(FLW)(LHG)

Plaintiff.

District Judge Freda L. WolfsonMagistrate Judge Lois H. Goodman

v.

MYLAN PHARMACEUTICALS INC. and : STIPULATED DISCOVERY

MYLAN INC., : CONFIDENTIALITY ORDER

Defendants.

x

FINDINGS SUPPORTING THE ENTRY OF THE

DISCOVERY CONFIDENTIALITY ORDER

Plaintiff Orexo AB (“Orexo”) and defendants Mylan Pharmaceuticals Inc. and Mylan Inc.

(collectively “Mylan”) have requested that the following Discovery Confidentiality Order

(“Order”) be entered to govern the exchange and use of discovery materials and testimony that

the Parties regard as confidential. In support of this request, the Parties have submitted the

declaration ofJohn E. Flaherty dated March 8, 2012 and Joseph Divinagracia dated March 8,

2012, pursuant to Local Civil Rule 5.3(b)(2) explaining why this Order is necessary. Orexo and

Mylan are referred to herein individually as a “Party” or collectively as the “Parties.”

Based upon the declarations before the Court and the record in this case, the Court makes

the following findings of fact;

This is a patent infringement action by Orexo against Mylan arising under the Hatch

Waxman Act, Orexo holds an approved New Drug Application from the United States Food and

Drug Administration (“FDA”) for a zolpidem tartrate sublingual product sold under the brand

name Edluar®, By letter dated, May 19, 2011, Mylan notified Orexo that it had filed

MEl l3l436Ov,l
businesses, deemed to be of a sensitive and proprietary nature. The areas may include, for

example: (i) research and development efforts, (ii) proprietary technology, (iii) and other

sensitive business information. Testimony and documents concerning these subjects may

contain contdential information, proprietary information, trade secrets and/or other sensitive

information. Because disclosure of such material may pose a substantial risk of causing harm to

the Parties’ competitive positions if publicly disclosed, the Parties developed and reached

agreement on a procedure for controlling disclosure of such information produced during

discovery. The agreed-upon procedure is embodied in this Order.

Good cause exists for entry of this Order. See Fed. R. Civ, P. 26(c); Pansy v. Borough of

Stroudsburg, 23 F.3d 772, 786 (3d Cir. 1994); L. Civ. R. 5.3(b). The nature of the case requires

the Parties to seek and/or produce documents and information and elicit deposition testimony,

the disclosure of which may pose a substantial risk of harm to the Parties’ legitimate proprietary

interests, This Order provides reasonable restrictions on the disclosure ofsuch sensitive

material. In order to streamline the discovery process and minimize the need for Court

intervention, this Order adopts a two-tier approach that allows the producing Party to designate

certain materials being produced as “Confidential” and certain materials as “Highly

ConfidentiaL” This Order limits disclosure of materials designated as “Confidential” and

“Highly Confidential” to specific classes of persons.

This Order also provides that the Party requesting production of the information may

challenge the producing Party’s confidentiality obligation before the Court, thereby minimizing

I

MEl 13143860v.1
23 F,3d at 787, n,17; Czpoi/one v. Liggett Group, Inc., 785 F.2d 1108, 1122 (3d Cir. 1986), ccii,

denied, 484 U.S. 976 (1987).

Accordingly, the Court hereby enters the following Order:

DISCOVERY CONFIDENTIALITY ORDER

WHEREAS, the Parties have agreed that certain information subject to discovery in this

action may be claimed to contain proprietary or confidential trade secret, technical, business, or

financial information of the producing party or applicable non-party within the meaning of Rule

26(c)(l )(G) of the Federal Rules of Civil Procedure (collectively, “Protected Material”); and

WHEREAS, these parties, through counsel, stipulate that the good cause standard set

forth in Pansy v. Borough ofStroudsburg, 23 F.3d 772 (3d Cir. 1994), exists for the entry of this

Discovery Confidentiality Order pursuant to Rule 26(c) to protect against improper disclosure or

use of confidential information produced in this case;

Therefore, the following provisions of this Order shall control the disclosure,

dissemination, and use of information in this case:

1. Designation Of Protected Material

a. Any person or entity (the “Producing Party”) producing documents,

things, information or other materials in the above captioned case (“Produced Material”)

for inspection or review by another person or entity (the “Receiving Party”) may

designate as “Confidential” or “Highly Confidential” pursuant to this Order any Produced

MEl 13143860v1
therein or derived therefrom shall hereinafter be referred to as ‘Protected Material.”

