Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 1 of 63 PageID
`#: 32370
`
`EXHIBIT 14
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 2 of 63 PageID
`#: 32371
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 3 of 63 PageID
`#: 32372
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`

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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 4 of 63 PageID
`Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 3 of 39 PageID #: 25901
`#: 32373
`AO 88A (Rev. 12/13) Subpoena to Testify at a Deposition in a Civil Action (Page 2)
`
`Civil Action No.
`
`Case No. 1:18-cv-00924-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 434-1 Filed 10/18/19 Page 5 of 63 PageID
`Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 4 of 39 PageID #: 25902
`#: 32374
`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 434-1 Filed 10/18/19 Page 6 of 63 PageID
`Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 5 of 39 PageID #: 25903
`#: 32375
`
`ATTACHMENT A
`
`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:
`
`DEFINITIONS
`
`“’196 patent” means U.S. Patent No. 6,627,196.
`
`“’379 patent” means U.S. Patent No. 7,371,379.
`
`“’811 patent” means U.S. Patent No. 10,160,811.
`
`“Amgen” means Amgen Inc.
`
`“Communication” means any exchange or transmittal of information in the form
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`of facts, ideas, inquiries, or otherwise, whether written, oral, electronic, or in any other form.
`
`6.
`
`“Concerning,” “relating to,” or “referring to” any given subject matter means,
`
`without limitation, identifying, assessing, stating, constituting, containing, embodying, tending to
`
`support or refute, referring directly or indirectly to, pertaining to, reflecting upon, evidencing,
`
`concerning, discussing, describing, mentioning, summarizing or connecting, in any way, to the
`
`particular subject matter.
`
`7.
`
`“Document(s)” is used in the broadest sense possible under Rule 34 of the Federal
`
`Rules of Civil Procedure and means all written, recorded, and graphic material or medium,
`
`however produced or reproduced, upon which information or intelligence is recorded or from
`
`which information or intelligence can be recorded, which is or has been in Your possession,
`
`custody or control, or of which You have knowledge. This definition includes all originals, copies,
`
`and drafts, including, but not limited to the following: literature, records, notes, summaries, bank
`
`3
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 7 of 63 PageID
`Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 6 of 39 PageID #: 25904
`#: 32376
`
`records or statements, brochures, booklets, calendars, charts, coding forms, communications
`
`(intra-company or intercompany), compilations, data, databases, schedules, contracts, agreements,
`
`electronic mail, magnetic media of all kinds (including discs, tapes or other media), drawings,
`
`sketches, orders, acknowledgments, diaries, reports, memoranda of all conversations by or with
`
`any person, telephone messages, all other memoranda, letters, telegrams, telexes, facsimiles and
`
`cables prepared, drafted, received or sent, tapes, transcripts, and recordings, photographs, pictures,
`
`and films, computer programs and data, all other graphic, symbolic, recorded, and written
`
`materials of any nature, whatsoever, and any other documents and tangible items subject to
`
`discovery under the Federal Rules of Civil Procedure. Any document which contains any
`
`comment, notation, addition, insertion, or marking of any kind constitutes a document separate
`
`from the unmarked version.
`
`8.
`
`9.
`
`“Dosing Patents” means the ’196 patent, the ’379 patent, and the ’811 patent.
`
`“F. Hoffmann-La Roche Ltd.” or “Roche” means any and all corporate parents,
`
`divisions, subsidiaries, affiliates, agents, employees, consultants, predecessors, successors,
`
`predecessors-in-interest, successors-in-interest, representatives, all persons or entities currently or
`
`previously under their control, and all persons or entities currently or previously acting on their
`
`behalf,
`
`including without
`
`limitation Roche Holding AG, Roche Diagnostics, Roche
`
`Pharmaceuticals (“Roche Pharma”), Roche Pharmaceuticals Research and Early Development
`
`(pRED), Genentech Research and Early Development (gRED), Chugai, and any other corporate
`
`entity operating under the Roche name.
`
`10.
`
`“Genentech” means Genentech, Inc.; and F. Hoffmann-La Roche Ltd.,
`
`individually and collectively, and includes their officers, directors, partners, corporate parents,
`
`divisions, subsidiaries, affiliates, agents, employees, consultants, predecessors, successors,
`
`4
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 8 of 63 PageID
`Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 7 of 39 PageID #: 25905
`#: 32377
`
`predecessors-in-interest, successors-in-interest, representatives, all persons or entities currently or
`
`previously under their control, and all persons or entities currently or previously acting on their
`
`behalf.
`
`11.
`
`“Herceptin” or “Herceptin®” or “trastuzumab” means the anti-HER2/neu/ErbB2
`
`monoclonal antibody also known as trastuzumab, and includes any products or formulations
`
`comprising the monoclonal antibody known as trastuzumab.
`
`12.
