1 | HOGAN LOVELLS US LLP Michele W. Sartori (Admitted Pro Hac Vice) 2 || James R. Johnson (Admitted Pro Hac Vice) 555 Thirteenth Street, N.W. 3 || Washington, D.C. 20004 Telephone: we) 637-5600 4 || Facsimile: (202) 637-5910 [email protected] 5 || [email protected] 6 | HOGAN LOVELLS US LLP Stephanie Yonekura Bat No. 187131) 7 || Jordan D. Teti (Bar 0. 284714) 1999 Avenue of the Stars, Suite 1400 8 || Los Angeles, California 90067 Telephone: (310) 785-4600 9 || Facsimile: (310) 785-4601 stephanie. □□□□□□□□□□□□□□□□□□□□□□□□□ 10 || [email protected] 11 || Attorneys for Defendant Me Pea ne eer 12 13 UNITED STATES DISTRICT COURT 14 CENTRAL DISTRICT OF CALIFORNIA 15 16 || UNITED STATES OF AMERICA, Case No.: 2:20-cv-09844-JAK-AFM 17 Plaintiff, STIPULATED {PROPOSED} PROTECTIVE ORDER'

|| MED-PHARMEX, INC., a corporation. GERALD P. MACEDO 20 || and VINAY M. RANGNEKAR, PH.D., individuals 21 Defendants. 22 23 24 25 26 27 | ' This Stipulated [Proposed] Protective Order is based substantially on the model 28 protective order provided under Magistrate Judge Alexander F. MacKinnon’s rocedures.

1 | 1. A. PURPOSES AND LIMITATIONS 2 Discovery in this action is likely to involve production of confidential, 3 || proprietary or private information for which special protection from public 4 || disclosure may be warranted. Accordingly, Plaintiff United States of America 5 || (United States”) and Defendants Med-Pharmex, Inc. (“Med-Pharmex”’), Gerald P. 6 || Macedo, and Vinay M. Rangnekar, Ph.D. (together, the “Parties”; each 7 || individually, a “Party’’) hereby stipulate to and petition the Court to enter the 8 || following Stipulated Protective Order. The Parties acknowledge that this Order 9 || does not confer blanket protections on all disclosures or responses to discovery and 10 || that the protection it affords from public disclosure extends only to the limited 11 || information or items that are entitled to confidential treatment under the applicable 12 || legal principles. 13 B. GOOD CAUSE STATEMENT 14 This action is likely to involve trade secrets, technical and/or proprietary 15 || information for which special protection from public disclosure is warranted. Such 16 || confidential and proprietary materials and information consist of, among other 17 || things, Med-Pharmex’s confidential business or financial information, information 18 || regarding Med-Pharmex’s confidential business practices, or other confidential 19 || manufacturing, research, development, or commercial information, information 20 || otherwise generally unavailable to the public, or which may be privileged or 21 || otherwise protected from disclosure under state or federal statutes, court rules, case 22 || decisions, or common law. Such confidential materials and information may also 23 || consist of, among other things, highly personal information that is not generally 24 || disclosed to the public by that Party or person, including but not limited to social 25 || security numbers, dates of birth, financial account numbers, passwords, and home 26 || addresses. In addition, the United States acknowledges that the Trade Secrets Act, 27 || the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA regulations protect 28 || trade secrets and confidential commercial information. See

; 21 -2-

1 || U.S.C. § 331G);

; 21 C.F.R. Parts 20 and 21. Accordingly, to 2 || expedite the flow of information, to facilitate the prompt resolution of disputes over 3 || confidentiality of discovery materials, to adequately protect information the Parties 4 || are entitled and/or required to keep confidential, to ensure that the Parties are 5 || permitted reasonable necessary uses of such material in preparation for and in the 6 || conduct of trial, to facilitate compliance with Local Civil Rule 79-5 regarding the 7 || sealing of documents, and to serve the ends of justice, a protective order for such 8 || information is justified in this matter. It is the intent of the Parties that information 9 || will not be designated as confidential for tactical reasons and that nothing be so 10 || designated without a good faith belief that it has been maintained in a confidential, 11 || non-public manner, and there is good cause why it should not be part of the public 12 || record of this case. 13 C. ACKNOWLEDGMENT OF PROCEDURE FOR FILING UNDER 14 SEAL 15 The Parties further acknowledge, as set forth in Section 10.3, below, that this 16 || Stipulated Protective Order does not entitle them to file confidential information 17 || under seal; Local Civil Rule 79-5 sets forth the procedures that must be followed 18 || and the standards that will be applied when a Party seeks permission from the court 19 || to file material under seal. 20 There is a strong presumption that the public has a right of access to judicial 21 || proceedings and records in civil cases. In connection with non-dispositive motions, 22 || good cause must be shown to support a filing under seal. See Kamakana v. City and 23 || County of Honolulu,

