United States of America ex rel. Steven M. Camburn et al. v. Novartis Pharmaceuticals Corporation

Filing 61

STIPULATED CONFIDENTIALITY AGREEMENT AND PROTECTIVE ORDER...regarding procedures to be followed that shall govern the handling of confidential material... (Signed by Magistrate Judge Gabriel W. Gorenstein on 9/24/2020) (va)

Case 1:13-cv-03700-KMW-GWG Document 60 Filed 09/24/20 Page 1 of 13

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF NEW YORK
UNITED STATES OF AMERICA; the States of
CALIFORNIA, COLORADO, CONNECTICUT,
DELAWARE, FLORIDA, GEORGIA, HAWAII,
ILLINOIS, INDIANA, IOWA, LOUISIANA,
MASSACHUSETTS, MICHIGAN,
MINNESOTA, MONTANA, NEVADA, NEW
JERSEY, NEW MEXICO, NEW YORK, NORTH
CAROLINA, OKLAHOMA, RHODE ISLAND,
TENNESSEE, TEXAS, VIRGINIA, WASHINGTON
and WISCONSIN; the DISTRICT OF COLUMBIA,
THE CITY OF CHICAGO and THE CITY OF NEW
YORK; ex rel., STEVEN M. CAMBURN
Plaintiffs and Relator,

No. 13 Civ. 3700 (KMW)
STIPULATED
CONFIDENTIALITY
AGREEMENT AND
PROTECTIVE ORDER

vs.
NOVARTIS PHARMACEUTICALS CORPORATION,
Defendant.

THE HONORABLE GABRIEL W. GORENSTEIN, UNITED STATES MAGISTRATE JUDGE:
WHEREAS, all of the parties to this action (collectively, the “Parties” and each
individually, a “Party”) request that this Court issue a protective order pursuant to Federal Rule
of Civil Procedure 26(c) to protect the confidentiality of nonpublic and competitively sensitive
information that they may need to disclose in connection with discovery in this action or that
they may otherwise produce or disclose to the opposing Party;
WHEREAS, the Parties, through their counsel, as evidenced by their signatures below,
agree to the following terms; and

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WHEREAS, this Court finds that good cause exists for issuance of an appropriately
tailored confidentiality order governing the pretrial phase of this action;
IT IS HEREBY ORDERED that the Parties to this action, their respective officers,
agents, servants, employees, and attorneys, any other person in active concert or participation
with any of the foregoing, and all other persons with actual notice of this Order will adhere to the
following terms, upon pain of contempt:
1.

With respect to “Discovery Material” (i.e., information of any kind

produced or disclosed in the course of discovery or otherwise in this action) that a person has
designated as “Confidential” pursuant to this Order, no person subject to this Order may disclose
such Confidential Discovery Material to anyone else except as expressly permitted hereunder:
2.

The Party or person producing or disclosing Discovery Material (each,

“Producing Party”) may designate as Confidential only the portion of such material that it
reasonably and in good faith believes consists of:
(a)

previously non-disclosed1 financial information (including without
limitation profitability reports or estimates, percentage fees, design fees,
royalty rates, minimum guarantee payments, sales reports, and sale
margins);

(b)

previously non-disclosed material relating to ownership or control of any
non-public company;

(c)

previously non-disclosed business plans, product-development
information, or marketing plans;

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For purposes of this protective order, previously non-disclosed information includes information disclosed under
seal or pursuant to a protective order.

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(d)

previously non-disclosed information related to formulas, patterns,
programs, plans, devices, methods, techniques, or processes used for the
preparing, manufacturing, or processing of pharmaceutical or biological
products;

(e)

any information protected from disclosure by applicable trade secrets law,
including the Uniform Trade Secrets Act (adapted by the vast majority of
states) and the Defend Trade Secrets Act (18 U.S.C. § 1839);

(f)

health care information subject to protection under the Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”), Privacy Rule, 45
C.F.R. §§ 160 and 164, and/or other applicable state or federal law
concerning confidential health information;

(g)

personal data subject to protection under the General Data Protection
Regulation (GDPR) and/or other applicable foreign national data
protection laws;

(h)

a trade secret or other confidential research, development or information;

(i)

any information of a personal or intimate nature regarding any individual;
or

(j)

any other category of information given confidential status by this Court
after the date of this Order.
Information to be treated as “Confidential” under this order includes all

materials labeled as confidential that have been produced to the United States Attorney’s Office
for the Southern District of New York in response to any Civil Investigative Demand or
subpoenas in connection with the investigation related to this action.

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3.

With respect to the Confidential portion of any Discovery Material other

than deposition transcripts and exhibits, the Producing Party or its counsel may designate such
portion as “Confidential” by: (a) stamping or otherwise clearly marking as “Confidential” the
protected portion in a manner that will not interfere with legibility or audibility; and
(b) producing for future public use another copy of said Discovery Material with the confidential
information redacted.
4.