`
`“Thing” means any tangible object, including without limitation devices, designs,
`
`plans, physical objects, samples, products, components, prototypes, models, specimens,
`
`photographs, and any audio, video, or digital recordings.
`
`13.
`
`14.
`
`“You” or “Your” means Brian R. Leyland-Jones.
`
`The connectors “and,” “or,” and “and/or” shall be construed either disjunctively
`
`or conjunctively as necessary in order to give the broadest meaning to the request.
`
`15.
`
`The use of the singular form of any word includes the plural and vice versa, and
`
`the past tense shall include the present tense and vice versa, as necessary, to bring within the scope
`
`of the discovery request all responses that might otherwise be construed to be outside of its scope.
`
`INSTRUCTIONS
`
`1.
`
`All Documents or Things requested herein shall be produced in the same sequence
`
`as they are contained or found and with the file folders and other identifying documents or
`
`containers (e.g., copy of envelope, file cabinet market, binder tab) in which such documents were
`
`located when these requests were served.
`
`2.
`
`If You object to a request, or any part of a request, please produce all documents to
`
`which Your objection does not apply.
`
`3.
`
`If any request, instruction, or definition is unclear to You, You are requested to
`
`5
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 9 of 63 PageID
`Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 8 of 39 PageID #: 25906
`#: 32378
`
`contact the undersigned counsel as soon as possible so that the request, instruction, or definition
`
`can be clarified to avoid unnecessary delays.
`
`4.
`
`You may designate documents, communications, things, or testimony under the
`
`Protective Order entered by the Court in this Litigation. See enclosure in Attachment B.
`
`DOCUMENTS AND THINGS TO BE PRODUCED
`
`1.
`
`All Documents and Things related to the conception, reduction to practice, design,
`
`and research and development of subject matter claimed in the Dosing Patents, including a two-
`
`or three-weekly dosing regimen for Herceptin.
`
`2.
`
`All Documents and Things relating to any proposed or actual clinical trials
`
`(including without limitation the trials coded as BO15935, WO16229, WO16982, and MO16419)
`
`involving dosing regimens of trastuzumab at intervals greater than one week, including, but not
`
`limited to, protocols, consent forms, agreements, efforts to publicize the trials, efforts to recruit
`
`patients, clinical trial brochures, and communications with enrolled patients or any other third
`
`parties.
`
`3.
`
`All Documents and Things relating to Your understanding of the pharmacokinetics
`
`of trastuzumab over time, including all documents and things relating to trastuzumab
`
`pharmacokinetics data and modeling of trastuzumab pharmacokinetics.
`
`4.
`
`All communications with Roche or Genentech concerning the subject matter of the
`
`Dosing Patents or the clinical trials references in Request No. 2, including without limitation
`
`communications with Sharon Baughman, Steven Shak, Robert Mass, or Rene Bruno.
`
`6
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 10 of 63 PageID
`Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 9 of 39 PageID #: 25907
`#: 32379
`
`ATTACHMENT B
`
`PROTECTIVE ORDER
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 11 of 63 PageID
`
`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 1 of 30 PageID # 3591Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 10 of 39 PageID #: 25908
`#: 32380
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`

`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 12 of 63 PageID
`
`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 2 of 30 PageID # 3592Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 11 of 39 PageID #: 25909
`#: 32381
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 13 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 F led 11/16/18 Page 3 of 30 PageID # 3593Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 12 of 39 PageID #: 25910
`#: 32382
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 14 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 4 of 30 PageID # 3594Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 13 of 39 PageID #: 25911
`#: 32383
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 15 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 5 of 30 PageID # 3595Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 14 of 39 PageID #: 25912
`#: 32384
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 16 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 6 of 30 PageID #: 3596Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 15 of 39 PageID #: 25913
`#: 32385
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 17 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 F led 11/16/18 Page 7 of 30 PageID # 3597Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 16 of 39 PageID #: 25914
`#: 32386
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 18 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 F led 11/16/18 Page 8 of 30 PageID # 3598Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 17 of 39 PageID #: 25915
`#: 32387
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 19 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 9 of 30 PageID #: 3599Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 18 of 39 PageID #: 25916
`#: 32388
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 20 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 10 of 30 PageID #: 3600Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 19 of 39 PageID #: 25917
`#: 32389
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 21 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 11 of 30 PageID #: 3601Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 20 of 39 PageID #: 25918
`#: 32390
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 22 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 12 of 30 PageID #: 3602Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 21 of 39 PageID #: 25919
`#: 32391
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 23 of 63 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 24 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 14 of 30 PageID #: 3604Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 23 of 39 PageID #: 25921
`#: 32393
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`Case 1:18-cv-00924-CFC-SRF Document 434-1 Filed 10/18/19 Page 25 of 63 PageID
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`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 15 of 30 PageID #: 3605Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 24 of 39 PageID #: 25922
`#: 32394
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