JAMES P. O'HARA, Magistrate Judge.
On December 7, 2015, the undersigned U.S. Magistrate Judge received a jointly proposed protective order from counsel. The court finds that good cause has been shown under Fed. R. Civ. P. 26(c) to enter this stipulated protective order.
Counsel for Defendants and Plaintiffs (collectively, the "Parties" and each, a "Party") in the above-captioned action have agreed that the Parties and non-parties will be required to produce or disclose in this proceeding certain information and documents that are subject to confidentiality limitations on disclosure under applicable law. Such documents, described in more detail below, include information that is a trade secret or other confidential research, development, or commercial information that is proprietary in nature. Disclosure of such information without reasonable restriction on the use of the information may cause competitive harm, damage, loss, or competitive disadvantage to the Producing Party or nonparty.
Accordingly, the defendants desire entry of an order, and the plaintiffs consent to the terms herein, pursuant to Rule 26(c) to ensure that protection is afforded only to material so entitled and that will address any inadvertent production of documents or information protected from disclosure by the attorney-client privilege, work-product immunity, or other applicable privilege.
Therefore, the Parties hereby stipulate to the following negotiated terms, subject to the Court's approval, and the Court, for good cause shown and after having an opportunity to discuss this Protective Order with the Parties, hereby ORDERS that the following procedures shall be followed in this proceeding to facilitate the orderly and efficient discovery while minimizing the potential for unauthorized disclosure or use of confidential or proprietary information and documents.
1.
a. This Protective Order shall govern all hard copy and electronic materials, the information contained therein, including all copies, excerpts, or compilations thereof, whether revealed in a document, deposition, other testimony, or discovery response, that any party to this proceeding (the "Producing Party" or "Designating Party) produces to any other party (the "Receiving Party") and that the Producing Party designates as confidential under this Protective Order.
b. This Protective Order is binding upon all Parties and their counsel in this proceeding, upon all signatories to Exhibit "A", and upon (as applicable) their respective corporate parents, subsidiaries, and affiliates, including their successors, and their respective attorneys, principals, experts, consultants, representatives, directors, officers, employees, and others as set forth in this Protective Order— and upon all signatories to Exhibit "A".
c. If additional parties are added other than parents, subsidiaries or affiliates of current parties to this litigation, their ability to receive a document protected by this Protective Order will be subject to their being bound, by agreement or Court Order, to this Protective Order.
d. Third Parties who so elect may avail themselves of, and agree to be bound by, the terms and conditions of this Protective Order and thereby become a Producing Party for purposes of this Protective Order.
e. Nothing herein shall be construed as an admission or concession by any Party that designated Confidential Material, or any Document or Information derived from Confidential Material, constitutes material, relevant, or admissible evidence in this matter.
2.
a. "Proceeding" or "Action" means the above-entitled proceeding.
b. "Court" means the judges currently assigned to this proceeding or any other judge to which this proceeding may be assigned, including Court staff participating in such proceedings.
c. "Document" or "Documents" shall have the meaning set out in the Federal Rules of Civil Procedure 34(a) and, for purposes of this order, shall include electronically stored information.
d. "Testimony" means all depositions, declarations or other pre-trial testimony taken or used in this Proceeding.
e. "Information" means the content of Documents or Testimony, as well as any matter derived therefrom or based thereon.
3.
a. Customer names.
b. Currently proprietary licensing, distribution, marketing, design, development, research and manufacturing information regarding products and medicines, whether previously or currently marketed or under development (not to include disseminated marketing materials or materials that, on its face, was published to the general public).
c. Personnel records.
d. Financial information not publicly filed with any federal or state regulatory authorities or not contained within any publicly available quarterly or annual reports.
e. Private medical information that identifies a person unless such identifying information is redacted.
f. Information submitted to any governmental or regulatory agency, which information is exempt from public disclosure.
g. All material, data, and information excerpted from "Confidential Material," to the extent the same are not publicly available or otherwise subject to the exclusions herein.
h. Specifically excluded from the definition of "Confidential Material" are:
i. "Designating Party" means the Party or non-party that designates Documents, Testimony, or Information as Confidential Material.
j. "Disclose," "Disclosed" or "Disclosure" means to reveal, divulge, give, or make available Documents, Testimony, or any part thereof, or any Information contained therein.
