Free Answering Brief in Opposition - District Court of Delaware - Delaware

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AUSTIN BOSTON
BRUSSELS BUDAPEST
DALLAS FRANKFURT

WElL, GOTSHAL& MANGES LLP
SILICON VALLEY OFFICE

201 REDWOOD SHORES PARKWAY
REDWOOD SHORES , CALIFORNIA 94065
(650) 802- 3000

FAX: (650) 802- 3100

HOUSTON LONDON
MIAMI

MUNICH

NEW YORK
PARIS PRAGUE PROVIDENCE SHANGHAI SINGAPORE WARSAW WASHINGTON , D.

WRITER S DIRECT LINE

eric. xanthopoulos(jjJweil. com

650- 802- 3/74

September 27 2007

VIA EMAIL
Christine Willgoos , Esq. Kirkland & Ellis LLP 153 E. 53rd Street New York , NY 10022- 4611 Fax: 2120446- 4900
CWillgoos(fjJkirkland. com

Re:
Dear Christine:

PDL BioPharma, Inc. v. Alexion Pharmaceuticals, Inc.
D. Del. Case No. 07- 156

We write further to your September 18 , 2007 letter regarding E-Discovery. The parties have been discussing a mutual exchange of E- discovery search terms , with an

initial search and then a supplemental search at some later point , although the parties have not agreed on the parameters of the supplemental search. Your September 18 letter reveals that the parties disagree about the parameters for the initial search , and thus it
makes no sense to do that search now.

First the September 18 letter takes the position that Alexion will not search for what it calls "damages " discovery, willfulness
There are two reasons for this.

discovery, and exceptional case discovery. As explained in PDL' s opposition to Alexion s bifurcation motion, there is substantial overlap between the damages (and willfulness and exceptional case) issues that Alexion seeks to parse from discovery and tria1. ! The issues cannot be parsed as Alexion suggests , and hence an initial search that excludes the broad categories that Alexion s proposal would exclude is not usefu1. Second it is in both parties ' interests to have the supplemental list be smaller and focused , in order to take into account , for example , new issues in the case or a re! Docket No. 35 (PDL's Opposition).

(#279991)

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WElL, GOTSHAL & MANGES

LLP

Christine Willgoos , Esq. September 27 2007
Page 2

emphasis on issues that had previously not been important. In order to do that , each party
should have made a substantial document production , so that documents can be analyzed

and appropriate search term lists be generated. Although PDL has so far produced more
than 50 000 pages ,

Alexion has not produced any documents in response to PDL' document requests , and based on that failure PDL is not in a position to create an initial
Based on the above , it is sensible that the parties exchange lists when they

list.

agree on the criteria discussed above. Perhaps we can discuss once the Court has
resolved Alexion s pending motion. Meantime , let' s defer exchange ofthe lists.

cc:

Gerald J. Flattmann , Esq. (via email) (GFlattmann(fjJkirkland.com) Josy Ingersoll , Esq. (via email) (Jlngersoll(fjJycst. com) Jack Blumenfeld , Esq. (via email) (JBlumenfeld(fjJMNATcom) Karen Jacobs Louden , Esq. (via email) (KLouden(fjJMNATcom)

(#279991)

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Exhibit C

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Exhibit E

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WEll, GOTSHAl & MANGES LLP
SILICON VALLEY OFFICE

201 REDWOOD SHORES PARKWAY

AUSTIN BOSTON
BUDAPEST
DALLAS

REDWOOD SHORES, CALIFORNIA 94065
(650) 802-3000
FAX: (650) 802-3100

FRANKFURT

HONG KONG
HOUSTON LONDON
MIAMI

MUNICH
NEW

YORK

PARIS
WRITER'S DIRECT LINE

650-802-3174
eric. xanth opo U I os (gwei i. co m

PRAGUE PROVIDENCE SHANGHAI WARSAW

WASHINGTON, D.C.

February 8, 2008

VIA

EMAL

Chrstine Wilgoos, Esq.

