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Pharma International Limited v. Anchen Pharmaceuticals

March 1, 2010

PHARMA INTERNATIONAL LIMITED AND JAZZ PHARMACEUTICALS, INC., PLAINTIFFS,
v.
ANCHEN PHARMACEUTICALS, INC. AND ANCHEN, INC., DEFENDANTS.



The opinion of the court was delivered by: The Hon. Mariana R. Pfaelzer

STIPULATED PROTECTIVE ORDER

Complaint Filed: Oct. 14, 2009

Elan Pharma International Limited and Jazz Pharmaceuticals, Inc., ("Plaintiffs") and Anchen Pharmaceuticals, Inc. and Anchen, Inc. ("Defendants") (individually, a "Party," collectively, the "Parties") have stipulated to this Order by their undersigned counsel.

The Parties represent that pre-trial discovery in this case will necessarily include matters that are confidential and proprietary to the on-going business of the Parties and may require the production of the Parties' respective research and development efforts, clinical trials, proprietary product formulations, methods of manufacture, and material non-public financial information.

Such information falls within recognized categories of information that may be protected from public disclosure through confidentiality designations under a protective order. See Fed. R. Civ. Proc. 26(c)(1)(G) (allowing protection of "trade secret or other confidential research, development or commercial information").

The Parties further represent that public disclosure of such material poses a substantial risk of great economic harm in that discovery of a Party's trade secrets and other proprietary commercial information would put the party at a competitive disadvantage and would be a windfall to the discovering (competing) Party.

For the foregoing reasons, good cause exists for entry of this Order to facilitate pre-trial disclosure while assuring the safety of these sensitive disclosures. See Fed. R. Civ. Proc. 26(c).

This Order shall apply to pre-trial out-of-court discovery and pre-trial filings with the Court, to include any third party discovery. The parties agree to confer in good faith, in consultation with the Court, in establishing procedures for the use of materials designated as confidential in any evidentiary hearing or trial, which may include a request to close the Courtroom when confidential information may be revealed in the course of such hearing or trial. In the absence of an agreement of the parties or further order of the Court, no confidential materials may be used in any public hearing. This Order does not restrict or govern the use of any materials at trial.

IT IS HEREBY ORDERED that the following provisions shall govern the conduct of pre-trial proceedings in this action.

1. This Stipulated Protective Order (the "Order") shall govern the handling and treatment of all confidential, trade secret, or proprietary documents, materials and other information, including deposition testimony and deposition transcripts that are produced or provided in the course of pre-trial discovery and preparation for trial in case SACV09-01193 (the "Litigation").

2. The period of time within which any action must or can be performed pursuant to this Order shall be calculated in accordance with Rule 6 of the Federal Rules of Civil Procedure.

3. Discovery Material (as defined in Paragraph 6 below) designated by any Producing Party as "CONFIDENTIAL" under the provisions of this Order shall be used solely for purposes of the preparation and trial of the Litigation, for any related appellate proceeding, and for no other purpose. For purposes of this Order, the term "Producing Party" means any party to this action or any third party, including its counsel, retained experts, directors, officers, employees, or agents, who produces any Discovery Material. The term "Receiving Party" means any party to this action or any third party, including its counsel, retained experts, directors, officers, employees, or agents, who receives any Discovery Material.

4. This Order shall apply to all information, documents and other items subject to discovery in this Litigation, including without limitation testimony adduced at depositions upon oral examination or upon written questions pursuant to Rules 30 and 31, answers to interrogatories pursuant to Rule 33, documents produced pursuant to Rule 34, information obtained from inspection of premises or things pursuant to Rule 34, answers to requests for admission pursuant to Rule 36, and documents, things, or testimony obtained from non-parties pursuant to Rule 45, and regardless of whether the material is filed with the Court.

5. For purposes of this Order, the term "document" means all tangible things which come within the meaning of "writing" contained in Rule 1001 of the Federal Rules of Evidence, or within the meaning of "document" or "tangible thing" contained in Rule 34 of the Federal Rules of Civil Procedure.

6. The term "Discovery Material" means any document, material, item, testimony, or thing filed with or presented to the Court or produced, served, or generated during the discovery process, including, for example, production documents, product samples and any information or data derived from such samples, exhibits, answers to interrogatories, responses to requests for admissions, responses to requests for production, subpoenas, declarations, affidavits, and deposition testimony or transcripts, and all copies, extracts, summaries, compilations, designations, and portions thereof.

