REGENXBIO, Inc. v. FOOD AND DRUG ADMINISTRATION et al
| REGENXBIO, Inc. |
| FOOD AND DRUG ADMINISTRATION, EDWARD THOMPSON, UNITED STATES OF AMERICA, BRETT GIROIR, ALEX M. AZAR II and ALEX M. AZAR, II |
| 1:2019cv03373 |
| November 7, 2019 |
| US District Court for the District of Columbia |
| Randolph D Moss |
| Administrative Procedure Act/Review or Appeal of Agency Decision |
| 05 U.S.C. § 551 |
| None |
Docket Report
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This docket was last retrieved on December 13, 2019. A more recent docket listing may be available from PACER.
| Document Text |
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MINUTE ORDER: Upon consideration of Defendants' motion for leave to file document under seal, Dkt. #25 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that, on or before December 20, 2019: (1) Plaintiff shall review the contents of the Combined Memorandum for confidential commercial information, and (2) Defendants shall file on the public record a redacted version of the Combined Memorandum reflecting Plaintiffs review. Signed by Judge Randolph D. Moss on 12/13/19. (lcrdm1)
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| Filing 28 TRANSCRIPT OF PROCEEDINGS before Judge Randolph D. Moss held on 12/4/19; Page Numbers: 1-80. Court Reporter/Transcriber Sara A. Wick, RPR, CRR, Telephone number 202-354-3284, Transcripts may be ordered by submitting the #Transcript Order FormFor the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter.NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 1/1/2020. Redacted Transcript Deadline set for 1/11/2020. Release of Transcript Restriction set for 3/10/2020.(ztnr) |
| Filing 27 Memorandum in opposition to re 19 MOTION Strike (Public Version) filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA. (Harlow, James) |
| Filing 26 REPLY to opposition to motion re #12 MOTION to Dismiss for Failure to State a Claim MOTION to Dismiss for Lack of Jurisdiction (Public Version) filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA. (Harlow, James) |
| Filing 25 MOTION for Leave to File Document Under Seal (Public Version) by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA (Harlow, James) |
| Filing 24 Memorandum in opposition to re #4 MOTION for Preliminary Injunction or in the Alternative, For Expedited Summary Judgment MOTION for Summary Judgment (Redacted Public Version) filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA. (Harlow, James) |
| Minute Entry for proceedings held before Judge Randolph D. Moss: Motion Hearing held on 12/4/2019 re: #4 MOTION for Preliminary Injunction or in the Alternative, For Expedited Summary Judgment MOTION for Summary Judgment filed by REGENXBIO, INC. The parties are ORDERED to continue to meet and confer. Administrative Record due by 1/13/2020. Motion Hearing set for 1/22/2020, at 10:00 AM, in Courtroom 21, before Judge Randolph D. Moss. (Court Reporter: Sara Wick.) (kt) |
| Filing 23 SEALED OPPOSITION filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA re 19 MOTION Strike (ztd) |
| Filing 22 SEALED REPLY TO OPPOSITION filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA re #12 MOTION to Dismiss for Failure to State a Claim MOTION to Dismiss for Lack of Jurisdiction (This document is SEALED and only available to authorized persons.)(ztd) |
| Filing 21 SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA (This document is SEALED and only available to authorized persons.) (Attachments: #1 Text of Proposed Order, #2 Exhibit Defendants' Combined Reply in Support of Motion to Dismiss, and Opposition to Plaintiff's Motion to Strike)(Harlow, James) |
