`
`bg0O0l2 phase 3 sun:
`
`109MS301/302 SMT AGENDA: Thursday 7th December 8:30AM Eastem/1:30PM UK
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`Page 1 0‘ 7
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`Biogen Exhibit 2216
`Coalition v. Biogen
`IPR2015—01993
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`Page 2 of 7
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`Page 2 of 7
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`BIIB Attendees
`
`BG00012 Phase 3
`109-MS-301 and 109-MS-302
`
`Thursday, 30"‘ November 2006
`
`DISTRIBUTION I ATTENDEES
`
`!a“ac"er
`lalna lingamaneni
`
`8 9
`
`EWSOD
`
`Irnlua lung
`
`Study Status Ugdate -—/P. Gallacher
`Australia:
`o
`First EC submission completed for‘
`Canada:
`
`- Central Regulatory Submission i_:ompl_et_e_d_ir_i [\lpyerpber‘2_0_CJ_7_fgr
`
` Site.
`or the end of
`- F is working with! site to schedule a Site initiation Vlsl
`ecember or -early anuary O07.- has requested it to be early in January 2007 rather
`then the end of December.
`
`_ - « 4 Formatted
`
`BGt2 SMT Meeting Minutes
`
`30 November 06
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`Page 3 of 7
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`Site Selection:
`0 The team is discussing the addition of more sites to make up for lack of responsiveness of sites
`0 Bulgaria, Romania and Italy are possibilities provided that the PO&T group can accommodate
`such needs
`The team will also work with the commercial group to see if we can get enough sites within these
`countries to ensure it is worth going to these countries for both 301 and 302. At a minimum 4
`sites per country are required needed, and for 301 Avonex lyo needs to be approved and for 302
`both Avonex lyo and Copaxone need to be approved.
`General:
`
`o
`
`36 sites have been approved to participate in 301, 12 apfiroved to participate in 302
`
`in the next few weeks. The
`o There are a large number of PSSVs to be completed by
`expectation is to have all sites selected by 15 December or 01 and 2 February 2007 for 302.
`B|lB has requested
`to provide the target/prospective dates of submission and SN.
`
`o
`
`o
`
`WI
`
`o Em suggests
`
`will be submitted before 301 in the UK. Clinical to discuss such rational
`
`
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`Page 4 of 7
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`Page 5 of 7
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`Page 5 of 7
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`ACTION ITEMS
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`§5£f_-‘H
`will forward
`
`email/information from
`
`_
`_
`il potential lead site
`to provide update on potential sites in
`o uth Africia
`to discuss sites with -
`suggested additional sites to
`
`Completed
`
`Complete
`
`BIlB confirmed with. to send out the
`feaslbilit uestionnaires.
`
`Page 6 of 7
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`
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`Page 7 of 7
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