throbber
Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 1 of 225 PageID
`#: 17661
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`GENENTECH, INC. and CITY OF HOPE,
`
`Plaintiffs,
`
`v.
`
`AMGEN INC.,
`
`Defendant and Counterclaim
`Plaintiff.
`
`
`
`
`
`
` Case No. 18-924-CFC
`
`
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`
`
`NOTICE OF SERVICE OF SUBPOENAS
`
`PLEASE TAKE NOTICE that Plaintiff Genentech, Inc. will serve the subpoenas attached
`
`hereto.
`
`
`ME1 30359746v.1
`
`PUBLIC VERSION FILED: May 14, 2019
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 2 of 225 PageID
`#: 17662
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`
`
`MCCARTER & ENGLISH, LLP
`
` /s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Counsel for Plaintiffs Genentech, Inc.,
`and City of Hope
`
`
`
`
`
`Dated: May 3, 2019
`
`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
`
`Darlyn Durie
`Adam Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`ME1 30359746v.1
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 3 of 225 PageID
`#: 17663
`AO 88A (Rev. 12/13) Subpoena to Testify at a Deposition in a Civil Action
`
`UNITED STATES DISTRICT COURT
`for the
`__________ District of __________
` District of Delaware
`
`Civil Action No.
`
`18-924-CFC
`
`))))))
`
`Genentech,Inc. and City of Hope
`Plaintiff
`v.
`Amgen Inc.
`
`Defendant
`
`SUBPOENA TO TESTIFY AT A DEPOSITION IN A CIVIL ACTION
`
`To:
`
`(Name of person to whom this subpoena is directed)
`✔
`(cid:117) Testimony: YOU ARE COMMANDED to appear at the time, date, and place set forth below to testify at a
`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 consent to testify on your behalf about the following matters, or
`those set forth in an attachment:
`See Schedule B.
`
`Place:
`
`Durie Tangri LLP
`530 Molino Street, Suite 111
`Los Angeles, CA 90013
`
`Date and Time:
`
`05/31/2019 9:00 am
`
`The deposition will be recorded by this method:
`
`Stenographic and videographic means
`
`✔
`(cid:117) Production: 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.
`
`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:
`
`05/03/2019
`
`CLERK OF COURT
`
`Signature of Clerk or Deputy Clerk
`
`OR
`
`/s/ Adam R. Brausa
`Attorney’s signature
`
`The name, address, e-mail address, and telephone number of the attorney representing (name of party)
`Plaintiffs Genentech, Inc. and City of Hope
`, who issues or requests this subpoena, are:
`Adam R. Brausa, Durie Tangri LLP, 217 Leidesdorff St., S.F., CA 94111, abrausa@durietangri.com, 415-362-6666
`
`Notice to the person who issues or requests this subpoena
`If this subpoena commands the production of documents, electronically stored information, or tangible things, a notice
`and a copy of the subpoena must be served on each party in this case before it is served on the person to whom it is
`directed. Fed. R. Civ. P. 45(a)(4).
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 4 of 225 PageID
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`AO 88A (Rev. 12/13) Subpoena to Testify at a Deposition in a Civil Action (Page 2)
`
`Civil Action No.
`
`18-924-CFC
`
`PROOF OF SERVICE
`(This section should not be filed with the court unless required by Fed. R. Civ. P. 45.)
`
`I received this subpoena for (name of individual and title, if any)
`.
`
`on (date)
`
`(cid:117) I served the subpoena by delivering a copy to the named individual as follows:
`
`(cid:117) I returned the subpoena unexecuted because:
`
`on (date)
`
`; or
`
`Unless the subpoena was issued on behalf of the United States, or one of its officers or agents, I have also
`tendered to the witness the fees for one day’s attendance, and the mileage allowed by law, in the amount of
`$
`.
`
`My fees are $
`
`for travel and $
`
`for services, for a total of $
`
`0.00
`
`.
`
`.
`
`I declare under penalty of perjury that this information is true.
`
`Date:
`
`Additional information regarding attempted service, etc.:
`
`Server’s signature
`
`Printed name and title
`
`Server’s address
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 5 of 225 PageID
`#: 17665
`AO 88A (Rev. 12/13) Subpoena to Testify at a Deposition in a Civil Action (Page 3)
`Federal Rule of Civil Procedure 45 (c), (d), (e), and (g) (Effective 12/1/13)
`(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
`not describe specific occurrences in 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.
`
`(c) Place of Compliance.
`
` (1) For a Trial, Hearing, or Deposition. A subpoena may command a
`person to attend a trial, hearing, or deposition only as follows:
` (A) within 100 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 commanded to 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 person resides, is
`employed, or regularly transacts business in person; and
` (B) inspection of premises at the premises to be inspected.