Kirkland & Ells LLP 153 E. 53rd Street New York, NY 10022-4611 CWilgoos(fkirkland. com

Re: PDL BioPharma, Inc. v. Alexion Pharmaceuticals, Inc.
D. DeL. Case No. 07-156
Dear Chrstine:

Further to our February 4 teleconference and PDL's February 5 meet-and-

confer letter, enclosed is PDL's initial list of proposed E-Discovery search terms. As noted on its list, PDL incorporates by reference all terms identified in Alexion's initial proposed E-Discovery search terms. As discussed, this list is subject to revisionlist of

to add or remove terms without prejudice - after the paries meet-and-confer on February

(#288599)

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Chrstine Willgoos, Esq.

February 8, 2008
Page

2

26. Please note that PDL's initial list is designated "Confidential" under § 3.1 of the
Stipulated Confidentiality Protective Order (D.I J.

EncL.

cc: Josy Ingersoll, Esq. (via email)

(Jlngersoll(fycst.com)

Karen Jacobs Louden, Esq. (via email) (KLouden(lATcom)
Wendy Adams (via email) (WAdams(fkirkland.com)

(#288599)

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PDL Biopharma, Inc. v. Alexion Pharm., Inc. C.A. No. 07-CV-lS6 67073.0003

Search Terms For Electronic Discovery
All search terms proposed by Alexion
(hyper)varable region

*exam*

*varabl*
'370 '761 '762

0239400 125166 20030229208 20040049014 20040058414 290,975 310,252 325,000 389,155 389,417 394,458 452,357 474,040 477,728 484,537 487,200 5,530,101 5,585,089 5,635,178 5,693,761 5,693,762 590,274 6,180,370 603,273 634,278 7,022,500 718,993 718,998 846,658

(#287633)

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90903 576.8

938,117 95105609.2 Abbott Actinium Pharmaceuticals
Adage Capital

Adair
affnity constant

agreement* Ajinomoto Alberto Zanella Alexion Antibody Technologies Alexion Bermuda Alexion Corporate Subsidiares and Sister Companies Alexion Delaware Holding Alexion Europe SAS Alexion Factory Locations Alexion Holding B.V. Alexion International SarI Alexion Manufactung LLC

Alexion Phara France
Alexion Pharma UK Alexion Pharaceuticals, Inc. (Alexion) Amit Anders Wahlin Andre Tichelli Anthony Mills antibod* Anticipat* antigen Anton Kuger
Arus Research Arold Ganser

audit*

Austin Research Institute (AR) autoimmune disease Avastin Avdalovic Axienda University, Napoli, Italy Bain Capital Bank of New York Barbara Konkle Barrett Bayer AG Bell

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Bendrck
Berg
Bernard Rio bevacizumab

binding affnity

Biogen Idec/Elan biologics license application (BLA) Biotechnology Research And Development Corporation (BRDC) Biotest Phara Biotransplant Bizley
BlackRock Advisors Boehrnger Ingelheim

Bouliane
Brigham And Women's Hospital Bristol-Myers Broder
Brookside Capital

Broughton

Bruo Rotoli
C5

Capital Royalty Care Capital
Carlos DeCastro

Caron, Daniel N.

Carer
Case Western, Cleveland, OH Cedar
Cel1ech Chiroscience

Celltech Therapeutics certolizumab
Challenger Capital

Chang Charles J. Parker Cheetham Chieh-Lin Fu
Chiron Corporation

Cholthia Choltia Chothia Chugai Ciba-Geigy AG Cimzia Clark Cleveland Clinic

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Co,

Man

Sung

Coelingh
Coissac, Patrce

Columbus Faring Corporation complement complement inhibitor
complementar* determining region (CDR) contract summary

contract* Cornett Corti Cowen Healthcare Cross Cross Cancer Institute Curagen D1.3 Daclizumab daclizumab David J. Araten David Kuter
Davidson Kempner Parters

Davies Dawes Dear Departent of Hemology, Belfast, UK Div di Ematologia, Milano, Italy Duare CA US 626-359-8111 65285
Dubin, Thomas LH.

DuBridge Duke Medical Centre, Durham, NC Duke University Duke University Medical Center Duncan Ebersole eculizumab Edmundson efalizumab Eli Lily & Company Ellis Enzon
. EP 0451216 EP 0566647 EP 0682040 EP 0939127
EP 1386932

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EP 1477497 EP 1491556

EP A 0120694
EP A 0125023

EP A 0318554 EP A 0323806 EP A 0328404 EP A 0365209
EP A 0365997

EP19920903551 EP19980204240 EP20030078175 EP20040076438 EP20040076439 Epp European Commission European Medicines Agency (EMEA) Exclusive License Agreement FDA number and agent for Soliris Application Federal Drug Administration (FDA) Feldmann Fidelity Foote framework Francesco Rodeghiero
Fujisawa Pharmaceutical Co., Ltd.

