`14215
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 18-1363-CFC
`
`)))))))))
`
`GENENTECH, INC., AND CITY OF HOPE,
`
`Plaintiffs,
`
`v.
`
`SAMSUNG BIOEPIS CO., LTD.,
`
`Defendant.
`
`SAMSUNG BIOEPIS’S NOTICE OF SUBPOENAS
`TO THE UNIVERSITY OF CALIFORNIA SAN FRANCISCO
`
`TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:
`
`PLEASE TAKE NOTICE that pursuant to Rules 30 and 45 of the Federal Rules of Civil
`
`Procedure, Defendant Samsung Bioepis Co., Ltd. (“Bioepis”) will cause the attached subpoenas (Exs. 1-
`
`2) to be served on the University of California San Francisco.
`
`OF COUNSEL:
`
`Dimitrios T. Drivas
`Scott T. Weingaertner
`Amit H. Thakore
`Holly Tao
`John P. Padro
`Leon Miniovich
`WHITE & CASE LLP
`1221 Avenue of the Americas
`New York, New York 10020-1095
`Tel: (212) 819-8200
`
`Dated: May 3, 2019
`6194056 / 45001
`
`POTTER ANDERSON & CORROON LLP
`
`By: /s/ Stephanie E. O’Byrne
`David E. Moore (#3983)
`Bindu A. Palapura (#5370)
`Stephanie E. O’Byrne (#4446)
`Jennifer Penberthy Buckley (#6264)
`Hercules Plaza, 6th Floor
`1313 N. Market Street
`Wilmington, DE 19801
`Tel: (302) 984-6000
`dmoore@potteranderson.com
`bpalapura@potteranderson.com
`sobyrne@potteranderson.com
`
`Attorneys for Defendant Samsung Bioepis Co.,
`Ltd.
`
`
`
`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 2 of 45 PageID #:
`14216
`
`
`
`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 3 of 45 PageID #:
`14217
`CQ!99D!!)Tgx/!23024*!Uwdrqgpc!vq!Rtqfweg!Fqewogpvu-!Kphqtocvkqp-!qt!Qdlgevu!qt!vq!Rgtokv!Kpurgevkqp!qh!Rtgokugu!kp!c!Ekxkn!Cevkqp
`
`WPKVGF!UVCVGU!FKUVTKEV!EQWTV
`hqt!vjg
`Fkuvtkev qh Fgncyctg
`aaaaaaaaaa!Fkuvtkev!qh!aaaaaaaaaa
`GENENTECH, INC. and CITY OF HOPE
`Plaintiff
`x/
`
`Ekxkn!Cevkqp!Pq/
`
`1:18-cv-1363-CFC
`
`******
`
`SAMSUNG BIOEPIS CO., LTD.
`Defendant
`
`Vq<
`
`SUBPOENA TO PRODUCE DOCUMENTS, INFORMATION, OR OBJECTS
`OR TO PERMIT INSPECTION OF PREMISES!IN!A CIVIL ACTION
`UCSF Health Information Management Services, Attn: Ken Grace, 400 Parnassus Ave., Room A88,
`San Francisco, CA 94143-0308
`(Name of person to whom this subpoena is directed)
`# Production:!YOU ARE COMMANDED vq!rtqfweg!cv!vjg!vkog-!fcvg-!cpf!rnceg!ugv!hqtvj!dgnqy!vjg!hqnnqykpi!
`fqewogpvu-!gngevtqpkecnn{!uvqtgf!kphqtocvkqp-!qt!qdlgevu-!cpf!vq!rgtokv!kpurgevkqp-!eqr{kpi-!vguvkpi-!qt!ucornkpi!qh!vjg
`ocvgtkcn<
`
`SEE ATTACHED SCHEDULE A
`
`Rnceg<
`
`White & Case LLP
`3000 El Camino Real, 2 Palo Alto Square, Suite 900
`Palo Alto, CA 94306, or by service to
`WCSamsungBioepisLitigationTeam@whitecase.com
`# Inspection of Premises:!YOU ARE COMMANDED!vq!rgtokv!gpvt{!qpvq!vjg!fgukipcvgf!rtgokugu-!ncpf-!qt!
`qvjgt!rtqrgtv{!rquuguugf!qt!eqpvtqnngf!d{!{qw!cv!vjg!vkog-!fcvg-!cpf!nqecvkqp!ugv!hqtvj!dgnqy-!uq!vjcv!vjg!tgswguvkpi!rctv{
`oc{!kpurgev-!ogcuwtg-!uwtxg{-!rjqvqitcrj-!vguv-!qt!ucorng!vjg!rtqrgtv{!qt!cp{!fgukipcvgf!qdlgev!qt!qrgtcvkqp!qp!kv/
`
`Fcvg!cpf!Vkog<
`
`05/13/2019 9:30 am
`
`Rnceg<
`
`Fcvg!cpf!Vkog<
`
`Vjg!hqnnqykpi!rtqxkukqpu!qh!Hgf/!T/!Ekx/!R/!56!ctg!cvvcejgf!!Twng!56)e*-!tgncvkpi!vq!vjg!rnceg!qh!eqornkcpeg=
`Twng!56)f*-!tgncvkpi!vq!{qwt!rtqvgevkqp!cu!c!rgtuqp!uwdlgev!vq!c!uwdrqgpc=!cpf!Twng!56)g*!cpf!)i*-!tgncvkpi!vq!{qwt!fwv{!vq
`tgurqpf!vq!vjku!uwdrqgpc!cpf!vjg!rqvgpvkcn!eqpugswgpegu!qh!pqv!fqkpi!uq/
`05/03/2019
`
`Fcvg<
`
`CLERK OF COURT
`
`Signature of Clerk or Deputy Clerk
`
`QT
`
`/s/ John Padro
`Attorney’s signature
`
`Vjg!pcog-!cfftguu-!g.ockn!cfftguu-!cpf!vgngrjqpg!pwodgt!qh!vjg!cvvqtpg{!tgrtgugpvkpi!(name of party)
`Defendant Samsung Bioepis Co., Ltd.