4.
a.
b.
c.
d.
e. With respect to Documents or Information produced or disclosed by a non-party, the non-party may designate the Documents or Information as Confidential Material pursuant to this Order. A Party so designating material produced by a non-Party shall notify all other Parties within fourteen (14) days of receipt of such Document or Information that the same or portions thereof constitute or contain Confidential Material. In order to avoid disruption of this Court's management of this litigation, transfer to this Court of any motions related to compliance with a FRCP 45 subpoena issued by this Court are encouraged pursuant to FRCP 45(f).
5.
a. Except as specifically provided in this Order, counsel shall keep all Confidential Material disclosed or produced to them within their exclusive possession and control, shall take all necessary and prudent measures to maintain the confidentiality of such materials and information, and shall not permit unauthorized dissemination of such materials to anyone.
b. Confidential Material shall not be disclosed in any way to anyone for any purpose other than as required for the preparation of trial in this action or other related actions as defined in Paragraph 10, below.
c. Access to and disclosure of Confidential Material shall be limited to those persons designated as Qualified Persons, below. Any Qualified Person who examines any Confidential Material shall not disseminate orally, or by any other means, any protected information other than as permitted by this Order.
d. Confidential Material shall not be used for any business, competitive or other non-litigation purpose without the express written consent of counsel for the Designating Party or by order of the Court.
e. To avoid security risks inherent in certain current technologies and to facilitate compliance with the terms of this Order, and unless otherwise ordered or agreed upon in writing by the Designating Party whose Confidential Material is at issue, all Qualified Persons (except Court personnel) with access to Confidential Material shall comply with the following:
6.
a.
b.
c. With respect to Qualified Persons encompassed by the preceding two paragraphs (a) and (b), such persons include the attorneys' employees and agents (e.g., outside copy services, organizations involved in organizing, filing, coding, converting, storing, or retrieving data or designing programs for handling data connected with this action, including the performance of such duties in relation to a computerized litigation support system, and stenographers). Disclosure shall be limited only to those attorneys' employees and agents who need access to Confidential Material for the purpose of litigation of this action.
d. Experts, consultants and case-specific medical professionals ("Consultants") whose assistance is necessary to assist counsel in the preparation of this Proceeding, whether or not the Consultant is designated as an expert and retained to testify, with the following qualifications:
e. Any expert to whom disclosure of Confidential Material is authorized must be informed of this Protective Order and must sign a copy of the Non-Disclosure Agreement attached hereto as Exhibit "A."
f. A deponent or a witness at a deposition or pre-trial hearing:
g. A person identified in the Confidential Material as an author, source, addressee, or recipient of the communication, or who already has a copy of the Confidential Material.
h. Any mediators or arbitrators selected to assist in resolution of this matter, and their personnel who are actively engaged in assisting them.
i. The Court or any Court personnel, including any court reporters.
j. Any person mutually agreed upon among the Parties, provided that such person has been informed of this Protective Order and has signed a copy of the Non-Disclosure Agreement attached hereto as Exhibit "A."
7.
a. Before being given access to any Confidential Material, each Qualified Person, other than the Court, the employees and staff of the Court, counsel of record, and the direct employees of counsel of record, and other than as set forth above with respect to those witnesses to whom Confidential Material is disclosed or shown at a deposition or pre-trial hearing as set forth in Paragraph 6(f), shall be advised of the terms of this Order, shall be given a copy of this Order, and shall agree in writing to be bound by the terms of this Order by signing a copy of the Non-Disclosure Agreement attached hereto as Exhibit "A." Counsel for each Party shall maintain a list of all Qualified Persons to whom they or their client(s) have provided any Confidential Material.
b. The witness who is a Qualified Person pursuant to Paragraph 6(f) but who has not signed a copy of the Non-Disclosure Agreement attached hereto as Exhibit "A" may be shown Confidential Material during his or her testimony, but shall not be given a copy of the Confidential Material to keep. Any Confidential Material distributed or disclosed to a Qualified Person who is a signatory of Exhibit "A" shall be returned to the Party's counsel who provided it to the Qualified Person or shall be destroyed at the completion of the Qualified Person's consultation or representation in this case.
