Case 1:18-cv-00924-CFC-SRF Document 139 Filed 04/16/19 Page 1 of 37 PageID #:
`16425
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE,
`
`Plaintiffs and Counterclaim
`Defendants,
`
`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 University of Florida.
`
`Dated:
`
`April 16, 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-SRF Document 139 Filed 04/16/19 Page 2 of 37 PageID #:
`16426
`
`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. and CITY OF HOPE,
`Plaintiff
`v.
`AMGEN INC.,
`
`Defendant
`
`SUBPOENA TO TESTIFY AT A DEPOSITION IN A CIVIL ACTION
`
`To:
`
`University of Florida, Attn: Amy M. Hass, 123 Tigert Hall, P.O. Box 113125, Gainesville, FL 32611-3125
`
`(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 ATTACHMENT B
`
`Place:
`
`Accurate Reporting & Video Services
`814 E Silver Springs Blvd # A,
`Ocala, FL 34470
`The deposition will be recorded by this method:
`
`Date and Time:
`
`04/29/2019 9:00 am
`
`Stenographer
`
`✔
`(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 ATTACHMENT 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:
`
`04/16/2019
`
`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:
`Orion Armon, oarmon@cooley.com, Cooley LLP, 380 Interlocken Crescent, Suite 900, Broomfield, CO 80021,
`720-566-4000
`
`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 139 Filed 04/16/19 Page 3 of 37 PageID #:
`16427
`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 139 Filed 04/16/19 Page 4 of 37 PageID #:
`16428
`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 139 Filed 04/16/19 Page 5 of 37 PageID #:
`16429
`
`ATTACHMENT A
`Pursuant to Rule 45 of the Federal Rules of Civil Procedure, Defendant Amgen Inc.
`hereby requests that University of Florida produce and permit inspection and copying of the
`following documents and things at the place, date and time specified in the accompanying
`subpoena.
`
`INSTRUCTIONS
`You should redact patient personal identifiers from documents, communications,
`1.
`and things before producing them.
`2.
`You may designate documents, communications, things, or testimony under the
`Protective Order entered by the Court in this Litigation. See enclosure in Attachment C.
`DOCUMENTS AND THINGS TO BE PRODUCED
`
`
`
`1. Redacted patient records regarding Herceptin® therapy administered to Jane Doe(s) prior
`to May 19, 2000, who were treated by Shahla Masood, MD (Associate Chair in Department
`of Pathology at University of Florida College of Medicine, Jacksonville, and Chief of
`Pathology and Laboratory Medicine at University Medical Center) after a diagnosis based
`on an immunohistochemistry (“IHC”) assay score of 0 or 1+ for HER-2/neu oncoprotein
`expression and a fluorescence in situ hybridization (“FISH”) assay score of positive, or
`gene amplified, for HER-2/neu gene amplification, including:
`a. Test results from IHC assays for HER-2/neu oncoprotein expression performed on
`tissue from biopsy of patient and preliminary diagnoses relating to breast cancer;
`b. Test results from FISH assays for HER-2/neu gene amplification performed on
`tissue from biopsy of the patient and preliminary diagnoses relating to breast
`cancer; and
`c. Patient diagnosis and Herceptin® therapy for breast cancer subsequent to reports
`of IHC and FISH assays.
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 139 Filed 04/16/19 Page 6 of 37 PageID #:
`16430
`
`
`
`
`
`
`
`ATTACHMENT B
`Pursuant to Rules 30 and 45 of the Federal Rules of Civil Procedure, Defendant Amgen
`Inc. hereby requests the deposition of University of Florida covering the following topics.
`DEPOSITION TOPICS
`
`1. The authentication of any patient records of Jane Doe(s) produced pursuant to the
`accompanying Subpoena for Documents and Things.
`
`2. Dr. Masood’s diagnosis and treatment of breast cancer patients with Herceptin® prior to
`May 19, 2000, after receiving IHC 0 or 1+ and FISH + scores.
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 139 Filed 04/16/19 Page 7 of 37 PageID #:
`16431
`
`ATTACHMENT C
`
`PROTECTIVE ORDER
`
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 139 Filed 04/16/19 Page 8 of 37 PageID #:
`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 1 of 30 PageID #: 3591
`16432
`
`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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`16433
`
`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
`
`2
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 139 Filed 04/16/19 Page 10 of 37 PageID
`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 3 of 30 PageID #: 3593
`#: 16434
`
`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
`
`3
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 139 Filed 04/16/19 Page 11 of 37 PageID
`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 4 of 30 PageID #: 3594
`#: 16435
`
`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.
