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`Case 1:18-cv-01363-CFC Page1of 52 PagelD #:Document140_ Filed 05/21/19
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`14680
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH,INC.,
`
`Plaintiff and Counterclaim
`Defendant,
`
`%
`SAMSUNGBIOEPIS CO., LTD,
`
`Defendant and Counterclaim
`Plaintiff.
`
`
`C.A. No. 18-1363-CFC
`PUBLIC REDACTED VERSION
`
`NOTICE OF SUBPOENA
`
`PLEASE TAKE NOTICE that, pursuant to Fed. R. Civ. P. 26, 30, 34, and 45, Plaintiff
`
`Genentech, Inc. will cause the attached Subpoenato Testify at a Deposition in a Civil Action to be
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`served on Biogen Idec MA Inc. The deposition will commence on May 28, 2019, at 9:00 a.m.at
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`Wilmer Cutler Pickering Hale and Dorr LLP, 60 State St., Boston, MA 02109, or at such other
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`time and place as may be agreedto by the parties. The deposition will continue from day-to-day
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`until completed, with such adjournmentsas to time and place as may be necessary. The deposition
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`will be taken before a Notary Public or other officer authorized by law to administer oaths, and the
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`testimony will be recorded stenographically and by video and LiveNote. The deposition will be
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`taken for the purposes of discovery, for use at trial in this matter, and for any other purpose
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`permitted under the Federal Rules of Civil Procedure and the Local Rules of this Court.
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`Documents are to be produced for inspection or copying at Wilmer Cutler Pickering Hale
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`and Dorr LLP, 60 State St., Boston, MA 02109, on May 28, 2019, at 9:00 a.m.
`
`

`

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`Filed 05/21/19
`Case 1:18-cv-01363-CFC Document 140
`14681
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`Page 2 of 52 PagelD #:
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`/s/ Jason J, Rawnsley
`Frederick L. Cottrell, TT (#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@rificom
`
`Counselfor PlaintiffGenentech, Inc.
`
`OfCounsel:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`Timothy A. Cook
`Stephanie Neely
`WILMER CUTLER PICKERING HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`
`Robert J. GuntherJr.
`WILMER CUTLER PICKERING HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`
`Robert M. Galvin
`WILMER CUTLER PICKERING HALE AND DORR LLP
`950 Page Mill Road
`Palo Alto, CA 94304
`
`Nora Q.E. Passamaneck
`WILMER CUTLER PICKERING HALE AND DORR LLP
`1225 17th Street
`Suite 2600
`Denver, CO 80202
`
`Naney Lynn Schroeder
`WILMER CUTLER PICKERING HALE AND Dorr LLP
`350 South Grand Avenue, Suite 2100
`Los Angeles, CA 90071
`
`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`Dated: May 14, 2019
`
`