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MINUTE ORDER: Upon consideration of Defendants' motion for leave to file document under seal, Dkt. #21 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that Defendants may file under seal their combined reply in support of their motion to dismiss and in opposition to Plaintiff's motion to strike; it is further ORDERED that Defendants shall file a redacted public version of the Combined Memorandum after Plaintiff REGENXBIO Inc. completes its review for confidential commercial information; and it is further ORDERED that Defendants shall file a public version (redacted if necessary) of their motion for leave to file document under seal on or before December 10, 2019. Signed by Judge Randolph D. Moss on 12/3/19. (lcrdm1)
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| Filing 20 SEALED DOCUMENT filed by REGENXBIO, INC.. (This document is SEALED and only available to authorized persons.) (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Exhibit C, #4 Exhibit D, #5 Exhibit E, #6 Exhibit F, #7 Exhibit G)(ztd) |
| Filing 19 MOTION Strike by REGENXBIO, INC. (ztd); (See docket entry no. #16 to view.) |
| Filing 18 Memorandum in opposition to re #12 MOTION to Dismiss for Failure to State a Claim MOTION to Dismiss for Lack of Jurisdiction filed by REGENXBIO, INC.. (ztd); (See docket entry no. #16 to view.) |
| Filing 17 SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by REGENXBIO, INC. (This document is SEALED and only available to authorized persons.) (Attachments: #1 Text of Proposed Order, #2 Declaration of Kenneth Mills, #3 Exhibit A, #4 Exhibit B, #5 Exhibit C, #6 Exhibit D, #7 Exhibit E, #8 Exhibit F, #9 Exhibit G)(Vergonis, Christian) |
| Filing 16 REPLY to opposition to motion re #4 MOTION for Preliminary Injunction or in the Alternative, For Expedited Summary Judgment MOTION for Summary Judgment, #12 MOTION to Dismiss for Failure to State a Claim MOTION to Dismiss for Lack of Jurisdiction filed by REGENXBIO, INC.. (Vergonis, Christian) |
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MINUTE ORDER: Upon consideration of Plaintiff's motion for leave to file supplemental and attached exhibits under seal, Dkt. #17 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that Plaintiff may file the Supplemental Mills Declaration and Exhibits A-G to that Declaration under seal. Signed by Judge Randolph D. Moss on 11/26/19. (lcrdm1)
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| Filing 15 SEALED REPLY TO OPPOSITION filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA re #12 MOTION to Dismiss for Failure to State a Claim MOTION to Dismiss for Lack of Jurisdiction (This document is SEALED and only available to authorized persons.)(ztd); (See docket entry no. #14 to view.) |
| Filing 14 SEALED OPPOSITION filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA re #4 MOTION for Preliminary Injunction or in the Alternative, For Expedited Summary Judgment MOTION for Summary Judgment (Attachments: #1 Exhibit Declaration, #2 Exhibit)(ztd) |
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MINUTE ORDER: Upon consideration of Defendants' consent motion for leave to file document under seal, Dkt. #13 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that Defendants may file under seal their Combined Memorandum in Support of Their Motion to Dismiss and in Opposition to Plaintiffs Motion for a Preliminary Injunction or Alternatively Summary Judgment, as well as Exhibits 1 and 2 to the Bryan Declaration. Signed by Judge Randolph D. Moss on 11/24/19. (lcrdm1)
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| Filing 13 SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA (This document is SEALED and only available to authorized persons.) (Attachments: #1 Text of Proposed Order, #2 Exhibit Defendants Combined Memorandum, #3 Exhibit 1, Bryan Decl., #4 Exhibit 2, Bryan Decl.)(Harlow, James) |
| Filing 12 MOTION to Dismiss for Failure to State a Claim, MOTION to Dismiss for Lack of Jurisdiction by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA (Attachments: #1 Memorandum in Support, #2 Text of Proposed Order, #3 Declaration of James W. Harlow, #4 Exhibit 1, Harlow Decl., #5 Exhibit 2, Harlow Decl., #6 Exhibit 3, Harlow Decl., #7 Exhibit 4, Harlow Decl., #8 Exhibit 5, Harlow Decl., #9 Declaration of Wilson Bryan, #10 Exhibit 1, Bryan Decl., #11 Exhibit 2, Bryan Decl.)(Harlow, James) |