Gage Garcia, Cheryl Garcia, Sergio
GB A2188941

gemtuzumab ozogamicin Genentech
Genetic Therapy

George Mills
Gerard Socié

Glaser Glaxo GlycAr Biotechnology AG Goodwin Gorman Guenot Guggenhime Gunar Nilsson
h5G1.1 *

Haematological Diagnostic Service, Leeds Hospital, Leeds, UK

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Hale Hallal, David L. Halluin Hanover, Germany Harding
heavy chain

Hepworth, Lawrence, Bryer & Bizley Herceptin Highland Capital Hinton HLBBshaw
Hoffian La Roche

homolog* Hooks, M. Stacy Hospital Laval, Ste-Foy, Quebec, Canada
Hospital Saint Louis, Hematology/Stem Cell Transplantation, Greffe de Moelle, Pars,

France Hubert Schrezenmeier Hugo Castro-Malaspina HuLuc63 Human Genome Sciences, Inc. humaniz*
humanized antibody

Huston
hypothetical * Ian Chin- Y ee

Icos IDEC Pharaceuticals Igeneon KrebsImuntherapie Forschungsund Entwicklungs AG IGHRLC* immunoglob* implied license Indiana Univiversity, Indianapolis inequitable conduct

infrng*
Inge1heim

Institute for Clinical Transfusion Medicine and Immunogenetics, Ulm, Germany InterMune Pharmaceuticals, Inc. Internal Medicine, Saarland University Medical School, Germany invalid* Invus Public Equities Ixsys Jaenichen Jain James Mason

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Jan Samuelsson

Jaroslaw P. Maciejewsk Jenzen J oerg Schubert
John Gallo

John Hopkins
John Hopkins University School of

Medicine

Norman Jones Jose Tongol Phoebe Juan
John

June 19, 1992

Junghans Jun-ichi Nishimura Kabat Kanebo Kantonsspital Basel Karolinska Institute Keiser, David Kerber Kettleborough Kirkman Kirkman Klein KLV56* Korn Kostelny Kubik Kung laches Landolfi Lesk Lesk Levitt Lewitt licens* licensee; licensor light chain Link Liverpool Hospital London Health Science Centre Lonza Loree Larratt Lorentz Brinch Louis-Philippe Boulet

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Lucentis
Lucio Luzzatto

Luke, Bary P. Lund University Hospital M. Edward Medof
m5G1.1 *

Madr, Joseph A. Market Authorization Application (MA) Massachusetts General Hospital
Mathis, Larry L.

Matsumura McDade McMaster University McMullin Mary Francis Medarex Medical Research Council (MRC)

MedImune
Merck Michael Montemuro milestone* Milennium Partners Milennium Pharmaceuticals Milstein Mintz Mochida Pharmaceutical Monica Bessler Morphotek

Morrson
Motola, Nancy C.
mUITne

Murray Mylotarg natalizumab National Institute for Cancer Research National Institutes Of Health National Institutes of Health, National, Heart, Lung and Blood Institute, Hematology Branch National University Hospital of Oslo
Neal S. Young

Neal Young NeoRx Netherlands Neuberger New Haven, Connecticut New York University Cancer Center

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NEWM

NI

Nijmegen Norby, R. Douglas

Novaris
Nuvion NY University Obvious Ohtorno Oklahoma Medical Research Foundation (OMR) Omalizumab oppos* Padlan palivizumab Palm Panka Paroxysmal Nocturnal Hemoglobinura (PNH)
Paren, Alvin S.

patent*

PaulO'Byme
Payne

Peter Hilmen
Muus Phase III PNH Research and Support Foundation Poljak Powers Presbyterian Medical Centre Presta Princess Alexandra Hospital Procter & Gamble Putney Memorial Hospital Queen Queen Elisabeth Hospital Queen et aI., "A Humanized Antibody That Binds To The Interleukin 2 Receptor," Proc. NatI. Acad. Sci., 86: 10029-10033 (1989) ranibizumab Raptiva reasonabl* Rees
Petra

Reichman Richard Herran
Riechmann Robert A. Brodsky Robert Brodsky

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Robert Nelson Roberts Roitt Rollins, Scott A. Romero Ronald Paquette
Rosaro Notaro

Rosen
Rother, Russell P.

