AO 88B (Rev. 02/14) Subpoena to Produce Documents, Information, or Objects or to Permit Inspection of Premises in a Civil Action
`
`UNITED STATES DISTRICT COURT
`for the
`__________ District of __________
`
`Civil Action No.
`
`))))))
`
`Plaintiff
`v.
`
`Defendant
`
`SUBPOENA TO PRODUCE DOCUMENTS, INFORMATION, OR OBJECTS
`OR TO PERMIT INSPECTION OF PREMISES IN A CIVIL ACTION
`
`To:
`
`(Name of person to whom this subpoena is directed)
`’ Production: YOU ARE COMMANDED to produce at the time, date, and place set forth below the following
`documents, electronically stored information, or objects, and to permit inspection, copying, testing, or sampling of the
`material:
`
`Place:
`
`Date and Time:
`
`’ Inspection of Premises: YOU ARE COMMANDED to permit entry onto the designated premises, land, or
`other property possessed or controlled by you at the time, date, and location set forth below, so that the requesting party
`may inspect, measure, survey, photograph, test, or sample the property or any designated object or operation on it.
`
`Place:
`
`Date and Time:
`
`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
`
`The name, address, e-mail address, and telephone number of the attorney representing (name of party)
`, who issues or requests this subpoena, are:
`
`Notice to the person who issues or requests this subpoena
`If this subpoena commands the production of documents, electronically stored information, or tangible things or the
`inspection of premises before trial, 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).
`
`District of New Jersey
`
`ADAPT PHARMA OPERATIONS LIMITED ET AL.
`
`2:16-cv-07721 (consolidated)
`
`TEVA PHARMACEUTICALS USA, INC. and
`TEVA PHARMACEUTICALS INDUSTRIES LTD.
`
`Indivior, Inc., c/o CORPORATION SERVICE COMPANY
`251 LITTLE FALLS DRIVE, WILMINGTON, DE 19808
`
`4
`
`See Schedule A, attached hereto.
`
`SHAW KELLER LLP
`1105 N Market St
`Wilmington, DE 19801
`
`02/08/2019 9:00 am
`
`01/11/2019
`
`/s/ Michael Bruns
`
`Teva
`
`Pharmaceuticals, Inc. and Teva Pharmaceuticals Industries, Ltd.
`
`Michael Bruns, STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C., 1100 New York Avenue NW, Suite 600,
`Washington D.C. 20005. mbruns@sternekessler.com. (202) 371-2600
`
`Opiant Exhibit 2194
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 1
`
`

`

`AO 88B (Rev. 02/14) Subpoena to Produce Documents, Information, or Objects or to Permit Inspection of Premises in a Civil Action (Page 2)
`
`Civil Action No.
`
`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)
`
`’ I served the subpoena by delivering a copy to the named person as follows:
`
`’ 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 $
`
`.
`
`.
`
`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
`
`2:16-cv-07721 (consolidated)
`
`0.00
`
`Opiant Exhibit 2194
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 2
`
`

`

`AO 88B (Rev. 02/14) Subpoena to Produce Documents, Information, or Objects or to Permit Inspection of Premises in a Civil Action(Page 3)
`
`(c) Place of Compliance.
`
`Federal Rule of Civil Procedure 45 (c), (d), (e), and (g) (Effective 12/1/13)
` (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.
`
` (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:
`(i) disclosing a trade secret or other confidential research,
`development, or commercial information; or
`
`(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).
`
`Opiant Exhibit 2194
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 3
`
`

`

`
`
`SCHEDULE A
`
`INSTRUCTIONS
`
`1.
`
`These requests shall apply to all documents and things in your possession,
`
`custody, or control at the present time, or coming into your possession, custody, or control before
`
`the return date of the subpoena.
`
`2.
`
`If no documents are responsive to a particular request, please confirm that no
`
`responsive documents exist by a written statement to that effect.
`
`3.
`
`If you decline to produce any document or part thereof based on a claim of
`
`privilege or any other claim in accordance with Rule 45(e)(2) of the Federal Rules of Civil
`
`Procedure, describe the nature and basis of the claim and the information withheld in a manner
`
`sufficient:
`
`A.
`
`B.
`
`to disclose the facts upon which you rely in asserting the claim;
`
`to permit the grounds and reasons for withholding the information to be
`
`identified unambiguously; and
`
`C.
`
`to permit the information withheld to be identified unambiguously.
`
`4. All documents requested are to be produced in the same file or other organizational
`
`environment in which they are maintained. For example, a document that is part of a file, docket,
`
`or other grouping, should be physically produced together with all other documents from said
`
`file, docket, or grouping, in the same order or manner of arrangement as the original.
`
`5. If any documents are kept electronically, those documents should be produced
`
`electronically along with their corresponding original file name. If any documents are in a text
`
`searchable format, those documents should be produced in a text-searchable format.
`
`
`
`Opiant Exhibit 2194
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 4
`
`

