`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 1 of 23 PageID #:
`14005
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC., and CITY OF HOPE,
`
`
`
`
`Plaintiffs,
`
`v.
`
`SAMSUNG BIOEPIS LTD.,
`
`Defendant.
`
`
`
` C.A. No. 18-1363-CFC
`
` FILED UNDER SEAL
`
`
`
`
`
`
`
`
`PLAINTIFFS GENENTECH, INC. AND CITY OF HOPE’S FIRST NOTICE
`OF DEPOSITION PURSUANT TO FED. R. CIV. P. 30(B)(6) TO DEFENDANT
`SAMSUNG BIOEPIS LTD.
`
`
`PLEASE TAKE NOTICE that, pursuant to Fed. R. Civ. P. 30(b)(6), Plaintiffs Genentech,
`
`Inc., and City of Hope (collectively “Plaintiffs”) will take the deposition upon oral examination of
`
`Defendant Samsung Bioepis Ltd. (“Samsung”), through one or more officers, directors, managing
`
`agents, or persons who consent to testify on their behalf with respect to the matters listed in
`
`Schedule A attached to this document. The deposition will occur at location(s) and time(s) to be
`
`determined by counsel and will continue from day-to-day until completed.
`
`Plaintiffs request that Samsung identify in writing at least one week in advance of the
`
`deposition the name(s) of the person(s) who will testify on its behalf and the subject matter on
`
`which each person will testify.
`
`
`
`The deposition may be recorded by any means permitted under the Federal Rules of Civil
`
`Procedure, including videotaping and stenographic recording. Samsung is invited to attend and
`
`cross-examine.
`
`
`
`
`
`1
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 2 of 23 PageID #:
`14006
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`
`
`
`
`
`
`/s/ Jason J. Rawnsley
`Frederick L. Cottrell, III (#2555)
`Jason J. Rawnsley (#5379)
`Alexandra M. Ewing (#6407)
`RICHARDS, LAYTON & FINGER, P.A.
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`cottrell@rlf.com
`rawnsley@rlf.com
`ewing@rlf.com
`
`Counsel for Plaintiffs Genentech, Inc.
`and City of Hope
`
`
`
`
`
`
`Of Counsel:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`Stephanie Neely
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`
`Robert J. Gunther Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`
`Nora Passamaneck
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`1225 17th Street, Suite 2600
`Denver, CO 80202
`
`Nancy Schroeder
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`350 S Grand Avenue, Suite 2100
`Los Angeles, CA 90071
`
`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff St.
`San Francisco, CA 94111
`(415) 362-6666
`ddurie@durietangri.com
`abrausa@durietangri.com
`
`DATED: April 9, 2019
`
`
`
`
`
`
`2
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 3 of 23 PageID #:
`14007
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`Definitions
`
`SCHEDULE A
`
`1.
`
`Plaintiffs incorporate by reference the definitions set forth in their First Set of
`
`Requests for Production of Documents served on November 7, 2018.
`
`2.
`
`“SB3,” “BIIB604” and/or “Ontruzant” as used herein shall mean Samsung’s
`
`biosimilar trastuzumab that is the subject of Samsung’s aBLA, or any Samsung human monoclonal
`
`antibody having substantially the same amino acid sequence of trastuzumab, in any form, including
`
`all compositions, formulations, or preparations containing SB3.
`
`3.
`
`“Merck” as used herein shall mean Merck Sharp & Dohme Corp. and all parent
`
`corporations, subsidiaries, and affiliates.
`
`4.
`
`“The ’811 Patent” refers to U.S. Patent No. 10, 160,811, titled “Treatment with
`
`Anti-ErbB2 Antibodies,” and issued by the Patent Office on Dec. 25, 2018.
`
`5.
`
`“Asserted Patents” means the ’213 Patent, the ’196 Patent, the ’379 Patent, the
`
`’811 Patent, the ’869 Patent, the ’834 Patent, the ’293 Patent, the ’983 Patent, the ’660 Patent, and
`
`the ’704 Patent.