Notwithstanding such designation, Protected Material does not include information that:

(I) Was, is, or becomes public knowledge, not in violation of this

Discovery Confidentiality Order;

(2) Is acquired or was possessed by the Receiving Party in good faith

without confidentiality restrictions or from a third party not subject to this

Discovery Confidentiality Order;

(3) Is discovered independently by the Receiving Party by means that

do not constitute a violation of this Discovery Confidentiality Order; or

(4) Was, is, or becomes expressly released from being designated as

Protected Material by the Producing Party or by order of the Court.

2. Labeling Of Protected Material

a. The designation of Protected Material for purposes of this Order shall be

made in the following manner:

(1) With regard to written material (including transcripts of

depositions or other testimonY) and electronic images (such as TIFFs), a Ie end

shall be affixed to each page substantially in the form, “Confidential” or “Highly

Confidential”: and

4

ME! 13143860v.1
Producing Party for inspection without confidentiality legends shall be deemed to be

Highly Confidential until otherwise designated by the Producing Party.

Each transcript of any deposition shall be treated as Highly Confidential in

its entirety, and the court reporter shall affix such a designation to the cover and every

page of the transcript. Testimony about Protected Material of a Producing Party shall bedeemed Protected Material disclosed by the Producing Party pursuant to this Discovery

Confidentiality Order. Within thirty (30) days after the deposition, any party may

propose Confidential or Highly Confidential designations by notifying all parties, in

writing, of specific pages and lines of the transcript to be either Confidential or Highly

Confidential. To the extent any portion of the deposition is not designated as

Confidential or Highly Confidential within thirty (30) days after the deposition, it shall be

considered not confidential. In the event of different designations for the same text, the

parties will confer to reach agreement on the appropriate designation, and may seek Court

intervention if necessary to resolve any disagreement. Until the issue is resolved, the

transcript portions at issue shall be treated as the most restrictive designation made by

anyone.

3 DisclosrideOf Protected Materi aJ Absent an agreement of the Producing

Party or an Order to the contrary by this Court or other court of competent jurisdiction, a

Receiving Party shall use Protected Material solely for purposes of assisting outside counsel in

connection with the above-captioned lawsuit, and will not use the information for any other

NIFI 13143860v.1
Material, such Receiving Party shall promptly notify the Producing Party, and inform the persons

seeking discovery in writing (with copy to the Producing Party and the Court) that providing the

Protected Material would be a violation of this Discovery Confidentiality Order.

4. “Confidential” Material

The designation “Confidential” shall be limited to information that any Producing Party,

including any third party, in good faith, believes to contain:

a. (1) proprietary or commercially sensitive information concerning the

formulation or composition of products; (2) proprietary or commercially sensitive

information concerning the design, development, production, or manufacturing of

products; (3) sensitive personal information; (4) trade secrets or other confidential

research, development or commercial information; or (5) other information required by

law or agreement to be kept confidential. For the avoidance of doubt, the following

information shall be of the type considered “Confidential” and not “Highly Confidential”

under this order: (1) All portions of ANDA 20-2657 and correspondence with FDA

relating thereto; (2) all portions ofthe NDA; (3) the DMF for the active ingredients and

correspondence with the FDA relating thereto; (4) all documents relating to the

composition, manufacture. specifications. testing, analysis, makeup, content, ingredients,

development and structure of Mylan’s ANDA products; (5) all samples of Mylan’s

ANDA product along with all testing and analysis of samples by or on behalf of any

party; (6) NJ. L. Pat, R. 36 disclosures and contentions and supporting documentation;

6

MIEI 13143860v.i
admission that the categories identified are in a Party’s possession, custody, and control.

