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`CONFIDENTIAL
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` AGENCY TELEPHONE CONTACT REPORT
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`PRODUCT: BG00012
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`Application #: IND 73,061
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`DATE/TIME OF CONTACT 27 October 2006, 02
`November 2006 and 03 November 2006
`AGENCY REPRESENTATIVE(S):
`James Reese, Project Manager 301-796-1136
`Biogen Idec PARTICIPANT(S): Tammy Sarnelli
`
`OUTGOING:
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`INCOMING:
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`SUBJECT:
`301 and 302
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`Receipt of the Request for Special Protocol Assessments (SPA) for Studies
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`On October 27, 2006 I left Jim Reese a voicemail to notify him that Biogen Idec submitted 2 Phase 3
`SPAs to the Agency for review. I also requested confirmation that the 45-day review period would
`end on December 11, 2006. I followed the voicemail message with an email as well.
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`On November 2, 2006, Jim Reese sent an email stating that he had received the 302 SPA (Serial No.
`0013) but was searching for the 301 SPA (Serial No. 0012). He stated that he would let me know if
`he could not find it, but he was certain he would.
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`On November 3, 2006, Jim Reese sent an email stating that the goal date for review is December 11,
`2006.
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`ACTION(S) REQUIRED
`FOLLOW-UP ACTIVITY
`RESPONSIBILITY
`N/A
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`DATE DUE
`N/A
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`N/A
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`cc: Regulatory CMC, Regulatory Cambridge, Regulatory UK, BG12 Program Team
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`Page 1 of 1
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`Biogen Exhibit 2299
`Coalition v. Biogen
`IPR2015-01993
`
`
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