A Producing Party or its counsel may designate deposition exhibits or

portions of deposition transcripts as Confidential Discovery Material either by: (a) indicating on
the record during the deposition that a question calls for Confidential information, in which case
the reporter will bind the transcript of the designated testimony in a separate volume and mark it
as “Confidential Information Governed by Protective Order;” or (b) notifying the reporter and all
counsel of record, in writing, within 30 days after a deposition has concluded, of the specific
pages and lines of the transcript that are to be designated “Confidential,” in which case all
counsel receiving the transcript will be responsible for marking the copies of the designated
transcript in their possession or under their control as directed by the Producing Party or that
person’s counsel. During the 30-day period following a deposition, all Parties will treat the
entire deposition transcript as if it had been designated Confidential.
5.

If at any time before the termination of this action a Producing Party

realizes that it should have designated as Confidential some portion(s) of Discovery Material that
it previously produced without limitation, the Producing Party may so designate such material by
notifying all Parties in writing. Thereafter, all persons subject to this Order will treat such
designated portion(s) of the Discovery Material as Confidential.

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6.

Nothing contained in this Order will be construed as: (a) a waiver by a

Party or person of its right to object to any discovery request; (b) a waiver of any privilege or
protection; or (c) a ruling regarding the admissibility at trial of any document, testimony, or other
evidence.
7.

Where a Producing Party has designated Discovery Material as

Confidential, other persons subject to this Order may disclose such information only to the
following persons:
(a)

the Parties to this action, their insurers and their external auditors;

(b)

counsel retained specifically for this action, including any paralegal,
clerical, or other assistant that such outside counsel employs and assigns to
this matter;

(c)

outside vendors or service providers (such as copy-service providers and
document-management consultants) that counsel hire and assign to this
matter;

(d)

any mediator or arbitrator that the Parties engage in this matter or that this
Court appoints, provided such person has first executed a Non-Disclosure
Agreement in the form annexed as Exhibit A hereto;

(e)

as to any document, its author, its addressee, and any other person
indicated on the face of the document as having received a copy;

(f)

any witness who counsel for a Party in good faith believes may be called
to testify at trial or deposition in this action, provided such person does not
retain any copies of Discovery Material designated as “Confidential” and

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has first executed a Non-Disclosure Agreement in the form annexed as
Exhibit A hereto;
(g)

any person a Party retains to serve as an expert witness or otherwise
provide specialized advice to counsel in connection with this action,
provided such person has first executed a Non-Disclosure Agreement in
the form annexed as Exhibit A hereto;

(h)

stenographers engaged to transcribe depositions the Parties conduct in this
action; and

(i)

this Court, including any appellate court, its support personnel, and court
reporters.

8.

Before disclosing any Confidential Discovery Material to any person

referred to in subparagraphs 7(d), 7(f), or 7(g) above, counsel must provide a copy of this Order
to such person, who must sign a Non-Disclosure Agreement in the form annexed as Exhibit A
hereto stating that he or she has read this Order and agrees to be bound by its terms. Said
counsel must retain each signed Non-Disclosure Agreement, hold it in escrow, and produce it to
opposing counsel either before such person is permitted to testify (at deposition or trial) or at the
conclusion of the case, whichever comes first.
9.

This Order binds the Parties and certain others to treat as Confidential any

Discovery Materials so classified. The Court has not, however, made any finding regarding the
confidentiality of any Discovery Materials, and retains full discretion to determine whether to
afford confidential treatment to any Discovery Material designated as Confidential hereunder.
All persons are placed on notice that the Court is unlikely to seal or otherwise afford confidential

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treatment to any Discovery Material introduced into evidence at trial, even if such material has
previously been sealed or designated as Confidential.
10. The Parties shall fully comply with Rule 5 of Judge Wood's Individual Rules
of Practice regarding the electronic filing under seal in civil/miscellaneous cases. Motions or
Letter Motions for approval of sealed or redacted filings, including the proposed sealed
document(s), must be filed electronically through the court’s ECF system in conformity with the
Court’s standing order, 19-mc-00583, and ECF Rules & Instructions, Section 6. The motion
must be filed in public view, must explain the particular reasons for seeking to file that
information under seal and should not include confidential information sought to be filed under
seal. Supporting papers must be separately filed electronically and may be filed under seal or
redacted only to the extent necessary to safeguard information sought to be filed under seal. The
proposed sealed document must be contemporaneously filed under seal in the ECF system and
electronically related to the motion. Where the motion seeks approval to redact information
from a document that is to be publicly filed, the filing party shall: (a) publicly file the document
with the proposed redactions, and (b) electronically file under seal a copy of the unredacted
document with the redactions highlighted. Both documents must be electronically filed through
the ECF system and related to the motion.
11.