`
`Topics of Examination
`
`1.
`
`2.
`
`Batch records for SB3, BIIB 604 and/or Ontruzant.
`
`The record keeping system in place for preserving documents related to the
`
`manufacturing process for SB3, BIIB 604 and/or Ontruzant.
`
`3.
`
`The geographic locations where SB3, BIIB 604 and/or Ontruzant is or will be
`
`manufactured in or for the United States.
`
`4.
`
`The disposition of any SB3, BIIB 604 and/or Ontruzant manufactured for the
`
`United States, including the amounts made, its current location, and plans for its distribution, sale,
`
`and use.
`
`
`3
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 4 of 23 PageID #:
`14008
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`5.
`
`The relationship between Samsung and the other corporate entities identified as
`
`being involved in the production of SB3, BIIB 604 and/or Ontruzant in Samsung’s aBLA (e.g.,
`
`Samsung’s BLA at Section 3.2.S.1 Facilities and Equipment),
`
`
`
`
`
`
`
`6.
`
`The relationship between Samsung and Merck with respect to SB3, BIIB 604
`
`and/or Ontruzant, including any agreements between Samsung and Merck with respect to SB3,
`
`BIIB 604 and/or Ontruzant.
`
`7.
`
`Any actual or proposed changes in manufacturing process and controls for SB3,
`
`BIIB 604 and/or Ontruzant since Samsung’s initial submission of its aBLA for SB3, BIIB 604
`
`and/or Ontruzant, including reasons for those changes, the identities of the individuals or groups
`
`of individuals responsible for implementing those changes, any testing conducted to implement
`
`those changes, and the comparison of those changes to other manufacturing processes.
`
`8.
`
`Samsung’s plans for the anticipated, projected, or intended commercial
`
`manufacture of SB3, BIIB 604 and/or Ontruzant for the United States, including documents
`
`sufficient to identify the persons and entities involved in such commercial manufacture.
`
`9.
`
`Samsung’s manufacturing process for SB3, BIIB 604 and/or Ontruzant including:
`
`a.
`
`the process controls, process development, and individuals involved in the
`
`process;
`
`b.
`
`c.
`
`
`
`
`
`4
`
`
`
`
`
`
`
`
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 5 of 23 PageID #:
`14009
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`d.
`
`e.
`
`f.
`
`g.
`
`
`
`
`
`
`
`10.
`
`Samsung’s evaluations, testing, predictions, estimates, opinions, discussion, or
`
`analysis related to cell growth, cell proliferation/division, growth phase, growth rate, antibody
`
`production and secretion, antibody titers, volumetric productivity, viable cell density, viable cell
`
`counts, total cell density, packed cell volume, and cell viability in the manufacture of SB3, BIIB
`
`604 and/or Ontruzant including any such evaluation, measurements, discussion, or analysis,
`
`during:
`
`
`
`5
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 6 of 23 PageID #:
`14010
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`
`
`
`
`
`
`
`
`
`
`6
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 7 of 23 PageID #:
`14011
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`11.
`
`The use of air and/or oxygen sparging during the manufacture of SB3, BIIB 604
`
`and/or Ontruzant, including air/oxygen sparging rates, dissolved oxygen concentration (%), levels
`
`of dissolved oxygen as a percentage of air saturation (DO %), including the DO % setpoint(s), the
`
`DO % controller setpoint(s), the target DO %, the DO % operating range, the minimum
`
`acceptable DO % levels, and the percentage saturation with air of the cell culture fluid, and all
`
`changes in the sparging rates, levels of dissolved oxygen, or the percentage saturation with air of
`
`the cell culture fluid, including the pre-harvest cell culture fluid and the harvested cell culture
`
`fluid, and during:
`
`a.
`
`b.
`
`c.
`
`d.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`7
`
`
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 8 of 23 PageID #:
`14012
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`e.
`
`f.
`
`
`
`
`
`
`
`
`
`
`
`
`
`12.