8.
9.
a. The Designating Party bears the burden of establishing confidentiality.
b. Nothing in this Order shall constitute a waiver of any Party's right to object to the designation or non-designation of Documents, Testimony, or Information as Confidential Material.
c. If a Party contends that any Document, Testimony, or Information has been erroneously or improperly designated as Confidential Material, or has been improperly redacted, the material at issue shall be treated as confidential under the terms of this Order until:
d. In the event that counsel for a Party receiving Confidential Material in discovery objects to such designation, said counsel shall advise counsel for the Designating Party, in writing, of such objections, the specific Confidential Material (identified by Bates number, if possible) to which each objection pertains, and the reasons and support for such objections (the "Designation Objections").
e. Counsel for the Designating Party shall have 15 days from receipt of written Designation Objections, pertaining up to 100 documents, to meet and confer in good faith and respond in writing as to whether the designations will be maintained or withdrawn.
f. If the Parties are unable to resolve the dispute regarding the Designation Objections, the Party challenging the designations may file a motion with the Court seeking an order to de-designate (i.e., to rule to be not confidential) the Confidential Material subject to the Designation Objections (the "Designation Motion").
10.
11.
a. To protect against unauthorized disclosure of Confidential Discovery Material, and to comply with all applicable state and federal laws and regulations, the Producing Party may redact from produced documents, materials and other things, the following items:
b. Defendants reserve the right to redact information (including but not limited to proprietary financial material and products unrelated to this litigation) that is not relevant to plaintiffs' claims.
c. Pursuant to 21 C.F.R. §§ 314.430(e) & (f) and 20.63(f), the names of any person or persons reporting adverse experiences of patients and the names of any patients that are not redacted shall be treated as Confidential, regardless of whether the document containing such names is designated as Confidential Material.
d. Notwithstanding any of the foregoing provisions, nothing contained herein shall be construed as a waiver of a party's ability to challenge such redactions pursuant to the procedures set forth in Section 9 herein. The burden as to the propriety of any redaction remains on the Designating Party at all times.
12.
a. If another court or an administrative agency requests, subpoenas, or orders the disclosure of Confidential Material from a Party that has obtained such material under the terms of this Order, the Party so requested, subpoenaed, or ordered shall notify the Designating Party by electronic mail transmission, express mail, or overnight delivery to counsel of record for the Designating Party not later than ten (10) days prior to producing or disclosing any Confidential Material, and shall furnish such counsel with a copy of the requests, subpoena, or order. The recipient of the Subpoena shall not disclose any Confidential Material pursuant to the Subpoena prior to the date specified for production on the Subpoena.
b. Upon receipt of this notice, the Designating Party may, in its sole discretion and at its own cost, move to quash or limit the request, subpoena, or order, otherwise oppose the disclosure of the Confidential Material, or seek to obtain confidential treatment of such Confidential Material, to the fullest extent available under law, by the person or entity issuing the request, subpoena, or order.
13.
a. Upon the request of any Party after the final conclusion of this action (including without limitation any appeals and after the time for filing all appellate proceedings has passed), each Party shall destroy all Confidential Material or otherwise shall comply with an applicable order of the Court, subject to the exception described herein.
b. The destruction of Confidential Material under this paragraph shall include, without limitation, all copies, and duplicates thereof.
c. The Parties shall certify, within 60 days of receipt of a written request for certification, that all Confidential Material required to be destroyed have been so destroyed.
d. As an exception to the above requirements, and unless otherwise ordered by the Court, counsel may retain: (a) copies of pleadings or other papers that have been filed with the Court and that are Confidential Material or that reflect, reference, or contain Confidential Material; (b) their work product; and (c) transcripts and exhibits thereto. The terms and provisions of this Order shall continue to apply to any such materials retained by counsel.