Routledge Royal Cornwall Hospital Royal Perth Hospital royalt* Royalty Pharma
Ryotaro Nakamura sale*

Sandoz Phara
Sankyo Co.

Sarah Higgins Sato Saul Saxe Scheinberg Schering Schneider
Scil Technology GmbH
Scripps Clinic

Seattle Genetics

Selick
Service d'Hematologie

Shah Shak Shankar

Shearan
Shelby SHEPHERD Sheriff Sinha, Vikas
Sloan Kettering

Smith Smithfield, Rhode Island SmithKline Soliris special protocol assessment (SPA) specificity

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Squinto, Stephen P. St. George's Hospital Stanford Strong Substitution Synagis T. Rowe Price Tanox Taussig Cancer Center Teijin Tempest

Thak

The Cleveland Clinic Foundation The Sidney Kimmel Comprehensive Cancer Centre Third Point Tibor Moskovits Toagosei Tocilizumab TPG-Axon Capital Tramontano trastuzumab

TRIPH

Tso Tsurushita Tysabri UCB Cel1ech UchIyama UDEC Pharaceuticals Ulrich Duhsen Umea Univiversity Hospital United States Patent and Trademark Office (USPTO) Universit Essen Universit Greifswald University of Alberta Hospitals University of California Los Angeles University of Iowa Medicine and Salt Lake City VA Medical Center University of Utah School of Vasquez Verhoeyen Vicenza, Italy Vijaya Raghavan Vincenti visilizumab
Waeger, Ruedi

Waldman
CONFIDENTIAL

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Washington University School of

Medicine

Weisner Wendell F. Rosse Westfield Capital Management

wilful*
Winter WO 88/09344 WO 89/01783 WO 89/09622 WO 92/11018 WO 93/02191
Wyeth! American Home Products

Xolair Xoma Yale Yamanouchi Pharmaceutical Company Zenapax

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Exhibit F

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AUSTIN

WEIL, GOTSHAL & MANGES LL P
767 FIFTH AVENUE - NEW YORK, NY 10153-0119

BOSTO N BUDAPEST DALLAS FRANKFURT HONG KON G

(212) 310-800 0
FAX : (212) 310-800 7

HOUSTON
LONDON MIA M I MUNICH

PARIS

DIRECT LIN E

PRAGU E PROVIDENCE

(212)310-868 3
jennifer .wu@weil .co m

March 4, 2008

SHANGHAI
SILICON VALLE Y WARSAW WASHINGTON, D .C .

BY ELECTRONIC MAI L Christine Willgoos, Esq . Kirkland & Ellis LLP 153 E. 53rd Street New York, NY 10022 cwillgoos@kirkland .com Re: Dear Christine: I attach PDL's revised list of electronic search terms to be discussed during our scheduled March 7 meet-and-confer . PDL reserves its right to revise this list after the meet-and-confer . As we discussed, the other topics for our scheduled meet-and confer are: · Alexion's discovery deficiencies . I addressed these issues in detail in my March 3, 2008 letter. · Case calendar . In addition to the timeline for exchanging claim constructions, we would like to discuss the possibility of extending deadlines in the Scheduling Order . PDL BioPharma, Inc . v. Alexion Pharmaceuticals, Inc . Case No . 07-156-JJF (D. Del.)

Sincerel , I/

Jennifer H . Wu

NY I :\1545541 \01 \X43POI S.DOC\67073 .0003

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PDL's Revised Proposal of Electronic Discovery Search Terms All search terms proposed by Alexion on February 8, 2008. (John! /2 Hopkins) or Brodsky (Oslo /10 hospital) or Brinch (University /3 Los Angeles) or UCLA or Paquette (University /3 Utah) or (Parker /3 Charl!) Abbott Actinium Adage Capital Adair Ajinomoto Alexion Antibody Technologies, Inc. Alexion Bermuda LP Alexion Delaware Holding Alexion Europe Alexion Holding Alexion International Alexion Manufacturing Alexion Pharma Alzari Amit Arius Austin Research Institute or ARI Avdalovic Azienda or Rotoli Bain Capital Bank of New York Barrett /3 Judy Basel or Tichelli Bayer! Bell /3 (Leonard or Lenny or Lennie or Len)