`
`Samsung’s evaluations, testing, predictions, estimates, opinions, discussion, or
`
`analysis related to sparging of the cell culture fluid with air and the levels of dissolved oxygen as
`
`a percentage of air saturation (DO %) in the manufacture of SB3, BIIB 604 and/or Ontruzant,
`
`including any evaluation, testing, discussion, or analysis, related to why sparging is used or
`
`whether dissolved oxygen has an effect on preventing the reduction of disulfide bonds in
`
`recombinant antibodies including during and following the cell culture process, including:
`
`a.
`
`b.
`
`c.
`
`
`
`
`
`8
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 9 of 23 PageID #:
`14013
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`d.
`
`e.
`
`f.
`
`
`
`
`
`.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`13.
`
`The selection of and specifications for any cell culture media—including the cell
`
`bank, expansion, basal, production, and feed media—and additives thereto, used to manufacture
`
`SB3, BIIB 604 and/or Ontruzant; the composition of and concentration of components in any
`
`such media and/or additives, including whether, when, and to what concentration glutamine,
`
`asparagine, or aspartic acid are contained therein; and the volumes and/or feed rates for any such
`
`media and/or additives added to the bioreactors during manufacture of SB3, BIIB 604 and/or
`
`Ontruzant.
`
`14.
`
`The composition of any cell culture media used in the process for manufacturing
`
`SB3, BIIB 604 and/or Ontruzant.
`
`
`
`9
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 10 of 23 PageID #:
`14014
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`15.
`
`The concentrations of the components of the cell culture media (including the
`
`concentrations of glutamine, asparagine, and aspartic acid) at every step of the manufacturing
`
`process of SB3, BIIB 604 and/or Ontruzant, including the concentrations present in the
`
`bioreactors during the production phase.
`
`16.
`
`The processes for monitoring the components of the cell culture media (including
`
`the concentrations of glutamine, asparagine, and aspartic acid) at every step of the manufacturing
`
`process SB3, BIIB 604 and/or Ontruzant, including the concentrations present in the bioreactors
`
`during the production phase.
`
`17.
`
`Samsung’s evaluations, testing, predictions, estimates, opinions, discussion, or
`
`analysis regarding the components of the cell culture media at every step of the manufacturing
`
`process of SB3, BIIB 604 and/or Ontruzant, including the concentrations of glutamine,
`
`asparagine, and aspartic acid.
`
`18.
`
`The concentration of citrate, citric acid, iron, or any other transition metal at every
`
`step of the cell culture process for the production of SB3, BIIB 604 and/or Ontruzant, including
`
`cell culture media and solutions, and feed additions.
`
`19.
`
`The sampling and measurement of components during every step of the cell
`
`culture process for the production of SB3, BIIB 604 and/or Ontruzant including measurements of
`
`citrate, citric acid, iron, or any other transition metal.
`
`20.
`
`Samsung’s development of the protein A chromatography method used to
`
`manufacture SB3, BIIB 604 and/or Ontruzant, including all bench scale, lab scale, pilot scale,
`
`and/or manufacturing scale processes and the temperatures at which the protein A
`
`chromatography at each scale was performed, all development reports and protocols, any changes
`
`to or testing of the protein A chromatography method as related to the temperature of the
`
`harvested cell culture fluid load and/or protein A chromatography method, all measurements of
`10
`
`
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 11 of 23 PageID #:
`14015
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`protein A leaching during both protein A chromatography process development and
`
`manufacturing, any process used to determine or reduce protein A leaching, and the parties and
`
`geographic location at which the protein A chromatography process was developed or tested.
`
`21.
`
`The temperatures at which protein A chromatography is performed in
`
`manufacturing SB3, BIIB 604 and/or Ontruzant, including the temperature of the harvested cell
`
`culture fluid prior to and during protein A chromatography, the temperature of the load lines for
`
`the protein A chromatography column, and the temperature of the eluate coming off the column.
`
`22.
`
`23.
