Biotech Values

[mouton29]

<<I only see ten documents linked here; where are the other 12?>>

Here is a cut and paste from the docket of all documents filed.

Date Filed # Docket Text
07/26/2010 1 COMPLAINT against FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS ( Filing fee $ 350, receipt number 4616031454) filed by SANOFI-AVENTIS U.S. LLC. (Attachments:# 1 Memorandum In Support # 2 Declaration Scott L. Cunningham, # 3 Civil Cover Sheet)(dr) Modified on 7/29/2010 to omit Memorandum in Support from Docket Entry and add to 3 Motion for TRO/PI (dr). (Entered: 07/26/2010)
07/26/2010 SUMMONS Not Issued as to FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS (dr) (Entered: 07/26/2010)

07/26/2010 2 LCvR 7.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by SANOFI-AVENTIS U.S. LLC identifying Corporate Parent SANOFI-AVENTIS for SANOFI-AVENTIS U.S. LLC. (dr) (Entered: 07/26/2010)

07/26/2010 3 MOTION for Temporary Restraining Order, MOTION for Preliminary Injunction by SANOFI-AVENTIS U.S. LLC (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P, # 17 Exhibit 65.1)(dr) (Additional attachment(s) added on 7/29/2010: # 18 Memorandum in Support) (dr). Modified on 7/29/2010 to add Memorandum in Support incorrectly filed with Complaint (dr). (Entered: 07/26/2010)

07/26/2010 4 NOTICE of Appearance by Andrew E. Clark on behalf of FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS (Clark, Andrew) (Entered: 07/26/2010)
07/26/2010 MINUTE ORDER. On July 26, 2010, the Court held a telephonic status conference with counsel for plaintiff, counsel for the federal defendants, and counsel for the proposed defendant-intervenor Sandoz Inc. ("Sandoz"). During this status conference, plaintiff informed the Court that it consents to having its motion for a temporary restraining order consolidated with its motion for preliminary injunction. The Court was also informed that Sandoz would be filing a consent motion to intervene on July 27, 2010, which the Court informed the parties that it would grant. Accordingly, the Court ordered expedited briefing on plaintiff's motion for preliminary injunction and entered the following briefing schedule: the federal defendants' opposition to plaintiff's motion for preliminary injunction shall be filed by no later than August 4, 2010. The opposition of defendant-intervenor shall be filed by no later than August 6, 2010; briefing by defendant-intervenor must be tailored to supplement - not to duplicate - the arguments of the federal defendants. Plaintiff's consolidated reply shall be filed by no later than August 11, 2010. A hearing on the motion will be held on August 17, 2010 at 10:30 a.m. in Courtroom 24A. The parties are further directed to deliver to the chambers of the Honorable Emmet G. Sullivan two copies of their pleadings and exhibits as well as binders containing one copy of the principal points and authorities relied upon by the parties (i.e., counsel should provide copies of principal cases, statutes, regulations, etc., but need not provide copies of cases relied upon merely for the standard of review or other well-established principals). In addition, the federal defendants shall file the administrative record with the Court by no later than August 4, 2010. Binders containing one copy of the administrative record shall also be delivered to the chambers of the Honorable Emmet G. Sullivan. Signed by Judge Emmet G. Sullivan on July 26, 2010. (lcegs1) (Entered: 07/26/2010)
07/27/2010 Set/Reset Deadlines/Hearings: Federal Defendant's opposition to the Motion for Preliminary Injunction due by 8/4/2010; defendant-intervenor opposition due by 8/6/10; Replies due by 8/11/2010. Motion Hearing set for 8/17/2010 10:30 AM in Courtroom 24A before Judge Emmet G. Sullivan. (clv, ) (Entered: 07/27/2010)

07/27/2010 5 NOTICE of Appearance by Emily Johnson Henn on behalf of SANOFI-AVENTIS U.S. LLC (Henn, Emily) (Entered: 07/27/2010)

07/27/2010 6 MOTION to Intervene by SANDOZ INC. (Attachments: # 1 Memorandum in Support, # 2 Text of Proposed Order, # 3 Motion for Pro Hac Vice - Milne, # 4 Affidavit Milne, # 5 Text of Proposed Order, # 6 Motion for Pro Hac Vice - Morioka, # 7 Affidavit Morioka, # 8 Text of Proposed Order, # 9 Motion for Pro Hac Vice - Pace, # 10 Affidavit Pace, # 11 Text of Proposed Order, # 12 Corporate Disclosure Statement)(rdj) (Entered: 07/28/2010)
07/28/2010 MINUTE ORDER granting 6 Sandoz Inc.'s Unopposed Motion for Leave to Intervene. Sandoz Inc. is given leave to intervene as a defendant in this action. Signed by Judge Emmet G. Sullivan on July 28, 2010. (lcegs1) (Entered: 07/28/2010)

