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Case 1:08-cv-00347-GMS

Document 108

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CLOSED, EGT, MEDREQ, STAYED

U.S. District Court Southern District of Florida (Ft. Lauderdale) CIVIL DOCKET FOR CASE #: 0:07-cv-61800-FAM

Sanofi-Aventis et al v. Apotex, Inc. et al Assigned to: Chief Judge Federico A. Moreno Referred to: Magistrate Judge Edwin G. Torres Cause: 35:0271 Patent Infringement Plaintiff Sanofi-Aventis

Date Filed: 12/10/2007 Date Terminated: 04/29/2008 Jury Demand: Defendant Nature of Suit: 830 Patent Jurisdiction: Federal Question

represented by Alfred John Saikali Shook Hardy & Bacon 201 S Biscayne Boulevard Suite 2400 Miami, FL 33131-4332 305-358-5171 Fax: 305-358-7470 Email: [email protected] LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton Kirkland & Ellis 153 E 53rd Street New York, NY 10022-4611 212-446-4800 Email: [email protected] ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. Kirkland & Ellis 153 E 53rd Street New York, NY 10022-4611 212-446-4800 Email: [email protected] ATTORNEY TO BE NOTICED John M. Desmarais Kirkland & Ellis 153 E 53rd Street New York, NY 10022-4611 212-446-4800 Fax: 446-4900

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Email: [email protected] ATTORNEY TO BE NOTICED William T. Vuk Kirkland & Ellis 153 E 53rd Street New York, NY 10022-4611 212-446-4800 Email: [email protected] ATTORNEY TO BE NOTICED Plaintiff Sanofi-Aventis, U.S. LLC represented by Alfred John Saikali (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address) ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED V. Defendant Apotex, Inc. represented by Jennifer Rae Coberly Zuckerman Spaeder Taylor & Evans 201 S Biscayne Boulevard Suite 900 Miami, FL 33131 305-358-5000 Fax: 579-9749 Email: [email protected] TERMINATED: 04/09/2008 LEAD ATTORNEY Stephen Jay Bronis Carlton Fields, P.A. 100 SE 2nd Street

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Suite 4000 Miami, FL 33131 305-530-0050 Fax: 305-530-0055 Email: [email protected] LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White Welsh & Katz 120 S Riverside Plaza 22nd Floor Chicago, IL 60606 312-655-1500 Fax: 312-655-1501 Email: [email protected] ATTORNEY TO BE NOTICED Laurel White Marc-Charles Richard & Richard 825 Brickell Bay Drive Suite 1748 Tower III Miami, FL 33131-2961 305-374-6688 Fax: 374-0384 Email: [email protected] ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. Welsh & Katz 120 S Riverside Plaza 22nd Floor Chicago, IL 60606 312-655-1500 Fax: 312-655-1501 Email: [email protected] ATTORNEY TO BE NOTICED Robert Burton Breisblatt Katten Muchin Rosenman LLP 525 West Monroe Street Chicago, IL 60661-3693 312-902-5200 Fax: 312-902-1061 Email: [email protected] TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo

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Welsh & Katz 120 S Riverside Plaza 22nd Floor Chicago, IL 60606 312-655-1500 Fax: 312-655-1501 Email: [email protected] ATTORNEY TO BE NOTICED Steven E. Feldman Welsh & Katz 120 S Riverside Plaza 22nd Floor Chicago, IL 60606 312-655-1500 Fax: 312-655-1501 Email: [email protected] ATTORNEY TO BE NOTICED Walter J. Tache Carlton Fields 4000 International Place 100 S.E. Second Street Miami, FL 33131-2114 305-530-0050 Fax: 530-0055 Email: [email protected] TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED Defendant Apotex Corp. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Stephen Jay Bronis (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White (See above for address) ATTORNEY TO BE NOTICED Laurel White Marc-Charles (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr.

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(See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman (See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED Counter Claimant Apotex, Inc. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Laurel White Marc-Charles (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. (See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman

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(See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED Counter Claimant Apotex Corp. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Laurel White Marc-Charles (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. (See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman (See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED V. Counter Defendant Sanofi-Aventis represented by Alexis Gorton (See above for address)

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ATTORNEY TO BE NOTICED Alfred John Saikali (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address) ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED Counter Defendant Sanofi-Aventis, U.S. LLC represented by Alfred John Saikali (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address) ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED Counter Claimant Apotex, Inc. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Laurel White Marc-Charles (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

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James P. White (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. (See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman (See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED Counter Claimant Apotex Corp. represented by Jennifer Rae Coberly (See above for address) TERMINATED: 04/09/2008 LEAD ATTORNEY Laurel White Marc-Charles (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED James P. White (See above for address) ATTORNEY TO BE NOTICED Phillip D. Segrest, Jr. (See above for address) ATTORNEY TO BE NOTICED Robert Burton Breisblatt (See above for address) TERMINATED: 05/02/2008 ATTORNEY TO BE NOTICED

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Sherry L. Rollo (See above for address) ATTORNEY TO BE NOTICED Steven E. Feldman (See above for address) ATTORNEY TO BE NOTICED Walter J. Tache (See above for address) TERMINATED: 04/09/2008 ATTORNEY TO BE NOTICED V. Counter Defendant Sanofi-Aventis represented by Alfred John Saikali (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address) ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED Counter Defendant Sanofi-Aventis, U.S. LLC represented by Alfred John Saikali (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Alexis Gorton (See above for address) ATTORNEY TO BE NOTICED Gerald J. Flattmann, Jr. (See above for address)

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ATTORNEY TO BE NOTICED John M. Desmarais (See above for address) ATTORNEY TO BE NOTICED William T. Vuk (See above for address) ATTORNEY TO BE NOTICED