`

`
`
`DEFINITIONS
`
`The following terms and definitions shall apply to the requests for documents and things
`
`identified below (“Requests”):
`
`1.
`
`The terms “document” or “documents” are used in a comprehensive sense
`
`as set forth in Federal Rule of Civil Procedure 45(a) and shall mean all written or graphic matter,
`
`however produced or reproduced, in your actual or constructive possession, custody, care or
`
`control, including, but not limited to, originals (or copies where originals are unavailable) of
`
`correspondence, e-mail, computer storage media, computer software needed to produce in
`
`human-readable form from said computer storage media, instructions for using said computer
`
`software, telegrams, notes or sound recordings of any type of personal or telephone
`
`conversations, or of meetings or conferences, minutes of directors or committee meetings,
`
`memoranda, inter-office communications, studies, analyses, reports, engineering drawings,
`
`results of investigations, catalogs, contracts, licenses, agreements, working papers, statistical
`
`records, ledgers, books of account, vouchers, invoices, charge slips, freight bills, time sheets or
`
`logs, stenographers’ notebooks, diaries, or papers similar to any of the foregoing however
`
`denominated. “Documents” also shall mean (1) any copy which is not identical to the original or
`
`to any other copy and (2) any tangible thing that is called for by or identified in response to a
`
`Request for documents. A draft or non-identical copy is a separate document within the meaning
`
`of this term.
`
`2.
`
`The terms “and” and “or” shall be construed both conjunctively and disjunctively
`
`and the plural shall be construed as the singular, and vice versa, as necessary and in order to
`
`bring within the scope of these Requests any information, documents, or things that might
`
`otherwise be construed to be outside their scope.
`
`
`
`Opiant Exhibit 2194
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 5
`
`

`

`
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`3.
`
`The term “all” shall mean all or any, and the term “any” shall mean all or any;
`
`“any” shall mean one or more.
`
`4.
`
`The use of the past tense shall include the present tense, and the use of the present
`
`tense shall include the past tense, so as to make the Request inclusive rather than exclusive.
`
`5.
`
`The singular includes the plural, and vice versa, so as to make the Request
`
`inclusive rather than exclusive.
`
`
`
`
`
` REQUEST NO. 1:
`
`REQUESTS FOR PRODUCTION
`
`The Complete Response Letter received from the FDA concerning Indivior, Inc.’s New
`
`Drug Application for an intranasal naloxone hydrochloride product (“Indivior’s NDA”).
`
`
`
` REQUEST NO. 2:
`
`Documents from Indivior’s NDA sufficient to show the formulation and delivery device
`
`of the subject intranasal naloxone hydrochloride product.
`
`
`
` REQUEST NO. 3:
`
`The Pharmaceutical Development Report from Indivior’s NDA.
`
`
`
` REQUEST NO. 4:
`
`Documents from Indivior’s NDA sufficient to show summary pharmacokinetic properties
`
`of the subject intranasal naloxone hydrochloride product, including but limited to Cmax, AUC,
`
`and Tmax after administration to human subjects.
`
`
`
` REQUEST NO. 5:
`
`Documents from Indivior’s NDA sufficient to show the spray characteristics of the
`
`subject intranasal naloxone hydrochloride product, including the ovality ratio, droplet size
`
`distribution, and percentage of droplets with a diameter less than 10 microns.
`
`
`
`Opiant Exhibit 2194
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 6
`
`

`

`
`
`
`
` REQUEST NO. 6:
`
`Documents sufficient to show the formulation and delivery device for “NALSCUE®”
`
`that is sold or distributed by or on behalf of Indivior, Inc. in Europe.
`
`
`
`Opiant Exhibit 2194
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 7
`
`