(9th Cir. 2006), Phillips v. Gen. Motors 24 || Corp.,

, 1210-11 (9th Cir. 2002), Makar-Welbon v. Sony Electrics, 25 || Inc.,

(E.D. Wis. 1999) (even stipulated protective orders 26 || require good cause showing), and a specific showing of good cause or compelling 27 || reasons with proper evidentiary support and legal justification, must be made with 28 || respect to Protected Material that a Party seeks to file under seal. The Parties’ mere -3-

1 || designation of Discovery Material as CONFIDENTIAL does not—without the 2 || submission of competent evidence by declaration, establishing that the material 3 || sought to be filed under seal qualifies as confidential, privileged, or otherwise 4 || protectable—constitute good cause. 5 Further, if a Party requests sealing related to a dispositive motion or trial, 6 || then compelling reasons, not only good cause, for the sealing must be shown, and 7 || the relief sought shall be narrowly tailored to serve the specific interest to be 8 || protected. See Pintos v. Pacific Creditors Ass’n.,

(9th Cir. 9 || 2010). For each item or type of information, document, or thing sought to be filed 10 || or introduced under seal in connection with a dispositive motion or trial, the Party 11 || seeking protection must articulate compelling reasons, supported by specific facts 12 || and legal justification, for the requested sealing order. Again, competent evidence 13 || supporting the application to file documents under seal must be provided by 14 || declaration. 15 Any document that is not confidential, privileged, or otherwise protectable in 16 || its entirety will not be filed under seal if the CONFIDENTIAL portions can be 17 || redacted. If documents can be redacted, then a redacted version for public viewing, 18 || omitting only the confidential, privileged, or otherwise protectable portions of the 19 || document, shall be filed. Any application that seeks to file documents under seal in 20 || their entirety should include an explanation of why redaction is not feasible. 21 | 2. DEFINITIONS 22 2.1 Action: the above-captioned action, United States of America v. Med- 23 || Pharmex, Inc., et al., Case No.: 2:20-cv-09844-JAK-AFM. 24 2.2 Challenging Party: a Party or Non-Party that challenges the 25 || designation of information or items under this Order. 26 2.3. “CONFIDENTIAL” Information or Items: information (regardless of 27 || how it is generated, stored or maintained) or tangible things that qualify for 28 _4-

1 || protection under Federal Rule of Civil Procedure 26(c), and as specified above in 2 || the Good Cause Statement. 3 2.4 Counsel: Outside Counsel of Record and In-House Counsel (as well as 4 || their support staff, in-house contractors, and professional litigation-support 5 || vendors); attorneys in the United States Department of Justice (as well as their 6 || support staff, in-house contractors, and professional litigation-support vendors); and 7 || attorneys in the United States Department of Health and Human Services Office of 8 || the General Counsel, including attorneys in the Food and Drug Administration 9 || Office of the Chief Counsel (as well as their support staff, in-house contractors, and 10 || professional litigation-support vendors). 1] 2.5 Designating Party: a Party or Non-Party that designates information or 12 || items that it produces in disclosures or in responses to discovery as 13 || “CONFIDENTIAL.” 14 2.6 Discovery Material: all items or information, regardless of the medium 15 || or manner in which it is generated, stored, or maintained (including, among other 16 || things, testimony, transcripts, and tangible things), that are produced or generated in 17 || disclosures or responses to discovery in this matter. 18 2.7 Expert: a person with specialized knowledge or experience in a matter 19 || pertinent to the litigation who has been retained by a Party or its counsel to serve as 20 || an expert witness or as a consultant in this Action and FDA employees who serve 21 || as expert witnesses or consultants for the United States in this Action 22 2.8 In-House Counsel: attorneys who are employees of a Defendant to this 23 || Action. In-House Counsel does not include Outside Counsel of Record or any other 24 || outside counsel. 25 2.9 Non-Party: any natural person, partnership, corporation, association or 26 || other legal entity not named as a Party to this action. 27 2.10 Outside Counsel of Record: attorneys who are not employees of a 28 || Defendant to this Action but are retained to represent or advise a Defendant to this -5-