`
`The indications in the approved label for SB3, BIIB 604 and/or Ontruzant.
`
`The patient population to be treated with SB3, BIIB 604 and/or Ontruzant,
`
`including any differences from the patient population to be treated with Herceptin.
`
`24.
`
`The diagnostic methods for identifying the patients for whom SB3, BIIB 604
`
`and/or Ontruzant is indicated, including the diagnostic methods described in the label for SB3,
`
`BIIB 604 and/or Ontruzant and the diagnostic methods used in the clinical trials for SB3, BIIB
`
`604 and/or Ontruzant.
`
`25.
`
`Any changes made to any proposed labeling for SB3, BIIB 604 and/or Ontruzant
`
`since Samsung filed its aBLA No. 761100.
`
`26.
`
`Communications with the FDA regarding any proposed label for SB3, BIIB 604
`
`and/or Ontruzant, including any changes made to any proposed labeling for SB3, BIIB 604 and/or
`
`Ontruzant.
`
`27.
`
`The differences between the approved label for SB3, BIIB 604 and/or Ontruzant
`
`and the label for Herceptin.
`
`28.
`
`All clinical studies on SB3, BIIB 604 and/or Ontruzant performed by or for
`
`Samsung.
`
`
`
`11
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 12 of 23 PageID #:
`14016
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`29.
`
`Samsung’s research or studies concerning whether SB3, BIIB 604 and/or
`
`Ontruzant is biosimilar to Herceptin.
`
`30.
`
`Any studies conducted by or for Samsung comparing SB3, BIIB 604 and/or
`
`Ontruzant with Herceptin including mechanisms of action, safety, efficacy, and therapeutic use.
`
`31.
`
`Any clinical trial, indication, instruction, or dosing schedule involving the
`
`administration of SB3, BIIB 604 and/or Ontruzant in combination with Perjeta and/or
`
`pertuzumab, including any statements relating to any such clinical trials, indications, instructions,
`
`or dosing schedules in marketing, advertising, or sales plans or materials.
`
`32.
`
`The dosing schedule(s) for SB3, BIIB 604 and/or Ontruzant, including the dosing
`
`schedule(s) described in any marketing, advertising, sales plans, materials, or physician education
`
`materials.
`
`33.
`
`Estimated or projected patient use of SB3, BIIB 604 and/or Ontruzant including
`
`any estimates or projections of the number of patients that will be administered SB3, BIIB 604
`
`and/or Ontruzant: (i) once every three weeks in the adjuvant treatment of breast cancer; (ii) during
`
`chemotherapy once per week in the adjuvant treatment of breast cancer; (iii) following
`
`chemotherapy once every three weeks in the adjuvant treatment of breast cancer; (iv) once per
`
`week in the treatment of metastatic breast cancer; (v) once every three weeks in the treatment of
`
`metastatic gastric cancer; or (vi) on any other dosing schedule.
`
`34.
`
`Samsung’s and/or Merck’s pricing decisions and strategies for SB3, BIIB 604
`
`and/or Ontruzant including any forecasts, estimates, or schedules for the rebates, discounts,
`
`wholesale acquisition cost, average wholesale price, average sale price, average manufacturer
`
`price, unit rebate amount, 340B ceiling price, and federal supply schedule price for SB3, BIIB
`
`604 and/or Ontruzant upon launch.
`
`
`
`12
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 13 of 23 PageID #:
`14017
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`35.
`
`Samsung’s and/or Merck’s pre-marketing of SB3, BIIB 604 and/or Ontruzant in
`
`the United States, including Merck’s role in pre-marketing.
`
`36.
`
`Samsung’s and/or Merck’s plans for marketing regarding the patient population
`
`eligible to receive SB3, BIIB 604 and/or Ontruzant, including any proposed advertising materials,
`
`promotional materials, or healthcare provider education materials.
`
`37.