07/28/2010 7 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Robert A. Milne, :Firm- White & Case LLP, :Address- 1155 Avenue of the Americas, New York, New York 10036. Phone No. - 212-819-8200. by SANDOZ INC. (jf, ) (Entered: 07/29/2010)

07/28/2010 8 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Leslie Morioka, :Firm- White & Case LLP, :Address- 1155 Avenue of the Americas, New York, New York 10036. Phone No. - 212-819-8200. by SANDOZ INC. (jf, ) (Entered: 07/29/2010)

07/28/2010 9 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Jack E. Pace III, :Firm- White & Case LLP,, :Address- 1155 Avenue of the Americas, New York, New York 10036. Phone No. - 212-819-8200. by SANDOZ INC. (jf, ) (Entered: 07/29/2010)

07/28/2010 10 LCvR 7.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by SANDOZ INC. identifying Corporate Parent NOVARTIS AG for SANDOZ INC.. (jf, ) (Entered: 07/29/2010)
08/02/2010 MINUTE ORDER granting 7 Motion for Leave to Appear Pro Hac Vice. Robert A. Milne is admitted pro hac vice in this action. Signed by Judge Emmet G. Sullivan on August 2, 2010. (lcegs1) (Entered: 08/02/2010)
08/02/2010 MINUTE ORDER granting 8 Motion for Leave to Appear Pro Hac Vice. Leslie Morioka is admitted pro hac vice in this action. Signed by Judge Emmet G. Sullivan on August 2, 2010. (lcegs1) (Entered: 08/02/2010)
08/02/2010 MINUTE ORDER granting 9 Motion for Leave to Appear Pro Hac Vice. Jack E. Pace III is admitted pro hac vice in this action. Signed by Judge Emmet G. Sullivan on August 2, 2010. (lcegs1) (Entered: 08/02/2010)

08/02/2010 11 MOTION for Leave to File a Brief Amicus Curiae by AARP (Attachments: # 1 Proposed Amicus Brief, # 2 Rule 7.1 Certificate)(znmw, ) (Entered: 08/02/2010)
08/02/2010 MINUTE ORDER granting 11 Unopposed Motion of AARP for Leave to File a Brief Amicus Curiae in Support of Defendants. AARP's amicus curiae brief is hereby deemed filed. Signed by Judge Emmet G. Sullivan on August 2, 2010. (lcegs1) (Entered: 08/02/2010)

08/02/2010 12 AMICUS BRIEF by AARP. (jf, ) (Entered: 08/03/2010)

08/02/2010 13 LCvR 7.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests NONE by AARP. (jf, ) (Entered: 08/03/2010)

08/04/2010 14 NOTICE of Motion to Seal Portions of Administrative Record by FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS (Attachments: # 1 Text of Proposed Order)(Clark, Andrew) (Entered: 08/04/2010)

08/04/2010 15 NOTICE of Filing Administrative Record by FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS (Clark, Andrew) (Entered: 08/04/2010)
08/04/2010 MINUTE ORDER granting 14 the federal defendants' consent motion to seal. Those portions of the administrative record that are labeled, "Confidential, Subject to the Court's Protective Order," shall be placed under seal. Signed by Judge Emmet G. Sullivan on August 4, 2010. (lcegs1) (Entered: 08/04/2010)

08/04/2010 16 Memorandum in opposition to re 3 MOTION for Temporary Restraining Order MOTION for Preliminary Injunction filed by FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS. (Clark, Andrew) (Entered: 08/04/2010)
08/05/2010 NOTICE OF CORRECTED DOCKET ENTRY: Document No. re 15 Notice of Filing Administrative Record was entered in error and counsel was instructed to refile said pleading using the correct category. (jf, ) (Entered: 08/05/2010)

08/05/2010 17 ADMINISTRATIVE RECORD by FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS. (Clark, Andrew) (Entered: 08/05/2010)

08/05/2010 18 ENTERED IN ERROR.....NOTICE of Appearance by William Barnett Schultz on behalf of SANDOZ INC. (Schultz, William) Modified on 8/6/2010 (jf, ). (Entered: 08/05/2010)
08/06/2010 NOTICE OF CORRECTED DOCKET ENTRY: Document No. re 18 Notice of Appearance on behalf of Carlos Angulo was entered in error. Counsel is not a member of this Court.(jf, ) (Entered: 08/06/2010)

