Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 1 of 39 PageID #: 25899
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC.,
`
`Plaintiff and Counterclaim
`Defendant,
`
`Case No. 1:18-cv-00924-CFC
`
`v.
`AMGEN INC.,
`
`Defendant and Counterclaim
`Plaintiff.
`
`NOTICE OF SUBPOENA
`
`TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:
`
`PLEASE TAKE NOTICE that pursuant to Rules 30 and 45 of the Federal Rules of
`
`Civil Procedure, Amgen will cause the attached subpoena to be served on Brian Leyland-Jones.
`
`Dated:
`
` July 30, 2019
`
`SMITH, KATZENSTEIN & JENKINS, LLP
`/s/ Eve H. Ormerod
`
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`Attorneys for Defendant Amgen Inc.
`
`

`

`Case 1:18-cv-00924-CFC Document 336 Filed 07/30/19 Page 2 of 39 PageID #: 25900
`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.
`
`Case No. 1:18-cv-00924-CFC
`
`))))))
`
`GENENTECH, INC.,
`Plaintiff
`v.
`AMGEN INC.,
`
`Defendant
`
`SUBPOENA TO TESTIFY AT A DEPOSITION IN A CIVIL ACTION
`
`To:
`
`Brian Leyland-Jones, 308 W Devitt Drive, Sioux Falls, SD 57108
`
`(Name of person to whom this subpoena is directed)
`✔Testimony: YOU ARE COMMANDED to appear at the time, date, and place set forth below to testify at a
`(cid:117)
`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:
`
`Place:
`
`Cooley LLP
`55 Hudson Yards, New York, NY 10001-2157
`
`Date and Time:
`
`August 8th, 2019 at 10:00 am
`
`The deposition will be recorded by this method:
`
`Stenographer and Videographer
`
`✔
`(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 ATTACHMENTS A AND B
`
`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:
`
`CLERK OF COURT
`
`OR
`
`Signature of Clerk or Deputy Clerk
`
`Attorney’s signature
`
`Amgen Inc.
`The name, address, e-mail address, and telephone number of the attorney representing (name of party)
`, who issues or requests this subpoena, are:
`Daniel J. Knauss, dknauss@cooley.com, Cooley LLP, 3175 Hanover Street, Palo Alto, CA 94304, 650-843-5000
`
`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 Document 336 Filed 07/30/19 Page 3 of 39 PageID #: 25901
`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 Document 336 Filed 07/30/19 Page 4 of 39 PageID #: 25902
`
`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 Document 336 Filed 07/30/19 Page 5 of 39 PageID #: 25903
`
`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 Document 336 Filed 07/30/19 Page 6 of 39 PageID #: 25904
`
`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 Document 336 Filed 07/30/19 Page 7 of 39 PageID #: 25905
`
`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 Document 336 Filed 07/30/19 Page 8 of 39 PageID #: 25906
`
`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 Document 336 Filed 07/30/19 Page 9 of 39 PageID #: 25907
`Case 1:18—cv-00924-CFC Document 336 Filed 07/30/19 Page 9 of 39 PageID #: 25907
`
`ATTACHMENT B
`ATTACHMENT B
`
`PROTECTIVE ORDER
`
`PROTECTIVE ORDER
`
`7
`
`

`

`
`
`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
`
`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
`
`

`

`
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`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
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`scientific and technical information; product information; financial, budgeting and/or accounting
`
`information; information about existing and potential customers; marketing and other business
`
`strategies, decisions, or negotiations; and personnel compensation, evaluations, and other
`
`employment information; information received from a Third Party pursuant to a confidentiality,
`
`non-disclosure or similar agreement; and includes such confidential and proprietary information
`
`about a Third Party, including parents, subsidiaries, and/or other Affiliates. Confidential
`
`information also includes Protected Health Information, which means any information that a party
`
`believes in good faith to be subject to the Health Insurance Portability and Accountability Act and
`
`the regulations thereunder, 45 CFR Part 160 and Subparts A and E of Part 164. Protected Health
`
`Information includes, but
`
`is not limited to, health information, including demographic
`
`information, relating to either, (a) the past, present or future physical or mental condition of an
`
`individual, (b) the provision of care to an individual, or ( c) the payment for care provided to an
`
`individual, which identifies the individual or which reasonably could be expected to identify the
`
`individual. Provisions of this Protective Order relating to CONFIDENTIAL information shall be
`
`understood to encompass any information derived from, as well as testimony and oral
`
`conversation related to, CONFIDENTIAL information, and all copies, excerpts, and summaries
`
`thereof.
`
`3.
`
`"CONFIDENTIAL Discovery Material" means Discovery Material a Producing
`
`Party designates as CONFIDENTIAL pursuant to the terms of this Protective Order, as well as
`
`information provided by a Party pursuant to 42 U.S.C. § 262(/)(1) and 42 U.S.C. § 262(/)(2).
`
`4.
`
`"Designated Inside Counsel" means an Inside Counsel who is designated during
`
`this Litigation pursuant to Paragraph 28(b) of this Protective Order.
`
`MEI 28563694v.l
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`2
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`