7. A Party may designate as "CONFIDENTIAL" any Discovery Material (including discovery responses or portions thereof) that is not publicly known and contains or discloses information relating to, referencing, or pertaining to highly sensitive or highly proprietary technical, business or personal information, the improper use or disclosure of which could do harm to the Producing Party's business, employees, or other persons, including but not limited to confidential customer lists, trade secrets relating to current or future products, non-public documents concerning pending patent applications, documents providing the formulation ingredients and amounts, and non-public FDA filings and/or FDA communications or drafts thereof, provided that such materials meet the definition of CONFIDENTIAL Discovery Material contained in this paragraph. The designation "Confidential" shall be made by stamping or writing the words "CONFIDENTIAL -- SUBJECT TO PROTECTIVE ORDER" on each page of the Discovery Material so designated. Discovery Material that is designated CONFIDENTIAL may be disclosed only to the individuals identified in Paragraph 13, infra. Discovery Material that is designated CONFIDENTIAL must be used solely for the Litigation and the preparation and trial of the Litigation, or in any related appellate proceedings. The Discovery Material and any information contained therein shall not be used for any other purpose, directly or indirectly, including without limitation any other litigation, any patent prosecution, or any communication with the FDA.

8. Discovery Material designated as "CONFIDENTIAL" in accordance with the terms of this Order and the information contained therein hereinafter is referred to collectively as "Confidential Material." All Confidential Material not reduced to documentary or tangible form or which cannot reasonably be designated in the manner set forth in Paragraph 7, supra, shall be designated as "CONFIDENTIAL" by informing the Receiving Party of such designation in writing contemporaneous with the production of the Confidential Material and by labeling the container for such Confidential Material with the appropriate legend.

9. Each person to whom Confidential Material is to be given, shown, disclosed, made available or communicated in any way in accordance with this Order and who is required to do so pursuant to Paragraph 13, shall first execute an Acknowledgement of Stipulated Protective Order in substantially the form shown in Exhibit A ("Acknowledgment"). An executed Acknowledgement shall be deemed a discovery paper and served in accordance with Rule 5 of the Federal Rules of Civil Procedure, or as agreed by the Parties. All Confidential Material must be used solely for the Litigation and the preparation and trial of the Litigation, or any related appellate proceedings, and not for any other purpose, including without limitation any other litigation, any patent prosecution, or any communication with the FDA.

10. A non-party to the Litigation (e.g., a third party producing Discovery Material pursuant to subpoena) may designate any Discovery Material as "CONFIDENTIAL" as set forth in Paragraph 7, supra. If so designated, such Discovery Materials shall be subject to the same restrictions and conditions as Discovery Materials designated by any Party as CONFIDENTIAL.

11. Notwithstanding the foregoing, a Producing Party's or producing nonparty's inadvertent failure to designate its Discovery Material as CONFIDENTIAL as set forth in Paragraph 7, supra, shall not constitute a waiver of any claim that the Discovery Material is entitled to protection under this Order, provided that the Producing Party notifies all Receiving Parties that such Discovery Material is CONFIDENTIAL within a reasonable amount of time from when the failure to designate first became known to the Producing Party. Within a reasonable time of learning of its inadvertent failure to designate its Discovery Material as CONFIDENTIAL, any Party or non-party may so designate its Discovery Material as CONFIDENTIAL, or may correct any mis-designation, with the effect that the Discovery Material thereafter shall be subject to the protections of this Order as if the desired designation originally had been made. In the event that a belated designation is made, each Receiving Party promptly shall take all reasonable steps to implement the designation in accordance with the Federal Rules of Civil Procedure.

12. A Party or non-party may designate any deposition transcript or portion thereof as "CONFIDENTIAL" by so stating on the record or by giving notice in writing to the other Parties and non-parties within ten (10) calendar days of receipt of the deposition transcript, prior to which time all deposition transcripts shall be treated as CONFIDENTIAL in their entirety. Whenever Confidential Material is expected to be disclosed in a deposition, a Party or non-party expecting to make a confidentiality designation shall have the right to exclude from attendance at the deposition every person except the deponent, the stenographer, the videographer, and those individuals authorized under Paragraphs 13 and 14 of this Order, infra, to receive the Confidential Material. All designations of confidentiality shall be made reasonably and in good faith. In the event the deposition is videotaped, the original and all copies of the videotape shall be marked by the video technician to indicate that the contents of the videotape are subject to the Order, substantially as set forth below:

This videotape contains confidential testimony used in this case and is not to be viewed or the contents thereof to be displayed or revealed except by order of the Court, or ...


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