`

`Case 1:18-cv-01363-CFC
`
`Document140_
`14682
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`Filed 05/21/19
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`Page 3 of 52 PagelD #:
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`CERTIFICATE OF SERVICE
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`Thereby certify that on May 14, 2019, I electronically filed the foregoing document with the Clerk
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`of Court using CM/ECF, which will send notification of suchfiling to counsel of record, and have
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`served true and correct copies by electronic mail on the following:
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`VIA EMAIL:
`David Moore
`Bindu Ann Palapura
`POTTER ANDERSON CORROON LLP
`1313 North Market Street, 6th Floor
`Wilmington, Delaware 19801
`dmoore@potteranderson.com
`bpalapura@potteranderson.com
`
`VIA EMAIL:
`Amit Thakore
`Dimitrios T. Drivas
`Holly Tao
`Scott T. Weingaertner
`John P. Padro
`WHITE & Case LLP
`1221 Avenue of the Americas
`New York, New York 10020-1095
`athakore@whitecase.com
`ddrivas@whitecase.com
`holly.tao@whitecase.com
`sweingaertner(@whitecase.com
`jpadro@whitecase.com
`
`/s/ Jason J. Rawnsley
`Jason J. Rawnsley (#5379)
`rawnsley@rlf.com
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`Case 1:18-cv-01363-CFC
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`Filed 05/21/19
`Document140_
`14683
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`Page 4 of 52 PagelD #:
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`ATTACHMENT
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`Case 1:18-cv-01363-CFC Page5of 52 PagelD #:Document140_ Filed 05/21/19
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`14684
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`AO 88A (Rev. 12/13) Subpoenato Testify at a Deposition in a Civil Action
`
`UNITED STATES DISTRICT COURT
`for the
`
`District of Delaware
`
`SUBPOENA TO TESTIFY AT A DEPOSITION IN A CIVIL ACTION
`
`To:
`
`
`
`Biogen Idec MAInc.
`
`225 Binney Street Cambridge, MA 02142
`(Name ofperson to whomthis subpoena is directed)
`ATestimony: YOU ARE COMMANDEDto appear at the time, date, and place set forth below to testify ata
`deposition to be taken in this civil action. If you are an organization, you must designate one or more officers, directors,
`or managing agents, or designate other persons who consentto testify on your behalf about the following matters, or
`those set forth in an attachment:
`See Schedule B
`
`
`
`The deposition will be recorded by this method:|Stenographic and videographic means
`WProduction: You, or your representatives, must also bring with you to the deposition the following documents,
`electronically stored information, or objects, and must permit inspection, copying, testing, or sampling of the
`material: See Schedule A
`
`Place: Wilmer Cutler Pickering Hale and Dorr LLP, 60 State St,|Date and Time:
`Boston, MA 02109
`05/28/2019 9:00 am
`
`
`
`
`The following provisions of Fed. R. Civ. P. 45 are attached — Rule 45(c), relating to the place of compliance;
`Rule 45(d), relating to your protection as a person subject to a subpoena; and Rule 45(e) and (g), relating to your duty to
`respond to this subpoena and the potential consequences of not doing so.
`
`Date:
`
`05/14/2019
`
`CLERK OF COURT
`
`
`Signature ofClerk ar Deputy Clerk
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`OR
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`_
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`Attorney's signature
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`The name, address, e-mail address, and telephone numberofthe attorney representing (ame ofparty)
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`Plaintifis Genentech, Inc. and City of Hope
`, who issues or requests this subpoena, are:
`Andrew Danford, Wilmer Cutler Pickering Hale and Dorr LLP, 60 State St, Boston, MA 02109,
`andrew.danford@wilmerhale.com, (617) 526-6806
`
`
`
`
`
`
`
`Defendant
`
`
`Genentech, Inc.
`Plaintiff
`¥V.
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`Samsung Bioepis Co., Ltd. NeedNaren!Spee’Seana”Smee”
`
`Civil Action No.
`
` 1:18-cv-1363-CFC
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`

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`Case 1:18-cv-01363-CFC Page6of 52 PagelD #:Document140_ Filed 05/21/19
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`14685
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`
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`AO 88A (Rev. 12/13) Subpoenato Testify at a Deposition in a Civil Action (Page 2}
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`Civil Action No, 1:18-¢v-1363-CFC
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`(This section should not befiled with the court unless required by Fed. R. Civ. P. 45.)
`
`PROOF OF SERVICE
`
`T received this subpoena for (name ofindividual andtitle, ifany)
`
`on (date)
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`(1 I served the subpoena by delivering a copy to the named individual as follows:
`
`
`
`
` on (date) > or
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`(J I returned the subpoena unexecuted because:
`
`
`
`Unless the subpoena was issued on behalf of the United States, or one ofits officers or agents, | have also
`tendered to the witness the fees for one day’s attendance, and the mileage allowed by law, in the amount of
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`$
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`My fees are $
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`for travel and $
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`for services, for a total of $
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`0.00
`
`.
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`I declare under penalty of perjury that this information is true.
`
`Date:
`
`
`
`Server's signature
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`Printed name and title
`
`
`Server's address
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`Additional information regarding attempted service, etc.:
`
`
`
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`