`-!yjq!kuuwgu!qt!tgswguvu!vjku!uwdrqgpc-!ctg<
`John Padro - (212) 819-7982, john.padro@whitecase.com
`White & Case LLP, 1221 Avenue of the Americas, New York, NY 10020
`Notice to the person who issues or requests this subpoena
`C!pqvkeg!cpf!c!eqr{!qh!vjg!uwdrqgpc!owuv!dg!ugtxgf!qp!gcej!rctv{!kp!vjku!ecug!dghqtg!kv!ku!ugtxgf!qp!vjg!rgtuqp!vq!yjqo
`kv!ku!fktgevgf/!!Hgf/!T/!Ekx/!R/!56)c*)5*/
`
`
`
`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 4 of 45 PageID #:
`14218
`CQ!99D!!)Tgx/!!23024*!Uwdrqgpc!vq!Rtqfweg!Fqewogpvu-!Kphqtocvkqp-!qt!Qdlgevu!qt!vq!Rgtokv!Kpurgevkqp!qh!Rtgokugu!kp!c!Ekxkn!Cevkqp!)Rcig!3*
`
`Ekxkn!Cevkqp!Pq/
`
`1:18-cv-1363-CFC
`
`PROOF OF SERVICE
`(This section should not be filed with the court unless required by Fed. R. Civ. P. 45.)
`
`K!tgegkxgf!vjku!uwdrqgpc!hqt!(name of individual and title, if any)
`
`qp!(date)
`
`/
`
`# K!ugtxgf!vjg!uwdrqgpc!d{!fgnkxgtkpi!c!eqr{!vq!vjg!pcogf!rgtuqp!cu!hqnnqyu<
`
`# K!tgvwtpgf!vjg!uwdrqgpc!wpgzgewvgf!dgecwug<
`
`qp!(date)
`
`=!qt
`
`Wpnguu!vjg!uwdrqgpc!ycu!kuuwgf!qp!dgjcnh!qh!vjg!Wpkvgf!Uvcvgu-!qt!qpg!qh!kvu!qhhkegtu!qt!cigpvu-!K!jcxg!cnuq!
`vgpfgtgf!vq!vjg!ykvpguu!vjg!hggu!hqt!qpg!fc{u!cvvgpfcpeg-!cpf!vjg!okngcig!cnnqygf!d{!ncy-!kp!vjg!coqwpv!qh
`
`%
`
`/
`
`O{!hggu!ctg!%
`
`hqt!vtcxgn!cpf!%
`
`hqt!ugtxkegu-!hqt!c!vqvcn!qh!%
`
`0.00
`
`/
`
`/
`
`K!fgenctg!wpfgt!rgpcnv{!qh!rgtlwt{!vjcv!vjku!kphqtocvkqp!ku!vtwg/
`
`Fcvg<
`
`Cffkvkqpcn!kphqtocvkqp!tgictfkpi!cvvgorvgf!ugtxkeg-!gve/<
`
`Server’s signature
`
`Printed name and title
`
`Server’s address
`
`
`
`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 5 of 45 PageID #:
`14219
`CQ!99D!!)Tgx/!!23024*!Uwdrqgpc!vq!Rtqfweg!Fqewogpvu-!Kphqtocvkqp-!qt!Qdlgevu!qt!vq!Rgtokv!Kpurgevkqp!qh!Rtgokugu!kp!c!Ekxkn!Cevkqp)Rcig!4*
`
`(c) Place of Compliance.