To be approved, any redaction or sealing of a court filing must be

narrowly tailored to serve whatever purpose justifies the redaction or sealing and must be
otherwise consistent with the presumption in favor of public access to judicial documents. See,
e.g., Lugosch v. Pyramid Co. of Onondaga, 435 F.3d 110, 119-20 (2d Cir. 2006). In general, the
parties’ consent or the fact that information is subject to a confidentiality agreement between
litigants is not, by itself, a valid basis to overcome the presumption in favor of public access to

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judicial documents. See, e.g., In re Gen. Motors LLC Ignition Switch Litig., No. 14-MD2543(JMF), 2015 WL 4750774, at *4 (S.D.N.Y. Aug. 11, 2015). The party seeking leave to file
sealed or redacted materials should meet and confer with any opposing parties (or third parties
seeking confidential treatment of the information, if any) in advance to narrow the scope of the
request. When a party seeks leave to file sealed or redacted materials on the ground that an
opposing party or third party has requested it, that party shall notify the opposing party or third
party that it must file, within three days, a letter explaining the need to seal or redact the
materials. Any party unable to comply with the requirement for electronic filing under seal
through the ECF system, or who has reason to believe that a particular document should not be
electronically filed, must move for leave of the Court to file in the traditional manner, on paper.
12.

In filing Confidential Discovery Material with this Court, or filing

portions of any pleadings, motions, or other papers that disclose such Confidential Discovery
Material (“Confidential Court Submission”), to the extent that they are permitted to file any such
materials under seal, the Parties shall publicly file a redacted copy of the Confidential Court
Submission via the Electronic Case Filing System. The Parties shall also file an unredacted copy
of the Confidential Court Submission under seal with the Clerk of this Court, and the Parties
shall serve this Court and opposing counsel with unredacted courtesy copies of the Confidential
Court Submission.
13.

Any Party who objects to any designation of confidentiality may at any

time before the trial of this action serve upon counsel for the Producing Party a written notice
stating with particularity the grounds of the objection. If the Parties cannot reach agreement
promptly, counsel for all affected Parties will address their dispute to this Court in accordance
with paragraph 2.B of Judge Gorenstein's Individual Practices.

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14.

Any Party who requests additional limits on disclosure (such as

“attorneys’ eyes only” in extraordinary circumstances), may at any time before the trial of this
action serve upon counsel for the recipient Parties a written notice stating with particularity the
grounds of the request. If the Parties cannot reach agreement promptly, counsel for all affected Parties
will address their dispute to this Court in accordance with paragraph 2.B of Judge Gorenstein's Court's
Individual Rules of Practice in Civil Cases.

15.

Recipients of Confidential Discovery Material under this Order may use

such material solely for the prosecution and defense of this action and any appeals thereto, and
not for any other purpose or in any other litigation proceeding. Nothing contained in this Order,
however, will affect or restrict the rights of any Party with respect to its own documents or
information produced in this action.
16.

Nothing in this Order will prevent any Party from producing any

Confidential Discovery Material in its possession in response to a lawful subpoena or other
compulsory process, or if required to produce by law or by any government agency having
jurisdiction, provided that such Party gives written notice to the Producing Party as soon as
reasonably possible, and if permitted by the time allowed under the request, at least 10 days
before any disclosure. Upon receiving such notice, the Producing Party will bear the burden to
oppose compliance with the subpoena, other compulsory process, or other legal notice if the
Producing Party deems it appropriate to do so.
17.

Each person who has access to Discovery Material designated as

Confidential pursuant to this Order must take all due precautions to prevent the unauthorized or
inadvertent disclosure of such material.

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18.

In the event of a disclosure of any Confidential Discovery Material to a

person not authorized to have had such disclosure made to him or her under this Order, and in
the event the party responsible for having made or allowed such disclosure becomes aware of
such disclosure, that party shall immediately inform counsel for the Producing Party whose
Confidential Discovery Material has thus been disclosed of all relevant information concerning
the nature and circumstances of such disclosure. The responsible party also shall take all
reasonable measures promptly to retrieve the Confidential Discovery Material and to ensure that
there is no further or greater unauthorized disclosure of the Confidential Discovery Material.
19.