`

`(1) Producing Decuments or Electrenicaily Stored Information. These
`procedures apply to producing documents or electronically stored
`information:
`(A) Documenis. A person responding to a subpoena to produce documenits
`must produce them as they are kept in the ordinary course of business or
`must organize and label them to correspond to the categories in the demand.
`(L) Avoiding Undue Burden or Expense; Sanctions. A party or attorney
`(8) Formfor Producing Electronically Stored Information Not Specified.
`responsible for issuing and serving a subpoena must take reasonable steps
`Ifa subpoena does not specify a form for producing electronically stored
`to avoid imposing undue burden or expense on a person subject to the
`information, the person responding must produceit in a form or forms in
`subpoena. The court for the district where compliance is required must
`whichif is ordinarily maintained or in a reasonably usable formor forms.
`enforce this duty and impose an appropriate sanction—which may include
`(C) Hlectronicaily Stored Information Produced in Only One Form. The
`lost earnings and reasonable attorney’s fees—onaparty or attorney who
`fails to comply,
`person responding need not produce the same electronically stored
`information in more than one form.
`(D) naccessible Electronically Stored Information. The person
`responding need not provide discovery ofelectronically stored information
`from sources that the person identifies as not reasonably accessible because
`ofundue burden or cost. On motion to compel discovery or for a protective
`order, the person responding must show that the information is not
`reasonably accessible because of undue burden orcost. If that showing is
`made, the court may nonetheless order discovery ftom such sources if the
`requesting party shows good cause, considering the limitations ofRule
`26(b\2)(C). The court may specify conditions for the discovery.
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`Filed 05/21/19 Page7of 52 PagelD #:
`Case 1:18-cv-01363-CFC Document 140
`14686
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`AO 88A (Rev, 12/13) Subpoenato Testify at a Deposition in a Civil Action (Page 3)
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`Federal Rule of Civil Procedure 45 (c), (d), (e), and (g) (Effective 12/1/13)
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`(c) Place of Compliance.
`
`(i) For a Trial, Hearing, er Deposition, A subpoena may command a
`person to attend a trial, hearing, or deposition only as follows:
`(A) within 106 miles of where the person resides, is employed, or
`regularly transacts business in person; or
`(B) within the state where the person resides, is employed, or regularly
`transacts business in person, if the person
`(i) is a party or a party’s officer; or
`(ii) is commandedto attend a trial and would not incur substantial
`expense.
`
`(2) For Other Discovery, A subpoena may command;
`(A) production of documents, electronically stored information, or
`tangible things at a place within 100 miles of where the personresides,is
`employed, or reguiarly transacts business in person; and
`(B) inspection ofpremises at the premises to be inspected.
`
`(4) Protecting a Person Subject to a Subpoena; Enforcement.
`
`{i) disclosing a trade secret or other confidential research, development,
`or commercial information; or
`(ii) disclosing an unretained expert’s opinion or information that does
`net describe specific occurrencesin dispute and results from the expert’s
`study that was not requested by a party.
`{C) Specifying Conditions as an Alternative. In the circumstances
`described in Rule 45(d}(3)(B), the court may, instead of quashing or
`modifying a subpoena, order appearance or production under specified
`conditions if the serving party:
`(i) shows a substantial need for the testimony or material that cannot be
`otherwise met without undue hardship; and
`(ii} ensures that the subpoenaed person will be reasonably compensated.
`
`(e) Duties in Responding to a Subpeena.
`
`(2) Command te Produce Materials or Permit Inspection,
`{A) Appearance Not Required, A person commanded to produce
`documents, electronicaily stored information, or tangible things, or to
`peunit the inspection of premises, need not appear in personat the place of
`preducticn or inspection unless also commanded to appearfor a deposition,
`hearing,ortrial,
`(B) Objections. A person commanded to produce documentsor tangible
`things or to permit inspection may serve on the party or attorney designated
`in the subpoena a written objection to inspecting, copying,testing, or
`sampling any or all ofthe materials or to inspecting the premises—orto
`producing electronically stored information in the form or forms requested.
`The objection must be served before the earlier of the time specified for
`compliance or 14 days after the subpoenais served. If an objection ts made,
`the following rules apply:
`(i} At any time, on notice to the commanded person, the serving party
`may move the court for the district where complianceis required for an
`order compelling production or inspection.
`{ii) These acts may be required only as directed in the order, and the
`order must protect a person who is neither a party nora party’s officer from
`significant expense resulting from compliance.
`
`G) Quashing or Modifying a Subpoena.
`
`(A) When Required. On timely motion, the court for the district where
`compliance is required must quash or modify a subpoena that:
`
`(i) faiis to allow a reasonable time to comply:
`(ii) requires a person to comply beyond the geographicailimits
`specified in Rule 45(c};
`(iii) requires disclosure ofprivileged or other protected matter, if no
`exception or waiver applies; or
`(iv) subjects a person to undue burden.
`(B) i¥hen Permitfed. To protect a person subject to or affected by a
`subpoena, the court for the district where compliance is required may, on
`motion, quash or modify the subpoenaifit requires:
`
`(2) Claiming Privilege or Protection.
`(A) Information Withheld, A person withholding subpoenaed information
`under a claim thatit is privileged or subject to protection as trial-preparation
`material must:
`(i} expressly make the claim; and
`(ii) describe the nature ofthe withheld documents, communications, or
`tangible things in a mannerthat, without revealing information itself
`privileged or protected, will enable the parties to assess the claim.
`(B) information Produced. Tf information produced in response to a
`subpoenais subject fo a claim ofprivilege or of protection as
`trial-preparation material, the person making the claim may notify any party
`that received the information of the claim and the basis for it. After being
`notified, a party must promptly return, sequester, or destroy the specified
`information and any copicsit has; must not use or disclose the information
`until the claim is resolved; must take reasonable steps to retrieve the
`information if the party disclosed it before being notified; and may promptly
`present the information underseal to the court for the district where
`compliance is required for a determination ofthe claim. The person who
`produced the information must preserve the information until the claim is
`resolved.
`
`{g) Contempt.
`The court for the district where compliance is required—and also,after a
`motion is transferred, the issuing court—may hold in contempt a person
`who, haviag been served, fails without adequate excuse to abey the
`subpoenaor an orderretatedto it.
`
`
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`For access to subpoena materials, see Fed. R. Civ. P. 45(a) Committee Note (2013).
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`