`
`Federal Rule of Civil Procedure 45 (c), (d), (e), and (g) (Effective 12/1/13)
`!!!!!!!!(ii)!fkuenqukpi!cp!wptgvckpgf!gzrgtvu!qrkpkqp!qt!kphqtocvkqp!vjcv!fqgu
`pqv!fguetkdg!urgekhke!qeewttgpegu!kp!fkurwvg!cpf!tguwnvu!htqo!vjg!gzrgtvu
`uvwf{!vjcv!ycu!pqv!tgswguvgf!d{!c!rctv{/
`!!!!(C)!Specifying Conditions as an Alternative. Kp!vjg!ektewouvcpegu
`fguetkdgf!kp!Twng!56)f*)4*)D*-!vjg!eqwtv!oc{-!kpuvgcf!qh!swcujkpi!qt
`oqfkh{kpi!c!uwdrqgpc-!qtfgt!crrgctcpeg!qt!rtqfwevkqp!wpfgt!urgekhkgf
`eqpfkvkqpu!kh!vjg!ugtxkpi!rctv{<
`!!!!!!!!(i)!ujqyu!c!uwduvcpvkcn!pggf!hqt!vjg!vguvkoqp{!qt!ocvgtkcn!vjcv!ecppqv!dg
`qvjgtykug!ogv!ykvjqwv!wpfwg!jctfujkr=!cpf
`!!!!!!!!(ii)!gpuwtgu!vjcv!vjg!uwdrqgpcgf!rgtuqp!yknn!dg!tgcuqpcdn{!eqorgpucvgf/
`
` (1) For a Trial, Hearing, or Deposition. C!uwdrqgpc!oc{!eqoocpf!c
`rgtuqp!vq!cvvgpf!c!vtkcn-!jgctkpi-!qt!fgrqukvkqp!qpn{!cu!hqnnqyu<
` (A)!ykvjkp!211!okngu!qh!yjgtg!vjg!rgtuqp!tgukfgu-!ku!gornq{gf-!qt
`tgiwnctn{!vtcpucevu!dwukpguu!kp!rgtuqp=!qt
` (B)!ykvjkp!vjg!uvcvg!yjgtg!vjg!rgtuqp!tgukfgu-!ku!gornq{gf-!qt!tgiwnctn{
`vtcpucevu!dwukpguu!kp!rgtuqp-!kh!vjg!rgtuqp
` (i)!ku!c!rctv{!qt!c!rctv{u!qhhkegt=!qt
` (ii)!ku!eqoocpfgf!vq!cvvgpf!c!vtkcn!cpf!yqwnf!pqv!kpewt!uwduvcpvkcn
`gzrgpug/
`
` (2) For Other Discovery. C!uwdrqgpc!oc{!eqoocpf<
` (A)!rtqfwevkqp!qh!fqewogpvu-!gngevtqpkecnn{!uvqtgf!kphqtocvkqp-!qt
`vcpikdng!vjkpiu!cv!c!rnceg!ykvjkp!211!okngu!qh!yjgtg!vjg!rgtuqp!tgukfgu-!ku
`gornq{gf-!qt!tgiwnctn{!vtcpucevu!dwukpguu!kp!rgtuqp=!cpf
` (B)!kpurgevkqp!qh!rtgokugu!cv!vjg!rtgokugu!vq!dg!kpurgevgf/
`
`(d) Protecting a Person Subject to a Subpoena; Enforcement.
`
` (1) Avoiding Undue Burden or Expense; Sanctions. C!rctv{!qt!cvvqtpg{
`tgurqpukdng!hqt!kuuwkpi!cpf!ugtxkpi!c!uwdrqgpc!owuv!vcmg!tgcuqpcdng!uvgru
`vq!cxqkf!korqukpi!wpfwg!dwtfgp!qt!gzrgpug!qp!c!rgtuqp!uwdlgev!vq!vjg
`uwdrqgpc/!Vjg!eqwtv!hqt!vjg!fkuvtkev!yjgtg!eqornkcpeg!ku!tgswktgf!owuv
`gphqteg!vjku!fwv{!cpf!korqug!cp!crrtqrtkcvg!ucpevkqpyjkej!oc{!kpenwfg
`nquv!gctpkpiu!cpf!tgcuqpcdng!cvvqtpg{u!hgguqp!c!rctv{!qt!cvvqtpg{!yjq
`hcknu!vq!eqorn{/
`
` (2) Command to Produce Materials or Permit Inspection.
`!!!!(A)!Appearance Not Required. C!rgtuqp!eqoocpfgf!vq!rtqfweg
`fqewogpvu-!gngevtqpkecnn{!uvqtgf!kphqtocvkqp-!qt!vcpikdng!vjkpiu-!qt!vq
`rgtokv!vjg!kpurgevkqp!qh!rtgokugu-!pggf!pqv!crrgct!kp!rgtuqp!cv!vjg!rnceg!qh
`rtqfwevkqp!qt!kpurgevkqp!wpnguu!cnuq!eqoocpfgf!vq!crrgct!hqt!c!fgrqukvkqp-
`jgctkpi-!qt!vtkcn/
`!!!!(B)!Objections. C!rgtuqp!eqoocpfgf!vq!rtqfweg!fqewogpvu!qt!vcpikdng
`vjkpiu!qt!vq!rgtokv!kpurgevkqp!oc{!ugtxg!qp!vjg!rctv{!qt!cvvqtpg{!fgukipcvgf
`kp!vjg!uwdrqgpc!c!ytkvvgp!qdlgevkqp!vq!kpurgevkpi-!eqr{kpi-!vguvkpi-!qt
`ucornkpi!cp{!qt!cnn!qh!vjg!ocvgtkcnu!qt!vq!kpurgevkpi!vjg!rtgokuguqt!vq
`rtqfwekpi!gngevtqpkecnn{!uvqtgf!kphqtocvkqp!kp!vjg!hqto!qt!hqtou!tgswguvgf/
`Vjg!qdlgevkqp!owuv!dg!ugtxgf!dghqtg!vjg!gctnkgt!qh!vjg!vkog!urgekhkgf!hqt
`eqornkcpeg!qt!25!fc{u!chvgt!vjg!uwdrqgpc!ku!ugtxgf/!Kh!cp!qdlgevkqp!ku!ocfg-
`vjg!hqnnqykpi!twngu!crrn{<
`!!!!!!!!(i)!Cv!cp{!vkog-!qp!pqvkeg!vq!vjg!eqoocpfgf!rgtuqp-!vjg!ugtxkpi!rctv{
`oc{!oqxg!vjg!eqwtv!hqt!vjg!fkuvtkev!yjgtg!eqornkcpeg!ku!tgswktgf!hqt!cp
`qtfgt!eqorgnnkpi!rtqfwevkqp!qt!kpurgevkqp/
`!!!!!! (ii)!Vjgug!cevu!oc{!dg!tgswktgf!qpn{!cu!fktgevgf!kp!vjg!qtfgt-!cpf!vjg
`qtfgt!owuv!rtqvgev!c!rgtuqp!yjq!ku!pgkvjgt!c!rctv{!pqt!c!rctv{u!qhhkegt!htqo
`ukipkhkecpv!gzrgpug!tguwnvkpi!htqo!eqornkcpeg/
`
` (3) Quashing or Modifying a Subpoena.