14.
15.
a. The Parties have agreed that, in discovery in this lawsuit, they do not intend to disclose information subject to a claim of attorney-client privilege or attorney work product protection.
b.
c. If a Disclosing Party notifies the Receiving Party of Inadvertently Disclosed Information, the Receiving Party shall, within ten (10) court days: (i) return or destroy (or in the case of electronically stored information, delete) all copies of such information (including all notes or other work product of the Receiving Party reflecting the contents of the Inadvertently Disclosed Information) within their possession, custody, or control— and instruct experts, consultants, or others to whom the Inadvertently Disclosed Information was provided that all copies must be destroyed—and (ii) provide a certification of counsel that all such Inadvertently Disclosed Information has been returned or destroyed.
d. If the Receiving Party contests the claim of attorney-client privilege or work product protection, the Receiving Party may—within 10 business days of receipt of the notice of disclosure—move the Court for an Order compelling production of the Inadvertently Disclosed Information ("Disclosure Motion"). Such a Disclosure Motion shall be filed or lodged conditionally under seal. Pending resolution of the Disclosure Motion, the Receiving Party must not use the challenged information in any way or disclose it to any person other than those required by law to be served with a copy of the sealed Disclosure Motion. On any such Disclosure Motion, the Disclosing Party shall retain the burden of establishing its privilege or work product claims. Nothing in this paragraph shall limit the right of any Party to petition the Court for an in camera review of the Inadvertently Disclosed Information.
e.
16.
a. Inadvertent or unintentional disclosure, without the required confidentiality designation, of any Document, Testimony, or Information that the Disclosing Party intended to designate as Confidential Material ("inadvertent production") shall not be deemed a waiver in whole or in part of the producing Party's claim of confidentiality, either as to specific documents and information disclosed or as to the same or related subject matter. In the event that a Designating Party makes such an inadvertent production, that Party shall promptly inform the receiving Party or Parties in writing of the inadvertent production and the specific material at issue and promptly reproduce the Confidential Material with the required legend.
b. Upon receipt of such notice, the receiving Party or Parties shall treat the material identified in the notice as confidential; within ten court days of receiving notice of the inadvertently disclosed Confidential Material the receiving Party shall destroy all copies of such Confidential Material and instruct any parties to whom it has disclosed Confidential Material to destroy all copies of such Confidential Material.
I hereby attest to my understanding that information or documents designated as Confidential Discovery Material are provided to me subject to the Protective Order dated ______________, 2015 (the "Order"), in the above-captioned litigation ("Litigation"); that I have been given a copy of and have read the Order; and, that I agree to be bound by its terms. I also understand that my execution of this Endorsement of Protective Order, indicating my agreement to be bound by the Order, is a prerequisite to my review of any information or documents designated as Confidential Discovery Material pursuant to the Order.
I further agree that I shall not disclose to others, except in accord with the Order, any Confidential Discovery Material, in any form whatsoever, and that such Confidential Discovery Material may be used only for the purposes authorized by the Order.
I further agree to return all copies of any Confidential Discovery Material or any document or thing containing Confidential Discovery Material I have received to counsel who provided them to me, or to destroy such materials, upon completion of the purpose for which they were provided and no later than the conclusion of this Litigation.
I further agree and attest to my understanding that my obligation to honor the confidentiality of such Confidential Discovery Material will continue even after this Litigation concludes.
I further agree and attest to my understanding that, if I fail to abide by the terms of the Order, I may be subject to sanctions, including contempt of court, for such failure. I agree to be subject to the jurisdiction of the [___________], for the purposes of any proceedings relating to enforcement of the Order. I further agree to be bound by and to comply with the terms of the Order as soon as I sign this Agreement, regardless of whether the Order has been entered by the Court.