`

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`Case 1:18-cv-01363-CFC Page8of 52 PagelD #:Document140_ Filed 05/21/19
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`14687
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`
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`SCHEDULE A
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`Pursuant to Rule 45 of the Federal Rules of Civil Procedure, Plaintiff Genentech Inc.
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`hereby requests that Biogen Idec MA Inc. produce and permit inspection and copying of the
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`following documents and things at the place, date and time specified in the accompanying
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`subpoena.
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`DEFINITIONS
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`The words and phrases used in these Requests shall have the meanings ascribed to them
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`underthe Federal Rules of Civil Procedure and the Local Rules of the United States District
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`Court for the District of Delaware.
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`In addition, the following terms shal! have the meaningsset
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`forth below wheneverused in any Request:
`
`1.
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`“You,” “your,” “yours,” and “Biogen”shall refer to Biogen Idec MA Inc.,
`
`collectively or singly, including corporate parents, corporate predecessors, corporate successors,
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`and all past or present subsidiaries, affiliates, divisions, units, departments, officers, directors,
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`principals, agents, employees, representatives, assigns, attorneys, experts, insurers, and each
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`person acting or purporting to act on Biogen Idec MAInc.’s behalf.
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`2,
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`3.
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`“Plaintiff,” “our,” and “Genentech” shall refer to Genentech, Inc.
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`“Defendant,” “Samsung,” and “Samsung’s”shall refer, collectively or singly, to
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`Samsung Bioepis Co., Ltd., its corporate parents, corporate predecessors, corporate successors,
`
`and all past or present subsidiaries, affiliates, divisions, units, departments, officers, directors,
`
`principals, agents, employees, representatives, assigns, attorneys, experts, insurers, and each
`
`person acting or purporting to act on its behalf.
`
`4,
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`“SB3”as used herein shail mean Samsung’s biosimilar trastuzumab, or any
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`Samsung human monoclonal antibody having substantially the same amino acid sequence of
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`
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`