`!!!!(A)!When Required. Qp!vkogn{!oqvkqp-!vjg!eqwtv!hqt!vjg!fkuvtkev!yjgtg
`eqornkcpeg!ku!tgswktgf!owuv!swcuj!qt!oqfkh{!c!uwdrqgpc!vjcv<
` (i)!hcknu!vq!cnnqy!c!tgcuqpcdng!vkog!vq!eqorn{=
`!!!!!!!!(ii)!tgswktgu!c!rgtuqp!vq!eqorn{!dg{qpf!vjg!igqitcrjkecn!nkokvu
`urgekhkgf!kp!Twng!56)e*=
`!!!!!!!!(iii)!tgswktgu!fkuenquwtg!qh!rtkxkngigf!qt!qvjgt!rtqvgevgf!ocvvgt-!kh!pq
`gzegrvkqp!qt!yckxgt!crrnkgu=!qt
`!!!!!!!!(iv)!uwdlgevu!c!rgtuqp!vq!wpfwg!dwtfgp/
`!!!(B)!When Permitted. Vq!rtqvgev!c!rgtuqp!uwdlgev!vq!qt!chhgevgf!d{!c
`uwdrqgpc-!vjg!eqwtv!hqt!vjg!fkuvtkev!yjgtg!eqornkcpeg!ku!tgswktgf!oc{-!qp
`oqvkqp-!swcuj!qt!oqfkh{!vjg!uwdrqgpc!kh!kv!tgswktgu<
`(i)!fkuenqukpi!c!vtcfg!ugetgv!qt!qvjgt!eqphkfgpvkcn!tgugctej-
`fgxgnqrogpv-!qt!eqoogtekcn!kphqtocvkqp=!qt
`
`(e) Duties in Responding to a Subpoena.
`
` (1) Producing Documents or Electronically Stored Information. Vjgug
`rtqegfwtgu!crrn{!vq!rtqfwekpi!fqewogpvu!qt!gngevtqpkecnn{!uvqtgf
`kphqtocvkqp<
`!!!!(A)!Documents. C!rgtuqp!tgurqpfkpi!vq!c!uwdrqgpc!vq!rtqfweg!fqewogpvu
`owuv!rtqfweg!vjgo!cu!vjg{!ctg!mgrv!kp!vjg!qtfkpct{!eqwtug!qh!dwukpguu!qt
`owuv!qticpk|g!cpf!ncdgn!vjgo!vq!eqttgurqpf!vq!vjg!ecvgiqtkgu!kp!vjg!fgocpf/
`!!!!(B)!Form for Producing Electronically Stored Information Not Specified.
`Kh!c!uwdrqgpc!fqgu!pqv!urgekh{!c!hqto!hqt!rtqfwekpi!gngevtqpkecnn{!uvqtgf
`kphqtocvkqp-!vjg!rgtuqp!tgurqpfkpi!owuv!rtqfweg!kv!kp!c!hqto!qt!hqtou!kp
`yjkej!kv!ku!qtfkpctkn{!ockpvckpgf!qt!kp!c!tgcuqpcdn{!wucdng!hqto!qt!hqtou/
`!!!!(C)!Electronically Stored Information Produced in Only One Form. Vjg
`rgtuqp!tgurqpfkpi!pggf!pqv!rtqfweg!vjg!ucog!gngevtqpkecnn{!uvqtgf
`kphqtocvkqp!kp!oqtg!vjcp!qpg!hqto/
`!!!!(D)!Inaccessible Electronically Stored Information. Vjg!rgtuqp
`tgurqpfkpi!pggf!pqv!rtqxkfg!fkueqxgt{!qh!gngevtqpkecnn{!uvqtgf!kphqtocvkqp
`htqo!uqwtegu!vjcv!vjg!rgtuqp!kfgpvkhkgu!cu!pqv!tgcuqpcdn{!ceeguukdng!dgecwug
`qh!wpfwg!dwtfgp!qt!equv/!Qp!oqvkqp!vq!eqorgn!fkueqxgt{!qt!hqt!c!rtqvgevkxg
`qtfgt-!vjg!rgtuqp!tgurqpfkpi!owuv!ujqy!vjcv!vjg!kphqtocvkqp!ku!pqv
`tgcuqpcdn{!ceeguukdng!dgecwug!qh!wpfwg!dwtfgp!qt!equv/!Kh!vjcv!ujqykpi!ku
`ocfg-!vjg!eqwtv!oc{!pqpgvjgnguu!qtfgt!fkueqxgt{!htqo!uwej!uqwtegu!kh!vjg
`tgswguvkpi!rctv{!ujqyu!iqqf!ecwug-!eqpukfgtkpi!vjg!nkokvcvkqpu!qh!Twng
`37)d*)3*)E*/!Vjg!eqwtv!oc{!urgekh{!eqpfkvkqpu!hqt!vjg!fkueqxgt{/
`
`(2) Claiming Privilege or Protection.