`
`Samsung’s and/or Merck’s statements regarding clinical trials involving
`
`Herceptin, trastuzumab, and/or SB3, BIIB 604 and/or Ontruzant, any phase III study of SB3, or
`
`the April 2018 article published in the European Journal of Cancer, by Pivot X, et al., titled “A
`
`phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference
`
`product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final
`
`safety, immunogenicity and survival results,” in any marketing materials, including Samsung
`
`and/or Merck’s decision regarding how to use those clinical trials in marketing materials and
`
`Merck’s role in the decision-making process.
`
`38.
`
`The structure, size, make-up, and training of the sales force for SB3, BIIB 604
`
`and/or Ontruzant, including both Samsung’s and Merck’s sales force.
`
`39.
`
`Samsung’s and/or Merck’s proposed advertising, promotional materials,
`
`conference materials (such as posters or abstracts), presentations, publications, or healthcare
`
`provider educational materials concerning SB3, BIIB 604 and/or Ontruzant, or any phase III study
`
`of SB3, including: (i) any materials that will be or have been presented to, given to, or made
`
`available to marketing and sales representatives and/or medical science liaisons who will
`
`participate in the marketing, discussion with medical providers, and/or sale of SB3, BIIB 604
`
`and/or Ontruzant; (ii) any advertising for SB3, BIIB 604 and/or Ontruzant, including print,
`
`television, internet, or other media; (iii) product websites; and (iv) any materials relating to the
`
`April 2018 article published in the European Journal of Cancer, by Pivot X, et al., titled “A phase
`13
`
`
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 14 of 23 PageID #:
`14018
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in
`
`HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety,
`
`immunogenicity and survival results.”
`
`40.
`
`All Phase 3 equivalence clinical trials relating to SB3, BIIB 604 and/or Ontruzant,
`
`including any public statements by or for Samsung relating to such trials and any reports relating
`
`to such trials submitted to and/or presented at meetings or conferences, including any statements
`
`made at conferences hosted by the American Society of Clinical Oncology (ASCO), the European
`
`Society for Medical Oncology (ESMO), or the American Society of Hematology (ASH).
`
`41.
`
`The identity of each healthcare provider with whom Samsung and/or Merck, or
`
`any Samsung and/or Merck agent, has communicated regarding SB3, BIIB 604 and/or Ontruzant
`
`and the use of SB3, BIIB 604 and/or Ontruzant.
`
`42.
`
`All agreements between Samsung and any other person or entity concerning SB3,
`
`BIIB 604 and/or Ontruzant, including key opinion leaders and authors of the April 2018 article
`
`published in the European Journal of Cancer, by Pivot X, et al., titled “A phase III study
`
`comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-
`
`positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety,
`
`immunogenicity and survival results.”
`
`43.
`
`All agreements between Samsung and any other person or entity concerning the
`
`Patents-in-Suit and/or this litigation.
`
`44.
`
`All proposals, contracts, presentations, and/or communications between or among
`
`Samsung, Merck, and/or any hospitals or third-party payers (e g. insurance companies)
`
`concerning SB3, BIIB 604 and/or Ontruzant.
`
`
`
`14
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 15 of 23 PageID #:
`14019
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`45.
`
`The range of use indications for SB3, BIIB 604 and/or Ontruzant for which
`
`coverage negotiations or reimbursement information has been or will be sought by Samsung
`
`and/or Merck from hospitals or third-party payers (e.g. insurance companies).
`
`46.
`
`Any plan or attempt by Samsung and/or Merck to enter into exclusive supply
`
`contracts with hospitals or third-party payers (e.g. insurance companies) with respect to SB3.
`
`47.
`
`Communications between or among Samsung, Merck and/or any third-party
`
`regarding the marketing or sales of any trastuzumab product, including without limitation
`
`Herceptin, SB3, BIIB 604 and/or Ontruzant, or other trastuzumab biosimilar products.
`
`48.
`
`Communications between or among Samsung, Merck, and/or any third parties
`
`regarding SB3, BIIB 604 and/or Ontruzant, including communications with any patients, potential
`
`patients, customers, potential customers, doctors, nurses, health care administrators, other health
`
`care professionals, distributors, potential distributors, the FDA, or any government agency
`
`regarding SB3, BIIB 604 and/or Ontruzant.