1 || Action and have appeared in this Action on behalf of that Defendant or are 2 || affiliated with a law firm that has appeared on behalf of that Defendant, and 3 || includes support staff. 4 2.11 Party: any Party to this Action, including all of its officers, directors, 5 || or employees. 6 2.12 Producing Party: a Party or Non-Party that produces Discovery 7 || Material in this Action. 8 2.13 Professional Vendors: persons or entities that provide litigation 9 || support services (e.g., photocopying, videotaping, translating, preparing exhibits or 10 || demonstrations, and organizing, storing, or retrieving data in any form or medium) 11 || and their employees and subcontractors. 12 2.14 Protected Material: any Discovery Material that is designated as 13 || “CONFIDENTIAL.” Also, in FDA’s regulatory oversight of Med-Pharmex and 14 || apart from discovery in this Action, FDA has received (and may receive in the 15 || future) certain documents and information from Med-Pharmex. To the extent that 16 || those documents or information contain trade secrets and/or confidential 17 || commercial information protected by

,

; 21 U.S.C. 18 || § 331G), and/or 21 C.F.R. Parts 20 and 21, those documents or information shall be 19 || subject to the procedures set forth for filing under seal in Local Civil Rule 79- 20 || 5.2.2(b) (‘Documents Designated by Another as Confidential Pursuant to a 21 || Protective Order.”). 22 2.15 Receiving Party: a Party that receives Discovery Material from a 23 || Producing Party. 24 | 3. SCOPE 25 The protections conferred by this Stipulation and Order cover not only 26 || Protected Material (as defined above), but also (1) any information copied or 27 || extracted from Protected Material; (2) all copies, excerpts, summaries, or 28 || compilations of Protected Material; and (3) any testimony, conversations, or -6-

1 || presentations by Parties or their Counsel that might reveal Protected Material. 2 Any use of Protected Material at trial shall be governed by the orders of the 3 || trial judge. This Order does not govern the use of Protected Material at trial. 4 || 4. DURATION 5 Once a case proceeds to trial, information that was designated as 6 || CONFIDENTIAL and that is used or introduced as an exhibit at trial becomes 7 || public and will be presumptively available to all members of the public, including 8 || the press, unless compelling reasons supported by specific factual findings to 9 || proceed otherwise are made to the trial judge in advance of the trial or by 10 || appropriate motion. See Kamakana,

(distinguishing “good 11 || cause” showing for sealing documents produced in discovery from “compelling 12 || reasons” standard when merits-related documents are part of court record). 13 || 5. DESIGNATING PROTECTED MATERIAL 14 5.1 Exercise of Restraint and Care in Designating Material for Protection. 15 || Each Party or Non-Party that designates information or items for protection under 16 || this Order must take care to limit any such designation to specific material that 17 || qualifies under the appropriate standards. The Designating Party must designate for 18 || protection only those parts of material, documents, items or oral or written 19 || communications that qualify so that other portions of the material, documents, 20 || items or communications for which protection is not warranted are not swept 21 || unjustifiably within the ambit of this Order. 22 Mass, indiscriminate or routinized designations are prohibited. Designations 23 || that are shown to be clearly unjustified or that have been made for an improper 24 || purpose (e.g., to unnecessarily encumber the case development process or to 25 || impose unnecessary expenses and burdens on other Parties) may expose the 26 || Designating Party to sanctions. 27 If it comes to a Designating Party’s attention that information or items that it 28 || designated for protection do not qualify for protection, that Designating Party must -7-

1 || promptly notify all other Parties that it is withdrawing the inapplicable designation. 2 5.2 Manner and Timing of Designations. Except as otherwise provided in 3 || this Order (see, e.g., Section 2.14 above), or as otherwise stipulated or ordered, 4 || Discovery Material that qualifies for protection under this Order must be clearly so 5 || designated before the material is disclosed or produced. 6 Designation in conformity with this Order requires: 7 (a) for information in documentary form (e.g., paper or electronic 8 || documents, but excluding transcripts of depositions or other pretrial or trial 9 || proceedings), that the Producing Party affix at a minimum, the legend 10 || “CONFIDENTIAL” (hereinafter “CONFIDENTIAL legend”), to each page that 11 || contains protected material or to each file name. If the Producing Party only secks 12 || to mark a portion of the material on a page as “CONFIDENTIAL,” then the 13 || Producing Party also must clearly identify the protected portion(s) (e.g., by making 14 || appropriate markings in the margins). 15 (b) for testimony given in depositions, that the Designating Party 16 || specifies the portions of testimony to be designated as “CONFIDENTIAL” (1) on 17 || the record before the close of the deposition, or (11) within 30 days after receipt by 18 || counsel for the Designating Party of the final copy of any deposition transcript. In 19 || the same manner, the entirety of testimony at any deposition may be designated as 20 || “CONFIDENTIAL,” if appropriate. 21 (c) for information produced in some form other than documentary 22 || and for any other tangible items, that the Producing Party affix in a prominent place 23 || on the exterior of the container or containers in which the information is stored the 24 || legend “CONFIDENTIAL.” If only a portion or portions of the information 25 || warrants protection, the Producing Party, to the extent practicable, shall identify the 26 || protected portion(s). 27 5.3 Inadvertent Failures to Designate. If timely corrected, an inadvertent 28 || failure to designate qualified information or items does not, standing alone, waive -§&-