`!!(A)!Information Withheld. C!rgtuqp!ykvjjqnfkpi!uwdrqgpcgf!kphqtocvkqp
`wpfgt!c!encko!vjcv!kv!ku!rtkxkngigf!qt!uwdlgev!vq!rtqvgevkqp!cu!vtkcn.rtgrctcvkqp
`ocvgtkcn!owuv<
`!!!!!!(i)!gzrtguun{!ocmg!vjg!encko=!cpf
`!!!!!!(ii)!fguetkdg!vjg!pcvwtg!qh!vjg!ykvjjgnf!fqewogpvu-!eqoowpkecvkqpu-!qt
`vcpikdng!vjkpiu!kp!c!ocppgt!vjcv-!ykvjqwv!tgxgcnkpi!kphqtocvkqp!kvugnh
`rtkxkngigf!qt!rtqvgevgf-!yknn!gpcdng!vjg!rctvkgu!vq!cuuguu!vjg!encko/
`!!(B)!Information Produced. Kh!kphqtocvkqp!rtqfwegf!kp!tgurqpug!vq!c
`uwdrqgpc!ku!uwdlgev!vq!c!encko!qh!rtkxkngig!qt!qh!rtqvgevkqp!cu
`vtkcn.rtgrctcvkqp!ocvgtkcn-!vjg!rgtuqp!ocmkpi!vjg!encko!oc{!pqvkh{!cp{!rctv{
`vjcv!tgegkxgf!vjg!kphqtocvkqp!qh!vjg!encko!cpf!vjg!dcuku!hqt!kv/!Chvgt!dgkpi
`pqvkhkgf-!c!rctv{!owuv!rtqorvn{!tgvwtp-!ugswguvgt-!qt!fguvtq{!vjg!urgekhkgf
`kphqtocvkqp!cpf!cp{!eqrkgu!kv!jcu=!owuv!pqv!wug!qt!fkuenqug!vjg!kphqtocvkqp
`wpvkn!vjg!encko!ku!tguqnxgf=!owuv!vcmg!tgcuqpcdng!uvgru!vq!tgvtkgxg!vjg
`kphqtocvkqp!kh!vjg!rctv{!fkuenqugf!kv!dghqtg!dgkpi!pqvkhkgf=!cpf!oc{!rtqorvn{
`rtgugpv!vjg!kphqtocvkqp!wpfgt!ugcn!vq!vjg!eqwtv!hqt!vjg!fkuvtkev!yjgtg
`eqornkcpeg!ku!tgswktgf!hqt!c!fgvgtokpcvkqp!qh!vjg!encko/!Vjg!rgtuqp!yjq
`rtqfwegf!vjg!kphqtocvkqp!owuv!rtgugtxg!vjg!kphqtocvkqp!wpvkn!vjg!encko!ku
`tguqnxgf/
`
`(g) Contempt.
`Vjg!eqwtv!hqt!vjg!fkuvtkev!yjgtg!eqornkcpeg!ku!tgswktgfcpf!cnuq-!chvgt!c
`oqvkqp!ku!vtcpuhgttgf-!vjg!kuuwkpi!eqwtvoc{!jqnf!kp!eqpvgorv!c!rgtuqp
`yjq-!jcxkpi!dggp!ugtxgf-!hcknu!ykvjqwv!cfgswcvg!gzewug!vq!qdg{!vjg
`uwdrqgpc!qt!cp!qtfgt!tgncvgf!vq!kv/
`
`Hqt!ceeguu!vq!uwdrqgpc!ocvgtkcnu-!ugg!Hgf/!T/!Ekx/!R/!56)c*!Eqookvvgg!Pqvg!)3124*/
`
`
`
`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 6 of 45 PageID #:
`14220
`
`SCHEDULE A
`
`Pursuant to Rule 45 of the Federal Rules of Civil Procedure, Samsung Bioepis Co., Ltd.,
`
`hereby requests that the University of California San Francisco produce the following documents
`
`and things at the place, date, and time specified in the accompanying subpoena.
`
`INSTRUCTIONS
`
`You should redact patient personal identifiers from documents, communications,
`
`and things before producing them.
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`You may designate documents, communications, things, or testimony under the
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`Protective Order entered by the Court in this Litigation (see attachment).
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`DOCUMENTS AND THINGS TO BE PRODUCED
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`1.
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`Redacted patient records regarding Jane Doe(s) 1-31, including:
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`a.
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`Test results from assays for HER-2/neu oncoprotein expression performed
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`on tissue from biopsy of the patient in 1999 and preliminary diagnoses
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`relating to breast cancer; and
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`b.
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`Patient diagnosis and treatment, including, specifically, whether Herceptin
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`therapy was initiated, for breast cancer subsequent to receiving Dr. Michael
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`Press’s (Professor, University of Southern California) 1999 consult report
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`showing that immunohistochemistry (“IHC”) assays for HER-2/neu
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`oncoprotein expression performed on tissue from biopsy were negative, and
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`that results of fluorescence in situ hybridization (“FISH”) for HER-2/neu
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`gene amplification performed on tissue from the biopsy of the same patient
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`were positive.
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`1 Counsel for Samsung Bioepis Co., Ltd., will arrange for identification of Jane Doe(s) in a
`manner that complies with applicable privacy requirements. Please contact the issuing attorney.
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`
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 7 of 45 PageID #:
`14221
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`ATTACHMENT
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`
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 8 of 45 PageID #:
`Case 1:18-cv-01363-CFC Document 38 Filed 11/26/18 Page 1 of 33 PageID #: 1189
`14222
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC., and CITY OF HOPE,
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`Plaintiffs,
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`V.
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`SAMSUNG BIOEPIS CO., LTD,
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`Defendant.
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`)
`)
`)
`)
`)
`) C.A. No. 18-1363-CFC
`)
`)
`)
`)
`)
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`STIPULATED PROTECTIVE ORDER
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`WHEREAS, Plaintiffs Genentech, Inc. and City of Hope and Defendant Samsung Bioepis
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`Co., Ltd. ( collectively, "the Parties") expect discovery requests made in this civil action C.A. No.