`
`(d) Protecting a Person Subject to a Subpoena; Enforcement.
`
` (1) Avoiding Undue Burden or Expense; Sanctions. A party or attorney
`responsible for issuing and serving a subpoena must take reasonable steps
`to avoid imposing undue burden or expense on a person subject to the
`subpoena. The court for the district where compliance is required must
`enforce this duty and impose an appropriate sanction—which may include
`lost earnings and reasonable attorney’s fees—on a party or attorney who
`fails to comply.
`
` (2) Command to Produce Materials or Permit Inspection.
`(A) Appearance Not Required. A person commanded to produce
`documents, electronically stored information, or tangible things, or to
`permit the inspection of premises, need not appear in person at the place of
`production or inspection unless also commanded to appear for a deposition,
`hearing, or trial.
`(B) Objections. A person commanded to produce documents or 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 of the materials or to inspecting the premises—or to
`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 subpoena is served. If an objection is 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 compliance is 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 nor a party’s officer from
`significant expense resulting from compliance.
`
` (3) 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) fails to allow a reasonable time to comply;
`(ii) requires a person to comply beyond the geographical limits
`specified in Rule 45(c);
`(iii) requires disclosure of privileged or other protected matter, if no
`exception or waiver applies; or
`(iv) subjects a person to undue burden.
`(B) When Permitted. 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 subpoena if it requires:
`
`(e) Duties in Responding to a Subpoena.
`
` (1) Producing Documents or Electronically Stored Information. These
`procedures apply to producing documents or electronically stored
`information:
`(A) Documents. A person responding to a subpoena to produce documents
`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.
`(B) Form for Producing Electronically Stored Information Not Specified.
`If a subpoena does not specify a form for producing electronically stored
`information, the person responding must produce it in a form or forms in
`which it is ordinarily maintained or in a reasonably usable form or forms.
`(C) Electronically Stored Information Produced in Only One Form. The
`person responding need not produce the same electronically stored
`information in more than one form.
`(D) Inaccessible Electronically Stored Information. The person
`responding need not provide discovery of electronically stored information
`from sources that the person identifies as not reasonably accessible because
`of undue 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 or cost. If that showing is
`made, the court may nonetheless order discovery from such sources if the
`requesting party shows good cause, considering the limitations of Rule
`26(b)(2)(C). The court may specify conditions for the discovery.
`
`(2) Claiming Privilege or Protection.
`(A) Information Withheld. A person withholding subpoenaed information
`under a claim that it is privileged or subject to protection as trial-preparation
`material must:
`(i) expressly make the claim; and
`(ii) describe the nature of the withheld documents, communications, or
`tangible things in a manner that, without revealing information itself
`privileged or protected, will enable the parties to assess the claim.
`(B) Information Produced. If information produced in response to a
`subpoena is subject to a claim of privilege 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 copies it 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 under seal to the court for the district where
`compliance is required for a determination of the 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, having been served, fails without adequate excuse to obey the
`subpoena or an order related to it.
`
`For access to subpoena materials, see Fed. R. Civ. P. 45(a) Committee Note (2013).
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 6 of 225 PageID
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`
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`SCHEDULE A
`
`Pursuant to Rule 45 of the Federal Rules of Civil Procedure, Plaintiff Genentech Inc.
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`hereby requests that
`
` Inc. produce and permit inspection and copying of the following
`
`documents and things at the place, date and time specified in the accompanying subpoena.
`
`DEFINITIONS
`
`The words and phrases used in these Requests shall have the meanings ascribed to them
`
`under the Federal Rules of Civil Procedure and the Local Rules of the United States District
`
`Court for the District of Delaware. In addition, the following terms shall have the meanings set
`
`forth below whenever used in any Request:
`
`1.
`
`“You,” “your,” and “yours” shall refer to, collectively or singly, to
`
` Inc.,
`
`and all of its corporate parents, including but not limited to
`
` 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.
`
`2.
`
`3.
`
`“Plaintiff,” “our,” and “Genentech” shall refer to Genentech.
`
`“Defendant,” “Amgen,” and “Amgen’s” shall refer, collectively or singly, to
`
`Amgen Inc., and all of 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.
`
`“Person” means any natural person or any business, legal, or governmental entity
`
`or association.
`
`5.
`
`“Third party” means a person that is not You, Amgen, or Genentech.
`
`
`
`1
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`

`

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`6.
`
`“FDA” means the United States Food and Drug Administration, including any of
`
`its centers, departments, divisions, offices, subsidiaries, and/or other units.