`
`49.
`
`Communications between or among Samsung, Merck, and/or any person other
`
`than the FDA regarding the use of SB3, BIIB 604 and/or Ontruzant, including any
`
`advertisements, promotional material, or directions for use that are not contained in the label for
`
`SB3, BIIB 604 and/or Ontruzant.
`
`50.
`
`Samsung’s and/or Merck’s marketing, advertising, promotion, or planned
`
`marketing, advertising, and/or promotion of SB3, BIIB 604 and/or Ontruzant in the United States,
`
`including the extent of Merck’s role in any such marketing, advertising and/or promotion, any
`
`pre-launch marketing of SB3, BIIB 604 and/or Ontruzant in the United States, and the
`
`identification of persons at Samsung and/or Merck with responsibility for such marketing,
`
`advertising and promotion.
`
`
`
`15
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 16 of 23 PageID #:
`14020
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`51.
`
`Any sources of information used by Samsung and/or Merck to determine the
`
`indication(s) for which SB3, BIIB 604 and/or Ontruzant is or will be used and how often SB3,
`
`BIIB 604 and/or Ontruzant is or will be used to treat those indications.
`
`52.
`
`The intended therapeutic market for SB3, BIIB 604 and/or Ontruzant, including
`
`studies, tests, analyses, investigations, and/or evaluations done by or on behalf of or known to
`
`Samsung and/or Merck concerning the intended therapeutic market for SB3, BIIB 604 and/or
`
`Ontruzant.
`
`53.
`
`Samsung’s decision to develop SB3, BIIB 604 and/or Ontruzant, including the
`
`identities and roles of the persons responsible for making that decision, the analyses and factors
`
`considered in making that decision, and when the decision was made.
`
`54.
`
`All labels Samsung considered, proposed, or filed for SB3, BIIB 604 and/or
`
`Ontruzant, including Samsung’s decision to prepare and file any labels; the preparation and filing
`
`of any labels; all analyses, information, evaluations, and data Samsung relied upon in preparing
`
`such labels; any plans to supplement or amend such labels; the amount of money and time spent
`
`in preparation and filing such labels; and the identity and roles of the individual or individuals
`
`involved in any labels.
`
`55.
`
`Samsung’s anticipated or intended label for SB3, BIIB 604 and/or Ontruzant at
`
`the time of its commercial launch.
`
`56.
`
`Samsung and/or Merck’s knowledge, awareness, and/or identification of the
`
`market and/or market segments for Herceptin and biosimilar versions thereof.
`
`57.
`
`The projected market for SB3, BIIB 604 and/or Ontruzant in the United States,
`
`including any studies, tests, analyses, investigations, and/or evaluations performed by or on behalf
`
`of Samsung or known to it concerning the actual or potential market for the treatment of HER2-
`
`overexpressing breast cancer and/or the treatment of HER2-overexpressing metastatic gastric or
`16
`
`
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 17 of 23 PageID #:
`14021
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`gastroesophageal junction adenocarcinoma, and the use of Herceptin and biosimilar versions
`
`thereof to treat those conditions.
`
`58.
`
`The expected and/or projected effect of the launch of biosimilar versions of
`
`Herceptin on the market for, market share of, and sales of Herceptin, including the effects of
`
`multiple biosimilar entrants on the market for Herceptin.
`
`59.
`
`The expected and/or projected effect of the launch of biosimilar versions of
`
`Herceptin on the market for, market share of, and sales of SB3, BIIB 604 and/or Ontruzant,
`
`including the effects of multiple biosimilar entrants on the market for SB3, BIIB 604 and/or
`
`Ontruzant.
`
`60.
`
`The effect of the order of entry of SB3, BIIB 604 and/or Ontruzant as compared
`
`with other biosimilar versions of Herceptin on the market for, market share of, and sales of SB3,
`
`BIIB 604 and/or Ontruzant.