1 || the Designating Party’s right to secure protection under this Order for such 2 || material. Upon timely correction of a designation, the Receiving Party must make 3 || reasonable efforts to assure that the material is treated in accordance with the 4 || provisions of this Order. 5 || 6. CHALLENGING CONFIDENTIALITY DESIGNATIONS 6 6.1 Timing of Challenges. Any Party or Non-Party may challenge a 7 || designation of confidentiality at any time that is consistent with the Court’s 8 || Scheduling Order. 9 6.2 Meet and Confer. The Challenging Party shall initiate the dispute 10 || resolution process under Local Rule 37-1 et seq. 1] 6.3. Joint Stipulation. Any challenge submitted to the Court shall be via a 12 || joint stipulation pursuant to Local Rule 37-2. 13 6.4 The burden of persuasion in any such challenge proceeding shall be on 14 || the Designating Party. Frivolous challenges, and those made for an improper 15 || purpose (e.g., to harass or impose unnecessary expenses and burdens on other 16 || Parties) may expose the Challenging Party to sanctions. Unless the Designating 17 || Party has waived or withdrawn the confidentiality designation, all Parties shall 18 || continue to afford the material in question the level of protection to which it is 19 || entitled under the Producing Party’s designation until the Court rules on the 20 || challenge. 21 |) 7. DISCLOSURE OF “CONFIDENTIAL” INFORMATION OR ITEMS TO 22 EXPERTS. 23 7.1 In addition to disclosure to Counsel (as defined in this Order), 24 || Professional Vendors (as defined in this Order), and court staff, a Receiving Party 25 || may disclose any information or item designated “CONFIDENTIAL” to Experts 26 || (as defined in this Order) of the Receiving Party to whom disclosure is reasonably 27 || necessary for this Action and who have signed the “Acknowledgment and 28 || Agreement to Be Bound” (Exhibit A). Experts (as defined in this Order) may use -9-

1 || Protected Material that is disclosed or produced by another Party or by a Non-Party 2 || in connection with this Action only for purposes related to this Action. FDA 3 || employees who serve as an expert witness or consultant for the Plaintiff in this 4 || action are permitted access to Protected Material, but they are not required to sign 5 || Exhibit A and nothing in this Order limits their use of such Protected Material to 6 || purposes related to this Action (see section 10.4). 7 || 8. A NON-PARTY’S PROTECTED MATERIAL SOUGHT TO BE 8 PRODUCED IN THIS LITIGATION 9 The terms of this Order are applicable to information produced by a Non- 10 || Party in this Action and designated as “CONFIDENTIAL.” Such information 11 || produced by Non-Parties in connection with this litigation is protected by the 12 || remedies and relief provided by this Order. Nothing in these provisions should be 13 || construed as prohibiting a Non-Party from seeking additional protections. 14 |] 9. INADVERTENT PRODUCTION OF PRIVILEGED OR OTHERWISE 15 PROTECTED MATERIAL 16 When a Producing Party gives notice to Receiving Parties that certain 17 || inadvertently produced material is subject to a claim of privilege or other 18 || protection, the obligations of the Receiving Parties are those set forth in Federal 19 || Rule of Civil Procedure 26(b)(5)(B) and any stipulated protective order entered in 20 || this Action pursuant to Federal Rule of Evidence Rule 502. 21 | 10. MISCELLANEOUS 22 10.1 Right to Further Relief. Nothing in this Order abridges the right of any 23 || person to seek its modification by the Court in the future. 24 10.2 Right to Assert Other Objections. By stipulating to the entry of this 25 || Protective Order, no Party waives any right it otherwise would have to object to 26 || disclosing or producing any information or item on any ground not addressed in 27 || this Stipulated Protective Order. Similarly, no Party waives any right to object on 28 -10-