`
`7.
`
`“HERCEPTIN®” refers to the product that is the subject of Biologic License
`
`Application No. 103792.
`
`8.
`
`“Trastuzumab” refers to any human monoclonal antibody having substantially the
`
`same amino acid sequence as the active monoclonal antibody contained in HERCEPTIN®.
`
`9.
`
`As used herein, “Amgen’s aBLA” shall mean any abbreviated biologic license
`
`application pertaining to ABP 980, including any amendments or supplements thereto.
`
`10.
`
` “ABP 980” as used herein shall mean Amgen’s biosimilar trastuzumab that is the
`
`subject of Amgen’s aBLA, or any Amgen monoclonal antibody having substantially the same
`
`amino acid sequence of trastuzumab, in any form including all compositions, formulations, or
`
`preparations containing ABP 980.
`
`11.
`
`“Kanjinti” refers to the commercial name for Amgen’s trastuzumab biosimilar
`
`product that is the subject of Amgen’s aBLA.
`
`12.
`
`“Document” means the complete original (or complete copy where the original is
`
`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 or electronic visual or sound
`
`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.
`
`
`
`2
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 8 of 225 PageID
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`13.
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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
`
`conversations, letters, telegrams, teletypes, telexes, telecopies, e-mail, text messages, other
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`computer linkups, written memoranda, and face-to-face conversations.
`
`14.
`
`“Concerning” means relating to, referring to, describing, evidencing, or
`
`constituting.
`
`15.
`
`16.
`
`“Including” means including but not limited to.
`
`“Produce” means to provide legible, complete, and exact copies of responsive
`
`documents to the undersigned counsel, or to make such documents available to the undersigned
`
`counsel for inspection and reproduction.
`
`17.
`
`“Relate to,” “relates to,” “refers to,” or “relating to” means relating to, referring
`
`to, mentioning, discussing, reflecting, containing, stating, describing, embodying, evidencing,
`
`constituting, dealing with, or making reference to in any way.
`
`18.
`
`“Describe” or “state” means to set forth fully and unambiguously every fact that
`
`relates to the answer called for by the request of which you have knowledge and to identify each
`
`individual with knowledge or information that relates to your answer.
`
`19.
`
`“Thing” shall mean any physical specimen or other tangible item other than a
`
`document, in your possession, custody, or control.
`
`The terms “all,” “each,” and “any” shall be construed as all and any.
`
`The use of the singular form of any word shall include the plural form and vice
`
`20.
`
`21.
`
`versa.
`
`22.
`
`The words “and” and “or” shall be construed conjunctively or disjunctively as
`
`necessary to make the request inclusive rather than exclusive.
`
`
`
`3
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 9 of 225 PageID
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`23.
`
`The use of a verb in any tense shall be construed as the use of the verb in all other
`
`tenses.
`
`24. Words in the masculine, feminine, or neuter form shall include each of the other
`
`genders.
`
`25.
`
`The use of any definition for the purposes of these Requests and shall not be
`
`deemed to constitute an agreement or acknowledgment on the part of Plaintiffs that such
`
`definition is accurate, meaningful, or appropriate for any other purpose in this litigation.
`
`26.
`
`The “Litigation” refers to the action captioned Genentech, Inc. v. Amgen, Inc.,
`
`C.A. No. 18-924-CMC (D. Del.).
`
`INSTRUCTIONS
`
`The following instructions shall apply to all the below Requests and should be considered
`
`part of each Request.
`
`1.
`
`You shall produce all 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 manner sufficient 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 Document or Thing:
`
`a.
`
`b.
`
`c.
`
`the request to which the Document or Thing is responsive;
`
`the title of the Document or Thing;
`
`the date appearing on the Document or Thing, and if no date appears
`
`thereon, so state and give the date, or approximate date, on which the
`
`Document or Thing was prepared;
`4
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 10 of 225 PageID
`#: 17670
`
`d.
`
`the type or general nature of the Document or Thing (i.e., whether it is a
`
`letter, memorandum, minutes of a meeting, etc.);
`
`e.
`
`f.
`
`g.
`
`h.
`
`number of pages;
`
`attachments;
`
`appendices;
`
`the name, title, and company affiliation of the Person who prepared the
`
`Document or Thing;
`
`i.
`
`the name, title, and company affiliation of each Person to whom the
`
`Document or Thing was disclosed, including the Person or Persons to
`
`whom it was addressed and the Person or Persons who received the
`
`Document or Thing, or copies of the Document or Thing, including blind
`
`copy recipients, and any individual to whom the Document or Thing was
`
`distributed, shown, or explained;
`
`j.