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`18-1363-CFC ("Litigation," which includes any appeals therefrom) to encompass certain
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`information that may constitute trade secrets and/or other confidential research, development,
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`business or commercial information within the meaning of Federal Rule of Civil Procedure
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`26(c)(l)(G) for which special protection from public disclosure and from use for any purpose
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`other than as provided below is warranted;
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`WHEREAS, the Parties in their business practices have gone to great lengths to safeguard
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`and protect the confidentiality of documents and information the disclosure of which would pose
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`a substantial risk of irreparable harm to legitimate proprietary interests;
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`WHEREAS, the Parties to this action seek to establish a mechanism to protect information
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`produced by the Parties and Third Parties in this case from improper disclosure;
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`ActiveUS 170333549v.l
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 9 of 45 PageID #:
`Case 1:18-cv-01363-CFC Document 38 Filed 11/26/18 Page 2 of 33 PageID #: 1190
`14223
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`NOW THEREFORE, the Parties, by and through their respective Outside Counsel,
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`HEREBY STIPULATE to the entry ofthis Protective Order regarding discovery in this
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`Litigation.
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`DEFINITIONS
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`1. "Affiliate" means any person or entity that directly or indirectly through one or more
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`intermediaries controls, or is controlled by, or is under common control with, a Party to this
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`Litigation.
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`2. "CONFIDENTIAL" means information that constitutes, contains, reveals, or reflects.
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`trade secrets or other confidential research, development, business, legal, or commercial
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`information within the meaning offed. R. Civ. P. 26(c)(l)(G), including but not limited to:
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`scientific and technical information; financial, budgeting and/or accounting information;
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`information about existing and potential customers; marketing, legal, and other business
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`strategies, decisions, or negotiations; personnel compensation, evaluations, and other
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`employment information; and includes such confidential and proprietary information about a
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`Third Party, including parents, subsidiaries, and/or Affiliates. Confidential information also
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`includes Protected Health Information, which means any information that a party believes in
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`good faith to be subject to the Health Insurance Portability and Accountability Act and the
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`regulations thereunder, 45 CFR Part 160 and Subparts A and E of Part 164. Protected Health
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`Information includes, but is not limited to, health information, including demographic
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`information, relating to either, (a) the past, present or future physical or mental condition of an
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`individual, (b) the provision of care to an individual, or ( c) the payment for care provided to an
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`individual, which identifies the individual or which reasonably could be expected to identify the
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`individual. Provisions of this Protective Order relating to CONFIDENTIAL information shall be
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`ActiveUS 170333549v.1
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 10 of 45 PageID #:
`Case 1:18-cv-01363-CFC Document 38 Filed 11/26/18 Page 3 of 33 PageID #: 1191
`14224
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`understood to encompass any information derived, copied or extracted therefrom, as well as all
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`copies, excerpts, summaries, or compilations thereof and testimony, conversations, or
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`presentations related thereto.
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`3. "CONFIDENTIAL Discovery Material" means Discovery Material a Producing Party
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`designates as CONFIDENTIAL pursuant to the terms of this Protective Order.
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`4. "THIRD PARTY HIGHLY CONFIDENTIAL" means information that constitutes,
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`contains, reveals, or reflects trade secrets or other highly sensitive research, development,
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`business, or commercial information within the meaning of Fed. R. Civ. P. 26(c)(l)(G) of a
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`Third Party. Provisions of this Protective Order relating to THIRD PARTY HIGHLY
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`CONFIDENTIAL information shall be understood to encompass any information derived,
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`copied or extracted therefrom, as well as all copies, excerpts, summaries, or compilations thereof
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`and testimony, conversations, or presentations related thereto.
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`5. "THIRD PARTY HIGHLY CONFIDENTIAL Discovery Material" means Discovery
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`Material a Producing Party designates as THIRD PARTY HIGHLY CONFIDENTIAL pursuant
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`to the terms of this Protective Order.
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`6. Information designated as CONFIDENTIAL Discovery Material and information
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`designated as THIRD PARTY HIGHLY CONFIDENTIAL Discovery Material are hereinafter
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`collectively referred to as "Protected Information."
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`7.
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`"Designated Inside Counsel" means in-house attorneys that may be designated
`
`during this Litigation pursuant to Paragraph 33(b) of this Protective Order.
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`8. "Discovery Material" means all documents, testimony, pleadings, exhibits, and all
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`other material or information produced or disclosed in this Litigation, including responses to
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`requests for production of documents and/or things, answers to interrogatories, responses to
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`ActiveUS l 70333549v. l
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 11 of 45 PageID #:
`Case 1:18-cv-01363-CFC Document 38 Filed 11/26/18 Page 4 of 33 PageID #: 1192
`14225
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`requests for admissions, documents and things made available for inspection, deposition
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`testimony, expert testimony and reports, and all other discovery taken pursuant to the
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`Federal Rules of Civil Procedure, including Third Party discovery pursuant to Rule 45,
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`matters in evidence and any other information hereafter furnished, directly or indirectly, by or
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`on behalf of any Party, Third Party, or witness in connection with this Litigation. This
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`Protective Order and protections herein shall apply to all Discovery Material.
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`9. "Expert" means a person with specialized knowledge or experience in a matter
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`pertinent to this Litigation who has been retained by a Party or its Inside or Outside Counsel to
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`serve as an expert witness or as a consultant in this Litigation who, at the time of retention, is not
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`an officer, director, or employee of a Party or an Affiliate and is not anticipated to become an
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`officer, director, or employee of a Party or an Affiliate. Nothing in this Protective Order
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`purports to alter in any way the requirements for offering testimony under Fed. R. Evid. 703, or
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`to define the term "expert" for purposes other than those addressed in this Protective Order.