`

`Case 1:18-cv-01363-CFC
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`Document140_
`14688
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`Filed 05/21/19
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`Page 9 of 52 PagelD #:
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`trastuzumab, in any form includingall compositions, formulations, or preparations containing
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`SB3.
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`5.
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`“Document” means the complete original (or complete copy where the original is
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`unavailable) and each non-identical copy (where different from the original because of notes
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`made on the copy or otherwise) of any writing or record, including but not limited to all written,
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`typewritten, handwritten, printed, electronic materials (including e-mail), or graphic matter of
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`any kind or nature, however produced or reproduced, any form of collected data for use with
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`electronic data processing equipment, and any mechanical orelectronic visual or sound
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`recordings, including, without limitation, all tapes and discs, now or formerly in your possession,
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`custody or control, including all documents as defined in the broadest sense permitted by the
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`Federal Rules of Civil Procedure.
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`6.
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`“Thing” shall mean any physical specimen or other tangible item other than a
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`document, in your possession, custody, or control,
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`7.
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`“Communication” means any transmission of information by one or more persons
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`and/or between two or more persons by means including, without limitation, telephone
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`conversations, letters, telegrams, teletypes, telexes, telecopies, e-mail, text messages, other
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`computer linkups, written memoranda, and face-to-face conversations.
`
`8.
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`“Concerning” meansrelating to, referring to, describing, evidencing, or
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`constituting.
`
`9,
`
`10.
`
`versa.
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`The terms “all,” “each,” and “any” shall be construed as all and any.
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`The use of the singular form of any word shall include the plural form and vice
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`Case 1:18-cv-01363-CFC
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`Filed 05/21/19
`Document140_
`14689
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`Page 10 of 52 PagelD #:
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`11.
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`The words “and” and “or” shall be construed conjunctively or disjunctively as
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`necessary to make the request inclusive rather than exclusive.
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`12.
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`The use of a verb in any tense shall be construed as the use of the verb in all other
`
`tenses,
`
`13.
`
`Words in the masculine, feminine, or neuter form shall include eachof the other
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`genders.
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`14.
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`The use of any definition for the purposes of these Requests and shall not be
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`deemed to constitute an agreement or acknowledgmenton the part of Plaintiffs that such
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`definition is accurate, meaningful, or appropriate for any other purposein this litigation.
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`15,
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`The “Litigation” refers to the action captioned Genentech, Inc. v. Samsung
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`Bioepis Lid., C.A. No. 18-1363-CFC (D. Del.).
`
`INSTRUCTIONS
`
`The following instructions shall apply to all the below Requests and should be considered
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`part of each Request.
`
`1.
`
`You shall produceall responsive Documents and Things (including any stored by
`
`electronic means). If you are withholding or intend to withhold any Documents or Things
`
`responsive to these requests, you are requested to state the basis for withholding the Document or
`
`Thing in a mannersufficient to enable Plaintiffs and the Court to adjudicate the validity of its
`
`withholding. In the case of any Documents and Things being withheld on the grounds of
`
`attorney-client privilege, work-product doctrine, or other privilege doctrine or immunity, please
`
`also provide a privilege log identifying the following information for each Documentor Thing:
`
`a.
`
`b,
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`the request to which the Document or Thing is responsive;
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`the title of the Document or Thing;
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`