b. Information designated as “Confidential” may be disclosed only to the

following persons:

(1) The following in-house counsel or other employees of a named

party, who has executed an Acknowledgement attached hereto as Exhibit A:

(a) For Mylan:

Jill M. Ondos

Senior Vice President and

Global General Counsel -Litigation

Mylan

1500 Corporate Drive

Canonsburg, PA 15317

Joseph Divinagracia

Litigation Counsel

Mylan

1500 Corporate Drive

Canonsburg, PA 15317

Andrea Tiglio

Associate Litigation Counsel

Mylan

1500 Corporate Drive

Canonsburg, PA 15317

JaimeB.Lebo

Associate Litigation Counsel

Mylan

1500 Corporate Drive

Canonsburg, PA 15317

7

MEl 13143860v.I
SE-75 1 05 UppsalaSweden

Susanne Bredenberg, PhD

Project Director& Formulation ScientistOrexo AB

P.O. Box 303

SE-75 1 05 UppsalaSweden

Christina Adde

Director Analytical Development

Orexo AB

P.O. Box 303

SE-75 1 05 Uppsala

Sweden

Stephen McNeeney

European Patent Attorney

Potter Clarkson LLPPark View House

58 The Ropewalk

Nottingham, England

NG1 5DD

Stephen Smith

European Patent Attorney

Potter Clarkson LLP

Park View House

58 The Ropewalk

Nottingham, England

NGI 5DD

The parties may add persons to the list above by mutual agreement in writing by counsel.

MEl 13143860vl
support services, document imaging services, and database/coding services

retained by counsel;

(4) litigation support consultants engaged to irovide services relating

to demonstrative exhibits, graphics, charts, and/or animations;

(5) an expert or consultant who (i) is retained by counsel for a party to

assist in this litigation, (ii) is not a current employee of a party or subsidiary or

affiliate of a party, and (iii) such expert or consultant executes an

Acknowledgement attached hereto as Exhibit A, subject to the disclosure

restrictions set forth in Paragraph 8;

(6) a person who prepared, received, or reviewed the “Confidential”

information prior to its production in this litigation;

(7) mock jurors engaged by any consultant in preparation for trial,

provided they are not otherwise an employee of a party or subsidiary or affiliate

of a party in this litigation and provided they execute an Acknowledgement

attached hereto as Exhibit A;

(8) any private mediators agreed to by the Parties utilized in this

litigation, provided such person is not otherwise an employee of a party or

subsidiary or affiliate of a party in this litigation and provided such person

executes an Acknowledgement attached hereto as Exhibit A;

9

MEl 13143860v,l
5. “Highly Confidential” Material

a. The designation “Highly Confidential” shall be limited to information that

any Producing Party, including any third party, in good faith, believes to contain:

highly sensitive financial, business, marketing, or sales information, including but notlimited to, financial plans, marketing plans, business plans, competitive strategies,

business relationships, future products, and customer information,

b. Information designated as “Highly Confidential” may be disclosed only to

the following persons:

(1) The following counsel of a named party, who has executed an

Acknowledgement attached hereto as Exhibit A, provided that any such employeedoes not have competitive decision making responsibility:

(a) For Mylan:

Jill M. Ondos

Senior Vice President and

Global General Counsel -Litigation

Mylan

1500 Corporate Drive

Canonsburg, PA 153 17

Joseph DivinagraciaLitigation CounselMvlan

1500 Corporate Drive

Canonsburg, PA 15317

Andrea Tiglio

Associate Litigation Counsel

10

MEl 13143860v,l
1500 Corporate Drive

Canonsburg, PA 15317

(b) For Orexo:

Stephen McNeeney

European Patent Attorney

Potter Clarkson LLP

Park View House

58 The Ropewalk

Nottingham, England

NG1 5DD

Stephen Smith

European Patent Attorney

Potter Clarkson LLP

Park View House

58 The Ropewalk

Nottingham, England

NG1 5DD

The parties may add persons to the list above by mutual agreement in writing by counsel.