`
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`Case 1:18-cv-00924-CFC Document 47 Filed 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
`
`5.
`
`"Discovery Material" means all documents, testimony, pleadings, exhibits, and all
`
`other material or information produced or disclosed in this Litigation, including responses to
`
`requests for production of documents and/or things, answers to interrogatories, responses to
`
`requests for admissions, documents and things made available for inspection, deposition
`
`testimony, expert testimony and reports, and all other discovery taken pursuant to the Federal
`
`Rules of Civil Procedure, including Third Party discovery pursuant to Fed. R. Civ. P. 45, matters in
`
`evidence and any other information hereafter furnished, directly or indirectly, by or on behalf of
`
`any Party, Third Party, or witness in connection with this Litigation. This Protective Order and
`
`protections herein shall apply to all Discovery Material.
`
`6.
`
`"Expert" means a person with specialized knowledge or experience in a matter
`
`pertinent to this Litigation who has been retained by a Party or its Inside or Outside Counsel to
`
`serve as an expert witness or as a consultant in this Litigation who, at the time of retention, is not an
`
`officer, director, or employee ofa Party or an Affiliate and is not anticipated to become an officer,
`
`director, or employee of a Party or an Affiliate. Nothing in this Protective Order purports to alter
`
`in any way the requirements for offering testimony under Fed. R. Evid. 703, or to define the term
`
`"expert" for purposes other than those addressed in this Protective Order.
`
`7.
`
`"Inside Counsel" means any United States attorney who works in the legal
`
`department of a Party and who is admitted to practice in the United States.
`
`8.
`
`"Outside Counsel" means any attorney from a law firm that has at least one
`
`attorney who has made a formal appearance as counsel of record for a Party in this Litigation and
`
`who is not an employee of a Party or ofan Affiliate as of the date of entry of this Order.
`
`9.
`
`"Party'' means a party to this Litigation.
`
`MEI 28563694v.l
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`3
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`