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`Case 1:18-cv-01363-CFC
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`Filed 05/21/19
`Document140_
`14690
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`Page 11 of 52 PagelD #:
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`c.
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`the date appearing on the Documentor Thing, and if no date appears
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`thereon, so state and give the date, or approximate date, on which the
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`Document or Thing was prepared;
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`d.
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`the type or general nature of the Document or Thing(i.e., whetherit is a
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`letter,memorandum, minutes of a meeting, etc.);
`
`e,
`
`f.
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`g.
`
`h.
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`i,
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`number of pages;
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`attachments;
`
`appendices;
`
`the name,title, and companyaffiliation of the Person who prepared the
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`Document or Thing;
`
`the name,title, and company affiliation of each Person to whom the
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`Document or Thing was disclosed, including the Person or Personsto
`
`whom it was addressed and the Person or Persons who received the
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`Documentor Thing, or copies of the Documentor Thing, including blind
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`copy recipients, and any individual to whom the Document or Thing was
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`distributed, shown, or explained;
`
`j.
`
`the name,title, and companyaffiliation of the Person or Persons who
`
`maintain custody of the Document or Thing; and
`
`k.
`
`the general subject matter of the Document or Thing andthe basis for
`
`withholding the Document or Thing, in a mannersufficient for Plaintiffs
`
`and the Court to determine the validity of your withholding.
`
`2,
`
`Produceall responsive Documents and Things in your actual or constructive
`
`possession, custody, or control, or the actual or constructive possession, custody, or control of
`
`
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`

`

`Case 1:18-cv-01363-CFC
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`Filed 05/21/19
`Document140-
`14691
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`Page 12 of 52 PagelD #:
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`your attorneys, accountants, representatives, consultants, agents, employees, or anyone else
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`acting on your behalf. Documents and Things in your actual or constructive possession, custody,
`
`or control include documents stored in electronic form on a server controlled by a related or
`
`unrelated entity (including but not limited to subsidiary companies, parent companies,
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`subsidiaries of parent companies, and unrelated third parties) that you have the ability to access
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`as part of the ordinary course of business. You are to produce entire Documents and Things,
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`including attachments, enclosures, cover letters, memoranda, and appendices.
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`3.
`
`Each Document and Thingis to be produced along with all nonidentical drafts
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`thereofin their entirety, without abbreviation or redaction, and as maintained in the ordinary
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`course of business. In the event that multiple copies of a Document or Thing exist, produce
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`every copy on which appear any notations or markings of any sort not appearing on any other
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`copy.
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`4,
`
`Ifa responsive Document or Thing is not in your possession, custody, or control,
`
`identify the names of the Persons who have possession, custody, or control of such Document
`
`and Thing. If such Document or Thing was in your possession, custody, or control in the past
`
`but is no longer in your possession, custody, or control, state what disposition was madeofit, the
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`reasons for such disposition, identify any Persons having any knowledgeof said disposition, and
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`identify the Persons responsible for such disposition.
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`5.
`
`If a responsive Document or Thing has been destroyed oris alleged to have been
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`destroyed, state the reasons for its destruction, the names of the Persons having any knowledge
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`of its destruction and the namesof the Persons responsible for its destruction.
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`
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`