`
`the name, title, and company affiliation of the Person or Persons who
`
`maintain custody of the Document or Thing; and
`
`k.
`
`the general subject matter of the Document or Thing and the basis for
`
`withholding the Document or Thing, in a manner sufficient for Plaintiffs
`
`and the Court to determine the validity of your withholding.
`
`2.
`
`Produce all responsive Documents and Things in your actual or constructive
`
`possession, custody, or control, or the actual or constructive possession, custody, or control of
`
`your attorneys, accountants, representatives, consultants, agents, employees, or anyone else
`
`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
`
`
`
`5
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 11 of 225 PageID
`#: 17671
`
`unrelated entity (including but not limited to subsidiary companies, parent companies,
`
`subsidiaries of parent companies, and unrelated third parties) that you have the ability to access
`
`as part of the ordinary course of business. You are to produce entire Documents and Things,
`
`including attachments, enclosures, cover letters, memoranda, and appendices.
`
`3.
`
`Each Document and Thing is to be produced along with all nonidentical drafts
`
`thereof in their entirety, without abbreviation or redaction, and as maintained in the ordinary
`
`course of business. In the event that multiple copies of a Document or Thing exist, produce
`
`every copy on which appear any notations or markings of any sort not appearing on any other
`
`copy.
`
`4.
`
`If a 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 made of it, the
`
`reasons for such disposition, identify any Persons having any knowledge of said disposition, and
`
`identify the Persons responsible for such disposition.
`
`5.
`
`If a responsive Document or Thing has been destroyed or is alleged to have been
`
`destroyed, state the reasons for its destruction, the names of the Persons having any knowledge
`
`of its destruction and the names of the Persons responsible for its destruction.
`
`6.
`
`If you contend that any Request is objectionable in whole or in part, you shall
`
`state with particularity each objection, the basis for it, and the categories of information to which
`
`the objection applies, and respond to the Request insofar as it is not deemed objectionable.
`
`
`
`6
`
`

`

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`#: 17672
`
`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 correspond to the categories in these Requests or, if not, (b)
`
`produced as they are maintained in the normal course of business, and in either case: (i) all
`
`associated file labels, file headings, and file folders shall be produced together with the
`
`responsive Documents and Things from each file and each file 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.
`
`None of 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.
`
`A copy of the Protective Order filed in the Litigation is attached as Exhibit A.
`
`
`
`
`
`7
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 13 of 225 PageID
`#: 17673
`
`DOCUMENT REQUESTS
`
`1.
`
`All documents related to the marketing or intended marketing of ABP 980 in the
`
`United States.
`
`2.
`
`All documents related to any agreements relating to ABP 980, directly and
`
`indirectly, involving You and Amgen.
`
`3.
`
`All documents related to ABP 980 that You have received from Amgen, including
`
`but not limited to materials provided to You before, during, or after
`
`
`
` at which ABP 980 is discussed.
`
`4.
`
`All documents related to PD/Operations meetings between You and Amgen,
`
`including but not limited to documents exchanged between
`
` and
`
`
`
` of
`
`5.
`
`6.
`
`.
`
`All communications between You and Amgen concerning the Litigation.
`
`All documents concerning the decision to develop, manufacture, commercialize,
`
`and sell ABP 980, including, without limitation, documents concerning business plans,
`
`regulatory plans, product or project proposals and approvals, meeting minutes, patent clearance
`
`or infringement reviews or investigations, strategic plans or forecasts, market studies, market or
`
`sales projects or forecasts, marketing plans, and competitive analyses.
`
`7.
`
`All documents concerning the anticipated, projected, or intended launch date of
`
`ABP 980 anywhere within the United States.
`
`8.
`
`All documents related to the strategy for selling or marketing of ABP 980 both
`
`before and after any launch, including but not limited to anticipated or actual market share,
`
`forecasted or actual impact on competitors, forecasted or actual price, forecasted or actual sales,
`
`forecasted or actual revenue, forecasted or actual costs, forecasted or actual profits; documents
`
`identifying target markets and planned points of market entry; sales action plans including
`8
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 14 of 225 PageID
`#: 17674
`
`regional or district action plans; notes, memoranda, communications, or emails summarizing
`
`communications or meetings with physicians or payors; marketing or sales materials developed
`
`for physicians, patients, payors, or other customers; presentations, telewebs, memoranda, emails,
`
`training materials, objection handlers, and any other documents used to communicate with and/or
`
`train sales representatives; documents relating to launch strategies or simulations; documents
`
`relating to speaker bureaus and sales and marketing strategies relating thereto; long range plans
`
`or projections; and brand plans.
