards Lifesciences v. Boston S
`IPR2017-00060 U 5 Patent 8,992,608
`
`2
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033860
`
`
`
`Manufacturing steps
`
`V In
`
`lid ward 5
`Development of manufacturing processes
`for CoCr alloy
`
`:93! Kova/sky
`Jam] 20):
`
`- Design Inputs
`- Verificalion of tests
`
`- Manufacturing documentation readiness
`- Pre-cllnical trlals results
`- Clinical trials readiness
`
`- Quality plan review
`
`- Approval of performance and safety
`
`Raw material formation
`
`
`
`[edema Litescmncea
`
`Ellnzmls linen-urea
`
`Design Inputs
`
`Procedures’ v 'flcation- Laser Cut
`
`Edwam Lifesciences
`
`Eduard: laknticncc-i
`
`Edwards Lifesciences v. Boston S
`lPR2017-00060 U 5 Patent 8,992,608
`
`1
`
`Highly Confiderfialm
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033861
`
`
`
`i Procedures' verlfication- Laser Cut
`
`'
`
`Exnansion
`
`Edwams Ld'cscimccs
`
`f Laser cut results
`
`" Procedures’ verificafion- Heat Treatment
`
`' Corner rounding Edwards Ufcsciwc-r»
`
`[Kiwanis Lifuxit‘ncc: r
`
`‘_ HT process repeatability
`
`Edwards Lifesciences v. Boston S
`lPR2017-00060 U 5 Patent 8,992,608
`
`
`2
`
`Highly Confidential
`
`PROTECTIVE ORDER MATERIAL
`
`EDWARDS 01033862
`
`
`
`HT: Tensile test
`
`~ Boundary conditions for HT'
`
`hriuunis LiIcaciciicx-s
`
`H‘r- Tamils finer
`
`H Boundary conditions for HT,_ Results
`
`Procedures’ verification- Eiectropollshlng
`
`Edward: LiL'ai-iemm
`
`Ldnuma Lilmcicure:
`
`HT: Grain size
`
`deda‘ hian‘mntr:
`
` Edwards Lifesciences v. Boston
`
`lPR2017-00060 U S Patent
`
`,
`
`,
`
`3
`
`Highly Confidential
`
`_ —
`' "
`
`“
`
`"
`
`Exhibit 2043 - Part 1
`PROTECTIVE ORDER MATERIAL
`
`Page 20 0f 43
`EDWARDS 01033863
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