(2) U.S. outside counsel ofrecord representing a named party who are

not otherwise an employee of a party or subsidiary or affiliate of a party in this

litigation, including all employees working under the supervision ofsuch counsel;

(3) court reporters, interpreters, translators, copy services, graphic

support services, document imaging services, and database/coding services

retained by counsel;

(4) litigation support consultants engaged to provide services relating

to demonstrative exhibits, graphics, charts, and/or animations;

11

NIFI 13I4386O.1
restrictions set forth in Paragraph 8;

(6) a person who prepared, received, or reviewed the “Highly

Confidential” information prior to its production in this litigation;

(7) mock jurors engaged by any consultant in preparation for trial,

provided they are not otherwise an employee of a party or subsidiary or affiliate

of a party in this litigation and provided they execute an Acknowledgement

attached hereto as Exhibit A;

(8) any private mediators agreed to by the Parties utilized in this

litigation, provided such person is not otherwise an employee of a party or

subsidiary or affiliate of a party in this litigation and provided such person

executes an Acknowledgement attached hereto as Exhibit A;

(9) any other person agreed to by the parties to the above captioned

case or allowed by the Court; and

(10) the Court, the Court’s staft and any Special Masters and/or

Mediators appointed by the Court, under seal.

6. QjfieferQns “Qualified Persons” shall refer to the persons designated under

Paragraphs 4(b) and 5(b).

7. Restrictions Not Imposed By This Order

a. This Order shall not restrict any Producing Party’s use, for any purpose. of

its own Protected Material.

MEl 13143860v.1
content of any Protected Material where such disclosure would not otherwise be

permitted under the terms of this Order,

8. Notification Of Intent To Disclose And Objections

a. Before Protected Material is disclosed to an expert or consultant under

Paragraphs 4(b)(5) or 5(b)(5), the Receiving Party shall, at least ten (10) business days

prior to such disclosure, notify the Producing Party in writing, of its intent to discloseProtected Material. Such notification shall include the name, current address,

employment affiliation (including job title, if any), and a current resume or curriculum

vitae ofthe expert or consultant to whom such disclosure is proposed.

b. The notification and signed acknowledgement shall be delivered by email

with confirmation by overnight courier.

Notification to Orexo shall be delivered to:

Errol B. TaylorMilbank, Tweed, Hadley & McCloy LLP

1 Chase Manhattan Plaza New York, NY 10005

Email: Edluar@milbank.com

Notification to Mylan shall be delivered to:

Beth D. Jacob

Kelley Drye & Warren LLP

101 Park Avenue New York, NY 10178

Email: BJacobKelleyDryecom

13

ME! 13143860v,1
shall include the basis for the objection and shall be delivered in accordance with

Paragraph 8.a within ten (10) business days of receipt of the notification of intent to

disclose to which objection is made. If the Producing Party objects, the proposed

disclosure shall not take place until the objection is resolved by agreement of the

Producing Party or order of this Court. Failure to object within the time period set forth

above shall be deemed a consent. If the objection cannot be resolved, either party mayseek relief from the Court but the Producing Party shall have the burden of proof that the

intended disclosure should not occur.

9. Examination Of Witnesses at Deposition Protected Material may be disclosed to

a witness at a deposition (a) ifthe witness is an officer, director, or employee of the party who

produced such Protected Material or (b) if the witness was formerly an officer, director, or

employee of the party who produced such Protected Material, and the Protected Material existed

during the period of his or her service or employrnent.

10. Inadvertent Production Of Privileged Or Protected Material

a. If information subject to a claim of attorney-client privilege, attorney work

product immunity or any other legal privilege protecting information from discovery is

inadvertenti produced. such production shall in no way preiudice or otherwise constitute

a waiver of. or estoppel as to. any claim of privilege, work product immunity’ or other

ground for withholding production to which the Producing Party or other person

othenvise would be entitled, provided that the Producing Party identifies in writing that

14

MEl 13143860v,1
the inadvertently produced material shall return to the Producing Party or destroy that

material and all copies or reproductions thereof of which that Receiving Party is aware in

whatever form these materials exist, and that information may not be used for any

purpose. Each Receiving Party shall give written notice of such destruction to Outside