`
`
`
`9
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 15 of 225 PageID
`#: 17675
`
`SCHEDULE B
`
`Pursuant to Rules 30 and 45 of the Federal Rules of Civil Procedure, Plaintiff Genentech
`
`Inc. hereby requests the deposition of
`
` covering the following topics. The
`
`definitions in Schedule A are expressly incorporated here by reference.
`
`TOPICS FOR TESTIMONY
`
`1.
`
`Any agreements relating to ABP 980, directly and indirectly, involving You and
`
`Amgen.
`
`2.
`
`The nature, frequency, content, and information shared as a result of
`
` meetings at which ABP 980 is discussed.
`
`3.
`
`The nature, frequency, content, and information shared as a result of
`
`PD/Operations meetings between You and Amgen, including but not limited to meetings
`
`between
`
`
`
` of
`
`.
`
`4.
`
`The commercial launch of ABP 980 and/or Kanjinti in the United States,
`
`including the actual, potential, or anticipated launch date, activities in preparation for
`
`commercial launch, the planning and execution of the commercial launch, and consideration of
`
`and any decisions regarding whether and when to launch.
`
`5.
`
`Communications between
`
` and any third-party regarding the marketing
`
`or sales of any trastuzumab product, including without limitation Herceptin, ABP 980 and/or
`
`Kanjinti, or other trastuzumab biosimilar products.
`
`6.
`
`Marketing, advertising, promotion or planned marketing, advertising, and/or
`
`promotion of ABP 980 and/or Kanjinti in the United States, including any pre-launch marketing
`
`of ABP 980 and/or Kanjinti in the United States and the identification of persons with
`
`responsibility for such marketing, advertising and promotion.
`
`
`
`10
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 16 of 225 PageID
`#: 17676
`
`7.
`
`The decision to develop ABP 980 and/or Kanjinti, 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.
`
`8.
`
`Business plans and forecasts for sales of ABP 980 and/or Kanjinti from 2015 to
`
`the present, including forecasts for the amount of revenue, profitability, and potential for growth
`
`for ABP 980 and/or Kanjinti; changes or revisions to business plans and forecasts; and the
`
`inputs, assumption, and/or data used to generate business plans and forecasts.
`
`9.
`
`The disposition of any ABP 980 and/or Kanjinti manufactured in or for the United
`
`States, including the amounts made, its current location, and plans for its distribution, sale, and
`
`use.
`
`10.
`
`Current inventory of ABP 980 and/or Kanjinti inside the United States and
`
`outside the United States, as well as current plans for manufacture and disposition of ABP 980
`
`over the next 15 months.
`
`11.
`
`The authenticity of any documents produced by You pursuant to this subpoena.
`
`
`
`11
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 17 of 225 PageID
`#: 17677
`
`
`
`
`
`
`EXHIBIT A
`
`
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 18 of 225 PageID
`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 1 of 30 PageID #: 3591
`#: 17678
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE,
`
`Plaintiffs,
`
`V.
`
`AMGEN INC.,
`
`Defendant.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No.: 18-924-GMS
`
`STIPULATED PROTECTIVE ORDER
`
`WHEREAS, Plaintiffs Genentech, Inc. ("Genentech") and City of Hope and Defendant
`
`Amgen Inc. ("Amgen") expect discovery requests made in this action (the "Litigation") to
`
`encompass certain information which may constitute trade secrets and/or other confidential
`
`research, development, or commercial information within the meaning of Federal Rule of Civil
`
`Procedure 26(c)(l)(G) for which special protection from public disclosure and from use for any
`
`purpose other than in this Litigation is warranted, the Parties, by and through their respective
`
`Outside Counsel, HEREBY STIPULATE to the entry of this Protective Order regarding
`
`discovery in this Litigation.
`
`DEFINITIONS
`
`1.
`
`"Affiliate" means any Third Party that directly or indirectly through one or more
`
`intermediaries, controls, or is controlled by, or is under common control with, a Party to this
`
`Litigation.
`
`2.
`
`"CONFIDENTIAL" means information that constitutes, contains, reveals, or
`
`reflects trade secrets or other confidential research, development, business, or commercial
`
`information within the meaning of Fed. R. Civ. P. 26(c)(l)(G), including but not limited to:
`
`MEI 28S63694v.l
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 202 Filed 05/14/19 Page 19 of 225 PageID
`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 2 of 30 PageID #: 3592
`#: 17679
`
`scientific and technical information; product information; financial, budgeting and/or accounting
`
`information; information about existing and potential customers; ma

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