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`Case 1:18-cv-01363-CFC
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`Filed 05/21/19
`Document140_
`14692
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`Page 13 of 52 PagelD #:
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`6.
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`If you contend that any Request is objectionable in whole or in part, you shall
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`state with particularity each objection, the basis for it, and the categories of information to which
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`the objection applies, and then respond to the Requestinsofar asit is not deemed objectionable.
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`7.
`
`If you find the meaning of any term in these Requests unclear or ambiguous, you
`
`shall assume a reasonable meaning, state what the assumed meaning is, and respond to the
`
`Request according to the assumed meaning.
`
`8.
`
`The Documents and Things produced in response to these Requests shall be (a)
`
`organized and designated to correspondto the categories in these Requestsor, if not, (b)
`
`producedas they are maintained in the normal course of business, and in either case:(i) all
`
`associated file labels, file headings, andfile folders shall be produced together with the
`
`responsive Documents and Things from eachfile and eachfile shall be identified as to its owner
`
`or custodian; (ii) all Documents and Things that cannot be legibly copied shall be produced in
`
`their original form; otherwise, you may produce photocopies; (iii) all photocopies shall be
`
`stapled or clipped as the originals; and (iv) each page shall be given a discrete production
`
`number.
`
`9,
`
`Noneof the Definitions or Requests set forth above shall be construed as an
`
`admission relating to the existence of evidence, to the relevance or admissibility of any evidence,
`
`or to the truth or accuracy of any statement or characterization in the Definition or Request.
`
`10.
`
`These Requests are continuing in nature and require supplemental or additional
`
`responses in accordance with Rule 26(e) of the Federal Rules of Civil Procedure.
`
`11.
`
`Acopy of the Protective Order filed in the Litigation is attached as Exhibit A.
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC
`
`Filed 05/21/19
`Document140_
`14693
`
`Page 14 of 52 PagelD #:
`
`DOCUMENT REQUESTS
`
`1.
`
`Documents sufficient to show communications between or among Samsung and
`
`Biogen regarding the manufacturing process for SB3.
`
`2.
`
`Documents sufficient to show the relationship between or among Samsung and
`
`Biogen relating to the manufacture of SB3.
`
`3,
`
`Documents sufficient to show Biogen’s roles and responsibilities relating to the
`
`manufacture of SB3.
`
`A,
`
`All documents sufficient to show each mammaliancell culture medium used for
`
`production of therapeutic antibodies, including SB3.
`
`5,
`
`Documents sufficient to show the amountofcitrate, citric acid, L-asparagine, L-
`
`aspattic acid, and L-glutamine in cach ggg cell culture media product used by Samsungor
`
`Biogen between January 1, 2011 and the present for production of therapeutic antibodies,
`
`including SB3.
`
`6.
`
`Documents sufficient to show the amountof citrate, citric acid, L-asparagine, L-
`
`aspartic acid, and L-glutamine in each ggg Custom Basal Powder used by Samsungor Biogen
`
`between January 1, 2011 and the present for production of therapeutic antibodies, including SB3.
`
`7.
`
`Documents sufficient to show the amountofcitrate, citric acid, L-asparagine, L-
`
`aspartic acid, and L-glutamine in cach ggg Nutrient Feed Medium used by Samsung or Biogen
`
`between January 1, 2011, and the present for production of therapeutic antibodies, including
`
`SB3.
`
`8.
`
`All communication between Samsung and Biogen concerning the amountof
`
`citrate, citric acid, L-asparagine, L-aspartic acid, and L-glutamine in any cell culture media used
`
`by Samsung between January 1, 2011, and the present for production of therapeutic antibodies,
`
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC
`
`Filed 05/21/19
`Document140_
`14694
`
`Page 15 of 52 PagelD #:
`
`9,
`
`All documents concerning communications regarding development of SB3
`
`protein A chromatography purification process between or among any Samsungentity and
`
`Biogen and within Biogen, specifically communications regarding evaluation of the Protein A
`
`chromatography step operating temperature (see SBE-ONT_003179006-22; SBE-
`
`ONT_002905926-33).
`
`10.
`
`All documents concerning protein A chromatographic purification of SB3 or any
`
`of its precursors, including but not limited to documents describing: the temperatures at which
`
`the protein A chromatographic purification of SB3 was performed for every batch or run of SB3,