Date Filed 12/10/2007

# 1

Docket Text COMPLAINT against Apotex, Inc., Apotex Corp. Filing fee $ 350. Receipt#: 971492, filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (dj) (Entered: 12/11/2007) ANSWER to Complaint with Jury Demand, COUNTERCLAIM and Affirmative Defenses against all plaintiffs by Apotex, Inc., Apotex Corp.. (Coberly, Jennifer) (Entered: 12/28/2007) ANSWER to Complaint with Jury Demand, Amended COUNTERCLAIM against all plaintiffs by Apotex, Inc., Apotex Corp.. (Coberly, Jennifer) (Entered: 01/02/2008) SCHEDULING ORDER; ORDER REFERRING CASE to Mediation. 15 days to appoint mediator. Jury Trial set for 5/27/2008 09:00 AM in Miami Division before Chief Judge Federico A. Moreno.Signed by Judge Federico A. Moreno on 1/3/2008.(lc1) (Entered: 01/03/2008) Pursuant to 4 , Set/Reset Scheduling Order Deadlines: Calendar Call set for 5/20/2008 02:00 PM in Miami Division before Chief Judge Federico A. Moreno. Amended Pleadings due by 1/31/2008. Discovery due by 3/27/2008. Joinder of Parties due by 1/31/2008. Mediation Deadline 4/28/2008. Motions due by 4/28/2008. Pretrial Stipulation due by 5/13/2008. (dg) (Entered: 01/04/2008) 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis. Responses due by 1/23/2008 (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 01/08/2008) AFFIDAVIT signed by : William Vuk. re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis. (Attachments: # 1 Exhibit 1# 2 Exhibit 2# 3 Exhibit 3# 4 Exhibit 4# 5 Exhibit 5# 6 Exhibit 6# 7 Exhibit 7# 8 Exhibit 8# 9 Exhibit 9# 10 Exhibit 10# 11 Exhibit 11# 12 Exhibit 12# 13 Exhibit 13# 14 Exhibit 14# 15 Exhibit 15# 16 Exhibit 16# 17 Exhibit 17# 18 Exhibit 18# 19 Exhibit 19)(Saikali, Alfred) (Entered: 01/08/2008) Plaintiff's MOTION for Hearing re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis. (Saikali, Alfred) (Entered: 01/08/2008)

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Plaintiff's MOTION to Stay Certain Deadlines and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis. Responses due by 1/23/2008 (Attachments: # 1 Text of Proposed Order Proposed Order) (Saikali, Alfred) (Entered: 01/08/2008) NOTICE of Instruction to Filer: re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law filed by Sanofi-Aventis, ERROR: Motion with Multiple Reliefs Filed as One Relief; Instruction to Filer: In the future please select all applicable Reliefs (You can select multiple reliefs by using the Ctrl key). This is for FUTURE reference only, it is not necessary to refile this document. (gp) (Entered: 01/09/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Filing for Gerald J. Flattmann, Jr., Filing Fee $75, Receipt #972917. (cw) (Entered: 01/10/2008) AFFIDAVIT signed by : William Vuk. in Support of Plaintiffs' Motion to Continue Pretrial Deadlines and Trial by Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1# 2 Exhibit Exhibit 2# 3 Exhibit Exhibit 3# 4 Exhibit Exhibit 4)(Saikali, Alfred) (Entered: 01/15/2008) Plaintiff's MOTION to Continue Pretrial Deadlines and Trial and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 1/30/2008 (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 01/15/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for Steven E. Feldman, Filing Fee $75, Receipt #973233. (cw) (Entered: 01/16/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Filing for Alexis Gorton, Filing Fee $75, Receipt #973247. (cw) (Entered: 01/16/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for Sherry L. Rollo, Filing Fee $75, Receipt #973233. (cw) (Entered: 01/16/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Filing for William T. Vuk, Filing Fee $75, Receipt #973246. (cw) (Entered: 01/16/2008) ORDER granting 10 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for Gerald J. Flattmann, Jr. Signed by Judge Federico A. Moreno on 1/17/2008. (lc1) (Entered: 01/17/2008) Plaintiffs' ANSWER to Counterclaim (Amended) of Apotex Inc. and

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Apotex Corp. by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC.(Saikali, Alfred) (Entered: 01/17/2008) 01/18/2008 19 ENDORSED ORDER granting 15 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. This is a paperless order. Signed by Judge Federico A. Moreno on 1/18/2008. (lc1) (Entered: 01/18/2008) ENDORSED ORDER granting 14 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. This is a paperless order. Signed by Judge Federico A. Moreno on 1/18/2008. (lc1) (Entered: 01/18/2008) ENDORSED ORDER granting 13 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. This is a paperless order. Signed by Judge Federico A. Moreno on 1/18/2008. (lc1) (Entered: 01/18/2008) ENDORSED ORDER granting 16 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. Signed by Judge Federico A. Moreno on 1/18/2008. (lc1) (Entered: 01/18/2008) ORDER granting 12 Motion to Continue and Revising Pretrial Deadlines. The trial is continued from May 27, 2008 to October 6, 2008. The calendar call is continued to Tuesday, September 30, 2008. Signed by Judge Federico A. Moreno on 1/22/2008. (lc1) (Entered: 01/22/2008) Set Deadlines/Hearings per Order at DE 23 : Discovery due by 8/6/2008. Pretrial Stipulation due by 9/23/2008. Calendar Call set for 9/30/2008 02:00 PM before Chief Judge Federico A. Moreno. Jury Trial set for 10/6/2008 09:00 AM before Chief Judge Federico A. Moreno. (bb) (Entered: 01/24/2008) 24 25 NOTICE /the parties have exchanged proposed mediators by SanofiAventis (tb) (Entered: 01/25/2008) MOTION for Protective Order and Incorporated Memorandum of Law by Apotex, Inc., Apotex Corp.. (Attachments: # 1 Text of Proposed Order)(Coberly, Jennifer) (Entered: 01/25/2008) MEMORANDUM in Opposition re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law filed by Apotex, Inc., Apotex Corp.. (Attachments: # 1 Exhibit # 2 Exhibit # 3 Exhibit # 4 Exhibit)(Coberly, Jennifer) (Entered: 01/28/2008) ORDER REFERRING MOTION to Magistrate Judge Andrea M. Simonton 25 MOTION for Protective Order and Incorporated Memorandum of Law filed by Apotex, Inc.,, Apotex Corp., Signed by Judge Federico A. Moreno on 1/31/2008.(lc1) (Entered: 01/31/2008) ORDER of Correction re 27 Order Referring Motion.Signed by Judge Federico A. Moreno on 1/31/2008.(lc1) (Entered: 01/31/2008)