NY1:\1545667\01\X4N701!.DOC\67073.0003

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Bendrick Berg Biogen Biotechnology Research And Development Corporation or BRDC Biotest Biotransplant Bizley BlackRock Advisors Boehringer or Ingelheim Boulianne Brigham And Women's Hospital or BWH Bristol Myers Broder Brookside Capital Broughton Capital Royalty Care Capital Caron Carter /3 Paul Case Western or Medof Cedar Celltech Challenger Capital Chang Cheetham Chiron Cholthia Choltia Chothia Chugai Ciba-Geigy Clark Cleveland Clinic or Fu or Maciejewsk 2

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Co /5 (Man or Sung or M. or S. or M.S.) Coelingh Coissac Columbus Farming Cornett Corti Cowen Healthcare Cross /3 Herb Cross Cancer Institute or Larratt Curagen Davidson Kempner Partners Davies Dawes De la Paz Dear /3 Paul Department of Hemology or Belfast or (Francis /3 Mary) Duarte or Nakamura Dubin DuBridge Duke or DeCastro or Rosse or Nishimura Duncan /3 (James or Jim) Ebersole Edmundson Eli Lilly Ellis Ematologia or Zanella Enzon Epp Essen or Duhrsen Feldmann Fidelity Foote Fujisawa 3

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Gage Garcia /3 Cheryl Garcia /3 Sergio Genentech Genetic Therapy Mills /3 George Glaser Glaxo GlycArt Goodwin Gorman Greifswald or Montemurro Guenot Guggenhime Hale Hallal Halluin Hanover or Ganser Harding Hepworth, Lawrence, Bryer & Bizley Highland Capital Hinton HLBBshaw Hoffman or La Roche Hooks /2 Stacy Hospital Saint Louis or Moelle or Socié Human Genome Sciences Huston Icos IDEC Igeneon Indiana or (Nelson /3 (Robert or Rob)) Ingelheim 4

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Clinical Transfusion Medicine or Ulm or Schrezenmeier InterMune Invus Public Equities Ixsys Jaenichen Jain Jenzen Jones Juan /3 Veronica Junghans Kabat Kanebo Karolinska or Samuelsson Keiser Kerber Kettleborough Kirkman Klein Korn Kostelny Kubik Kung Landolfi Laval or Boulet Leeds or Hillmen Lesk Levitt Lewitt Link/3 Max ( Liverpool or Gallo London Health Science or Chin-Yee Luke /3 Barry Lund or Nilsson 5

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Madri Massachusetts General Hospital or MGH or Kuter Mathis Matsumura McDade McMaster or O'Byrne Medarex Medical Research Council or MRC MedImmune Merck Millennium /3 Pharm! Millennium Partners Milstein Mintz Mochida Morphotek Morrison /3 Sherie Motola Murray /3 Rich! National Institute for Cancer or Luzzatto or Notaro National Institutes Of Health or NIH National, Heart, Lung and Blood Institute or NHLBI or (Neal /3 Young) NeoRx Netherlands or Muus Neuberger New York University or NY University or Araten or Moskovits Nijmegen Norby Novartis Ohtorno Oklahoma Medical Research Foundation or OMRF Padlan Palm /3 Norbert 6

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Panka Parven Payne PNH or (Higgins /3 Sara!) Poljak Powers /3 Dav! Presbyterian Medical or Konkle Presta Princess Alexandra or (Mills /3 (Anthony or Tony) Procter & Gamble Putney Memorial or (Phoebe /3 Jose) Queen Queen Elisabeth or (Norman /3 John) Raghavan Rees Reichmann Riechmann Roberts /3 (Tom! or Thomas) Roitt Rollins Romero Rosen Rother Routledge Royal Cornwall or Kuger Royal Perth or Herrmann Royalty Pharma Saarland or Schubert Sandoz Sankyo Sato Saul Saxe 7