`
`61.
`
`Information regarding Samsung’s and/or Merck’s customers and/or potential
`
`customers for SB3, BIIB 604 and/or Ontruzant, including wholesalers and group purchasing
`
`organizations, including: (i) the identities of those customers and potential customers and the
`
`indications for which those customers and potential customers intended to use SB3, BIIB 604
`
`and/or Ontruzant; (ii) the identities of the Samsung and/or Merck employees who interact most
`
`frequently with customers and/or potential customers regarding SB3, BIIB 604 and/or Ontruzant;
`
`(iii) communications with customers and/or potential customers concerning SB3, BIIB 604 and/or
`
`Ontruzant, Herceptin, or other trastuzumab biosimilar products, including without limitation any
`
`communications concerning the terms and conditions under which SB3, BIIB 604 and/or
`
`Ontruzant are priced, price-protected, returned, purchased or sold, and the identity of persons
`
`involved in those communications; (iv) Samsung’s and/or Merck’s reasons for targeting and
`
`
`
`17
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 18 of 23 PageID #:
`14022
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`promoting sales of SB3, BIIB 604 and/or Ontruzant to specific customers and/or potential
`
`customers; and (v) Merck’s role with respect to any of (i)-(iv) above.
`
`62.
`
`Information regarding the end-users and/or potential end-users of SB3, BIIB 604
`
`and/or Ontruzant, including the identities of those end-users and potential end-users and the
`
`indications for which those end-users and potential end-users intended to use SB3, BIIB 604
`
`and/or Ontruzant.
`
`63.
`
`The commercial launch of SB3, BIIB 604 and/or Ontruzant in the United States,
`
`including the actual, potential, or anticipated launch date, Samsung’s and/or Merck’s activities in
`
`preparation for commercial launch, and Samsung’s consideration of and any decisions regarding
`
`whether and when to launch.
`
`64.
`
`The planning and execution of the launch of SB3, BIIB 604 and/or Ontruzant,
`
`including: (i) the selection of which customers will receive product; (ii) Samsung’s and/or
`
`Merck’s communications with customers, potential customers, or other third parties (other than
`
`the parties in this case or the Court) about the launch, including timing, quantities, and pricing;
`
`(iii) the extent to which Samsung and/or Merck has provided or is providing advance notice to its
`
`customers that they would receive SB3, BIIB 604 and/or Ontruzant (and if no advance notice has
`
`or will be provided, why not); (iv) the existence and terms of any agreements with
`
`customers/third parties that require the customer/third-party to accept delivery of SB3, BIIB 604
`
`and/or Ontruzant without notice and/or without a purchase order (regardless of whether such
`
`agreements expressly reference SB3, BIIB 604 and/or Ontruzant); (v) persons and departments
`
`involved; and (vi) pre-launch projections, forecasts, plans and/or budgets concerning the
`
`following: (a) the impact of the launch on Herceptin sales, profits, prices, and market share; (b)
`
`gross and net prices of SB3, BIIB 604 and/or Ontruzant; (c) revenues associated with SB3, BIIB
`
`604 and/or Ontruzant; and/or (d) profits associated with SB3, BIIB 604 and/or Ontruzant.
`
`
`
`18
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 19 of 23 PageID #:
`14023
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`65.
`
`Samsung and/or Merck’s business plans and forecasts for sales of SB3, BIIB 604
`
`and/or Ontruzant, including Samsung and/or Merck’s forecasts for the amount of revenue,
`
`profitability, and potential for growth for SB3, BIIB 604 and/or Ontruzant; changes or revisions
`
`to Samsung and/or Merck’s business plans and forecasts; and the inputs, assumption, and/or data
`
`used to generate Samsung and/or Merck’s business plans and forecasts.
`
`66.