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`10. "Final Disposition" occurs after an order, mandate, or dismissal finally terminating
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`the above-captioned action with prejudice, including all appeals.
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`11. "Inside Counsel" means any attorney who is an employee of a Party or its Affiliates.
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`12. "Outside Counsel" means any attorney from a law firm that has made a formal
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`appearance as counsel of record for a Party in this Litigation and who is not an employee of a
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`Party or of an Affiliate.
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`13. "Party" means a party to this Litigation.
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`14. "Plaintiffs" means Genentech, Inc. and City of Hope, collectively.
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`15. "Defendant" means Samsung Bioepis Co., Ltd.
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`ActiveUS 170333549v.l
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`4
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 12 of 45 PageID #:
`Case 1:18-cv-01363-CFC Document 38 Filed 11/26/18 Page 5 of 33 PageID #: 1193
`14226
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`16. "SB3" means Defendant's proposed trastuzumab biosimilar product that is the subject
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`of an Abbreviated Biologics License Application.
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`17. "Producing Party" means any Party or any Third Party who produces or otherwise
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`discloses, whether through formal or informal means, Discovery Material in this Litigation.
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`18. "Professional Vendor(s)" means persons or entities that provide litigation support
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`services ( e.g., photocopying; audio or video recording; translating; preparing exhibits or
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`demonstratives; and organizing, storing, or retrieving data in any form or medium; jury
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`consulting; courtroom presentation; and mock trial coordination) and their employees and
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`subcontractors.
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`19. "Prosecution" means participation in or contribution to drafting; revising; amending;
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`modifying; or advising regarding the drafting, revising, amending, or modifying the scope of
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`patent claims during prosecution proceedings or post-grant proceedings, including but not
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`limited to reexaminations, inter partes reexaminations, reissues, covered business method review
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`proceedings, inter partes review proceedings, and post grant review proceedings, in the United
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`States or any similar proceedings in any foreign country.
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`20. "Protective Order" means this Stipulated Protective Order.
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`21. "Receiving Party" means any Party or Third Party that receives Discovery Material
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`produced or otherwise disclosed by any Producing Party.
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`22. "Third Party" means a person or entity that is not a Party or an Affiliate of a Party.
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`DESIGNATION
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`23. Any Producing Party may designate Discovery Material as CONFIDENTIAL or
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`THIRD PARTY HIGHLY CONFIDENTIAL in accordance with this Protective Order if such
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`ActiveUS 170333549v.l
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`5
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 13 of 45 PageID #:
`Case 1:18-cv-01363-CFC Document 38 Filed 11/26/18 Page 6 of 33 PageID #: 1194
`14227
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`party in good faith believes that such Discovery Material contains CONFIDENTIAL or THIRD
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`PARTY HIGHLY CONFIDENTIAL information as defined above.
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`24. Discovery Material may, as appropriate, be marked by the Producing Party with the
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`legend "CONFIDENTIAL Discovery Material" or "THIRD PARTY HIGHLY
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`CONFIDENTIAL - ATTORNEYS' EYES ONLY Discovery Material" and the Producing Party
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`must use reasonable efforts to ensure that such legend appears on each page of each document or
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`file as the format permits.
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`25. Information revealed by inspection of things and premises under Fed. R. Civ. P. 34,
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`shall be treated as though it were designated CONFIDENTIAL or THIRD PARTY HIGHLY
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`CONFIDENTIAL provided that, prior to or at any time up to thirty (30) calendar days after the
`
`inspection, the Party permitting inspection specifically identifies in writing which of the
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`Discovery Material that will be or that was disclosed by the inspection is to be designated as
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`CONFIDENTIAL or THIRD PARTY HIGHLY CONFIDENTIAL. There will be no waiver of
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`confidentiality, or any privilege or immunity, by the inspection of Discovery Material before it is
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`copied and marked pursuant to this Order. Inspection of CONFIDENTIAL or THIRD PARTY
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`HIGHLY CONFIDENTIAL Discovery Material by any Party shall be conducted by eligible
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`persons as described below. Documents and things produced or made available for inspection
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`may be subject to redaction, in good faith by the Producing Party, of information that is neither
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`relevant to the subject matters of this Litigation nor reasonably calculated to lead to the
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`discovery of admissible evidence, or is subject to the attorney-client privilege, to work-product
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`immunity, or any other applicable privilege or immunity. For avoidance of doubt, no information
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`may be redacted or withheld on relevance grounds if it directly relates to the patents-in-suit,
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`trastuzumab, or any trastuzumab biosimilar product. Each such redaction, regardless of size,
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`ActiveUS l 70333549v. l
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`6
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 14 of 45 PageID #:
`Case 1:18-cv-01363-CFC Document 38 Filed 11/26/18 Page 7 of 33 PageID #: 1195
`14228
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`shall be clearly labeled "Redacted - Non-Responsive" or "Redacted - Privileged" as appropriate.
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`The Parties further agree that non-responsive attachments to responsive parent documents need
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`not be produced and a placeholder slip-sheet endorsed "Withheld Non-Responsive" will be
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`produced to capture the relationship. This Paragraph shall not be construed as a waiver of any
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`Party's right to seek disclosure of redacted or withheld information.