Counsel for the Producing Party. The Receiving Party may subsequently move the Courtfor an Order compelling production of the material, but such motion shall not disclose the

substance of the inadvertently produced material except to the extent that an in camera

inspection of the materials may be requested.

b. inadvertent failure to designate any material which a Producing Party

claims should be Protected Material will not be deemed a waiver of the right to make that

designation. Upon receiving notice of such failure to designate, all Receiving Parties

shall cooperate to restore the confidentiality of the inadvertently or unintentionally

disclosed Produced Material, No party shall be held in breach of this Order if, prior to

notification of such later designation, such Produced Material had been disclosed or used

in a manner inconsistent with such later designation. The Producing Party shall provide

substitute copies bearing the corrected designation. The Receiving Parties shall return or

certify the destruction of the undesignated Produced Material.

ii. Obligations of Outside Counsel It shall be the responsibility of Outside Counsel

to ensure strict compliance with the provisions of this Discovery Confidentiality Order and to

15

MEl 13l43860v,l
otherwise restrict public access to, those materials pursuant to Local Civil Rules 5.3(c) and 7.1.

a. The burden of proving to the Court that such material designated as

“Confidential” or “Highly Confidential” information should be sealed under Local CivilRule 5.3 shall at all times remain with the party that initially produced the material and

designated it as “Confidential” or “Highly Confidential” information; and

b. If the party filing the material is not the designating party, the filing party

nonetheless is obligated to make a reasonable effort when filing material designated as

“Confidential” or “Highly Confidential” information to meet the provisions of Local

Civil Rule 5.3 to protect the designating party’s materials, The designating party shall be

responsible for filing supplemental motion papers pursuant to Local Civil Rule 5.3(c)(2).

13. Conclusion of the Action Within sixty (60) days after entry of a final judgment or

dismissal with prejudice (including appeals or petitions for review) or the execution of a

settlement agreement, finally disposing of all issues raised in the above captioned case, all

Receiving Parties no longer in such case(s) shall: (a) return all Protected Material and any copies

thereof to the appropriate Outside Counsel produced the Protected Material; or (b) destroy

such Protected Material. Each Receiving Party shall give written notice of such destruction to

Outside Counsel for the Producing Party. However, Outside Counsel who are trial counsel may

retain one copy of all pleadings for archival purposes. Further, all notes, summaries, or other

documents prepared by Qualified Persons, derived from or containing Protected Material, shall

16

MEl 13143860v,1
designation is made, and failure to do so shall not preclude a subsequent challenge thereto, If the

Receiving Party disagrees with the designation of any Protected Material, the Receiving Partymay. after holding a meeting with the Producing Party, make a request of the Court for an order

removing such Protected Material from the restrictions of this Discovery Confidentiality Order.

15. Non-Waiver The production of Produced Material under the terms of this Order

in response to a request by an opposing party shall not be construed to mean that the Producing

Party has waived any objection to the production, relevancy or admissibility of said Produced

Material. Nothing contained herein shall preclude any party from opposing any discovery on

any basis. Further, nothing in this Order constitutes an admission by any party that any specific

item of Protected Material is a trade secret or otherwise confidential and proprietary to a party.

16. Additional Parties If an additional party joins or is joined in the above captioned

case, the newly joined party shall not have access to Protected Material until all parties to the

above captioned case agree to a supplemental Discovery Confidentiality Order governing the

protection of Protected Material.

17. Third Parties Any third party from whom discovery is sought in the above

captioned case may, in accordance with this Order, designate some or all of its production as

Protected Material, aM each Receiving Party will have the same rights, obligations and

restrictions which that Receiving Party has with respect to the Protected Material of any other

Producing Party.

17

MEl 13143860v,I
for access to Protected Material may be excluded from the trial and any hearings and conferences

in these actions.

19. Unauthorized Disclosure In the event of disclosure of any Protected Material to a

person not authorized to have access to such material, the party responsible for having made, and

any party with knowledge of, such disclosure shall immediately inform Outside Counsel for the

party whose Protected Material has thus been disclosed of all known relevant information

concerning the nature and circumstances of the disclosure. The responsible party shall also

promptly take all reasonable measures to ensure that no further or greater unauthorized

disclosure or use of such information or materials is made. Each party shall cooperate in good

faith in that effort.