`
`Financial information concerning SB3, BIIB 604 and/or Ontruzant, including: (i)
`
`business, marketing, or strategic plans; (ii) forecasted or projected gross and net sales by product,
`
`including unit sales and revenues, on a monthly basis; (iii) forecasted projected costs and
`
`expenses associated with SB3, BIIB 604 and/or Ontruzant on a monthly basis, including without
`
`limitation, Samsung and/or Merck’s fixed and variable unit expenses, its costs, its method of
`
`allocating costs, its administrative or overhead expenses, costs of raw materials or API (active
`
`pharmaceutical ingredient), production costs, royalties paid, marketing, sales or promotional
`
`costs, and/or general and administrative costs; (iv) forecasted or projected gross and net profit by
`
`product from all sales of SB3, BIIB 604 and/or Ontruzant; (v) method(s) used by Samsung and/or
`
`Merck to determine gross and net profit and an explanation of all measures of profit used in
`
`connection with SB3, BIIB 604 and/or Ontruzant including gross profit and/or operating profit;
`
`and (vi) sharing of revenue or profits earned on SB3, BIIB 604 and/or Ontruzant between
`
`Samsung, Merck, and/or any other entity including any agreements concerning or reflecting such
`
`profit-sharing.
`
`67.
`
`Information concerning pricing for SB3, BIIB 604 and/or Ontruzant, including:
`
`(i) forecasted or projected average gross and net selling prices; (ii) prices offered and/or accepted
`
`by each specific Samsung and/or Merck customer; (iii) the impact of sales and offers for sale of
`
`Herceptin, and/or other trastuzumab biosimilars on pricing for SB3, BIIB 604 and/or Ontruzant;
`
`and (iv) the methodology used in setting prices.
`
`
`
`19
`
`

`

`
`Case 1:18-cv-01363-CFC Document 106 Filed 04/16/19 Page 20 of 23 PageID #:
`14024
`CONFIDENTIAL – SUBJECT TO PROTECTIVE ORDER
`
`68.
`
`Information concerning forecasted, projected, and/or expected reimbursement
`
`practices or policies of third-party payors with respect to reimbursement for SB3, BIIB 604 and/or
`
`Ontruzant, including whether reimbursement was contingent upon use of SB3, BIIB 604 and/or
`
`Ontruzant for an indication included on the product’s label.
`
`69.
`
`Samsung’s current inventory of SB3, BIIB 604 and/or Ontruzant inside the
`
`United States and outside the United States, including any inventory of SB3, BIIB 604 and/or
`
`Ontruzant stored on Samsung’s behalf, as well as Samsung’s current plans for manufacture and
`
`disposition of SB3, BIIB 604 and/or Ontruzant over the next 15 months.
`
`70.
`
`Samsung and/or Merck’s forecasts of sales (in dollars and units), gross revenues,
`
`and net profit attributable to SB3, BIIB 604 and/or Ontruzant that Samsung and/or Merck projects
`
`to receive as a result of manufacturing, importing, or selling SB3, BIIB 604 and/or Ontruzant in
`
`the United States, and to the extent available, broken down by market segment (specialty
`
`pharmacies, 340B hospitals, etc.), by market share, and by indication, from 2015 to the present.
`
`71.
`
`Samsung’s and/or Merck’s strategy for marketing biosimilar products, including
`
`any efforts by Samsung and/or Merck to use SB3, BIIB 604 and/or Ontruzant to promote other
`
`Samsung biosimilar products.
`
`72.
`
`Samsung’s and/or Merck’s marketing strategy for distinguishing SB3, BIIB 604
`
`and/or Ontruzant from other biosimilar trastuzumab products.
`
`73.
`
`The identity of the legal entities, senior responsible persons, and locations and
`
`facilities involved with each of the following activities from the time Samsung submitted aBLA
`
`No. 761100 to the present: (i) manufacture of SB3, BIIB 604 and/or Ontruzant; (ii) sale of SB3,
`
`BIIB 604 and/or Ontruzant in the United States; (iii) offers for sale of SB3, BIIB 604 and/or
`
`Ontruzant in the United States; (iv) importation of SB3, BI