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Defendant's MOTION for Extension of Time to File Joint Scheduling Report by Apotex, Inc., Apotex Corp.. (Attachments: # 1 Exhibit Apotex Scheduling Report)(Tache, Walter) (Entered: 01/31/2008) Plaintiff's MOTION for Leave to File Scheduling Report and Proposed Scheduling Order by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 1# 2 Exhibit 2# 3 Text of Proposed Order 3)(Saikali, Alfred) (Entered: 02/01/2008) AFFIDAVIT signed by : Alexis Gorton. in Support of Plaintiffs' Emergency Motion to Stay Pending JPML Decision by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 1# 2 Exhibit 2# 3 Exhibit 3# 4 Exhibit 4# 5 Exhibit 5# 6 Exhibit 6# 7 Exhibit 7# 8 Exhibit 8# 9 Exhibit 9# 10 Exhibit 10# 11 Exhibit 11# 12 Exhibit 12# 13 Exhibit 13)(Saikali, Alfred) (Entered: 02/07/2008) Emergency MOTION to Stay re 31 Affidavit, Pending JPML Decision and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 2/22/2008 (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 02/07/2008) Plaintiff's MOTION for Hearing re 32 Emergency MOTION to Stay re 31 Affidavit, Pending JPML Decision and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/07/2008) REPLY to Response to Motion re 5 Plaintiff's MOTION to Stay and Transfer and Supporting Memorandum of Law filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/07/2008) AFFIDAVIT signed by : Alexis Gorton. re 34 Reply to Response to Motion, in Support of Motion to Transfer or Stay by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 20# 2 Exhibit 21# 3 Exhibit 22# 4 Exhibit 23)(Saikali, Alfred) (Entered: 02/07/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Filing for John M. Desmarais, Filing Fee $75, Receipt #974606. (cw) (Entered: 02/11/2008) ORDER denying as moot 29 Motion for Extension of Time to File, denying as moot 30 Motion for Leave to File. Signed by Judge Federico A. Moreno on 02/08/2008. (lc1) (Entered: 02/08/2008) NOTICE of Instruction to Filer: re 32 Emergency MOTION to Stay re 31

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Affidavit, Pending JPML Decision and Supporting Memorandum of Law filed by Sanofi-Aventis, U.S. LLC, Sanofi-Aventis. Regarding Emergency Motions/Requests for Emergency Hearing. Pursuant to 5F in the Administrative Procedures, because the matters require the immediate attention of the Judge, the Original Emergency Motion and a Copy for the Judge must be filed in conventional paper format in the division where the Judge is chambered. This is for FUTURE reference only, it is not necessary to refile this document. (gp) (Entered: 02/08/2008) 02/11/2008 39 MEMORANDUM in Opposition re 25 MOTION for Protective Order and Incorporated Memorandum of Law filed by Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/11/2008) AFFIDAVIT signed by : Alexis Gorton. re 39 Memorandum in Opposition, To Defendants' Motion for Protective Order by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1# 2 Exhibit Exhibit 2# 3 Exhibit Exhibit 3# 4 Exhibit Exhibit 4# 5 Exhibit Exhibit 5# 6 Exhibit Exhibit 6)(Saikali, Alfred) (Entered: 02/11/2008) RESPONSE in Opposition re 32 Emergency MOTION to Stay re 31 Affidavit, Pending JPML Decision and Supporting Memorandum of Law filed by Apotex Corp., Apotex, Inc.. (Coberly, Jennifer) Modified on 2/14/2008 (ls). [Filers modified by Clerk] (Entered: 02/13/2008) ORDER granting 38 Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings. Signed by Judge Federico A. Moreno on 02/14/2008. (lc1) (Entered: 02/14/2008) REPLY to Response to Motion re 32 Emergency MOTION to Stay re 31 Affidavit, Pending JPML Decision and Supporting Memorandum of Law filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/14/2008) Plaintiff's MOTION for Protective Order and Supporting Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order)(Saikali, Alfred) (Entered: 02/14/2008) AFFIDAVIT signed by : William Vuk. re 44 Plaintiff's MOTION for Protective Order and Supporting Memorandum of Law by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 1# 2 Exhibit 2# 3 Exhibit 3)(Saikali, Alfred) (Entered: 02/14/2008) Plaintiff's MOTION for Hearing re 44 Plaintiff's MOTION for Protective

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Order and Supporting Memorandum of Law by Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/14/2008) 02/15/2008 47 REPLY to Response to Motion re 25 MOTION for Protective Order and Incorporated Memorandum of Law Plaintiffs' Opposition to Motion for Protective Order filed by Apotex, Inc., Apotex Corp.. (Coberly, Jennifer) (Entered: 02/15/2008) ORDER denying 32 Emergency Motion to Stay, denying 33 Motion for Hearing. Signed by Judge Federico A. Moreno on 02-18-2008. (lc1) (Entered: 02/19/2008) Corporate Disclosure Statement by Apotex, Inc., Apotex Corp.. (Coberly, Jennifer) (Entered: 02/19/2008) NOTICE of Attorney Appearance by Robert Burton Breisblatt on behalf of all defendants (Breisblatt, Robert) (Entered: 02/20/2008) ORDER granting Defendants' 25 Motion for Protective Order. Signed by Magistrate Judge Andrea M. Simonton on 2/20/08. (js) (Entered: 02/20/2008) Corporate Disclosure Statement by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 02/20/2008) AMENDED DOCUMENT by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Amendment to 52 Corporate Disclosure Statement/Certificate of Interested Parties. (Saikali, Alfred) (Entered: 02/21/2008) Plaintiff's MOTION to Compel Defendants to Comply with Court's 2/20/08 Order , and Incorporated Memorandum of Law, by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 3/11/2008 (Attachments: # 1 Text of Proposed Order Proposed Order) (Saikali, Alfred) (Entered: 02/26/2008) AFFIDAVIT signed by : William Vuk. re 54 Plaintiff's MOTION to Compel Defendants to Comply with Court's 2/20/08 Order , and Incorporated Memorandum of Law, by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1# 2 Exhibit Exhibit 2# 3 Exhibit Exhibit 3# 4 Exhibit Exhibit 4# 5 Exhibit Exhibit 5# 6 Exhibit Exhibit 6)(Saikali, Alfred) (Entered: 02/26/2008) Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 02/27/2008) AFFIDAVIT signed by : Alexis Gorton. re 56 Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law by