20. Termination Of Access

a. In the event that any person or party ceases to be engaged in the conduct

of these actions, such person’s or party’s access to Protected Material shall be terminated,and all copies thereof shall be returned or destroyed in accordance with the terms of

Paragraph 13 hereof, except that such return or destruction shall take place as soon as

practicable after such person or party ceases to be engaged in the conduct of these

actions,

b. The provisions of this Order shall remain in full force and effect as to any

person or party who previously had access to Protected Material, except as may be

specifically ordered by the Court or consented to by the Producing Party.

18

MEl 13143860v.l
Confidential.” Until such time as the documents and things are redesignated (pursuant to this

paragraph or otherwise), all documents or things produced prior to the date of this Order will bedeemed “Confidential” under the terms of this Order,

22. Modification Stipulations may be made, between Counsel for the respective

parties, as to the application of this Order to specific situations, provided that such stipulations

are recorded in writing or contained in the record of any oral proceeding. Nothing contained

herein shall preclude any party from seeking an order of the Court modifying or supplementing

this Order,

/1 A /7 /

SO ORDERED this ç dái of ((jJ 2012

L

I /

THE HON

UNITED STkTES MAGISTRATE JUDGE

We hereby request and consent to the entry of the foregoing Discovery Confidentiality Order.

JohjFiahen Ls/Amold B. Calmann

John E. Flaherty Arnold B. Calrnann (abc@saibercom)

Jonathan M. H. Short Jeffrey Soos Gs@saibercom)

McCARTER & ENGLISH Katherine A. Escanlar (kae@saibercom)

Four Gateway Center SAIBER LLC

I 00 Mulberr Street One Gateway Center, 10th Floor

uk \ev Jerse\ 0102 \eark \J Y102-53l I

973) 622-4444 Telephone: (973) 622-3333

Facsimile: (973) 286-2465

MEl 13143860v.1

19
312-857-7070

312-857-7096 (facsimile)

Beth D, Jacob (BJacob@KelleyDryecom)

Clifford Katz (CKatzKel1eyDrye.com)

KELLEY DRYE & WARREN LLP

101 Park Avenue

New York, NY 10178

212-808-7800

212-808-7897 (facsimile)

Attornej’s for Defendants/Counterclaim Plaintiffs

Mv/an Pharmaceuticals Inc. andjvIvlan Inc.

New York,Telephone:Facsimile:

New York 10005-14 13

(212) 530-5000

(212) 822-5137

Attorneysfor Plaintiff

Orexo AR

MEl 13143860v.1

20
UIN 1AO98EHEI

llllfflX3 V
v, : District Judge 

eda 

. 

Magistrate Judge Lois H. Goodman

MYLAN PHARMACEUTICALS INC. and

MYLAN INC., ACKNOWLEDGEMENT TO

ABIDE BY THE DISCOVERY

Defendants. : CONFIDENTIALITY ORDER

x

I,

declare that:

1. I have read the foregoing Discovery Confidentiality Order entered as an Order of the

United States District Court for the District of New Jersey, in the action entitled Orexo AR v. Mvlan

Pharmaceuticals Inc. and Mylan Inc., Civil Action No. 11 -CV-03788 (FLW)(LHG).

2, I understand and agree to be bound by the terms of this Discovery Confidentiality

Order.

3. I will hold in confidence and will not disclose to anyone who is not a Qualified

Person under the Discovery Confidentiality Order and will use only for purposes of this litigation,any Protected Material disclosed to me.

4. I will return all Protected Material that comes into my possession, and documents or

things that I have prepared relating thereto, to counsel for the party by whom I am employed or

retained when requested to do so by that counsel.

5. I hereby submit to the jurisdiction of this Court for the purpose of enforcement of this

Discovcrv Confidentiality Order.

(Signature)

(Printed Name)

(Date)

ME] 13143860v,1