`
`including during process development; any process used to determine leaching of Protein A
`
`during protein A chromatographic purification of SB3, including during process development;
`
`the amountof protein A leached from the column during protein A chromatographic purification
`
`of SB3, including during process development; evaluation of the Protein A chromatography step
`
`operating temperature; batch records of Protein A chromatography step, including during process
`
`development.
`
`11.
`
`Documents sufficient to show 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 including any such evaluation, measurements, discussion, or analysis,
`
`during: the 15,000L production bioreactor cell culture process; the bioreactorfinal cooling
`
`process; the cell culture transfer operation;
`
`the centrifugation operation and the POD filtration
`
`operation; the centrate tank process; and the transfer out to purification operation.
`
`
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC
`
`Filed 05/21/19
`Document140_
`14695
`
`Page 16 of 52 PagelD #:
`
`12.
`
`Documents sufficient to show the use of air and/or oxygen sparging during the
`
`manufacture of SB3, including air/oxygen sparging rates, dissolved oxygen concentration (%),
`
`levels of dissolved oxygen as a percentage ofair 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: the 15,000L production bioreactor cell culture process; the bioreactor
`
`final cooling process; the cell culture transfer operation; the centrifugation operation and the
`
`PODfiltration operation; the centrate tank process; and the transfer out to purification operation.
`
`13,
`
`Documents sufficient to show 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 percentageof air saturation (DO %) in the manufacture of SB3,
`
`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
`
`recombinantantibodies including during and followingthe cell culture process, including the
`
`15,000L production bioreactor cell culture process; the bioreactor final cooling process; the cell
`
`culture transfer operation; the centrifugation operation and the PODfiltration operation; the
`
`centrate tank process; and the transfer out to purification operation.
`
`
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC
`
`Filed 05/21/19
`Document140_
`14696
`
`Page 17 of 52 PagelD #:
`
`SCHEDULE B
`
`Pursuant to Rules 30 and 45 of the Federal Rules of Civil Procedure, Plaintiff Genentech
`
`Inc. hereby requests the deposition of Biogen Idec MA Inc. covering the following topics. The
`
`definitions in Schedule A are expressly incorporated here by reference.
`
`TOPICS FOR TESTIMONY
`
`1. Documents sufficient to show communications between or among Samsung and
`
`Biogen regarding the manufacturing process for SB3.
`
`2. Documents sufficient to show the relationship between or among Samsung and
`
`Biogenrelating to the manufacture of SB3.
`3. Documents sufficient to show Biogen’s roles and responsibilities relating to the
`
`manufacture of SB3.
`
`4, Each mammalian cell culture medium used by Samsung or Biogen for production of
`
`therapeutic antibodies, including SB3.
`
`5. The amountofcitrate, citric acid, L-asparagine, L-aspartic acid, and L-glutamine in
`
`eachI cell culture media product used by Samsung or Biogen between January 1, 2011, and
`
`the present.
`
`6. The amountofcitrate, citric acid, L-asparagine, L-aspartic acid, and L-glutamine in
`
`each IMF6 Custom Basal Powder used by Samsung or Biogen between January 1, 2011, and the
`
`present.
`
`7. The amountof citrate, citric acid, L-asparagine, L-aspartic acid, and L-glutamine in
`
`each JJ Nutrient Feed Medium used by Samsung or Biogen between January 1, 2011, and the
`
`present.
`
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC
`
`Filed 05/21/19
`Document140_
`14697
`
`Page 18 of 52 PagelD #:
`
`8. All communication with Samsung or Biogen concerning the amountofcitrate, citric
`
`acid, L-asparagine, L-aspartic acid, and L-glutamine in any cell culture media between January
`
`1, 2011, and the present.
`
`9. Development of SB3 protein A chromatography downstream purification process,
`
`specifically:
`
`the temperatures at which the protein A chromatographic purification of SB3 was
`
`performed for every batch or run of SB3, including during process development; any process
`
`used to determine leaching of Protein A during protein A chromatographic purification of SB3,
`
`including during process development; the amount of protein A leached from the column during
`
`protein A chromatographic purification of SB3, including during process development;
`
`evaluation of the Protein A chromatography step operating temperature.
`
`10. Communications regarding development of SB3 protein A chromatography
`
`purification process between or among any Samsungentity and Biogen and within Biogen,
`
`specifically c