`
`12.
`
`"Prosecution" means directly, indirectly, or otherwise participating in (a) the
`
`drafting of, amending of, or advising on any patent or patent application anywhere in the
`
`world, including the drafting of, amending of, advising on, or otherwise affecting the scope
`
`or maintenance of patent claims, and (b) the amendment or addition of claims in any
`
`proceeding (e.g., an inter part es review proceeding, post-grant review proceeding,
`
`reexamination, reissue, covered business method review proceeding, or any similar
`
`proceeding.)
`
`13.
`
`"Prosecution Bar Patent or Application" means any patent or application (a) to
`
`which any of the patents-in-suit in this Litigation assert priority, or which asserts priority to any of
`
`the patents-in-suit, or which asserts priority to an application or patent to which any of the
`
`patents-in-suit assert priority; (b) is a foreign counterpart of any patent or application defined in (a)
`
`of this Paragraph; (c) that concerns in whole or in part trastuzumab, including without limitation
`
`developing, making, purifying, manufacturing, formulating, using or administering any product,
`
`formulation or composition that contains trastuzumab, including without limitation methods of
`
`treating any disease or medical condition; or (d) that concerns in whole or in part subject matter
`
`related to the patents identified on Genentech's list under 42 U.S.C. § 262(/)(3)(A), including
`
`without limitation as supplemented pursuant to 42 U.S.C. § 262(/)(7).
`
`ME I 28563694v. l
`
`4
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 139 Filed 04/16/19 Page 12 of 37 PageID
`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 5 of 30 PageID #: 3595
`#: 16436
`
`14.
`
`"Protective Order" means this Stipulated Protective Order.
`
`15.
`
`"Receiving Party" means any Party that receives information produced or
`
`otherwise disclosed by any Producing Party.
`
`16.
`
`"Related Litigation" means any additional litigation or adversarial proceeding
`
`( including without limitation reexaminations, inter part es reexaminations, reissues, covered
`
`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
`
`appeals, between any of the Parties that involves the infringement, validity or enforceability of the
`
`patents-in-suit or a Prosecution Bar Patent or Application.
`
`17.
`
`"Third Party'' means a person or entity that is not a Party.
`
`DESIGNATION
`
`18.
`
`Any Producing Party may designate Discovery Material as CONFIDENTIAL in
`
`accordance with this Protective Order if such Party in good faith believes that such Discovery
`
`Material contains CONFIDENTIAL information as defined above.
`
`19.
`
`Discovery Material may, as appropriate, be marked by the Producing Party with the
`
`legend "CONFIDENTIAL" in conjunction with the identity of the Producing Party, or another
`
`suitable legend, and the Producing Party must use reasonable efforts to ensure that such legend
`
`appears on each page of each document or file as the format permits. In the case of computer
`
`media, the designation shall be placed on the medium and its label and/or cover. In the case of files
`
`produced in native format, the designation shall be included in the accompanying metadata and/or
`
`in the file's name.
`
`20.
`
`Information revealed by inspection of things and premises under Fed. R. Civ. P. 34
`
`shall be treated as though it were designated CONFIDENTIAL provided that prior to, or at any
`
`time up to, thirty days (as calculated by Fed. R. Civ. P. 6) after the inspection, the Party permitting
`
`ME 1 28563694v. l
`
`5
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 139 Filed 04/16/19 Page 13 of 37 PageID
`Case 1:18-cv-00924-CFC Document 47 Filed 11/16/18 Page 6 of 30 PageID #: 3596
`#: 16437
`
`inspection specifically identifies in writing which of the Discovery Material that will be or that was
`
`disclosed by the inspection is to be designated as CONFIDENTIAL. There will be no waiver of
`
`confidentiality, or any privilege or immunity, by the inspection of Discovery Material before it is
`
`copied and marked pursuant to this Order. Inspection of Discovery Material by any Party shall be
`
`conducted by persons eligible under Paragraph 28.
`
`21.
`
`Documents and things produced or made available for inspection may be subject to
`
`redaction, in good faith by the Producing Party, of information that is (a) subject to the
`
`attorney-client privilege, to work-product immunity, or any other applicable privilege or
`
`immunity; (b) protected data, including (i) individually identifiable health information, (ii)
`
`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
`
`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
`
`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
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`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
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`labeled "Redacted - Privileged," "Redacted - Protected Data" as appropriate. This Paragraph
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`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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`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 CONFIDENTIAL.