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Scheinberg Schering Schneider Scil Scripps or (Mason /3 (James or Jim)) Seattle Genetics Sectoral Asset Management Selick Service d'Hematologie or (Rio /3 Bernard) Shah Shak Shankar Shearman Shelby Sheriff Sidney Kimmel or Brodsky Sims Sinha Sloan Kettering or Castro-Malaspina Smith /3 (William or Bill) SmithKline Squinto St. George's or Elebute Stanford Strong /3 Scott T. Rowe Price Tanox Teijin Tempest Thakur Third Point Toagosei TPG-Axon Capital 8

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Tramontano Tso Tsurushita Tsurushurita Uchlyama UDEC Umea or Wahlin University of Iowa Vasquez /3 Max Verhoeyen Vicenza or Rodeghiero Vincenti Waeger Waldmann Washington University or Bessler Weinzierl Weisner Westfield Capital Management Wiedmer Winter Wyeth or American Home Products or AHP Xoma Yale Yamanouchi (agreement! or licens! or contract! or term sheet or subscri!) /30 (antibod! or humani! or research or Soliris or eculizumab or immunoglobulin or Ab or Ig!) (antibod! or humani! or manufact! or Soliris or eculizumab or immunoglobulin or Ab or Ig!) /30 (New Haven or Connecticut) (antibod! or humani! or manufact! or Soliris or eculizumab or immunoglobulin or Ab or Ig!) /30 (Smithfield or Rhode Island) (European Commission or EC) /30 (Soliris or antibod!) (European Medicines Agency or EMEA) /30 (Soliris or antibod!)

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(Food and Drug Administration or FDA) /30 (Soliris or antibod!) (framework or FR) /15 (homolog! or identit! or mutat! or substitut!) (special protocol assessment or SPA) /30 (Soliris or antibod!) antibod! /15 (specificity or affinity) antibod! /15 graft anti-C5 or -C5 Avastin or bevacizumab biologics license application or BLA Cimzia or certolizumab complementar! determining region! or CDR D1.3 Daclizumab eculizumab Exclusive License Agreement h5G1.1! Herceptin or trastuzumab HuLuc63 humani! /10 (antibod! or Ab or immunoglobulin or Ig!) humanization or humanisation hypervariable IGHRLC! June 19, 1992 /10 (licens! or agreement!) KLV56! Lonza Lucentis or ranibizumab m5G1.1! Market Authorization Application or MAA /30 (Soliris or antibod!) murine /10 (antibod! or Ab or immunoglobulin or Ig!) Mylotarg or gemtuzumab ozogamicin NEWM Nuvion or visilizumab Paroxysmal Nocturnal Hemoglobinuria or PNH Phase III /30 (Soliris or antibod!) 10

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Raptiva or efalizumab reexam! /30 patent! SHEPHERD Soliris Synagis or palivizumab Tocilizumab TRIUMPH Tysabri or natalizumab United States Patent and Trademark Office or USPTO /30 (Soliris or antibod!) Xolair or Omalizumab Zenapax or daclizumab 3734266 or 266 0239400 or 400 0451216 or 216 0682040 or 040 08/207,841 or 841 125166 or 166 20030229208 or 208 20040049014 or 014 20040058414 or 414 290,975 or 975 310,252 or 252 325,000 or 000 389,155 or 155 389,417 or 417 394,458 or 458 452,357 or 357 474,040 or 040 477,728 or 728 484,537 or 537 487,200 or 200 5,530,101 or 101 11

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5,585,089 or 089 5,635,178 or 178 5,693,761 or 761 5,693,762 or 762 590,274 or 274 6,180,370 or 370 603,273 or 273 634,278 or 278 7,022,500 or 500 718,993 or 993 718,998 or 998 846,658 or 658 88/09344 or 344 0120694 or 694 90 903 576.8 938,117 or 117 95105609.2 0451216 or 216 0566647 or 647 0939127 or 127 1386932 or 932 1477497 or 497 1491556 or 556 0125023 or 023 0318554 or 554 0323806 or 806 0328404 or 404 0365209 or 209 0365997 or 997 19920903551 or 551 19980204240 or 240 20030078175 or 175 20040076438 or 438 12

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20040076439 or 439 2188941 or 941 88/09344 or 344 89/01783 or 783 89/09622 or 622 92/11018 or 018 93/02191 or 191 Alexion to add to search term list: Patents or patent applications relating to humanized antibody technology owned by, assigned to, or licensed to Alexion. Relevant project or code names.

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Exhibit G

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