08/06/2010 19 NOTICE of Appearance by William Barnett Schultz on behalf of SANDOZ INC. (Schultz, William) (Entered: 08/06/2010)

08/06/2010 20 Memorandum in opposition to re 3 MOTION for Temporary Restraining Order MOTION for Preliminary Injunction / Sandoz Inc.'s Memorandum of Points and Authorities in Opposition to Plaintiff Sanofi-Aventis US LLC's Application for Temporary Restraining Order and Preliminary Injunction filed by SANDOZ INC.. (Attachments: # 1 Declaration of Robert M. Milne, # 2 Exhibit 1 to Milne Declaration, # 3 Exhibit 2 to Milne Declaration, # 4 Exhibit 3 to Milne Declaration, # 5 Exhibit 4 to Milne Declaration, # 6 Exhibit 5 to Milne Declaration, # 7 Exhibit 6 to Milne Declaration, # 8 Exhibit 7 to Milne Declaration, # 9 Exhibit 8 to Milne Declaration, # 10 Exhibit 9(a) to Milne Declaration, # 11 Exhibit 9(b) to Milne Declaration, # 12 Exhibit 9(c) to Milne Declaration, # 13 Exhibit 9(d) to Milne Declaration, # 14 Exhibit 9(e) to Milne Declaration, # 15 Exhibit 9(f) to Milne Declaration, # 16 Exhibit 9(g) to Milne Declaration, # 17 Exhibit 9(h) to Milne Declaration, # 18 Exhibit 9(i) to Milne Declaration, # 19 Exhibit 9(j) to Milne Declaration, # 20 Exhibit 9(k) to Milne Declaration, # 21 Exhibit 9(l) to Milne Declaration, # 22 Exhibit 9(m) to Milne Declaration, # 23 Exhibit 9(n) to Milne Declaration, # 24 Exhibit 9(o) to Milne Declaration, # 25 Exhibit 9(p) to Milne Declaration, # 26 Exhibit 10 to Milne Declaration, # 27 Declaration of Craig A. Wheeler, # 28 Declaration of David Picard, # 29 Declaration of Jeffrey May, # 30 Declaration of John B. Kostis, M.D., F.A.C.P., F.A.C.C., # 31 Declaration of Thomas C. Crawford, Ph.D., # 32 Text of Proposed Order)(Vasquez, Francis) (Entered: 08/06/2010)

08/11/2010 21 REPLY to opposition to motion re 3 MOTION for Temporary Restraining Order MOTION for Preliminary Injunction filed by SANOFI-AVENTIS U.S. LLC. (Attachments: # 1 Appendix Addendum)(Henn, Emily) (Entered: 08/11/2010)
08/14/2010 MINUTE ORDER. The federal defendants are hereby directed to file a surreply by no later than 3:00 p.m. on August 16, 2010. In addition, the federal defendants are directed to make Dr. Keith O. Webber, Deputy Director of the Center for Drug Evaluation and Research's Office of Pharmaceutical Science available to testify at the hearing on August 17, 2010. In the event that Dr. Webber is unavailable, the federal defendants shall notify the Court and the parties of his unavailability by filing an electronic notice, and shall identify an individual to testify on his behalf. Dr. Webber, or any individual designated to testify on his behalf, shall be prepared to answer the Court's questions regarding impurities and immunogenicity. Finally, the hearing scheduled for August 17, 2010 at 10:30 a.m. will now take place on August 17, 2010 at 10:00 a.m. in Courtroom 24A. PLEASE NOTE THE TIME CHANGE. The Court regrets any inconvenience to the parties. Signed by Judge Emmet G. Sullivan on August 14, 2010. (lcegs1) (Entered: 08/14/2010)
08/16/2010 Set/Reset Deadlines/Hearings: federal defendants surreply due by 3:00 p.m. on 8/16/2010. Motion Hearing set for 8/17/2010 10:00 AM in Courtroom 24A before Judge Emmet G. Sullivan. (clv, ) (Entered: 08/16/2010)

08/16/2010 22 SURREPLY to re 3 MOTION for Temporary Restraining Order MOTION for Preliminary Injunction filed by FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS. (Attachments: # 1 Exhibit)(Clark, Andrew) (Entered: 08/16/2010)
08/16/2010 23 NOTICE of Unavailability by FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS (Clark, Andrew) (Entered: 08/16/2010)