1 || any ground to use in evidence of any of the material covered by this Protective 2 || Order. 3 10.3 Filing Protected Material. A Party that seeks to file under seal any 4 || Protected Material must comply with Local Civil Rule 79-5. Protected Material 5 || may only be filed under seal pursuant to a court order authorizing the sealing of the 6 || specific Protected Material at issue. If a Party’s request to file Protected Material 7 || under seal is denied by the court, then the Receiving Party may file the information 8 || in the public record unless otherwise instructed by the court. 9 10.4 Notwithstanding the foregoing, nothing in this Order shall be 10 || construed to limit the ability or authority of employees of the United States 11 || Department of Justice, the United States Department of Health and Human 12 || Services, and the United States Food and Drug Administration to access 13 || documents, testimony, or other information received from Defendants in this action. 14 10.5 Nothing in this Order shall impose any restrictions on the use or 15 || disclosure of Protected Material by the Department of Justice, HHS, or FDA for 16 || law-enforcement or regulatory purposes or pursuant to any legal obligation imposed 17 || on the Department, HHS, or FDA, including but not limited to a request from the 18 || United States Congress and a request under the Freedom of Information Act. 19 | 11. VIOLATION 20 Any violation of this Order may be punished by appropriate measures 21 || including, without limitation, contempt proceedings and/or monetary sanctions. IT IS SO STIPULATED, THROUGH COUNSEL OF RECORD.

24 Dated: April 15, 2021 HOGAN LOVELLS US LLP By: /s/ Jordan D. Teti 26 Michele Sartori (Admitted Pro Hac Vice) Jordan D. Teti 38 Attorneys for Defendant Med-Pharmex, Inc.

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1 2 Dated: April 15, 2021 CROWELL & MORING LLP 3 By: /s/ Chalana Damron 4 Chalana N. Damron (Admitted Pro Hac Vice) John Fuson (Admitted Pro Hac Vice) 5 David Griffith 6 Attorneys for Defendants Gerald P. Macedo and 7 Vinay M. Rangnekar 8 9 Dated: April 15, 2021 UNITED STATES OF AMERICA By: /s/ Rachel Baron 10 Rachel Baron 1] Attorneys for Plaintiff United States of America 12 13 4 LOCAL RULE 5-4.3.4 ATTESTATION

5 I attest and certify that all above-referenced signatories listed, on whose

behalf this filing is submitted, concur with the filing’s content and have authorized the filing. 17 . 18 Dated: April 15, 2021 By: /s/ Jordan D. Teti 19 Jordan D. Teti 20 21 9 FOR GOOD CAUSE SHOWN, IT IS SO ORDERED. DATED: _ 4/16/2021 23 24 (tly Mla {K<—_—~ 25 HON. ALEXANDER F. MacKINNON %6 United States Magistrate Judge 27 28 -12-

1 EXHIBIT A 2 ACKNOWLEDGMENT AND AGREEMENT TO BE BOUND 3 4} I, [print or type full name], of 5 [print or type full address], declare under penalty of perjury 6 || that I have read in its entirety and understand the Stipulated Protective Order that 7 || was issued by the United States District Court for the Central District of California 8 || on [date] in the case of United States of America v. Med-Pharmex, Inc., et al., Case 9 || No.: 2:20-cv-09844-JAK-AFM. I agree to comply with and to be bound by all the 10 || terms of this Stipulated Protective Order and I understand and acknowledge that 11 || failure to so comply could expose me to sanctions and punishment in the nature of 12 || contempt. I solemnly promise that I will not disclose in any manner any 13 || information or item that is subject to this Stipulated Protective Order to any person 14 || or entity except in strict compliance with the provisions of this Order. I further 15 || agree to submit to the jurisdiction of the United States District Court for the Central 16 || District of California for enforcing the terms of this Stipulated Protective Order, 17 || even if such enforcement proceedings occur after termination of this action. I 18 || hereby appoint [print or type full name] of 19 [print or type full address and 20 || telephone number] as my California agent for service of process in connection with 21 || this action or any proceedings related to enforcement of this Stipulated Protective 22 || Order. 23 |) Date: 24 || City and State where sworn and signed: 25 26 || Printed name: 27 28 || Signature: -13-