If a Producing Party believes that it has, for any reason, inadvertently

disclosed documents, testimony, information and/or things protected from disclosure under the
attorney-client privilege, work-product protection or any other legal privilege or immunity
protecting such information from discovery, or the Receiving Party discovers such disclosure,
the disclosure, pursuant to Fed. R. Evid. 502(d) shall not be deemed a waiver—in this litigation
or in any other proceeding, including in Federal, State, arbitral, foreign, or other proceedings—of
the applicable privilege or protection.
Upon such discovery, by either the Producing Party or the Receiving
Party, prompt written notice identifying such materials shall be provided to the non-discovering
party. The Receiving Party shall immediately return to the Producing Party, or destroy, all
summaries or copies of such documents, testimony, information and/or things, shall provide a
certification of counsel that all such disclosed materials (including copies or summaries of such
material) have been returned or completely destroyed and shall not use such items for any
purpose until further order of the Court.

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In all events, such return or destruction and certification must occur within
five (5) business days of the receipt of the request. Within fifteen (15) business days of the
notification that the disclosed materials have been returned or destroyed, the Producing Party
shall produce a privilege log with respect to the disclosed materials. Alleged privileged
documents shall remain protected against disclosure and use during the pendency of any dispute
over their status. Nothing in this Stipulation and Order shall affect any Party’s right to withhold
from disclosure documents or information that are privileged or otherwise protected from
disclosure.
20.

Within 60 days of the final disposition of this action—including all

appeals—all recipients of Confidential Discovery Material must either return it—including all
copies thereof—to the Producing Party, or, upon permission of the Producing Party, destroy such
material—including all copies thereof. In either event, by the 60-day deadline, the recipient
must certify its return or destruction by submitting a written certification to the Producing Party
that affirms that it has not retained any copies, abstracts, compilations, summaries, or other forms
of reproducing or capturing any of the Confidential Discovery Material. Notwithstanding this
provision, the attorneys that the Parties have specifically retained for this action may retain an
archival copy of all pleadings, motion papers, transcripts, expert reports, legal memoranda,
correspondence, or attorney work product, even if such materials contain Confidential Discovery
Material. Any such archival copies that contain or constitute Confidential Discovery Material
remain subject to this Order. This paragraph does not apply to the Court.
21.

This Order will survive the termination of the litigation and will continue

to be binding upon all persons subject to this Order to whom Confidential Discovery Material is
produced or disclosed.

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22.

This Court will retain jurisdiction over all persons subject to this Order to

the extent necessary to enforce any obligations arising hereunder or to impose sanctions for any
contempt thereof.
RESPECTFULLY SUBMITTED, SO STIPULATED AND AGREED.
Dated: September 24, 2020
SHEPHERD, FINKELMAN,
MILLER & SHAH, LLP

CRAVATH, SWAINE
& MOORE LLP

/s/ Laurie Rubinow
James E. Miller
Laurie Rubinow (LR6637)
65 Main Street
Chester, CT 06412
Tel: [phone]
Fax: [phone]
Email: [e-mail]
[e-mail]

/s/ Benjamin Gruenstein
Evan R. Chesler
Benjamin Gruenstein
Damaris Hernandez
Worldwide Plaza
825 Eighth Avenue
New York, NY 10019
Tel: [phone]
Email: [e-mail]
[e-mail]
[e-mail]

Attorneys for Plaintiff-Relator

Attorneys for Defendant

IT IS SO ORDERED.
24
Dated: September __, 2020
New York, New York

Gabriel W. Gorenstein
United States Magistrate Judge

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IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF NEW YORK
UNITED STATES OF AMERICA; the States of
CALIFORNIA, COLORADO, CONNECTICUT,
DELAWARE, FLORIDA, GEORGIA, HAWAII,
ILLINOIS, INDIANA, IOWA, LOUISIANA,
MASSACHUSETTS, MICHIGAN,
MINNESOTA, MONTANA, NEVADA, NEW
JERSEY, NEW MEXICO, NEW YORK, NORTH
CAROLINA, OKLAHOMA, RHODE ISLAND,
TENNESSEE, TEXAS, VIRGINIA, WASHINGTON
and WISCONSIN; the DISTRICT OF COLUMBIA,
THE CITY OF CHICAGO and THE CITY OF NEW
YORK; ex rel., STEVEN M. CAMBURN
Plaintiffs and Relator,

No. 13 Civ. 3700 (KMW)
NON-DISCLOSURE
AGREEMENT

vs.
NOVARTIS PHARMACEUTICALS CORPORATION,
Defendant.

I, __________________________________, acknowledge that I have read and
understand the Protective Order in this action governing the non-disclosure of those portions of
Discovery Material that have been designated as Confidential. I agree that I will not disclose
such Confidential Discovery Material to anyone other than for purposes of this litigation and that
at the conclusion of the litigation I will return all discovery information to the Party or attorney
from whom I received it. By acknowledging these obligations under the Protective Order, I
understand that I am submitting myself to the jurisdiction of the United States District Court for
the Southern District of New York for the purpose of any issue or dispute arising hereunder and
that my willful violation of any term of the Protective Order could subject me to punishment for
contempt of Court.
_________________________________________
Name:
Date:

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