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`Counsel for any Party or Third Party also may designate the transcript or portions thereof to be
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`CONFIDENTIAL Discovery Material during the deposition. The appropriate legend described in
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`Paragraph 19 shall be placed on the front of any deposition transcript (and, if recorded, any copies
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`of the recording) containing CONFIDENTIAL Discovery Material.
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`23.
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`Any court filing that contains, describes, or discusses CONFIDENTIAL Discovery
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`Material shall be filed under seal pursuant to the requirements of District ofDelaware Local Rule
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`5.1.3, the Court's CM/ECF Procedures, and any other applicable rules or procedures. The filing
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`Party must include on the cover page of the brief or other filing a descriptive legend in the
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`following
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`format: "CONTAINS PLAINTIFFS' CONFIDENTIAL INFORMATION" or
`
`"CONTAINS DEFENDANT'S CONFIDENTIAL
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`INFORMATION" or "CONTAINS
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`PLAINTIFFS' AND DEFENDANT'S CONFIDENTIAL INFORMATION" or another suitable
`
`legend. The sealed material shall not be opened or released from the custody of the Clerk of Court
`
`except by order of the Court. Outside Counsel for the Party filing papers containing, describing, or
`
`discussing CONFIDENTIAL Discovery Material shall be responsible for providing appropriately
`
`redacted copies of the filed document to the Court in accordance with any local rules or
`
`procedures. If the filing contains the CONFIDENTIAL Discovery Material of the Party who did
`
`not file the document, within four (4) days from the date of a filing made under seal, Outside
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`Counsel for the filing Party or filing Third Party shall deliver to Outside Counsel for the non-filing
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`ME 1 28563694v. l
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`Party or Third Party a proposed public version of the filing that was made under seai and this
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`proposed public version shall include redactions of CONFIDENTIAL or Discovery Material.
`
`Within three (3) days after receipt of the proposed public version, Outside Counsel for the
`
`non-filing Party shall provide any additional redactions it believes appropriate. Redacted versions
`
`of papers filed under seal may be made publicly available provided that (a) all CONFIDENTIAL
`
`Discovery Material is redacted; and (b) such redacted versions are clearly marked "Public
`
`Version," and clearly identify each place where information or exhibits have been redacted or
`
`deleted. A Party shall not disclose another Party's CONFIDENTIAL Discovery Material in a
`
`public hearing or at trial absent either (a) advance notice to the other Party to enable the Party to
`
`seek appropriate relief from the Court in the form of an order sealing the courtroom or otherwise;
`
`or (b) an order of the Court.
`
`USE
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`24.
`
`CONFIDENTIAL Discovery Material produced by a Party or Third Party may be
`
`used by a Receiving Party only for purposes of this Litigation or future United States patent
`
`infringement litigation between the Parties arising from Amgen's filing of Biologics License
`
`Application for ABP 980. CONFIDENTIAL Discovery Material shall not be used for any other
`
`purpose including, but not limited to, any other lawsuit; Prosecution; any dispute resolution
`
`proceeding unrelated to this Litigation; any petitioning, counseling, or litigation; or for any other
`
`business, proprietary, commercial, governmental, or regulatory purpose, domestic or foreign.
`
`Nothing in this Protective Order precludes a Producing Party from using or disseminating its own
`
`Discovery Material, including CONFIDENTIAL Discovery Material, for purposes other than this
`
`Litigation.
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`ME I 28563694v. l
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`25.
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`During the deposition or trial testimony of any fact witness, such witness may be
`
`shown, testify concerning, or be examined concerning CONFIDENTIAL Discovery Material only
`
`if:
`
`(a)
`
`the witness is a current employee of the Producing Party;
`
`(b)
`
`the witness authored the CONFIDENTIAL Discovery Material or the
`
`witness received the CONFIDENTIAL Discovery Material in the ordinary
`
`course ofbusiness and outside the context of this Litigation; or
`
`(c)
`
`the witness is a former director, officer, agent and/or employee of a
`
`Producing Party and the examining Party reasonably believes the witness
`
`had access to the CONFIDENTIAL Discovery Material in the course of his
`
`or her employment and outside the context of this litigation.
`
`26.
`
`At the deposition of any corporate representative designated pursuant to Fed. R.
`
`Civ. P. 30(b)(6) to testify on behalf of a Party on a particular topic or subject area, such witness
`
`may be shown CONFIDENTIAL Dis