| Filing 11 Memorandum in opposition to re #4 MOTION for Preliminary Injunction or in the Alternative, For Expedited Summary Judgment MOTION for Summary Judgment filed by ALEX M. AZAR, II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA. (Harlow, James) |
| Minute Entry for proceedings held before Judge Randolph D. Moss: Status Conference held on 11/20/2019. A Preliminary Injunction Hearing is set for 12/4/2019, at 10:00 AM, in Courtroom 21, before Judge Randolph D. Moss. (Court Reporter: Jeff Hook.) (kt) |
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Filing 10
STANDING ORDER: The parties are hereby ORDERED to comply with the directives set forth in the attached Standing Order. See document for details. Signed by Judge Randolph D. Moss on 11/15/19. (lcrdm1)
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| Filing 9 Case randomly reassigned to Judge Randolph D. Moss. Judge Richard J. Leon is no longer assigned to the case. (rj) |
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MINUTE ORDER: In light of the pending motion for preliminary injunction, Dkt. #4 , and this case's recent reassignment to Judge Moss, it is hereby ORDERED that the parties shall appear for a status conference on Wednesday, November 20, 2019 at 10:00 a.m. Signed by Judge Randolph D. Moss on 11/15/19. (lcrdm1)
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| Filing 8 NOTICE of Appearance by Kaytlin L. Roholt on behalf of REGENXBIO, Inc. (Roholt, Kaytlin) |
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MINUTE ORDER. The briefing schedule for Plaintiff's Motion for Preliminary Injunction is as follows: Defendants' brief due by 11/22/2019; Plaintiff's reply due at noon 11/26/2019; Preliminary Injunction Hearing set for 12/3/2019 at 03:00 PM in Courtroom 18 before Judge Richard J. Leon. SO ORDERED. Signed by Judge Richard J. Leon on 11/13/2019. (lcrjl1)
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| Set/Reset Deadlines/Hearings: Defendants' brief due by 11/22/2019; Plaintiff's reply due at noon on 11/26/2019; Preliminary Injunction Hearing set for 12/3/2019, at 3:00 PM in Courtroom 18 before Judge Richard J. Leon. (tg) |
| Filing 7 NOTICE of Appearance by James William Harlow on behalf of All Defendants (Harlow, James) |
| Filing 6 SUMMONS (6) Issued Electronically as to ALEX M. AZAR II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, U.S. Attorney and U.S. Attorney General (Attachments: #1 Notice and Consent)(zrdj) |
| Filing 5 LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by REGENXBIO, Inc. (Vergonis, Christian) |
| Case Assigned to Judge Richard J. Leon. (zrdj) |
| Filing 4 MOTION for Preliminary Injunction or in the Alternative, For Expedited Summary Judgment by REGENXBIO, Inc. (Attachments: #1 Memorandum in Support, #2 Text of Proposed Order, #3 Declaration of Kenneth T. Mills, #4 Exhibit A, #5 Exhibit B)(Vergonis, Christian). Added MOTION for Summary Judgment on 11/12/2019 (zrdj). |
| Filing 3 REQUEST FOR SUMMONS TO ISSUE re #1 Complaint, filed by REGENXBIO, Inc.. Related document: #1 Complaint, filed by REGENXBIO, Inc.. (Attachments: #1 Summons, #2 Summons, #3 Summons, #4 Summons, #5 Summons)(Vergonis, Christian) |
| Filing 2 CIVIL COVER SHEET by REGENXBIO, Inc. re #1 Complaint, filed by REGENXBIO, Inc.. Related document: #1 Complaint, filed by REGENXBIO, Inc..(Vergonis, Christian) |
| Filing 1 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF against ALEX M. AZAR II, FOOD AND DRUG ADMINISTRATION, BRETT GIROIR, EDWARD THOMPSON, UNITED STATES OF AMERICA ( Filing fee $ 400 receipt number ADCDC-6519876) filed by REGENXBIO, Inc..(Vergonis, Christian) |
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