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Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1)(Saikali, Alfred) (Entered: 02/27/2008) 02/28/2008 58 Plaintiff's MOTION To Withdraw in Part Plaintiffs' Motion to Compel Defendants to Comply with the Court's 2/20/08 Order re 54 Plaintiff's MOTION to Compel Defendants to Comply with Court's 2/20/08 Order , and Incorporated Memorandum of Law, by Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 02/28/2008) Notice of Supplemental Authority re 56 Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC (Attachments: # 1 Exhibit Exhibit 1)(Saikali, Alfred) (Entered: 02/28/2008) MEMORANDUM in Opposition re 44 Plaintiff's MOTION for Protective Order and Supporting Memorandum of Law to Plaintiffs' Motion for Protective Order to Avoid Having to Respond to Outstanding Discovery filed by Apotex, Inc.. (Attachments: # 1 Exhibit A # 2Exhibit B)(Davidson, Matthew) Modified text on 3/3/2008 (tp). (Entered: 02/29/2008) TEXT ORDER denying as moot 54 Motion to Compel, granting 58 Motion to withdraw motion to compel and for extension of time file joint proposed protective order. On or before March 10, 2008, the parties shall file a proposed Protective Order in accordance with this Court's February 20, 2008 Order. This is a paperless Order.Signed by Magistrate Judge Andrea M. Simonton on 2/29/08. (AMS) (Entered: 02/29/2008) Courtesy Copy of MDL #1941 Reply Brief in Further Support of Plaintiff's Motion to Transfer and Consolidate for Pretrial Proceedings. (SDFL Case #07cv61800-FAM) (Attachments: #(1) Exhibits #1-#9 and Certificate of Service) (de) (Entered: 03/10/2008) RESPONSE to Motion re 56 Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law filed by Apotex, Inc., Apotex Corp.. Replies due by 3/14/2008. (Attachments: # 1 Exhibit A)(Coberly, Jennifer) (Entered: 03/07/2008) REPLY to Response to Motion re 44 Plaintiff's MOTION for Protective Order and Supporting Memorandum of Law filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 03/10/2008) AFFIDAVIT signed by : William Vuk. re 64 Reply to Response to Motion, by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Exhibit 4# 2 Exhibit 5# 3 Exhibit 6)(Saikali, Alfred)

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(Entered: 03/10/2008) 03/10/2008 66 Joint MOTION for Extension of Time to File Protective Order by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 03/10/2008) AMENDED DOCUMENT by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC. Amendment to 66 Joint MOTION for Extension of Time to File Protective Order (Amended Proposed Order). (Saikali, Alfred) (Entered: 03/10/2008) NOTICE of Instruction to Filer: re 67 Amended Document, filed by Sanofi-Aventis, U.S. LLC, Sanofi-Aventis. Error: Proposed Order/Exhibit Docketed as Main Document; Instruction to Filer=Proposed Orders, unless otherwise directed by a Judge, shall be filed initially as an attachment to a motion, notice, or other filing. Please refer to the CM/ECF Administrative Procedures. This is for FUTURE reference only. It is not necessary to refile this document. (gp) (Entered: 03/11/2008) TEXT ORDER granting 66 Joint Motion for Enlargement of Time to File Proposed Protective Order. On or before March 12, 2008, the parties shall file a Proposed Protective Order in accordance with this Court's February 20, 2008 Order. This is a paperless Order. Signed by Magistrate Judge Andrea M. Simonton on 3/11/08. (js) (Entered: 03/11/2008) NOTICE of Compliance with Order GRanting Defendants' Motion for Entry of a Protective Order by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC re 51 Order on Motion for Protective Order (Attachments: # 1 Exhibit 1 (Protective Order))(Saikali, Alfred) (Entered: 03/12/2008) Statement of: Apotex Defendants' Position on Disputed Paragraph 12 of the Protective Order Pertaining to Materials Believed to be Covered by the EU Privacy Directive by Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp.. (Attachments: # 1 Exhibit A# 2 Exhibit B)(Breisblatt, Robert) (Entered: 03/13/2008) ORDER Regarding Protective Order. Signed by Magistrate Judge Andrea M. Simonton on 3/17/08.(js) (Entered: 03/17/2008) REPLY to Response to Motion re 56 Plaintiff's MOTION for Hearing (Status Conference) and Incorporated Memorandum of Law filed by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Saikali, Alfred) (Entered: 03/17/2008) AFFIDAVIT signed by : Alexis Gorton. re 73 Reply to Response to Motion, for Status Conference, by Sanofi-Aventis, Sanofi-Aventis, U.S.

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LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, SanofiAventis, U.S. LLC. (Attachments: # 1 Exhibit Exhibit 1# 2 Exhibit Exhibit 2# 3 Exhibit Exhibit 3)(Saikali, Alfred) (Entered: 03/17/2008) 03/20/2008 75 NOTICE of Compliance with Order Regarding Protective Order Dated March 17, 2008 by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC re 72 Order (Attachments: # 1 Text of Proposed Order Exhibit 1) (Saikali, Alfred) (Entered: 03/20/2008) PROTECTIVE ORDER signed by Magistrate Judge Andrea M. Simonton on 3/21/08.(js) (Entered: 03/21/2008) Courtesy Copy of MDL #1941 Notice of Related Action. (SDFL Case #07cv61800-FAM) (Attachments: # 1 Complaint, Civil Cover Sheet and Docket Sheet for District of Delaware) (de) (Entered: 03/24/2008) Defendant's MOTION to Compel Discovery Responses and Incorporated Memorandum of Law by Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp.. Responses due by 4/8/2008 (Attachments: # 1 Exhibit A)(Breisblatt, Robert) (Entered: 03/25/2008) NOTICE of Compliance by Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp., Apotex, Inc., Apotex Corp. re 78 Defendant's MOTION to Compel Discovery Responses and Incorporated Memorandum of Law filed by Apotex, Inc.,, Apotex Corp., (Breisblatt, Robert) (Entered: 03/25/2008) MOTION to Withdraw as Attorney Stephen Bronis, Jennifer Coberly, Walter Tache and the Law Firm of Zuckerman Spaeder LLP by Apotex, Inc., Apotex Corp.. Responses due by 4/10/2008 (Attachments: # 1 Text of Proposed Order)(Coberly, Jennifer) (Entered: 03/27/2008) Notice of Pendency of Other Action by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC (Attachments: # 1 Exhibit 1)(Saikali, Alfred) (Entered: 03/27/2008) NOTICE of Attorney Appearance by Laurel White Marc-Charles on behalf of all defendants (Marc-Charles, Laurel) (Entered: 04/04/2008) ORDER granting 80 Motion to Withdraw as Attorney. Attorneys Walter J. Tache; Stephen Jay Bronis and Jennifer Rae Coberly terminated.Signed by Judge Federico A. Moreno on 04/07/2008. (lc1) (Entered: 04/07/2008) Case Reassignment of Paired Magistrate Judge pursuant to Administrative Order 2008-09 to Magistrate Judge Edwin G. Torres Judge Andrea M. Simonton no longer assigned to the case. (ra) (Entered: 04/08/2008) Attorney Jennifer Rae Coberly and Walter J. Tache terminated. Sent terminated attorney(s) instructions for tracking future case activity. (lk) (Entered: 04/09/2008)