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`
`10.
`
`"Producing Party'' means any Party or any Third Party who produces or otherwise
`
`discloses, whether through formal or informal means, Discovery Material in this Litigation.
`
`11.
`
`"Professional Vendor(s)" means persons or entities that provide litigation support
`
`services (e.g., photocopying, audio or video recording, translating, preparing exhibits or
`
`demonstrations, and organizing, storing, or retrieving data in any form or medium; jury consulting,
`
`mock trial coordination) and their employees and subcontractors.
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`12.
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`"Prosecution" means directly, indirectly, or otherwise participating in (a) the
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`drafting of, amending of, or advising on any patent or patent application anywhere in the
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`world, including the drafting of, amending of, advising on, or otherwise affecting the scope
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`or maintenance of patent claims, and (b) the amendment or addition of claims in any
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`proceeding (e.g., an inter part es review proceeding, post-grant review proceeding,
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`reexamination, reissue, covered business method review proceeding, or any similar
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`proceeding.)
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`13.
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`"Prosecution Bar Patent or Application" means any patent or application (a) to
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`which any of the patents-in-suit in this Litigation assert priority, or which asserts priority to any of
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`the patents-in-suit, or which asserts priority to an application or patent to which any of the
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`patents-in-suit assert priority; (b) is a foreign counterpart of any patent or application defined in (a)
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`of this Paragraph; (c) that concerns in whole or in part trastuzumab, including without limitation
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`developing, making, purifying, manufacturing, formulating, using or administering any product,
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`formulation or composition that contains trastuzumab, including without limitation methods of
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`treating any disease or medical condition; or (d) that concerns in whole or in part subject matter
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`related to the patents identified on Genentech's list under 42 U.S.C. § 262(/)(3)(A), including
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`without limitation as supplemented pursuant to 42 U.S.C. § 262(/)(7).
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`ME I 28563694v. l
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`14.
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`"Protective Order" means this Stipulated Protective Order.
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`15.
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`"Receiving Party" means any Party that receives information produced or
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`otherwise disclosed by any Producing Party.
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`16.
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`"Related Litigation" means any additional litigation or adversarial proceeding
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`( including without limitation reexaminations, inter part es reexaminations, reissues, covered
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`business method review proceedings, inter partes review proceedings, and post grant review
`
`proceedings, in the United States or any similar proceedings in any foreign country), including any
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`appeals, between any of the Parties that involves the infringement, validity or enforceability of the
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`patents-in-suit or a Prosecution Bar Patent or Application.
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`17.
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`"Third Party'' means a person or entity that is not a Party.
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`DESIGNATION
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`18.
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`Any Producing Party may designate Discovery Material as CONFIDENTIAL in
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`accordance with this Protective Order if such Party in good faith believes that such Discovery
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`Material contains CONFIDENTIAL information as defined above.
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`19.
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`Discovery Material may, as appropriate, be marked by the Producing Party with the
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`legend "CONFIDENTIAL" in conjunction with the identity of the Producing Party, or another
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`suitable legend, and the Producing Party must use reasonable efforts to ensure that such legend
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`appears on each page of each document or file as the format permits. In the case of computer
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`media, the designation shall be placed on the medium and its label and/or cover. In the case of files
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`produced in native format, the designation shall be included in the accompanying metadata and/or
`
`in the file's name.
`
`20.
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`Information revealed by inspection of things and premises under Fed. R. Civ. P. 34
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`shall be treated as though it were designated CONFIDENTIAL provided that prior to, or at any
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`time up to, thirty days (as calculated by Fed. R. Civ. P. 6) after the inspection, the Party permitting
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`ME 1 28563694v. l
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`inspection specifically identifies in writing which of the Discovery Material that will be or that was
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`disclosed by the inspection is to be designated as CONFIDENTIAL. There will be no waiver of
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`confidentiality, or any privilege or immunity, by the inspection of Discovery Material before it is
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`copied and marked pursuant to this Order. Inspection of Discovery Material by any Party shall be
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`conducted by persons eligible under Paragraph 28.
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`21.
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`Documents and things produced or made available for inspection may be subject to
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`redaction, in good faith by the Producing Party, of information that is (a) subject to the
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`attorney-client privilege, to work-product immunity, or any other applicable privilege or
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`immunity; (b) protected data, including (i) individually identifiable health information, (ii)
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`information from any jurisdiction outside the United States that pertains to a specific individual
`
`that can be linked to that individual and that reveals race, ethnic origin, sexual orientation, political
`
`opinions, religious or philosophical beliefs, trade union or political party membership or that
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`concerns an individual's health, and (iii) sensitive proprietary information concerning antibodies
`
`or small molecules not relevant/responsive to the issues in this Litigation that the Producing Party
`
`claims requires protections under the terms of this Order; or ( c) information in a license agreement
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`or settlement agreement concerning U.S. Patent Nos. 6,331,415 or 7,923,221 that would tend to
`
`identify the counterparty to such agreement. For avoidance of doubt, no information may be
`
`redacted or withheld on relevance grounds if it directly relates to the patents-in-suit, trastuzumab,
`
`or any trastuzumab biosimilar product. Each such redaction, regardless of size, shall be clearly
`
`labeled "Redacted - Privileged," "Redacted - Protected Data" as appropriate. This Paragraph
`
`shall not be construed as a waiver of any Party's right to seek disclosure ofredacted information.
`
`22.
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`Information of a Producing Party revealed during a deposition upon oral or written
`
`examination under Fed. R. Civ. P. 30 shall be treated as CONFIDENTIAL by a Receiving Party
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`MEI 28563694v.1
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`6
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`during and following the deposition, and for thirty days (as calculated by Fed. R. Civ. P. 6)
`
`following receipt of the final transcript by Outside Counsel for the Producing Party, but not
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`thereafter unless, before the thirty day period has expired, Outside Counsel or Inside Counsel for
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`the Producing Party notifies Outside Counsel or Designated Inside Counsel for the Receiving
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`Party in writing that the Discovery Material set forth in the transcript is CONFIDE