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`26. Information revealed during a deposition upon oral or written examination under
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`Fed. R. Civ. P. 30 shall be treated as CONFIDENTIAL or THIRD PARTY HIGHLY
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`CONFIDENTIAL, as appropriate, for thirty (30) calendar days following receipt of the final
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`transcript by Outside Counsel for the Producing Party, but not thereafter unless, before the
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`thirty (30) calendar day period has expired, Outside Counsel or Inside Counsel for the
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`Producing Party notifies Outside Counsel or Designated Inside Counsel for the Receiving Party
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`in writing that the Discovery Material set forth in the transcript is CONFIDENTIAL or THIRD
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`PARTY HIGHLY CONFIDENTIAL. Consistent with the terms herein, counsel for any Party
`
`or Third Party also may designate the transcript or portions thereof to be CONFIDENTIAL or
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`THIRD PARTY HIGHLY CONFIDENTIAL Discovery Material during the deposition. The
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`appropriate legend described in Paragraph 24 shall be placed on the front of any deposition
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`transcript (and, if recorded, on any copies of the recording) containing CONFIDENTIAL or
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`THIRD PARTY HIGHLY CONFIDENTIAL Discovery Material.
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`27. Any pleading, brief, declaration, affidavit, expert report, or other filing that contains,
`
`describes, or discusses CONFIDENTIAL or THIRD PARTY HIGHLY CONFIDENTIAL
`
`Discovery Material shall be filed under seal pursuant to the requirements ofD. Del. LR 5.1.3 and
`
`the Court's CM/ECF procedures. The filing Party must include on the cover page of the brief or
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`other filing a descriptive legend in the following format: "CONTAINS PLAINTIFFS'
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`ActiveUS l 70333549v. l
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`7
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 15 of 45 PageID #:
`Case 1:18-cv-01363-CFC Document 38 Filed 11/26/18 Page 8 of 33 PageID #: 1196
`14229
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`CONFIDENTIAL INFORMATION"; "CONTAINS DEFENDANTS' CONFIDENTIAL
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`INFORMATION"; "CONTAINS PLAINTIFFS AND DEFENDANTS' CONFIDENTIAL
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`INFORMATION"; "CONTAINS THIRD PARTY HIGHLY CONFIDENTIAL
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`INFORMATION - ATTORNEYS' EYES ONLY"; or another suitable legend. The sealed
`
`material shall not be opened or released from the custody of the Clerk of Court except by order
`
`of the Court. Outside Counsel for the Party filing papers containing, describing, or discussing
`
`Protected Information shall be responsible for providing appropriately redacted copies of the
`
`filed document to the Court in accordance with paragraph (G)(l) of the United States District
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`Court for the District of Delaware's Revised Administrative Procedures Governing Filing and
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`Service by Electronic Means dated May 25, 2017. If the filing contains the Protected
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`Information of the party who did not file the document, within four (4) calendar days from the
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`date of a filing made under seal, Outside Counsel for the filing Party or filing Third Party shall
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`deliver to Outside Counsel for the non-filing Party or Parties a proposed public version of the
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`filing that was made under seal if it contains the non-filing Party's Protected Information, and
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`this proposed public version shall include redactions of the filing Party's Protected Information
`
`(if any). Within three (3) calendar days after receipt of the proposed public version, Outside
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`Counsel for the non-filing Party or Parties shall provide any additional redactions that such Party
`
`or Parties believes appropriate. Redacted versions of papers filed under seal may be made
`
`publicly available, provided that (a) all Protected Information, including any related underlying
`
`metadata, is redacted and/or deleted and (b) such redacted versions are clearly marked "Public
`
`Version," and clearly identify each place where information or exhibits have been redacted
`
`and/or deleted.
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`ActiveUS l 70333549v. l
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`8
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`Case 1:18-cv-01363-CFC Document 124 Filed 05/03/19 Page 16 of 45 PageID #:
`Case 1:18-cv-01363-CFC Document 38 Filed 11/26/18 Page 9 of 33 PageID #: 1197
`14230
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`ACCESS AND USE
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`28. The following limitations on use shall apply to all Protected Information produced in
`
`this Litigation. For the avoidance of doubt, the restrictions in this Protective Order regarding
`
`participation in Prosecution, litigation, or in regulatory matters or in competitive or business
`
`functions, as described in Paragraph 29, by individuals with access to Protected Information are
`
`specific to the receiving individuals, and shall not apply to other individuals ("Non-Receiving
`
`Individuals") within the same firm or company as the receiving individuals, so long as the Non(cid:173)
`
`Receiving Individuals do not directly or indirectly access, receive, or otherwise obtain Protected
`
`Information. Notwithstanding the preceding sentence, Non-Receiving Individuals who access
`
`Protected Information sol~ly in one of the ways described in Paragraph 40 shall not be subject to
`
`the restrictions in this Protective Order by reason of such access alone.
`
`29. All Protected Information produced by a Party or Third Party may be used by the
`
`Receiving Party only for purposes of this Litigation, and not for any other purpose whatsoever,
`
`including without limitation any other litigation (including any other litigation that may be
`
`consolidated or coordinated with this Litigation), any patent prosecution, patent or application
`
`licensing or acquisition, including the preparation thereof and strategy related thereto; patent
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`reexamination or reissue proceedings; any unrelated dispute resolution proceeding; any
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`petitioning, counseling, litigation, or other work involving the United States Food and Drug
`
`Administration ("FDA"), including any Citizen Petition; any competitive purpose or function; or
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`for any other business, proprietary, commercial, governmental or regulatory purpose, domestic
`
`or foreign. For example, Protected Information may not be used in connection with searching
`