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Unopposed MOTION for Extension of Time to File Opposition to Defendants' Motion to Compel Discovery Responses by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. (Attachments: # 1 Text of Proposed Order Proposed Order)(Saikali, Alfred) (Entered: 04/10/2008) ORDER granting 85 Plaintiff's Unopposed Motion for Four-Day Enlargement of Time. Plaintiff shall file a response by no later than April 15, 2008. Signed by Judge Federico A. Moreno on 4/11/2008. (lc3) (Entered: 04/11/2008) ORDER STRIKING CASE FROM TRIAL CALENDAR. Signed by Judge Federico A. Moreno on 04/11/2008. (lc1) (Entered: 04/14/2008) Sealed Document. (vjk) (Entered: 04/16/2008) Sealed Document. (vjk) (Entered: 04/16/2008) Sealed Document. (vjk) (Entered: 04/16/2008) Unopposed MOTION to Continue Mediation Deadline by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 5/6/2008 (Attachments: # 1 Text of Proposed Order Proposed Order) (Saikali, Alfred) (Entered: 04/22/2008) Unopposed MOTION to Continue Mediation Deadline by SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 5/6/2008 (Attachments: # 1 Text of Proposed Order)(Saikali, Alfred) (Entered: 04/22/2008) NOTICE of Striking Document From Court Docket, Docket Entry 91 and [91-2] by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC (Saikali, Alfred) Modified on 4/28/2008 (lk). (Entered: 04/23/2008) ORDER DENYING PLAINTIFFS' MOTION TO FILE UNDER SEAL. Signed by Judge Federico A. Moreno on 04/21/2008.(lc1) (Entered: 04/23/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for James P. White, Filing Fee $75, Receipt #979080. (cw) (Entered: 04/24/2008) MOTION for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Electronic Filings for Phillip D. Segrest, Jr., Filing Fee $75, Receipt #979079. (cw) (Entered: 04/24/2008) Plaintiff's MOTION for clarification 94 Order Denying Plaintiffs' Motion to File Under Seal by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC, SanofiAventis, Sanofi-Aventis, U.S. LLC, Sanofi-Aventis, Sanofi-Aventis, U.S. LLC. Responses due by 5/8/2008 (Saikali, Alfred) (Entered: 04/24/2008) NOTICE of Docket Correction and Instruction to Filer: re 93 Notice of

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Striking filed by Sanofi-Aventis, U.S. LLC,, Sanofi-Aventis, Error: NO Document Link; Correction=Document Relinked To DE 91 . Instruction to Filer=In the future please link the Document to the proper entry; (lk) (Entered: 04/28/2008) 04/28/2008 99 MOTION to Withdraw as Attorney and to Substitute New Lead Counsel. by Apotex, Inc., Apotex Corp.. Responses due by 5/12/2008 (Breisblatt, Robert) (Entered: 04/28/2008) ORDER RECONSIDERING ORDER DENYING EMERGENCY MOTION TO STAY, CLOSING CASE FOR STATISTICAL PURPOSES, AND PLACING MATTER IN CIVIL SUSPENSE FILE. Signed by Judge Federico A. Moreno on 04/28/2008.(lc1) (Entered: 04/29/2008) ORDER GRANTING MOTIONS FOR LIMITED APPEARANCE [96,97]. Signed by Judge Federico A. Moreno on 04/30/2008.(lc1) (Entered: 05/01/2008) ORDER GRANTING MOTION TO WITHDRAW AND TO SUBSTITUTE NEW LEAD COUNSEL. Signed by Judge Federico A. Moreno on 04/30/2008.(lc1) (Entered: 05/01/2008) Attorney Robert Burton Breisblatt terminated per 102 ; Sent terminated attorney instructions for tracking future case activity. (nm) (Entered: 05/02/2008) 103 NOTICE by Sanofi-Aventis, Sanofi-Aventis, U.S. LLC re 100 Order Staying Case (Notice of JPML Decision) (Attachments: # 1 Exhibit A) (Saikali, Alfred) (Entered: 06/10/2008) FINAL TRANSFER ORDER and ORDER CLOSING CASE. Signed by Chief Judge Federico A. Moreno on 06/10/2008. (lc1) (Entered: 06/11/2008) TRANSFER ORDER (Dated 06/09/2008) from Judicial Panel on Multidistrict Litigation transferring case to the District of Delaware re: MDL # 1941 for consolidated pretrial proceedings pursuant to 28 USC 1407 and assigned to Judge Gregory M. Sleet. (Signed by John G. Heyburn, II, Chairman) (de) (Entered: 06/16/2008) TRANSFER ORDER (Dated 06/09/2008) from Judicial Panel on Multidistrict Litigation transferring case to the District of Delaware re: MDL # 1941 for consolidated pretrial proceedings pursuant to 28 USC 1407 and assigned to Judge Gregory M. Sleet. (Signed by John G. Heyburn, II, Chairman) (de) (Entered: 06/17/2008) Transmittal Letter Sent With Certified Docket Sheet, To: District of Delaware re MDL 1941. The District of Delaware will obtain remaining documents via PACER. (de) (Entered: 06/17/2008)

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UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF FLORIDA Miami Division Case Number: 07-61800-CIV-MORENO SANOFI-AVENTIS and SANOFI-AVENTIS U.S. LLC, Plaintiffs, vs. APOTEX INC. and APOTEX CORP., Defendants. _____________________________________/ ORDER GRANTING MOTION FOR LIMITED APPEARANCE THIS CAUSE came before the Court upon Plaintiffs' Motion for Limited Appearance, Consent to Designation and Request to Electronically Receive Notices of Filing (D.E. No. 10), filed on January 9, 2008. THE COURT has considered the motion and the pertinent portions of the record, and being otherwise fully advised in the premises, it is ADJUDGED that the motion is GRANTED. Gerald J. Flattmann, Jr. is admitted for the purposes of limited appearance as co-counsel on behalf of the Plaintiffs and is permitted to receive electronic filings in the above-styled action. DONE AND ORDERED in Chambers at Miami, Florida, this 17th day of January, 2008.

_______________________________________ FEDERICO A. MORENO UNITED STATES DISTRICT JUDGE Copies provided to: Parties and Counsel of Record

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UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA MIAMI DIVISION Case No. 07-61800-Civ-MORENO/SIMONTON SANOFI-AVENTIS and SANOFI-AVENTIS U.S. LLC, Plaintiffs, vs. APOTEX INC. and APOTEX CORP., Defendants.
/

PLAINTIFFS' REPLY TO DEFENDANTS APOTEX INC. AND APOTEX CORP.'S AMENDED COUNTERCLAIMS Plaintiffs sanofi-aventis and sanofi-aventis U.S. LLC, for their Reply to the numbered paragraphs of the Counterclaims of Defendants Apotex Inc. and Apotex Corp. (collectively "Apotex"), hereby state as follows: 1. 2. 3. 4. 5. Admitted, upon information and belief. Admitted, upon information and belief. Admitted. Admitted. Admitted that Apotex purports to state declaratory judgment

counterclaims that arise under the Patent Laws of the United States, 35 U.S.C. § 100 et seq., the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §301 et seq., as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 21 U.S.C. § 355), and the Medicare Prescription Drug, Improvement, and Modernization Act of

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2003, Pub.L. No. 108-173, 117 Stat. 2066 (2003), but denied that there is any factual or legal basis for these counterclaims. 6. Admitted that the Court has jurisdiction over the subject matter of the

counterclaims related to the '491 patent, but denied that such jurisdiction exists for the counterclaims related to the '940 patent. 7. Plaintiffs do not contest personal jurisdiction in this Court for this Action;

to the extent that Paragraph 7 contains any other or further allegations, they are superfluous allegations to which no response is required. 8. While Plaintiffs do not dispute this judicial district is a possible venue for

this action, they believe that the District of Delaware is a more convenient venue; therefore on January 8, 2008, Plaintiffs respectfully moved this Court to transfer this action to the District of Delaware where an identical, parallel, first-filed action against Apotex, Civil Action No.07-792 (GMS) (MPT), has been pending since December 6, 2007 in front of the same Judge and Magistrate Judge as two related actions involving the same patent(s), claims and defenses against 13 other defendants, Civil Actions Nos.07-572 (GMS) (MPT) and 07-574 (GMS) (MPT), that have been pending since September 21, 2007. 9. 10. Admitted. Admitted that sanofi-aventis is the assignee of the '491 patent and has a

right to enforce the '491 patent. 11. Busto Arisizio. 12. Admitted that sanofi-aventis is an assignee and exclusive licensee of the Admitted, except denied that the `940 patent issued to anyone named

'940 patent and has a right to enforce the '940 patent.

2

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13.

Admitted that the '491 patent and the '940 patent are listed in the Orange

Book for Uroxatral®, and that sanofi-aventis U.S. is the holder of New Drug Application No. 21-287. 14. Admitted that plaintiffs have sued other ANDA filers seeking FDA

approval for alfuzosin hydrochloride extended release tablets for infringement of the `940 patent; otherwise denied. 15. 16. 17. 18. Admitted. Admitted. Admitted. Admitted, except denied that Apotex served its Paragraph IV certification

letter, dated October 25, 2007, on or about October 15, 2007. 19. 20. Admitted. Admitted that sanofi-aventis has sued Apotex for infringement of the `491

patent in this District, but denied that Apotex has a reasonable apprehension of being sued by sanofi-aventis for alleged infringement of the `940 patent; to the extent that Paragraph 20 contains any other or further allegations, they are superfluous allegations to which no response is required. 21. The allegations of Paragraph 21 of Apotex's Counterclaims set forth legal

conclusions and characterizations to which no response from sanofi-aventis is required. To the extent a response is necessary, sanofi-aventis denies the allegations of Paragraph 21. 22. Admitted, except denied that there is any justiciable controversy as to the

validity or infringement of the `940 patent. 23. Plaintiffs restate and incorporate by reference their responses to the

allegations contained in Paragraphs 1-22 as though set forth specifically herein. 3

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24. 25. 26.

Denied. Denied. Plaintiffs restate and incorporate by reference their responses to the

allegations contained in Paragraphs 1-25 as though set forth specifically herein. 27. 28. 29. Denied. Denied. Plaintiffs restate and incorporate by reference their responses to the

allegations contained in Paragraphs 1-28 as though set forth specifically herein. 30. The `940 patent is not currently in dispute and therefore no response from

sanofi-aventis as to the allegations contained within Paragraph 30 is necessary. To the extent a response is necessary, sanofi-aventis denies Paragraph 30. 31. 32. Denied. Plaintiffs restate and incorporate by reference their responses to the

allegations contained in Paragraphs 1-31 as though set forth specifically herein. 33. The `940 patent is not currently in dispute and therefore no response from

sanofi-aventis as to the allegations contained within Paragraph 33 is necessary. To the extent a response is necessary, sanofi-aventis denies Paragraph 33. 34. Denied.

Wherefore, Plaintiffs deny that Apotex Inc. or Apotex Corp. is entitled to any relief, either as prayed for in their Counterclaims or otherwise. Plaintiffs further deny each allegation contained in Apotex Inc. and Apotex Corp.'s Counterclaims that was not specifically admitted, denied, or otherwise responded to in this Reply to Defendant Apotex Inc. and Apotex Corp.'s Counterclaims.

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Without prejudice to the denials set forth in its Reply to Defendant Apotex Inc. and Apotex Corp.'s Counterclaims, and without admitting any allegations of the Counterclaims not otherwise admitted, Plaintiffs assert the following defenses to the Counterclaims: (1) Subject matter jurisdiction does not exist for Apotex's counterclaims directed toward the '940 patent; and (2) This second-filed action should be transferred to the more convenient venue of the District of Delaware where an identical, parallel, first-filed action against Apotex has been pending since December 6, 2007 in front of the same Judge and Magistrate Judge as two related actions against 13 other defendants that have been pending since September 21, 2007.

Dated this 17th day of January 2008. Miami, Florida Respectfully submitted, SHOOK, HARDY & BACON L.L.P. s/ Alfred J. Saikali________ Alfred J. Saikali Fla. Bar No.: 178195 201 South Biscayne Boulevard - Suite 2400 Miami, Florida 33131-4332 Telephone: 305.358.5171 Facsimile: 305.358.7470 [email protected] Attorneys for Plaintiffs

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CERTIFICATE OF SERVICE I HEREBY CERTIFY that on January 17, 2008, I electronically filed the foregoing document with the Clerk of the Court using CM/ECF. I also certify that the foregoing document is being served this day on all counsel of record identified on the attached Service List in the manner specified, either via transmission of Notices of Electronic Filing generated by CM/ECF or in some other authorized manner for those counsel or parties who are not authorized to receive electronically Notices of Electronic Filing.

Respectfully submitted, s/ Alfred J. Saikali________ Alfred J. Saikali (Florida Bar No.: 178195) E-mail: [email protected] SHOOK, HARDY & BACON L.L.P. 201 South Biscayne Boulevard - Suite 2400 Miami, Florida 33131-4332 Telephone: 305.358.5171 Facsimile: 305.358.7470 Attorneys for Plaintiffs

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SERVICE LIST SANOFI-AVENTIS ET. AL. vs. APOTEX, INC. ET. AL
Case No.: 07-61800-CIV-Moreno/Simonton United States District Court Southern District of Florida (Miami Division)

Stephen J. Bronis, Esq. Jennifer Coberly, Esq. ZUCKERMAN SPAEDER, LLP Attorneys for Apotex Corp. and Apotex, Inc. 201 South Biscayne Blvd., Suite 900 Miami, FL 33131 VIA CM/ECF

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UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF FLORIDA Miami Division Case Number: 07-61800-CIV-MORENO SANOFI-AVENTIS and SANOFI-AVENTIS U.S. LLC, Plaintiffs, vs. APOTEX INC. and APOTEX CORP., Defendants. _____________________________________/ ORDER OF CONTINUANCE AND ORDER REVISING PRETRIAL DEADLINES THIS CAUSE came before the Court upon Plaintiffs' Motion to Continue Pretrial Deadlines and Trial (D.E. No. 12), filed on January 15, 2008. THE COURT has considered the motion and the pertinent portions of the record, and being otherwise fully advised in the premises, it is ADJUDGED that for good cause shown, the motion is GRANTED as follows. (1) TRIAL DATE - The trial is CONTINUED from the two-week period of May 27,

2008, to the two-week period of October 6, 2008, in Miami, Florida. (2) CALENDAR CALL - Counsel must appear at Calendar Call which shall take place

before the undersigned at the United States Courthouse, Federal Justice Building, Courtroom IV, Tenth Floor, 99 Northeast 4th Street, Miami, Florida 33132, on Tuesday, September 30, 2008, at 2:00 P.M. The parties need not appear at Calendar Call. At Calendar Call counsel may bring all matters relating to the scheduled trial date to the attention of the Court. (3) PLAINTIFF'S WITNESS AND EXHIBIT LISTS - Plaintiff shall provide

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Defendant, by either fax or hand delivery, a copy of Plaintiff's Witness List and a copy of Plaintiff's Exhibit List no later than Wednesday, September 17, 2008, at 5:00 P.M. (a) PLAINTIFF'S WITNESS LIST - Plaintiff's Witness List shall include all

the witnesses, both lay and expert, that Plaintiff intends to call at trial. Plaintiff's Witness List shall briefly describe the nature of each witness's testimony and whether such witness will be testifying live or by deposition. Witnesses omitted from the list will not be allowed at trial. (b) PLAINTIFF'S EXHIBIT LIST - Plaintiff's Exhibit List shall include all the

exhibits that Plaintiff intends to use at trial. Plaintiff's Exhibit List shall in consecutively numbered paragraphs adequately describe the nature of each document listed. The actual exhibits shall be pre-marked with corresponding numbers (e.g. Plaintiff's Exhibit #1, P.E. #2, P.E. #3...) which numbers they will retain through the end of trial. The exhibit list shall refer to specific items and shall not include blanket statements such as all exhibits produced during depositions or Plaintiff reserves the use of any other relevant evidence. Exhibits omitted from the list will not be allowed at trial. (4) DEFENDANT'S WITNESS AND EXHIBIT LISTS - Defendant shall provide

Plaintiff, by either fax or hand delivery, a copy of Defendant's Witness List and a copy of Defendant's Exhibit List no later than Friday, September 19, 2008, at 5:00 P.M. (a) DEFENDANT'S WITNESS LIST - Defendant's Witness List shall include

only those additional lay and expert witnesses not included on Plaintiff's Witness List. Witnesses listed by Plaintiff will be available for both parties and should not -2-

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be re-listed on Defendant's Witness List. Defendant's Witness List shall briefly describe the nature of each additional witness's testimony and whether such witnesses will be testifying live or by deposition. Witnesses omitted from Defendant's Witness List and not listed on Plaintiff's Witness List will not be allowed at trial. (b) DEFENDANT'S EXHIBIT LIST - Defendant's Exhibit List shall include

only those additional exhibits that Defendant wishes to introduce at trial which are not on Plaintiff's Exhibit List. Defendant's Exhibit List shall in consecutively numbered paragraphs adequately describe the nature of each document listed. The actual exhibits shall be pre-marked with corresponding numbers (e.g. Defendant's Exhibit #1, D.E. #2, D.E. #3...) which numbers they will retain through the end of trial. The exhibit list shall refer to specific items and shall not include blanket statements such as all exhibits produced during depositions or Plaintiff reserves the use of any other relevant evidence. Exhibits omitted from Defendant's Exhibit List and not listed on Plaintiff's Exhibit List will not be allowed at trial. (5) PRETRIAL STIPULATION - Pursuant to S.D. Fla. L.R. 16.1.E., the parties shall

file a Pretrial Stipulation no later than Tuesday, September 23, 2008. The Pretrial Stipulation shall conform to the requirements of S.D. Fla. L.R. 16.1.E. The parties shall attach to the Pretrial Stipulation copies of the witness and exhibit lists along with any objections as allowed for under S.D. Fla. L.R. 16.1.E.9. (6) OTHER PRETRIAL DEADLINES (a) Discovery - The parties shall complete all expert and non-expert discovery

no later than August 6, 2008. -3-

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(b)

Summary Judgment - The parties shall file all motions for summary

judgment no later than August 20, 2008. (c) Pretrial Motions - The parties shall file all other pretrial motions no later

than September 5, 2008. (7) PREVIOUS SCHEDULING ORDERS - This Order shall supercede only the

inconsistent provisions of previous Scheduling Orders.

DONE AND ORDERED in Chambers at Miami, Florida, this 22nd day of January, 2008.

_______________________________________ FEDERICO A. MORENO UNITED STATES DISTRICT JUDGE Copies provided to: Parties and Counsel of Record

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UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA Case No. 07-61800-CIV-MORENO/SIMONTON SANOFI-AVENTIS and SANOFI-AVENTIS U.S. LLC, Plaintiffs, vs. APOTEX INC. and APOTEX CORP., Defendants. ______________________________/ THE APOTEX DEFENDANTS' MOTION FOR ENTRY OF A PROTECTIVE ORDER AND INCORPORATED MEMORANDUM OF LAW The Apotex Defendants move pursuant to Fed. R. Civ. P. 26 for entry of the proposed Protective Order attached hereto as Exhibit A. Apotex submitted this proposed protective order to counsel for Sanofi on January 17, 2008. Apotex's proposed Protective Order is substantively identical (with appropriate modification to account for the parties here) to a protective order that Sanofi's lawyers recently negotiated with Apotex's counsel in another ANDA case involving a different plaintiff. Nevertheless, Sanofi has refused to agree to Apotex's proposed protective order or to propose an alternative protective order that it finds acceptable. Discovery is

underway and the entry of a Protective Order is necessary to provide the timely exchange of documents. I. Delaying The Entry Of A Protective Order Only Delays Discovery There is no dispute that a Protective Order is necessary to protect the interests of both parties and is a staple of almost every patent case. See Karolewicz v. Drummond Press, Inc., 2007 U.S. Dist. LEXIS 51818 (M.D. Fla. 2007) (finding protective orders frequently entered in

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patent infringement cases stating "it has become apparent the issuance of a protective order is necessary to facilitate the flow of discovery and preserve material worthy of protection."). This case involves confidential and proprietary drug formulations, research materials and other information that is not generally known to competitors. The Court has set a discovery cut-off date of August 6, 2008 and a trial date in October, 2008. See Revised Scheduling Order of 1/22/08 (Dkt. 23). Given the quick pace of this litigation, a Protective Order is needed now so that discovery can proceed and these deadlines can be met. The parties already have had their Rule 26(f) conference and have exchanged Rule 26(a)(1) disclosures (although no documents have yet been produced). On January 18, 2008, Apotex served document requests on Sanofi and will soon be serving interrogatories and other discovery requests on Sanofi. Sanofi's responses, due February 18, 2008, no doubt will include objections that the requests call for documents containing confidential and sensitive information unless a Protective Order is entered. In fact Sanofi already has refused to produce, even on a provisional attorney's eyes only basis, any core documents underlying its claims in this case, such as Sanofi's New Drug Applications, lab notebooks, research notes, data and memoranda underlying the development of the drug product and method that are the subjects of Sanofi's patents in suit. II. Apotex's Proposed Protective Order Is Substantially Identical to A Protective Order To Which Sanofi's Counsel Previously Agreed Although Apotex's proposed protective order is essentially identical to that which Sanofi's counsel previously agreed in another currently pending ANDA litigation, Sanofi has nevertheless refused to agree to this one, stating that it is not yet "prudent" to negotiate and enter into a Protective Order until its motion to transfer is decided. Sanofi's counsel also characterized negotiations over a Protective Order at this time as premature, nevermind that the Court has set

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an August, 2008 discovery cut-off and an October trial date, and the parties already have had their Rule 26(f) conference. See Fed. R. Civ. P. 26(d). Discovery in this case is not optional. Sanofi chose to sue Apotex for patent infringement here. Even though it is based in France, Sanofi still is subject to the Rules of Civil Procedure. Regardless of whether this litigation remains before the Southern District of Florida or is transferred to the District of Delaware, Sanofi will be subject to the same discovery. There simply is no reason to delay the entry of a Protective Order and discovery in this matter. Sanofi's intransigence on the protective order only serve to delay the litigation process and operate in opposition to the requirements imposed by the Hatch-Waxman Act, that the parties to an ANDA action "reasonably cooperate in expediting the action." 21 USC §355(j)(5)(B)(iii) (emphasis added). Sanofi also has suggested in discussions with Apotex's counsel that the "EU Data Privacy Directive" may have some impact on the Protective Order. This is nonsense. Sanofi has failed to identify any specific provisions of the proposed Protective Order that are contrary to the EU Data Privacy Directive, despite being invited on multiple occasions to do so. Furthermore, in another currently pending ANDA litigation between Sanofi and Apotex, the Protective Order includes no mention of the EU Data Policy Directive. Finally, Apotex suggested that to the extent that Sanofi has concerns about the EU Data Privacy Directive, it should propose some language dealing with the issue. That Sanofi has refused to do so speaks volumes of the true dilatory nature of this objection. Sanofi's counsel has not engaged in meaningful efforts to negotiate a Protective Order and cooperate in moving discovery along. Sanofi's counsel simply rejected Apotex's proposal without making a suggestion of an acceptable Protective Order. Apotex believes the Protective

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Order proposed is reasonable, fair and will protect the interests of both parties. As such, Apotex requests the Court enter the Protective Order. Pursuant to Local Rule 7.1(A)(3), Counsel for the movant has conferred with all parties or non-parties who may be affected by the relief sought in the motion in a good faith effort to resolve the issues raised in the motion and has been unable to do so. III. Conclusion For the foregoing reasons, Apotex requests the Court enter the Protective Order attached hereto as Exhibit A.

Dated: January 25, 2008

Respectfully submitted,

s/. Jennifer Coberly Stephen J. Bronis [email protected] Fla. Bar No. 145970 Jennifer Coberly [email protected] Fla. Bar No. 930466 ZUCKERMAN SPAEDER LLP 201 South Biscayne Boulevard, Suite 900 Miami, FL 33131 Tel: 305-358-5000 Fax: 305-579-9749 Robert B. Breisblatt [email protected] Fl. Bar No. 145928 Steven E. Feldman Sherry L. Rollo WELSH & KATZ, LTD. 120 South Riverside Plaza Chicago, Illinois 60606 Tel: 312-655-1500 Fax: 312-655-1501 Attorneys for Apotex Corp and Apotex Inc.

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CERTIFICATE OF SERVICE I hereby certify that a true and correct copy of the foregoing served by mail on January 2, 2008 on all counsel of record on the attached service list.

s/.

Jennifer Coberly Jennifer Coberly

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